Every material Form 8-K Cue Biopharma, Inc. has filed with the SEC since August 03, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Cue Biopharma announced positive topline results from a Phase 2 trial of CUE-221 in chronic spontaneous urticaria (CSU), conducted in China by Genesis Life Sciences with 145 participants. The primary endpoint was met at all dose levels, and the company plans a Phase 2b/3 CSU trial and a Phase 2 food allergy trial, subject to FDA review of the Phase 2 data. The filing contains clinical data only, with no revenue, earnings, cash or financing figures.
Primary endpoint (complete resolution of hives, HSS7=0, at week 12): 54% at 4 mg/kg, 53% at 2 mg/kg and 43% at 1 mg/kg, vs. 11% for placebo and 41% for omalizumab 300 mg.
Key secondary endpoint (UAS7=0 at week 12) was statistically significant at 4 mg/kg: 46% vs. 11% for placebo.
At week 28, 12 weeks off drug, complete resolution of hives was 60% at 4 mg/kg vs. 24% for omalizumab, a 36% difference (post hoc analysis).
No treatment-related serious adverse events and no hypersensitivity reactions, including anaphylaxis, were reported; the company will present full data at an upcoming scientific meeting.
Cue Biopharma reported a second quarter 2026 revenue increase to $7.9 million from $3.0 million, but its net loss grew to $153.1 million from $8.5 million. The company attributed the larger loss mainly to one-time non-cash losses and expenses tied to its CUE-221 license agreement with Ascendant, and it had $17.4 million in cash at June 30, 2026 before a $50 million private placement completed after quarter end.
Second quarter revenue was $7.9 million, versus $3.0 million a year earlier, driven by a preclinical milestone under the Boehringer Ingelheim collaboration.
Net loss was $153.1 million, or $24.14 per share, versus $8.5 million, or $2.67 per share, in the second quarter of 2025.
Cash and cash equivalents were $17.4 million at June 30, 2026; a $50 million private placement was completed after quarter end.
Phase 2 data readout for CUE-221 in Chronic Spontaneous Urticaria is anticipated by the end of the third quarter of 2026.
Cue Biopharma's board appointed James Ahlers as Chief Financial Officer, effective July 30, 2026, and he will serve as the company's principal financial officer. Ahlers previously served as consulting CFO to life sciences companies and spent nearly two decades as CFO of Intarcia Therapeutics. The filing sets his annualized base salary at $450,000 and describes inducement equity grants and severance terms.
Appointment effective July 30, 2026; Ahlers, age 62, will serve as principal financial officer.
Annualized base salary of $450,000, with a discretionary annual bonus target of up to 45% of base salary.
Initial option exercise price of $30.40, the Nasdaq closing price on the effective date; RSU award for 25,500 shares; grants vest quarterly over four years.
Qualifying termination entitles him to a lump sum of nine months' base salary plus a prorated target bonus.
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