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Item 2 — Management's Discussion and Analysis
Generate Biomedicines, Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and with our audited financial statements and the notes thereto for the year ended December 31, 2025 included in our final prospectus dated February 27, 2026 filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act of 1933, as amended. This discussion and analysis and other parts of this Quarterly Report contain forward-looking statements based upon our current plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, strategies, objectives, expectations, intentions and beliefs. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and elsewhere in this Quarterly Report. You should carefully read the “Risk Factors” section of this Quarterly Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see “Cautionary Note Regarding Forward-Looking Statements.”
Overview
We are a clinical-stage generative biology company pioneering the AI revolution in biotechnology and drug design and development. Our vision is to program biology to generate optimal therapeutics for the greatest impact on human health. Central to our vision is The Generate Platform, designed to be a therapeutic area and protein modality agnostic system integrating computational innovation with scalable biohardware to address therapeutic challenges beyond the reach of traditional technologies. We have built The Generate Platform to be a tight and fully-integrated loop (design–build–test–learn) to create proprietary, therapeutically relevant data and differentiated molecular solutions for the biological challenges we aim to address. In addressing these challenges, The Generate Platform can engineer solutions against therapeutic targets starting from either existing reference proteins or by suggesting completely novel ones without a reference starting point, also known as de novo design. The Generate Platform’s therapeutic potential has been demonstrated by successfully progressing three computationally engineered proteins into human clinical testing, the most advanced of which is GB-0895, an investigational long-acting anti-thymic stromal lymphopoietin (“TSLP”) monoclonal antibody, which is being evaluated in pivotal Phase 3 clinical trials for severe asthma. Also, in connection with our Phase 1 clinical trial for GB-4362, an investigational monomethyl auristatin E ("MMAE") neutralizer, we have activated clinical trial sites and dosed initial patients, and, in connection with our planned Phase 1 clinical trial for GB-5267, an investigational armored CAR-T therapy in collaboration with Roswell Park Comprehensive Cancer Center ("Roswell Park"), which is now recruiting and the first patient expected to be dosed in 2026.
Since our inception, we have devoted substantially all of our resources to drug discovery, the development of The Generate Platform and the advancement of GB-0895 and our other product candidates, along with multiple preclinical programs in immunology and oncology. In addition to our research and development efforts, we have invested in establishing and protecting our intellectual property portfolio, raising capital and obtaining financing, organizing and staffing our company, and providing general and administrative support for these operations. We do not have any products approved for sale.
To date, we have not generated any revenue from product sales. On March 2, 2026, we closed our initial public offering ("IPO"), pursuant to which we issued and sold 25,000,000 shares of common stock, resulting in net proceeds of $369.3 million. Prior to our IPO, we had principally raised capital through the private placement of our Series A, Series B and Series C convertible preferred stock, par value $0.001 per share (collectively, the “convertible preferred stock”), the issuance of convertible notes, payments from Amgen Inc. (“Amgen”) and Novartis Pharma AG (“Novartis”), and cost-sharing payments from our other partnership, collaboration or licensing arrangements which resulted in aggregate gross cash proceeds in excess of $934.0 million. We also have benefited from cost-sharing arrangements in our collaboration arrangements with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”), Roswell Park and Pioneering Medicines 02, Inc. (“PMCo”). On February 26, 2026, we acquired all of the outstanding capital stock of PMCo, thereby eliminating the non-controlling interest. 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.
As needed, we will seek additional funding through public or private equity or debt financings, government or other third-party grants, asset sales, royalty financings, partnership, collaboration and licensing arrangements, or a combination of these approaches. We may not be able to obtain funding on acceptable terms, or at all. The terms of any future financing may adversely affect the holdings or the rights of our current stockholders.
If we are unable to obtain funding, we could be forced to delay, limit, reduce or eliminate some or all of our research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all.
We have incurred significant operating losses since inception, and we expect to continue to incur substantial losses for the foreseeable future. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the
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successful development and eventual commercialization of one or more of our product candidates and any additional product candidates we may develop. Our net losses were $129.0 million and $101.1 million, of which $0.3 million and $6.9 million were attributable to a non-controlling interest for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $805.0 million.
We anticipate that our expenses and operating losses will increase substantially for the foreseeable future if and as we:
•expand the number of our research and development programs;
•continue or expand our scope of research or development of our current programs and product candidates in preclinical development;
•continue or expand the scope of our clinical trials for our product candidates;
•initiate additional preclinical, clinical or other studies for our programs and product candidates, including pursuant to some of our partnership, collaboration and licensing arrangements;
•change or add additional manufacturers or suppliers;
•add additional infrastructure to our quality control and quality assurance groups to support our operations as we progress our product candidates toward commercialization;
•attract and retain skilled personnel;
•create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts;
•seek marketing approvals and reimbursement for our product candidates and products;
•establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
•acquire or in-license technologies;
•make payments under any in-license agreements;
•maintain, protect and expand our intellectual property portfolio; and
•experience any delays or encounter issues with any of the above.
