Management commentary
SOLAIRIA-1 AND SOLAIRIA-2 Phase 3 studies for GB-0895 (anti-TSLP) in severe asthma continue to advance with recruitment underway across all six global regions
Corporate events
Phase 1b data for GB-0895 in COPD to be presented in a poster at the European Respiratory Society (ERS) Congress 2026 on Sept. 8
All patients enrolled in first cohort of the Phase 1 study for GB-4362 (MMAE neutralizer)
Management commentary
Platform advancements extend across strategic collaborations
Results
Approximately $457.4 million in cash, cash equivalents, and marketable securities as of June 30, 2026
Management commentary
“Our team’s focus on execution for our clinical programs and translating our generative biology platform into the next generation of differentiated medicines drove strong progress in the second quarter,” said Mike Nally, chief executive officer of Generate Biomedicines Inc. “With GB-0895, our global Phase 3 SOLAIRIA studies in severe asthma continue to advance.
We dosed the first cohort in our Phase 1 study of our MMAE neutralizer, designed to reduce treatment-limiting toxicities from antibody drug conjugates, and Novartis advanced a biologic designed with our platform into its preclinical pipeline for further development.
Together, these milestones demonstrate that we can repeatedly advance programs in our own pipeline and through collaborations.”
“Our platform and continued pipeline progress create optionality,” said Jason Silvers, president and chief financial officer of Generate Biomedicines Inc. “Because our platform is inherently scalable, we can simultaneously advance our internal pipeline, execute on existing collaborations, and enter into additional strategic partnerships.
That growing opportunity set makes disciplined capital allocation increasingly important as we determine the optimal path for each program and opportunity.”
Recent Progress
The Generate Platform connects computational design, large-scale experimentation, and development as one system, repeatably advancing programs across multiple development paths.
Strategic investments in agentic systems are enabling the platform and our new pipeline programs to advance at increased speed, scale, and efficiency.
In inflammation and immunology, Generate is advancing GB-0895 in severe asthma and COPD.
GB-0895 is an investigational anti-TSLP monoclonal antibody for which the World Health Organization has proposed the international nonproprietary name golukibart.
Corporate events
In severe asthma, the global SOLAIRIA-1 and SOLAIRIA-2 replicate Phase 3 studies continue to advance.
To date, the studies have received regulatory approvals in 33 countries as part of a planned 42-country development program.
Additional approvals
Management commentary
are ongoing, and recruitment is underway across all six global regions, including North America; Eastern Europe/Central Europe; Asia; Western Europe; LATAM; and the Middle East, Africa, and South Asia.
Corporate events
At the European Respiratory Society (ERS) Congress 2026, Generate will present three posters on GB-0895 in COPD and severe asthma.
The COPD poster will present safety, pharmacokinetic, and pharmacodynamic data from the ongoing Phase 1b study in adults with COPD on Sept. 8.
Two additional posters will present complete Phase 1 data in asthma and the design of the ongoing SOLAIRIA-1 and SOLAIRIA-2 replicate Phase 3 studies in severe asthma.
Management commentary
In oncology, Generate is advancing GB-4362 , an MMAE neutralizer designed to selectively bind and neutralize circulating free MMAE after it is released from the ADC, with the goal of reducing treatment-limiting MMAE-related toxicities while preserving the intended activity of the ADC.
4GB-4362 has received FDA Fast Track designation for the prevention and/or reduction of enfortumab vedotin-induced toxicity in patients with urothelial cancer.
Results
All patients were enrolled and initial patients dosed in the first cohort of the Phase 1 study evaluating GB-4362 in combination with enfortumab vedotin and pembrolizumab for locally advanced or metastatic urothelial cancer.
Corporate events
A trial-in-progress abstract for GB-4362 has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2026, to be held Oct. 23–27, 2026, in Madrid, Spain.
Management commentary
Through a multi-target collaboration, Novartis has advanced a biologic designed with The Generate Platform into its preclinical pipeline for further development.
This marks the first time a biologic engineered using an AI-enabled platform has reached this stage.
Corporate events
The Phase 1 study evaluating GB-5267 , an IL-18 armored MUC16 CAR T for patients with advanced, platinum-resistant ovarian cancer, which Generate is conducting in collaboration with Roswell Park Comprehensive Cancer Center, is now recruiting.
The first patient is expected to be dosed in 2026.
Results
Financial Results
8Cash, cash equivalents, and marketable securities were $457.4 million as of June 30, 2026, compared with $516.6 million as of March 31, 2026.
Generate believes its existing cash, cash equivalents, and marketable securities 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.
1Revenue for the quarter ended June 30, 2026, was $6.3 million, compared with $10.1 million for the same period in 2025.
This revenue reflects developments in the ongoing Amgen and Novartis research programs.
6Research and development expenses were $64.3 million for the quarter ended June 30, 2026, compared with $59.7 million for the same period in 2025.
7The increase was driven primarily by continued investment in the GB-0895 Phase 3 SOLAIRIA clinical trials in severe asthma and was offset by a decrease in external discovery and other program-related costs.
5General and administrative expenses were $13.6 million for the quarter ended June 30, 2026, compared with $10.5 million for the same period in 2025.
The increase was driven primarily by an increase in stock-based compensation.
2Net loss was $67.3 million for the quarter ended June 30, 2026, compared with $56.7 million for the same period in 2025, which includes noncash, stock-based compensation expense of $8.2 million and $5.5 million, respectively.
3Net cash used in operating activities was $138.3 million for the six months ended June 30, 2026, compared with $101.9 million for the six months ended June 30, 2025.
20 boilerplate lines (safe-harbor disclaimer, contacts, call details) are set aside.