Generate Biomedicines Reports Third Quarter 2026 Financial Results and Provides Business Update
Generate expects to need additional capital for long-term operations despite its October partnership payment.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Generate Biomedicines (Nasdaq: GENB) reported a third-quarter 2026 net loss of $87.7 million while advancing respiratory and oncology clinical programs. Revenue fell to $4.2 million from $9.6 million a year earlier; net loss widened from $60.0 million. Cash, cash equivalents and marketable securities totaled $404.2 million at September 30, down from $457.4 million at June 30.
The Zealand Pharma agreement delivered $30 million upfront in October, with nearly $1.2 billion in potential milestones and tiered royalties. Generate expects existing funds plus that payment to support operations into the first half of 2028. GB-0895 remains in two Phase 3 severe asthma trials; a single dose sustained inflammatory biomarker reductions for at least six months in Phase 1b COPD participants. Oncology milestones included second-cohort enrollment for GB-4362 and first-patient dosing for GB-5267. An Anthropic collaboration will explore AI-guided CAR T-cell research.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major point. Forward-looking: it has not happened yet and may not happen.Zealand agreement offers nearly $1.2 billion in potential milestones, including up to $35 million in early preclinical milestones. 69% of market cap
- Moderate pointZealand Pharma collaboration delivered $30 million upfront in October for two initial obesity and metabolic disease programs. 1.7% of market cap
- Moderate point. Forward-looking: it has not happened yet and may not happen.Generate expects existing funds plus Zealand's payment to support its operating plan into the first half of 2028.
- Moderate pointGB-0895 has two ongoing Phase 3 studies evaluating twice-yearly dosing in severe uncontrolled asthma.
- Minor point. Forward-looking: it has not happened yet and may not happen.Zealand agreement includes tiered royalties on future worldwide net sales of any commercialized products.
10 minor points
- Minor pointZealand agreement permits an optional third program for additional financial consideration.
- Minor pointGB-0895 Phase 1 asthma findings showed inflammatory biomarker reductions lasting at least six months after one dose.
- Minor pointGB-0895 at 300 mg achieved maximal biomarker suppression and an approximately 98-day half-life in Phase 1 asthma findings.
- Minor pointGB-0895 Phase 1b COPD findings showed at least six months of biomarker reductions, with comparable suppression at 300 mg and 600 mg.
- Minor pointGB-4362 advanced to second-cohort enrollment and dosing in its Phase 1 advanced urothelial cancer study.
- Minor pointGB-5267 reached first-patient dosing in Phase 1 platinum-resistant ovarian cancer research without chemotherapy-based lymphodepletion.
- Minor point. Forward-looking: it has not happened yet and may not happen.Anthropic research collaboration will explore AI-guided CAR T-cell research and antigen combinations for early-stage solid tumors.
- Minor pointEarly preclinical CAR T-cell research showed improved tumor-cell killing versus the comparison design in laboratory tests.
- Minor pointThird-quarter interest income rose to $4.149 million from $3.105 million a year earlier.
- Minor pointThird-quarter interest expense fell to $192,000 from $253,000 a year earlier.
Negative
- Moderate pointThird-quarter net loss widened to $87.7 million from $60.0 million a year earlier.
- Moderate pointThird-quarter revenue fell to $4.2 million from $9.6 million as Amgen and Novartis performance obligations neared completion.
- Moderate pointThird-quarter research and development expense rose to $82.3 million from $62.2 million, primarily from SOLAIRIA investment.
- Moderate pointCash, cash equivalents and marketable securities declined to $404.2 million at September 30 from $457.4 million at June 30.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Generate expects to require additional capital to support long-term operations.
5 minor points
- Minor pointThird-quarter administrative expense rose to $13.5 million from $10.3 million, primarily from increased stock-based compensation.
- Minor pointNine-month collaboration revenue fell to $17.758 million from $28.582 million a year earlier.
- Minor pointNine-month net loss widened to $216.626 million from $161.089 million a year earlier.
- Minor pointNine-month research and development expense rose to $204.396 million from $168.711 million a year earlier.
- Minor pointNine-month administrative expense rose to $40.595 million from $30.987 million a year earlier.
