Cue Books CUE-221 Food-Allergy IND After Licensing
The clinical-stage biopharmaceutical company posted a $153.1 million net loss as it absorbed one-time costs of licensing CUE-221 and then raised $50 million after quarter-end.
Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company targeting immune-mediated diseases, submitted an Investigational New Drug application to the FDA for CUE-221 in food allergy applications and said it expects Phase 2 data in chronic spontaneous urticaria by the end of the third quarter of 2026.
The first-quarter plan to expand the anti-IgE program into food allergy is complete, setting the company’s near-term clinical calendar. Cue also said it remains on track to submit an IND and initiate a Phase 1 study of CUE-401 by year-end 2026.
The quarter’s financials were dominated by the licensing of CUE-221 from Ascendant Health Sciences, a deal first disclosed in the first-quarter release. Research and development expenses were $49.0 million for the three months ended June 30, 2026, compared with $7.9 million a year earlier. The increase consisted primarily of about $20.0 million of one-time cash payments, including the upfront payment to Ascendant, and transaction-related costs, plus about $20.0 million of expense recognized as the fair value of warrants issued to Ascendant, with a corresponding credit to shareholders’ equity and no net impact on stockholders’ equity.
General and administrative expenses were $46.6 million, compared with $3.7 million a year earlier. The increase primarily reflected one-time expenses tied to a strategic transformation, including about $23.0 million related to integration with a newly assembled management team and transaction-related costs, as well as about $19.7 million of non-cash stock-based compensation.
Other income and expense included a net non-cash loss of $63.1 million related to the Ascendant license agreement, comprising a loss on issuance of liability-classified warrants partially offset by a gain on fair-value measurement. Net loss was $153.1 million, or $24.14 a share, compared with $8.5 million, or $2.67 a share, in the year-ago quarter. The increase was primarily due to those one-time non-cash losses and license-related expenses.
Collaboration revenue was $7.9 million, compared with $3.0 million a year earlier, earned from the Boehringer Ingelheim collaboration upon achievement of a preclinical milestone triggered in the second quarter of 2026.
Cash and cash equivalents were $17.4 million as of June 30, 2026, after one-time cash outflows related to the license agreement. Subsequent to quarter-end, Cue completed a private placement for gross proceeds of $50 million, primarily to support clinical development, pipeline advancement, and infrastructure growth. That followed a $30 million private placement in the first quarter.
Leadership additions continued the first-quarter rebuild that began with the appointment of President and Chief Executive Officer Shao-Lee Lin. In the second quarter, Cue appointed Dr. Dominic Borie as Chief Medical Officer and Head of Research and Development and James M. Ahlers as Chief Financial Officer.
CUE-221, a novel anti-IgE antibody with a dual mechanism of action, is in Phase 2 development for allergic diseases. Cue recently submitted the food-allergy IND, and a Phase 2 readout in chronic spontaneous urticaria is anticipated by the end of the third quarter of 2026. CUE-401, an Immuno-STAT platform candidate designed to regulate inflammation and drive Treg-mediated tolerance, is advancing toward Phase 1.
Lin said the CUE-221 license agreement augments the portfolio and that higher expenditures reflect expected one-time non-cash items and payments related to the transaction. Combined with the IND submission, financing with high-quality investors, and the leadership additions, he said the company is well positioned for the next phase of execution.