Cue Biopharma, Inc. 2025 Annual Report: Key Highlights for Investors

Overview

Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company headquartered in Boston, Massachusetts, has released its Annual Report for the fiscal year ended December 31, 2025. The company remains focused on the development of a novel class of immunotherapies designed to selectively modulate the human immune system for the treatment of cancer and autoimmune diseases.

Key Financial and Corporate Highlights

• Public Float: As of June 30, 2025, Cue Biopharma’s aggregate market value of voting and non-voting common equity held by non-affiliates was approximately \$52.0 million, based on a closing share price of \$0.68.
• Shares Outstanding: As of March 13, 2026, the company had 97,660,791 shares of Common Stock outstanding.
• Nasdaq Listing: The company’s shares trade on the Nasdaq Capital Market under the ticker symbol CUE.
• Filing Status: Cue Biopharma is a non-accelerated filer and a smaller reporting company. It is not considered a well-known seasoned issuer or an emerging growth company.
• Regulatory Compliance: The company has filed all required reports under Section 13 or 15(d) of the Securities Exchange Act of 1934 and submitted all Interactive Data Files as required.
• Going Concern: The report raises a substantial doubt regarding Cue Biopharma’s ability to continue as a going concern due to recurring losses from operations.

Forward-Looking Statements

The report includes numerous forward-looking statements regarding the company’s future plans, strategies, and expectations. These statements cover the timing, progress, and results of ongoing and planned preclinical studies and clinical trials, research and development programs, capital requirements, intellectual property position, and ability to secure additional funding and collaborations.

Management cautions that these forward-looking statements are subject to numerous risks, uncertainties, and changes in circumstances, many of which are outside the company’s control.

Risk Factor Summary – Material Items for Investors

• Substantial Doubt About Going Concern: The company’s recurring losses from operations raise substantial doubt about its ability to continue as a going concern. This is a critical issue for shareholders, as it may directly impact the company’s stock price and future viability.
• No Commercial Revenue: Cue Biopharma is a clinical-stage company with no history of generating commercial revenue and a history of operating losses. There is no guarantee that the company will achieve or maintain profitability.
• Need for Additional Capital: The company will require substantial additional financing to support growth and ongoing operations. There is a risk that additional capital may be difficult to obtain, may restrict operations, require relinquishment of rights to technologies or drug product candidates, encumber assets, result in ongoing debt service costs, or cause further dilution to existing shareholders.
• Competition: Many competitors have greater financial, technical, and human resources, as well as more experience in product development, regulatory approval, and commercialization. This may put Cue Biopharma at a competitive disadvantage.
• Regulatory Risks: Even if Cue Biopharma or its collaborators obtain marketing approvals for drug candidates, the terms of those approvals and ongoing regulation could require substantial expenditure and may limit how products are manufactured and marketed, potentially impairing the ability to generate revenue.
• Dependence on Collaborations and Funding: The company’s ability to continue operations, expand its pipeline, and bring products to market is highly dependent on its ability to maintain existing collaborations and secure additional funding.

Other Noteworthy Information

• Documents Incorporated by Reference: Portions of Cue Biopharma’s forthcoming definitive proxy statement (to be filed within 120 days after year-end) are incorporated by reference into Part III of the Annual Report.
• Government Regulation: The company faces extensive regulation in the United States and internationally, covering all aspects of drug development, approval, manufacturing, marketing, and post-approval monitoring.
• Legal Proceedings: No specific legal proceedings are highlighted in this section of the report.

Potential Shareholder Impacts and Price Sensitivity

The mention of substantial doubt regarding Cue Biopharma’s ability to continue as a going concern is a major red flag for investors. This statement, combined with the need for significant additional financing and no commercial revenue, are highly material and could negatively impact share value. The company’s competitive position, potential dilution from future financing, and regulatory hurdles also present significant risks that shareholders must consider.

Conclusion

Shareholders and potential investors should carefully consider the company’s financial condition, ongoing need for funding, competitive landscape, and operational risks before making investment decisions. The company’s future is highly dependent on successful fundraising and progression of its clinical pipeline, and there are substantial risks that could impact share value.

Disclaimer: This summary is for informational and educational purposes only and does not constitute financial advice or a recommendation to buy or sell any securities. Investors should review the full Annual Report and consult with their financial advisor before making investment decisions.

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