We do not expect to generate revenue from product sales unless and until we or our collaboration partners successfully complete the clinical development or future clinical development of, and obtain regulatory approval for, one or more of our current or future product candidates, including any jointly-developed product candidates, which will not be for several years, if ever. If we obtain regulatory approval for any of our product candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, manufacturing, marketing, market access and distribution.
Our net losses may fluctuate significantly from period to period, depending on the timing of our current and potential future clinical trials and expenditures related to our research and developmental activities. Furthermore, we expect to incur additional costs associated with operating as a public company, including significant audit, legal and regulatory expenses, as well as director and officer insurance premiums and investor relations costs. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such a time when we can generate significant revenue from product sales, if ever, we expect to finance our operations through public or private equity or debt financings, government or other third-party grants, asset sales, royalty financings, partnership, collaboration and licensing arrangements, or a combination of these approaches. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. Our failure to raise capital or enter into such agreements or arrangements as, and when needed, could have a material adverse effect on our business, results of operations and financial condition, including potentially requiring us to delay, limit, reduce or eliminate product development or future commercialization efforts, or grant rights to develop and market current or future development product candidates that we would otherwise prefer to develop and market ourselves.
As there are numerous risks and uncertainties associated with product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $457.4 million. We believe, based upon our
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current operating plan, that these amounts will be sufficient to fund our current operating plan into the first half of 2028. We expect to require additional capital to support our long-term operations.
Components of Results of Operations
Revenues
We have not generated any revenues from the sale of products to date and do not expect to generate any revenues from the sale of products for the next several years, if at all. If our development efforts for our current or future product candidates are successful and result in regulatory approval, we may generate revenues in the future from product sales. For the foreseeable future, we expect substantially all of our revenues to be generated from our current collaboration arrangements with Novartis and Amgen. For more information on our collaboration agreements with Novartis and Amgen, please see “License, Collaboration and Other Agreements” below and Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Operating Expenses
Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
Research and Development Expenses
Research and development expenses consist primarily of external and internal costs incurred for our research and development activities, including development of The Generate Platform, our product discovery efforts and the development of our future product candidates. These expenses include:
•external expenses, including expenses incurred under arrangements with third-parties, such as contract development and manufacturing organizations (“CDMOs”), contract research organizations (“CROs”), providers of sponsored research, consultants and our scientific advisors;
•costs related to compliance with regulatory authorities;
•direct costs of conducting internal research and development for our internal preclinical programs;
•intellectual property and related future payments should certain development and regulatory milestones be achieved;
•personnel-related costs, including salaries, bonuses, benefits and stock-based compensation for employees engaged in research and development functions;
•expenses incurred for the procurement of materials, third-party license fees, laboratory supplies and non-capital equipment used in the research and development process; and
•depreciation, amortization and other direct and allocated expenses, including rent, insurance, maintenance of facilities and other operating costs, incurred as a result of our research and development activities.
We expense research and development costs as incurred. Non-refundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered.
We record accruals for estimated ongoing research costs and receive updated estimates of costs and amounts owed on a monthly basis from our third-party service providers. When evaluating the adequacy of the prepaid expenses and accrued liabilities, we analyze progress of the studies, including the phase or completion of events, invoices received and contracted cost estimates from its third-party service providers. Estimates are made in determining the balances at the end of any reporting period.
We use our personnel and infrastructure resources for our research and development efforts, including the advancement and development of The Generate Platform, product candidates and managing external research and development efforts. A significant portion of our research and development costs have been, and will continue to be, external costs. External expenses, which are specific to a program, are tracked on a program-by-program basis for partner programs or upon development candidate nomination. Due to our ability to use certain resources across several programs, personnel-related expenses and indirect or shared operating costs incurred for our research and development programs are not recorded or maintained on a program-by-program basis.
