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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________________________________________________
FORM 10-Q
_____________________________________________________
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2025
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-39321
_____________________________________________________
Avidity Biosciences, Inc.
(Exact name of registrant as specified in its charter)
_____________________________________________________
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| Delaware |
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46-1336960 |
(State or other jurisdiction of incorporation or organization) |
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(IRS Employer Identification No.) |
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3020 Callan Road
San Diego, California
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92121 |
| (Address of principal executive offices) |
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(Zip Code) |
(858) 401-7900
(Registrant’s telephone number, including area code)
_____________________________________________________
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
| Common Stock, $0.0001 par value |
RNA |
The Nasdaq Global Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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| Large accelerated filer |
x |
Accelerated filer |
o |
| Non-accelerated filer |
o |
Smaller reporting company |
o |
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Emerging growth company |
o |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x
As of October 31, 2025, the registrant had 150,675,742 shares of common stock outstanding.
Avidity Biosciences, Inc.
FORM 10-Q
TABLE OF CONTENTS
PART I - FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (unaudited)
Avidity Biosciences, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except par value)
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September 30, 2025 |
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December 31, 2024 |
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(unaudited) |
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| Assets |
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| Current assets: |
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| Cash and cash equivalents |
$ |
350,158 |
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$ |
219,868 |
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| Marketable securities |
1,525,678 |
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1,281,629 |
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| Prepaid and other current assets |
90,181 |
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40,793 |
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| Total current assets |
1,966,017 |
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1,542,290 |
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| Property and equipment, net |
21,504 |
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12,670 |
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| Restricted cash |
2,798 |
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2,795 |
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| Right-of-use assets |
52,848 |
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5,619 |
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| Other assets |
91,042 |
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521 |
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| Total assets |
$ |
2,134,209 |
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$ |
1,563,895 |
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| Liabilities and Stockholders’ Equity |
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| Current liabilities: |
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| Accounts payable |
$ |
9,626 |
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$ |
8,461 |
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| Accrued expenses and other liabilities |
137,163 |
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64,726 |
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| Lease liabilities, current portion |
3,967 |
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3,844 |
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| Deferred revenue, current portion |
19,123 |
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20,987 |
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| Total current liabilities |
169,879 |
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98,018 |
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| Lease liabilities, net of current portion |
45,999 |
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2,957 |
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| Deferred revenue, net of current portion |
32,066 |
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37,961 |
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| Total liabilities |
247,944 |
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138,936 |
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| Commitments and contingencies (Note 7) |
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| Stockholders’ equity: |
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Common stock, $0.0001 par value; authorized shares – 400,000; issued and outstanding shares – 146,771 and 119,893 at September 30, 2025 and December 31, 2024, respectively |
15 |
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12 |
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| Additional paid-in capital |
3,225,078 |
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2,315,111 |
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| Accumulated other comprehensive income |
1,768 |
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2,902 |
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| Accumulated deficit |
(1,340,596) |
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(893,066) |
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| Total stockholders’ equity |
1,886,265 |
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1,424,959 |
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| Total liabilities and stockholders’ equity |
$ |
2,134,209 |
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$ |
1,563,895 |
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See accompanying notes.
Avidity Biosciences, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
| Collaboration revenue |
$ |
12,475 |
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$ |
2,336 |
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$ |
17,895 |
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$ |
7,924 |
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| Operating expenses: |
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| Research and development |
154,948 |
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77,197 |
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392,563 |
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207,968 |
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| General and administrative |
46,333 |
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23,273 |
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116,797 |
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57,902 |
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| Total operating expenses |
201,281 |
|
|
100,470 |
|
|
509,360 |
|
|
265,870 |
|
| Loss from operations |
(188,806) |
|
|
(98,134) |
|
|
(491,465) |
|
|
(257,946) |
|
| Other income (expense): |
|
|
|
|
|
|
|
| Interest income |
14,744 |
|
|
17,968 |
|
|
45,401 |
|
|
38,350 |
|
| Other expense |
(380) |
|
|
(232) |
|
|
(1,466) |
|
|
(449) |
|
| Total other income |
14,364 |
|
|
17,736 |
|
|
43,935 |
|
|
37,901 |
|
| Net loss |
$ |
(174,442) |
|
|
$ |
(80,398) |
|
|
$ |
(447,530) |
|
|
$ |
(220,045) |
|
| Net loss per share, basic and diluted |
$ |
(1.27) |
|
|
$ |
(0.65) |
|
|
$ |
(3.38) |
|
|
$ |
(2.08) |
|
| Weighted-average shares outstanding, basic and diluted |
137,895 |
|
123,375 |
|
132,281 |
|
105,902 |
| Other comprehensive income (loss): |
|
|
|
|
|
|
|
| Net unrealized (losses) gains on marketable securities |
(4) |
|
|
7,555 |
|
|
(1,258) |
|
|
6,977 |
|
| Foreign currency translation adjustment |
(5) |
|
|
— |
|
|
124 |
|
|
— |
|
| Comprehensive loss |
$ |
(174,451) |
|
|
$ |
(72,843) |
|
|
$ |
(448,664) |
|
|
$ |
(213,068) |
|
See accompanying notes.
Avidity Biosciences, Inc.
Condensed Consolidated Statements of Stockholders' Equity
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional Paid-in Capital |
|
Accumulated Other Comprehensive Income |
|
Accumulated Deficit |
|
Total Stockholders’ Equity |
|
Shares |
|
Amount |
|
|
|
|
| Balance at December 31, 2024 |
119,893 |
|
$ |
12 |
|
|
$ |
2,315,111 |
|
|
$ |
2,902 |
|
|
$ |
(893,066) |
|
|
$ |
1,424,959 |
|
| Issuance of common stock upon exercise of stock options |
114 |
|
— |
|
|
1,937 |
|
|
— |
|
|
— |
|
|
1,937 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Issuance of common stock in connection with vesting of restricted stock units and performance stock units |
505 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Stock-based compensation |
— |
|
— |
|
|
17,736 |
|
|
— |
|
|
— |
|
|
17,736 |
|
| Net loss |
— |
|
— |
|
|
— |
|
|
— |
|
|
(115,773) |
|
|
(115,773) |
|
| Other comprehensive loss |
— |
|
— |
|
|
— |
|
|
(136) |
|
|
— |
|
|
(136) |
|
| Balance at March 31, 2025 |
120,512 |
|
$ |
12 |
|
|
$ |
2,334,784 |
|
|
$ |
2,766 |
|
|
$ |
(1,008,839) |
|
|
$ |
1,328,723 |
|
| Issuance of common stock upon exercise of stock options |
130 |
|
— |
|
|
2,109 |
|
|
— |
|
|
— |
|
|
2,109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Issuance of common stock under Employee Stock Purchase Plan |
92 |
|
— |
|
|
2,477 |
|
|
— |
|
|
— |
|
|
2,477 |
|
| Issuance of common stock in connection with vesting of restricted stock units |
44 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Stock-based compensation |
— |
|
— |
|
|
17,659 |
|
|
— |
|
|
— |
|
|
17,659 |
|
| Net loss |
— |
|
— |
|
|
— |
|
|
— |
|
|
(157,315) |
|
|
(157,315) |
|
| Other comprehensive loss |
— |
|
— |
|
|
— |
|
|
(989) |
|
|
— |
|
|
(989) |
|
| Balance at June 30, 2025 |
120,778 |
|
$ |
12 |
|
|
$ |
2,357,029 |
|
|
$ |
1,777 |
|
|
$ |
(1,166,154) |
|
|
$ |
1,192,664 |
|
| Issuance of common stock upon exercise of stock options |
832 |
|
— |
|
12,133 |
|
— |
|
— |
|
12,133 |
| Issuance of common stock upon exercise of pre-funded warrants |
2,208 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Issuance of common stock in public offerings, net of issuance costs of $43,337 |
22,897 |
|
3 |
|
|
836,892 |
|
|
— |
|
|
— |
|
|
836,895 |
|
| Issuance of common stock in connection with vesting of restricted stock units |
56 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Stock-based compensation |
— |
|
— |
|
|
19,024 |
|
|
— |
|
|
— |
|
|
19,024 |
|
| Net loss |
— |
|
— |
|
|
— |
|
|
— |
|
|
(174,442) |
|
|
(174,442) |
|
| Other comprehensive loss |
— |
|
— |
|
|
— |
|
|
(9) |
|
|
— |
|
|
(9) |
|
Balance at September 30, 2025 |
146,771 |
|
$ |
15 |
|
|
$ |
3,225,078 |
|
|
$ |
1,768 |
|
|
$ |
(1,340,596) |
|
|
$ |
1,886,265 |
|
See accompanying notes.
Avidity Biosciences, Inc.
Condensed Consolidated Statements of Stockholders' Equity
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional Paid-in Capital |
|
Accumulated Other Comprehensive Income |
|
Accumulated Deficit |
|
Total Stockholders’ Equity |
|
Shares |
|
Amount |
|
|
|
|
| Balance at December 31, 2023 |
79,275 |
|
$ |
8 |
|
|
$ |
1,071,395 |
|
|
$ |
125 |
|
|
$ |
(570,764) |
|
|
$ |
500,764 |
|
| Issuance of common stock upon exercise of stock options |
541 |
|
— |
|
|
3,896 |
|
|
— |
|
|
— |
|
|
3,896 |
|
Issuance of common stock in public offering, net of issuance costs of $143 |
418 |
|
— |
|
|
5,594 |
|
|
— |
|
|
— |
|
|
5,594 |
|
Issuance of common stock in a private placement, net of issuance costs of $12,821 |
15,225 |
|
2 |
|
|
238,386 |
|
|
— |
|
|
— |
|
|
238,388 |
|
Issuance of pre-funded warrants in a private placement, net of issuance costs of $7,605 |
— |
|
— |
|
|
141,395 |
|
|
— |
|
|
— |
|
|
141,395 |
|
| Issuance of common stock in connection with vesting of restricted stock units |
135 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Stock-based compensation |
— |
|
— |
|
|
10,306 |
|
|
— |
|
|
— |
|
|
10,306 |
|
| Net loss |
— |
|
— |
|
|
— |
|
|
— |
|
|
(68,855) |
|
|
(68,855) |
|
| Other comprehensive loss |
— |
|
— |
|
|
— |
|
|
(589) |
|
|
— |
|
|
(589) |
|
| Balance at March 31, 2024 |
95,594 |
|
$ |
10 |
|
|
$ |
1,470,972 |
|
|
$ |
(464) |
|
|
$ |
(639,619) |
|
|
$ |
830,899 |
|
| Issuance of common stock upon exercise of stock options |
1,201 |
|
— |
|
|
14,308 |
|
|
— |
|
|
— |
|
|
14,308 |
|
Issuance of common stock in public offering, net of issuance costs of $28,263 |
12,133 |
|
1 |
|
|
432,771 |
|
|
— |
|
|
— |
|
|
432,772 |
|
| Issuance of common stock under Employee Stock Purchase Plan |
138 |
|
— |
|
|
1,027 |
|
|
— |
|
|
— |
|
|
1,027 |
|
| Issuance of common stock in connection with vesting of restricted stock units |
200 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Stock-based compensation |
— |
|
— |
|
|
12,812 |
|
|
— |
|
|
— |
|
|
12,812 |
|
| Net loss |
— |
|
— |
|
|
— |
|
|
— |
|
|
(70,793) |
|
|
(70,793) |
|
| Other comprehensive income |
— |
|
— |
|
|
— |
|
|
11 |
|
|
— |
|
|
11 |
|
| Balance at June 30, 2024 |
109,266 |
|
$ |
11 |
|
|
$ |
1,931,890 |
|
|
$ |
(453) |
|
|
$ |
(710,412) |
|
|
$ |
1,221,036 |
|
| Issuance of common stock upon exercise of stock options |
1,007 |
|
— |
|
|
17,363 |
|
|
— |
|
|
— |
|
|
17,363 |
|
Issuance of common stock in public offering, net of issuance costs of $21,406 |
8,418 |
|
1 |
|
|
323,731 |
|
|
— |
|
|
— |
|
|
323,732 |
|
| Issuance of common stock in connection with vesting of restricted stock units |
209 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Stock-based compensation |
— |
|
— |
|
|
14,092 |
|
|
— |
|
|
— |
|
|
14,092 |
|
| Net loss |
— |
|
— |
|
|
— |
|
|
— |
|
|
(80,398) |
|
|
(80,398) |
|
| Other comprehensive income |
— |
|
— |
|
|
— |
|
|
7,555 |
|
|
— |
|
|
7,555 |
|
| Balance at September 30, 2024 |
118,900 |
|
$ |
12 |
|
|
$ |
2,287,076 |
|
|
$ |
7,102 |
|
|
$ |
(790,810) |
|
|
$ |
1,503,380 |
|
See accompanying notes.
Avidity Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
2025 |
|
2024 |
| Cash flows from operating activities |
|
|
|
| Net loss |
$ |
(447,530) |
|
|
$ |
(220,045) |
|
| Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
| Depreciation |
2,655 |
|
|
2,038 |
|
| Stock-based compensation expense |
54,419 |
|
|
37,210 |
|
| Amortization of premiums and discounts on marketable securities, net |
(11,037) |
|
|
(14,281) |
|
| Gain on disposal of property and equipment |
83 |
|
|
— |
|
|
|
|
|
| Non-cash operating lease costs |
2,672 |
|
|
2,473 |
|
| Changes in operating assets and liabilities: |
|
|
|
| Prepaid and other assets |
(140,283) |
|
|
(16,928) |
|
| Accounts payable |
1,112 |
|
|
(1,147) |
|
| Accrued expenses and other liabilities |
67,031 |
|
|
19,775 |
|
| Operating right-of-use assets and lease liabilities, net |
(2,031) |
|
|
(2,752) |
|
| Deferred revenue |
(7,759) |
|
|
(7,342) |
|
| Net cash used in operating activities |
(480,668) |
|
|
(200,999) |
|
| Cash flows from investing activities |
|
|
|
| Proceeds from maturities of marketable securities |
862,604 |
|
|
349,655 |
|
| Purchases of marketable securities |
(1,096,874) |
|
|
(1,136,534) |
|
| Purchases of property and equipment |
(7,808) |
|
|
(3,150) |
|
| Tenant improvements capitalized to right-of-use assets |
(3,175) |
|
|
— |
|
| Net cash used in investing activities |
(245,253) |
|
|
(790,029) |
|
| Cash flows from financing activities |
|
|
|
| Proceeds from issuance of common stock in public offerings, net of issuance costs |
837,420 |
|
|
762,661 |
|
| Proceeds from issuance of common stock under employee incentive equity plans |
18,656 |
|
|
36,189 |
|
| Proceeds from the issuance of common stock in a private placement, net of issuance costs |
— |
|
|
238,388 |
|
| Proceeds from issuance of pre-funded warrants in a private placement, net of issuance costs |
— |
|
|
141,395 |
|
| Net cash provided by financing activities |
856,076 |
|
|
1,178,633 |
|
| Effect of exchange rate on cash, cash equivalents and restricted cash |
138 |
|
|
— |
|
| Net increase in cash, cash equivalents and restricted cash |
130,293 |
|
|
187,605 |
|
| Cash, cash equivalents and restricted cash at beginning of period |
222,663 |
|
|
185,377 |
|
| Cash, cash equivalents and restricted cash at end of period |
$ |
352,956 |
|
|
$ |
372,982 |
|
|
|
|
|
| Supplemental schedule of noncash investing and financing activities: |
|
|
|
| Right-of-use assets obtained in exchange for operating lease liabilities |
$ |
45,195 |
|
|
$ |
— |
|
| Costs incurred, but not paid, in connection with public offering included in accounts payable and accrued expenses and other liabilities |
$ |
525 |
|
|
$ |
565 |
|
| Tenant improvements capitalized to right-of-use assets within accounts payable and accrued expenses |
$ |
1,145 |
|
|
$ |
— |
|
| Receivables from stock option exercises included in prepaid and other current assets |
$ |
— |
|
|
$ |
406 |
|
| Costs incurred, but not paid, in connection with purchases of property and equipment included in accounts payable and accrued expenses and other liabilities |
$ |
3,763 |
|
|
$ |
655 |
|
See accompanying notes.
Avidity Biosciences, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
1. Description of Business and Basis of Presentation
Description of Business
Avidity Biosciences, Inc. (the Company or Avidity) is a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs). The Company’s proprietary AOC platform is designed to combine the specificity of monoclonal antibodies with the precision of RNA therapeutics to target the root cause of diseases previously untreatable with such therapeutics.
Agreement and Plan of Merger & Separation and Distribution Agreement
On October 25, 2025,the Company entered into an Agreement and Plan of Merger (the Merger Agreement) with Novartis AG, a company limited by shares (Aktiengesellschaft) incorporated under the laws of Switzerland (Novartis or Parent), and Ajax Acquisition Sub, Inc., a Delaware corporation and an indirect wholly owned subsidiary of Parent (Merger Sub), pursuant to which, on the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge with and into the Company (the Merger), with the Company surviving the Merger as an indirect wholly owned subsidiary of Parent. In connection with the Merger, the Company, Bryce Therapeutics, Inc., a newly formed Delaware corporation and wholly owned subsidiary of the Company (SpinCo), and Parent (with respect to certain sections specified therein) also entered into a Separation and Distribution Agreement, dated October 25, 2025 (the Separation and Distribution Agreement), to effect a pre-closing reorganization of certain assets related the Company’s early stage precision cardiology programs and certain collaboration agreements. Refer to footnote 10, Subsequent Events, for more information.
Liquidity
Since inception, the Company has relied on various means of raising capital, including public offerings, at-the-market (ATM) sales agreements, the sale and issuance of convertible preferred stock, funding under collaboration agreements, and private placements of common stock. The Company has devoted substantially all of its resources to organizing and staffing the Company, business planning, raising capital, developing its proprietary AOC platform, identifying potential product candidates, establishing its intellectual property portfolio, conducting research and preclinical studies, advancing its clinical programs, and providing other general and administrative support for these operations. In addition, the Company has a limited operating history, has incurred operating losses since inception and expects that it will continue to incur net losses into the foreseeable future as it continues the development of its product candidates and development programs. As of September 30, 2025, the Company had an accumulated deficit of $1.3 billion, cash and cash equivalents of $350.2 million, and marketable securities of $1.5 billion.
The Company believes that existing cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations for at least 12 months from the date of the filing of this Form 10-Q. The Company plans to finance its future cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. If the Company is not able to secure adequate additional funding, it may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or delay or reduce the scope of its planned development programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and the rules and regulations of the Securities and Exchange Commission (SEC) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited condensed consolidated financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair presentation of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods.
These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2024 included in the Company’s annual report on Form 10-K filed with the SEC on February 27, 2025.
In December 2023, the Company formed Avidity Biosciences Ireland Limited, a wholly-owned subsidiary (the Subsidiary). The accompanying unaudited condensed consolidated financial statements reflect the operations of Avidity Biosciences, Inc. and the Subsidiary. Intercompany balances and transactions have been eliminated in consolidation.
Certain amounts reported in the Company's prior fiscal periods consolidated financial statements have been reclassified to conform to the current period presentation, including the reclassification of accounts payable from “Accounts payable and accrued liabilities” into “Accounts payable” and the reclassification of accrued compensation from “Accrued compensation” into “Accrued expenses and other liabilities" on the condensed consolidated balance sheets. There are no changes to the Company’s financial position or results of operations as a result of this reclassification.
2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of condensed consolidated financial statements in accordance with GAAP requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the condensed consolidated financial statements and accompanying notes. Although estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.
Summary of Significant Accounting Policies
The Company’s significant accounting policies are discussed in “Note 2 – Summary of Significant Accounting Policies” of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the SEC on February 27, 2025. There have been no significant changes to these policies during the nine months ended September 30, 2025.
Foreign Currency Translation
The foreign subsidiary uses its local currency as the functional currency. The financial statements of the foreign subsidiary are translated into U.S. dollars using the exchange rate in effect at the balance sheet date for assets and liabilities, stockholders’ equity is translated at the historical rates, and revenues and expenses are translated at the average exchange rates for the period. Translation adjustments are recorded as a component of accumulated other comprehensive income within stockholders’ equity.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, adjusted for the weighted-average number of common shares outstanding that are subject to repurchase or forfeiture. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the common stock equivalent securities would be anti-dilutive. The pre-funded common stock warrants are included in the calculation of basic and diluted net loss per share as the exercise price of $0.001 per share is not substantive and the shares are issuable for little or no consideration.
Common stock equivalent securities not included in the calculation of diluted net loss per share, because to do so would be anti-dilutive, are as follows (in common stock equivalent shares; in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
2025 |
|
2024 |
| Common stock options issued and outstanding |
13,705 |
|
12,190 |
| Restricted stock units |
3,131 |
|
1,608 |
| Performance stock units |
810 |
|
375 |
| ESPP shares pending issuance |
59 |
|
25 |
| Total |
17,705 |
|
14,198 |
Recently Issued Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (ASU) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances income tax disclosures, primarily through standardization and disaggregation of the income tax rate reconciliation and disaggregation of income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. ASU 2023-09 can be applied either prospectively or retrospectively and early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its condensed consolidated financial statements and accompanying notes.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), which requires that public business entities disclose additional information about specific expense captions in the notes to financial statements at interim and annual reporting periods. The amendment in the update does not change or remove current expense disclosures, rather, it requires enhanced disaggregated disclosures of specific expense captions and affects where that information is presented within the notes to the financial statements. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. ASU 2024-03 can be applied either prospectively or retrospectively and early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its condensed consolidated financial statements and accompanying notes.
In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40), which eliminates the project stage model and introduces a probable-to-complete recognition threshold for the capitalization of software development costs. The amendment in the update requires an assessment of uncertainty associated with software development activities, additional disclosures for capitalized internal-use software costs and consideration of website development costs. ASU 2025-06 is effective for annual periods beginning after December 15, 2027. ASU 2025-06 can be applied prospectively, through a modified transition approach, or retrospectively and early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its condensed consolidated financial statements and accompanying notes.
3. Fair Value Measurements
The following tables summarize the Company’s cash equivalents and marketable securities measured at fair value (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using |
| As of September 30, 2025 |
Total |
|
Quoted Prices in Active Markets for Identical Assets (Level 1) |
|
Significant Other Observable Inputs (Level 2) |
|
Significant Unobservable Inputs (Level 3) |
| Cash equivalents: |
|
|
|
|
|
|
|
| U.S. Treasury securities |
$ |
51,836 |
|
|
$ |
51,836 |
|
|
$ |
— |
|
|
$ |
— |
|
| Marketable securities: |
|
|
|
|
|
|
|
| U.S. Treasury securities |
1,525,678 |
|
|
1,525,678 |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total |
$ |
1,577,514 |
|
|
$ |
1,577,514 |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using |
| As of December 31, 2024 |
Total |
|
Quoted Prices in Active Markets for Identical Assets (Level 1) |
|
Significant Other Observable Inputs (Level 2) |
|
Significant Unobservable Inputs (Level 3) |
| Cash equivalents: |
|
|
|
|
|
|
|
| U.S. Treasury securities |
$ |
7,439 |
|
|
$ |
7,439 |
|
|
$ |
— |
|
|
$ |
— |
|
| Marketable securities: |
|
|
|
|
|
|
|
| U.S. Treasury securities |
1,281,139 |
|
|
1,281,139 |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
| Negotiable certificates of deposit |
490 |
|
|
— |
|
|
490 |
|
|
— |
|
|
|
|
|
|
|
|
|
| Total |
$ |
1,289,068 |
|
|
$ |
1,288,578 |
|
|
$ |
490 |
|
|
$ |
— |
|
4. Marketable Securities
The Company’s marketable securities, which consist of highly liquid marketable debt securities, are classified as available-for-sale and are stated at fair value. The following tables summarize the Company’s marketable securities (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| As of September 30, 2025 |
Maturity (in years) |
|
Amortized Cost |
|
Unrealized Gains |
|
Unrealized Losses |
|
Estimated Fair Value |
| U.S. Treasury securities |
1 or less |
|
$ |
927,070 |
|
|
$ |
1,765 |
|
|
$ |
(72) |
|
|
$ |
928,763 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| U.S. Treasury securities |
1 - 2 |
|
596,965 |
|
|
331 |
|
|
(381) |
|
|
596,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total |
|
|
$ |
1,524,035 |
|
|
$ |
2,096 |
|
|
$ |
(453) |
|
|
$ |
1,525,678 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| As of December 31, 2024 |
Maturity (in years) |
|
Amortized Cost |
|
Unrealized Gains |
|
Unrealized Losses |
|
Estimated Fair Value |
| U.S. Treasury securities |
1 or less |
|
$ |
947,916 |
|
|
$ |
2,154 |
|
|
$ |
(80) |
|
|
$ |
949,990 |
|
|
|
|
|
|
|
|
|
|
|
| Negotiable certificates of deposit |
1 or less |
|
490 |
|
|
— |
|
|
— |
|
|
490 |
|
|
|
|
|
|
|
|
|
|
|
| U.S. Treasury securities |
1 - 2 |
|
330,321 |
|
|
1,218 |
|
|
(390) |
|
|
331,149 |
|
|
|
|
|
|
|
|
|
|
|
| Total |
|
|
$ |
1,278,727 |
|
|
$ |
3,372 |
|
|
$ |
(470) |
|
|
$ |
1,281,629 |
|
The unrealized losses on the Company’s marketable securities were caused by interest rate increases and resulted in the decrease in market value of these securities. There were no allowances for credit losses at September 30, 2025 and December 31, 2024 because (i) the decline in fair value is attributable to changes in interest rates and not credit quality, (ii) the Company does not intend to sell the investments before maturity, and (iii) it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases.
