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Cue Biopharma, Inc.

CUE
๐Ÿข Pharmaceutical Preparations

Business Operations Summary

The company, Cue Biopharma, Inc., is a clinical-stage biopharmaceutical entity focused on developing injectable therapeutics designed to selectively engage and modulate disease-specific T cells for autoimmune and inflammatory diseases, leveraging its Immuno-STATยฎ platform . The core business model involves generating revenue through collaboration and license agreements, as well as potential future product sales, though the company has no history of commercial revenue from product sales . Primary customer segments are not explicitly detailed, but the company's focus on autoimmune and inflammatory diseases implies targeting patients suffering from these conditions.

The company's product pipeline is categorized into three series. The CUE-400 series targets autoimmune diseases by exploiting TGF-ฮฒ and IL-2 signaling to induce an anti-inflammatory process, foster regulatory T cell (Treg) proliferation, and induce Tregs from T effector cells, with CUE-401 being the lead preclinical candidate . The CUE-500 series, including CUE-501, is designed for targeted anti-viral T cell-mediated depletion of pathogenic cells, such as autoreactive B cells, for autoimmune conditions . The CUE-100 series, which historically focused on oncology with CUE-101 for HPV+ cancers and CUE-102 for WT1-expressing cancers, aims to selectively activate and expand tumor-specific T cells .

For the fiscal year ended December 31, 2025, the company reported total research and development expenses of $37.7 million , compared to $36.3 million for the year ended December 31, 2024. Employee compensation for research and development was $10.3 million in 2025, down from $13.1 million in 2024. Contract manufacturing costs increased to $8.8 million in 2025 from $5.4 million in 2024. Facilities and overhead costs were $4.9 million in 2025, a slight decrease from $5.1 million in 2024. Lab costs decreased to $3.9 million in 2025 from $4.9 million in 2024. Acquired in-process research and development costs were $3.9 million in 2025, with no comparable figure in 2024. Clinical trial costs decreased to $3.7 million in 2025 from $7.1 million in 2024. License fees increased to $1.6 million in 2025 from $0.1 million in 2024. Professional fees remained consistent at $0.6 million for both years. The company had cash and cash equivalents of $27.1 million as of December 31, 2025, and an accumulated deficit of $368.5 million .

Year-over-year comparisons show a slight increase in total research and development expenses from $36.3 million in 2024 to $37.7 million in 2025. This was driven by increases in contract manufacturing costs and acquired in-process research and development costs, offset by decreases in employee compensation, lab costs, and clinical trial costs. License fees also saw a significant increase. The company's cash and cash equivalents decreased, and the accumulated deficit continued to grow, reflecting ongoing operating losses.

Significant operational developments during the period include the regaining of worldwide development and commercialization rights for CUE-401 from Ono Pharmaceutical, effective March 6, 2025 . On April 10, 2025, the company entered into a Collaboration and License Agreement with Boehringer Ingelheim International GmbH (BI) for the research, development, and commercialization of B cell depletion molecules, including CUE-501 . In connection with this, the company paid Einstein $0.9 million in fees related to an amendment to the Einstein License. On November 6, 2025, ImmunoScape Pte. Ltd. (IMSCP) exercised its option to obtain licenses for the CUE-100 series, including CUE-101 and CUE-102, for oncology indications . In connection with the IMSCP agreement, the company received an aggregate of $9.5 million , net of withholding taxes, in the fourth quarter of 2025 and is entitled to receive an additional $5.0 million before the first anniversary of the effective date. The company also regained rights to the LG Chem Territory for the CUE-101 program on March 11, 2025 .

Business Outlook & Future Growth Drivers

The company anticipates receiving human safety data for CUE-401 starting in the second half of 2026 , following the planned filing of an Investigational New Drug (IND) application in the second quarter of 2026 . These early clinical trial results are expected to provide pharmacokinetic and pharmacodynamic evidence to support the premise of establishing immune balance and inducing durable immune tolerance with CUE-401, which the company believes could represent a breakthrough as a new standard of care in multiple high-value autoimmune disease indications.

