On November 12, 2026 Generate Biomedicines, Inc. (NASDAQ:GENB) ("Generate") reported financial results for the third quarter ended Sept. 30, 2026, and provided an update on recent business progress.

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"Our third quarter results reflect both strong execution across all of our clinical programs and our continued efforts to push the frontiers of programmable biology and therapeutic intelligence," said Mike Nally, chief executive officer of Generate Biomedicines. "We are making strong progress with GB-0895 in severe asthma, and the data we shared at ERS in COPD further demonstrated the sustained pharmacological activity to support robust modulation of key biomarkers and twice-a-year dosing. At the same time, our scientists are extending the impact of our platform, from new CAR T engineering to our collaboration with Anthropic on agentic science. We start with what a therapy needs to do, then engineer and test the biology to get there."

Recent Progress

GB-0895 in severe asthma and COPD

GB-0895, Generate’s most advanced internal drug candidate, is an investigational anti-TSLP monoclonal antibody engineered with AI for dosing twice a year. The two global Phase 3 SOLAIRIA studies are ongoing in adults and adolescents with severe uncontrolled asthma, and recent Phase 1b results in COPD patients highlight an opportunity to expand into a large and underserved patient population.

Generate presented three posters on GB-0895 at the European Respiratory Society Congress, held Sept. 5–9, 2026, in Barcelona, Spain.

Phase 1 asthma findings. Complete Phase 1 findings showed that a single dose of GB-0895 sustained inflammatory biomarker reductions for at least six months in participants with mild-to-moderate asthma. At 300 mg, GB-0895 achieved maximal biomarker suppression and had a half-life of approximately 98 days, supporting the dosing interval being evaluated in Phase 3.
Phase 1b COPD findings. A single dose of GB-0895 sustained inflammatory biomarker reductions for at least six months in participants with COPD. Comparable suppression was demonstrated for 300 mg and 600 mg, extending the evidence supporting six-month pharmacological activity to a second respiratory indication.
SOLAIRIA Phase 3 study design. The study-design poster detailed the ongoing SOLAIRIA-1 and SOLAIRIA-2 trials in adults and adolescents with severe uncontrolled asthma. The replicate trials evaluate 300 mg administered every 26 weeks, with annualized asthma exacerbation rate over 52 weeks as the primary endpoint.

Zealand Pharma collaboration in obesity and metabolic diseases

On Oct. 13, Generate and Zealand Pharma announced a collaboration and license agreement providing Generate with $30 million upfront and up to $35 million in early preclinical milestones within nearly $1.2 billion in total potential milestone payments, plus tiered royalties on future worldwide net sales of any commercialized products.

The agreement covers two initial programs to develop multispecific protein therapeutics for obesity and other metabolic diseases, with an option to add a third for additional financial consideration. Generate will lead research through lead-candidate selection. Zealand will assume responsibility for subsequent preclinical and clinical development, regulatory submissions, and worldwide commercialization.

Anthropic collaboration and AI-driven CAR T-cell research

On Oct. 27, Generate and Anthropic announced a research collaboration to explore a novel application of an agentic approach to advance next-generation CAR T-cell research.

In early preclinical research, a team of six Generate scientists combined AI agents with the company’s computational and experimental capabilities over approximately six months to engineer a CAR signaling domain approximately 70% shorter than the second-generation design used for comparison. In laboratory tests, CAR T cells incorporating the compact domain showed improved tumor-cell killing compared with the comparison design.

The research also supported expression of four different CARs from a shared mRNA dose, suggesting potential applications in designs targeting multiple tumor antigens. The collaboration focuses on selecting and validating antigen combinations for early-stage solid tumors.

Oncology pipeline advances

GB-4362 aims to address treatment-limiting toxicities associated with antibody-drug conjugates, while GB-5267 is designed to address the difficulty of sustaining CAR T-cell activity in solid tumors.

GB-4362 advanced to the second of potentially three dose-escalation cohorts. Enrollment has begun in the second cohort of the Phase 1 study evaluating GB-4362 with enfortumab vedotin and pembrolizumab in advanced urothelial cancer.
On Oct. 23, Generate presented a trial-in-progress poster describing the Phase 1 clinical study design of GB-4362 at the 2026 European Society for Medical Oncology Congress in Madrid.
On Oct. 1, Generate and Roswell Park Comprehensive Cancer Center announced that the first patient had been dosed in the Phase 1 study of the investigational autologous IL-18-armored CAR T-cell therapy in platinum-resistant ovarian cancer. GB-5267 targets MUC16, an antigen overexpressed in more than 80% of ovarian tumors, and was engineered with AI to optimize tumor-cell killing, T-cell expansion, and persistence. The trial begins the clinical evaluation of that function-first design without requiring chemotherapy-based lymphodepletion.
On Oct. 18, Roswell Park delivered an oral presentation at the 16th Biennial Rivkin Ovarian Cancer Research Symposium in Philadelphia detailing the scientific rationale and study design. The presentation highlighted IL-18 armoring intended to support CAR T-cell activity and a Phase 1 study evaluating GB-5267 without chemotherapy-based lymphodepletion
"We continue to advance GB-0895 through the Phase 3 SOLAIRIA studies in severe asthma and make progress across our clinical pipeline. Following the quarter-end, we also entered into a new collaboration agreement with Zealand Pharma," said Jason Silvers, president and chief financial officer of Generate Biomedicines. "Dosing is underway in cohort 2 of GB-4362, and our first patient has been dosed in the GB-5267 study with Roswell Park. Under the Zealand agreement, Generate received a $30 million upfront payment in October, may receive additional near-term milestones, and is now partnered to explore multispecific protein therapeutics for obesity and metabolic disease. We plan to continue pursuing partnerships that apply our platform to new therapeutic areas, advance differentiated medicines, and provide non-equity-dilutive capital to support our internal programs."

Financial Results

Cash, cash equivalents, and marketable securities were $404.2 million as of Sept. 30, 2026, compared with $457.4 million as of June 30, 2026. Generate believes its existing cash, cash equivalents, and marketable securities, together with the $30.0 million upfront payment received from Zealand in October 2026 in connection with the Zealand collaboration, will be sufficient to fund its current operating plan into the first half of 2028. Generate expects to require additional capital to support long-term operations.

Revenue for the quarter ended Sept. 30, 2026, was $4.2 million, compared with $9.6 million for the same period in 2025. This revenue reflects developments in the ongoing Amgen and Novartis research programs and that Generate is near completion of its performance obligations under both agreements.

Research and development expenses were $82.3 million for the quarter ended Sept. 30, 2026, compared with $62.2 million for the same period in 2025. The increase was driven primarily by continued investment in the GB-0895 Phase 3 SOLAIRIA clinical trials in severe asthma and was partially offset by a decrease in external discovery and other program related costs.

General and administrative expenses were $13.5 million for the quarter ended Sept. 30, 2026, compared with $10.3 million for the same period in 2025. The increase was driven primarily by an increase in stock-based compensation.

Net loss was $87.7 million for the quarter ended Sept. 30, 2026, compared with $60.0 million for the same period in 2025. These amounts include noncash stock-based compensation expense of $8.1 million and $4.8 million, respectively.

(Press release, Generate Biomedicines, NOV 12, 2026, View Source [SID1234674696])