The following table summarizes marketable securities in a continuous unrealized loss position for which an allowance for credit losses was not recorded (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months |
|
12 Months or Greater |
|
Total |
| As of September 30, 2025 |
Fair Value |
|
Unrealized Losses |
|
Fair Value |
|
Unrealized Losses |
|
Fair Value |
|
Unrealized Losses |
| U.S. Treasury securities |
$ |
745,377 |
|
|
$ |
(439) |
|
|
$ |
10,052 |
|
|
$ |
(14) |
|
|
$ |
755,429 |
|
|
$ |
(453) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total |
$ |
745,377 |
|
|
$ |
(439) |
|
|
$ |
10,052 |
|
|
$ |
(14) |
|
|
$ |
755,429 |
|
|
$ |
(453) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months |
|
12 Months or Greater |
|
Total |
| As of December 31, 2024 |
Fair Value |
|
Unrealized Losses |
|
Fair Value |
|
Unrealized Losses |
|
Fair Value |
|
Unrealized Losses |
| U.S. Treasury securities |
$ |
247,404 |
|
|
$ |
(470) |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
247,404 |
|
|
$ |
(470) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total |
$ |
247,404 |
|
|
$ |
(470) |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
247,404 |
|
|
$ |
(470) |
|
Accrued interest receivable on available-for-sale securities was $14.3 million and $8.7 million at September 30, 2025 and December 31, 2024, respectively. The Company has not written off any accrued interest receivable for the nine months ended September 30, 2025 and 2024.
5. Collaboration, License and Research Agreements
Research Collaboration and License Agreement with Bristol Myers Squibb Company
In November 2023, the Company entered into a Research Collaboration and License Agreement (the BMS Collaboration Agreement) with Bristol Myers Squibb Company (BMS) to expand on its research with MyoKardia Inc. In connection with the BMS Collaboration Agreement, the Company recognized revenue of $2.3 million and $2.3 million for the three months ended September 30, 2025 and 2024, respectively, and $7.8 million and $6.8 million for the nine months ended September 30, 2025 and 2024, respectively. There were no collaboration receivables related to the BMS Collaboration Agreement in any of the periods presented.
Research Collaboration and License Agreement with Eli Lilly and Company
In April 2019, the Company entered into a Research Collaboration and License Agreement (the Lilly Agreement) with Eli Lilly and Company (Lilly) for the discovery, development and commercialization of AOC products directed against certain targets in immunology and other select indications on a worldwide basis. The Company recognized revenue of $10.0 million for the three months ended September 30, 2025, and no revenue for the three months ended September 30, 2024. The Company recognized revenue of $10.0 million and $1.1 million for the nine months ended September 30, 2025 and 2024, respectively. In August 2025, Lilly paid the Company $10.0 million as the result of the achievement of a clinical development milestone under the Lilly Agreement for a collaboration target. There were no collaboration receivables related to the Lilly Agreement as of September 30, 2025 and December 31, 2024. There was no deferred revenue related to the Lilly Agreement at September 30, 2025.
The amounts received that have not yet been recognized as revenue are deferred on the Company’s condensed consolidated balance sheet and will be recognized over the remaining research and development period until the performance obligation is satisfied. A reconciliation of the closing balance of deferred revenue related to all collaboration agreements for the nine months ended September 30, 2025 and 2024 is as follows (in thousands):
|
|
|
|
|
|
| Balance at December 31, 2024 |
$ |
58,948 |
|
| Revenue recognized that was included in the balance at the beginning of the period |
(1,573) |
|
| Balance at March 31, 2025 |
57,375 |
|
| Revenue recognized that was included in the balance at the beginning of the period |
(3,847) |
|
| Balance at June 30, 2025 |
53,528 |
|
| Revenue recognized that was included in the balance at the beginning of the period |
(2,339) |
|
| Balance at September 30, 2025 |
$ |
51,189 |
|
|
|
|
|
|
|
| Balance at December 31, 2023 |
$ |
69,263 |
|
| Revenue recognized that was included in the balance at the beginning of the period |
(2,961) |
|
| Balance at March 31, 2024 |
66,302 |
|
| Revenue recognized that was included in the balance at the beginning of the period |
(2,045) |
|
| Balance at June 30, 2024 |
64,257 |
|
| Revenue recognized that was included in the balance at the beginning of the period |
(2,336) |
|
| Balance at September 30, 2024 |
$ |
61,921 |
|
6. Composition of Certain Consolidated Financial Statement Items
Prepaid and other current assets (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2025 |
|
December 31, 2024 |
|
|
|
|
| Prepaid assets |
$ |
15,152 |
|
|
$ |
12,571 |
|
Interest receivable |
15,037 |
|
|
9,447 |
Other current assets |
59,992 |
|
|
18,775 |
| Total prepaid and other current assets |
$ |
90,181 |
|
|
$ |
40,793 |
|
Other current assets included reimbursable tenant improvements of $39.5 million and $7.1 million as of September 30, 2025 and December 31, 2024, respectively.
Property and equipment, net (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2025 |
|
December 31, 2024 |
| Laboratory equipment |
$ |
18,056 |
|
|
$ |
14,180 |
|
| Computers and software |
3,310 |
|
|
261 |
|
| Office furniture and equipment |
6,918 |
|
|
1,979 |
|
| Leasehold improvements |
3,358 |
|
|
288 |
|
| Construction in process |
309 |
|
|
3,959 |
|
| Property and equipment, gross |
31,951 |
|
|
20,667 |
|
| Less accumulated depreciation |
(10,447) |
|
|
(7,997) |
|
| Total property and equipment, net |
$ |
21,504 |
|
|
$ |
12,670 |
|
Depreciation expense related to property and equipment was $1.1 million and $0.7 million for the three months ended September 30, 2025 and 2024, respectively, and $2.7 million and $2.0 million for the nine months ended September 30, 2025 and 2024, respectively.
Other assets
During the second quarter of 2025, the Company entered into reservation agreements with a Contract Manufacturing Organization (CMO) to purchase an agreed upon number of production batches during the years 2026-2028. Nonrefundable reservation fees of approximately $82.1 million were recorded in non-current assets on the consolidated balance sheet as of September 30, 2025. The nonrefundable reservation fees will be credited against purchases, beginning in 2026, up to the total amount of the reservation fees.
Accrued expenses and other liabilities (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2025 |
|
December 31, 2024 |
| Accrued manufacturing and technical development |
$ |
72,868 |
|
|
$ |
35,680 |
|
| Accrued clinical development |
13,994 |
|
|
8,157 |
| Accrued other research and development |
1,609 |
|
|
3,852 |
|
| Accrued compensation |
37,085 |
|
|
3,663 |
|
| Accrued other |
11,607 |
|
|
13,374 |
| Total accrued expenses and other liabilities |
$ |
137,163 |
|
|
$ |
64,726 |
|
7. Commitments and Contingencies
Operating Lease
In April 2024, the Company entered into a sublease agreement with Turning Point Therapeutics, Inc. (the Sublease) to rent 105,000 square feet for office and laboratory space for the Company’s corporate headquarters. In addition, in March 2025, the Company exercised the option to rent an additional 80,000 square feet in an adjacent available building under the amended sublease agreement with Turning Point Therapeutics, Inc. (the Amended Sublease).
Pursuant to the terms of the Sublease, the sublandlord provided the Company with a tenant improvement allowance of $33.6 million. An additional tenant improvement allowance of $5.0 million was utilized and will be repaid in equal installments through monthly rent payments, subject to increases of 3% per annum. The Sublease commenced on August 14, 2025, with a term of 9 years, 9 months. There are no options to extend or terminate the Sublease. Upon commencement, the Company recognized a right-of-use asset of $49.9 million and a lease liability of $45.2 million.
The undiscounted future lease payments for the Company's operating leases are as follows (in thousands):
|
|
|
|
|
|
|
|
|
Year Ending December 31, |
|
|
2025 (remaining) |
|
$ |
2,402 |
|
| 2026 |
|
8,323 |
|
| 2027 |
|
7,259 |
|
| 2028 |
|
9,230 |
|
| 2029 |
|
9,506 |
|
Thereafter |
|
47,364 |
|
Total lease payments |
|
84,084 |
|
| Less imputed interest |
|
(34,118) |
|
|
|
|
Total operating lease liabilities |
|
49,966 |
|
| Less lease liabilities, current portion |
|
(3,967) |
|
| Lease liabilities, net of current portion |
|
$ |
45,999 |
|
As of September 30, 2025 and December 31, 2024, the weighted-average discount rate was 11.3% and 5.9%, respectively, and the weighted-average remaining lease term was 9.1 years and 1.9 years, respectively. Total lease costs for the three months ended September 30, 2025 and 2024 were $2.3 million and $0.8 million, respectively. Total lease costs for the nine months ended September 30, 2025 and 2024 were $3.9 million and $2.5 million, respectively. Short-term and variable lease costs were immaterial for all periods presented.
The term of the Amended Sublease is approximately 9 years, 1 month with payments expected to begin in April 2026. Pursuant to the terms of the Amended Sublease, the sublandlord will provide the Company with a tenant improvement allowance of up to $19.9 million. An additional tenant improvement allowance of up to $5.1 million is also available under the master lease, subject to certain spending conditions by the Company. Total aggregate future lease commitments under the Amended Sublease are approximately $53.7 million and inclusive of 3% annual rent increases and various agreed upon rent abatement amounts. The Amended Sublease will be measured and recognized upon commencement of the Amended Sublease. As of September 30, 2025, the Amended Sublease had not commenced because construction of improvements to the facility for its intended use was not substantially complete.
In connection with the Sublease and Amended Sublease, the Company is required to maintain a letter of credit for the benefit of the sublandlord in the amount of $2.5 million, which was delivered in April 2024 and is included in restricted cash in the Company’s condensed consolidated balance sheets.
Unconditional Purchase Obligations
On August 1, 2025, the Company entered into a commercial manufacturing agreement (the Manufacturing Agreement) with a CMO for the manufacturing of the Company’s drug substances, conjugated drug substances, and drug products. The non-cancellable Manufacturing Agreement requires the Company to meet minimum purchase obligations on an annual basis, beginning in 2026 and ending in 2028. The Manufacturing Agreement includes a variable component whereby service prices may be adjusted once per calendar year based on movements in an applicable price index, in addition to other adjustment and payments for certain raw material and other costs.
As of September 30, 2025, the aggregate amount of future unconditional minimum purchase obligations under the Manufacturing Agreement was $621.6 million, subject to foreign currency changes, annual price increases, other adjustments and payments for certain costs and net of the nonrefundable reservation fees outlined in Note 6, "Composition of Certain Consolidated Financial Statement Items".
The future minimum annual purchase obligations under the Manufacturing Agreement as of September 30, 2025, are as follows (in thousands):
|
|
|
|
|
|
|
|
|
Year Ending December 31, |
|
|
| 2026 |
|
$ |
58,484 |
|
| 2027 |
|
225,161 |
|
| 2028 |
|
337,960 |
|
Total purchases, net |
|
$ |
621,605 |
|
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. There are no such matters currently outstanding for which any liabilities have been accrued.
8. Stockholders’ Equity
Common Stock
On July 23, 2025, pre-funded warrants, originally issued by the Company on March 4, 2024 (the 2024 Pre-Funded Warrants), to purchase 2,208,114 shares of the Company’s common stock were exercised in a cashless transaction, which resulted in an aggregate of 2,208,048 shares of the Company’s common stock being issued. As of September 30, 2025, 2024 Pre-Funded Warrants to purchase a total of 6,822,737 shares of the Company’s common stock remained available for exercise. See Note 10 for a discussion of additional exercises of 2024 Pre-funded Warrants subsequent to September 30, 2025.
On August 9, 2024, the Company entered into a sales agreement (the 2024 Sales Agreement) with TD Securities (USA) LLC (the 2024 Sales Agent). Under the 2024 Sales Agreement, the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $400.0 million through the 2024 Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the 2024 Sales Agent. The Company is not obligated to sell, and the 2024 Sales Agent is not obligated to buy or sell, any shares of common stock under the 2024 Sales Agreement. During the three and nine months ended September 30, 2025, the Company sold 5,646,583 shares of its common stock pursuant to the 2024 Sales Agreement and received net proceeds of $185.5 million, after deducting offering-related transaction costs and commissions of $4.8 million, at an average price of $33.69 per share.
On September 15, 2025, the Company completed an underwritten public offering of 17,250,000 shares of its common stock at a public offering price of $40.00 per share. Net proceeds from the offering were approximately $651.4 million, after deducting underwriting discounts and offering expenses of $38.6 million. The shares sold in the offering were registered pursuant to the Company's shelf registration statement on Form S-3, which became automatically effective upon filing on May 9, 2024.
Stock-Based Compensation Expense
The allocation of stock-based compensation expense across the Company's equity incentive plans described in the Company's annual report on Form 10-K was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2025 |
|
2024 |
|
2025 |
|
2024 |
| Research and development expense |
$ |
9,661 |
|
|
$ |
6,680 |
|
|
$ |
28,271 |
|
|
$ |
18,945 |
|
| General and administrative expense |
9,363 |
|
|
7,412 |
|
|
26,148 |
|
|
18,265 |
|
| Total stock-based compensation expense |
$ |
19,024 |
|
|
$ |
14,092 |
|
|
$ |
54,419 |
|
|
$ |
37,210 |
|
As of September 30, 2025, the unrecognized compensation cost related to outstanding time-based options and restricted stock units was $113.2 million and $74.5 million, respectively, which is expected to be recognized over a weighted-average period of 2.6 years and 2.7 years, respectively. As of September 30, 2025 the unrecognized compensation cost related to performance stock units was $34.2 million, none of which were deemed probable of vesting.
Employee Stock Purchase Plan
The Company issued 92,348 and 137,913 shares of common stock under the Employee Stock Purchase Plan (ESPP) during the nine months ended September 30, 2025 and 2024, respectively. The Company had an outstanding liability of $1.5 million at September 30, 2025, which is included in accrued expenses and other liabilities on the condensed consolidated balance sheet, for employee contributions to the ESPP for shares pending issuance at the end of the current offering period. As of September 30, 2025, 1,299,919 shares of common stock were available for issuance under the ESPP. As of September 30, 2025, the unrecognized compensation cost related to stock purchase rights under the ESPP was $0.4 million, which is expected to be recognized over a weighted-average period of 0.2 years.
9. Segment Information
The Company's operations constitute a single operating and reportable segment. The material accounting policies of the segments are described in the notes to the consolidated financial statements included in the Company's Annual Report filed on Form 10-K for the fiscal year ended December 31, 2024. The Company's Chief Operating Decision Maker (CODM) is the Chief Executive Officer, who utilizes consolidated net loss in assessing performance and allocating resources by comparing net loss against prior periods and the Company’s forecast. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.
The following table presents financial information, including significant segment expenses, which are regularly provided to the CODM and included within consolidated net loss (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2025 |
|
2024 |
|
2025 |
|
2024 |
Collaboration revenue |
$ |
12,475 |
|
|
$ |
2,336 |
|
|
$ |
17,895 |
|
|
$ |
7,924 |
|
| Operating expenses, excluding stock-based compensation and depreciation |
|
|
|
|
|
|
|
Research and development |
(144,616) |
|
|
(69,927) |
|
|
(362,263) |
|
|
(187,345) |
|
General and administrative |
(36,585) |
|
|
(15,741) |
|
|
(90,023) |
|
|
(39,279) |
|
| Total operating expenses, excluding stock-based compensation and depreciation |
(181,201) |
|
|
(85,668) |
|
|
(452,286) |
|
|
(226,624) |
|
| Stock-based compensation |
(19,024) |
|
|
(14,092) |
|
|
(54,419) |
|
|
(37,210) |
|
| Depreciation |
(1,056) |
|
|
(710) |
|
|
(2,655) |
|
|
(2,036) |
|
| Total operating expenses |
(201,281) |
|
|
(100,470) |
|
|
(509,360) |
|
|
(265,870) |
|
| Other income |
14,364 |
|
|
17,736 |
|
|
43,935 |
|
|
37,901 |
|
| Net loss |
$ |
(174,442) |
|
|
$ |
(80,398) |
|
|
$ |
(447,530) |
|
|
$ |
(220,045) |
|
The following table presents the measure of segment assets regularly provided to the CODM (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2025 |
|
December 31, 2024 |
Cash, cash equivalents and marketable securities |
$ |
1,875,836 |
|
|
$ |
1,501,497 |
|
10. Subsequent Events
Pending Acquisition by Novartis AG and Spin-Off
On October 25, 2025, the Company entered into the Merger Agreement with Novartis and Merger Sub, pursuant to which, on the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge with and into the Company, with the Company surviving the Merger as an indirect wholly owned subsidiary of Parent.
At the effective time of the Merger (the Effective Time), each share of the Company’s common stock issued and outstanding immediately prior to the Effective Time (including any shares issued as a result of the exercise of any Company Warrants (as defined below) prior to the Effective Time, but excluding each share of the Company's common stock (i) held in the treasury of the Company, (ii) owned by Parent or Merger Sub or any direct or indirect wholly owned Subsidiary of Parent or the Company immediately prior to the Effective Time or (iii) held by any stockholder who is entitled to demand and has properly and validly demanded their statutory right of appraisal of such shares of the Company’s common stock in accordance with, and in compliance in all respects with, Section 262 of the General Corporation Law of the State of Delaware) will automatically be cancelled and converted into the right to receive an amount in cash equal to $72.00, without interest and subject to any applicable tax withholdings (the Merger Consideration).
At the Effective Time, each option to purchase shares of the Company’s common stock granted under any equity plans, agreements or arrangements of the Company (each, a Company Stock Option) that is then outstanding and unexercised, whether or not vested and which has a per share exercise price that is less than the Merger Consideration, will be cancelled and converted into the right to receive a cash payment (without interest and subject to any withholding taxes required by applicable law) equal to the product of the excess of the Merger Consideration over the per share exercise price of such Company Stock Option, multiplied by the total number of shares of the Company’s common stock subject to such Company Stock Option immediately prior to the Effective Time.
At the Effective Time and subject to certain exceptions, each then-outstanding award of restricted stock units denominated in the Company’s common stock, whether subject to time-based or performance-based vesting, that are granted under any equity plans, agreements or arrangements of the Company (each, a Company RSU), whether or not vested, will be cancelled and the holder thereof will be entitled to receive a cash payment (without interest and subject to any withholding taxes required by applicable law) equal to the product of the Merger Consideration and the number of shares of the Company’s common stock subject to such Company RSU.
In connection with the Merger, the Company, SpinCo, and Parent (with respect to certain sections specified therein) entered into the Separation and Distribution Agreement, pursuant to which, on the terms and subject to the conditions set forth in the Separation and Distribution Agreement, prior to the Effective Time: (i) the Company will effect a pre-closing reorganization (the Pre-Closing Reorganization), which will result in SpinCo owning, assuming or retaining all assets and liabilities of the Company and its subsidiaries related to their early stage precision cardiology programs and certain collaboration agreements, and the Company owning, assuming or retaining all other assets and liabilities; and (ii) thereafter, the Company will either (a) distribute to its stockholders (and holders of Company Stock Options, Company RSUs or Warrants) as of the record date for the Spin-Off Distribution, as may be determined by the Company Board or a committee of the Company Board (the Distribution Record Date), on a pro rata basis, all of the issued and outstanding shares of SpinCo's common stock, at a ratio of 1 share of SpinCo's common stock per 10 shares of the Company’s common stock outstanding or underlying such Company Stock Option, Company RSU or Warrant, as further described below, subject to certain exceptions, with SpinCo continuing its existence as a separate and independent company (the Spin-Off Distribution) or (b) subject to Parent's written consent, consummate a sale of SpinCo to a third party in accordance with the terms of the Merger Agreement (a Permitted Third Party Sale), subject to the terms and conditions specified in the Merger Agreement and the Separation and Distribution Agreement. Following completion of the transactions contemplated by the Separation and Distribution Agreement (the Spin-Off), the Company will have no continuing ownership interest in SpinCo. The Spin-Off also includes certain assets of the Company that trigger a right of first negotiation (the ROFN) with an existing collaboration partner of the Company that was notified concurrently with the Company’s announcement of its entry into the Merger Agreement.
Consummation of the Merger is subject to closing conditions related to the Spin-Off and other customary Merger closing conditions. The parties expect the Merger, the Spin-Off and the other transactions contemplated by the Merger Agreement to close in the first half of 2026.
The Merger Agreement contains certain termination rights for the Company and Parent. Subject to the terms and conditions of the Merger Agreement, the Company or Parent may terminate the Merger Agreement if the Merger is not consummated by 5:00 P.M. New York City time on July 27, 2026 (as it may be extended, the Outside Date), which period automatically extends for one additional 3-month period ending no later than 5:00 P.M. New York City time on October 26, 2026, if at the end of the initial period, the only outstanding conditions to closing the Merger are (i) the expiration or termination of any waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act), and, potentially, the applicable antitrust laws of specified other jurisdictions (the Springing Jurisdictions) (if applicable) in the circumstances described in the Merger Agreement; (ii) the absence of certain legal restraints preventing or otherwise making illegal the consummation of the Merger (solely in respect of the HSR Act and, potentially, a Springing Jurisdiction in the circumstances described in the Merger Agreement); (iii) the absence of legal proceedings brought under the HSR Act and, potentially, a Springing Jurisdiction in the circumstances described in the Merger Agreement; (iv) the adoption of the Merger Agreement and the Separation and Distribution Agreement by the Company stockholders constituting the Requisite Company Vote; (v) that the registration statement filed in connection with the spin-off of SpinCo (Spin-Off) has become effective; or (vi) the consummation of the Spin-Off or, subject to Parent’s written consent, a Permitted Third Party Sale (as defined in the Merger Agreement). Upon termination of the Merger Agreement, under specified circumstances, the Company will be required to pay Parent a termination fee of $450 million. Such circumstances include where the Merger Agreement is terminated (i) in connection with the Company accepting and entering into an agreement for the consummation of a transaction which the Company’s board of directors (the Company Board) determines is a Superior Proposal (as defined in the Merger Agreement); (ii) due to the Company Board’s failure to include in the proxy statement, or its change of, or failure to reaffirm as required by the Merger Agreement, its recommendation of adopting the Merger Agreement and the Separation and Distribution Agreement to the Company’s stockholders; and (iii) in connection with the termination of the Merger Agreement by (a) either Parent or the Company if the Merger is not consummated prior to the Outside Date or (b) Parent as a result of the Company’s breach of any representation or warranty or its failure to perform any covenant, and following any such termination, the Company consummates or enters into a binding agreement to consummate an acquisition proposal within twelve months of such termination date. The Merger Agreement further provides that Parent will be required to pay the Company a reverse termination fee of $600 million in the event the Merger Agreement is terminated by either Parent or the Company (i) because the Merger is not consummated before the Outside Date and at that time certain conditions related to antitrust laws have not been satisfied or (ii) as the result of a legal restraint preventing or otherwise making illegal the consummation of the Merger under an antitrust law.
If the Spin-Off does not occur and instead the cash proceeds received by the Company, any of its affiliates or SpinCo in a sale pursuant to the ROFN or Permitted Third Party Sale less the total amount of certain related expenses incurred by or on behalf of the Company or SpinCo (Permitted Sale Proceeds) are distributed to Company stockholders prior to the Effective Time following either a sale of assets of the Company subject to the ROFN or a Permitted Third Party Sale, holders of Company Stock Options and Company RSUs as of the record date used by the Company for such distribution will receive a cash payment from the Permitted Sale Proceeds, subject to applicable tax withholding, equal to the product of the per share amount payable to holders of the Company's common stock in such distribution and the number of shares of the Company’s common stock underlying each such Company Stock Option or Company RSU.