A major growth area for the company is the development of CUE-401 for autoimmune diseases. This preclinical, bifunctional fusion protein is designed to promote immune tolerance by inducing newly formed regulatory T cells (iTregs) from T effector cells and expanding existing natural regulatory T cells (nTregs), while reducing pro-inflammatory autoreactive cells . The company believes this approach has the therapeutic potential to re-establish immune balance and induce tolerance across a range of T cell-mediated autoimmune and inflammatory diseases, offering long-lasting tolerance . Scale-up manufacturing and other IND-enabling studies for CUE-401 are nearing completion, with GLP toxicology studies already finished in both mice and non-human primate species . The Phase 1 trial for CUE-401 will be a two-part study, comprising a single ascending dose and a multiple ascending dose in healthy volunteers .

Another growth vector is the CUE-500 series, which has been licensed to Boehringer Ingelheim International GmbH (BI) for research, development, and commercialization . This series is designed to enable targeted anti-viral T cell-mediated depletion of pathogenic cell types, including autoreactive B cells, for autoimmune diseases . The company believes this novel approach, by redirecting existing anti-viral memory T cells, offers highly effective killing of targeted cells while potentially reducing side effects compared to competing approaches . The modularity of the CUE-500 series suggests therapeutic potential across multiple disease areas by swapping different cell-targeting antibody domains .

The company expects research and development expenses to remain consistent in future periods . The company's current operating plans indicate sufficient funds to meet obligations into the first quarter of 2027 . The company plans to finance future cash needs through a combination of equity offerings, collaborations, and other strategic alliances .

The company has flagged several structural headwinds and execution risks. Volatility in capital markets and general economic conditions, including heightened inflation, interest rate and currency rate fluctuations, trade barriers, and geopolitical events, may hinder the ability to raise required funds . The company's reliance on third-party CROs and CMOs for clinical trials and manufacturing introduces risks of delays, non-compliance, or termination of agreements . Changes in U.S. and international trade policies, such as tariffs and export rules, could negatively impact costs of materials, production processes, and supply chain stability . Specifically, the BIOSECURE Act and potential blacklisting of Chinese biotechnology companies could disrupt reliance on CMOs and service providers in China . The company is also subject to the Inflation Reduction Act (IRA), which requires manufacturers of certain drugs to engage in price negotiations with Medicare, potentially capping prices and subjecting manufacturers to civil monetary penalties or excise taxes for non-compliance . The IRA also established inflation rebate programs under Medicare Part B and Part D .

Major Risk Factors & Challenges

The company faces material risks including recurring losses from operations that raise substantial doubt about its ability to continue as a going concern, with cash and cash equivalents of $27.1 million as of December 31, 2025, projected to last only into the first quarter of 2027 . Significant competition from established and emerging pharmaceutical and biotechnology companies, many with greater financial and technical resources, poses a risk to the commercial success of its drug product candidates . Regulatory risks are substantial, as the marketing approval process is expensive, time-consuming, and uncertain, with potential for delays or denial of approval, and ongoing post-approval regulatory requirements . Changes in U.S. and international trade policies, including tariffs and export restrictions, could negatively impact costs and supply chains, as exemplified by the BIOSECURE Act and potential investigations into Chinese biotechnology companies . The Inflation Reduction Act (IRA) introduces risks related to Medicare price negotiations and inflation rebates, potentially capping prices and imposing penalties . Furthermore, the company is exposed to product liability lawsuits, intellectual property infringement claims, and the risk of misconduct by employees or partners, which could lead to substantial liabilities, fines, or reputational harm .

Management Priorities & Sentiments

Management's message to shareholders emphasizes leveraging the differentiated Immuno-STAT platform to establish new standards of care, forge strategic partnerships, and accelerate clinical development. The company intends to maximize shareholder value by focusing on the development of CUE-401, for which an IND application is being prepared for filing in the second quarter of 2026 , with human safety data anticipated in the second half of 2026 . Strategic priorities include advancing CUE-401 through clinical development, as well as maintaining and establishing collaborations, such as the agreements with BI for CUE-501 and IMSCP for the CUE-100 series. Management acknowledges the need for substantial additional financing to support future operations and growth, expecting to fund these needs through equity offerings, collaborations, and other strategic alliances .

