Sana Biotechnology, Inc.

Previous wording

We were founded on the belief that engineered cells will be one of the most important transformations in medicine over the next several decades. The burden of diseases that can be addressed at their root cause through engineered cells is significant. We view engineered cells as having the potential to be as therapeutically disruptive as biologic drugs to clinical practice, enabling us to repair cells in the body when possible and replace them when needed. We are developingex vivo andin vivo cell engineering platforms to revolutionize treatment across a broad array of therapeutic areas with unmet treatment needs, including type 1 diabetes, B-cell mediated autoimmune diseases, and oncology.

Current wording

We were founded on the belief that engineered cells will be one of the most important transformations in medicine over the next several decades. The burden of diseases that can be addressed at their root cause through engineered cells is significant. We view engineered cells as having the potential to be as therapeutically disruptive as biologic drugs to clinical practice, enabling us to repair cells in the body when possible and replace them when needed. We are developingex vivo andin vivo cell engineering platforms to revolutionize treatment of various diseases with unmet treatment needs, including type 1 diabetes, B-cell cancers, and B-cell mediated autoimmune diseases.

Previous wording

We currently focus our efforts across three areas and have three ongoing clinical trials across multiple disease types and therapeutic areas, including type 1 diabetes (T1D), B-cell mediated autoimmune diseases, and B-cell malignancies. We retain worldwide rights to each of the product candidates described below.

Current wording

We are currently focused on advancing our pipeline across two platforms for the treatment of various disease types, including type 1 diabetes (T1D), B-cell cancers, and B-cell mediated autoimmune diseases. We retain worldwide rights to each of the product candidates described below.

Previous wording

Type 1 Diabetes: Approximately nine million people suffer from T1D worldwide, and there have been no major novel medicines for the disease since insulin. We are preclinically developing SC451, a HIP-modified, stem cell-derived pancreatic islet cell therapy, for the treatment of T1D. The goal of this therapy is euglycemia, or normal blood glucose, without the need for exogenous insulin injections or immunosuppression. We currently have an ongoing Phase 1 investigator-sponsored first-in-human study (IST) evaluating UP421, an allogeneic, primary islet cell therapy engineered with our HIP technology addressing T1D. We expect to share additional data from the IST in 2025 and file an investigational new drug application (IND) for SC451 as early as 2026.

Current wording

Hypoimmune Platform – Type 1 Diabetes: Approximately nine million people suffer from T1D worldwide, and there have been no major novel medicines for the disease since insulin. We are preclinically developing SC451, a HIP-modified, stem cell-derived pancreatic islet cell therapy, for the treatment of T1D. The goal of this therapy is euglycemia, or normal blood glucose, without the need for exogenous insulin injections or immunosuppression. We currently have an ongoing Phase 1 investigator-sponsored first-in-human study (IST) evaluating UP421, an allogeneic, primary islet cell therapy engineered with our HIP technology addressing T1D, for which we have disclosed positive six-month results and expect to share additional data as the study progresses. We expect to file an investigational new drug application (IND) and begin our Phase 1 clinical trial for SC451 as early as 2026.

Previous wording

In vivo CAR T cells: Using our fusogen platform, which allows for cell-specific, in vivo delivery of various payloads, we are preclinically developing our SG299 product candidate, which is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver and gonadal tissue. We plan to develop SG299 in a range of B-cell cancers and B-cell mediated autoimmune diseases and expect to file an IND for SG299 as early as 2026.

Current wording

Fusogen Platform –In vivo CAR T cells: Using our fusogen platform, which allows for cell-specific, in vivo delivery of various payloads, we are developing SG293, the next-generation version of our prior SG299 product candidate, which was renamed to reflect an updated construct and manufacturing process. SG293 is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver. SG293 builds on data from SG299, showing cell-specific delivery and deep B-cell depletion–as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return–in non-human primates without the use of any lymphodepleting chemotherapy. We intend to explore SG293 in both B-cell cancers and B-cell mediated autoimmune diseases and expect to file an IND for SG293 as early as 2027.

