8-K: Cue Biopharma Forges Strategic Oncology Partnership

Cue Biopharma enters a significant collaboration with ImmunoScape for its CUE-100 Series, securing $15M, 40% equity, and royalties.

Summary

• ImmunoScape Pte. Ltd. (IMSCP) exercised its option to license molecules from Cue Biopharma's CUE-100 Series, including CUE-101 and CUE-102, for all oncology indications.
• The collaboration establishes a co-exclusive development license for five years, with Cue Biopharma retaining non-exclusive research rights, and an exclusive commercial license for molecules IMSCP advances to IND-enabling studies.
• Cue Biopharma received an aggregate of $5 million in the fourth quarter of 2025 in connection with the option agreement and its exercise.
• The company is entitled to receive an additional $5 million in or prior to December 2025, and another $5 million before the first anniversary of the option exercise (by November 6, 2026).
• Cue Biopharma will receive equity in IMSCP equal to 40% of its issued and outstanding equity, with additional warrants for future dilution events.
• The agreement includes high single-digit royalties on global net sales and lowto mid-double digit royalties from sublicensing income.
• The collaboration aims to develop a novel 'Seed-and-Boost' immunotherapy combining Cue Biopharma's Immuno-STAT T-cell engagers with ImmunoScape's proprietary TCRs for solid tumors.
• Preclinical data supports this approach in multiple solid tumors, including pancreatic and ovarian, with IND-enabling studies on track for 2027 submission.

Sentiment

Score: 7

Explanation: The collaboration is a strong positive, providing significant non-dilutive funding, a substantial equity stake, and future royalty potential, while validating the company's platform and enabling a strategic focus shift. However, the explicit 'going concern' warning and ongoing need for capital temper the overall sentiment, indicating significant underlying financial risks remain.

Positives

• Secured a significant collaboration and license agreement for the CUE-100 Series, validating the Immuno-STAT platform.
• Received an aggregate of $5 million in Q4 2025, with an additional $10 million in time-based payments expected by November 2026.
• Obtained a substantial 40% equity stake in ImmunoScape, providing potential for future value appreciation.
• Eligible for high single-digit royalties on global net sales and lowto mid-double digit royalties from sublicensing, creating long-term revenue streams.
• The collaboration allows Cue Biopharma to strategically focus on its autoimmune disease programs while advancing its oncology platform through a partner.
• The 'Seed-and-Boost' approach shows compelling preclinical data and aims to overcome limitations of existing cell therapies, potentially leading to a breakthrough treatment.

Negatives

• ImmunoScape retains the ability to terminate the agreement in its entirety on 60 days advanced written notice, introducing a degree of risk to the partnership's longevity.

Risks

• Ability to maintain the collaboration with ImmunoScape.
• Limited operating history, limited cash, and a history of losses.
• Ability to achieve profitability.
• Ability to obtain adequate financing to fund business operations in the future.
• Ability to successfully remediate the current going concern determination, which indicates insufficient capital for operations beyond the next twelve months.
• Reliance on licensors, collaborators, contract research organizations, suppliers, and other business partners.
• Potential setbacks in research and development efforts, including negative or inconclusive results from preclinical studies or clinical trials.
• Ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of product candidates.
• Serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials.
• Ability to secure required U.S. Food and Drug Administration (FDA) or other governmental approvals for product candidates and the breadth of any approved indication.
• Adverse effects caused by public health pandemics.
• Delays and changes in regulatory requirements, policy, and guidelines, including potential delays in submitting required regulatory applications to the FDA.
• Ability to maintain and enforce necessary patent and other intellectual property protection.
• Competitive factors.
• General economic and market conditions.

Future Outlook

The collaboration is expected to advance a novel 'Seed-and-Boost' immunotherapy for solid tumors, with IND-enabling studies on track for submission in 2027. Cue Biopharma anticipates receiving future time-based milestone payments and royalty payments on net sales. The company plans to focus its internal efforts on autoimmune disease programs while leveraging this partnership for oncology development.

Management Comments

• Usman Azam, M.D., president and chief executive officer of Cue Biopharma, stated, "We believe this strategic collaboration with ImmunoScape represents a significant development for treating solid tumors with immunotherapy and creating potential value for our shareholders. It positions the Company to focus on our autoimmune disease programs and continue to advance the Immuno-STAT platform for oncology with our partners at ImmunoScape."
• Michael Fehlings, chief executive officer of ImmunoScape, commented, "ImmunoScape is excited to partner with Cue Biopharma to pioneer this novel immunotherapy against solid tumors and potentially provide patients with a promising treatment option. Based on our extensive preclinical work, we believe this Seedand-Boost approach will transform T cell therapy for long-term efficacy against a range of solid tumors while avoiding the deleterious side effects of broad immune activation. We aim to transform patients lives by enabling superior cell therapy and streamlining the patient journey."

Industry Context

This collaboration represents a significant move in the competitive landscape of T-cell therapy for solid tumors, an area known for its challenges in achieving durable responses and managing toxicities. The 'Seed-and-Boost' approach, designed to enable in vivo expansion and activation of T cells while reducing manufacturing complexity and systemic immune activation, could position the combined technology as a differentiated solution. It aligns with the broader industry trend of developing more targeted and tolerable immunotherapies, potentially offering a breakthrough standard of care.

Comparison to Industry Standards

• NA

Stakeholder Impact

• Shareholders: Potential for increased value through upfront payments, future milestones, royalties, and the 40% equity stake in ImmunoScape. The strategic focus on autoimmune programs could also be seen positively, though the 'going concern' risk remains a significant concern.
• Employees: Strategic refocusing may lead to shifts in internal priorities and resource allocation, potentially impacting roles related to the CUE-100 oncology series while creating new opportunities in autoimmune development.
• Customers/Patients: The collaboration offers the potential for a novel, more effective, and tolerable cell therapy for solid tumors in the future, addressing a high unmet medical need.
• Creditors: The new revenue streams and equity stake could improve the company's financial outlook, potentially mitigating some of the 'going concern' risks and improving creditworthiness.

Next Steps

• ImmunoScape will further develop and potentially commercialize the Licensed Program.
• IND-enabling studies for the novel therapeutic approach are on track for submission in 2027.
• Cue Biopharma plans to file the complete Collaboration and License Agreement as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2025.
• Cue Biopharma will focus its internal resources on advancing its autoimmune disease programs.

Key Dates

Recommendation

The collaboration with ImmunoScape is a significant positive development, providing substantial non-dilutive funding, a valuable equity stake, and future royalty potential, which validates Cue Biopharma's technology and allows for a strategic pivot to autoimmune programs. This materially improves the company's financial position and strategic outlook. However, the company's explicit 'going concern' determination, indicating insufficient capital for operations beyond 12 months, remains a critical risk. While the new funds alleviate immediate pressure, the underlying need for sustained financing persists. Therefore, a 'Hold' recommendation is prudent, acknowledging the strong positive catalysts while maintaining caution due to the ongoing financial stability concerns.

Keywords

Cue Biopharma, ImmunoScape, Collaboration, License Agreement, CUE-100 Series, Immuno-STAT, T-cell therapy, Solid Tumors, Oncology, Biotechnology, Drug Development, Preclinical Data, IND-enabling studies, Royalties, Equity Stake, Autoimmune Disease