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We anticipate that our research and development expenses will increase substantially for the foreseeable future in connection with our ongoing clinical trials and our planned clinical development activities in the near term and in the future. However, we cannot reasonably estimate the costs or timing of the efforts that will be necessary to complete the development of any of our product candidates due to the numerous risks and uncertainties associated with their development, including the uncertainty of:
•the scope, timing, costs and progress of clinical development activities related to GB-0895, including expansion into other indications, and our other product candidates;
•the number and scope of additional preclinical and clinical programs we decide to pursue, and the number of product candidates we decide to develop further;
•our successful enrollment in and completion of clinical trials;
•our ability to commercialize products, if and when approved, whether alone or in collaboration with others;
•third-party maintaining existing, or arranging for new CDMOs, to support clinical trials of our product candidates;
•seeking regulatory approvals for any of our product candidates that successfully complete clinical trials;
•securing access rights to external products, technologies or intellectual property;
•hiring additional clinical, quality control, manufacturing and other scientific personnel;
•the terms and timing of any partnership, collaboration, or license arrangement, including the terms and timing of any milestone or royalty payments thereunder, if any; and
•general economic conditions, including inflation.
Any changes in the outcome of any of these variables with respect to the development of our programs and product candidates or any future programs and product candidates that we may identify could result in a significant change in the costs and timing associated with the development of that program or product candidate. For example, if the U.S. Food and Drug Administration (the “FDA”), the Medicines and Healthcare products Regulatory Agency (the “MHRA”), the European Medicines Agency (the “EMA”), Pharmaceuticals and Medical Devices Agency and other comparable foreign regulatory authorities (collectively, the “Regulatory Authorities”) were to require us to conduct clinical trials beyond those that we anticipate would be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to slower than expected patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development. We may never succeed in achieving regulatory approval for any of our product candidates or any future product candidates that we may identify.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits and stock-based compensation expenses for employees in executive, accounting and finance, business development, human resources, legal and other administrative functions. Other significant general and administrative expenses include allocated facility related costs including depreciation, legal fees relating to corporate and intellectual property matters and other corporate matters, professional fees for accounting, auditing and tax services, consulting fees and insurance costs.
We anticipate that our general and administrative expenses will increase as we increase our headcount to support our research and development activities and the potential commercialization of our product candidates, if approved. Additionally, these increases will likely include increased costs related to the hiring of additional personnel, among other expenses. We also expect to incur increased expenses associated with being a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and the Securities and Exchange Commission's (the “SEC”) requirements, director and officer insurance costs, and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as we file patent applications to protect innovations arising from our research and development activities.
Other Income (Expense), Net
Other income (expense), net primarily consists of interest income generated from interest bearing cash, cash equivalents and marketable securities, change in fair value associated with the convertible preferred stock warrant liability, realized and unrealized gains and losses on foreign currency transactions and interest expense associated with our finance lease of lab equipment.
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Income Taxes
Income tax expenses (benefit) consists of U.S. federal and state income taxes. As of December 31, 2025, we had $331.8 million and $287.6 million of U.S. federal and state net operating loss ("NOL") carryforwards, respectively. The federal NOL carryforwards are not subject to expiration and the state NOL carryforwards begin to expire in 2042. These loss carryforwards are available to reduce future federal and state taxable income, if any.
Utilization of our NOL carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future in accordance with Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar state provisions. These “ownership changes,” as defined by Section 382 of the Code, may limit the amount of NOL and research and development credit carryforwards that can be utilized annually to offset future taxable income and taxes, respectively. In general, an ownership change as defined by Section 382 of the Code results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. In the third quarter of 2021, we had an ownership change as defined by Sections 382 and 383 of the Code. We do not believe that ownership changes as defined by Sections 382 and 383 of the Code have occurred as a result of our IPO. However, if we engage in future equity transactions, we may experience additional ownership changes that could further limit our ability to utilize our NOL carryforwards and other tax attributes. Accordingly, we may be subject to additional limitations that could be material and could significantly reduce or potentially eliminate our ability to utilize a portion of our NOL carryforwards and other tax attributes in the future.
As a result, if we earn net taxable income, our ability to use our pre-ownership change NOL carryforwards and other pre-change tax attributes to offset such taxable income may be subject to limitations, which could result in increased future tax liability to us and could have an adverse effect on our future results of operations.
Income taxes are determined at the applicable tax rates adjusted for non-deductible expenses and other permanent differences. Our income tax provision may be significantly affected by changes to our estimates.
Loss attributable to non-controlling interest
In connection with our agreement with PMCo prior to its termination and our acquisition of all of the outstanding capital stock of PMCo on February 26, 2026, we determined that we were the primary beneficiary of PMCo, and therefore we consolidated PMCo. However, prior to such acquisition, we did not have any equity interest in PMCo, therefore all net losses associated with PMCo were attributable to the the Company as the sole non-controlling interest holder. The net losses attributable to the non-controlling interest holder was the loss absorbed by the previous holders of the ownership interest of PMCo, which consist primarily of research and development costs that were reimbursed by PMCo under our collaboration agreement with PMCo. On February 4, 2026, we entered into a stock purchase agreement (the “Stock Purchase Agreement”) with PMCo, PM LLC and Flagship Labs to acquire the non-controlling interest of PMCo, contingent upon the execution of the underwriting agreement relating to our IPO. Upon the closing of the transactions contemplated by the Stock Purchase Agreement on February 26, 2026, we no longer allocated net income (loss) to such non-controlling interest, as we thereafter owned 100% of the equity of PMCo.