Previous wording

We believe the time is right to develop engineered cell therapies across a broad range of therapeutic areas. Substantial progress in the understanding of genetics, gene editing, protein engineering, stem cell biology, immunology, process analytics, and computational biology have converged to create an opportunity to markedly increase the breadth and depth of the potential impact of cellular medicines. We continue to make progress developing ourex vivo cell engineering platforms – our hypoimmune allogeneic CAR T cell platform and our stem-cell derived platform that also leverages our HIP technology – and ourin vivo cell engineering platform.

Current wording

We believe the time is right to develop engineered cell therapies in various therapeutic areas. Substantial progress in the understanding of genetics, gene editing, protein engineering, stem cell biology, immunology, process analytics, and computational biology have converged to create an opportunity to markedly increase the breadth and depth of the potential impact of cellular medicines. We continue to make progress developing ourex vivo cell engineering platform that leverages our HIP technology and ourin vivo cell engineering platform. Each of our programs provides the potential for meaningful standalone value while also supporting our potential ability to further exploit our platforms in a manner that leads to the development of broadly applicable medicines.

Previous wording

We announced positive six-month results from the UP421 IST demonstrating that all primary and secondary endpoints were met. Results of the study through six months after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test during testing at these timepoints, consistent with insulin secretion in response to a meal. 12-week PET-MRI scanning also demonstrated islet cells at the transplant site, a forearm muscle. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection. The trial continues to evaluate safety, persistence, and function of the transplanted cells. In August 2025, the New England Journal of Medicine published a journal article titled "Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression," which discusses the 12-week results of the trial. In June 2025, the six-month results of the trial were presented at the 85th Annual American Diabetes Association (ADA) Scientific Sessions. We and our collaborators at Uppsala University Hospital expect to report additional data from the study, including longer-term follow-up, as the year progresses. In addition, we continue preclinical development of SC451, and a recent FDA INTERACT meeting increases our confidence in moving forward with our HIP-edited master cell bank for good manufacturing practices (GMP) manufacturing and our non-clinical testing plan.

Current wording

We announced positive six-month results from the UP421 IST demonstrating that all primary and secondary endpoints were met. Results of the study through six months after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test during testing at these timepoints, consistent with insulin secretion in response to a meal. 12-week PET-MRI scanning also demonstrated islet cells at the transplant site, a forearm muscle. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection. The trial continues to evaluate safety, persistence, and function of the transplanted cells. In August 2025, The New England Journal of Medicine published a journal article titled "Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression," which discusses the 12-week results of the trial. In June 2025, the six-month results of the trial were presented at the 85th Annual American Diabetes Association (ADA) Scientific Sessions. We and our collaborators at Uppsala University Hospital expect to report additional data from the study, including longer-term follow-up. We continue preclinical development of SC451, and recent regulatory interactions, including an FDA INTERACT meeting, increase our confidence in moving forward with our HIP-edited master cell bank for good manufacturing practices (GMP) manufacturing and our nonclinical testing plan.

Previous wording

We continue to make progress on advancing our research- and preclinical-stage product candidates into and through preclinical development and toward potential IND submissions. As certain of our product candidates advance toward potential IND submissions, we are conducting good laboratory practices toxicity studies and establishing necessary scale-up for our manufacturing processes.

Current wording

We continue to make progress on advancing our research- and preclinical-stage product candidates into and through preclinical development and toward potential IND submissions. As certain of our product candidates advance toward potential IND submissions, we are conducting good laboratory practices toxicology studies and establishing necessary scale-up for our manufacturing processes.

Previous wording

Given the depth and breadth of our portfolio, we expect to continue to assess and prioritize our programs on an ongoing basis based on various factors, including internal and external opportunities and constraints, which may result in our decision to advance certain programs ahead or instead of others. For details regarding our product candidates, see the section titled “Business— Overview” in Part I, Item 1 included in our 2024 Annual Report.

