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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 7, 2024
PROTAGONIST THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-37852 | 98-0505495 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
Protagonist Therapeutics, Inc.
7707 Gateway Blvd., Suite 140
Newark, California 94560-1160
(Address of principal executive offices, including zip code)
(510) 474-0170
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
||
| Common Stock, par value $0.00001 | PTGX | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
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. ¨
Item 2.02. Results of Operations and Financial Condition.
On November 7, 2024, Protagonist Therapeutics, Inc. reported its financial results for the third quarter ended September 30, 2024. A copy of the press release titled “Protagonist Reports Third Quarter 2024 Financial Results and Provides Corporate Update” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release, dated November 7, 2024, titled “Protagonist Reports Third Quarter 2024 Financial Results and Provides Corporate Update.” | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Protagonist Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.
SIGNATURE
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 hereunto duly authorized.
| Protagonist Therapeutics, Inc. | ||
| Dated: November 7, 2024 | ||
| By: | Asif Ali | |
| Asif Ali | ||
| Chief Financial Officer | ||
Exhibit 99.1
Protagonist Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Top line results for JNJ-2113 Phase 3 ICONIC-LEAD and Phase 3 ICONIC-TOTAL clinical trials in patients with moderate to severe psoriasis expected in Q4 2024
Top line results for JNJ-2113 Phase 2b ANTHEM clinical trial in moderate to severe ulcerative colitis expected in Q1 2025
Top line results for rusfertide Phase 3 VERIFY clinical trial in polycythemia vera expected in Q1 2025
Development candidate nomination for oral IL-17 peptide antagonist expected in Q4 2024
Cash, cash equivalents and marketable securities of $583.3 million as of September 30, 2024, anticipated to provide cash runway through end of 2027
NEWARK, Calif., November 7, 2024 – Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist” or “the Company”) today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update.
“Protagonist is approaching multiple transformational events with the pending readouts of JNJ-2113 in Phase 3 psoriasis studies this year, Phase 2b ulcerative colitis study in Q1 2025, and rusfertide Phase 3 study in polycythemia vera in Q1 2025,” said Dinesh V. Patel, Ph.D., the Company’s President and CEO. “In addition, we look forward to unveiling more details on an IL-17 oral peptide antagonist development candidate later this year, as well as other development candidates from our hematology and obesity programs in 2025. Our strong cash position affords us the flexibility to progress them independently into pre-clinical and clinical development over the coming years.”
Upcoming Milestones
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV)
| · | The top line data for the Phase 3 VERIFY study1 in polycythemia vera, which has a 32-week primary efficacy endpoint, is expected in Q1 2025. |
JNJ-2113: Oral IL-23 Receptor Antagonist
| · | Top line results for the Phase 3 ICONIC-LEAD and ICONIC-TOTAL studies2 in moderate to severe plaque psoriasis, are expected in Q4 2024. |
| · | Top line results for the Phase 2b ANTHEM multicenter, randomized, placebo- controlled, dose-ranging study of JNJ-2113 for the treatment of moderately to severely active ulcerative colitis3, is expected in Q1 2025. |
| · | Top line results for the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 superiority studies4, evaluating the safety and efficacy of JNJ-2113 compared with both placebo and deucravacitinib in moderate to severe plaque psoriasis, is expected in Q2 2025. |
| · | Top line results for the Phase 3 in pustular and erythrodermic psoriasis5 evaluating the safety and efficacy of JNJ-2113 in approximately 16 subjects compared with placebo, is expected in Q2 2025. |
Discovery Programs
| · | Protagonist is pursuing the discovery of novel and potent oral peptides against various clinically and commercially validated biological targets in hematology, inflammation and immunomodulatory diseases, and obesity. |
| · | The Company expects to nominate a development candidate from its oral IL-17 peptide antagonist program in Q4 2024. |
| · | Protagonist is also anticipating the nomination of an oral development candidate in the hepcidin mechanism-based hematology program in Q1 2025, and an oral peptide-based development candidate in the obesity program by the middle of 2025. |
1 VERIFY (NCT05210790)
2 ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
3 ANTHEM (NCT06049017)
4 ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
5 Pustular/Erythrodermic (NCT06295692)
Third Quarter 2024 Financial Results
| · | Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2024, were $583.3 million as compared to $341.6 million as of December 31, 2023. |
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| (in thousands, except per share amounts) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (Unaudited) | ||||||||||||||||
| License and collaboration revenue | $ | 4,675 | $ | - | $ | 263,795 | $ | - | ||||||||
| Research and development expense | $ | 35,970 | $ | 30,664 | $ | 103,224 | $ | 91,262 | ||||||||
| General and administrative expense | $ | 10,158 | $ | 7,662 | $ | 34,508 | $ | 25,439 | ||||||||
| Net income (loss) | $ | (33,210 | ) | $ | (34,105 | ) | $ | 143,514 | $ | (106,290 | ) | |||||
| Basic earnings (loss) per share | $ | (0.54 | ) | $ | (0.58 | ) | $ | 2.34 | $ | (1.91 | ) | |||||
| Diluted earnings (loss) per share | $ | (0.54 | ) | $ | (0.58 | ) | $ | 2.22 | $ | (1.91 | ) | |||||
