Generate Biomedicines — Third Quarter 2026 Earnings Summary

Financial Performance:

• Revenue for the quarter ended September 30, 2026, was $4.2 million, a decrease from $9.6 million in the same period of 2025, driven by nearing completion of performance obligations under Amgen and Novartis research programs.
• Research and development expenses were $82.3 million for the quarter, an increase from $62.2 million in 2025, primarily due to continued investment in GB-0895 Phase 3 SOLAIRIA trials.
• General and administrative expenses were $13.5 million for the quarter, up from $10.3 million in 2025, driven by increased stock-based compensation.
• Net loss was $87.7 million for the quarter compared to $60.0 million in 2025; these figures include noncash stock-based compensation of $8.1 million and $4.8 million, respectively.
• Cash, cash equivalents, and marketable securities totaled $404.2 million as of September 30, 2026, down from $457.4 million as of June 30, 2026.
• Total assets were $515.9 million as of September 30, 2026, compared to $330.2 million as of December 31, 2025.
• Total stockholders' equity was $381.2 million as of September 30, 2026, compared to a deficit of $616.0 million as of December 31, 2025.

Guidance and Future Outlook:

• Management expects existing cash, cash equivalents, marketable securities, and the $30.0 million upfront payment from Zealand received in October 2026 to fund operations into the first half of 2028.
• The company anticipates requiring additional capital to support long-term operations.
• Management plans to continue pursuing partnerships to apply the platform to new therapeutic areas and provide non-equity-dilutive capital.

Business Segments and Product Lines:

• GB-0895 (Severe Asthma): Two global Phase 3 SOLAIRIA studies (SOLAIRIA-1 and SOLAIRIA-2) are ongoing in adults and adolescents with severe uncontrolled asthma, evaluating 300 mg administered every 26 weeks. Phase 1 data showed a single dose sustained inflammatory biomarker reductions for at least six months with a half-life of approximately 98 days.
• GB-0895 (COPD): Phase 1b data demonstrated sustained inflammatory biomarker reductions for at least six months in COPD patients for both 300 mg and 600 mg doses, supporting twice-a-year dosing.
• Zealand Pharma Collaboration: A new agreement provides $30 million upfront, up to $35 million in early preclinical milestones, and nearly $1.2 billion in total potential milestones plus tiered royalties. The partnership focuses on multispecific protein therapeutics for obesity and metabolic diseases, with Zealand assuming responsibility for subsequent development and commercialization.
• Anthropic Collaboration: A research partnership explores agentic AI approaches for CAR T-cell research, resulting in a CAR signaling domain approximately 70% shorter than second-generation designs with improved tumor-cell killing in preclinical studies.
• GB-4362: Enrollment has begun in the second cohort of a Phase 1 study evaluating GB-4362 with enfortumab vedotin and pembrolizumab in advanced urothelial cancer.
• GB-5267: First patient dosed in a Phase 1 study for platinum-resistant ovarian cancer in collaboration with Roswell Park Comprehensive Cancer Center; the therapy targets MUC16 and is designed to function without chemotherapy-based lymphodepletion.

Market and Competitive Landscape:

• The company highlights the opportunity to expand GB-0895 into the large and underserved COPD patient population.
• The Generate Platform integrates computational design with large-scale biological experimentation to address historically undruggable targets.
• The GB-5267 trial is noted for evaluating a function-first design without requiring chemotherapy-based lymphodepletion.

Risks and Challenges:

• Forward-looking statements note risks related to the ability to successfully develop and obtain regulatory approval for drug candidates.
• Risks include uncertainties regarding the initiation, design, progress, timing, and results of preclinical studies and clinical trials.
• Potential risks involve the ability to obtain, maintain, and enforce intellectual property protection and dependence on third parties for manufacturing and development.
• The company faces risks regarding the ability to realize benefits from collaborations and the impact of competitive products.
• There is a risk regarding the ability to obtain additional capital to fund operations.

Management Commentary and Tone:

• CEO Mike Nally stated that the third quarter reflected strong execution across clinical programs and efforts to push the frontiers of programmable biology.
• CFO Jason Silvers noted that the Zealand agreement provides non-equity-dilutive capital and that the company plans to continue pursuing partnerships to advance differentiated medicines.
• Management expressed confidence in the sustained pharmacological activity of GB-0895 and the potential of the AI-driven CAR T research.

Other Key Points:

• The Zealand Pharma collaboration agreement was announced on October 13, 2026, with a $30 million upfront payment received in October.
• The company has 129,021,869 shares issued and outstanding as of September 30, 2026, compared to 33,116,957 as of December 31, 2025.
• Convertible preferred stock was eliminated from the balance sheet as of September 30, 2026, compared to $811.8 million as of December 31, 2025.
• The company presented data on GB-0895 at the European Respiratory Society Congress (Sept 5–9, 2026) and GB-4362 at the 2026 European Society for Medical Oncology Congress (Oct 23, 2026).
• The GB-5267 study design was presented at the 16th Biennial Rivkin Ovarian Cancer Research Symposium on October 18, 2026.