News Explained
Generate’s third-quarter report lists 129,021,869 common shares issued and outstanding on
Key Figures
- Cash, cash equivalents and marketable securities
- $404.2 million
- As of Sept. 30, 2026
- Expected funding runway
- Into the first half of 2028
- Based on existing cash, cash equivalents and marketable securities plus the October Zealand upfront payment
- Revenue
- $4.2 million vs. $9.6 million
- Quarter ended Sept. 30, 2026 vs. same period in 2025
- Research and development expenses
- $82.3 million vs. $62.2 million
- Quarter ended Sept. 30, 2026 vs. same period in 2025
- Net loss
- $87.7 million vs. $60.0 million
- Quarter ended Sept. 30, 2026 vs. same period in 2025
- Zealand upfront payment
- $30 million
- Received in October 2026 under the collaboration agreement
- Total potential Zealand milestones
- Nearly $1.2 billion
- Potential milestone payments under the collaboration agreement
- Sustained biomarker reductions
- At least six months
- Single-dose GB-0895 Phase 1 asthma and Phase 1b COPD findings
Previous Earnings Reports
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Revenue declined and net loss widened year over year as Phase 3 asthma trials advanced.
-
Reported $7.2 million revenue, $61.7 million net loss, and expected runway into first-half 2028.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
monoclonal antibody medical
annualized asthma exacerbation rate medical
tiered royalties financial
mRNA medical
lymphodepletion medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
GB-0895 is being evaluated in two Phase 3 severe asthma studies for dosing twice a year
A single dose of GB-0895 produced sustained pharmacological activity for at least six months in COPD
Zealand Pharma collaboration provides
Anthropic collaboration builds on AI agent–guided CAR T research yielding smaller signaling domains with improved function in preclinical studies
Oncology clinical programs advance with second-cohort enrollment for GB-4362 in advanced urothelial cancer and first-patient dosing of GB-5267 in platinum-resistant ovarian cancer
Cash, cash equivalents, and marketable securities of
SOMERVILLE, Mass., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Generate Biomedicines, Inc. (Nasdaq: GENB) (“Generate”) today reported financial results for the third quarter ended Sept. 30, 2026, and provided an update on recent business progress.
“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
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
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
Financial Results
Cash, cash equivalents, and marketable securities were
Revenue for the quarter ended Sept. 30, 2026, was
Research and development expenses were
General and administrative expenses were
Net loss was
About Generate Biomedicines
Generate (Nasdaq: GENB) is a clinical-stage generative biology company founded at the intersection of machine learning, biological engineering, and medicine, advancing a new era of programmable biology to engineer better drug candidates for patients, faster. The Generate Platform integrates computational design with large-scale biological experimentation, enabling the creation of novel, optimized therapeutics that address historically undruggable and hard-to-drug targets, as well as known targets in new and more effective ways. The platform has enabled the generation of a broad pipeline across multiple therapeutic areas and protein-based modalities, addressing health challenges out of reach of traditional approaches. Founded in 2018, Generate is leading a fundamental shift from drug discovery to drug generation. Learn more at www.generatebiomedicines.com or follow us on X, LinkedIn, and YouTube.
Digital Media Disclosure
From time to time Generate has used, or expects in the future to use, its investor website (investors.generatebiomedicines.com), the Generate LinkedIn account (linkedin.com/company/generate-biomedicines), and the Generate X account (@generate_biomed) as means of disclosing information to the public in a broad, nonexclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor the investor website and these social media channels in addition to news releases, SEC filings, public conference calls, and webcasts, as the information posted on them could be material to investors.
Cautionary Note Regarding Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this news release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the advancement of Generate’s drug candidates; the initiation, design, conduct, timing, progress, and results of preclinical studies and clinical trials, including SOLAIRIA-1 and SOLAIRIA-2 and the Phase 1 studies of GB-5267 and GB-4362; the potential benefits of GB-0895 and dosing twice a year; the likelihood and timing of a decision to proceed with development of GB-0895 in COPD; the scope and potential benefits of the collaboration with Zealand, including the design and development of multispecific protein therapeutics, the potential addition of a third program, and the potential milestone payments and royalties; the scope and potential benefits of the research collaboration with Anthropic, including the application of agentic methods to target selection and validation and further development of redesigned CAR signaling domains; Generate's expected cash runway; and the expected enhancements, benefits, and potential of The Generate Platform.