Current wording

Given the depth and breadth of our portfolio, we expect to continue to assess and prioritize our programs on an ongoing basis based on various factors, including internal and external opportunities and constraints, which may result in our decision to advance certain programs ahead or instead of others or suspend, discontinue, or divest certain programs that represent our current development focus.

Previous wording

Our operations to date have included developing ourex vivo andin vivo cell engineering platforms, identifying and developing potential product candidates, executing preclinical studies, establishing manufacturing capabilities, conducting clinical trials of our product candidates, supporting clinical trials of product candidates developed using our technologies, acquiring technologies, staffing the company, business planning, establishing and maintaining our intellectual property portfolio, raising capital, and providing general and administrative support for these operations. All of our programs are currently in the development stage, and we do not have any products approved for sale. We have incurred net losses each year since our inception. Our net losses for the six months ended June 30, 2025 and 2024 were $143.2 million and $157.8 million, respectively. As of June 30, 2025, we had an accumulated deficit of $1.7 billion. Our net losses resulted primarily from our research and development programs, and, to a lesser extent, general and administrative costs associated with our operations.

Current wording

Our operations to date have included developing ourex vivo andin vivo cell engineering platforms, identifying and developing potential product candidates, executing preclinical studies, establishing manufacturing capabilities, conducting clinical trials of our product candidates, supporting clinical trials of product candidates developed using our technologies, acquiring technologies, staffing the company, business planning, establishing and maintaining our intellectual property portfolio, raising capital, and providing general and administrative support for these operations. All of our programs are currently in the development stage, and we do not have any products approved for sale. We have incurred net losses each year since our inception. Our net losses for the nine months ended September 30, 2025 and 2024 were $185.3 million and $217.7 million, respectively. As of September 30, 2025, we had an accumulated deficit of $1.8 billion. Our net losses resulted primarily from our research and development programs, and, to a lesser extent, general and administrative costs associated with our operations.

Previous wording

In August 2025, we completed an underwritten public offering (the Offering) pursuant to which we sold 20.9 million shares of our common stock and pre-funded warrants to purchase 1.5 million shares of our common stock for net proceeds of approximately $70.0 million, after deducting underwriting discounts and commissions and offering expenses.

Current wording

In August 2025, we completed an underwritten public offering (the Offering) pursuant to which we sold 24.3 million shares of our common stock, including 3.4 million shares pursuant to the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 1.5 million shares of our common stock for net proceeds of approximately $80.6 million, after deducting underwriting discounts and commissions and offering expenses.

Previous wording

In May 2025, we entered into a sales agreement (the Sales Agreement) with TD Securities (USA) LLC (TD Cowen), acting as sales agent, pursuant to which we may offer and sell through TD Cowen up to $119.0 million of shares of our common stock from time to time in a series of one or more at the market equity offerings (collectively, the ATM facility). Concurrently with entering into the Sales Agreement, we terminated our prior sales agreement with TD Cowen (as successor to Cowen and Company, LLC) entered into in August 2022 (the Prior Sales Agreement). As of June 30, 2025, we had sold an aggregate of 0.2 million shares of our common stock under the Sales Agreement. We received gross proceeds of $0.5 million for sales of common stock under the Sales Agreement during the quarter ended June 30, 2025, and did not sell any common stock under the Prior Sales Agreement during the quarter ended June 30, 2025. From July 1, 2025 through the date of this Quarterly Report, we raised $28.6 million in net proceeds under the Sales Agreement.

Current wording

In May 2025, we entered into a sales agreement (the Sales Agreement) with TD Securities (USA) LLC (TD Cowen), acting as sales agent, pursuant to which we may offer and sell through TD Cowen up to $119.0 million of shares of our common stock from time to time in a series of one or more at the market equity offerings (collectively, the ATM facility). During the quarter ended September 30, 2025, we sold an aggregate of 7.3 million shares of our common stock under the Sales Agreement, for net proceeds of $28.6 million, after deducting commissions and expenses.

