Immunome Inc. SEC 10-Q Report

Immunome Inc., a biopharmaceutical company focused on developing targeted oncology therapies, has released its 10-Q report for the quarter ended September 30, 2023. The report provides a comprehensive overview of the company's financial performance, business operations, strategic initiatives, and the challenges it faces as it continues to advance its pipeline and expand its capabilities.

Financial Highlights

• Collaboration revenue: $2.9 million, decreased by $0.7 million from $3.6 million for the three months ended September 30, 2023.
• Collaboration revenue: $6.3 million, decreased by $3.9 million from $10.2 million for the nine months ended September 30, 2023.
• Loss from operations: $(50.5) million, increased by $45.9 million from $(4.6) million for the three months ended September 30, 2023.
• Loss from operations: $(222.8) million, increased by $208.0 million from $(14.9) million for the nine months ended September 30, 2023.
• Net loss: $(47.1) million, increased by $42.8 million from $(4.3) million for the three months ended September 30, 2023.
• Net loss: $(212.7) million, increased by $198.5 million from $(14.2) million for the nine months ended September 30, 2023.
• Net loss per share, basic and diluted: $(0.78), increased from $(0.36) for the three months ended September 30, 2023.
• Net loss per share, basic and diluted: $(3.72), increased from $(1.16) for the nine months ended September 30, 2023.
• Interest income: $3.4 million, increased by $3.1 million from $0.3 million for the three months ended September 30, 2023.
• Interest income: $10.1 million, increased by $9.4 million from $0.7 million for the nine months ended September 30, 2023.

Business Highlights

• Clinical Asset AL102: AL102, an investigational gamma secretase inhibitor (GSI), is currently under evaluation in a Phase 3 trial for the treatment of desmoid tumors. The trial, named RINGSIDE Part B, is a global, double-blind, randomized, placebo-controlled clinical trial conducted at 61 clinical sites. Enrollment was completed in February 2024, and topline data is expected in the second half of 2025.
• Preclinical Asset IM-1021: IM-1021, a receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate (ADC), showed sustained tumor regression in preclinical studies. The company plans to submit an IND for IM-1021 to the FDA in the first quarter of 2025.
• Preclinical Asset IM-3050: IM-3050, a fibroblast activation protein (FAP) targeted radioligand therapy (RLT), is being developed for the treatment of solid tumors. An IND submission for IM-3050 is expected in the first quarter of 2025.
• Merger with Morphimmune: On October 2, 2023, Immunome completed its merger with Morphimmune Inc., a preclinical biotechnology company focused on developing targeted oncology therapies. Morphimmune became a wholly owned subsidiary of Immunome.
• Acquisition of AL102: On March 25, 2024, Immunome acquired AL102 from Ayala Pharmaceuticals, Inc. This acquisition included the assumption of certain liabilities associated with the acquired assets.
• License Agreement with Zentalis: In January 2024, Immunome entered into a license agreement with Zentalis Pharmaceuticals, Inc. for the exclusive rights to Zentalis’ proprietary ADC platform technology, ROR1 antibodies, and ADCs targeting ROR1. This agreement was later terminated in October 2024, and Immunome acquired the Zentalis Licensed Assets outright.
• Expansion of Office and Laboratory Space: In May 2024, Immunome expanded its office and laboratory space in Bothell, Washington, adding 15,000 square feet to its existing facilities. The lease for this space expires on January 31, 2029.
• Future Outlook: Immunome expects to continue investing in discovery efforts to expand its pipeline, particularly focusing on additional ADC programs. The company aims to develop therapies that bring substantial benefits to patients by pairing quality antibodies with suitable linkers and payloads.

Strategic Initiatives

Immunome, Inc. has undertaken several strategic initiatives to advance its pipeline and expand its capabilities. The company completed the acquisition of AL102 from Ayala Pharmaceuticals, Inc., which is currently under evaluation in a Phase 3 trial for the treatment of desmoid tumors. Additionally, Immunome acquired certain antibody-related assets from Atreca, Inc., and completed its merger with Morphimmune Inc., a preclinical biotechnology company focused on developing targeted oncology therapies. The company also entered into a license agreement with Zentalis Pharmaceuticals, Inc. for the development of IM-1021, a preclinical stage ADC targeting ROR1, and later acquired the Zentalis Licensed Assets, terminating all contingent milestone and royalty payment obligations. Furthermore, Immunome is developing IM-3050, a FAP-targeted radioligand therapy for the treatment of solid tumors, and plans to expand its intellectual property estate and discovery efforts to add several new candidates to its pipeline.

Immunome has actively managed its capital to support its strategic initiatives. In February 2024, the company completed a follow-on public offering, issuing 11,500,000 shares of common stock at $20.00 per share, raising net proceeds of $215.4 million. Additionally, in May 2024, Immunome entered into a $200 million 'at the market' sales agreement with TD Securities (USA) LLC, although no shares have been sold under this agreement as of September 30, 2024. The company also received $61 million in prepayments from a PIPE transaction associated with the closing of the Morphimmune merger. Immunome has utilized these funds to finance acquisitions, such as the purchase of AL102 from Ayala and the Zentalis Licensed Assets, and to support its ongoing research and development activities.

Immunome expects its expenses to increase substantially as it advances and expands its clinical development of AL102, seeks regulatory approval, and continues the preclinical and potential clinical development of IM-1021 and IM-3050. The company anticipates that its existing cash, cash equivalents, and marketable securities will be sufficient to fund its current and planned operating expenses and capital expenditures for at least 12 months from the filing date of this Quarterly Report on Form 10-Q. Beyond that, Immunome may need to raise additional capital through equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements to achieve its longer-term business objectives. The company plans to continue its business development strategy, including potential acquisitions of additional clinical-stage programs and expansion of its intellectual property estate to support the development of first-in-class or best-in-class oncology therapies.

Challenges and Risks

Immunome faces several challenges and risks as it continues to develop its pipeline and expand its operations. Key risks include:

• Immunome is a biopharmaceutical company with a history of losses and expects to continue incurring significant losses for the foreseeable future. The company may never achieve or maintain profitability.
• The company has a limited operating history, making it difficult to evaluate its drug development capabilities and predict future performance.
• Immunome has not yet demonstrated successful completion of clinical development, submitted a New Drug Application, obtained FDA approval for marketing, or successfully commercialized a drug product. The acquisition of AL102, currently in Phase 3 development, does not guarantee future success.
• The company may not be successful in using and expanding its discovery and ADC platforms to build and progress a pipeline.
• Immunome may be unable to advance its development candidates into and through clinical development, obtain regulatory approvals, and ultimately commercialize them, or could experience significant delays in doing so.
• Clinical trials are expensive, time-consuming, and difficult to design and implement. If undesirable side effects are identified, the ability to market and derive revenue from the program or development candidate could be compromised.
• Reliance on third parties for manufacturing, supply, and testing could lead to limited or interrupted supply or unsatisfactory quality.
• Protecting intellectual property and proprietary technologies is difficult and costly, and the company may not be able to ensure their protection.
• The market price of Immunome's common stock is expected to be volatile, and purchasers could incur substantial losses.

Immunome's management is focused on addressing these risks through strategic planning, careful management of resources, and ongoing efforts to advance its pipeline and expand its capabilities.

SEC Filing: Immunome Inc. [ IMNM ] - 10-Q - Nov. 13, 2024