At the Effective Time, each warrant to purchase shares of the Company's common stock, including the 2024 Pre-Funded Warrants (each, a Company Warrant) that is outstanding immediately prior to the Effective Time will become exercisable solely for the same Merger Consideration as the holder of such Company Warrant would have received if such Company Warrant was exercised immediately prior to the Effective Time. Additionally, the Company may distribute an amount in cash from the Permitted Sale Proceeds to the holders of Company Warrants pursuant to the terms of the Company Warrants.
Separation and Distribution Agreement
The Separation and Distribution Agreement sets forth the terms and conditions regarding the Spin-Off, including the transfer of certain assets by the Company to SpinCo and the assumption of certain liabilities by SpinCo from the Company.
SpinCo will be funded by a cash contribution immediately prior to the Distribution Effective Time (as defined in the Separation and Distribution Agreement) from the Company of $270 million, minus the sum of the amount of cash, cash equivalents and marketable securities contained in any bank and brokerage accounts owned by SpinCo as of the close of business on the day prior to the date of the Spin-Off (such net amount, the SpinCo Funding). If the aggregate amount of cash, cash equivalents and marketable securities contained in any bank and brokerage accounts owned by the RemainCo Group (as defined in the Separation and Distribution Agreement) as of the close of business on the day prior to the Distribution Effective Time is less than the SpinCo Funding, concurrently with the closing of the Merger, Parent will either (i) cause the Company to pay, or (ii) pay on behalf of the Company, the difference to SpinCo (except in the event of a Sale (as defined in the Separation and Distribution Agreement)).
In the Spin-Off, and pursuant to the Separation and Distribution Agreement, the Company will distribute to the Company’s stockholders as of the Distribution Record Date, all of the issued and outstanding shares of SpinCo's common stock as of the distribution time on a pro rata basis of 1 share of SpinCo common stock per 10 shares of the Company’s common stock. The Company will also deliver shares of SpinCo common stock to the holders of the Company Warrants in accordance with their terms. In addition, in the event of the Spin-Off, holders of Company Stock Options and Company RSUs as of the Distribution Record Date will receive 1 share of SpinCo common stock per 10 shares of the Company’s common stock underlying such Company Stock Options and Company RSUs, subject to certain exceptions.
The consummation of the Spin-Off is subject to, among other things: (i) satisfaction of the conditions to closing set forth in the Merger Agreement (with certain exceptions); (ii) the absence of any judgment or law prohibiting or making illegal the consummation of the Spin-Off, the Pre-Closing Reorganization or the Merger; (iii) the license agreement being in full force and effect; (iv) execution of a transition services agreement; and (v) completion of the Pre-Closing Reorganization.
Exercise of Pre-Funded Warrants
Subsequent to September 30, 2025, 2024 Pre-Funded Warrants to purchase an aggregate of 3,761,945 shares of the Company’s common stock were exercised in cashless transactions, which resulted in an aggregate of 3,761,868 shares of the Company’s common stock being issued.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes thereto included elsewhere in this quarterly report on Form 10-Q and with our audited financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations, both of which are contained in our annual report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission, or SEC, on February 27, 2025.
Cautionary Note Regarding Forward-Looking Statements
This quarterly report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategies and plans, the planned completion and timing of the transactions contemplated by the Merger Agreement or the Separation and Distribution Agreement (each as defined in Notes to Unaudited Condensed Consolidated Financial Statements – Note 10 – Subsequent Events of this quarterly report), research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and clinical trials for our product candidates, the timing and likelihood of regulatory filings and approvals for our product candidates, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, inflationary pressures, and the ongoing hostilities outside the United States on our business, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other comparable terminology. These forward-looking statements are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this quarterly report and are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A, “Risk Factors.” The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Overview
We are a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates, or AOCs. Our proprietary AOC platform is designed to combine the specificity of monoclonal antibodies, or mAbs, with the precision of RNA therapeutics to target the root cause of diseases previously untreatable with such therapeutics. Our pipeline currently has three programs in potentially registrational trials. Delpacibart zotadirsen, or del-zota (formerly AOC 1044), is designed for people living with Duchenne muscular dystrophy, or DMD, and is currently in development with the ongoing Phase 2 EXPLORE44 Open-Label Extension (EXPLORE44-OLE™) study. Del-zota is specifically designed for people with mutations amenable to exon 44 skipping, or DMD44, and is the first of multiple AOCs we are developing for DMD. Delpacibart etedesiran, or del-desiran (formerly AOC 1001), is designed to treat people with myotonic dystrophy type 1, or DM1, and is currently in development with the global Phase 3 HARBOR™ trial and ongoing HARBOR Open-Label Extension (HARBOR-OLE™) trial. Delpacibart braxlosiran, or del-brax (formerly AOC 1020), is the first investigational therapy designed to directly target DUX4 in people living with facioscapulohumeral muscular dystrophy, or FSHD, and is currently in development in the registrational fully enrolled ongoing FORTITUDE™ biomarker cohort in the Phase 1/2 FORTITUDE trial, the Phase 2 FORTITUDE Open-Label Extension (FORTITUDE-OLE™) trial and the Phase 3 FORTITUDE-3™ (formerly known as FORWARD™) trial. Del-desiran, del-brax and del-zota have all been granted Orphan Designation by the FDA and the European Medicines Agency, or EMA, and Fast Track Designation by the FDA. In addition, the FDA has granted del-desiran and del-zota Breakthrough Therapy designation and granted del-zota Rare Pediatric Disease designation. Del-desiran has also been granted Orphan Drug Designation by the Japan Ministry of Health, Labour and Welfare (MHLW).
Recent Developments - Merger Agreement with Novartis AG and Spin-Off
On October 25, 2025, we entered into an Agreement and Plan of Merger, or the Merger Agreement, with Novartis AG, a company limited by shares (Aktiengesellschaft) incorporated under the laws of Switzerland, which we refer to as Novartis or Parent, and Ajax Acquisition Sub, Inc., a Delaware corporation and an indirect wholly owned subsidiary of Parent, or Merger Sub, pursuant to which, on the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge with and into us, and we will survive the Merger as an indirect wholly owned subsidiary of Parent, which we refer to as the Merger.
In connection with the Merger, we, Bryce Therapeutics, Inc. (which will be renamed prior to the Effective Time (as defined below)), a newly formed Delaware corporation and wholly owned subsidiary of ours, or SpinCo, and Parent (with respect to certain sections specified therein) entered into a Separation and Distribution Agreement, dated October 25, 2025, or the Separation and Distribution Agreement, pursuant to which, on the terms and subject to the conditions set forth in the Separation and Distribution Agreement, prior to the effective time of the Merger, or the Effective Time: (i) we will effect a pre-closing reorganization, or the Pre-Closing Reorganization, which will result in SpinCo owning, assuming or retaining all assets and liabilities held by us and our subsidiaries related to our early stage precision cardiology programs and certain collaboration agreements, and us owning, assuming or retaining all other assets and liabilities; and (ii) thereafter, we will either (a) distribute to our stockholders as of the record date for the Spin-Off Distribution, as may be determined by the Company Board or a committee of the Company Board (the Distribution Record Date), on a pro rata basis, all of the issued and outstanding shares of SpinCo common stock, par value $0.001 per share, or SpinCo Common Stock, at a ratio of 1 share of SpinCo Common Stock per 10 shares of our common stock, with SpinCo continuing its existence as a separate and independent company, or the Spin-Off Distribution or (b) subject to Parent's written consent, consummate a sale of SpinCo to a third party in accordance with the terms of the Merger Agreement, or a Permitted Third Party Sale, subject to the terms and conditions specified in the Merger Agreement and the Separation and Distribution Agreement. Following completion of the transactions contemplated by the Separation and Distribution Agreement, or the Spin-Off, we will have no continuing ownership interest in SpinCo. The Spin-Off also includes certain assets of the Company that trigger a right of first negotiation, or the ROFN, with an existing collaboration partner of ours that was notified concurrently with our announcement of our entry into the Merger Agreement.
The parties expect the Merger, the Spin-Off and the other transactions contemplated by the Merger Agreement to close in the first half of 2026. In the event the Merger Agreement is terminated, under specified circumstances, we will be required to pay Parent a termination fee of $450 million. The Merger Agreement further provides that Parent will be required to pay us a reverse termination fee of $600 million in the event the Merger Agreement is terminated by either Parent or the Company under certain circumstances. Refer to Note 10, "Subsequent Events" to our condensed consolidated financial statements included elsewhere in this quarterly report on Form 10-Q for further details.
Delpacibart zotadirsen (del-zota) for the treatment of DMD44:
Del-zota is currently being studied for the treatment of people living with DMD44 and is the first of multiple AOCs we are developing for DMD. Del-zota is designed to deliver phosphorodiamidate morpholino oligomers, or PMOs, to skeletal muscle and heart tissue to specifically skip exon 44 of dystrophin mRNA to enable production of near full-length functional dystrophin. Del-zota is currently in Phase 2 development as part of the ongoing Phase 2 EXPLORE44-OLE™ study in people living with DMD44.
In October 2025, we completed a positive pre-BLA meeting with the FDA and aligned on a clear path forward for a planned BLA submission for potential accelerated approval of del-zota. This BLA submission is planned for 2026.
We plan to submit to the FDA amendments to the IND for del-zota to generate certain additional data which we will include in our BLA submission.
In October 2025, Kevin M. Flanigan, M.D., Nationwide Children’s Hospital, presented del-zota data at four or five months, as compared to placebo from the completed EXPLORE44® trial in participants living with DMD44, at the 30th Annual International Congress of the World Muscle Society. As part of our exploratory analysis, this early data showed trends toward functional improvement in the EXPLORE44 study, with trends across EXPLORE44 and EXPLORE44-OLE continuing after one year of treatment compared to the PRO-DMD-01 database analyzed by Analysis Group®, or DMD44 natural history.
In September 2025, we reported positive topline and functional del-zota data from a total of 17 participants (12 ambulatory and 5 non-ambulatory) in the EXPLORE44 trial®. Participants treated continuously with del-zota for approximately one year began treatment in EXPLORE44 and continued into EXPLORE44-OLE™. Data demonstrated reversal of disease progression and unprecedented improvement compared to baseline and DMD44 natural history (Nat Hx) across multiple functional measures. Treated participants demonstrated statistically significant increases of approximately 25 percent of normal in dystrophin production and restored total dystrophin up to 58 percent of normal. Creatine kinase (CK) levels rapidly reduced by greater than 80 percent compared to baseline and were sustained at near normal levels throughout the duration of evaluation with participants followed for up to 16 months. Additionally, 50 percent of participants had CK levels within the normal range at one year of treatment.
Given the study design, some participants received 5 mg/kg once every six weeks (Q6W) and some received 10 mg/kg once every eight weeks during EXPLORE44. All participants were transitioned to the 5 mg/kg (Q6W) dosing schedule during EXPLORE44-OLE. Not all participants could complete all assessments. Functional data from these pooled dosing cohorts for del-zota-treated participants, compared to DMD44 natural history, demonstrated:
•4-Stair Climb (4SC): Improved from baseline by 2.1 seconds. In contrast, the natural history group declined from baseline by 2.7 seconds (DMD44 Nat Hx N=22; del-zota N=10).
•10-Meter Walk/Run Test (10mWRT): Improved from baseline by 0.7 seconds. In contrast, the natural history group declined from baseline by 1.5 seconds (DMD44 Nat Hx N=22; del-zota N=10).
•Time to Rise from Floor (TTR): Improved from baseline by 3.2 seconds. In contrast, the natural history group declined from baseline by 1.6 seconds (DMD44 Nat Hx N=19; del-zota N=6).
•North Star Ambulatory Assessment (NSAA): Remained stable. In contrast, the natural history group declined from baseline by 2.4 points (DMD44 Nat Hx N=20; del-zota N=10).
•Performance of Upper Limb (PUL2): Improved from baseline by 1.5 points. In contrast, the natural history group declined from baseline by 0.7 points. Similar PUL improvements were seen in both ambulatory and non-ambulatory participants (DMD44 Nat Hx N=27; del-zota N=17).
Safety and tolerability data were assessed from 39 participants in the ongoing EXPLORE44-OLE study, as of June 2025. Del-zota continued to demonstrate favorable long-term safety and tolerability results. Most treatment emergent adverse events (TEAEs) were mild or moderate with the most common TEAEs (occurring in greater than 3 participants) being upper respiratory tract symptoms, diarrhea, fall, back pain and headache. One participant discontinued from EXPLORE44-OLE following an event of hypersensitivity.
In July 2025, we announced the FDA granted Breakthrough Therapy designation to del-zota for the treatment of DMD44.
Delpacibart etedesiran (del-desiran) for the treatment of myotonic dystrophy type 1 (DM1):
Del-desiran is currently being studied in the global Phase 3 HARBOR™ trial and ongoing HARBOR-OLE™ trial in people living with DM1. The Phase 2 MARINA-OLE™ trial has concluded. As of October 2025, participants who completed the MARINA-OLE trial and provided their consent, have transitioned to the HARBOR-OLE trial. Prior to initiation of the HARBOR trial, Avidity aligned with global regulators, including the FDA, on the registrational path for del-desiran. Del-desiran is designed to address the underlying genetic cause of DM1 by reducing levels of a disease-related mRNA called DMPK. Del-desiran consists of a proprietary mAb that binds to the transferrin receptor 1 (TfR1) conjugated with an siRNA targeting DMPK mRNA. Data presented in March 2024 from the MARINA-OLE trial showed reversal of disease progression in people living with DM1 across multiple endpoints including video hand opening time (vHOT) as a measure of hand function and myotonia, muscle strength and activities of daily living when compared to END-DM1 natural history study population over one year.
The global Phase 3 HARBOR trial is a randomized, placebo-controlled, double-blind pivotal study evaluating del-desiran in 159 people (age 16 to 65 years) living with DM1. The trial is being conducted at 34 sites globally. Patients are administered either del-desiran or placebo (1:1) every eight weeks. The trial is designed to assess the multiple key functional aspects of DM1. The primary endpoint is vHOT, a measurement of myotonia, which is the hallmark symptom of DM1. Key secondary endpoints include muscle strength as measured by hand grip strength and quantitative muscle testing (QMT) total score, and activities of daily living as measured by DM1-Activ, a patient reported outcome (PRO) scale to assess the impact of del-desiran on the multi-systemic nature of the DM1 disease.
All study participants, regardless of whether they receive active treatment or placebo, have the option to enroll into the HARBOR-OLE trial where all patients will receive active drug administered every eight weeks. The HARBOR-OLE trial is designed to assess the long-term safety, tolerability, and efficacy of del-desiran for the treatment of DM1.
We plan to submit to the FDA a protocol amendment for the HARBOR trial, which amendment will move the data cutoff date and related items from 30 weeks to 54 weeks. This change is a significant opportunity for patients and the HCP community as it will demonstrate the long-term efficacy and safety benefits of del-desiran. We believe that a larger safety database and longer efficacy data at 54 weeks will increase likelihood of demonstrating a treatment effect in a slowly progressing disease on multiple endpoints.
In July 2025, we announced the Phase 3 HARBOR trial is fully enrolled with a total of 159 participants enrolled. We remain on track to deliver multiple updates from the del-desiran program, including:
•Expected publication of data analyses from the completed Phase 1/2 MARINA trial in the fourth quarter of 2025.
•54-week topline data readout from global Phase 3 HARBOR study expected in the second half of 2026.
Delpacibart braxlosiran (del-brax) for the treatment of facioscapulohumeral muscular dystrophy (FSHD):
Del-brax is currently being studied in the registrational fully enrolled ongoing Biomarker Cohort in the Phase 1/2 FORTITUDE trial, the Phase 2 FORTITUDE-OLE trial and the FORTITUDE-3 (formerly known as FORWARD™) global confirmatory Phase 3 trial in participants living with facioscapulohumeral muscular dystrophy (FSHD). Del-brax is designed to address the underlying cause of FSHD, which is caused by the aberrant expression of a gene called double homeobox 4 or DUX4. Del-brax consists of a proprietary mAb that binds to the transferrin receptor 1 (TfR1) conjugated with an siRNA targeting DUX4 mRNA.
In June 2025, we announced multiple milestones for the del-brax program including FDA alignment on accelerated and full approval pathways for del-brax, and initiation of our global confirmatory Phase 3 FORTITUDE-3 study in FSHD. In addition, we shared positive topline Phase 1/2 FORTITUDE data from the del-brax dose escalation cohorts. Topline del-brax data, compared to placebo, demonstrated:
•Consistent improvement of functional mobility and muscle strength as measured by 10-Meter Walk-Run Test (10MWRT), Timed Up and Go (TUG) and Quantitative Muscle Testing (QMT)
•Consistent improvement in multiple measures of quality of life as measured by patient reported outcomes;
•Rapid and significant reductions in levels of KHDC1L or cDUX, a DUX4-regulated circulating biomarker, and creatine kinase, a biomarker of muscle damage; and
•Favorable long-term safety and tolerability with most adverse events (AEs) mild or moderate, with no related serious or severe adverse events and no discontinuations.
In March 2025, we announced that enrollment was completed for the del-brax biomarker cohort with a total of 51 participants enrolled.
Topline data from the FORTITUDE biomarker cohort is expected in the second quarter of 2026 and the FORTITUDE 3 data readout and global regulatory submissions are expected in 2028.
FORTITUDE™ and FORTITUDE-OLE™ trials
The FORTITUDE™ trial is a randomized, placebo-controlled, double-blind, Phase 1/2 clinical trial designed to evaluate single and multiple doses of del-brax in 90 participants with facioscapulohumeral muscular dystrophy (FSHD). The two dose escalation cohorts in FORTITUDE (N=39) evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of del-brax administered intravenously. Though the Phase 1/2 trial is not statistically powered to assess functional benefit, it explores the clinical activity of del-brax including measures of functional mobility and muscle strength as well as patient reported outcomes and quality of life measures, as well as changes in in key biomarkers including KHDC1L or cDUX, a DUX4-regulated circulating biomarker.
Two dose escalation cohorts evaluated 2 mg/kg or 4 mg/kg of del-brax every 13 weeks with a booster dose at 6 weeks in the first three months of the study versus placebo and informed the dose and dose regimen of del-brax for registrational studies. We have identified 2 mg/kg of del-brax every six weeks as the dose for the registrational studies, FORTITUDE Biomarker Cohort and FORTITUDE-3 Phase 3 study.
Participants who complete FORTITUDE have the option to enroll in the ongoing FORTITUDE-OLE study evaluating the long-term safety and tolerability of del-brax.
FORTITUDE Biomarker Cohort
The ongoing biomarker cohort in the FORTITUDE trial (N=51) assesses the impact of del-brax 2 mg/kg administered intravenously every six weeks versus placebo for 12 months in people living with FSHD, ages 16-70. The primary endpoint of the biomarker cohort is reduction of KHDC1L, or cDUX, a novel DUX4-regulated circulating biomarker discovered by Avidity in collaboration with Stephen Tapscott, M.D., Ph.D., Professor of Human Biology and Clinical Research at the Fred Hutchinson Cancer Center. We have aligned with the FDA on the use of cDUX as a surrogate endpoint to support a potential submission for accelerated approval of del-brax.
Global Phase 3 FORTITUDE-3™ Study
FORTITUDE-3™ is a global, confirmatory Phase 3, randomized, placebo-controlled, double-blind, 18-month study designed to evaluate del-brax in approximately 200 people (ages 16-70) living with FSHD. The trial is being conducted at approximately 45 global sites including in the U.S., Canada, Europe and Japan. Patients will be administered either 2 mg/kg of del-brax or placebo (1:1) intravenously every six weeks. The Phase 3 FORTITUDE-3 study is designed to be a confirmatory study to support potential full approval of del-brax. FORTITUDE-3 is assessing the impact of del-brax on key FSHD-related endpoints that measure functional mobility (10-Meter Walk-Run test, or 10 MWRT, and Timed Up and Go, or TUG), strength (quantitative muscle testing, or QMT, total score), patient-reported outcomes (PROs) and decrease in KHDC1L, or cDUX, a novel, DUX4-regulated circulating biomarker. All study participants, regardless of whether they receive active treatment or placebo, will have the option to enroll into an open-label extension trial where all participants will receive del-brax.
Company Advancements
We are advancing and expanding our innovative AOC pipeline to develop potential treatment options for people living with rare diseases across a wide range of therapeutic areas. Our first AOC programs are from our rare neuromuscular disease franchise where we have leveraged our deep experience with oligonucleotide therapeutics, modulation of RNA processes, antibody engineering and conjugation and drug delivery techniques. We have now expanded beyond rare neuromuscular disorders and into precision cardiology, advancing two wholly-owned precision cardiology development candidates targeting rare genetic cardiomyopathies - AOC 1072 targeting PRKAG2 (Protein Kinase AMP-activated non-catalytic subunit Gamma 2) Syndrome and AOC 1086 targeting PLN (phospholamban) cardiomyopathy.
We continue to execute on our global commercial infrastructure development as we plan for three potential successive product launches for DMD, DM1 and FSHD starting in 2026 and transition to the next stage as we advance our AOC technology in rare neuromuscular and precision cardiology, and next-generation innovations. In addition to our own internal research programs, we continue to explore the full potential of our AOC platform through collaborations and partnerships, including programs in immunology, cardiology and other select indications outside of muscle.
Since our inception in 2012, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, developing our proprietary AOC platform, identifying potential product candidates, establishing our intellectual property portfolio, conducting research, preclinical and clinical studies, preparing for potential commercial activities, and providing other general and administrative support for these operations. We have not generated any revenue from product sales. We are currently building our capabilities to support potential launches of product candidates currently in clinical development and to potentially operate as a commercial organization. In June 2020, we completed our initial public offering, or IPO, and have since raised capital through additional public offerings and private placements, and under collaboration and research license agreements.
We have incurred operating losses in each year since inception. Our net losses were $322.3 million and $212.2 million for the years ended December 31, 2024 and 2023, respectively, and $447.5 million for the nine months ended September 30, 2025. As of September 30, 2025, we had an accumulated deficit of $1.3 billion. We expect our expenses and operating losses will increase substantially as we conduct our ongoing and planned preclinical studies and clinical trials, continue our research and development activities, utilize third parties to manufacture our product candidates and related raw materials, hire additional personnel and protect our intellectual property.
Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies and clinical trials and our expenditures on other research and development activities, as well as the generation of any collaboration and services revenue.
Based upon our current operating plans, we believe that our existing cash, cash equivalents and marketable securities of approximately $1.9 billion (as of September 30, 2025) will be sufficient to fund our operations for at least 12 months from the date of the filing of this Form 10-Q. While we may generate revenue under our current and/or future collaboration agreements, we do not expect to generate any revenues from product sales until we successfully complete development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Research Collaboration with Bristol Myers Squibb Company
In November 2023, we entered into (i) a Research Collaboration and License Agreement, or the BMS Collaboration Agreement, to expand on the research with MyoKardia for up to five targets utilizing our proprietary AOC platform technology and (ii) a Securities Purchase Agreement with BMS, or the BMS Purchase Agreement, for the purchase by BMS in a private placement of 5,075,304 shares of our common stock at a purchase price of $7.8813 per share, for an aggregate purchase price of approximately $40 million. We refer to the BMS Collaboration Agreement and the BMS Purchase Agreement together as the "BMS Agreements." Under the terms of the BMS Agreements, we received approximately $100 million upfront, which includes a $60 million cash payment under the terms of the BMS Collaboration Agreement, and approximately $40 million for the purchase of our common stock under the terms of the BMS Purchase Agreement. We are also eligible to receive up to approximately $1.35 billion in research and development milestone payments, up to approximately $825 million in commercial milestone payments, and tiered royalties from high single digits to low double-digits on net sales. We are responsible for our own research collaboration costs incurred under the agreement, subject to a cumulative spending limit of $40 million. BMS will fund all future clinical development, regulatory and commercialization activities coming from this collaboration.