Previous wording

As of June 30, 2025, we had cash, cash equivalents, and marketable securities of $72.7 million. Based on our current operating plan, we believe that our existing cash, cash equivalents, and marketable securities as of the date of this Quarterly Report, including the net proceeds received from the Offering and the ATM facility, will be sufficient to fund our planned operations for at least one year from the filing of this Quarterly Report. However, we will need to raise additional financing in the future to fund our operations, including the commercialization of any approved product candidates. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents, and marketable securities, proceeds from any future equity or debt financings, and milestone, royalty, and other payments received under any future licenses, collaborations, or other arrangements. Additional capital may not be available on terms that are reasonable or acceptable to us, if at all. If we are unable to raise capital when needed or on attractive terms, our business, results of operations, and financial condition would be adversely affected.

Current wording

As of September 30, 2025, we had cash, cash equivalents, and marketable securities of $153.1 million. Based on our current operating plan, we believe that our existing cash, cash equivalents, and marketable securities as of the date of this Quarterly Report, including the net proceeds received from the Offering and the ATM facility, will be sufficient to fund our planned operations for at least one year from the filing of this Quarterly Report. However, we will need to raise additional financing in the future to fund our operations, including the conduct of clinical trials and the commercialization of any approved product candidates. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents, and marketable securities, proceeds from any future equity or debt financings, and milestone, royalty, and other payments received under any future licenses, collaborations, or other arrangements. Additional capital may not be available on terms that are reasonable or acceptable to us, if at all. If we are unable to raise capital when needed or on attractive terms, our business, results of operations, and financial condition would be adversely affected.

Previous wording

Excluding one-time items, we expect our operating losses and expenses to decrease in 2025 compared to 2024 as a result of our portfolio prioritization announced in November 2024. Operating expenses may increase over the longer term if our clinical trials are successful and if we expand our research and development efforts. Cost increases would be driven in large part by commencing and advancing our current and future product candidates through clinical trials; identifying additional product candidates; continuing to establish our manufacturing capabilities, including through third-party contract development and manufacturing organizations (CDMOs); initiating and advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of our ex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with ourex vivo andin vivo cell engineering platforms, or modifying the terms of existing acquisition or license arrangements; seeking regulatory approval of our current and future product candidates; engaging in commercialization activities for any of our product candidates for which we obtain marketing approval; increasing our personnel, including those required to support our research, clinical and preclinical development, manufacturing, and potential future commercialization efforts; expanding our operational, financial, and management systems; continuing to develop, prosecute, and defend our intellectual property portfolio; and continuing to incur legal, accounting, or other expenses to operate our business, including the costs associated with being a public company.

Current wording

Although our historical portfolio prioritizations have enabled reduced operating expenses, our operating expenses may increase over the longer term if our future clinical trials are successful and if we expand our research and development efforts. Cost increases would be driven in large part by commencing and advancing our current and future product candidates through clinical trials; identifying additional product candidates; continuing to establish our manufacturing capabilities, including through third-party contract development and manufacturing organizations (CDMOs); initiating and advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of our ex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with ourex vivo andin vivo cell engineering platforms, or modifying the terms of existing acquisition or license arrangements; seeking regulatory approval of our current and future product candidates; engaging in commercialization activities for any of our product candidates for which we obtain marketing approval; increasing our personnel, including those required to support our research, clinical and preclinical development, manufacturing, and potential future commercialization efforts; expanding our operational, financial, and management systems; continuing to develop, prosecute, and defend our intellectual property portfolio; and continuing to incur legal, accounting, or other expenses to operate our business, including the costs associated with being a public company.