| · | License and Collaboration Revenue: The Takeda Collaboration Agreement included a one-time nonrefundable upfront payment of $300.0 million, of which we recognized $255.0 million during the first quarter of 2024. The remaining $45.0 million was recorded as deferred revenue to be recognized over time as the Company satisfies its performance obligation to complete the ongoing Phase 3 VERIFY trial for rusfertide. | |
| During the third quarter of 2024, we recognized $4.7 million of this deferred revenue balance as revenue based on costs incurred in the quarter compared to the total budget for this performance obligation. License and collaboration revenue of $263.8 million for the nine months ended September 30, 2024, was comprised of: (i) $255.0 million of the $300.0 million upfront cash payment for the Takeda Collaboration Agreement recorded in the first quarter of 2024, and (ii) a total of $8.8 million recorded as revenue during the second and third quarters of 2024. |
| · | Research and Development ("R&D") Expenses: Increased by $5.3 million and $12.0 million for the three and nine months ended September 30, 2024, respectively, from the prior year periods. The increases were primarily due to increases in drug discovery and pre-clinical research expenses. |
| · | General and Administrative ("G&A") Expenses: Increased by $2.5 million for the three months ended September 30, 2024, from the prior year period primarily due to increases in stock-based compensation and other personnel-related expenses. The increase of $9.1 million in G&A expenses for the nine months ended September 30, 2024, from the prior year period was primarily due to $4.6 million in one-time advisory and legal fees related to the Takeda collaboration and increases in stock-based compensation and other personnel-related expenses. |
| · | Net Income (Loss): Net loss was ($33.2) million, or ($0.54) per basic and diluted share, for the three months ended September 30, 2024, as compared to a net loss of ($34.1) million, or ($0.58) per basic and diluted share, for the three months ended September 30, 2023. Net income was $143.5 million, or $2.34 per basic share and $2.22 per diluted share, for the nine months ended September 30, 2024, as compared to a net loss of ($106.3) million, or ($1.91) per basic and diluted share, for the nine months ended September 30, 2023. |
About Protagonist
Protagonist Therapeutics is a late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist’s proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA potentially in 2025. JNJ-2113 is an oral Interleukin-23 receptor (IL-23R) antagonist licensed to Johnson & Johnson (JNJ) that is currently in Phase 3 development for psoriasis and is nearing completion of Phase 2b development for ulcerative colitis. Following JNJ-2113’s joint discovery by Protagonist and JNJ scientists pursuant to the companies’ IL-23R collaboration, Protagonist was primarily responsible for development of JNJ-2113 through Phase 1, with JNJ assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including IL-17, hepcidin mimetic, and anti-obesity programs.
More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at https://www.protagonist-inc.com/.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of JNJ-2113 and rusfertide, the timing of JNJ-2113 and rusfertide clinical trials, and timing of developments and announcements in our discovery programs. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.
Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577
Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061
PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
(Amounts in thousands except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| License and collaboration revenue | $ | 4,675 | $ | - | $ | 263,795 | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | 35,970 | 30,664 | 103,224 | 91,262 | ||||||||||||
| General and administrative (1) | 10,158 | 7,662 | 34,508 | 25,439 | ||||||||||||
| Total operating expenses | 46,128 | 38,326 | 137,732 | 116,701 | ||||||||||||
| Income (loss) from operations | (41,453 | ) | (38,326 | ) | 126,063 | (116,701 | ) | |||||||||
| Interest income | 7,682 | 4,252 | 19,462 | 10,656 | ||||||||||||
| Other income (expense), net | 141 | (31 | ) | 219 | (245 | ) | ||||||||||
| Income (loss) before income tax benefit (expense) | (33,630 | ) | (34,105 | ) | 145,744 | (106,290 | ) | |||||||||
| Income tax benefit (expense) | 420 | - | (2,230 | ) | - | |||||||||||
| Net income (loss) | $ | (33,210 | ) | $ | (34,105 | ) | $ | 143,514 | $ | (106,290 | ) | |||||
| Net income (loss) per share, basic | $ | (0.54 | ) | $ | (0.58 | ) | $ | 2.34 | $ | (1.91 | ) | |||||
| Net income (loss) per share, diluted | $ | (0.54 | ) | $ | (0.58 | ) | $ | 2.22 | $ | (1.91 | ) | |||||
| Weighted-average shares used to compute net income (loss) per share, basic | 61,767,934 | 59,182,899 | 61,311,310 | 55,542,543 | ||||||||||||
| Weighted-average shares used to compute net income (loss) per share, diluted | 61,767,934 | 59,182,899 | 64,611,941 | 55,542,543 | ||||||||||||
(1) Amount includes non-cash stock-based compensation expense.
Stock-based Compensation
(Unaudited, in thousands)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Research and development | $ | 5,212 | $ | 3,780 | $ | 15,597 | $ | 13,171 | ||||||||
| General and administrative | 4,953 | 2,985 | 12,864 | 9,521 | ||||||||||||
| Total stock-based compensation expense | $ | 10,165 | $ | 6,765 | $ | 28,461 | $ | 22,692 | ||||||||
Selected Consolidated Balance Sheet Data
(Unaudited, in thousands)
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 583,281 | $ | 341,617 | ||||
| Working capital | 432,191 | 334,303 | ||||||
| Total assets | 603,857 | 357,951 | ||||||
| Deferred revenue | 36,205 | - | ||||||
| Accumulated deficit | (472,196 | ) | (615,710 | ) | ||||
| Total stockholders' equity | 531,915 | 336,677 | ||||||