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Results of Operations
Comparison of the three months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the periods presented (in thousands):
Three Months Ended
June 30, June 30,
2026 2025 Change
Revenue:
Collaboration revenue $ 6,314 $ 10,130 $ (3,816 )
Operating expenses:
Research and development 64,330 59,735 4,595
General and administrative 13,598 10,545 3,053
Total operating expenses 77,928 70,280 7,648
Loss from operations (71,614 ) (60,150 ) (11,464 )
Other income (expense), net
Change in fair value of convertible preferred stock warrant liability - - -
Interest expense (155 ) (307 ) 152
Interest income 4,629 3,789 840
Foreign currency exchange loss (62 ) (30 ) (32 )
Total other income (expense), net 4,412 3,452 960
Loss before provision for income taxes (67,202 ) (56,698 ) (10,504 )
Provision for income taxes (53 ) (44 ) (9 )
Net loss $ (67,255 ) $ (56,742 ) $ (10,513 )
Net loss attributable to non-controlling interests - (4,313 ) 4,313
Net loss attributable to Generate Biomedicines, Inc. stockholders $ (67,255 ) $ (52,429 ) $ (14,826 )
Collaboration Revenue
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 on costs incurred to conduct those activities relative to the total estimated costs. Collaboration revenue decreased to $6.3 million for the three months ended June 30, 2026 compared to $10.1 million for the three months ended June 30, 2025. Total revenue recognized pursuant to the Novartis Agreement was $5.6 million during the three months ended June 30, 2026 compared to $6.7 million during the three months ended June 30, 2025. Additionally, pursuant to the Amgen Collaboration Agreement we recognized revenue of $0.7 million from Amgen during the three months ended June 30, 2026 compared to $3.4 million during the three months ended June 30, 2025. The decrease was due to us nearing completion of our performance obligations under both agreements, which we expect will be completed in 2027.
Research and Development Expense
The following table summarizes our research and development expenses for the periods presented (in thousands):
Three Months Ended
June 30, June 30,
2026 2025 Change
External research and development costs by program:
GB-0895 $ 20,490 $ 13,280 $ 7,210
Discovery and other programs 1,824 6,542 (4,718 )
Other research and development costs:
External - early research and infrastructure 15,055 14,578 477
Personnel-related (excluding stock-based compensation) 20,405 19,279 1,126
Stock-based compensation 3,350 2,772 578
Depreciation expense 3,206 3,284 (78 )
Total research and development expense $ 64,330 $ 59,735 $ 4,595
Research and development expenses increased to $64.3 million for the three months ended June 30, 2026 compared to $59.7 million for the three months ended June 30, 2025. The $4.6 million increase in research and development expenses for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was primarily due to an increase of $7.2 million in spending on GB-0895 and an increase in personnel-related costs of $1.1 million offset by a decrease in external discovery and other program related costs of $4.7 million.
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External research and development expenses related to the GB-0895 program for the three months ended June 30, 2026 and 2025 were $20.5 million and $13.3 million, respectively. The increase of $7.2 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was primarily driven by expenses attributable to the continued advancement of our GB-0895 program including commencement of our global Phase 3 clinical trial in severe asthma in the first quarter of 2026 and Chemistry, Manufacturing and Controls ("CMC") expenses.
External discovery and other program costs in the three months ended June 30, 2026 decreased by $4.7 million from the three months ended June 30, 2025, primarily driven by a decrease in CMC and toxicology activities for development candidates.
Personnel-related expenses and stock-based compensation expense increased by $1.1 million and $0.6 million in the three months ended June 30, 2026, respectively, compared to the three months ended June 30, 2025. These increases related to salaries, benefits and other compensation costs attributable to the hiring of additional full-time employees in order to support the growth of our research and development programs. Depreciation expense decreased by $0.1 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily due to certain property and equipment becoming fully depreciated.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the periods presented (in thousands):
Three Months Ended
June 30, June 30,
2026 2025 Change
Personnel-related (excluding stock-based compensation) $ 4,546 $ 4,457 $ 89
Stock-based compensation 4,888 2,716 2,172
Professional fees 2,929 2,281 648
Other costs 1,235 1,091 144
Total general and administrative expense $ 13,598 $ 10,545 $ 3,053
General and administrative expenses increased to $13.6 million for the three months ended June 30, 2026, from $10.5 million for the three months ended June 30, 2025. The $3.1 million increase in general and administrative expenses for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, was primarily due to an increase of stock-based compensation expense of $2.2 million driven by stock options granted to employees in the first quarter upon completion of initial public offering, an increase in professional fees of $0.6 million and an increase in other costs of $0.1 million.