Previous wording

Research and development activities account for a significant portion of our operating expenses. As a result of our portfolio prioritization and associated workforce reduction announced in November 2024, we expect our research and development expenses to decrease in 2025 compared to 2024, excluding one-time items. However, research and development expenses may increase over the longer term (or our expected decreases may be less than anticipated) due to a variety of factors, including if our clinical trials are successful and if we expand our research and development efforts. Cost increases, if they occur, would be driven in large part by advancing our current and future product candidates into and through clinical trials; identifying additional product candidates; continuing to establish our manufacturing capabilities, including through CDMOs, initiating and advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of ourex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with ourex vivo andin vivo cell engineering platforms, or modifying the terms of existing acquisition or license arrangements; seeking regulatory approval of our current and future product candidates; and increasing our workforce to support our expanded research, clinical, and preclinical development efforts. A change in the outcome of any of these factors could result in a significant change in the costs and timing associated with the development of our product candidates. In addition, recent and potential future developments in international trade, including tariffs imposed on imports from other countries, could cause unanticipated increases in our research and development costs, primarily through increased CDMO costs and costs of our laboratory supplies, and we may not be able to accurately forecast their impacts on our business.

Current wording

Research and development activities account for a significant portion of our operating expenses. As a result of our portfolio prioritization and associated workforce reduction announced in November 2024, we have decreased our research and development expenses. However, research and development expenses may increase over the longer term (or our expected decreases may be less than anticipated) due to a variety of factors, including if our future clinical trials are successful and if we expand our research and development efforts. Cost increases, if they occur, would be driven in large part by advancing our current and future product candidates into and through clinical trials; identifying additional product candidates; continuing to establish our manufacturing capabilities, including through CDMOs, initiating and advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of ourex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with ourex vivo andin vivo cell engineering platforms, or modifying the terms of existing acquisition or license arrangements; seeking regulatory approval of our current and future product candidates; and increasing our workforce to support our expanded research, clinical, and preclinical development efforts. A change in the outcome of any of these factors could result in a significant change in the costs and timing associated with the development of our product candidates. In addition, recent and potential future developments in international trade, including tariffs imposed on imports from other countries, could cause unanticipated increases in our research and development costs, primarily through increased CDMO costs and costs of our laboratory supplies, and we may not be able to accurately forecast their impacts on our business.

Previous wording

General and administrative expenses consist of personnel-related costs, including salaries, benefits, and non-cash stock-based compensation for our employees in finance, legal, executive, human resources, and information technology functions, legal and consulting fees, insurance fees, and facility costs not otherwise included in research and development expenses. Legal fees include those related to corporate and patent matters.

Current wording

General and administrative expenses consist of personnel-related costs, including salaries, benefits, and non-cash stock-based compensation for our employees in finance, legal, executive, human resources, and information technology functions, legal and consulting fees, insurance fees, and facility costs not otherwise included in research and development expenses. Legal fees include those related to corporate, patent, and litigation matters.

Previous wording

As a result of our portfolio prioritization and associated workforce reduction announced in November 2024, we expect our general and administrative expenses to decrease in 2025 compared to 2024. General and administrative expenses may increase over the longer term to support potential expanded research and development activities.

Current wording

As a result of our portfolio prioritization and associated workforce reduction announced in November 2024, our general and administrative expenses have decreased in 2025 compared to 2024. General and administrative expenses may increase over the longer term to support potential expanded research and development activities.

Previous wording

Impairment of long-lived assets consists of non-cash losses recognized for the impairment of the right-of-use (ROU) asset, construction in progress, and laboratory equipment for our manufacturing facility in Bothell, Washington (the Bothell facility), and the ROU asset, leasehold improvements, and laboratory equipment for certain office and laboratory space in Seattle, Washington (the Seattle facility). We also recognized additional non-cash impairment losses for other long-lived assets. The losses were recorded in operating expenses in the statement of operations. Refer to Note 11, Impairment of long-lived assets to our condensed consolidated financial statements included elsewhere in this Quarterly Report for details on the impairment.

Current wording

Impairment of long-lived assets consists of non-cash losses recognized for the impairment of the right-of-use (ROU) asset, construction in progress, and laboratory equipment for our manufacturing facility in Bothell, Washington (the Bothell facility), and the ROU asset, leasehold improvements, and laboratory equipment for certain office and laboratory space in Seattle, Washington (the Seattle facility). We also recognized additional non-cash impairment losses for other long-lived assets. The losses were recorded in operating expenses in the statement of operations in the second quarter of 2025. Refer to Note 11, Impairment of long-lived assets to our condensed consolidated financial statements included elsewhere in this Quarterly Report for details on the impairment.

