GENB — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• The following table summarizes our results of operations for the periods presented (in thousands):

• Change in fair value of convertible preferred stock warrant liability

• Net loss attributable to Generate Biomedicines, Inc. stockholders

• Collaboration revenue consisted entirely of revenue from the Novartis Collaboration Agreement and Amgen Collaboration Agreement. Revenue under these agreements was recognized as we conducted research activities related to the research program or target program within the respective agreements based …

• The following table summarizes our research and development expenses for the periods presented (in thousands):

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• We have not yet completed a comprehensive analysis to determine whether ownership changes as defined by Sections 382 and 383 of the Code have occurred as a result of our initial public offering or the extent of any resulting limitations. Accordingly, we may be subject to additional limitations that …

• Comparison of the three months ended March 31, 2026 and 2025

• Since our inception, we have incurred significant operating losses and negative cash flows from operations. We have not yet commercialized any of our product candidates, which are in clinical or preclinical development, and we do not expect to generate revenue from sales of any products for several …

• Roswell Park and PMCo. During the period ended March 31, 2026, we acquired the non-controlling interest in PMCo. At that time, our collaboration, including our cost-sharing arrangements, terminated and we became obligated to make certain payments to PMCo’s parent based on net sales.

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Emerging Growth Company and Smaller Reporting Company Status

• We are an “emerging growth company” or "EGC," as defined in Section 2(a) of the Securities Act of 1933, as amended (the "Securities Act"), as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we have elected to take advantage of certain exemptions from various reporti…

• We expect to continue to qualify as an EGC as defined in Section 2(a)(19) of the Securities Act and Section 3(a)(80) of the Exchange Act, until the earliest of (i) the last day of the fiscal year in which our total annual gross revenues equal or exceed $1.235 billion, subject to inflation adjustment…

• We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an “emerging growth company.” We may take advantage of certain of the scaled disclosures available to smaller reporting companies, including an exem…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• We are an “emerging growth company,” (ECG) as defined in Section 2(a) of the Securities Act of 1933, as amended (the "Securities Act"), as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we have elected to take advantage of certain exemptions from various reporting …

• We expect to continue to qualify as an ECG as defined in Section 2(a)(19) of the Securities Act and Section 3(a)(80) of the Exchange Act, until the earliest of (i) the last day of the fiscal year in which our total annual gross revenues equal or exceed $1.235 billion, subject to inflation adjustment…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• such combination products, we may experience additional delays in the development and commercialization of such product candidates due to regulatory timing constraints and uncertainties in the product development and approval process.

• For example, we began our pivotal Phase 3 trials of GB-0895 using a syringe and vial presentation, similar to the presentation used in prior trials of GB-0895. We intend to submit the PFS presentation to Regulatory Authorities in our marketing submissions, including our BLA submission to the FDA. Du…

• The Regulatory Authorities may require us to submit product samples of any lot of any approved product together with the protocols showing the results of applicable tests at any time. Under some circumstances, the Regulatory Authorities may require that we do not distribute a lot or lots until the r…

• These factors may materially adversely affect the willingness or ability of third-parties to conduct our preclinical studies and clinical trials and may subject us to unexpected cost increases that are beyond our control. If the CROs do not perform preclinical studies and clinical trials in a satisf…

• it would consume time and divert management resources away from operations, damage our reputation, impact our ability to enter into future partnership, collaboration and licensing arrangements and may further result in substantial payments from us to our collaboration partners to settle those disput…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• For example, we currently plan to begin our pivotal Phase 3 trials of GB-0895 using a syringe and vial presentation, similar to the presentation used in prior trials of GB-0895. We intend to submit the PFS presentation to Regulatory Authorities in our marketing submissions, including our BLA submiss…

• The Regulatory Authorities may require us to submit product samples of any lot of any approved product together with the protocols showing the results of applicable tests at any time. Under some circumstances, the Regulatory Authorities may

• require that we do not distribute a lot or lots until the relevant agency authorizes such release. Deviations in the manufacturing process, including those affecting quality attributes and stability, may result in unacceptable changes in the product that could result in lot failures or product recal…

• These factors may materially adversely affect the willingness or ability of third-parties to conduct our preclinical studies and clinical trials and may subject us to unexpected cost increases that are beyond our control. If the CROs do not perform preclinical studies and clinical trials in a satisf…

• requirements, the development, regulatory approval and commercialization of our product candidates may be delayed, we may not be able to obtain regulatory approval and commercialize our product candidates, or our development programs may be materially and irreversibly harmed. If we are unable to rel…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• On March 13, 2026, Sean Martin, Chief Legal Officer and General Counsel, adopted a written trading plan (the “Martin Plan” and together with the Arnold Plan, the "Plans") for the sale of up to 116,800 shares of the Company’s common stock. The Martin Plan is intended to satisfy the conditions of Rule…