Generate Biomedicines, Inc.: Q3 FY2026 earnings call
What management said about Q3 FY2026, from the documents filed with the SEC on 12 November 2026: press release. Guidance figures: 1 kept. The quarter’s numbers.
Key takeaways
- Net loss widened to $87.7 million: Net loss was $87.7 million, against $60.0 million a year earlier. Noncash stock-based compensation was $8.1 million, against $4.8 million in the prior-year quarter. Source
- Two Phase 3 SOLAIRIA studies ongoing: Management reported the two global Phase 3 SOLAIRIA studies are ongoing in adults and adolescents with severe uncontrolled asthma. GB-0895 is the company's most advanced internal candidate. Source
- GB-5267 first patient dosed in October: The first patient was dosed in the Phase 1 study of GB-5267, an autologous IL-18-armored CAR T therapy in platinum-resistant ovarian cancer, announced with Roswell Park on Oct. 1. Source
- Zealand obesity deal signed: The Zealand deal gives Generate $30 million upfront and up to $35 million in early preclinical milestones, within nearly $1.2 billion in total potential milestones, plus tiered royalties. Source
- R&D spend rose on Phase 3 trials: R&D expenses were $82.3 million, against $62.2 million a year earlier. Management attributed the rise mainly to GB-0895 Phase 3 SOLAIRIA spending, partly offset by lower discovery costs. Source
- Cash position declined to $404.2 million: Cash, cash equivalents and marketable securities were $404.2 million at Sept. 30, 2026, against $457.4 million at June 30, 2026. Source
- Runway into first half of 2028: Management said existing cash, together with the Zealand upfront received in October, is expected to fund the current operating plan into the first half of 2028. Source
- Partnerships to fund internal programs: Management plans to keep pursuing partnerships that apply the platform to new therapeutic areas, advance differentiated medicines, and provide non-equity-dilutive capital for internal programs. Source
“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,”
Jason Silvers, president and chief financial officer of Generate Biomedicines
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Cash runway Source | Current operating plan | into the first half of 2028 | Kept |
What changed from last quarter
- New: Zealand Pharma collaboration and license agreement announced on Oct. 13, after the prior quarter-end. Source
- New: Research collaboration with Anthropic on agentic AI for CAR T-cell research announced on Oct. 27. Source
- Guidance kept: Cash runway date is unchanged at the first half of 2028. The company now cites the $30.0 million Zealand upfront as an additional source alongside existing cash. Source
Results and growth drivers
- Collaboration revenue fell year on year: Collaboration revenue was $4.2 million, against $9.6 million a year earlier. Management linked the change to the Amgen and Novartis research programs, which are near completion of their performance obligations. Source
- Net loss widened to $87.7 million: Net loss was $87.7 million, against $60.0 million a year earlier. Noncash stock-based compensation was $8.1 million, against $4.8 million in the prior-year quarter. Source
- Loss per share was $0.68: Net loss per share, basic and diluted, was $0.68, against $1.97 a year earlier. Weighted average common shares were 128,514,700 for the quarter. Source
GB-0895 respiratory programs
- Two Phase 3 SOLAIRIA studies ongoing: Management reported the two global Phase 3 SOLAIRIA studies are ongoing in adults and adolescents with severe uncontrolled asthma. GB-0895 is the company's most advanced internal candidate. Source
- Asthma biomarker effect lasted six months: Complete Phase 1 asthma findings showed that a single dose of GB-0895 sustained inflammatory biomarker reductions for at least six months in mild-to-moderate asthma. Source
- COPD Phase 1b showed similar six-month effect: In the Phase 1b COPD study, a single dose also sustained biomarker reductions for at least six months. Comparable suppression was reported at 300 mg and 600 mg. Source
- Three ERS posters presented in September: Three GB-0895 posters were presented at the ERS Congress in Barcelona, covering asthma Phase 1 data, COPD Phase 1b data and the SOLAIRIA study design. Source
“We start with what a therapy needs to do, then engineer and test the biology to get there.”