Research Collaboration with Eli Lilly and Company
In April 2019, we entered into a Research Collaboration and License Agreement, or the Lilly Agreement, with Eli Lilly and Company, or Lilly, for the discovery, development and commercialization of AOC products in immunology and other select indications on a worldwide basis. Under the Lilly Agreement, we and Lilly will collaborate on preclinical research and discovery activities for such products, with Lilly being responsible for funding the cost of such activities by both parties. Lilly will also lead the clinical development, regulatory approval and commercialization of all such products, at its sole cost. We granted Lilly an exclusive, worldwide, royalty-bearing license, with the right to sublicense, under our technology to research, develop, manufacture, and sell products containing AOCs that are directed to up to six mRNA targets. We retain the right to use our technology to perform our obligations under the agreement and for all purposes not granted to Lilly. Lilly paid us an upfront license fee of $20.0 million in 2019, and we are eligible to receive up to $60.0 million in development milestone payments per target, up to $140.0 million in regulatory milestone payments per target and up to $205.0 million in commercialization milestone payments per target. We are eligible to receive a tiered royalty ranging from the mid-single to low-double digits from Lilly on worldwide annual net sales of licensed products, subject to specified and capped reductions for the market entry of biosimilar products, loss of patent coverage of licensed products and for payments owed to third parties for additional rights necessary to commercialize licensed products in the territory. In August 2025, Lilly paid us $10.0 million as the result of the achievement of a clinical development milestone under the Lilly Agreement for a collaboration target.
Components of Results of Operations
Revenue
Our revenue to date has been derived from payments received under our license and research collaboration agreements, including revenue from reimbursements of services, as well as a combination of upfront payments and, milestone payments under our current and/or future collaboration agreements. We do not expect to generate any revenue from the sale of products unless and until such time that our product candidates have advanced through clinical development and regulatory approval, if ever. We expect that any revenue we generate, if at all, will fluctuate from quarter-to-quarter as a result of the timing and amount of payments relating to such services and milestones and the extent to which any of our products are approved and successfully commercialized. If we fail to complete preclinical and clinical development of product candidates or obtain regulatory approval for our product candidates, our ability to generate future revenues and our results of operations and financial position would be adversely affected.
Operating Expenses
Research and Development
Research and development expenses consist of costs associated with our research and development activities, including our discovery and research efforts, and the preclinical and clinical development of our product candidates. Our research and development expenses include:
•external costs, including expenses incurred under arrangements with third parties, such as contract research organizations, contract manufacturers, consultants and our scientific advisors; and
•internal costs, including;
◦employee-related expenses, including salaries, benefits, and stock-based compensation;
◦the costs of laboratory supplies and acquiring, developing, and manufacturing preclinical study materials; and
◦facilities, information technology and depreciation, which include direct and allocated expenses for rent and maintenance of facilities and depreciation of leasehold improvements and equipment.
Research and development costs, including costs reimbursed under collaboration agreements, are expensed as incurred, with reimbursements of such amounts being recognized as revenue. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received.
At any one time, we are working on multiple programs. Our internal resources, employees and infrastructure are not directly tied to any one research or drug discovery program and are typically deployed across multiple programs.
We expect our research and development expenses to increase for the foreseeable future as we continue to conduct ongoing research and development activities, advance preclinical research programs toward clinical development, including IND-enabling studies, and conduct clinical trials. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming, and can vary significantly for each product candidate and development program. We may never succeed in achieving marketing approval for any of our product candidates.
We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to preclinical and clinical results, regulatory developments, ongoing assessments as to each program’s commercial potential, and our ability to maintain or enter into new collaborations, to the extent we determine the resources or expertise of a collaborator would be beneficial for a given program. If the Merger is not completed, we will need to raise substantial additional capital in the future. In addition, we cannot forecast which development programs may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
Our development costs may vary significantly based on factors such as:
•the number and scope of clinical, preclinical and IND-enabling studies;
•per patient trial costs;
•the number of trials required for approval;
•the number of sites included in the trials;
•the countries in which the trials are conducted;
•the length of time required to enroll eligible patients;
•the number of patients that participate in the trials;
•the number of doses that patients receive;
•the drop-out or discontinuation rates of patients;
•potential additional safety monitoring requested by regulatory agencies;
•the duration of patient participation in the trials and follow-up;
•the cost and timing of manufacturing our product candidates;
•the various phases of development of our product candidates; and
•the efficacy and safety profiles of our product candidates.
General and Administrative
General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits, and stock-based compensation, for employees in our executive, finance, accounting, legal, business development, and other support functions. Other general and administrative expenses include allocated facility, information technology, and depreciation related costs not otherwise included in research and development expenses, and professional fees for auditing, tax, intellectual property, and legal services. Costs related to filing and pursuing patent applications are recognized as general and administrative expenses as incurred since recoverability of such expenditures is uncertain.
We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities, commercial readiness initiatives, and other corporate activities.
Other Income (Expense)
Other income (expense) consists primarily of interest earned on our cash, cash equivalents, and marketable securities.
Results of Operations
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations for the periods presented (in thousands):
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|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Change |
|
Nine Months Ended September 30, |
|
Change |
|
2025 |
|
2024 |
|
|
2025 |
|
2024 |
|
| Revenue |
$ |
12,475 |
|
|
$ |
2,336 |
|
|
$ |
10,139 |
|
|
$ |
17,895 |
|
|
$ |
7,924 |
|
|
$ |
9,971 |
|
| Research and development expenses |
154,948 |
|
|
77,197 |
|
|
77,751 |
|
|
392,563 |
|
|
207,968 |
|
|
184,595 |
|
| General and administrative expenses |
46,333 |
|
|
23,273 |
|
|
23,060 |
|
|
116,797 |
|
|
57,902 |
|
|
58,895 |
|
| Other income |
14,364 |
|
|
17,736 |
|
|
(3,372) |
|
|
43,935 |
|
|
37,901 |
|
|
6,034 |
|
Revenue
Revenue increased by $10.1 million and $10.0 million for the three and nine months ended September 30, 2025 as compared to the same periods in 2024, primarily due to the recognition of a $10.0 million milestone under the Lilly Agreement.
Research and Development Expenses
The following tables illustrate the components of our research and development expenses for the periods presented (in thousands):
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|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Change |
|
Nine Months Ended September 30, |
|
Change |
|
2025 |
|
2024 |
|
|
2025 |
|
2024 |
|
| External costs: |
|
|
|
|
|
|
|
|
|
|
|
| Del-desiran |
$ |
25,930 |
|
|
$ |
15,578 |
|
|
$ |
10,352 |
|
|
$ |
62,839 |
|
|
$ |
33,719 |
|
|
$ |
29,120 |
|
| Del-brax |
23,483 |
|
|
6,900 |
|
|
16,583 |
|
|
55,732 |
|
|
20,831 |
|
|
34,901 |
|
| Del-zota |
11,669 |
|
|
8,671 |
|
|
2,998 |
|
|
34,122 |
|
|
19,591 |
|
|
14,531 |
|
| Other programs |
6,607 |
|
|
1,158 |
|
|
5,449 |
|
|
19,171 |
|
|
3,582 |
|
|
15,589 |
|
| Unallocated |
39,919 |
|
|
16,330 |
|
|
23,589 |
|
|
95,316 |
|
|
49,895 |
|
|
45,421 |
|
| Total external costs |
107,608 |
|
|
48,637 |
|
|
58,971 |
|
|
267,180 |
|
|
127,618 |
|
|
139,562 |
|
| Internal costs: |
|
|
|
|
|
|
|
|
|
|
|
| Employee-related expenses |
40,434 |
|
|
22,823 |
|
|
17,611 |
|
|
105,174 |
|
|
63,713 |
|
|
41,461 |
|
| Facilities, lab supplies and other |
6,906 |
|
|
5,737 |
|
|
1,169 |
|
|
20,209 |
|
|
16,637 |
|
|
3,572 |
|
Total internal costs |
47,340 |
|
|
28,560 |
|
|
18,780 |
|
|
125,383 |
|
|
80,350 |
|
|
45,033 |
|
| Total research and development expenses |
$ |
154,948 |
|
|
$ |
77,197 |
|
|
$ |
77,751 |
|
|
$ |
392,563 |
|
|
$ |
207,968 |
|
|
$ |
184,595 |
|
Research and development expenses increased by $77.8 million for the three months ended September 30, 2025 as compared to the same period in 2024, primarily due to increased external costs associated with the progression of clinical trials and preclinical studies, including $21.6 million in higher manufacturing costs related to the production of monoclonal antibodies used across programs, as well as higher internal costs including $17.6 million in higher personnel costs. Similarly, research and development costs increased by $184.6 million for the nine months ended September 30, 2025 as compared to the same period in 2024, due to increased external costs associated with the progression of clinical trials and preclinical studies, including $41.6 million in higher manufacturing costs related to the production of monoclonal antibodies used across programs, as well as higher internal costs including $41.5 million in higher personnel costs.
General and Administrative Expenses
General and administrative expenses increased by $23.1 million for the three months ended September 30, 2025 as compared to the same period in 2024, primarily due to $11.4 million in higher personnel costs and $7.4 million in higher professional fees to support our expanded operations. Similarly, general and administrative expenses increased by $58.9 million for the nine months ended September 30, 2025 as compared to the same period in 2024, primarily due to $29.1 million in higher personnel costs and $19.1 million in higher professional fees to support our expanded operations.
Other Income
Other income decreased by $3.4 million for the three months ended September 30, 2025 as compared to the same period in 2024, primarily due to due to lower interest income earned on marketable securities investments and cash and cash equivalent balances. Other income increased by $6.0 million for the nine months ended September 30, 2025 as compared to the same period in 2024, respectively, due to higher interest income earned on marketable securities investments and cash and cash equivalent balances.
Liquidity and Capital Resources
Sources of Liquidity
On August 9, 2024, we entered into a sales agreement (the 2024 Sales Agreement) with TD Securities (USA) LLC (the 2024 Sales Agent). Under the 2024 Sales Agreement, we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $400.0 million through the 2024 Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the 2024 Sales Agent. We are not obligated to sell, and the 2024 Sales Agent is not obligated to buy or sell, any shares of common stock under the 2024 Sales Agreement. During the three and nine months ended September 30, 2025, we sold 5,646,583 shares of common stock pursuant to the 2024 Sales Agreement, and received net proceeds of $185.5 million, after deducting offering-related transaction costs and commissions of $4.8 million, at an average price of $33.69 per share.
On September 15, 2025, we completed an underwritten public offering of 17,250,000 shares of our common stock at a public offering price of $40.00 per share. Net proceeds from the offering were approximately $651.4 million, after deducting underwriting discounts and offering expenses of $38.6 million. The shares sold in the offering were registered pursuant to our shelf registration statement on Form S-3, which became automatically effective upon filing on May 9, 2024.
Other sources of capital to fund our operations include potential revenue pursuant to the BMS Collaboration Agreement and the Lilly Agreement. In August 2025, Lilly paid us $10.0 million as the result of the achievement of a clinical development milestone under the Lilly Agreement for a collaboration target.
Future Capital Requirements
As of September 30, 2025, we had cash, cash equivalents and marketable securities of $1.9 billion. Based upon our current operating plans, we believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations for at least 12 months from the date of the filing of this Form 10-Q. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain. In addition, the Merger Agreement contains restrictions on our issuance of shares of our common stock, subject to certain exceptions described therein.
If the Merger is not completed, our future capital requirements are difficult to forecast and will depend on many factors, including but not limited to:
•the type, number, scope, progress, expansions, results, costs, and timing of discovery, preclinical studies, and clinical trials of our product candidates that we are pursuing or may choose to pursue in the future;
•the costs and timing of manufacturing for our product candidates and commercial manufacturing if any product candidate is approved;
•the costs, timing, and outcome of regulatory review of our product candidates;
•the terms and timing of establishing and maintaining collaborations, licenses, and other similar arrangements;
•the costs of obtaining, maintaining, and enforcing our patents and other intellectual property rights;
•the costs associated with hiring additional personnel and consultants as we continue to grow our company;
•the timing and amount of the milestone or other payments made to us under current or future research and collaboration agreements;
•the costs and timing of establishing or securing sales and marketing capabilities if any product candidate is approved;
•our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; and
•costs associated with any products or technologies that we may in-license or acquire.
While we may generate revenue under our current and/or future collaboration agreements, we do not expect to generate any revenues from product sales until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which we do not expect will occur in the immediate term, and may never occur. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Accordingly, if the Merger is not completed, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, including current and potential future collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Cash Flows
The following table summarizes our cash flows for the periods presented (in thousands):
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|
|
|
Nine Months Ended September 30, |
|
Change |
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2025 |
|
2024 |
|
| Net cash provided by (used in): |
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|
|
|
|
| Operating activities |
$ |
(480,668) |
|
|
$ |
(200,999) |
|
|
$ |
(279,669) |
|
| Investing activities |
(245,253) |
|
|
(790,029) |
|
|
544,776 |
|
| Financing activities |
856,076 |
|
|
1,178,633 |
|
|
(322,557) |
|
| Effect of exchange rate on cash, cash equivalents and restricted cash |
138 |
|
|
— |
|
|
138 |
|
Net increase in cash, cash equivalents and restricted cash |
$ |
130,293 |
|
|
$ |
187,605 |
|
|
$ |
(57,312) |
|
Operating Activities
Net cash used in operating activities of $480.7 million and $201.0 million for the nine months ended September 30, 2025 and 2024, respectively, consisted primarily of cash used to fund our operations related to the development of del-desiran, del-brax, del-zota, and other potential programs. The increase in cash used in our operations is primarily due to increased research and development costs as well as general and administrative expenses as described under “Results of Operations” above.
Investing Activities
Net cash used in investing activities of $245.3 million for the nine months ended September 30, 2025 consisted primarily of $1,096.9 million for purchases of marketable securities due to investing the proceeds from the issuance of common stock, as well as the reinvestment of proceeds from matured marketable securities, and $7.8 million in purchases of property and equipment, offset by $862.6 million of proceeds from maturities of marketable securities. Net cash used in investing activities of $790.0 million for the nine months ended September 30, 2024 consisted of $1.1 billion for purchases of marketable securities and $3.2 million in purchases of property and equipment, offset by $349.7 million of proceeds from maturities of marketable securities.
Financing Activities
Net cash provided by financing activities of $856.1 million for the nine months ended September 30, 2025 consisted of $837.4 million in net proceeds from sales of our common stock and $18.7 million in proceeds from the issuance of common stock under employee incentive equity plans. Net cash provided by financing activities of $1.2 billion for the nine months ended September 30, 2024 consisted primarily of $1.0 billion in net proceeds from sales of our common stock, $141.4 million in net proceeds from the sale of pre-funded warrants in a private placement, and $36.2 million in proceeds from the issuance of common stock under employee incentive equity plans.
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. On an ongoing basis, we evaluate these estimates and judgments. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenue and expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates. As of September 30, 2025, there have been no material changes to our critical accounting estimates from those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates,” included in our annual report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 27, 2025.
Contractual Obligations and Commitments
In April 2024, we entered into a sublease agreement to rent office and laboratory space for our corporate headquarters. The sublease commenced in August 2025, with total aggregate future lease commitments under the sublease agreement of approximately $79.2 million. In March 2025, we exercised the option to rent an additional 80,000 square feet in an adjacent available building under the amended sublease agreement with Turning Point Therapeutics, Inc. Total aggregate future lease commitments attributable to the option under the amended sublease agreement are approximately $53.7 million.
In August 2025, we entered into a manufacturing agreement with a Contract Manufacturing Organization (CMO) for the manufacturing of the Company’s drug substances, conjugated drug substances, and drug products. The manufacturing agreement requires the Company to meet minimum purchase obligations on an annual basis, beginning in 2026 and ending in 2028. The total aggregate amount of future unconditional minimum purchase obligations under the manufacturing agreement is approximately $621.6 million, subject to foreign currency changes, annual price increases, other adjustments, and payments for certain costs and net of the nonrefundable reservation fees.
Refer to Note 7, "Commitments and Contingencies" to our condensed consolidated financial statements included elsewhere in this quarterly report on Form 10-Q for further details of our commitments.
Except for the sublease agreement and manufacturing agreement, as of September 30, 2025, there have been no material changes outside the ordinary course of our business to the contractual obligations we reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Contractual Obligations and Commitments,” included in our annual report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 27, 2025.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of September 30, 2025, there have been no material changes in our market risk from that described in “Quantitative and Qualitative Disclosures About Market Risk,” included in our annual report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 27, 2025.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Our management, with the participation of our principal executive officer and principal financial officer, has evaluated, as of the end of the period covered by this quarterly report on Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on such evaluation, our principal executive officer and principal financial officer have concluded that, as of September 30, 2025, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not currently subject to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.
ITEM 1A. RISK FACTORS
Other than as set forth below, we do not believe that there have been any material changes to the risk factors set forth in Part I, Item 1A of our annual report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 27, 2025. The risk factors described in such reports are not the only risks we face. Factors that are not currently known to us, factors that we currently consider immaterial or factors that are not specific to us, such as general economic conditions, may also materially adversely affect our business or financial condition.
Risks Related to Our Pending Acquisition by Novartis
We may not complete the pending transaction with Novartis within the timeframe we anticipate, or at all, which could have an adverse effect on our business, financial results, and/or operations.
On October 25, 2025, we entered into the Merger Agreement with Novartis, pursuant to which, and on the terms and subject to the conditions thereof, Merger Sub will merge with and into us, and we will survive as an indirect wholly owned subsidiary of Novartis.
In connection with the Merger, we, SpinCo, and Parent entered into the Separation and Distribution Agreement, pursuant to which, on the terms and subject to the conditions set forth therein, prior to the Effective Time: (i) we will effect the Pre-Closing Reorganization and (ii) thereafter, we will either (a) complete the Spin-Off Distribution or (b) subject to Parent's written consent, consummate a Permitted Third Party Sale, subject to the terms and conditions specified in the Merger Agreement and the Separation and Distribution Agreement. Following completion of the Spin-Off, we will have no continuing ownership interest in SpinCo. The Spin-Off also includes certain assets of the Company that trigger a ROFN with an existing collaboration partner of ours that was notified concurrently with our announcement of our entry into the Merger Agreement.
Consummation of the Merger is subject to (i) closing conditions related to the Spin-Off, including (a) the effectiveness of the registration statement on Form 10 (or Form S-1 if the Company so determines after consultation with Parent) to be filed with respect to the registration of the SpinCo Common Stock and the absence of any stop order or similar proceeding, and (b) completion of either the Spin-Off or, subject to Parent’s written consent, a Permitted Third Party Sale (as defined in the Merger Agreement); and (ii) other customary closing conditions, including, (a) the absence of certain legal restraints preventing or otherwise making illegal the consummation of the Merger, (b) the absence of any Company Material Adverse Effect (as defined in the Merger Agreement) having occurred since October 25, 2025, (c) the expiration or termination of any waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, including any extensions thereof, applicable to the Merger and, potentially, the applicable antitrust laws of specified other jurisdictions and (d) the adoption of the Merger Agreement and the Separation and Distribution Agreement by holders of Company’s common stock representing at least a majority of the Company’s common stock outstanding. In addition, the Merger Agreement may be terminated under certain specified circumstances, including, but not limited to, by Novartis in the event we accept and enter into an agreement for the consummation of a transaction that our board of directors, or the Company Board, determines is a Superior Proposal (as defined in the Merger Agreement).
In addition, consummation of the Spin-Off is subject to, among other things: (i) satisfaction of the conditions to closing set forth in the Merger Agreement (with certain exceptions); (ii) the absence of any judgment or law prohibiting or making illegal the consummation of the Spin-Off, the Pre-Closing Reorganization or the Merger; (iii) the license agreement entered into between the Company and SpinCo being in full force and effect; (iv) execution of a transition services agreement; and (v) completion of the Pre-Closing Reorganization.
As a result, we cannot assure you that the transaction with Novartis will be completed, or that, if completed, it will be exactly on the terms set forth in the Merger Agreement as of its date or within the expected timeframe.
If the Merger is not completed within the expected timeframe or at all, we may be subject to a number of material risks. The price of our common stock may decline to the extent that current market prices of our common stock reflect a market assumption that the Merger will be completed. We could be required to pay Novartis a termination fee of $450 million if the Merger Agreement is terminated under specific circumstances described in the Merger Agreement. The failure to complete the Merger also may result in negative publicity and negatively affect our relationship with our stockholders, employees, regulators, and other business partners. We may also be required to devote significant time and resources to litigation related to any failure to complete the Merger or related to any enforcement proceeding commenced against us to perform our obligations under the Merger Agreement.
The pendency of the Merger and Spin-Off could adversely affect our business, financial results and/or operations.
Our efforts to complete the Merger and Spin-Off could cause substantial disruptions in, and create uncertainty surrounding, our business, which may materially adversely affect our results of operations and our business. Uncertainty as to whether the Merger or Spin-Off will be completed may affect our ability to recruit prospective employees or to retain and motivate existing employees. Employee retention or focus may be particularly challenging while the Merger and Spin-Off are pending because employees may experience uncertainty about their roles following consummation of both the Merger and Spin-Off. A substantial amount of our management’s and certain employees’ attention is being directed toward the completion of the Merger and Spin-Off and thus is being diverted from our day-to-day operations. Any exercise of the ROFN would result in further diversion of management and employee attention. Uncertainty as to our future could adversely affect our business and our relationship with collaborators, vendors, customers, regulators, and other business partners. For example, vendors, collaborators, and other counterparties may defer decisions concerning working with us, or seek to change existing business relationships with us. Changes to or termination of existing business relationships could adversely affect our results of operations and financial condition, as well as the market price of our common stock. The adverse effects of the pendency of the Merger could be exacerbated by any delays in completion of the Merger of Spin-Off, including because of any exercise of the ROFN, or termination of the Merger Agreement.
While the Merger Agreement is in effect, we are subject to restrictions on our business activities.
While the Merger Agreement is in effect, subject to certain exceptions, including, among others, actions required by the Separation and Distribution Agreement and a potential transaction pursuant to the ROFN, we are subject to restrictions on our business activities, generally requiring us to conduct our business in the ordinary course and consistent with past practice in all material respects, and subjecting us to a variety of specified restrictions absent Novartis’s prior consent. These limitations include, among other things, restrictions on our ability to acquire other businesses and assets, dispose of our assets, make investments, enter into certain contracts, repurchase or issue securities, pay dividends, make capital expenditures, take certain actions relating to intellectual property, amend our organizational documents, and incur indebtedness. These restrictions could prevent us from pursuing business opportunities, taking actions with respect to our business that we may consider advantageous and responding effectively and/or timely to competitive pressures and industry developments, and may, as a result, materially and adversely affect our business, results of operations and financial condition.
In certain instances, the Merger Agreement requires us to pay a termination fee to Novartis, which could require us to use available cash that would have otherwise been available for general corporate purposes.
Under the terms of the Merger Agreement, we may be required to pay Novartis a termination fee of $450 million if the Merger Agreement is terminated under specific circumstances described in the Merger Agreement, including, but not limited to, in the event we accept and enter into an agreement for the consummation of a transaction which the Company Board determines is a Superior Proposal. If the Merger Agreement is terminated under such circumstances, the termination fee we would be required to pay under the Merger Agreement may require us to use available cash that would have otherwise been available for general corporate purposes and other uses. For these and other reasons, termination of the Merger Agreement could materially and adversely affect our business operations and financial condition, which in turn would materially and adversely affect the price of our common stock.
We have incurred, and will continue to incur, direct and indirect costs as a result of the pending transaction with Novartis.
We have incurred, and will continue to incur, significant costs and expenses, including fees for professional services and other transaction costs, in connection with the pending transaction. We must pay substantially all of these costs and expenses whether or not the transaction is completed. There are a number of factors beyond our control that could affect the total amount or the timing of these costs and expenses.
Litigation may arise in connection with the Merger or the Spin-Off, which could be costly and divert management’s attention and otherwise materially harm our business.
Lawsuits may be filed challenging aspects of the proposed Merger or Spin-Off or otherwise related to the Merger or the Spin-Off. Regardless of the outcome of any future litigation related to the proposed Merger or Spin-Off, such litigation may be time-consuming and expensive and may distract our management from running the day-to-day operations of our business. The litigation costs and diversion of management’s attention and resources to address the claims and counterclaims in any litigation related to the proposed Merger or Spin-Off may materially adversely affect our business, financial condition and operating results. The outcome of any lawsuit filed or that may be filed challenging the Merger or Spin-Off is uncertain. If any lawsuit is successful in obtaining an order enjoining the Merger or Spin-Off, then the transactions may not be consummated within the expected time frame, or at all, and could result in substantial costs, including but not limited to, costs associated with the indemnification of our directors and officers. If the Merger or the Spin-Off is not consummated for any reason, litigation could be filed in connection with the failure to consummate the Merger or the Spin-Off. Any litigation related to the proposed Merger or the Spin-Off may result in negative publicity or an unfavorable impression of us, which could adversely affect the price of our common stock, impair our ability to recruit or retain employees, damage our relationships with our partners, or otherwise materially harm our operations and financial performance.
The Merger Agreement contains provisions that could discourage a potential competing acquirer of our company or could result in any competing proposal being at a lower price than it might otherwise be.
