Generate Biomedicines, Inc.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001193125-26-210059
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001193125-26-336437
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 144 previous paragraphs and 154 current paragraphs.
103 unchanged; 34 reworded; 7 added; 5 removed; 2 previous and 10 current paragraphs rearranged.
Tables are not compared: 4 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
Comparison of the three months ended June 30, 2026 and 2025
Current report
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.
Current report
Comparison of the six months ended June 30, 2026 and 2025
Current report
Collaboration Revenue
Current report
Research and Development Expense
Current report
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
Current report
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.
Removed paragraphs (5)
Previous report
General and Administrative Expenses
Previous report
Other Income (Expense), Net
Previous report
Comparison of thet hreem onthse nded March 31, 2026 and 2025
Previous report
General and Administrative Expenses
Previous report
Other Income (Expense), Net
Reworded paragraphs (34)
Previous wording
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 our 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 asde 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 enrolling patients 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 expect to dose the first patient in mid-2026, 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"), we expect to dose the first patient in the second half of 2026.
Current wording
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 asde 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.
Previous wording
Since our inception, we have devoted substantially all of our resources to drug discovery, the development of our 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.
Current wording
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.
Previous wording
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”). 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.
Current wording
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.
Previous wording
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 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 $61.7 million and $44.3 million, of which $0.3 million and $2.6 million were attributable to a non-controlling interest for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $737.7 million.
Current wording
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 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.
Previous wording
As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $516.6 million. We believe, based upon our current operating plan, that these amounts will be sufficient to fund our operations into the first half of 2028. We expect to require additional capital to support our long-term operations.
Current wording
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 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.
Previous wording
Research and development expenses consist primarily of external and internal costs incurred for our research and development activities, including development of our platform, our product discovery efforts and the development of our future product candidates. These expenses include:
Current wording
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:
Previous wording
We use our personnel and infrastructure resources for our research and development efforts, including the advancement and development of our 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.
Current wording
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.
Previous wording
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. In addition, in connection with our IPO and other equity transactions, we may have experienced, or may in the future experience, additional ownership changes that could further limit our ability to utilize our NOL carryforwards and other tax attributes.
Current wording
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.
Previous wording
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 non-controlling interest holders. The net losses attributable to non-controlling interest holders is 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 the Stock Purchase Agreement 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 the non-controlling interest, as we thereafter owned 100% of the equity of PMCo.
Current wording
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.
Previous wording
Collaboration revenue consists entirely of revenue from the Novartis Collaboration Agreement and Amgen Collaboration Agreement. Revenue under these agreements is recognized as we conduct 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 $7.2 million for the three months ended March 31, 2026 compared to $8.8 million for the three months ended March 31, 2025. Total revenue recognized under the Novartis Agreement was $6.5 million during the three months ended March 31, 2026 compared to $6.7 million during the three months ended March 31, 2025. Additionally, under the Amgen Agreement we recognized revenue of $0.7 million from Amgen during the three months ended March 31, 2026 compared to $2.1 million during the three months ended March 31, 2025. The decrease was due to us nearing completion of our performance obligations under the Amgen Agreement, which we expect will be completed in 2026.
Current wording
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.
Previous wording
Research and development expenses increased to $57.8 million for the three months ended March 31, 2026 compared to $46.8 million for the three months ended March 31, 2025. The $11.0 million increase in research and development expenses for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to an increase of $11.8 million in spending on GB-0895 and an increase in personnel-related costs of $1.8 million offset by a decrease in external discovery and other program related costs of $2.2 million.
Current wording
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.
Previous wording
External discovery and other program costs in the three months ended March 31, 2026 decreased by $2.2 million from the three months ended March 31, 2025, primarily driven by an decrease in Chemistry, Manufacturing and Controls ("CMC") and toxicology activities for development candidates.
Current wording
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.
Previous wording
Personnel-related expenses and stock-based compensation increased by $1.8 million and $0.3 million in the three months ended March 31, 2026, respectively, compared to the three months ended March 31, 2025, related to salaries, benefits and other compensation costs related 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 March 31, 2026 compared to the three months ended March 31, 2025, primarily due to certain property and equipment becoming fully depreciated and a decrease in purchases of property and equipment during the period.
Current wording
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.
Previous wording
General and administrative expenses increased to $13.5 million for the three months ended March 31, 2026, from $10.1 million for the three months ended March 31, 2025. The $3.4 million increase in general and administrative expenses for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, was primarily due to an increase of stock-based compensation of $1.4 million and an increase in professional fees of $1.9 million, which was offset by a $0.1 million decrease in other costs.
Current wording
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.
