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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):
March 28, 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: (610) 321-3700
665 Stockton Drive, Suite 300
Exton, Pennsylvania, 19341
(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 March 28, 2024, Immunome, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 2023 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 Number |
Description | |
| 99.1 | Press Release dated March 28, 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: March 28, 2024 | Immunome, Inc. | |
| By: | /s/ Clay Siegall | |
| Name: | Clay Siegall, Ph.D. | |
| Title: | President and Chief Executive Officer | |
Exhibit 99.1
Immunome Reports Full-Year 2023 Financial Results and Provides Update on Recently Acquired Assets
| - | Topline data for Phase 3 RINGSIDE trial of AL102 expected in first quarter of 2025 | |
| - | IM-1021 and IM-3050 IND filings expected in first quarter of 2025 | |
| - | Current cash expected to fund activities into 2026 |
BOTHELL, Wash. – Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the full-year ended December 31, 2023, and provided an overview of recent developments.
“2023 was a transformative year for Immunome as we closed the merger with Morphimmune, advanced our pipeline and expanded the company’s leadership team,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “These accomplishments laid the groundwork for a productive start to 2024, including the acquisition of two promising assets and a successful financing.”
Dr. Siegall continued, “We are focused on efficiently developing our four existing assets and expanding our pipeline. We expect to add novel antibody-drug conjugates (ADCs) and radioligand therapies (RLTs) to the pipeline through internal discovery efforts while continuing to evaluate opportunities to acquire high-quality assets on favorable financial terms. We are well-positioned to develop best-in-class or first-in-class therapies to improve the lives of cancer patients.”
Pipeline Highlights
The purchase of AL102 from Ayala Pharmaceuticals closed on March 25, 2024. Immunome expects to report topline data for the ongoing Phase 3 RINGSIDE Part B trial of AL102 in the first quarter of 2025. Ayala previously announced the full enrollment of RINGSIDE in February 2024. In parallel, Immunome is evaluating and performing additional manufacturing and pharmacology work required to support an NDA submission of AL102.
Immunome’s preclinical pipeline includes IM-1021, a ROR1 ADC; IM-3050, a FAP-targeted RLT; and IM-4320, an anti-IL-38 immunotherapy candidate. Immunome anticipates submitting investigational new drug applications (INDs) for IM-3050 and IM-1021 in the first quarter of 2025. Anticipated timing for an IND for IM-4320 will be shared at a later date.
Highlights from 2023 and early 2024
| · | Successfully completed an underwritten offering of 11.5M shares priced at $20 per share for gross proceeds of $230.0M in February 2024, providing capital that is expected to support completion of the RINGSIDE trial and advancement of IM-1021, IM-3050 and IM-4320 into clinic. Immunome’s current cash runway is expected to extend into 2026. |
| · | Acquired AL102, a Phase 3 gamma secretase inhibitor with best-in-class potential, from Ayala Pharmaceuticals in March 2024. | |
| · | Exclusively licensed IM-1021 (formerly known as ZPC-21), a preclinical ROR1 ADC with first-in-class potential, as well as the underlying ADC linker-payload technology, from Zentalis in January 2024. | |
| · | Nominated IM-3050 as a FAP RLT candidate with first-in-class potential in December 2023. | |
| · | Completed the acquisition of Morphimmune, Inc, a concurrent PIPE of $125 million, and the transition to Clay Siegall, Ph.D. as President and CEO in October 2023. | |
| · | Filled leadership positions post-merger, including key members of the Executive Committee and five VP/SVP roles. |
Full-year 2023 Financial Results
| · | As of December 31, 2023, cash, cash equivalents and marketable securities totaled $138.1 million, which does not include gross proceeds of $230 million from the February financing. | |
| · | Research and development expenses for the year ended December 31, 2023 were $23.1 million. In-process research and development expenses for the year ended December 31 2023 were $80.8 million. | |
| · | General and administrative expenses for the year ended December 31, 2023 were $19.7 million. | |
| · | Immunome reported a net loss of $106.8 million, or basic and diluted net loss per share attributable to common stockholders of $5.38, for the year ended December 31, 2023. |
About Immunome, Inc.