Other Income (Expense), Net
Other income (expense), net increased to $4.4 million for the three months ended June 30, 2026 from $3.5 million for the three months ended June 30, 2025. The $1.0 million increase for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 in other income (expense), net was primarily related to an increase in interest income of $0.8 million due to increases in our average cash, cash equivalents and marketable securities balance.
Loss Attributable to Non-Controlling Interest
Loss attributable to non-controlling interest decreased to zero for the three months ended June 30, 2026, from $4.3 million for the three months ended June 30, 2025. The $4.3 million decrease for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was a result of no longer allocating net income (loss) to the non-controlling interest in PMCo as we own 100% of the equity of PMCo as of February 2026.
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Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the periods presented (in thousands):
Six Months Ended
June 30, June 30,
2026 2025 Change
Revenue:
Collaboration revenue $ 13,538 $ 18,948 $ (5,410 )
Operating expenses:
Research and development 122,142 106,560 15,582
General and administrative 27,122 20,692 6,430
Total operating expenses 149,264 127,252 22,012
Loss from operations (135,726 ) (108,304 ) (27,422 )
Other income (expense), net
Change in fair value of convertible preferred stock warrant liability (363 ) - (363 )
Interest expense (337 ) (675 ) 338
Interest income 7,542 8,070 (528 )
Foreign currency exchange loss (4 ) (47 ) 43
Total other income (expense), net 6,838 7,348 (510 )
Loss before provision for income taxes (128,888 ) (100,956 ) (27,932 )
Provision for income taxes (81 ) (100 ) 19
Net loss $ (128,969 ) $ (101,056 ) $ (27,913 )
Net loss attributable to non-controlling interests (268 ) (6,942 ) 6,674
Net loss attributable to Generate Biomedicines, Inc. stockholders $ (128,701 ) $ (94,114 ) $ (34,587 )
Collaboration Revenue
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 on costs incurred to conduct those activities relative to the total estimated costs. Collaboration revenue decreased to $13.5 million for the six months ended June 30, 2026 compared to $18.9 million for the six months ended June 30, 2025. Total revenue recognized pursuant to the Novartis Agreement was $12.1 million during the six months ended June 30, 2026 compared to $13.4 million during the six months ended June 30, 2025. Additionally, pursuant to the Amgen Collaboration Agreement we recognized revenue of $1.4 million from Amgen during the six months ended June 30, 2026 compared to $5.5 million during the six months ended June 30, 2025. This decrease in revenue was due to us nearing completion of our performance obligations pursuant to the Novartis and Amgen agreements, both of which we expect will be completed in 2027.
Research and Development Expense
The following table summarizes our research and development expenses for the periods presented (in thousands):
Six Months Ended
June 30, June 30,
2026 2025 Change
External research and development costs by program:
GB-0895 $ 36,076 $ 17,074 $ 19,002
Discovery and other programs 4,263 11,154 (6,891 )
Other research and development costs:
External - early research and infrastructure 29,075 29,137 (62 )
Personnel-related (excluding stock-based compensation) 40,218 37,290 2,928
Stock-based compensation 6,053 5,225 828
Depreciation expense 6,457 6,680 (223 )
Total research and development expense $ 122,142 $ 106,560 $ 15,582
Research and development expenses increased to $122.1 million for the six months ended June 30, 2026 compared to $106.6 million for the six months ended June 30, 2025. The $15.6 million increase in research and development expenses for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was primarily due to an increase of
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$19.0 million in spending on GB-0895 and an increase in personnel-related costs of $2.9 million offset by a decrease in external discovery and other program related costs of $6.9 million.
External research and development expenses related to the GB-0895 program for the six months ended June 30, 2026 and 2025 were $36.1 million and $17.1 million, respectively. The increase of $19.0 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was primarily driven by expenses attributable to the continued advancement of our GB-0895 program, including expenses attributable to our Phase 1b clinical trial in COPD and expenses attributable to the commencement of our global Phase 3 clinical trial in severe asthma in the first quarter of the 2026 fiscal year, including related CMC costs.
External discovery and other program costs in the six months ended June 30, 2026 decreased by $6.9 million from the six months ended June 30, 2025, primarily driven by a decrease in CMC and toxicology activities for development candidates.
