Cue Biopharma, Inc. (CUE) Earnings Call Transcripts

Cue Biopharma, Inc.'s Latest Earnings Call - April 7, 2026

In the Q1 2026 earnings call, Cue Biopharma, Inc. highlighted significant advancements in its lead asset, CUE-401, which is positioned as a potential first-in-class treatment for autoimmune diseases. The company announced successful completion of IND activities and plans to file an IND in June 2026, with Phase I trials expected to begin shortly thereafter. Revenue from milestone payments related to collaborations was noted, including a $7.5 million milestone from Boehringer Ingelheim, which underscores the company's strategic partnerships and financial health. Management maintained a positive outlook on the potential of CUE-401, emphasizing its unique mechanism of action and broad applicability across various autoimmune conditions.

Reported metrics

Guidance from management

Management remains optimistic about the upcoming IND submission and the potential for CUE-401 to address unmet needs in autoimmune diseases. No changes to previous guidance were indicated, maintaining a focus on advancing the clinical development timeline.

What management said

Thanks, Rich. In addition, we are pleased to have Dr. Jonathan Kay with us today to discuss our findings in multiple relative immune cell types. Dr. Kay is the Timothy S. and Elaine L. Peterson Chair of Rheumatology at University of Massachusetts Chan Medical School. He is Professor of Medicine and Population and Quantitative Health Sciences. Take it away, Jon.

Thank you, Dan. We'll now conduct a question-and-answer session with our -- with the management team who is currently on the line. So we had a question come in, and I'd like to introduce Dr. Natasha Girgis, who's joined us as the Director of Translational Pharmacology. The question that's come in is about the TGF-beta mask. It seems to be a reduced avidity binder, not a true conditional mask that turns on in the pr...

What analysts pressed on

Analysts expressed concerns about the long-term safety profile of CUE-401, particularly regarding the TGF-beta component and its potential for off-target effects. Questions were raised about the durability of Treg effects post-treatment and the overall competitive landscape in autoimmune therapies.

Main topics on the call

• CUE-401 Development Progress — Cue Biopharma is preparing to submit an IND for CUE-401 in June 2026, with Phase I trials expected to commence shortly after. Management stated, "CUE-401 is rapidly approaching its first-in-human trial," indicating stron...
• Milestone Payments and Collaborations — The company reported a $7.5 million milestone payment from Boehringer Ingelheim, which was achieved due to the completion of preclinical milestones. This reflects Cue's ability to monetize its assets effectively and redu...
• Mechanism of Action for CUE-401 — CUE-401 utilizes a bifunctional approach by combining TGF-beta and IL-2 to enhance Treg expansion while suppressing inflammatory responses. Management noted, "This combination of mechanisms makes CUE-401 a powerful toler...
• Clinical Trial Design — The Phase I trial design includes a single ascending dose (SAD) and multiple ascending dose (MAD) studies, aimed at determining optimal dosing regimens. Management emphasized that these trials will be "pharmacodynamicall...

Read the full Cue Biopharma, Inc. transcript (April 7, 2026) → Summary generated from the call transcript; every figure above is stated by management on the record.

Earnings Call History

EarningsCalls.dev has 22 Cue Biopharma, Inc. earnings call transcripts on record, spanning March 17, 2020 to September 21, 2026. Based on this history, Cue Biopharma, Inc. reports quarterly. The most recent call on file is dated September 21, 2026. The full list is below — each row opens the complete, free-to-read transcript.

Ticker

CUE

Exchange

NasdaqCM

Country

US

Sector

Health Care

Industry

Biotechnology

Calls on record

22

First call

March 17, 2020

Most recent

September 21, 2026

Reporting cadence

quarterly