Previous wording

Comparison of the three and six months ended June 30, 2025 and 2024

Current wording

Comparison of the three and nine months ended September 30, 2025 and 2024

Previous wording

Research and development expense was $29.8 million and $60.9 million for the three months ended June 30, 2025 and 2024, respectively. The decrease of $31.1 million was primarily due to:

Current wording

Research and development expense was $30.1 million and $53.2 million for the three months ended September 30, 2025 and 2024, respectively. The decrease of $23.1 million was primarily due to:

Previous wording

a decrease of $10.3 million in personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount related to the portfolio prioritization announced in November 2024;

Current wording

a decrease of $10.7 million in personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount primarily related to the portfolio prioritization announced in November 2024;

Previous wording

a decrease of $12.1 million in laboratory, research, and clinical development expenses primarily related to lower research and development headcount related to the portfolio prioritization announced in November 2024, the suspension of the ARDENT trial in November 2024, and clinical development milestones recorded in the second quarter of 2024 that did not recur in 2025;

Current wording

a decrease of $7.1 million in laboratory, research, and clinical development expenses primarily related to lower research and development headcount related to the portfolio prioritization announced in November 2024, the suspension of the ARDENT trial and the SC379 glial progenitor cell program in November 2024, and clinical development milestones recorded in the third quarter of 2024 that did not recur in 2025; and

Previous wording

a decrease of $4.7 million in facility and other allocated costs primarily due to the portfolio prioritization announced in November 2024; and

Current wording

a decrease of $4.1 million in facility and other allocated costs primarily due to the portfolio prioritization announced in November 2024.

Previous wording

Research and development expense was $67.0 million and $117.3 million for the six months ended June 30, 2025 and 2024, respectively. The decrease of $50.4 million was primarily due to:

Current wording

Research and development expense was $97.1 million and $170.5 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease of $73.5 million was primarily due to:

Previous wording

a decrease of $18.4 million in personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount related to the portfolio prioritization announced in November 2024;

Current wording

a decrease of $29.1 million in personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount primarily related to the portfolio prioritization announced in November 2024;

Previous wording

a decrease of $20.8 million in laboratory, research, and clinical development expenses primarily expenses primarily related to lower research and development headcount related to the portfolio prioritization announced in November 2024, the suspension of the ARDENT trial in November 2024, and clinical development milestones recorded in the first half of 2024 that did not recur in 2025;

Current wording

a decrease of $28.0 million in laboratory, research, and clinical development expenses primarily expenses primarily related to lower research and development headcount related to the portfolio prioritization announced in November 2024, the suspension of the ARDENT trial and the SC379 glial progenitor cell program in November 2024, and clinical development milestones recorded in the nine months ended September 30, 2024 that did not recur in 2025; and

Previous wording

a decrease of $7.7 million in facility and other allocated costs primarily due to the portfolio prioritization announced in November 2024; and

Current wording

a decrease of $11.8 million in facility and other allocated costs primarily due to the portfolio prioritization announced in November 2024.

Previous wording

The expense related to the change in the estimated fair value of our Cobalt Success Payment was $3.6 million for the three months ended June 30, 2025, compared to a gain of $20.7 million for the same period in 2024. The changes in value were due to changes in our market capitalization during the relevant periods. The expense related to the change in the estimated fair value of our Harvard Success Payments was $0.4 million for the three months ended June 30, 2025, compared to a gain of $3.9 million for the same period in 2024. The changes in value were primarily due to changes in our common stock price during the relevant periods. The expense related to the change in the estimated fair value of our Cobalt Contingent Consideration was $6.3 million compared to a gain of $3.4 million for the three months ended June 30, 2025 and 2024, respectively. The changes in value were due primarily to changes in the timing and probability of the achievement of milestones during the relevant periods.