Personnel-related expenses and stock-based compensation expense increased by $2.9 million and $0.8 million in the six months ended June 30, 2026, respectively, compared to the six months ended June 30, 2025. This increase related to salaries, benefits and other compensation costs attributable to the hiring of additional full-time employees in order to support the growth of our research and development programs.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the periods presented (in thousands):
Six Months Ended
June 30, June 30,
2026 2025 Change
Personnel-related (excluding stock-based compensation) $ 9,185 $ 8,888 $ 297
Stock-based compensation 8,580 5,007 3,573
Professional fees 6,927 4,423 2,504
Other costs 2,430 2,374 56
Total general and administrative expense $ 27,122 $ 20,692 $ 6,430
General and administrative expenses increased to $27.1 million for the six months ended June 30, 2026, from $20.7 million for the six months ended June 30, 2025. The $6.4 million increase in general and administrative expenses for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, was primarily due to an increase of stock-based compensation expense of $3.6 million, driven by stock options granted to employees in the first quarter of 2026 upon completion of IPO, and an increase in professional fees of $2.5 million.
Other Income (Expense), Net
Other income (expense), net decreased to $6.8 million for the six months ended June 30, 2026, from $7.3 million for the six months ended June 30, 2025. The $0.5 million decrease for the six months ended June 30, 2026, compared to the six months ended June 30, 2025 in other income (expense), net was primarily related to a decrease in interest income of $0.5 million due to decreases in our average cash, cash equivalents and marketable securities balance.
Loss Attributable to Non-Controlling Interest
Loss attributable to non-controlling interest decreased to $0.3 million for the six months ended June 30, 2026, from $6.9 million for the six months ended June 30, 2025. The $6.6 million decrease for the six months ended June 30, 2026 compared to the six months ended June 30, 2025, was a result of no longer allocating net income (loss) to the non-controlling interest in PMCo as we own 100% of the equity of PMCo as of February 2026.
Liquidity and Capital Resources
Sources of Liquidity
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 years, if at all. On March 2, 2026, we closed our IPO, pursuant to which we issued and sold 25,000,000 shares of common stock, resulting in net proceeds of $369.3 million. Prior to our IPO, we had principally raised capital through the private placement of our convertible preferred stock, par value $0.001 per share, the issuance of convertible notes, payments from Amgen and Novartis, and cost-sharing payments from our other partnership, collaboration or licensing arrangements which resulted in aggregate gross cash proceeds in excess of $934.0
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million. In addition, we have benefited from cost-sharing arrangements in our collaboration arrangements with MD Anderson, Roswell Park and PMCo. On February 26, 2026, we acquired all of the outstanding capital stock of PMCo, thereby eliminating the non-controlling interest. 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.
Cash Flows
The following table provides information regarding our cash flows for the periods presented (in thousands):
Six Months Ended
June 30, June 30,
2026 2025 Change
Net cash provided by (used in):
Operating activities $ (138,332 ) $ (101,929 ) $ (36,403 )
Investing activities (226,623 ) 58,464 (285,087 )
Financing activities 378,312 20,297 358,015
Net increase (decrease) in cash and cash equivalents $ 13,357 $ (23,168 ) $ 36,525
Operating Activities
Our cash flows from operating activities were greatly influenced by our use of cash for operating expenses and working capital requirements to support our business. We have historically experienced negative cash flows from operating activities as we invested in research and development of The Generate Platform, product candidates, including preclinical studies, clinical trials, manufacturing and manufacturing process development. The cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges, which were generally due to stock-based compensation, depreciation and amortization and non-cash lease expense, as well as changes in components of operating assets and liabilities, which were generally due to deferred revenue, increased expenses and timing of vendor payments.
For the six months ended June 30, 2026, operating activities used $138.3 million of cash, primarily resulting from a net loss of $129.0 million and changes in operating assets and liabilities that used $35.1 million in cash partially offset by changes in net non-cash expenses of $25.7 million.
For the six months ended June 30, 2025, operating activities used $101.9 million of cash, primarily resulting from a net loss of $101.1 million and changes in operating assets and liabilities that used $18.8 million of cash, which was partially offset by $17.9 million of net non-cash expenses.
Investing Activities
During the six months ended June 30, 2026, net cash used in investing activities was $226.6 million, which primarily consisted of purchases of marketable securities with the net proceeds of our IPO as well as purchases of equipment, offset by sales of marketable securities.
During the six months ended June 30, 2025, net cash provided by investing activities was $58.5 million, which primarily consisted of sales and maturities of marketable securities, offset by purchases of marketable securities and equipment.
Financing Activities
During the six months ended June 30, 2026, net cash provided by financing activities of $378.3 million primarily related to proceeds received from issuance of our common stock, net of issuance costs and contributions from our non-controlling interest, offset by payments on finance lease obligations.