We are subject to certain restrictions on our ability to solicit alternative acquisition proposals from third parties, to provide information to third parties and to enter into or continue discussions or negotiations with third parties regarding alternative acquisition proposals, subject to customary exceptions. In addition, we may be required to pay Novartis a termination fee of $450 million under specific circumstances described in the Merger Agreement, including, but not limited to, in the event we accept and enter into an agreement for the consummation of a transaction which the Company Board determines is a Superior Proposal. These provisions could discourage a potential competing acquirer that might have an interest in acquiring all or a significant part of our company from considering or proposing such an acquisition, including, if the Merger Agreement is terminated prior to the consummation of the Merger, after such termination of the Merger Agreement, even if it were prepared to pay a purchase price per share higher than the purchase price per share proposed to be paid in the Merger, or might result in a potential competing acquirer proposing to pay a lower price than it might otherwise have proposed to pay because of the added expense of the termination fee that may become payable in specified circumstances under the Merger Agreement, including, in certain circumstances, after a valid termination of the Merger Agreement in accordance with the terms thereof.
The value of SpinCo Common Stock may not be as anticipated.
Even if the distribution of SpinCo Common Stock is completed, the value of SpinCo Common Stock, if any, may not be equal to or greater than the value anticipated. SpinCo as an independent company will be subject to similar risks and uncertainties as those previously described by the Company with respect to its business in its filings with the SEC, including those relating to capital requirements, discovery and development of product candidates, regulatory review and approval and intellectual property matters. In addition, the value of SpinCo Common Stock could be lower than anticipated for a variety of reasons, including the consummation of any transaction pursuant to the ROFN resulting in fewer assets being transferred to SpinCo, SpinCo’s limited operating history, the failure of SpinCo to develop any product candidates or operate and compete effectively as an independent company. SpinCo Common Stock may experience periods of extreme volatility. SpinCo will be smaller than the Company currently, with a narrower and less diversified business focus, and may be more vulnerable to changing market conditions.
If the Merger is consummated, our stockholders will not be able to participate in any further upside to the portion of our business acquired by Novartis.
If the Merger is consummated,each share of the Company’s common stock issued and outstanding immediately prior to the Effective Time (including any shares issued as a result of the exercise of any Company Warrants (as defined below) prior to the Effective Time, but excluding each share of Company Common Stock (i) held in the treasury of the Company, (ii) owned by Parent or Merger Sub or any direct or indirect wholly owned Subsidiary of Parent or the Company immediately prior to the Effective Time or (iii) held by any stockholder who is entitled to demand and has properly and validly demanded their statutory right of appraisal of such shares of the Company’s common stock in accordance with, and in compliance in all respects with, Section 262 of the General Corporation Law of the State of Delaware) will automatically be cancelled and converted into the right to receive an amount in cash equal to $72.00, without interest and subject to any applicable tax withholdings.In addition, holders of Company Common Stock as of the Distribution Record Date will receive, at the Distribution Effective Time, shares of SpinCo Common Stock on a pro rata basis of 1 share of SpinCo Common Stock per 10 shares of Company Common Stock.
As a result, even if the portion of our business acquired by Novartis performs well following the Merger, our current stockholders will not receive any additional consideration or benefit from any such future performance of the portion of our business acquired by Novartis.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Unregistered Sales of Equity Securities
None.
Issuer Repurchases of Equity Securities
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Rule 10b5-1 Trading Arrangements
From time to time, our officers (as defined in Rule 16a–1(f)) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading arrangements (as each such term is defined in Item 408 of Regulation S-K). During the three months ended September 30, 2025, none of our officers or directors adopted or terminated any such trading arrangements. In connection with our entry into the Merger Agreement, all active Rule 10b5-1 trading arrangements to which our officers and directors were a party automatically terminated or suspended in accordance with the terms of such trading arrangements.
Item 6. Exhibits
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Exhibit Number |
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Exhibit Description |
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Incorporated by Reference |
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Filed Herewith |
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Form |
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Date |
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Number |
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2.1^ |
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8-K |
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10/27/2025 |
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2.1 |
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2.2^ |
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8-K |
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10/27/2025 |
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2.2 |
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| 3.1 |
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8-K |
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6/16/2020 |
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3.1 |
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| 3.2 |
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8-K |
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12/13/2023 |
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3.1 |
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| 4.1 |
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S-1 |
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5/22/2020 |
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4.1 |
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| 4.2 |
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8-K |
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2/29/2024 |
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4.1 |
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10.1# |
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8-K |
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9/10/2025 |
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10.1 |
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10.2† |
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| 31.1 |
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| 31.2 |
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| 32.1* |
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| 32.2* |
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| 101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
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| 101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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| 101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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| 101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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| 101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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| 101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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| 104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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^Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish supplementally to the SEC a copy of any omitted exhibits or schedules upon request; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any exhibits or schedules so furnished.
#Indicates management contract or compensatory plan
† Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions are (i) not material and (ii) treated by the Registrant as private or confidential.
*This certification is deemed not filed for purpose of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Avidity Biosciences, Inc. |
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Date: November 10, 2025 |
By: |
/s/ Sarah Boyce |
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Sarah Boyce
President, Chief Executive Officer and Director
(Principal Executive Officer)
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Date: November 10, 2025 |
By: |
/s/ Michael F. MacLean |
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Michael F. MacLean
Chief Financial Officer
(Principal Financial and Accounting Officer)
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EX-10.2
2
rna-20250930xex102xlonza.htm
EX-10.2
rna-20250930xex102xlonza
Exhibit 10.2 Portions of this Exhibit have been redacted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”. Manufacturing Services Agreement (the “Agreement”) by and between Lonza LTD Münchensteinerstrasse 38 CH-4002 Basel Switzerland Lonza Sales LTD Münchensteinerstrasse 38 CH-4002 Basel Switzerland Lonza LTD (“Lonza AG”) and Lonza Sales LTD (“Lonza Sales AG”) hereinafter together referred to as (“Lonza”) and Avidity Biosciences, Inc. 10578 Science Center Dr., Suite 125 San Diego, CA 92121 USA (“Customer”) Effective as of date of last signature (the “Effective Date”)
2 Table of Contents Page 1 Definitions and Interpretation .............................................................................. 3 2 Performance of Services ................................................................................... 10 3 Project Management / Steering Committee ...................................................... 16 4 Quality ............................................................................................................... 17 5 Insurance .......................................................................................................... 18 6 Forecasting, Ordering and Cancellation ............................................................ 18 7 Customs, Delivery and Acceptance .................................................................... 21 8 Price and Payment ............................................................................................ 23 9 Capital Equipment ............................................................................................. 25 10 Intellectual Property .......................................................................................... 25 11 Warranties ......................................................................................................... 28 12 Indemnification and Liability .............................................................................. 30 13 Confidentiality.................................................................................................... 32 14 Term and Termination ....................................................................................... 34 15 Force Majeure ................................................................................................... 36 16 Additional Covenants ........................................................................................ 36 17 Miscellaneous ................................................................................................... 37 Appendix A Appendix B Appendix C
3 Recitals WHEREAS, Customer is engaged in the development and research of certain products and requires assistance in the development and manufacture of product; WHEREAS, Lonza and its Affiliates have expertise in the evaluation, development and manufacture of products; WHEREAS, the Parties have entered into a Manufacturing Service Agreement covering the development of a certain product dated April 26, 2019 (the “MSA”) and Customer wishes now to engage Lonza for Services relating to the commercial manufacture of the Product as described in this Agreement; and WHEREAS, Lonza, and/or its Affiliates, are prepared to perform such Services for Customer on the terms and subject to the conditions set out herein. NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the parties intending to be legally bound, agree as follows: 1 Definitions and Interpretation “Affiliate” means, with respect to either Party, any corporation, company, partnership or other business entity which directly or indirectly, through one or more intermediaries, Controls, is Controlled by or is under common Control with such Party. For purposes of this definition, the term “Control” and, with the correlative meanings, the terms “Controlled by” and “under common Control” means direct or indirect ownership of fifty percent (50%) or more of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest of such entity or the power to direct or cause the direction of the management and policies of such entity, whether through the ownership of voting securities, by contract, or otherwise. “Agreement” means this agreement incorporating all Appendices and each Project Plan together with this agreement but separate from other Project Plans, each of the foregoing as amended from time to time by written agreement of the Parties. “Applicable Laws” means all relevant federal, state and local laws, statutes, rules, and regulations of the United States, the European Union, Japan once any necessary gap assessment has been completed for Japan, and any other countries the Parties may mutually agree upon in writing and upon the completion of any necessary gap assessment(s), which are applicable to the performance of the Services (as defined below) and/or the Parties’
4 respective obligations hereunder, including, the applicable regulations and guidelines of any Regulatory Authority, and all applicable cGMP together with amendments thereto. In addition, each Facility will comply with all relevant federal, state and local laws, statutes, rules and regulations where the Facility is located. “API” means Active Pharmaceutical Ingredient “Approval” means the marketing approval by the FDA or EMA or other Regulatory Authority (as defined below) of Product from the Facility for commercial supply. “Assist” means the supply of Customer Materials to Lonza free of charge or at a reduced cost. “Background Intellectual Property” means any Intellectual Property either (i) owned or controlled by a Party or any of its Affiliates prior to the Effective Date or (ii) developed or acquired by a Party or any of its Affiliates independently from the performance of the Services hereunder during the Term of this Agreement. Lonza Confidential Information shall form part of, and be included in, Lonza’s Background Intellectual Property. Customer Confidential Information shall form part of, and be included in, Customer’s Background Intellectual Property. For clarity, Background Intellectual Property of a Party shall exclude any Intellectual Property licensed (whether under this or any other agreement) to it by the other Party or any Affiliate of the other Party. “BASM” Biological Active Starting Material (pivotal intermediate material) “Batch” means the Product produced from a single run of the Manufacturing Process. For clarity, a Batch can be a Process Validation Batch, cGMP Drug Product Batch, cGMP Conjugation Batch or cGMP Drug Substance (mAb) Batch. “Batch Record” has the meaning set forth in the Quality Agreement which definition is incorporated herein by reference and made fully a part hereof. “Campaign” means the number of cGMP Batches specified for manufacture in a series during a defined period of time as set forth in detail in the applicable SOW or Purchase Order, as applicable.
5 “Cancellation Fee” has the meaning given in Clause 6.6. “Capital Equipment“ means those certain pieces of new equipment described in the Project Plan which are to be acquired and paid for on terms to be agreed in accordance with this Agreement. “Cell Bank” means the cell banks to be established by Lonza or provided by Customer as described in the Project Plan. “Cell Bank Storage” means the storage of Customer’s Cell Bank in accordance with Appendix B of this Agreement. “Certificate of Analysis” means a document prepared by or for Lonza listing tests performed by Lonza or approved External Laboratories, the Specifications and test results. “Certificate of Compliance” means a document prepared by or for Lonza: (i) listing the manufacturing date, unique Batch number, and concentration of Product in such Batch, and (ii) certifying that such Batch was manufactured in accordance with the Master Batch Record and cGMP, if applicable. “cGMP” means any laws, regulations and regulatory guidelines, applicable in the United States, the European Union, and any other countries the Parties may mutually agree upon in writing, including but not limited to Japan, relating to the manufacture of medicinal products for human use (together with amendments thereto), including (without limitation) current Good Manufacturing Practices as specified in the ICH guidelines and, in particular (without limitation), ICH Q7A “ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, the US Federal Food Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610, 820), the Rules Governing Medicinal Products in the European Union (Eudralex), Volume 4 in particular - without limitation- Part I (for Drug Products) and/or Part II (for APIs) as promulgated under the European Union Directives 2001/83/EC and 2001/20/EC and European Commission Directives 2003/94/EC and 91/356/EC; European Medicines Agency Note for Guidance CPMP/ICH/4106/00; the US FDA 21 CFR 210/211/600, and 21 CFR part 11 and 610; and other agency regulations and regulatory guidelines as applicable in the agreed- upon jurisdictions to API manufacture. For the avoidance of doubt, Lonza’s operational quality
6 standards are defined in internal cGMP policy documents. In addition, each Facility will comply with all relevant federal, state and local laws, statutes, rules and regulations relating to the manufacture of drug products for human use where the Facility is located. “cGMP Batches” means any cGMP Drug Substance Batches, cGMP Conjugation Batches, or any cGMP Drug Product Batches. “cGMP Conjugation Batch” means a Batch of conjugated Product which uses material from an cGMP Drug Substance Batch as a starting material which is further conjugated to be manufactured in accordance with cGMP. “cGMP Drug Product Batch” means a Drug Product Batch, which is required under the Project Plan to be manufactured in accordance with cGMP. “cGMP Drug Substance Batch” means a Drug Substance (mAb) Batch, which is required under the Project Plan to be manufactured in accordance with cGMP. “Commencement Date” is defined in Section 2.8. “Conjugated Drug Substance” or “CDS” means a molecule comprising a covalent linkage between two molecules, at least one of which is a biomolecule. “Confidential Information” means all information that is maintained in confidence by a Party or any Affiliate of a Party and that is disclosed by or on behalf of the Party or any Affiliate of the Party to the other Party under or in connection with this Agreement, including the know-how and trade secrets of a Party. The Confidential Information of each Party shall exclude any Confidential Information of the other Party or any Affiliate of the other Party provided under this Agreement or which was or is provided in any other written agreement between the Parties. “Corruption Laws” means all applicable anti-bribery and anti- corruption laws and regulations, including but not limited to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act 2010, and the Organization for Economic Co-operation and Development (OECD) Convention on Combating Bribery of Foreign Public Officials in International Business Transactions.
7 “Customer Materials” means any Raw Materials, components of Product, or other materials of any nature provided by or on behalf of Customer, including Drug Substance and cGMP Conjugation Batch once Released by Lonza. “Customer-Provided Items” means Customer Confidential Information, Customer Background Intellectual Property, Customer Materials, and any and all other information, materials and Intellectual Property that in each case is provided by or on behalf of the Customer to Lonza or any of Lonza’s Affiliates. “Delivery” has the meaning provided in Clause 7.1 “Development Services” means all activities other than the manufacture of a Batch or activities performed in support of such Batch. “Drug Product” means the dosage form in the final immediate packaging intended for marketing “Drug Substance” or “DS” means the Product in bulk drug substance form “EMA” means the European Medicines Agency, or any successor agency thereto. “External Laboratories” means any Third Party instructed by Lonza, with Customer’s prior consent, to conduct certain activities not customarily performed by Lonza which are required to complete the Services. “Facility” means [***]. “Failed Conjugation Batch” shall have the meaning set out in Clause 7.4.3. “Failed Drug Product Batch” shall have the meaning set out in Clause 7.5.3. “Failed Drug Substance Batch” shall have the meaning set out in Clause 7.3.3. “FDA” means the U.S. Food and Drug Administration or any successor agency thereto “GDPR” means any applicable data protection or privacy laws, rules and regulations, including but not limited to, the European Union e-Privacy Directive 2002/58/EC, the European Union General Data Protection Regulation 2016/679, the UK Data Protection Act 2018, and any other laws equivalent thereto. “Handling Fee” means the: (i) actual acquisition cost of Raw Materials by Lonza plus a [***] percent handling
8 fee ([***]%) (ii) procurement and handling fee of [***] percent ([***]%) of the acquisition cost of Special Material(s) and Customer Material specifically set forth in a Project Plan to be procured by Lonza on behalf of Customer. For clarity, both (i) and (ii) VAT/taxes/surcharges, such as tariffs, are expressly excluded from the Handling Fee and no handling fee or other markup may be charged for them. “IBIMP” means Intermediate Biological Investigational Medicinal Product. “IBMP” Intermediate Biological Medicinal Product “Intellectual Property” means (i) inventions (whether or not patentable), patents, trade secrets, copyrights, trademarks, trade names, service marks, logos, domain names, rights in designs, rights in computer software, database rights, rights in confidential information (including know-how) and any other intellectual property rights, in each case whether registered or unregistered, (ii) all applications (or rights to apply) for, and renewals or extensions of, any of the rights described in the foregoing clause (i) and (iii) all rights and applications that are similar or equivalent to the rights and application described in the foregoing clauses (i) and (ii), which exist now, or which come to exist in the future, in any part of the world. “International Trade Restrictions” means any export control requirements and trade, financial and economic sanctions which apply to this Agreement and the Services under the laws, regulations and rules of the United States, the European Union, the United Kingdom, Switzerland and any other relevant jurisdiction; and all necessary export and re- export written consents, permits, and authorizations required by International Trade Restrictions. “JSC” means Joint Steering Committee “Lonza Competitor” means a company acting in the same field of CDMO business whose primary purpose is to provide manufacturing services for a fee to third parties in the field of biologic products. “Lonza Operating Documents” may include in either electronic or paper form, Lonza’s corporate standards, standard operating procedures, and facility and equipment designs
9 and maintenance procedures, used in the process of producing the Product, excluding any of the foregoing that are solely applicable to the manufacture of Product. Lonza Operating Documents are considered Lonza Intellectual Property. “Lonza Manufacturing Process” means, in either electronic or paper form, documents used in the Manufacturing Process wherein Lonza’s custom and platform manufacturing processes and/or Lonza developed analytical methods are used to produce the Product including, but not limited to, manufacturing procedures, raw material specifications and Lonza developed compendial methods. For clarity, “Lonza Manufacturing Process Documents” does not include any such documents which include or incorporate any Customer Background Intellectual Property, New Customer Intellectual Property and/or other Customer Confidential Information. “Lonza Procured Materials” means Raw Materials that Lonza purchases for use in Services hereunder. For avoidance of doubt, Lonza Procured Materials excludes Customer Materials. “Lonza Responsibility” means a failure primarily due to Lonza’s negligence, misconduct, or material breach of its obligations hereunder. “Manufacturing Process” means any and all processes, methods, procedures and activities (or any step therein) used or planned to be used by Lonza to manufacture Product as set forth in the Batch Records or Master Batch Records. but excluding processes performed pursuant to the Lonza Operating Documents. “Master Batch Record” means the unexecuted batch record which has been technically and Quality Assurance approved prior to the cGMP batch which set forth the details of the steps and elements for the manufacture of a Batch of Product under the Manufacturing Process, including any tests, analytical methods or other required procedures. These documents are held electronically within the Documentum system, or as paper copies for disaster recovery. Master Batch Records explicitly exclude Lonza Operating Documents. “New Customer Intellectual Property” has the meaning given in Clause 10.2.1.
10 “New Lonza Intellectual Property” has the meaning given in Clause 10.2.3. “Party” or “Parties” means each of Lonza and Customer and, together, the “Parties”. “Price” means the fees for the performance of Services and Manufacture of Products as set out and agreed upon in the applicable SOW (the Price excludes the cost of the Raw Materials, pass through costs and the Handling Fee). “Process Validation Batch” means a Batch that is produced with the intent to show reproducibility of the Manufacturing Process and is required to complete process validation studies. “Product” means the Drug Substance or Drug Product as described in Project Plan to be manufactured by Lonza for Customer as specified in the Project Plan “Project Plan” means a Statement of Work (SOW) or plan(s) describing the Services (as defined below) and Price, including any update and amendment of the Project Plan to which the Parties may agree from time to time in an executed writing. Each Project Plan shall make reference to this Agreement and be governed by the terms hereof, and upon signature by both Parties the Project Plans are each incorporated into and shall be an integral part of this Agreement but separate from any other Project Plans. The initial Project Plan will be attached hereto as Appendix A. “Quality Agreement” means the agreement, that, subject to cGMP requirements, defines, establishes, and documents manufacturing and testing activities and responsibilities of the Parties in relation to quality. Upon signature by both Parties, the Quality Agreement and any amendments thereto are incorporated into and shall be an integral part of this Agreement. “Raw Materials” means all qualified ingredients, solvents, primary packaging materials, filter, single-use liquid- paths and other components of the Product required to perform the Manufacturing Process or Services set forth in the bill of materials. Raw Materials expressly includes Special Material(s), Lonza Procured Materials, and Customer Materials. “Regulatory Approval” means the approval by any Regulatory Authority to market and sell the Products in the respective
11 markets, including any pricing approval. For clarity, “Regulatory Approvals” include accelerated, conditional or temporary authorizations or approvals. “Regulatory Authority” means the FDA, EMA and any other similar regulatory authority as may be agreed upon in writing by the Parties. “Release” has the meaning given in Clause 7.1. “Safety Stock” means the stock of Raw Materials and consumables in addition to the net needs for a particular Batch to mitigate the potential risk of Raw Materials and consumables shortages necessary for the performance of Services. Required Safety Stock amounts are shown in Appendix C. “Services” means all or any part of the services (including manufacturing of Batches) to be performed by Lonza under this Agreement, particulars of which are set forth in an executed Project Plan. “Services Data” means the data obtained by Lonza or any Affiliate, Subcontractor or External Laboratories of Lonza in the course of Lonza’s or such other entities’ performing Services hereunder which is (i) anonymized and/or aggregated so that Customer, Customer’s Product, Customer’s manufacturing strategy including but not limited to its Batch numbers, yields, raw materials or regulatory filings or strategy are not discernible or identifiable; (ii) does not contain any Customer Confidential Information; (iv) does not disclose any Customer Intellectual Property and which may not be used in a way that enables identification of the Customer or Product. “SOP” means a standard operating procedure. “Special Material(s)” means certain Raw Materials identified as having high value that are used in the Manufacturing Process, including but not limited to, [***]. “Specifications” means the list of tests, references to any analytical procedures and acceptance criteria which are numerical limits, ranges or other criteria for tests described in order to establish a set of criteria to which final Product should conform to be considered acceptable for its intended use to be agreed upon between the Parties in writing incorporated herein by reference and made fully a part of this
12 Agreement and which may be amended from time to time by the Parties in accordance with this Agreement. “Stage of Work” means the individual stages of the Services as set out in the Project Plan. “Statement of Work” or “SOW” means a document which inserts a new Stage of Work into a Project Plan or amends an existing Stage of Work in a Project Plan. “Storage Requirements” means the storage requirements for Cell Banks, Product, and/or Customer Materials as set out in the Project Plan or as otherwise provided by Customer in writing. “Subcontractors” means any Third Party who, for the purposes of the Services, performs activities under an agreement with Lonza, provided that these activities are part of the services which Lonza customarily provides to Customers. “Technology License” means the separately executed license agreement dated 12 November 2019, as amended 21 February 2023, between Lonza Sales AG and Customer for GS Xceed® and corresponding intellectual property used by Lonza in the performance of Services under this Agreement. “Term” has the meaning given in Clause 14.1. “Third Party” means any party other than Customer, Lonza or their respective Affiliates. “US” means United States of America. In this Agreement, (a) references to the Parties are to the Parties to this Agreement, (b) headings are used for convenience only and do not affect the interpretation of the Agreement, (c) references to a statutory provision include references to the statutory provision as modified or re-enacted or both from time to time and to any subordinate legislation made under the statutory provision, (d) references to the singular include the plural and vice versa, and (e) references to the word “including” are to be construed without limitation. 2 Performance of Services 2.1 Lonza AG, Lonza Sales AG, and Affiliates. 2.1.1 Lonza AG shall be independently accountable for the performance of the Services under this Agreement which is required to be performed by Lonza in Switzerland and such performance shall be subject to the terms of this Agreement and any applicable SOW. Lonza Sales AG shall have no
13 responsibility with respect to the performance of said Services by Lonza AG in Switzerland and Lonza AG shall under no circumstance be deemed a subcontractor of Lonza Sales AG. 2.1.2 Services under this Agreement outside of Switzerland shall be performed or procured by Lonza Sales AG and such performance shall be subject to the terms of this Agreement and Lonza Sales AG will be responsible therefor. Lonza AG shall have no responsibility with respect to the performance of such Services by Lonza Sales AG and Lonza Sales AG shall under no circumstance be deemed a subcontractor of Lonza AG. 2.1.3 Subject to Customer’s approval, Lonza AG, Lonza Sales AG, or any of their respective Affiliates may execute a Project Plan or Statement of Work with Customer pursuant to this Agreement and submit invoices to Customer under such Project Plan or Statement of Work. In such circumstances all references in this Agreement to Lonza shall be deemed to include the Affiliate of Lonza with respect to that particular Project Plan or Statement of Work. Such Affiliate shall be entitled to enforce this Agreement with respect to such Project Plan or Statement of Work in its own name as an intended Third Party beneficiary and the Lonza AG or Lonza Sales AG, as applicable, shall be jointly liable to Customer (under the terms of this Agreement) for any obligations and liabilities undertaken by such Affiliate pursuant to such Project Plan or Statement of Work. 2.2 Performance of Services. Execution of a given Project Plan or Statement of Work by the Parties, shall establish Customer’s retention of Lonza to perform the Services set out in the Project Plan. Lonza shall diligently carry out the Services as provided in the Project Plan, including by use of its Affiliates as set forth in Section 2.6 and shall Manufacture Product in accordance with any agreed-upon timelines and Purchase Orders shall use commercially reasonable efforts to perform the Services in the manufacture of Product without any material defect. Lonza shall retain appropriately qualified and trained personnel with the requisite knowledge and experience to perform the Services in accordance with this Agreement. 2.3 Subcontractors and External Laboratories. With Customer’s prior written consent, not to be unreasonably withheld or delayed, Lonza may subcontract the performance of specific obligations of Lonza under this Agreement or a Statement of Work to a qualified Subcontractor and/or External Laboratory; provided that (a) the relevant Statement of Work identifies the Subcontractor or External Laboratory and the specific Services to be performed by the Subcontractor or External Laboratory or Customer separately approves such Subcontractor or External Laboratory in writing, (b) the Subcontractor or External Laboratory performs such Services or obligations under the relevant Statement of Work in a manner consistent with the terms and conditions of this Agreement and such Statement of Work and (c) prior to performing any Services hereunder, such Subcontractor and/or External Laboratory has executed a quality agreement with Lonza. Except as otherwise agreed upon in a Statement of Work, Lonza will be solely responsible for the performance of any permitted Subcontractor or External Laboratory, and for Losses arising out of such performance as if such performance had been provided by Lonza itself under this Agreement or the relevant Project Plan or Statement of Work. Lonza will cause any such permitted Subcontractor and/or External Laboratory to be bound by, and to comply with, the terms of this Agreement or the relevant Statement of
14 Work, including all confidentiality, intellectual property, recordkeeping, audit and inspection, quality assurance, regulatory and other obligations and requirements of Lonza set forth in this Agreement or the relevant Statement of Work. For the avoidance of doubt, Lonza shall not be responsible for any services performed by External Laboratories or any subcontractor which Customer requires Lonza to use and which Lonza has not selected or qualified independently. 2.4 Affiliates. Lonza, in its sole but reasonable discretion, may instruct one or more of its Affiliates which are pre-approved by Customer in writing to perform any of Lonza’s obligations contained in this Agreement and any particular Project Plan as set forth in a Project Plan, provided, however, that Lonza shall remain fully responsible and liable to Customer in respect of those obligations. Any of Lonza’s Affiliates shall be subject to all of the applicable terms and conditions applicable to Lonza under this Agreement and shall be entitled to all rights and protections afforded to Lonza under this Agreement. Lonza shall provide notice to Customer of such instruction to Customer within [***] of such instruction to an Affiliate. 2.5 Technology Transfer and Supply of Customer Confidential Information and Customer Materials to Lonza. 2.5.1 Customer shall transfer to Lonza the Customer Confidential Information, Customer Background Intellectual Property, Customer Materials and any other information or materials, which are reasonably required for Lonza to perform the Services, as set forth in a Project Plan. The Parties expressly agree that they shall work together to complete the transfer. 2.5.2 The customs value of the finished Product provided by Lonza to the Customer comprises of the contractual Price of the Batch, in addition to the value of the Customer provided Assist. In order for Lonza to comply with its customs obligations, the value of an Assist must be declared to the customs authority at the time of import and export, and therefore Customer shall declare to Lonza the value of the Assist which shall be incorporated into the customs declaration. 2.5.3 Upon request, Customer shall provide the export control classification or any government classification or commodity jurisdiction determinations, any preferential trade agreements under which the Product originates, Certifications of Origin or certifications/declarations of preferential origin eligibility, and Country of Origin. Unless otherwise set forth in the applicable SOW, Lonza shall provide Customer export compliance services under this Agreement including but not limited to export clearance of direct shipments until such time as the Parties agree otherwise. 2.5.4 US Facility. In the event that Lonza has available manufacturing capacity (either acquired and/or built) that can support the manufacturing of the Product from a Lonza manufacturing facility in the US (“US Facility”), which is approved by the FDA (and/or another Regulatory Authority) and successfully audited by Customer, the Parties may agree to transfer the Manufacturing Process of the Product from the Facility at which Manufacturing is then being conduct to the US Facility to increase supply chain security for the Product and/or to fulfil Product Forecast. 2.6 Master Batch Record. Preparation and translation of the Master Batch Records is governed by the Quality Agreement.