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, RLTs and immunotherapies. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
For more information, visit www.immunome.com or follow us on Twitter and LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). We use words such as “may,” “could,” “potential,” “will,” “plan,” “believe,” “goal,” “optimistic,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. These forward-looking statements include, but are not limited to, statements regarding immunome’s expectation to add novel ADCs and RLTs to its pipeline; Immunome’s expectation to report topline data for the ongoing Phase 3 RINGSIDE Part B trial of AL102 in the first quarter of 2025; Immunome’s expected timeline for filing INDs for IM-3050 and IM-1021 in the first quarter of 2025; Immunome’s expectation that it will share a date for filing an IND for IM-4320; Immunome’s expectation that the funds from the February financing will support completion of the RINGSIDE trial and advancement of IM-1021, IM-3050 and IM-4320 into clinic; Immunome’s expected cash runway; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Such forward-looking statements are based on Immunome’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the risk that Immunome will not be able to realize the benefits of its strategic transactions, Immunome’s ability to grow and successfully execute on its business plan, including the development and commercialization of its pipeline; changes in the applicable laws or regulations; the possibility that Immunome may be adversely affected by other economic, business, and/or competitive factors; 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 interim results of a clinical trial do not necessarily predict final results; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the risk that our product and development candidates fail to achieve their intended endpoints; the complexity of numerous regulatory and legal requirements that Immunome needs to comply with to operate its business; the reliance on Immunome’s management; the prior experience and successes of the Immunome’s management team not being indicative of any future success; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; the failure to obtain, adequately protect, maintain or enforce Immunome’s intellectual property rights; and other risks and uncertainties indicated from time to time described in exhibit 99.2 filed with Immunome’s Current Report on Form 8-K with Securities and Exchange Commission (“SEC”) on February 13, 2024, and in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2023, being filed with the SEC later today, and in Immunome’s other filings with the SEC. Immunome cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Moreover, Immunome operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, Immunome does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in their expectations.
Investor Contact:
Max Rosett
Interim Chief Financial Officer
investors@immunome.com
Immunome, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| December 31, 2023 | December 31, 2022 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 98,679 | $ | 20,323 | |||
| Marketable securities | 39,463 | - | |||||
| Prepaid expenses and other current assets | 6,561 | 2,326 | |||||
| Total current assets | 144,703 | 22,649 | |||||
| Property and equipment, net | 2,073 | 681 | |||||
| Operating right-of-use asset, net | 1,564 | 284 | |||||
| Restricted cash | 100 | 100 | |||||
| Deferred offering costs | - | 332 | |||||
| Other long-term assets | 100 | - | |||||
| Total assets | $ | 148,540 | $ | 24,046 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 3,311 | $ | 2,400 | |||
| Accrued expenses and other current liabilities | 8,025 | 4,931 | |||||
| Deferred revenue, current | 10,493 | - | |||||
| Total current liabilities | 21,829 | 7,331 | |||||
| Deferred revenue, non-current | 5,489 | - | |||||
| Other long-term liabilities | 1,340 | 62 | |||||
| Total liabilities | 28,658 | 7,393 | |||||
| Commitments and contingencies (Note 8) | |||||||
| Stockholders’ equity: | |||||||
| Preferred stock | — | — | |||||
| Common stock | 4 | 1 | |||||
| Additional paid-in capital | 342,663 | 132,653 | |||||
| Accumulated other comprehensive income | 22 | - | |||||
| Accumulated deficit | (222,807 | ) | (116,001 | ) | |||
| Total stockholders’ equity | 119,882 | 16,653 | |||||
| Total liabilities and stockholders’ equity | $ | 148,540 | $ | 24,046 | |||
Immunome, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| Year Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Collaboration revenue | $ | 14,018 | $ | — | ||||
| Operating expenses: | ||||||||
| In-process research and development | 80,802 | — | ||||||
| Research and development | 23,089 | 23,272 | ||||||
| General and administrative | 19,657 | 13,629 | ||||||
| Total operating expenses | 123,548 | 36,901 | ||||||
| Loss from operations | (109,530 | ) | (36,901 | ) | ||||
| Other income: | ||||||||
| Interest income, net | 2,724 | 5 | ||||||
| Total other income | 2,724 | 5 | ||||||
| Net loss | $ | (106,806 | ) | $ | (36,896 | ) | ||
| Deemed dividend arising from warrant modification | — | (622 | ) | |||||
| Net loss attributable to common stockholders | $ | (106,806 | ) | $ | (37,518 | ) | ||
| Per share information: | ||||||||
| Net loss per common share, basic and diluted | $ | (5.38 | ) | $ | (3.09 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 19,843,651 | 12,126,573 | ||||||
| Comprehensive loss | ||||||||
| Net loss | $ | (106,806 | ) | $ | (37,518 | ) | ||
| Unrealized gain on marketable securities | 22 | — | ||||||
| Comprehensive loss | $ | (106,784 | ) | $ | (37,518 | ) | ||