During the six months ended June 30, 2025, net cash provided by financing activities of $20.3 million primarily related to proceeds received from issuance of our Series C convertible preferred stock, net of issuance costs and contributions from our non-controlling interest in PMCo, offset by payments on finance lease obligations.
Future Funding Requirements
We expect our future capital requirements to increase substantially over time in connection with our ongoing research and development activities, particularly as we advance our current and planned clinical development of GB-0895 and our other product candidates, and maintain our research efforts and preclinical activities associated with The Generate Platform and our other programs. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant expenses related to product sales, marketing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Further, we expect to incur costs associated with operating as a public company. As a result, we expect to incur substantial operating losses and negative operating cash flows for the foreseeable future.
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Inflation generally affects us by increasing our cost of labor and certain products and services. We do not believe that inflation had a material effect on our unaudited condensed consolidated financial statements. However, the United States has recently experienced historically high levels of inflation. If the inflation rate increases, our expenses may increase, including expenses attributable to employee compensation and external research and development activities.
As of June 30, 2026, we had total cash, cash equivalents and marketable securities of $457.4 million. We believe, based on our current operating plan, our cash, cash equivalents and marketable securities will be sufficient to fund our current operating plan into the first half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Furthermore, our forecast for the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties and actual results could vary materially. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses associated with these studies and trials is often uncertain. We expect to need to raise substantial additional capital in the future.
Because of the numerous risks and uncertainties associated with product development, and because the extent to which we may enter into collaborations with third-parties for the development of our product candidates is unknown, we may incorrectly estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates. Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including, but not limited to:
•the progress, results and costs of, discovery and preclinical studies for our programs and development candidates;
•our ability to advance our clinical-stage product candidates into later-stage trials, which we expect will be required in order to seek marketing approval of our product candidates;
•the costs associated with maintaining and improving The Generate Platform;
•our ability to scale up our manufacturing processes and capabilities, or arrange for a third-party to do so on our behalf, to support our clinical trials of our product candidates and commercialization of any of our product candidates for which we obtain marketing approval;
•our ability to seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;
•the costs associated with acquiring or in-licensing products, product candidates or technologies or intellectual property;
•the costs associated with maintaining, expanding, enforcing, defending and protecting our intellectual property;
•the costs associated with hiring additional clinical, quality control, manufacturing and other scientific personnel;
•the costs and timing of establishing or securing sales and marketing capabilities if any current or future product candidate is approved; and
•the costs associated with making any milestone, royalty or other payments under any collaboration or license agreements that we enter into.
Identifying potential product candidates and conducting preclinical studies and clinical trials is a time consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.
Our expectation with respect to our ability to fund current planned operations is based on estimates that are subject to risks and uncertainties. Our operating plan may change as a result of many factors currently unknown to management and there can be no assurance that the current operating plan will be achieved in the time frame anticipated by us, and we may need to seek additional funds sooner than planned. If we are unable to raise this capital when needed, we may be forced to delay, limit, reduce or eliminate one or more of our research and development programs or other operations.
Adequate additional funds may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or issuance of convertible debt securities, our stockholders' ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders' rights as common stockholders. Additional debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends and may require the issuance of warrants, which could potentially dilute our stockholders' ownership interest. If we raise additional funds through partnership, collaboration or licensing arrangements with third-parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or development product candidates or grant licenses on terms that may not be favorable to us. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to
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pursue our business plans and strategies. For instance, if we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development programs or any future commercialization efforts or grant rights to develop and market development product candidates to third-parties that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Other Commitments
Leases
We lease office space in Somerville, Massachusetts under a non-cancelable operating lease that expires in June 2032 and lease office and laboratory space in Andover, Massachusetts under a non-cancelable operating lease, as amended, that expires in December 2034. Our operating lease in Andover, Massachusetts includes an option of early termination allowing us to terminate the lease on or after December 31, 2031. We also entered into a finance lease agreement for the purchase of lab equipment. Additionally, we have entered into a service agreement with a CRO in relation to the conduct of our phase 3 clinical studies for GB-0895, which contains embedded leases for certain equipment. Future minimum commitments under these leases are $86.1 million as of June 30, 2026. These commitments are also recognized as operating lease liabilities and finance lease liabilities on our balance sheet as of June 30, 2026.
Purchase and Other Obligations
We enter into contracts in the normal course of business with third-party CROs, CDMOs and other third-party vendors for preclinical, clinical trials and testing and manufacturing services. These contracts generally do not contain minimum purchase commitments and are cancellable by us upon written notice. Payments due upon cancellation generally consist of payments for services provided or expenses incurred up to the date of cancellation, including non-cancelable obligations of our service providers and, in some cases, wind-down costs.
