CUE

Cue Biopharma, Inc. (CUE) - 10-K Summary for Fiscal Year Ended December 31, 2024

Business Context and Reporting Period

Cue Biopharma, Inc. is a clinical-stage biopharmaceutical company developing precision immunotherapies for cancer and autoimmune diseases using its proprietary Immuno-STAT platform. The company focuses on selectively modulating disease-relevant T cells. This report covers the fiscal year ended December 31, 2024. As of March 27, 2025, the company had 61,819,101 shares of common stock outstanding. The company is classified as a "smaller reporting company" and a "non-accelerated filer."

Key Financial Metrics

Note: The company has no commercial product revenue. Revenue is derived solely from collaboration agreements.

Material Changes vs. Prior Period

• Revenue Increase: Collaboration revenue increased by $3.8 million (69%) year-over-year, primarily driven by the Ono Collaboration and Option Agreement.
• Expense Reduction: Total operating expenses decreased by $6.9 million. Research and Development (R&D) expenses declined by $4.5 million due to reduced clinical trial costs and employee compensation. General and Administrative (G&A) expenses decreased by $2.1 million.
• Net Loss Improvement: The net loss narrowed by $10.1 million to $40.7 million, reflecting the revenue increase and cost containment measures.
• Strategic Reprioritization: In July 2024, the company shifted focus to prioritize autoimmune programs (CUE-401 and CUE-501) and deprioritized oncology programs (CUE-101 and CUE-102), leading to a workforce reduction of approximately 25%.
• Capital Raise: In September 2024, the company completed an underwritten public offering, raising net proceeds of $10.8 million.

Guidance, Outlook, and Risks

Going Concern: Management has determined that the company's cash runway extends only into the fourth quarter of 2025. This raises "substantial doubt" about the company's ability to continue as a going concern without additional financing. The company plans to raise capital through equity offerings, collaborations, or strategic alliances.

Outlook and Strategy:

• Autoimmune Focus: The company is advancing CUE-401 (Treg expansion) and CUE-501 (B cell depletion) toward clinical development. An IND filing for CUE-401 is targeted for the third quarter of 2026.
• Oncology Partnerships: The company is seeking third-party partnerships to develop the CUE-100 series (CUE-101 and CUE-102) rather than funding them internally.
• Collaboration Updates: In March 2025 (subsequent to year-end), the company terminated its agreement with Ono Pharmaceutical, regaining worldwide rights to CUE-401. It also regained rights to CUE-101 from LG Chem, though LG Chem retains rights to CUE-102.

Key Risks:

• Liquidity: Immediate need for additional capital to fund operations beyond late 2025.
• Development Risk: No products are approved; clinical success is not guaranteed.
• Debt Covenants: The company has a $4.0 million loan due December 1, 2025, with strict covenants requiring maintenance of specific cash balances.
• Regulatory: Changes in FDA guidance and potential impacts of new administration policies on clinical trial requirements.

Investor Verification Checklist

• Cash Runway: Verify the specific timeline for the next capital raise and the terms of any new financing to confirm the ability to fund operations through 2026.
• Debt Maturity: Confirm the repayment plan for the $4.0 million loan due December 1, 2025, and assess the risk of covenant breach if cash balances fall below required thresholds.
• Partnership Status: Monitor progress on securing new partners for the CUE-100 series (oncology) and CUE-501 (autoimmune) given the termination of the Ono agreement and the strategic shift.
• Stock Dilution: Review the impact of outstanding warrants (approx. 15.1 million common stock warrants and 12.4 million pre-funded warrants) on future dilution.
• IND Timeline: Track the progress of IND-enabling studies for CUE-401 to ensure the Q3 2026 filing target remains viable.