Current wording

The expense related to the change in the estimated fair value of our Cobalt Success Payment was $4.8 million for the three months ended September 30, 2025, compared to a gain of $4.9 million for the same period in 2024. The changes in value were due to changes in our market capitalization during the relevant periods. The expense related to the change in the estimated fair value of our Harvard Success Payments was $0.3 million for the three months ended September 30, 2025, compared to a gain of $0.8 million for the same period in 2024. The changes in value were primarily due to changes in our common stock price during the relevant periods. The gain related to the change in the estimated fair value of our Cobalt Contingent Consideration was $2.0 million compared to an expense of $0.2 million for the three months ended September 30, 2025 and 2024, respectively. The changes in value were due primarily to changes in the timing and probability of the achievement of milestones during the relevant periods.

Previous wording

The expenses related to the change in the estimated fair value of our Cobalt Success Payment was $3.7 million for the six months ended June 30, 2025, compared to $7.2 million for the same period in 2024. The changes in value were due to changes in our market capitalization during the relevant periods. The expenses related to the change in the estimated fair value of our Harvard Success Payments was $0.4 million for the six months ended June 30, 2025, compared to $0.8 million for the same period in 2024. The changes in value were primarily due to changes in our common stock price during the relevant periods. The expenses related to the change in the estimated fair value of our Cobalt Contingent Consideration was $8.2 million compared to $2.0 million for the six months ended June 30, 2025 and 2024, respectively. The changes in value were due primarily to changes in the timing and probability of the achievement of milestones during the relevant periods.

Current wording

The expense related to the change in the estimated fair value of our Cobalt Success Payment was $8.5 million for the nine months ended September 30, 2025, compared to $2.3 million for the same period in 2024. The changes in value were due to changes in our market capitalization during the relevant periods. The expense related to the change in the estimated fair value of our Harvard Success Payments was $0.7 million for the nine months ended September 30, 2025, compared to an immaterial gain for the same period in 2024. The changes in value were primarily due to changes in our common stock price during the relevant periods. The expense related to the change in the estimated fair value of our Cobalt Contingent Consideration was $6.2 million compared to $2.3 million for the nine months ended September 30, 2025 and 2024, respectively. The changes in value were due primarily to changes in the timing and probability of the achievement of milestones during the relevant periods.

Previous wording

General and administrative expenses were $10.3 million and $21.8 million for the three and six months ended June 30, 2025, respectively, compared to $16.4 million and 32.7 million for the same periods in 2024.

Current wording

General and administrative expenses were $10.3 million and $32.1 million for the three and nine months ended September 30, 2025, respectively, compared to $14.1 million and 46.8 million for the same periods in 2024.

Previous wording

The decrease of $10.9 million for the six months ended June 30, 2025 was primarily due to lower personnel-related costs, including non-cash stock-based compensation of $6.0 million due to a decrease in headcount as a result of our portfolio prioritization announced in November 2024, and a decrease in legal and consulting fees of $2.2 million and $1.7 million, respectively.

Current wording

The decrease of $3.8 million for the three months ended September 30, 2025 was primarily due to lower personnel-related costs, including non-cash stock-based compensation of $3.2 million due to a decrease in headcount as a result of our portfolio prioritization announced in November 2024 and a decrease in legal fees of $0.5 million.

Previous wording

The decrease of $6.1 million for the three months ended June 30, 2025 was primarily due to lower personnel-related costs, including non-cash stock-based compensation of $3.7 million due to a decrease in headcount as a result of our portfolio prioritization announced in November 2024, and a decrease in consulting and legal fees of $1.0 million and $0.7 million, respectively.

Current wording

The decrease of $14.7 million for the nine months ended September 30, 2025 was primarily due to lower personnel-related costs, including non-cash stock-based compensation of $9.3 million due to a decrease in headcount as a result of our portfolio prioritization announced in November 2024, and a decrease in legal and consulting fees of $2.7 million and $1.5 million, respectively.