License, Collaboration and Other Agreements
Below is a summary of the key terms for certain of our license and collaboration agreements. For a more detailed description of these agreements, see Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Agreement with Novartis
On September 19, 2024, we entered into the Novartis Collaboration Agreement to discover, develop, manufacture and commercialize protein therapeutics using The Generate Platform. The collaboration covers multiple collaboration targets, conducted under applicable research plans during defined research terms. As consideration for the collaboration, we received a $50.0 million upfront payment. Novartis also purchased 1,265,822 shares of our Series C convertible preferred stock for $15.0 million. We are eligible to receive up to $1.0 billion across all programs upon the achievement of certain performance-based milestones, including $130.0 million in development and regulatory milestones and $210.0 million in commercial milestones per research program. None of such milestones have been achieved to date. Novartis is also obligated to pay, on a licensed product-by-licensed product and on a country-by-country basis, tiered royalties ranging from a mid-single digit to a low tens percentage on worldwide net sales of any licensed product, subject to specified reductions and offsets.
Agreement with Amgen
On December 24, 2021, we entered into the Amgen Collaboration Agreement, with Amgen to identify biologic proteins and antibodies directed against specified targets. The Amgen Collaboration Agreement initially covered five collaboration targets. In addition, Amgen has the option to nominate up to five additional collaboration targets, at additional cost, the first of which was exercised in December 2023 related to the sixth target. As consideration for the collaboration, we received a $50.0 million upfront payment. In connection with the Second Amendment, which added an additional collaboration target, we received an additional payment of $5.0 million. We are eligible to receive up to $370.0 million for each program upon the achievement of certain milestones, including $160.0 million in development and regulatory milestones and $210.0 million in commercial milestones per program. We received a $5.0 million development milestone payment in August 2024. Amgen is also obligated to pay, on a licensed product-by-licensed product and on a country-by-country basis, tiered royalties ranging from a mid-single digit up to a low tens percentage on worldwide net sales of any licensed product, subject to customary reductions and offsets.
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Agreements with PMCo and Pioneering Medicines 02, LLC ("PM LLC")
On June 22, 2023, we entered into a collaboration agreement (the "Prior PMCo Agreement") with PMCo, an affiliate of Flagship Pioneering and a wholly owned subsidiary of PM LLC, pursuant to which the parties agreed to collaborate on research and development activities with respect to the licensed products containing certain antibodies against TSLP and/or IL-4Rα and share research and development costs, with us bearing 65% and PMCo bearing 35% of all fully-burdened research costs and development expenses, which percentage commitments were subject to adjustment. In addition, concurrently with the Prior PMCo Agreement, we and PM LLC entered into a Drag-Along Agreement pursuant to which PM LLC agreed to, among other things, vote in favor of certain transactions with respect to PMCo.
On February 4, 2026, we entered into the Stock Purchase Agreement with PMCo, PM LLC and Flagship Labs, pursuant to which we agreed to purchase, and PM LLC agreed to sell, all of the issued and outstanding capital stock in PMCo. In consideration for such sale, PMCo, PM LLC and we agreed to terminate the Prior PMCo Agreement and the Drag-Along Agreement, and we agreed to pay PM LLC a portion of our net sales, if any, arising from the sale of certain products covered by certain patents or containing certain know-how (“Generate Products”) developed pursuant to the Prior PMCo Agreement. The termination of the Prior PMCo Agreement and the closing of the transactions contemplated by the Stock Purchase Agreement occurred on February 26, 2026.
We will generally be obligated to make payments equal to a high-single digit percentage of net sales of Generate Products, including any Generate Product that contains GB-0895. However, if a Generate Product (i) does not contain GB-0895, (ii) binds to at least one of TSLP or IL-4Rα, and (iii) binds to other proteins in addition to TSLP or IL-4Rα, then the sales payment is reduced based on the composition of the product. Further, if we exclusively license our rights to exploit a Generate Product in one or more countries to a third party, and the royalties on net sales of such Generate Product to be paid by such third party are subject to certain specified reductions, then we may be allowed to further proportionally reduce the sales payment due to PM LLC, depending on the relative value of the future royalties due to us from such third party as compared to the total deal consideration.
Critical Accounting Policies, Estimates and Significant Judgments
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States ("GAAP"). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, costs and expenses and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no significant changes from the significant accounting policies and estimates disclosed in Note 2 of the “Notes to Consolidated Financial Statements” in the audited consolidated financial statements for the year ended December 31, 2025, and notes thereto, included in the Company’s final prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on February 27, 2026.
Recently Issued Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.