In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions.
These forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, but not limited to, risks and uncertainties related to Generate’s ability to successfully develop and obtain regulatory approval for its drug candidates; the initiation, design, progress, timing, and results of preclinical studies and clinical trials; Generate’s ability to obtain, maintain, and enforce intellectual property protection; Generate’s dependence on third parties for the manufacturing and development of its drug candidates; Generate's ability to realize the intended benefits of collaborations with third parties; the impact of competitive products and technologies; Generate’s ability to replicate results from earlier preclinical studies or clinical trials in current or future clinical trials; Generate’s ability to demonstrate that its drug candidates are safe and effective for their proposed indications; Generate’s ability to obtain additional capital to fund its operations; and general economic, industry, and market conditions.
Additional information on these and other risks and uncertainties that could affect Generate’s business, financial condition, and results of operations is included in Generate’s filings with the Securities and Exchange Commission, including its Quarterly Reports. The forward-looking statements in this news release are made as of the date hereof, and Generate undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this news release, except as required by applicable law.
Generate Media Contact
Megan McLaughlin
pr@generatebiomedicines.com
| GENERATE BIOMEDICINES, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) (unaudited) | ||||||||
| As of September 30, | As of December 31, | |||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 140,350 | $ | 121,650 | ||||
| Marketable securities | 263,862 | 99,848 | ||||||
| Restricted cash and cash equivalents (VIE) | — | 339 | ||||||
| Prepaid expenses and other current assets | 10,429 | 12,528 | ||||||
| Total current assets | 414,641 | 234,365 | ||||||
| Property and equipment, net | 38,653 | 29,151 | ||||||
| Operating lease right-of-use assets | 53,255 | 59,860 | ||||||
| Other assets | 9,341 | 6,806 | ||||||
| Total assets | $ | 515,890 | $ | 330,182 | ||||
| Liabilities, convertible preferred stock, non-controlling interest and stockholders’ deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable(1) | $ | 7,892 | $ | 3,837 | ||||
| Accrued expenses and other current liabilities | 43,554 | 42,164 | ||||||
| Deferred revenue - current | 7,947 | 21,194 | ||||||
| Current portion of finance lease liabilities | 12,499 | 4,311 | ||||||
| Operating lease liabilities - current | 10,830 | 10,697 | ||||||
| Total current liabilities | 82,722 | 82,203 | ||||||
| Non-current liabilities: | ||||||||
| Warrant to purchase convertible preferred stock | — | 1,205 | ||||||
| Non-current portion of finance lease liabilities | 5,891 | 2,908 | ||||||
| Deferred revenue - non-current | — | 4,511 | ||||||
| Operating lease liabilities - non-current | 46,121 | 50,610 | ||||||
| Other long term liabilities | — | 116 | ||||||
| Total liabilities | 134,734 | 141,553 | ||||||
| Commitments and contingencies (Note 13) | ||||||||
| Convertible preferred stock | — | 811,826 | ||||||
| Non-controlling interest | — | (7,232 | ) | |||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, par value | 129 | 33 | ||||||
| Additional paid-in capital | 1,273,942 | 60,189 | ||||||
| Accumulated other comprehensive (loss) income | (264 | ) | 106 | |||||
| Accumulated deficit | (892,651 | ) | (676,293 | ) | ||||
| Total stockholders’ equity (deficit) | 381,156 | (615,965 | ) | |||||
| Total liabilities, convertible preferred stock, non-controlling interests and stockholders’ equity (deficit) | $ | 515,890 | $ | 330,182 | ||||
| (1) | Includes related party amounts of |
| GENERATE BIOMEDICINES, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Collaboration revenue | $ | 4,220 | $ | 9,634 | $ | 17,758 | $ | 28,582 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development(1) | 82,254 | 62,151 | 204,396 | 168,711 | ||||||||||||