15 2.7 Commencement Date. “Commencement Date” means the date of initiation of specific Services under an SOW which for the manufacture of cGMP Batches shall mean as follows for each of the following: 2.7.1 for cGMP mAb manufacture Services: the date on which a vial of cells is removed from frozen storage for the production of a Batch; 2.7.2 for cGMP Drug Substance Batch manufacture Services: the date on which the mAb is removed from frozen storage for the production of a Batch; and 2.7.3 for cGMP Drug Product Batch manufacture Services: the date on which the bulk drug substance is removed from frozen storage for the production of a Batch; 2.8 cGMP Drug Substance Batches, cGMP Conjugation Batches and cGMP Drug Product Batches. Lonza will, in accordance with the terms of this Agreement and the Quality Agreement: 2.8.1 Manufacture and Release to Customer cGMP Drug Substance Batches in accordance with cGMP and which meet the applicable Specifications, together with a Certificate of Analysis; 2.8.2 Manufacture and Release to Customer cGMP Conjugation Batches in accordance with cGMP and which meet the applicable Specifications, together with a Certificate of Analysis; 2.8.3 Manufacture and release to Customer cGMP Drug Product Batches in accordance with cGMP and which meet the Specifications, together with a Certificate of Analysis; However, Lonza shall comply with its performance obligations set out in Clause Error! Reference source not found.2 and 2.9 and shall in relation to all cGMP Batches of Product be responsible for meeting such Specifications, as may be agreed in writing prior to commencement of the Services, in respect of the following: For cGMP Drug Substance Batches (i) bioburden; (ii) mycoplasma; (iii) in vitro tests (3 cell lines); (iv) endotoxin; and (v) minute virus of mice (MVM) For cGMP Conjugation Batches: the Specifications agreed upon in the Quality Agreement. For cGMP Drug Product Batches: (i) sterility; and (ii) fill volume 2.9 Raw Materials.
16 2.9.1 Lonza Procured Materials. Lonza shall purchase the necessary Lonza Procured Materials and consumables necessary for the manufacturing of the Product as well as any Safety Stock. Customer shall, in accordance with the terms and conditions of this Agreement, be responsible for the costs for all Raw Materials, consumables, and Special Materials ordered or irrevocably committed to be procured by Lonza hereunder (including the Safety Stock), as well as the applicable Handling Fee. If the actual costs of any Raw Materials is anticipated to be more than [***] of the estimated price set out in the Project Plan, then Lonza shall notify Customer and the Parties shall then discuss and agree any next steps (noting always that not buying such Raw Materials could have an impact on the timelines). If no such agreement can be reached Lonza may purchase such Raw Materials and shall use its reasonable endeavors to obtain a price which is reasonable in the circumstances. In the event that Customer requires Lonza to source Lonza Procured Materials from a supplier outside of Lonza’s supply chain, and as a result Lonza is unable to obtain the necessary quantity of Lonza Procured Materials to initiate the manufacture of a Batch in accordance with the estimated timeline, the delay shall be deemed a Customer delay and subject to Clause 6.4. Lonza shall invoice Customer for all Raw Material disposition costs for which Customer is responsible for under Section 2.9.5. Lonza shall be responsible for the cost of any expired Raw Materials if (a) Lonza delays any Batch or Campaign causing the expiry of any Raw Materials or Customer Materials or (b) if Lonza purchases Safety Stock in excess of Lonza’s written policy with respect to Safety Stock without Customer’s written approval. Accordingly in the case of (a) or (b) above, if Customer has already made payment for such expired Raw Materials, then Lonza shall credit the cost of such Raw Materials, including Handling Fees and taxes. 2.9.2 Customer Materials. Customer shall, at its cost, provide all required Customer Materials indicated in the Project Plan as Customer Materials, including any Customer Materials required for any Safety Stock in accordance with the Quality Agreement. If not set forth in the Quality Agreement, Lonza shall provide sufficient notice to Customer in order for customer to procure any Customer-supplied Customer Materials. 2.9.3 Safety Stock. Lonza shall manage the Safety Stock in accordance with Lonza’s Safety Stock standard practices. Any request from Customer to maintain the Safety Stock below the required minimums according to Appendix C shall be agreed in writing between the Parties at least [***] before the start of the first Batch in a Campaign or as otherwise agreed between the Parties. Notwithstanding Clause 2.9.5, if, as a direct result of Customer requesting in writing that minimums be maintained below the required Safety Stock levels, Lonza does not have the necessary quantity of Raw Materials, consumables or Special Materials to initiate the manufacture of a Batch in accordance with the agreed upon timeline, the Batch shall be deemed a customer delay and subject to Section 6.4. In the event that Lonza fails to reasonably manage Safety Stock and as a result of such failure, Customer’s manufacturing schedule during the Binding Period is affected by a delay of [***], Section 7.5 shall be applicable accordingly. Lonza agrees to use commercially reasonable efforts to monitor Safety Stock and Customer’s Project Manager reasonably and regularly informed and updated of any anticipated shortages in Safety Stock.
17 2.9.4 On a rolling [***] basis by the [***] during which a Project Plan is in place, Lonza shall provide Customer an inventory on hand report to Customer of all Product and Customer Materials. Lonza shall provide regular inventory reporting or a transaction report on a [***] basis and promptly assist in the reconciliation of any variance by answering inquiries, and resolving discrepancies as soon as possible and in any event within [***]. 2.9.5 Disposition of Raw Materials. 2.9.5.1 Batch Cancellation. Upon cancellation of a Batch by Customer or expiration or termination of this Agreement, Customer shall, within [***] from written notice of the cancellation, expiration or termination, request in writing from Lonza one of the following options, at Customer’s cost, for disposition of unused Raw Materials, consumables and Special Materials purchased for Customer: (i) store, for a reasonable period of time, Raw Materials, consumables and Special Materials for a subsequent Batch of Product manufactured under this Agreement; (ii) ship Raw Materials, consumables and Special Materials to Customer or Customer’s third party designee; or (iii) dispose of the Raw Materials, consumables and Special Materials. If Customer does not provide a written request regarding the Raw Materials, consumables and Special Materials within [***] then Lonza shall decide on the disposition of the Raw Materials, consumables and Special Materials. 2.9.5.2 Expiration of Raw Materials. Lonza shall rotate all Raw Material, including Safety Stock in accordance with its SOPs, and shall use all Raw Materials in the order of expiry (from earliest to latest) in order to avoid unnecessary expiry of Raw Materials. Customer shall pay any associated disposal cost of Raw Materials in the event that they pass their expiry date only where such expiration is caused by reasons within Customer’s reasonable control; provided, however, that Customer will not be obligated to pay for any Raw Material costs incurred by Lonza to replace inventory of Raw Materials in the Safety Stock that has expired prior to the Commencement of the next Batch to the extent that such expiration is due to a delay or postponement of the Commencement Date caused by Lonza. 2.9.5.3 Process and Material Changes. Where a process or material change request is requested by Customer which will lead to costs for the purchase and/or disposition of Raw Materials, an estimate of the costs will be provided to Customer in writing. Upon Customer’s confirmation in writing of the purchase of Raw Materials for a process or material change, Customer shall be fully liable for the disposition costs of the Raw Materials. 2.9.5.4 Vendor Raw Material Changes. Where the vendor or supplier of a certain Raw Material makes a change to the Raw Material such that the change will result in the inability of Lonza to use the current inventories of that certain Raw Material and therefore requiring disposition of the Raw Material, Lonza and Customer will work jointly to minimize such disposition costs.
18 2.9.5.5 The disposition costs of Raw Materials for purposes not enumerated herein shall be negotiated in good faith between the Parties. 2.9.5.6 Mitigating Disposition Costs. Lonza agrees to use reasonable efforts to mitigate Customer’s cost related to the disposition of Raw Materials and consumables costs in connection with a cancelled Batch. 2.10 Technology License. Customer acknowledges that the terms and conditions, including technology transfer and any payments due, under the Technology License are separate and distinct from the terms and conditions, including any payment due, under a technology transfer agreement for the Manufacturing Process, as set forth in Clause 10.6. 2.11 Cell Bank Storage. In the event that Lonza shall provide Cell Bank Storage then Appendix B will apply. 2.12 Continued Process Verification. Continued process verification will be performed after each manufacturing Campaign in accordance with Lonza's policy and procedures. 2.13 Key Performance Indicators. The Parties agree that performance under this Agreement shall be evaluated using Key Performance Indicators (KPIs), which shall be monitored, reviewed, and updated as agreed by both parties to ensure quality, efficiency, and reliability of manufacturing Services. Unless otherwise agreed in the JSC the following KPIs shall be used to assess Lonza's performance: [***]. Lonza shall prepare and provide to Customer a [***] KPI report presented during the JSCs. The report shall include performance data, trend analysis, and any corrective actions taken. The Parties shall meet at least [***] (in person or via teleconference) to review KPI results, discuss any areas of concern, and implement continuous improvement initiatives where applicable. 3 Project Management 3.1 Project Plans. A Project Plan, to be attached by an amendment to this Agreement shall be agreed by the Parties in writing and shall include a description of the Services to be provided, the Product to be manufactured, Customer Materials), a Bill of Materials, Specifications, a schedule for completion of the Project Plan, pricing details, and such other information as is necessary for the relevant Services. In case of conflict between this Agreement and a Project Plan, this Agreement shall prevail to the extent such Project Plan does not expressly provide that it shall govern with respect to such conflict and specifically identifies the Clauses of this Agreement that such Project Plan intends to modify. 3.2 Project Management. With respect to each Project Plan, each Party will appoint a project manager who will be responsible for overseeing the performance of the Project Plan (each a “Project Manager”). All day-to-day communication(s) between
19 Parties related to the performance of the Services shall be between such appointed project managers, unless otherwise agreed in writing between the Parties. Lonza’s Project Manager and team providing Services to Customer under this Agreement shall be qualified to perform the project management tasks and shall be replaced as soon as reasonably practicable by Lonza if not performing in Customer’s reasonable opinion. Each Project Manager shall be available on at least once every [***] basis for consultation (i.e. face-to-face meetings (if required), telephone- conferences and/or videoconferences) at times prearranged by the Parties during the term of this Agreement. Each Party shall appoint a substitute or replacement Project Manager in the absence of its original Project Manager by notifying the other Party in writing of such substitution or replacement. 3.3 Person in Plant. Subject to Lonza’s prior reasonable approval, Customer shall be permitted to have [***] for the purpose of observing, reporting on, and consulting as to the performance of the Services. The duration, timing and other specifics of such visit will be mutually agreed upon by the Parties but for clarity, Lonza’s prior approval shall not be unreasonably withheld. Such [***] shall be subject to and agree to abide by confidentiality obligations set forth in Clause 13 and Lonza’s customary practices, operating procedures and security procedures regarding persons in plant, and any related instructions of Lonza’s employees at the Facility, all to the extent provided to the Customer. If Customer requires long-term access for such [***], the Parties shall set forth any agreed upon office support Lonza will provide in a Statement of Work or other executed written agreement between the Parties. [***], as applicable of Customer and not of Lonza. 4 Quality 4.1 Responsibility for quality assurance and quality control of Product shall be allocated between Customer and Lonza as set forth in the Quality Agreement. If there is a conflict between the terms and conditions of this Agreement and the Quality Agreement, the terms and conditions of this Agreement shall prevail with the exception that the Quality Agreement shall control for matters solely relating to the quality and disposition matters, including cGMP. If the Quality Agreement is not in place at the Effective Date, Lonza and Customer commit to enter into the Quality Agreement in a timely manner, but in no event later than the Commencement Date of cGMP Services. 4.2 Provisions regarding inspections by Regulatory Authorities and audits shall be set out in the Quality Agreement. 4.3 Records. Lonza will maintain accurate records for the manufacture of the Product, in accordance with, and for the time periods required by, Applicable Laws and in accordance with the Quality Agreement. Such records are the sole and exclusive property of Customer and shall constitute Customer’s Confidential Information except to the extent they incorporate any Lonza Operating Documents, Lonza Confidential Information, New Lonza Intellectual Property or Lonza Background Intellectual Property. 4.4 Regulatory Support. 4.4.1 In connection with a filing for Approval of the Product to a Regulatory Authority, and securing and maintaining such Approval, Lonza will provide Customer with the documents reasonably requested by Customer or necessary for Customer to address an inquiry from a Regulatory Authority.
20 If the Manufacturing Process is performed using a Lonza proprietary process or Lonza proprietary analytical assay(s), Lonza will provide the necessary Lonza Manufacturing Process Documents to the regulatory affairs department of Customer solely for the purpose of including in a filing for Approval of the Product to a Regulatory Authority. Lonza shall at Customer’s discretion and not prohibited by the Regulatory Authority, either provide the Lonza Operating Document directly to the Regulatory Authority or provide the Lonza Operating Documents under strict confidentiality to the regulatory affairs department of Customer solely for the purpose of including in a filing for Approval of the Product to a Regulatory Authority or to address an inquiry from a Regulatory Authority. 4.4.2 At a reasonable time prior to Customer’s submission of any information to a Regulatory Authority related to Lonza or the Services provided under this Agreement, Customer shall provide to Lonza, for Lonza’s review, copies of the information. Lonza shall provide Customer with its comments in accordance with a timeline to be agreed on a case by case basis, at all times with due regard to the timetable set by the applicable Regulatory Authority. 5 Insurance 5.1 Each Party shall for itself and all of its applicable Affiliates obtain and maintain at its own cost and expense from a qualified insurance company, 5.1.1 comprehensive general liability insurance (including public, products and pollution liability) coverage in the amount of at least [***] (or equivalent in other tradable currency) per claim or [***] (or equivalent in other tradable currency) in the annual aggregate, during the Term and for [***] after Release of the last Product manufactured or Services provided under this Agreement; and 5.1.2 employer’s liability or workers compensation in accordance with the minimum amount required by Applicable Law(s). 5.2 Customer shall, during the Term obtain and maintain at its own cost and expense from a qualified insurance company, 5.2.1 adequate property insurance covering the risk of loss of Customer Materials; and 5.2.2 such other insurance as may be relevant to the performance of any provision of this Agreement including but not limited to Clause 7.2. 5.3 In respect of the insurances required from Customer in Clauses 5.1 and 5.2, Customer shall procure that insurers waive all rights of subrogation against Lonza. 5.4 Each Party shall provide the respective other Party with a certificate of such insurance upon reasonable request. 5.5 Nothing contained within this Clause shall limit a Party’s liability under this Contract. 6 Forecasting, Ordering and Cancellation
21 6.1 Forecasting. No later than [***], Customer shall supply Lonza with a written forecast showing Customer’s good faith estimated [***] requirements for Batches for the following [***] period (the “Rolling Forecast”). No later than [***] following Lonza’s receipt of a Rolling Forecast, Lonza shall provide written response to Customer and inform Customer of (i) acceptance of the newly added months of the Rolling Forecast, (ii) rejection of such forecast or (iii) additional time required corresponding to a new response date from Lonza. for the newly added months of the Rolling Forecast (the “Response”). Lonza's failure to provide a Response within [***] shall be deemed acceptance of such Rolling Forecast. Upon acceptance by Lonza, the first [***] for Drug Substance (mAb), the first [***] for Conjugated Drug Substance and the first [***] of for Drug Product shall constitute a binding and non-cancellable commitment by Lonza to Manufacture such Batches and a binding and non-cancellable commitment by Customer to purchase such Batches on the timelines set forth therein (“Binding Forecast”). For clarity, the Parties explicitly agree that such Forecast and Lonza’s obligation to Manufacture such Batches may not be for less than the Minimum Volume Commitment. In addition, Lonza shall provide capacity availability for the period outside the Binding Forecast and reserve this capacity, however only amounts within the Binding Forecast and Minimum Volume Commitment are bound. The remaining months in such Rolling Forecast will constitute a non-binding commitment by Lonza to Manufacture such Batches and a non-binding commitment by Customer to purchase such Batches (the “Non-Binding Forecast”). 6.2 Minimum Volume Commitments. The Parties agree that the Batches set forth in Table 1 of Attachment A to the Capacity Reservation Agreement between the Parties dated May 8, 2025 are the minimum number of Batches [***] committed to be manufactured by Lonza and purchased by Customer for each of the years during the period from 2026 to 2028 (the “Minimum Volume Commitments”). The Parties may agree to add additional Batches to the Minimum Volume Commitments pursuant to executed written agreement between the Parties. If Customer fails to purchase such Minimum Volume Commitments for reasons other than Lonza’s material breach of this Agreement or the Capacity Reservation Agreement, or Lonza’s failure to Deliver the Minimum Volume Commitments, then Customer shall owe the [***] for the number of Batches below the Minimum Volume Commitment, less any amounts paid for such Batches, within [***] following receipt of accurate invoice for same. 6.3 Purchase Orders. Within [***] of acceptance by Lonza of each Rolling Forecast, Customer shall submit a Purchase Order for the quantities subject to the Binding Forecast (or newly-added portion thereof), which shall be deemed accepted by Lonza and become a part of this Agreement if it accords with the Binding Forecast accepted by Lonza (each such purchase order submitted hereunder, a “Purchase Order”). In addition to Purchase Orders submitted in connection with the Rolling Forecast, Customer may, from time to time, place Purchase Orders with Lonza for Manufacture and delivery of Batches of Product, including any Product for which a Binding Forecast is not required by the applicable SOW and in cases where Customer desires to submit a Purchase Order increasing the number of Batches to be manufactured during the period corresponding to the Binding Forecast, all of which must conform to any lead times specified in the applicable SOW and will be subject to acceptance by Lonza. Each Purchase Order shall be signed by Customer
22 and shall authorize Lonza to manufacture such Batches of the Product as are set forth therein. Lonza shall use commercially reasonable efforts to accept any Purchase Order in excess of the quantities set forth in the Binding Forecast. To the extent that the terms of a Purchase Order are inconsistent with the terms of this Agreement, this Agreement shall control. Subject to Section 6.4 below and the Reservation Agreement, a delivery date set forth in Lonza’s written confirmation of a purchase order shall be an estimated delivery date only. For clarity, Lonza is bound by the commitment in the Reservation Agreement with respect to delivery of Batches within the Minimum Volume Commitment for the years set forth in Appendix A thereto. Any additional or inconsistent terms or conditions of any document including a Customer purchase order, acknowledgement or similar standardized form given or received pursuant to this Agreement shall have no effect and such terms and conditions are hereby rejected unless explicitly stated to take precedence over, amend, or govern this Agreement and executed by both Lonza and Customer. 6.4 Rescheduling. For reasons not within Lonza’s reasonable control, Lonza shall have the right to reschedule a Commencement Date of any Batch or Campaign upon [***] prior written notice to Customer, provided that the rescheduled Commencement Date is mutually agreed in writing between the Parties, where Customer`s agreement shall not be unreasonably withheld. If Lonza reschedules any Batches within the Binding Forecast it shall ensure prior to such rescheduling it has the Raw Materials and Customer Materials available for such Rescheduled Commencement Date. If Lonza requests an additional delay in writing, Customer shall use good faith efforts in evaluating such request. 6.5 Customer Delay. 6.5.1 Where caused by Customer’s failure to provide the (a) Manufacturing Process, Customer Confidential Information, Customer Background Intellectual Property or (b) Customer Materials for reasons within Customer’s reasonable control, Customer shall be responsible for any material delays in the Services and for all actual additional costs and expenses incurred by Lonza, including any disposition of Raw Materials under 2.9.55, directly arising out of such delay, including, if applicable, any idle Facility capacity costs. 6.5.2 For reasons not within Customer’s reasonable control, Customer shall have the right to request to reschedule a Commencement Date of any Batch or Campaign upon reasonable prior written notice to Lonza, provided that the requested rescheduled Commencement Date is no later than [***] from the Commencement Date originally agreed upon at the time of Lonza’s acceptance of the Purchase Order. Lonza shall use good faith efforts in accommodating such request. If Customer requests an additional delay in writing, Lonza shall use good faith efforts in evaluating such request. 6.6 Cancellation of Services. Customer may cancel Services, including production of a Batch to be manufactured under a Project Plan, upon written irrevocable (unless agreed to in writing by Lonza) notice to Lonza, subject to Customer’s obligation to pay for all Services rendered up to the date of cancellation, plus the payment of a cancellation fee as calculated below (the “Cancellation Fee”):
23 6.6.1 Minimum Volume Commitments. If Customer does not purchase the Minimum Volume Commitments for the applicable year for reasons other than Lonza’s material breach of this Agreement or the Reservation Agreement, or Lonza’s failure to Deliver the Minimum Volume Commitments, including any additions to the Minimum Volume Commitments memorialized in an executed writing by the Parties, then Customer shall owe [***]% Cancellation Fee for such Batches less any amounts already paid. 6.6.2 Batches ordered in addition to the annual Minimum Volumes Commitments may be canceled by Customer and Cancellation Fees shall be governed by Section 6.1 (Binding Forecast) 6.6.3 Clinical Failure. [***] 6.6.4 Payment of Cancellation Fee. Any Cancellation Fee and any fees payable under Clause 6.6 shall be payable within [***] or as otherwise mutually agreed in writing by the Parties following the written notice of cancellation associated with the cancelled Service or Batch. 6.6.5 Additional Costs. In the event of cancellation by Customer for reasons other than Force Majeure, in addition to any Cancellation Fee, Customer shall reimburse Lonza for any non-cancellable, out-of-pocket costs for Raw Materials and consumables reasonably incurred by Lonza in fulfilling such cancelled Batch or Purchase Order up to the time of Lonza’s receipt of such notice of cancellation. Such reimbursement shall only be made to the extent of costs that are not otherwise recoverable by Lonza. Title in all Raw Materials for which Customer so reimburses Lonza shall vest in Customer. Such Raw Materials and consumables shall not be used for any purpose other than the manufacture of Products for Customer hereunder, unless otherwise agreed in writing by Customer. At Customer 's request, all Raw Materials and consumables paid for by Customer under this Section 6.6 shall be shipped to Customer at Customer’s expense. 6.6.6 Replacement Project. Notwithstanding the foregoing, following the cancellation of a Batch, Lonza shall use good faith commercially reasonable efforts to mitigate damages and secure a replacement project (which shall exclude any batch associated with a project then under contract with Lonza, unless additional batches are ordered within the framework of such existing project) for the cGMP manufacturing space, and for the dates and duration that would have been occupied by Customer. In the event that Lonza is able to secure such a replacement project from a bona fide third party, the Cancellation Fee for the cancelled Batch shall be reduced by an amount equal to [***] of the Cancellation Fee. If another of Customer’s products is the replacement project, then no Cancellation Fee shall be owed for any such cancelled cGMP Batch of Product. 7 Customs, Delivery, and Acceptance 7.1 Packaging and Shipping. Lonza will package and label the Product for shipment in accordance with the Master Batch Record and Lonza’s standard practices in effect at the time of performance by Lonza. Lonza shall supply to Customer within [***] of completion the Certificate of Analysis, the Certificate of Compliance, the Batch Records, analytical raw data, and such other documentation as is reasonably
