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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 13, 2024
Immunome, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39580 | 77-0694340 | ||
| (state or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 18702 N. Creek Parkway, Suite 100 Bothell, WA |
98011 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (425) 939-7410
N/A
(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 (see General Instruction A.2. below):
| ¨ | 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 | Name
of each exchange on which registered |
||
| Common Stock, $0.0001 par value per share | IMNM | The Nasdaq Capital Market |
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 x
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 13, 2024, Immunome, Inc. (the “Company”) announced its financial results for the third quarter ended September 30, 2024 and provided a business update in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d)
|
Exhibit |
Description | |
| 99.1 | Press Release dated November 13, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: November 13, 2024 | Immunome, Inc. | |
| By: | /s/ Max Rosett | |
| Name: | Max Rosett | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Immunome Reports Third Quarter 2024 Financial Results and Provides Business Update
11/13/2024
BOTHELL, Wash. –Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on the development of first-in-class and best-in-class targeted oncology therapies, today announced financial results for the third quarter ended September 30, 2024, and provided a business update.
“Immunome continues to advance its pipeline,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “Topline data for the RINGSIDE Part B trial of AL102 is expected in the second half of 2025, and IND submissions for IM-1021 and IM-3050 are on track.”
“Our discovery team is focused on discovering ADCs that effectively pursue the novel targets we believe will define the next generation of transformative cancer therapies. In particular, the differentiated profile of HC74, our proprietary TOP1 payload, offers exciting opportunities for portfolio expansion when combined with our large repertoire of antibodies.”
Pipeline Highlights
Full enrollment for the Phase 3 RINGSIDE Part B study of AL102 for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102.
Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed.
Third Quarter 2024 Financial Results
| · | As of September 30, 2024, cash, cash equivalents and marketable securities totaled $240.1 million. Immunome’s current cash runway is expected to extend into 2026. | |
| · | Research and development expenses for the quarter ended September 30, 2024 were $37.2 million, including stock-based compensation costs of $1.8 million. | |
| · | In-process research and development expenses for the quarter ended September 30, 2024 were $6.7 million. These expenses were related to Immunome’s business development activity. | |
| · | General and administrative expenses for the quarter ended September 30, 2024 were $9.5 million, including stock-based compensation expense of $3.1 million. | |
| · | Immunome reported a net loss of $47.1 million for the quarter ended September 30, 2024. |
About Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugates (ADCs). In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. For more information, visit www.immunome.com.
Cautionary Statement Regarding Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “expects,” “believe,” “opportunities,” “anticipates” and similar expressions to identify these forward-looking statements. These forward-looking statements include Immunome’s expected timing for providing topline data for the Phase 3 RINGSIDE Part B trial; Immunome’s expected timing for filing an IND for IM-1021 and IM-3050; Immunome’s expectation that it will commence clinical development of IM-1021 and IM-3050 in early 2025; the potential of Immunome’s ADC targets to provide first-in-class or best-in-class potential; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including the risk that Immunome will not be able to realize the benefits of its strategic transactions; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that Immunome’s product candidates and development candidates fail to achieve their intended endpoints; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; Immunome’s ability to grow and successfully execute on its business plan; and other risks and uncertainties indicated from time to time described in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 12, 2024, in Immunome’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, being filed with the SEC today, and in Immunome’s other filings with the SEC. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.
Investor Contact:
Max Rosett
Chief Financial Officer
investors@immunome.com
Immunome, Inc.
Consolidated Balance Sheets
(Unaudited; In thousands)
| September 30, 2024 | December 31, 2023 | Delta | ||||||||||
| Assets | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 155,568 | $ | 98,679 | 56,889 | |||||||
| Marketable securities | 84,562 | 39,463 | 45,099 | |||||||||
| Prepaid expenses and other current assets | 3,910 | 6,561 | (2,651 | ) | ||||||||
| Total current assets | 244,040 | 144,703 | 99,337 | |||||||||
| Property and equipment, net | 7,172 | 2,073 | 5,099 | |||||||||
| Operating right-of-use assets | 2,388 | 1,564 | 824 | |||||||||
| Restricted cash | 100 | 100 | — | |||||||||
| Other long-term assets | 3,198 | 100 | 3,098 | |||||||||
| Total assets | $ | 256,898 | $ | 148,540 | 108,358 | |||||||
| Liabilities and stockholders’ equity | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 3,518 | $ | 3,311 | 207 | |||||||
| Accrued expenses and other current liabilities | 26,331 | 8,025 | 18,306 | |||||||||
| Deferred revenue, current | 9,679 | 10,493 | (814 | ) | ||||||||
| Total current liabilities | 39,528 | 21,829 | 17,699 | |||||||||
| Deferred revenue, non-current | — | 5,489 | (5,489 | ) | ||||||||
| Operating lease liabilities, net of current portion | 2,464 | 1,340 | 1,124 | |||||||||
| Total liabilities | 41,992 | 28,658 | 13,334 | |||||||||
| Stockholders’ equity: | ||||||||||||
| Preferred stock | — | — | — | |||||||||
| Common stock | 6 | 4 | 2 | |||||||||
| Additional paid-in capital | 650,351 | 342,663 | 307,688 | |||||||||
| Accumulated other comprehensive income | 70 | 22 | 48 | |||||||||
| Accumulated deficit | (435,521 | ) | (222,807 | ) | (212,714 | ) | ||||||
| Total stockholders’ equity | 214,906 | 119,882 | 95,024 | |||||||||
| Total liabilities and stockholders’ equity | $ | 256,898 | $ | 148,540 | 108,358 | |||||||
Immunome, Inc.
Consolidated Statements of Operations
(Unaudited; In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Collaboration revenue | $ | 2,910 | $ | 3,565 | $ | 6,303 | $ | 10,192 | ||||||||
| Operating expenses: | ||||||||||||||||
| In-process research and development | 6,706 | — | 124,972 | — | ||||||||||||
| Research and development(1) | 37,200 | 3,823 | 81,652 | 13,452 | ||||||||||||
| General and administrative(1) | 9,526 | 4,375 | 22,509 | 11,617 | ||||||||||||
| Total operating expenses | 53,432 | 8,198 | 229,133 | 25,069 | ||||||||||||
| Loss from operations | (50,522 | ) | (4,633 | ) | (222,830 | ) | (14,877 | ) | ||||||||
| Interest income | 3,422 | 288 | 10,116 | 705 | ||||||||||||
| Net loss | $ | (47,100 | ) | $ | (4,345 | ) | $ | (212,714 | ) | $ | (14,172 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.78 | ) | $ | (0.36 | ) | $ | (3.72 | ) | $ | (1.16 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 60,205,327 | 12,202,335 | 57,239,668 | 12,194,277 | ||||||||||||
| Comprehensive loss | ||||||||||||||||
| Net loss | $ | (47,100 | ) | $ | (4,345 | ) | $ | (212,714 | ) | $ | (14,172 | ) | ||||
| Unrealized loss on marketable securities | 68 | — | 48 | — | ||||||||||||
| Comprehensive loss | $ | (47,032 | ) | $ | (4,345 | ) | $ | (212,666 | ) | $ | (14,172 | ) | ||||
(1) Amounts include non-cash stock based compensation as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Research and development | $ | 1,820 | $ | 466 | $ | 3,244 | $ | 1,323 | ||||||||
| General and administrative | 3,072 | 617 | 7,034 | 2,017 | ||||||||||||
| Total share-based compensation expense | $ | 4,892 | $ | 1,083 | $ | 10,278 | $ | 3,340 | ||||||||