| General and administrative(2) | 13,473 | 10,295 | 40,595 | 30,987 | ||||||||||||
| Total operating expenses | 95,727 | 72,446 | 244,991 | 199,698 | ||||||||||||
| Loss from operations | (91,507 | ) | (62,812 | ) | (227,233 | ) | (171,116 | ) | ||||||||
| Other income (expense), net | ||||||||||||||||
| Change in fair value of convertible preferred stock warrant liability | — | — | (363 | ) | — | |||||||||||
| Interest expense | (192 | ) | (253 | ) | (529 | ) | (928 | ) | ||||||||
| Interest income | 4,149 | 3,105 | 11,691 | 11,175 | ||||||||||||
| Foreign currency exchange loss | (58 | ) | (39 | ) | (62 | ) | (86 | ) | ||||||||
| Total other income (expense), net | 3,899 | 2,813 | 10,737 | 10,161 | ||||||||||||
| Loss before provision for income taxes | (87,608 | ) | (59,999 | ) | (216,496 | ) | (160,955 | ) | ||||||||
| Provision for income taxes | (49 | ) | (34 | ) | (130 | ) | (134 | ) | ||||||||
| Net loss | (87,657 | ) | (60,033 | ) | (216,626 | ) | (161,089 | ) | ||||||||
| Net loss attributable to non-controlling interests | — | (6,418 | ) | (268 | ) | (13,360 | ) | |||||||||
| Net loss attributable to Generate Biomedicines, Inc. stockholders | (87,657 | ) | (53,615 | ) | (216,358 | ) | (147,729 | ) | ||||||||
| Convertible preferred stock accrued dividends | — | (11,592 | ) | (7,749 | ) | (34,777 | ) | |||||||||
| Net loss attributable to Generate Biomedicines, Inc. common stockholders | $ | (87,657 | ) | $ | (65,207 | ) | $ | (224,107 | ) | $ | (182,506 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.68 | ) | $ | (1.97 | ) | $ | (2.09 | ) | $ | (5.54 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 128,514,700 | 33,038,657 | 107,441,915 | 32,943,260 | ||||||||||||
| Other comprehensive loss: | ||||||||||||||||
| Net loss | (87,657 | ) | (60,033 | ) | (216,626 | ) | (161,089 | ) | ||||||||
| Unrealized (loss) gain on marketable securities | (135 | ) | 132 | (370 | ) | 4 | ||||||||||
| Comprehensive loss | $ | (87,792 | ) | $ | (59,901 | ) | $ | (216,996 | ) | $ | (161,085 | ) | ||||
| Comprehensive loss attributable to non-controlling interest | — | (6,418 | ) | (268 | ) | (13,360 | ) | |||||||||
| Comprehensive loss attributable to Generate Biomedicines, Inc. stockholders | $ | (87,792 | ) | $ | (53,483 | ) | $ | (216,728 | ) | $ | (147,725 | ) | ||||
| (1) | Includes related party amounts of |
| (2) | Includes related party amounts of |
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Generate Biomedicines' third-quarter 2026 financial results?
Generate reported $4.2 million in revenue and a $87.7 million net loss for the quarter ended September 30, 2026. Revenue was $9.6 million and net loss was $60.0 million in the same period of 2025.
What does Generate Biomedicines receive under the Zealand Pharma agreement?
Generate received $30 million upfront and may receive nearly $1.2 billion in total milestone payments, including up to $35 million in early preclinical milestones, plus tiered royalties on future worldwide net sales of any commercialized products. The agreement covers two initial programs, with an option for a third for additional financial consideration.
What do Generate Biomedicines' Phase 3 SOLAIRIA asthma trials measure?
SOLAIRIA-1 and SOLAIRIA-2 use annualized asthma exacerbation rate over 52 weeks as their primary endpoint. The replicate trials evaluate GB-0895 at 300 mg every 26 weeks in adults and adolescents with severe uncontrolled asthma.
How are development responsibilities divided in Generate Biomedicines' Zealand partnership?
Generate leads research through lead-candidate selection, after which Zealand assumes responsibility for subsequent preclinical and clinical development. Zealand also handles regulatory submissions and worldwide commercialization.
What did Generate Biomedicines' early AI-guided CAR T-cell research produce?
The early preclinical research produced a CAR signaling domain approximately 70% shorter than the second-generation comparison design. Six Generate scientists worked with AI agents over approximately six months. The research also supported expression of four different CARs from a shared mRNA dose, suggesting potential applications targeting multiple tumor antigens.