24 required to meet all applicable regulatory requirements of the Regulatory Authorities which shall constitute release by Lonza of the Product which meets Specifications for delivery (the “Release”) and in any event not later than the agreed upon date of the Delivery (as defined below) of Product. Lonza shall deliver the Product Free Carrier (FCA) (Incoterms® 2020) at the applicable Facility cleared for export and loaded onto any collecting vehicle by Lonza (“Delivery”). Lonza shall promptly inform Customer if Lonza reasonably believes that it shall be unable to meet the agreed upon Delivery date. 7.2 Risk of Loss. 7.2.1 Product. Title in the Product shall pass to Customer upon Release in accordance with Clause 7.1. When there is no additional Lonza Services, risk of loss shall remain with Lonza until the earlier of (a) Delivery to Customer and (b) [***] after Release. When Release occurs but Product stays with Lonza for further Services, including shipment between Facilities, Product shall be considered Customer Materials for purposes of such further Services. 7.2.2 Customer Materials. With respect to any Customer Materials, title and risk of loss shall remain with the Customer throughout Services and shall not transfer to Lonza Notwithstanding the foregoing, Lonza shall bear risk of loss for all Customer Materials, including but not limited to Product to the extent any such loss is due in any part to Lonza’s [***], except with respect to transfer of cGMP Batch(es) Product by Lonza between Lonza sites, in which case the applicable standard will be [***]. 7.3 Storage. Customer shall arrange for shipment and take Delivery of such Product from the Facility, at [***]’s expense, within [***] after Release or pay applicable storage costs. Lonza shall provide storage on a bill and hold basis for such Product at no charge for up to [***] after Release. Any additional storage beyond[***] and up to a maximum of [***] after Release will be subject to availability and, if storage is available, a storage fee will be charged to [***]. At Lonza’s sole discretion, any additional storage beyond [***] may require a separate agreement. Notwithstanding the foregoing, Lonza shall not charge the Customer for any storage of any Batch prior to or following shipment between the Lonza Facilities whilst such Batch is waiting further Services from Lonza. In any event, beyond [***] after Release, Customer shall be required to insure Product. Notwithstanding anything to the contrary contained in this Agreement, in no event shall Lonza be required to store any Drug Product for more than [***] after Release. Within [***] following a written request from Lonza, Customer shall provide Lonza with a letter in form satisfactory to Lonza confirming the bill and hold status of each stored Product. 7.4 Acceptance/Rejection of cGMP Batches. 7.4.1 Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] of Release, after which time all unrejected Batches shall be deemed accepted; provided that (a) Lonza provides timely answers to information requests and resolution of issues arising from Customer’s review of such Batch (and the [***] period shall be extended to account for Lonza’s failure to provide timely answers to
25 information requests and resolution of such issues); and (b) failure to notify shall not prejudice Customer’s right to reject or revoke acceptance of the Batch if the non-conforming condition causing the Product to fail to meet Specifications could not have been detected by Customer’s inspection undertaken pursuant to this Clause 7.4.1 (“Latent Defect”), provided that any such notification shall be provided to Lonza within [***] of delivery of the Product; and (c) the warranty provided in 11.1 and Lonza’s obligations under Clause 7.4.3 shall survive acceptance of the Batch by Customer until expiration of the additional [***] period specified above for Latent Defects. In the event that Customer desires to accept a Batch prior to the end of the applicable notice period, Customer will provide written notice of such acceptance to Lonza. 7.4.2 Any Batches rejected by Customer are to be returned to Lonza, at Lonza’s expense, or held in quarantine and in no circumstances shall the Customer use or destroy the Batches. Customer shall provide Lonza with written notice of rejection of any Batch, which shall specify the manner in which the Batch fails to conform to Specifications and/or the warranties set forth in Clause 11.1. If Lonza believes in good faith that a cGMP Batch, which has been incorrectly rejected, Lonza may require that Customer provides samples to Lonza for testing. Lonza may retain and test such samples. If there is a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within the relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall appoint an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the cGMP Drug Substance Batch that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 7.4.3 If it is determined (by the Parties or the independent laboratory) that a rejected cGMP Batch failed to comply with cGMP or conform with the Specifications (such Batch being a “Failed Batch”) due to a Lonza Responsibility, Lonza shall, at Customer’s election either: (i) Provide [***] paid by Customer in respect of such Failed Batch and associated Raw Materials, to the extent paid by Customer; or (ii) schedule a replacement cGMP Batch to be manufactured (the timing of which shall be subject always to available capacity in the Facility), and Customer shall be responsible for the cost of such replacement cGMP Batch and Raw Materials used therein but not the Failed Batch (and any money it paid towards the Failed Batch, Raw Materials, Special Materials, shall be credited to the Price of such replacement cGMP Batch and materials therefor). Such replacement shall be made as promptly as practicable, in light of available manufacturing capacity, rejection, and in any case as soon as reasonably possible. Where possible and if acceptable to Customer, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. In addition to providing the replacement Batch in accordance with the
26 foregoing terms, for each Failed cGMP Drug Product Batch or a Failed cGMP Conjugated Batch where the failure of such Batch is due to a Lonza Responsibility, Lonza shall also credit an amount of [***]. Customer acknowledges and agrees that its sole remedy with respect to a Failed Batch that is a Lonza Responsibility and is not a substantial failure is as set forth in Clauses 7.4.3 above. 7.5 Substantial Failure. [***] 8 Price and Payment 8.1 Pricing. Customer shall pay for all of the Services performed hereunder and the Batches delivered in conformance with Specifications, cGMP and applicable laws as agreed upon in the in the applicable SOW. The Price is deemed full compensation for all work performed by Lonza relating to the manufacture and supply of Product hereunder, including without limitation all overhead, quality inspection and agreed upon activities performed by Lonza unless provided otherwise herein or in the applicable SOW or Project Plan. In the event of proposed changes to the Services at Customer’s request Lonza shall prepare pricing for Customer’s review and no such changes or increased costs shall be effective unless agreed upon in writings. 8.2 Raw Materials, Special Materials and Handling Fees. In addition to Clause 8.1, Customer shall also pay for all Raw Materials and Special Materials ordered or irrevocably committed to be procured by Lonza specifically for the Services and the Handling Fee. Customer shall have the right on its own costs and during the Term and for a period of [***] thereafter, to have an independent certified public accountant reasonably acceptable to Lonza examine the relevant books and records of Lonza and its Affiliates during normal business hours, not more than [***] without cause, to verify the pass through costs that have been charged to Customer under this Agreement. In the event a determination is made that Lonza has been underpaid, the Customer shall promptly pay Lonza the amount by which Lonza was underpaid. In the event a determination is made that the Customer has been overcharged Lonza shall promptly pay Customer the amount by which Customer was overcharged and the cost of the audit. Any accountants who examines the books and records of Lonza pursuant to this provision shall be bound by confidentiality obligations reasonably satisfactory to Lonza. 8.3 Taxes. Unless otherwise indicated in writing by Lonza, all Prices and charges are exclusive of value added tax (VAT) and of any other applicable taxes, levies, import, duties and fees (the “Taxes”) of whatever nature imposed by or under the authority of any government or public authority and all such charges applicable to the Services shall be paid by Customer. 8.4 Invoicing. Lonza shall issue invoices to Customer for [***] percent ([***]%) of the Price for Services and Batches upon commencement of the applicable Stage of Work and [***] percent ([***]%) upon Release of applicable Batches or completion of applicable Stage of Work, unless otherwise stated in the Project Plan. Charges for Raw Materials and the Handling Fee for each Batch shall be invoiced upon the
27 Release of each Batch, other than charges for Special Materials identified in a Project Plan which shall be invoiced by Lonza upon placement of purchase orders for such Special Materials identified in a Project Plan by Lonza at the cost plus Handling Fee. All invoices are strictly net and payment must be made within [***] of date of invoice. Until such time that Lonza receives payment in full for each Batch and any other deliverable, Lonza shall maintain a security interest or pledge in such Batch and other deliverable. Payment shall be made without deduction, deferment, set-off, lien or counterclaim. When sending payment to Lonza, the Customer shall quote the relevant invoice number in its remittance advice. All invoices shall include reference to the applicable Avidity purchase order number and purchase order line item number. If in default of payment of any undisputed invoice on the due date, interest shall accrue on any amount overdue at a rate of [***]. Interest shall accrue until full payment; and Lonza shall, at its sole discretion 8.5 Price adjustments. 8.5.1 Annual Price Increase. Services. Not more than [***] with notification no later than [***], Lonza may adjust the Price in accordance with [***]. Lonza shall, in its written notification to Customer, set forth the specific Purchase Orders for affected Services and state the prior price and the new price. The new Price reflecting such Batch Price adjustment shall be effective for any Batch identified for which the agreed upon Commencement Date has prior to such notice already been set as after the first day of April following receipt of such written notice. 8.5.2 Exceptional Price Increase. In addition to the above, the Price may be changed by Lonza, upon reasonable prior written notice but in no event less than [***] to Customer (providing reasonable detail in support thereof), to reflect an increase in variable costs (such as energy or Raw Materials) by [***] (based on the initial Price or any previously amended Price) 9 Capital Equipment 9.1.1 Any Capital Equipment required to be acquired for the performance of the Services shall be acquired on terms to be agreed by the Parties prior to commencement of the relevant Services. 9.1.2 Unless otherwise agreed in a Statement of Work, Lonza will procure all Capital Equipment necessary to perform the Services. 9.1.3 For Capital Equipment procured by Lonza, the one time cost of the Capital Equipment, qualification and validation of the Capital Equipment and recurring normal maintenance costs for the Equipment, outside warranty and covered maintenance that were included with the original equipment purchase agreement negotiated by Lonza on behalf of Customer shall be paid by Customer to Lonza as a pass through cost, in which case the Capital Equipment is dedicated to Customer and shall be used solely for the performance of Services to Customer. 9.1.4 Lonza shall provide proof of purchase, warranties, maintenance agreements, invoices or other relevant documents substantiating any
28 expense incurred at the request of Customer. 9.1.5 Title to such Capital Equipment will always remain with Lonza (for insurance purposes) and Lonza will ensure that the Equipment is properly labelled and remains free and clear of any liens or encumbrances. 9.1.6 At Customer’s request, the dedicated Capital Equipment and title thereto will be returned to Customer, or to its designee for a nominal fee to be agreed in the Statement of Work. Lonza will promptly notify Customer if at any time it believes any Capital Equipment has been damaged, lost or stolen. 10 Intellectual Property 10.1 Background Intellectual Property; No Implied License. Except as expressly otherwise provided herein, neither Party nor its Affiliates will, as a result of this Agreement, acquire any license, right, title, interest in or to, any Background Intellectual Property of the other Party. 10.2 New Intellectual Property Ownership 10.2.1 Customer Ownership. Customer shall own all right, title, and interest in and to [***] (collectively, the “New Customer Intellectual Property”). Customer’s Background IP and New Customer Intellectual Property collectively, the “Customer Intellectual Property”) 10.2.2 Customer is not permitted to include or disclose [***]. For clarity, New Customer Intellectual Property shall exclude Lonza Intellectual Property. 10.2.3 Lonza Ownership. Intellectual Property developed, conceived or reduced to practice in the course of the performance of the Services, that relates [***], is and shall become the sole property of Lonza (collectively “New Lonza Intellectual Property”). 10.2.4 Lonza is not permitted, in seeking protection for, or exploiting, New Lonza Intellectual Property, to disclose Customer Confidential Information, without prior written consent from Customer. For clarity, New Lonza Intellectual Property shall exclude Customer Intellectual Property and no right, title or ownership of any Customer Intellectual Property is granted to Lonza for it to use the New Lonza Intellectual Property or otherwise, except to the extent explicitly stated in this Agreement. 10.3 Assignment of New Intellectual Property. 10.3.1 Assignment to Customer. Lonza hereby assigns to Customer all of its right, title and interest in any New Customer Intellectual Property. Lonza shall execute, and shall require its personnel as well as its Affiliates, Subcontractors, External Laboratories or other contractors or agents and their personnel involved in the performance of the Services to execute, any documents reasonably required to confirm Customer’s ownership of the New Customer Intellectual Property, and any documents required to apply for, maintain and enforce any patent or other right in the New Customer Intellectual Property.
29 10.3.2 Assignment to Lonza. To the extent that Customer has or obtains any rights, title or interest in New Lonza Intellectual Property, Customer hereby assigns to Lonza all of its right, title and interest in any New Lonza Intellectual Property. Customer shall execute, and shall require its personnel as well as its Affiliates, or contractors or agents and their personnel involved in the performance of the Services, to execute, any documents reasonably required to confirm Lonza’s ownership of the New Lonza Intellectual Property, and any documents required to apply for, maintain and enforce any patent or other right in the New Lonza Intellectual Property. 10.4 Prosecution of Patents. 10.4.1 Subject to the following subsection, Customer shall have the sole right and discretion whether or not to file, prosecute and maintain patent applications and patents claiming the New Customer Intellectual Property, at Customer’s expense. Lonza shall reasonably cooperate with Customer, at Customer’s expense, to the extent that Lonza’s cooperation is necessary for the Customer to file, prosecute, maintain, defend, and enforce patent applications and patents claiming any New Customer Intellectual Property. 10.4.2 Customer shall not, in connection with any patent filings and prosecution for New Customer Intellectual Property seek or obtain any patent claims that would be considered to be New Lonza Intellectual Property. Nonetheless, to the extent that that a patent claim that covers any New Lonza Intellectual Property ("Non-Specific Patent Claims") is included in a patent granted from prosecution of New Customer Intellectual Property, Customer hereby grants to Lonza a non-exclusive, worldwide, fully paid-up, irrevocable, non- terminable, sublicensable and transferable license under the Non-Specific Patent Claims, with the right to grant and authorize sublicenses, to make, use, sell, offer to sell, and import, a product or service (the "Non-Specific License"). The Parties agree that such Non-Specific License shall not include a license to any Intellectual Property of Customer other than as expressly set out in this Agreement. 10.4.3 Unless the Parties agree otherwise, at least [***] prior to filing any application disclosing or claiming any New Customer Intellectual Property, Customer shall provide a draft thereof to Lonza, for Lonza’s prior review and approval. Within [***] of receipt of such an application (“Review Period”), Lonza shall notify Customer of any Lonza Confidential Information or New Lonza Intellectual Property and Customer shall delete the information that Lonza has identified as Lonza Confidential Information. 10.4.4 Lonza shall have the sole right and discretion whether or not to file, prosecute and maintain patent applications and patents claiming the New Lonza Intellectual Property, at Lonza’s expense. Customer shall reasonably cooperate with Lonza, at Lonza’s expense, to file, prosecute, maintain, defend, and enforce patent applications and patents claiming any New Lonza Intellectual Property. 10.5 License Grants. 10.5.1 Subject to Clause 2.11, Lonza hereby grants to Customer, solely to the extent necessary for Customer to research, develop, make, have made, use, sell, offer to sell and import the Product produced by Lonza in its Services
30 under this Agreement and subject to the terms and conditions set forth herein a non-exclusive, irrevocable, world-wide, fully paid-up license, transferable including the right to grant sublicenses, under the Lonza Background Intellectual Property and New Lonza Intellectual Property. 10.5.2 Customer hereby grants Lonza and its Affiliates, sub-contractors and the External Laboratories the non-exclusive right to use the Customer Confidential Information, Customer Background Intellectual Property and New Customer Intellectual Property during the Term solely for the purpose of fulfilling Lonza’s obligations under this Agreement. 10.6 Technology Transfer to Customer or Third Party. 10.6.1 Technology Transfer Process. Customer may, upon providing written notice to Lonza, have the Manufacturing Process (as provided by Customer and excluding any Lonza Intellectual Property) transferred to itself or to a Third Party manufacturer by Customer without the requirement of a separate technology transfer agreement. 10.6.2 Technology Transfer Fees. The technology transfer will be subject to a fee for Lonza’s services and technical support and, where the Manufacturing Process is provided by Lonza and/or includes any Lonza Intellectual Property, a licensing fee (the “Technology Transfer Licensing Fee”). The price of the Technology Transfer Licensing Fee will depend on the extent in which the transfer of the Manufacturing Process includes Lonza Intellectual Property. Lonza will not include in the Manufacturing Process any Lonza Confidential Information or Lonza Background Intellectual Property that would require Customer to pay any Technology Transfer Licensing Fee in order to transfer the Manufacturing Process to itself, its Affiliates and/or any Third Party, without first obtaining Customer’s prior written consent and advising Customer as to the applicable anticipated Technology Transfer Licensing Fee, which the Parties shall agree upon in advance in writing. If Customer has provided such written consent and the Manufacturing Process includes the use of any such Lonza Confidential Information or Lonza Background Intellectual Property which trigger a Technology Transfer Licensing Fee, then Customer will pay to Lonza the Technology Transfer Licensing Fee. Lonza shall provide reasonably necessary documents to complete such technology transfer, and [***] (based on a full-time employee rate for such support) and expenses, provided that the total cost of such assistance (excluding any costs paid to Lonza for the use of Lonza’s Confidential Information or Lonza Background Intellectual Property) will not exceed [***]. If no Lonza Intellectual Property is included, no Technology Transfer Licensing Fee will apply. For clarity, the Technology Transfer Licensing Fee is separate and distinct from any fee(s) associated with a Technology License. 10.7 Inventor Remuneration. Customer shall comply with all applicable country-specific inventor reward and remuneration laws and regulations associated with New Customer Intellectual Property when inventor reward and remuneration obligations are triggered by an employee of Lonza and/or its Affiliates, Customer and/or its Affiliates, Subcontractors, External Laboratories or other contractors or agents and their personnel involved in generating the New Customer Intellectual Property. 11 Assurances and Warranties
31 11.1 Lonza warrants that: 11.1.1 it has the necessary corporate authorizations to enter into and perform this Agreement; 11.1.2 there are no outstanding agreements, assignments, licenses, encumbrances or rights of any kind, that would breach the provisions of this Agreement; 11.1.3 to the best of Lonza’s knowledge and belief or what reasonably should have been known or believed, the conduct and the provision of the Services, excluding the use of Customer-Provided Items, will not infringe, misappropriate or violate (as the case may be) any proprietary or Intellectual Property rights of any Third Party; 11.1.4 it shall promptly notify Customer in writing if it receives or is notified of a formal written claim from a Third Party alleging that Lonza Confidential Information, Lonza Background Intellectual Property or New Lonza Intellectual Property, as it relates to the Services under this Agreement, infringes, misappropriates or violates (as the case may be) any proprietary or Intellectual Property rights of any Third Party; 11.1.5 the Services shall be performed in accordance with all Applicable Laws; 11.1.6 the manufacture of Product shall be performed in accordance with cGMP and each cGMP Batch of Product will (i) meet the Specifications upon Release; (ii) be transferred free and clear of any liens or encumbrances of any kind to the extent arising through or as a result of the acts or omissions of Lonza and (iii) have been manufactured, handled, stored, labeled, packaged and transported in accordance with the Master Batch Records, and with cGMP and all other applicable laws, regulations and other requirements of all applicable Regulatory Authorities; 11.1.7 it or its Affiliate holds all necessary permits, approvals, consents and licenses to enable it to perform the Services at the Facility; and 11.1.8 Lonza, its Affiliates, officers, directors, employees and agents and the officers, directors, employees and agents of its Affiliates, have not paid and will not pay, offer or promise to pay, directly or indirectly, any monies or anything of value to any governmental official or employee or any political party or candidate for political office for the purpose of influencing any act or decision of such official, employee or candidate to obtain or retain business, or to direct business to any person. 11.2 Customer warrants that: 11.2.1 it has the necessary corporate authorizations, and the full power and right, to enter into and perform this Agreement, and there are no outstanding agreements, assignments, licenses, encumbrances or rights of any kind, that would breach the provisions of this Agreement; 11.2.2 all Customer-Provided Items supplied by Customer shall be provided with any environmental, health and safety information related to the Customer- Provided Items (including employee health and safety, of the handling,
32 manufacture, distribution, use and disposal of the Customer Provided Items), and will update, clarify, correct, supplement and amend such information as necessary; 11.2.3 to the best of Customer’s knowledge and belief or what reasonably should have been known or believed, it has all the rights necessary to permit Lonza and its relevant Affiliates (and any Subcontractors and External Laboratories) to manufacture the Product and perform the Services without infringing, misappropriating or violating the Intellectual Property rights of any Third Party and the Customer-Provided Items used in the provision of the Services and manufacture of the Product, shall not infringe, misappropriate or violate (as the case may be) any proprietary or Intellectual Property rights of any Third Party; 11.2.4 it has not entered into any agreement with a Third Party (including, without limitation, governmental entities, universities, funding authorities or consortia) and will not enter into any agreement without Lonza’s prior written consent that: 11.2.4.1 would convey to a Third Party any rights that would conflict with Lonza's exclusive ownership and control of Lonza Intellectual Property, including New Lonza Intellectual Property, or Lonza’s use thereof, as set forth in this Agreement; 11.2.5 as at the time that the Quality Agreement is signed, it will have an appropriate Quality function to ensure Customer’s ongoing compliance with cGMP; 11.2.6 Customer will promptly notify Lonza in writing if it receives or is notified of a formal written claim from a Third Party that Customer Information and/or Customer Intellectual Property or that the use by Lonza thereof for the provision of the Services infringes any Intellectual Property or other rights of any Third Party; 11.2.7 Customer, its Affiliates, officers, directors, employees and agents and the officers, directors, employees and agents of its Affiliates, have not paid and will not pay, offer or promise to pay, directly or indirectly, any monies or anything of value to any governmental official or employee or any political party or candidate for political office for the purpose of influencing any act or decision of such official, employee or candidate to obtain or retain business, or to direct business to any person. 11.2.8 Customer will ensure that, to the extent not otherwise covered in the Quality Agreement, Customer-Provided Items supplied by Customer, as applicable, will be, to the extent required, provided with a Certificate of Analysis or other relevant documentation demonstrating that such Customer-Provided Items meet the applicable Lonza acceptance criteria: [***]. 11.3 DISCLAIMER: THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, AND ALL OTHER WARRANTIES, BOTH EXPRESS AND IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, WITH RESPECT TO THE PRODUCTS, RAW MATERIALS, AND SERVICES PROVIDED UNDER THIS AGREEMENT ARE EXPRESSLY DISCLAIMED, INCLUDING WITHOUT
33 LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO SUCH PRODUCTS, RAW MATERIALS, OR SERVICES. 12 Indemnification and Liability 12.1 Indemnification by Lonza. Subject to Clauses 12.5 and 12.6, Lonza shall indemnify the Customer, its Affiliates, and the respective officers, employees and agents of Customer and/or its Affiliates (“Customer Indemnitees”) from and against any loss, damage, costs, liability, and/or expenses (including reasonable attorney fees) payable to Third Parties that Customer Indemnitees may suffer as a result of any Third Party claim arising directly out of [***]. 12.2 Indemnification by Customer. Subject to Clauses 12.5 and 12.6, Customer shall indemnify Lonza, Lonza’s Affiliates, and the respective officers, employees and agents of Lonza and/or its Affiliates (“Lonza Indemnitees”) from and against any loss, damage, costs, liability, and/or expenses (including reasonable attorney fees) payable to Third Parties that Lonza Indemnitees may suffer as a result of any Third Party claim arising directly out of [***]. 12.3 Indemnification Procedure. In order for a Party to be indemnified under this Clause 12, [***]. 12.4 DISCLAIMER OF CERTAIN DAMAGES. EXCEPT FOR BREACH OF CONFIDENTILIATY UNDER CLAUSE 13 AND EXCEPT TO THE EXTENT RESULTING FROM FRAUD, GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT, IN NO EVENT SHALL EITHER PARTY AND/OR ANY OF ITS AFFILIATES BE LIABLE (IN EACH CASE WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY, UNDER INDEMNITY OR OTHERWISE HOWSOEVER ARISING) FOR [***]; ARISING FROM OR RELATED TO THIS AGREEMENT, SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH THIS AGREEMENT, INCLUDING BUT NOT LIMITED TO [***]; PROVIDED THAT THIS CLAUSE 12.4 SHALL NOT PRECLUDE ANY CLAIM BY LONZA OR ANY OF ITS AFFILIATES FOR ANY UNPAID INVOICES (INCLUDING THE PROFIT ELEMENT OF ITS CHARGES) AND/OR THE CANCELLATION FEES AND/OR TERMINATION FEES 12.5 LIMITATION OF LIABILITY. EXCEPT WITH RESPECT TO LONZA’S BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER CLAUSE 13, SUBJECT TO CLAUSE 12.6, THE AGGREGATE LIABILITY OF EITHER PARTY AND THEIR RESPECTIVE AFFILIATES UNDER OR IN RELATION TO THIS AGREEMENT AND THE PROJECT PLANS (WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY, UNDER INDEMNITY, OR OTHERWISE HOWSOEVER ARISING) SHALL NOT EXCEED, [***] UNDER THIS AGREEMENT BY CUSTOMER TO LONZA IN [***] PRECEDING THE FIRST CLAIM EXCEPT TO THE EXTENT RESULTING FROM FRAUD, GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT. FOR THE AVOIDANCE OF DOUBT THIS LIMITATION OF LIABILITY SHALL BE AN AGGREGATE LIMITATION OF LIABILITY WHICH IS SHARED BETWEEN EACH PARTY AND ALL OF ITS AFFILIATES (INCLUDING IN THE CASE OF LONZA, LONZA AG AND LONZA SALES AG), AND THERE SHALL NOT BE A SEPARATE LIMIT OF LIABILITY FOR EACH SEPARATE AFFILIATE ENTITY.
