• A next-generation Merck (Keytruda) or Bristol Myers Squibb (Opdivo), focused on developing highly precise immunotherapies that 'train' specific immune cells to fight cancer and autoimmune diseases.
• Like a CRISPR Therapeutics or Editas Medicine, but instead of editing genes, they are precisely engineering specific immune cells (T-cells) to treat diseases.
• An early-stage Amgen or Gilead Sciences focused on a unique platform to develop 'smart' biologic drugs that selectively activate or de-activate key immune cells for therapeutic benefit.

• CUE-101: A novel, T cell-selective IL-2-based biologic currently in clinical trials for the treatment of HPV-driven cancers.
• CUE-102: An investigational T cell-selective IL-2-based biologic in preclinical development, designed to target specific tumor antigens for various cancers.
• CUE-300 Series: A pipeline of preclinical biologics being developed to modulate T cell activity for the treatment of autoimmune diseases.

Cue Biopharma (CUE) is a clinical-stage biotechnology company that sells primarily to other companies through collaboration and licensing agreements. It does not sell products directly to individuals.

Its major customers and partners, which provide revenue through research funding, milestone payments, and potential royalties, include:

• Merck KGaA, Darmstadt, Germany: A leading science and technology company operating in healthcare, life science, and electronics. It is important to note that this is a private German company and is distinct from Merck & Co., Inc. (MRK) in the United States.
• LG Chem Life Sciences: This is the life sciences division of LG Chem Ltd., a diversified South Korean chemical company. LG Chem Ltd.'s stock symbol is KRX: 051910 on the Korea Exchange.

Goodwin Biotechnology, Inc.

Sanofi S.A. (SNY)

Usman “Oz” Azam, M.D. President and Chief Executive Officer

Dr. Azam was appointed President and Chief Executive Officer of Cue Biopharma effective September 29, 2025. He brings over 25 years of leadership experience in drug discovery and development. Most recently, Dr. Azam served as CEO of Inspirna, Inc., a privately held clinical-stage biopharmaceutical company focused on cancer drugs. Prior to Inspirna, he was CEO of Empyrean Neuroscience, a genetic engineering company. As President and CEO of Tmunity Therapeutics, he was involved in developing genetically engineered CAR-T cell therapies. He also served as Global Head of the Cell and Gene Therapies unit at Novartis, where he played a role in the launch of the first FDA-approved CAR-T cell therapy. Dr. Azam has held leadership positions at Pfizer Pharmaceuticals, Aspreva Pharmaceuticals, Johnson & Johnson, and GlaxoSmithKline (GSK).

Currently, Cue Biopharma's official leadership page does not list a Chief Financial Officer. Kerri-Ann Millar, the former CFO, resigned effective June 13, 2025. Daniel Passeri, who was CEO at the time, stepped in as interim Principal Financial and Accounting Officer until a permanent successor could be found. On September 29, 2025, Mr. Passeri transitioned from CEO to Strategic Advisor.

Lucinda Warren Chief Business Officer

Ms. Warren was appointed Chief Business Officer of Cue Biopharma on September 9, 2024. She possesses over 30 years of global experience in the pharmaceutical and biotechnology sectors. Before joining Cue Biopharma, she served as Vice President of Business Development for Neuroscience and Japan Regionally at Johnson & Johnson from 2014 to 2024. In this role, she was responsible for comprehensive business development activities, including licensing, mergers and acquisitions, and alliance management. Her experience also includes significant leadership roles at Janssen Cilag Australia and Centocor/Janssen Biologics.

Matteo Levisetti, M.D. Chief Medical Officer

Dr. Levisetti brings extensive experience in leading global clinical development for pharmaceutical companies of various sizes. Prior to Cue Biopharma, he held the position of Chief Medical Officer at DNAtrix, where he managed clinical operations and regulatory strategy for multiple clinical trials. He also served as Chief Medical Officer at Dauntless Pharmaceuticals and directed immuno-oncology programs as Executive Director of Clinical Development at Mirati Therapeutics. His career includes senior positions with Pfizer, such as Global Clinical Lead, and Global Head & Vice President, Translational Medicine, Immunology and Inflammation at Roche Pharma Research & Early Development.

Daniel Baker, M.D. Interim Chief Development Officer

Dr. Baker serves as the Interim Chief Development Officer at Cue Biopharma.

Colin Sandercock, M.S.E., J.D. Senior Vice President and General Counsel

Mr. Sandercock holds the roles of Senior Vice President and General Counsel at Cue Biopharma.

Key Risks to Cue Biopharma (CUE)

Cue Biopharma (CUE) faces several significant risks to its business, primarily stemming from its financial viability, compliance with listing requirements, and the inherent challenges of being a clinical-stage biotechnology company.