References

  1. [1] Item 1, Business โ€” Overview
  2. [2] Item 1A, Risk Factors โ€” We are a clinical-stage biopharmaceutical company, have no history of generating commercial revenue, have a history of operating losses and may never achieve or maintain profitability.
  3. [3] Item 1, Business โ€” CUE-401
  4. [4] Item 1, Business โ€” CUE-500 Series
  5. [5] Item 1, Business โ€” CUE-100 Series
  6. [6] Item 7, MD&A โ€” Research and Development Costs
  7. [7] Item 7, MD&A โ€” Research and Development Costs
  8. [8] Item 7, MD&A โ€” Research and Development Costs
  9. [9] Item 7, MD&A โ€” Research and Development Costs
  10. [10] Item 7, MD&A โ€” Research and Development Costs
  11. [11] Item 7, MD&A โ€” Research and Development Costs
  12. [12] Item 7, MD&A โ€” Research and Development Costs
  13. [13] Item 7, MD&A โ€” Research and Development Costs
  14. [14] Item 7, MD&A โ€” Research and Development Costs
  15. [15] Item 7, MD&A โ€” Research and Development Costs
  16. [16] Item 7, MD&A โ€” Research and Development Costs
  17. [17] Item 7, MD&A โ€” Research and Development Costs
  18. [18] Item 7, MD&A โ€” Research and Development Costs
  19. [19] Item 7, MD&A โ€” Research and Development Costs
  20. [20] Item 7, MD&A โ€” Research and Development Costs
  21. [21] Item 7, MD&A โ€” Research and Development Costs
  22. [22] Item 1A, Risk Factors โ€” Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern.
  23. [23] Item 1A, Risk Factors โ€” We are a clinical-stage biopharmaceutical company, have no history of generating commercial revenue, have a history of operating losses and may never achieve or maintain profitability.
  24. [24] Item 1, Business โ€” Our Collaboration and Option Agreement with Ono
  25. [25] Item 1, Business โ€” Our Collaboration and License Agreement with BI
  26. [26] Item 1, Business โ€” Our License Agreement with Einstein
  27. [27] Item 1, Business โ€” Our Collaboration and License Agreement with ImmunoScape
  28. [28] Item 1, Business โ€” Our Collaboration and License Agreement with ImmunoScape
  29. [29] Item 1, Business โ€” Our Collaboration and License Agreement with ImmunoScape
  30. [30] Item 1, Business โ€” Our Collaboration Agreement with LG Chem
  31. [31] Item 1, Business โ€” CUE-401
  32. [32] Item 1, Business โ€” CUE-401
  33. [33] Item 7, MD&A โ€” Research and Development Costs
  34. [34] Item 7, MD&A โ€” Events that Raise Substantial Doubt About Our Ability to Continue as a Going Concern
  35. [35] Item 1A, Risk Factors โ€” We will need substantial additional financing to support our growth and ongoing operations.
  36. [36] Item 1A, Risk Factors โ€” We rely on third parties to conduct our clinical trials.
  37. [37] Item 1A, Risk Factors โ€” Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact our business and operating results.
  38. [38] Item 1A, Risk Factors โ€” Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact our business and operating results.
  39. [39] Item 1A, Risk Factors โ€” The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if approved.
  40. [40] Item 1A, Risk Factors โ€” The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if approved.
  41. [41] Item 1A, Risk Factors โ€” We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  42. [42] Item 1A, Risk Factors โ€” Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming, and uncertain and may prevent us from obtaining approvals for the commercialization of any of our drug product candidates.
  43. [43] Item 1A, Risk Factors โ€” If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our drug product candidates.

Report on May 22, 2026