XML 53 R8.htm IDEA: XBRL DOCUMENT v3.24.1
Nature of the business
12 Months Ended
Dec. 31, 2023
Nature of the business  
Nature of the business

1. Nature of the business

Organization

Immunome, Inc., or the Company, is a biopharmaceutical company focused on the development of targeted oncology therapies. The Company believes that the pursuit of novel or underexplored targets will be central to the next generation of transformative therapies. For that reason, Immunome pursues therapeutics that it believes have best-in-class or first-in-class potential. The Company’s goal is to establish a broad pipeline of preclinical and clinical assets which it can efficiently develop through successive value inflection points. To support that goal, the Company pairs business development activity with significant investment in its internal discovery programs.

Immunome is advancing a named pipeline comprising one clinical and three preclinical assets. The clinical asset is AL102, an investigational gamma secretase inhibitor, currently under evaluation in a Phase 3 trial for the treatment of desmoid tumors that was acquired from Ayala Pharmaceuticals, Inc. on March 25, 2024. The preclinical assets are IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugates, or ADC; IM-3050, a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT, candidate; and IM-4320, an anti-IL-38 immunotherapy candidate.

The Company was incorporated as a Pennsylvania corporation on March 2, 2006, and was converted to a Delaware corporation on December 2, 2015. Since its inception, the Company has devoted substantially all its resources to research and development, raising capital, building its management team, extending its intellectual property portfolio, and executing strategic partnerships and transactions. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, risks associated with research, development, and manufacturing activities, uncertain results of preclinical and clinical testing, development of new technological innovations and products by competitors, dependence on key personnel, partners and third-party vendors, protection of proprietary technology, compliance with government regulations, regulatory approval of products and the ability to secure additional capital to fund operations. 

On October 2, 2023, the Company completed its merger with Morphimmune Inc., or Morphimmune, a preclinical biotechnology company focused on developing targeted oncology therapies. Under the terms of the Agreement and Plan of Merger and Reorganization dated as of June 28, 2023, or the Merger Agreement, among the Company, Morphimmune and Ibiza Merger Sub, Inc., a wholly owned subsidiary of the Company, or Merger Sub, Morphimmune merged with and into Merger Sub, with Morphimmune surviving as a wholly-owned subsidiary of Immunome, or the Merger. 

Liquidity

The Company has incurred net losses since inception, including net losses of $106.8 million and $36.9 million for the years ended December 31, 2023 and 2022, respectively, and it expects to generate losses from operations for the foreseeable future primarily due to research and development costs for its programs and development candidates. As of December 31, 2023, the Company had an accumulated deficit of $222.8 million. The Company expects to generate operating losses for the foreseeable future.

Through December 31, 2023, the Company has funded its operations primarily through sales of equity securities and strategic partnerships and transactions as well as expense reimbursements from the Department of Defense, or DoD, under the Other Transaction Authority for Prototype Agreement, or the OTA Agreement.

In February 2024, the Company raised $230.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, from a public offering of 11,500,000 shares of the Company’s common stock, or the 2024 Financing.

In June 2023, the Company entered into subscription agreements with certain investors pursuant to which the Company sold 21,690,871 shares of its common stock, immediately following the completion of the Merger in October 2023, in exchange for gross proceeds of $125.0 million.

The Company expects that its existing cash, cash equivalents and marketable securities at December 31, 2023, in combination with the proceeds from the 2024 Financing, will enable the Company to fund its current and planned operating expenses and capital expenditures for at least 12 months from the filing date of this Annual Report on Form 10-K. Beyond that date, more funding will be necessary to fund additional research and development activities and operations in order to pursue the Company’s growth strategy. 

If the Company cannot obtain the necessary funding, it will need to delay or scale back some of its research and development programs, enter into collaborations with third parties relative to potential programs, products or technologies that it might otherwise seek to progress independently (or enter into these collaborations sooner than it might otherwise have intended to), or reduce operations. Additionally, volatility in the capital markets generally and the biotechnology sector specifically, as well as general economic conditions in the United States may be a significant obstacle to raising the required funds on satisfactory terms, if at all.

Operations of the Company are subject to certain risks and uncertainties including various internal and external factors that will affect whether and when the Company’s programs and development candidates become approved drugs and how significant their market share will be, many of which are outside of the Company’s control. The length of time and cost of developing and commercializing these programs and development candidates and/or failure of them at any stage of the drug approval process will materially affect the Company’s financial condition and future operations.