Mike Nally, chief executive officer of Generate Biomedicines
Oncology pipeline advances
- GB-4362 moved to second cohort: GB-4362 advanced to the second of potentially three dose-escalation cohorts in the Phase 1 study with enfortumab vedotin and pembrolizumab in urothelial cancer. Source
- GB-5267 first patient dosed in October: The first patient was dosed in the Phase 1 study of GB-5267, an autologous IL-18-armored CAR T therapy in platinum-resistant ovarian cancer, announced with Roswell Park on Oct. 1. Source
- GB-5267 trial omits lymphodepletion chemotherapy: The trial evaluates GB-5267 without chemotherapy-based lymphodepletion, testing a function-first design intended to sustain CAR T activity in solid tumors. Source
- ESMO trial-in-progress poster presented: A poster describing the GB-4362 Phase 1 study design was presented at the ESMO Congress in Madrid on Oct. 23, 2026. Source
Collaborations and platform research
- Zealand obesity deal signed: The Zealand deal gives Generate $30 million upfront and up to $35 million in early preclinical milestones, within nearly $1.2 billion in total potential milestones, plus tiered royalties. Source
- Anthropic-guided CAR domain engineered shorter: Six Generate scientists working with AI agents engineered a CAR signaling domain about 70% shorter than the second-generation comparison design, over roughly six months of preclinical work. Source
- Compact CAR T cells killed tumor cells better: In laboratory tests, CAR T cells with the compact signaling domain showed improved tumor-cell killing compared with the comparison design. Source
- Anthropic collaboration targets antigen selection: The Anthropic collaboration focuses on selecting and validating antigen combinations for early-stage solid tumors. Source
Operating expenses
- R&D spend rose on Phase 3 trials: R&D expenses were $82.3 million, against $62.2 million a year earlier. Management attributed the rise mainly to GB-0895 Phase 3 SOLAIRIA spending, partly offset by lower discovery costs. Source
- G&A rose on stock compensation: G&A expenses were $13.5 million, against $10.3 million a year earlier. Management attributed the increase primarily to higher stock-based compensation. Source
- Total operating expenses reached $95.7 million: Total operating expenses were $95.7 million for the quarter, producing a loss from operations of $91.5 million. Source
Cash, capital and runway
- Cash position declined to $404.2 million: Cash, cash equivalents and marketable securities were $404.2 million at Sept. 30, 2026, against $457.4 million at June 30, 2026. Source
- Runway into first half of 2028: Management said existing cash, together with the Zealand upfront received in October, is expected to fund the current operating plan into the first half of 2028. Source
- Further capital needed for long-term operations: Generate expects to require additional capital to support long-term operations, beyond the current operating plan. Source
Strategy and partnering
- Partnerships to fund internal programs: Management plans to keep pursuing partnerships that apply the platform to new therapeutic areas, advance differentiated medicines, and provide non-equity-dilutive capital for internal programs. Source
- Platform extended into agentic science: Management said scientists are extending the platform from new CAR T engineering to the Anthropic collaboration on agentic science. Source
Coming up, as management said on 12 November 2026
- Zealand takes over after lead selection: Generate leads research through lead-candidate selection. After that, Zealand takes responsibility for later development, regulatory submissions and worldwide commercialization. Source
- Possible near-term Zealand milestones: Generate may receive additional near-term milestones under the Zealand agreement. The documents give no dates or amounts for these. Source
- Option to add a third program: The Zealand agreement covers two initial programs, with an option to add a third for additional financial consideration. Source
- SOLAIRIA primary endpoint set: The SOLAIRIA trials dose 300 mg every 26 weeks, with annualized asthma exacerbation rate over 52 weeks as the primary endpoint. Source
Figures management reported
| Figure | Reported |
|---|---|
| R&D expenses Source | $82.3 million for the quarter |
| GB-0895 half-life (Phase 1 asthma) Source | approximately 98 days at 300 mg |
| GB-5267 Phase 1 first patient Source | dosed Oct. 1, 2026 |
| GB-4362 dose-escalation cohorts Source | second of potentially three cohorts |
Risks management discussed
- Financial: Management said the company expects to need additional capital to support long-term operations. Source
- Financial: Collaboration revenue is declining as the Amgen and Novartis research programs near completion of their performance obligations. Source
Earlier plans management reported on
- Met: Management said in the prior quarter it would present three ERS posters; the current release reports three posters presented Sept. 5 - 9, 2026.
- Met: The prior release said an ESMO abstract was accepted; the current release reports the poster was presented Oct. 23, 2026.
- Met: The prior release expected first dosing in 2026; the current release reports the first patient was dosed on Oct. 1, 2026.
- Not stated: The prior release stated the runway; the current release repeats it and adds the Zealand upfront as a funding input.
Other quarters
Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.