1. Substantial Doubt About Going Concern: The most significant risk to Cue Biopharma is the substantial doubt about its ability to continue as a going concern. The company has a history of recurring losses and negative cash flows, with a projected cash runway of less than one year based on current financial data. This financial instability, highlighted by an Altman Z-Score indicating a potential risk of bankruptcy within the next two years, necessitates the company seeking additional capital to fund its operations.
2. Nasdaq Listing Non-Compliance: Cue Biopharma has encountered challenges in maintaining compliance with Nasdaq's continued listing requirements, particularly the minimum bid price rule. While the company has recently regained compliance after receiving a deficiency letter, the potential for future non-compliance remains a significant concern. Any delisting could severely impact the stock's market liquidity, diminish the company's ability to secure favorable capital terms, and erode stakeholder confidence.
3. Clinical Trial and Regulatory Risks / Dependence on Pipeline Success: As a clinical-stage biotechnology company, Cue Biopharma has not yet generated revenue from product sales and is entirely dependent on the successful development and eventual commercialization of its drug candidates. With only a limited number of drug candidates in clinical trials, setbacks such as negative or inconclusive trial results, delays in regulatory approvals from the U.S. Food and Drug Administration (FDA), or unexpected drug-related side effects, would have a material adverse impact on the company's prospects and financial stability.

1. Growth in Collaboration Revenue through Upfront Payments and Milestone Achievements: Cue Biopharma has demonstrated a strategy of securing partnerships, which has already led to increased collaboration revenue. The company’s collaboration with Ono Pharmaceutical, established in February 2023, has contributed to this growth. More recently, a partnership with Boehringer Ingelheim concerning CUE-501 included a $12 million upfront payment in Q2 2025 and holds potential for up to $345 million in milestone payments. Additionally, a collaboration with ImmunoScape announced in November 2025 is expected to provide $15 million in upfront payments ($10 million in Q4 2025 and $5 million in November 2026), alongside a 40% equity stake in ImmunoScape and eligibility for high-single-digit royalty payments on net sales. Continued achievement of milestones in these existing collaborations and the formation of new strategic partnerships will be a significant revenue driver.
2. Advancement of the Autoimmune Disease Pipeline: Cue Biopharma has strategically refocused its efforts on its autoimmune programs, particularly CUE-401 and the CUE-500 series. CUE-401, developed in collaboration with Ono Pharmaceutical, is progressing with the anticipation of lead candidate selection in Q1 2025 and an intention to advance an Investigational New Drug (IND) submission following positive FDA feedback. The CUE-500 series is being positioned for strategic partnering to address B-cell-mediated autoimmune diseases. Successful progression of these candidates through preclinical and early clinical stages is expected to trigger further collaboration and milestone payments.
3. Strategic Partnering for Oncology Programs: While Cue Biopharma has downsized its direct investment in oncology programs to focus on autoimmune diseases, it intends to preserve the potential value of its clinical oncology programs, CUE-101 and CUE-102, by pursuing partnerships. CUE-101 has shown promising clinical activity in Phase 1 trials for HPV+ recurrent/metastatic head and neck squamous cell carcinoma, both as a monotherapy and in combination with KEYTRUDA®. Securing new out-licensing or co-development agreements for these oncology assets would generate upfront payments, milestone payments, and potential future royalties.
4. Expansion and Diversification of the Immuno-STAT Platform into New Indications: The company's proprietary Immuno-STAT™ platform is described as modular and versatile, designed to selectively engage and modulate targeted T cells for a broad range of indications beyond oncology, including autoimmune and infectious diseases. This inherent flexibility of the platform creates opportunities for Cue Biopharma to discover and develop new therapeutic candidates and enter into additional collaborations across various therapeutic areas, further diversifying its potential revenue streams.

Share Issuance

• In April 2025, Cue Biopharma raised approximately $20 million in gross proceeds through a public offering of common stock and accompanying warrants, including pre-funded warrants.
• As of September 30, 2024, the company had sold 9,028,573 shares of common stock under an At-The-Market (ATM) agreement initiated in October 2021, yielding $40.4 million in net proceeds.
• In November 2022, Cue Biopharma completed a Post IPO funding round for $30 million.

Inbound Investments

• In April 2025, Cue Biopharma entered a strategic collaboration and license agreement with Boehringer Ingelheim for its CUE-501 candidate, receiving a $12 million upfront payment and eligible for up to approximately $345 million in potential milestone payments.
• In November 2025, Cue Biopharma announced a strategic collaboration with ImmunoScape, entitling Cue Biopharma to an upfront payment of $15 million ($10 million in Q4 2025 and $5 million in November 2026), a 40% equity stake in ImmunoScape, and high-single-digit royalties on net sales.