Previous wording
Loss attributable to non-controlling interest decreased to $0.3 million for the three months ended March 31, 2026, from $2.6 million for the three months ended March 31, 2025. The $2.4 million decrease for the three months ended March 31, 2026 compared to the three months ended March 31, 2025, was a result of no longer allocating net income (loss) to the non-controlling interest as we own 100% of the equity of PMCo upon the closing of the transactions contemplated by the Stock Purchase Agreement in February 2026.
Current wording
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.
Previous wording
External research and development expenses related to the GB-0895 program for the three months ended March 31, 2026 and 2025 were $15.6 million and $3.8 million, respectively. The increase of $11.8 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily driven by the continued advancement of our GB-0895 program, including our Phase 1b clinical trial in chronic obstructive pulmonary disease ("COPD") and the commencement of our global Phase 3 clinical trial in severe asthma during the three months ended March 31, 2026, including related CMC costs.
Current wording
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.
Previous wording
Other income (expense), net decreased to $2.4 million for the three months ended March 31, 2026 from $3.9 million for the three months ended March 31, 2025. The $1.5 million decrease for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 in other income (expense), net was primarily related to a decrease in interest income of $1.4 million due to decreases in our average cash, cash equivalents and marketable securities balance, which was offset by a $0.2 million decrease in interest expense due to the expiration of certain financing leases during the three months ended March 31, 2026.
Current wording
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.
Previous wording
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 million. In addition, we have benefited from cost-sharing arrangements in our collaboration arrangements with MD Anderson,
Current wording
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 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.
Previous wording
Our cash flows from operating activities are 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 our 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 are 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 are generally due to deferred revenue, increased expenses and timing of vendor payments.
Current wording
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.
Previous wording
For the three months ended March 31, 2026, operating activities used $80.4 million of cash, primarily resulting from a net loss of $61.7 million and changes in operating assets and liabilities that used $30.7 million in cash partially offset by changes in net non-cash expenses of $12.0 million.
Current wording
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.
Previous wording
For the three months ended March 31, 2025, operating activities used $53.2 million of cash, primarily resulting from a net loss of $44.3 million and changes in operating assets and liabilities of $17.4 million, which was partially offset by changes in net non-cash expenses of $8.6 million.
Current wording
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.
Previous wording
During the three months ended March 31, 2026, net cash used in investing activities was $259.9 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.
Current wording
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.
Previous wording
During the three months ended March 31, 2025, net cash provided by investing activities was $75.5 million, which primarily consisted of sales and maturities of marketable securities, offset by purchases of marketable securities and equipment.
Current wording
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.
Previous wording
During the three months ended March 31, 2026, net cash provided by financing activities of $378.9 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.
Current wording
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.
Previous wording
During the three months ended March 31, 2025, net cash provided by financing activities of $20.6 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, offset by payments on finance lease obligations.
Current wording
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.
Previous wording
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 our product candidates and maintain the research efforts and preclinical activities associated with our other existing programs and discovery platform. 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 additional 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.
Current wording
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.
Previous wording
Inflation generally affects us by increasing our cost of labor and certain 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 continues to increase, it may affect our expenses, such as employee compensation and research and development charges due to, for example, increases in the costs of labor and supplies.
Current wording
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.
Previous wording
As of March 31, 2026, we had total cash, cash equivalents and marketable securities of $516.6 million. We believe, based on our current operating plan, our cash, cash equivalents and marketable securities will be sufficient to fund our operations 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. However, 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 in these studies and trials is uncertain. We will need to raise substantial additional capital in the future.
Current wording
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.
Previous wording
the costs associated with maintaining and improving our Generate Platform;
Current wording
the costs associated with maintaining and improving The Generate Platform;
Previous wording
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 $90.7 million as of March 31, 2026. These commitments are also recognized as operating lease liabilities and finance lease liabilities on our balance sheet as of March 31, 2026.
Current wording
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.
Previous wording
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 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. For further information regarding certain of our license agreements and amounts that could become payable in the future under those agreements, please see Note 5 in our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report.
Current wording
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.
Previous wording
On September 19, 2024, we entered into the Novartis Collaboration Agreement to discover, develop, manufacture and commercialize protein therapeutics using our 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.
Current wording
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.
Previous wording
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. 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.
Current wording
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.
Previous wording
On February 4, 2026, we entered into a stock purchase agreement (“Stock Purchase Agreement”) with PM LLC, 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 under 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.
Current wording
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.
Rearranged current paragraphs (10)
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the periods presented (in thousands):
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the periods presented (in thousands):
Current report — wording carried from elsewhere
$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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
The following table summarizes our general and administrative expenses for the periods presented (in thousands):
Current report — wording carried from elsewhere
Loss Attributable to Non-Controlling Interest
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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 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.
Previous report — wording carried elsewhere
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.