34 12.6 Nothing in this Agreement shall operate so as to exclude or in any way limit any liability for fraud, gross negligence or intentional misconduct, or for any liability that may not be excluded or limited as a matter of the governing law of this Agreement. Nothing in this Agreement shall exclude or limit Customer’s liability to pay invoices and/or the Cancellation Fees or agreed capital expenditure. 13 Confidentiality 13.1 A Party receiving Confidential Information (the “Receiving Party”) agrees to strictly keep secret any and all Confidential Information received during the Term, from or disclosed on behalf of the other Party (the “Disclosing Party”) using at least the same level of measures as it uses to protect its own Confidential Information, but in any case at least commercially reasonable and customary efforts. Confidential Information shall include information disclosed in any form including but not limited to in writing, orally, graphically or in electronic or other form to the Receiving Party or its Affiliates, observed by or learned by the Receiving Party or its Affiliates, or their employees, agents, consultants, or representatives including any person in plant (in each case such employees, agents, consultants, representatives, or persons in plant, of Customer or any of its Affiliates) under or in relation to this Agreement, which the Receiving Party knows or reasonably should know is confidential or proprietary or would in the normal course of business be considered as being confidential or proprietary, and shall include the terms of this Agreement. 13.2 Notwithstanding the foregoing, Receiving Party may disclose to any courts and/or other authorities Confidential Information which the Receiving Party reasonably believes is or will be required pursuant to applicable governmental or administrative or public law, rule, regulation or order (except to any governmental patent office). In such case the Party that received the Confidential Information will, to the extent legally permitted, inform the other Party promptly in writing and shall seek to minimize the extent of Confidential Information which is required to be disclosed to the courts and/or authorities, and shall cooperate with the Disclosing Party, to the extent legally permitted, to seek the imposition of a protective order or of similar protective measures. 13.3 The obligation to maintain confidentiality under this Agreement does not apply to Confidential Information, which the Receiving Party can reasonably establish by contemporaneous written records: 13.3.1 at the time of disclosure was publicly available; or 13.3.2 is or becomes publicly available other than as a result of a breach of this Agreement by the Receiving Party; or 13.3.3 was rightfully in its possession at the time of disclosure by the Disclosing Party and had not been received from or on behalf of Disclosing Party; or 13.3.4 is supplied to a Party by a Third Party which was not in breach of an obligation of confidentiality to Disclosing Party or any other party; or 13.3.5 is developed by the Receiving Party independently from and without access to or aid, application or use of the Confidential Information. 13.3.6 The foregoing exceptions, however, shall not apply to:
35 (i) Confidential Information disclosed within more-general information that may fall within one or more of the exceptions; or (ii) any combination of features or items of Confidential Information where one or more of the relevant individual features or items (but not the combination itself) may fall within one or more of the exceptions. 13.4 The Receiving Party will use Confidential Information of the Disclosing Party only for the purposes of this Agreement and will not make any use of the Confidential Information of the Disclosing Party for its own separate benefit or the benefit of any Third Party including with respect to research or product development or any reverse engineering or similar testing. The Receiving Party agrees to return or destroy promptly (and certify such destruction) on Disclosing Party’s request all written or tangible Confidential Information of the Disclosing Party, except that one copy of such Confidential Information may be kept by the Receiving Party in its confidential files for record keeping purposes only. 13.5 Each Party will restrict the disclosure of Confidential Information of the Disclosing Party to such officers, employees, consultants and representatives of itself and its Affiliates who have been informed of the confidential nature of the Confidential Information and who have a need to know such Confidential Information for the purpose of this Agreement. Prior to disclosure to such persons, the Receiving Party shall bind its and its Affiliates’ officers, employees, consultants and representatives to confidentiality and non-use obligations no less stringent than those set forth herein. The Receiving Party shall notify the Disclosing Party as promptly as practicable of any unauthorized use or disclosure of the Confidential Information of the Disclosing Party. Lonza may disclose the Customer’s Confidential Information to Lonza’s Affiliates, Subcontractors and the External Laboratories, in each case for the purposes of this Agreement. 13.6 The Receiving Party shall at all times be fully liable for any and all breaches of the confidentiality obligations in this Clause 13 by any of its Affiliates or the employees, officers, agents, consultants and representatives of itself or its Affiliates, including persons on plant. 13.7 Each Party hereto expressly agrees that any breach or threatened breach of the undertakings of confidentiality provided under this Clause 13 by a Party may cause irreparable harm to the other Party and that money damages may not provide a sufficient remedy to the non-breaching Party for any breach or threatened breach. In the event of any breach and/or threatened breach, then, in addition to all other remedies available at law or, if relevant, in equity, the non-breaching Party shall be entitled to seek injunctive relief and any other relief deemed appropriate by the non- breaching Party. 13.8 Data Usage. Notwithstanding the confidentiality provisions in this Clause 13 as they may relate to the use of Services Data: The Parties agree that all Services Data may be collected, aggregated, hosted, mined or otherwise stored and maintained by Lonza and its Affiliates, contractors and External Laboratories. Both Lonza and its Affiliates, and Customer and its Affiliates, may use said Services Data, in any manner that is not inconsistent with the intellectual property-ownership terms set forth in Clause 10, for further research, development, commercialization of, and securing rights to, development, manufacturing and testing systems, platforms, and service offerings, provided that said data shall be anonymized and aggregated when used externally.
36 14 Term and Termination 14.1 Term. This Agreement shall commence on the Effective Date and shall end on the seventh (7th) anniversary of the Effective Date unless terminated earlier as provided herein or extended by mutual written consent of the Parties (the “Term”). 14.2 Termination. This Agreement or any Project Plan may be terminated as follows: 14.2.1 Customer may terminate any Project Plan or SOW by providing written notice of termination no less than [***] in advance of such date of termination. For the avoidance of doubt, in the event of termination of Plan by Customer under this 14.2.1, Customer shall remain liable for all fees owed pursuant to the applicable Project Plan, SOW and this Agreement but Lonza shall mitigate any such damages; 14.2.2 Either Party may terminate this Agreement, by written notice to the other Party, for any material breach of this Agreement by the other Party, if such breach is not cured within [***] after the breaching Party receives written notice of such breach from the non-breaching Party; provided, however, that if such breach is not capable of being cured within such [***] period and the breaching Party has commenced and diligently continued actions to cure such breach within such [***] period, except in the case of a payment default, the cure period shall be extended to [***], so long as the breaching Party is making diligent efforts to do so. Such termination shall be effective upon expiration of such cure period; provided that in the event that the breaching Party disputes in good faith the non-breaching Party’s grounds for termination this Agreement pursuant to this Section 14.2, then the Parties shall attempt to resolve in good faith. To the extent any material breach by a Party relates specifically to an SOW or Project Plan, the non-breaching Party may elect to have the termination rights set forth in this Section 14.2.2 apply to just such SOW or Project Plan, rather than to this Agreement generally.; 14.2.3 by either Party, immediately, upon: (a) the dissolution, termination of existence, liquidation or business failure of the other Party; (b) the appointment of a custodian or receiver for the other Party who has not been terminated or dismissed within [***] of such appointment; (c) the institution by the other Party of any proceeding under national, federal or state bankruptcy, reorganization, receivership or other similar laws affecting the rights of creditors generally or the making by such Party of a composition or any assignment for the benefit of creditors under any national, federal or state bankruptcy, reorganization, receivership or other similar law affecting the rights of creditors generally, which proceeding is not dismissed within [***] of filing. All rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Bankruptcy Code (or any same or similar provision in any jurisdiction other than the United States), licenses of rights of “intellectual property” as defined therein; or 14.2.4 by either Party pursuant to Clause 15. 14.3 Consequences of Termination. In the event of termination of this Agreement or any Project Plan, all Services and Batches which have been ordered or otherwise committed in accordance with this Agreement (including those in the Project Plan
37 to which the Parties are committed) shall be deemed to have been cancelled and in addition Customer shall, within [***] of the date of termination pay Lonza for (i) Services rendered up to the date of termination, including in respect of any Product in-process; (ii) all costs incurred through the date of termination, including Raw Materials and Handling Fees used or purchased for use or for which Lonza is irrevocably committed in connection with the Project Plan and External Laboratory charges and Handling Fees (following payment, at Customer’s option and cost such Raw Materials and Resins will either be: (a) held by Lonza for future use for the production of Product; (b) delivered to Customer; or (c) disposed of by Lonza; (iii) all unreimbursed Capital Equipment and related decommissioning charges incurred pursuant to Clause 9; (iv) all amounts due under Clause 6.6 without proration of the final calendar year and (v) if cancelled by Customer subject to 14.2.1, Cancellation Fees in respect of all Batches and/or Services which have been ordered or to which Customer is bound in accordance with this Agreement. In the case of termination by Lonza for Customer’s material breach, Cancellation Fees shall be calculated as of the date of written notice of termination. 14.4 Survival. Neither the termination nor expiration of this Agreement shall affect the liability of a Party for breach of this Agreement. Notwithstanding anything contained in Clause 14, the rights and obligations of each Party which by their nature survive the termination or expiration of this Agreement shall survive the termination or expiration of this Agreement, including Clauses 5, 10-13, and 17 (to the extent relevant). Termination of this Agreement (including the consequences of termination set out in this Clause 1414) shall not affect the accrued rights or liabilities of either Party and shall not preclude either Party from pursuing any remedies it may have hereunder, or at law or in equity, with respect to any breach of, or default under, this Agreement (subject always to Clauses 12.4 and 12.5). All confidentiality obligations set out in this Agreement shall survive termination or expiry of this Agreement. 14.5 Disposition of Remaining Customer Property and Confidential Information. Upon termination or expiration of this Agreement, Lonza will, at Customer’s option, return or destroy any Customer Confidential Information in the possession or control of Lonza. Likewise, Customer will, at Lonza’s option, return or destroy any Lonza Confidential Information on in the possession or control of Customer. Notwithstanding the foregoing provisions: (i) Lonza may retain and preserve, in a secure manner, at its sole cost and expense, samples and standards of each Product following termination or expiration of this Agreement as required by Applicable Law solely for use in determining Lonza’s rights and obligations hereunder; (ii) Customer may retain and preserve, in a secure manner, any Lonza Confidential Information following termination or expiration of this Agreement (A) for use in determining Customer’s rights and obligations hereunder, (B) as necessary, in connection with Customer’s regulatory filings or Regulatory Approvals, or (C) as required by Applicable Law and (iii) each Party may retain a single copy of the other Party’s Confidential Information for documentation on purposes only and which shall remain subject to the termination of nonuse and confidentiality set forth in this Agreement. 15 Force Majeure 15.1 If either Party or any of its Affiliates is prevented or delayed in the performance of any of its obligations under the Agreement by Force Majeure, it shall give written notice thereof to the other Party specifying the matters constituting Force Majeure together with such evidence as the notifying Party reasonably can give and
38 specifying the period for which it is estimated that such prevention or delay will continue. Such Party shall be excused from the performance or the punctual performance of such obligations, as the case may be, for so long as such cause of prevention or delay shall continue. Provided that, if such Force Majeure persists for a period of [***] or more, either Party may terminate the Agreement (if the event of Force Majeure affects the whole Agreement) or the relevant Project Plan(s) under this Agreement by delivering written notice to the other. “Force Majeure” shall be deemed to include any reason or cause beyond a Party’s reasonable control affecting the performance by it of its obligations under the Agreement, including, but not limited to, any cause arising from or attributable to acts of God, earthquakes or other natural disasters, epidemic, pandemic, strike, lockouts, restrictive governmental orders or decrees, riots, insurrection, war, terrorists acts, or the inability of Lonza to obtain any required Raw Materials (provided that Lonza has pursued timely ordering of such Raw Material according to applicable lead times), energy source, or detection of a viral, bacterial or mycoplasmal contamination that causes a shutdown of the Facility or any part thereof. 15.2 If due to Force Majeure, the quantity of raw materials available to Lonza is at any time reduced so as to be insufficient to satisfy the whole of Lonza’s and its Affiliates’ requirements and contractual commitments, then for so long as such insufficiency shall continue, Lonza shall be entitled to apportion the quantity of raw materials available in an equitable pro-rata manner amongst its own and its Affiliates’ requirements and contractual commitments. 15.3 With regard to Lonza, any such event of Force Majeure affecting services or production at its Affiliates shall be regarded as an event of Force Majeure. 16 Additional Covenants 16.1 Each Party shall comply with, and shall cause its Affiliates, subsidiaries, subcontractors, directors, officers, employees, agents or any other person acting on behalf of Lonza to comply with, all applicable Corruption Laws and International Trade Restrictions, and shall obtain all necessary export and re-export written consents, permits, and authorizations required by International Trade Restrictions; and 16.2 In connection with the preparation and the performance of this Agreement, each Party shall take appropriate technical and organizational measures to comply with the GDPR. Lonza shall in compliance with GDPR as well as on Customer’s request, destroy all personal data, unless Applicable Law prevents Lonza from such destruction. Lonza confirms that any personal identifiable data shared with Customer for the purposes of the Services, the preparation and the performance of this Agreement is done in accordance with the requirements of the GDPR. 17 Miscellaneous 17.1 Independent Contractors. Each of the Parties is an independent contractor and nothing herein contained shall be deemed to constitute the relationship of partners, joint venturers, nor of principal and agent between the Parties. Neither Party shall at any time enter into, incur, or hold itself out to Third Parties as having authority to enter into or incur, on behalf of the other Party, any commitment, expense, or liability whatsoever.
39 17.2 No Presumption Against Drafter. Each Party and its legal counsel have reviewed and revised this Agreement. The rule of construction that requires that ambiguities in this Agreement (including any Appendix hereto) be construed against the drafter shall be waived by both Parties in the interpretation of this Agreement. 17.3 Waiver. The failure of any Party at any time or times to require performance of any provision of this Agreement (including any Appendix hereto) will in no manner affect its rights at a later time to enforce the same. No waiver by any Party of any term, provision or condition contained in this Agreement (including any Appendix hereto), whether by conduct or otherwise, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, provision or condition or of any other term, provision or condition of this Agreement (including any Appendix hereto). 17.4 Severability. If any provision hereof is or becomes at any time illegal, invalid or unenforceable in any respect, neither the legality, validity nor enforceability of the remaining provisions hereof shall in any way be affected or impaired thereby. The Parties hereto undertake to substitute any illegal, invalid or unenforceable provision by a provision which is as far as possible approximate to the intent of the Parties and/or commercially equivalent, considering the Parties’ interests and the purpose of the provision. 17.5 Amendments. Modifications and/or amendments of this Agreement must be in writing and signed by the Parties. The Parties may amend this Agreement without the consent of the Affiliates of either Party. 17.6 Assignment. Subject to Clause 2.4, neither Party may assign its interest under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, provided, however that (a) either Party may assign this Agreement to (i) any Affiliate of that Party or (ii) any Third Party in connection with the sale or transfer (by whatever method) of all or substantially all of its assets related to this Agreement, provided that Customer may not assign this Agreement to a Lonza Competitor without Lonza’s prior written approval, and (b) each Party shall be entitled to sell, assign and/or transfer its trade receivables resulting from this Agreement, in each instance in respect of clauses (a) or (b), without the consent of the other Party. For purposes of this Clause 17.6, the terms “assign” and “assignment” shall include (i) the sale of fifty percent (50%) or more of the outstanding stock of such Party to an Affiliate of such Party or an unrelated entity or natural person, (ii) the sale or transfer or other assignment of all or substantially all of the assets of the Party or the line of business or Product to which this Agreement relates, and (iii) a merger, consolidation, acquisition or other form of business combination. Any purported assignment without a required consent shall be void. No assignment shall relieve any Party of responsibility for the performance of any obligation or liability that accrued prior to the effective date of such assignment. 17.7 Notice. Any notice required or permitted to be given under this Agreement by any Party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by a nationally-recognized courier service guaranteeing next-day or second day delivery, charges prepaid, (d) delivered by electronic mail (with documented evidence of a read receipt), to the electronic mail address of the other Party set forth below, followed by hard copy within [***]; or (e) delivered at such other addresses as may from time to time be furnished by similar notice by any Party. The effective date of any notice under this
40 Agreement shall be the date of receipt by the receiving Party. If to Lonza: Lonza AG Head of Legal department, Muenchensteinerstrasse 38 CH-4052 Basel Switzerland If to Customer: Chief Technical Officer Avidity Biosciences, Inc. 10578 Science Center Drive, Suite 125 San Diego, CA 92121 USA With a copy to: Chief Legal Officer Avidity Biosciences, Inc. 10578 Science Center Drive, Suite 125 San Diego, CA 92121 USA 17.8 Governing Law/Jurisdiction. This Agreement or any matter, claim or dispute arising out of or in connection with this Agreement, whether contractual or non-contractual, is to be governed by and determined exclusively in accordance with the laws of [***]. The parties expressly agree that, irrespective of any other provisions relating to jurisdiction or venue, the courts of this jurisdiction shall have sole authority to resolve any such disputes. 17.9 Third Parties. The Parties to this Agreement do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999 (or any same or similar provision in any jurisdiction other than England) by any person who is not a party to this Agreement, save that Affiliates of Lonza may rely on the indemnities granted to them and limitations and exclusions of liability contained herein and Affiliates of Lonza which have executed a Statement of Work or Project Plan under this Agreement shall be entitled to enforce this Agreement with respect to such Project Plan or Statement of Work in its own name as an intended Third party beneficiary. This Agreement may be amended by Lonza without the consent of any Affiliates of Lonza. 17.10 Announcements / Press Releases. Neither Party shall: (i) make any press release or announcement of any kind and in any format and on any media of any nature (including social media, photographs, video messages and any other format of media that is not in use or known as at the date of this Agreement) regarding the subject matter of this Agreement; (ii) make any publication or promotional material of any kind in any format and on any type of media (including social media, photographs, video messages and any other format of media that is not in use or known as at the date of this Agreement) which uses or refers to any name, trademark or branding of the other; in each case without the prior written consent of an authorized signatory of the other. For clarity, an authorized signatory of Avidity is a senior executive of Avidity. 17.11 Entire Agreement; Counterparts.
41 17.11.1 This Agreement, including the Appendices attached hereto and referenced herein, contains the entire agreement between the Parties as to the Services for commercial supply of Product and supersedes all prior and contemporaneous agreements, oral and written, among the Parties with respect to the Services contemplated herein. This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, and all of which together shall constitute one and the same document. Each party acknowledges that an original signature or a copy thereof transmitted by .pdf shall constitute an original signature for purposes of this Agreement. 17.11.2 If this Agreement is executed using an electronic signature program (such as DocuSign or AdobeSign), the Parties hereby agree to the terms and conditions of this Agreement by clicking the “SIGN” button. The Parties agree that an electronic signature is the legal equivalent of a manual signature on this Agreement, and that, if applicable, selecting “SIGN” constitutes such Party’s electronic signature. The Parties also agree that no certification authority or other Third Party verification is necessary to validate either Party’s electronic signature and that the lack of such certification or Third Party verification will not in any way affect the enforceability of such Party’s electronic signature or any resulting contract between the Parties. The Parties understand and agree that electronically signing and submitting this Agreement (or any amendment thereof) is the legal equivalent of having placed a handwritten signature on the submitted Agreement. 17.12 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of the Agreement. IN WITNESS WHEREOF, each of the Parties hereto has caused this Manufacturing Services Agreement to be executed by its duly authorized representative effective as of the date written above. LONZA LTD LONZA SALES LTD Avidity Biosciences, Inc.
APPENDIX A Table 1: Commercial Batch Pricing [***] Table 2: Commercial batches under reservation [***]
43 Project Plan A - 1 [***]
APPENDIX B Cell Bank Storage [***]
45 APPENDIX C Standard Safety stock levels [***]
EX-31.1
3
rna-20250930xex311.htm
EX-31.1
Document
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Sarah Boyce, certify that:
1.I have reviewed this quarterly report on Form 10-Q of Avidity Biosciences, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: November 10, 2025 |
/s/ Sarah Boyce |
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Sarah Boyce |
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President, Chief Executive Officer and Director |
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(Principal Executive Officer) |
EX-31.2
4
rna-20250930xex312.htm
EX-31.2
Document
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael F. MacLean, certify that:
1.I have reviewed this quarterly report on Form 10-Q of Avidity Biosciences, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: November 10, 2025 |
/s/ Michael F. MacLean |
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Michael F. MacLean |
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Chief Financial Officer |
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(Principal Financial Officer) |
EX-32.1
5
rna-20250930xex321.htm
EX-32.1
Document
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report of Avidity Biosciences, Inc. (the “Company”) on Form 10-Q for the quarter ended September 30, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Sarah Boyce, President, Chief Executive Officer and Director of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1)The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Date: November 10, 2025 |
/s/ Sarah Boyce |
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Sarah Boyce |
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President, Chief Executive Officer and Director |
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(Principal Executive Officer) |
The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.
EX-32.2
6
rna-20250930xex322.htm
EX-32.2
Document
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report of Avidity Biosciences, Inc. (the “Company”) on Form 10-Q for the quarter ended September 30, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael F. MacLean, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1)The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Date: November 10, 2025 |
/s/ Michael F. MacLean |
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Michael F. MacLean |
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Chief Financial Officer |
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(Principal Financial Officer) |
The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.