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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

AreaPeriodFigureAgainst last quarter
Cash runway SourceCurrent operating planinto the first half of 2028Kept

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

FigureReported
R&D expenses Source$82.3 million for the quarter
GB-0895 half-life (Phase 1 asthma) Sourceapproximately 98 days at 300 mg
GB-5267 Phase 1 first patient Sourcedosed Oct. 1, 2026
GB-4362 dose-escalation cohorts Sourcesecond 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.