Previous wording

Impairment of long-lived assets was $44.6 million for the three and six months ended June 30, 2025. See Note 11, Impairment of long-lived assets to our condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.

Current wording

Impairment of long-lived assets was $44.6 million for the nine months ended September 30, 2025. See Note 11, Impairment of long-lived assets to our condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.

Previous wording

Interest income, net, was $0.6 million and $1.6 million for the three and six months ended June 30, 2025, respectively, compared to $3.2 million and $6.2 million for the same periods in 2024, respectively, and consisted primarily of interest earned on our cash and marketable securities balances.

Current wording

Interest income, net, was $1.0 million and $2.6 million for the three and nine months ended September 30, 2025, respectively, compared to $2.6 million and $8.8 million for the same periods in 2024, respectively, and consisted primarily of interest earned on our cash and marketable securities balances.

Previous wording

Other income, net, was $0.6 million and $0.8 million for the three and six months ended June 30, 2025, respectively, compared to other expense, net of $4.1 million and $3.9 million for the three and six months ended June 30, 2024, respectively. The increases of $4.7 million for each of the three and six months ended June 30, 2025, were due to an other-than-temporary impairment of an other asset recorded in the second quarter of 2024.

Current wording

Other income, net, was $0.4 million and $1.2 million for the three and nine months ended September 30, 2025, respectively, compared to other expense, net of $0.7 million and $4.6 million for the three and nine months ended September 30, 2024, respectively. The increases of $1.1 million and $5.8 million for the three and nine months ended September 30, 2025, respectively, were due to other-than-temporary impairments of other assets recorded in the second and third quarters of 2024.

Previous wording

As of June 30, 2025, we had $72.7 million in cash, cash equivalents, and marketable securities. Since inception through June 30, 2025, we have raised an aggregate of approximately $1.5 billion in net proceeds from sales of common stock and private placements of our convertible preferred stock.

Current wording

As of September 30, 2025, we had $153.1 million in cash, cash equivalents, and marketable securities. Since inception through September 30, 2025, we have raised an aggregate of approximately $1.6 billion in net proceeds from sales of our equity securities.

Previous wording

In August 2025, we completed the Offering pursuant to which we sold 20.9 million shares of our common stock and pre-funded warrants to purchase 1.5 million shares of our common stock for net proceeds of approximately $70.0 million, after deducting underwriting discounts and commissions and offering expenses.

Current wording

In August 2025, we completed the Offering pursuant to which we sold 24.3 million shares of our common stock, including 3.4 million shares pursuant to the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 1.5 million shares of our common stock for net proceeds of approximately $80.6 million, after deducting underwriting discounts and commissions and offering expenses.

Previous wording

In May 2025, we entered into the Sales Agreement, pursuant to which we may offer and sell up to $119.0 million of shares of our common stock from time to time under the ATM facility. Concurrently with entering into the Sales Agreement, we terminated the Prior Sales Agreement. As of June 30, 2025, we had sold an aggregate of 0.2 million shares of our common stock under the Sales Agreement. We received gross proceeds of $0.5 million for sales of common stock under the Sales Agreement during the quarter ended June 30, 2025, and did not sell any common stock under the Prior Sales Agreement during the quarter ended June 30, 2025. From July 1, 2025 through the date of this Quarterly Report, we raised $28.6 million in net proceeds under the Sales Agreement.

Current wording

In May 2025, we entered into the Sales Agreement, pursuant to which we may offer and sell up to $119.0 million of shares of our common stock from time to time under the ATM facility. During the quarter ended September 30, 2025, we sold an aggregate of 7.3 million shares of our common stock under the Sales Agreement, for net proceeds of $28.6 million, after deducting commissions and expenses.

Previous wording

Until such time, if ever, as we can generate significant revenue from product sales, we expect to finance our operations with our existing cash, cash equivalents, and marketable securities, proceeds from any future equity or debt financings, and milestone, royalty, and other payments received under any future licenses, collaborations, or other arrangements. In the event that additional financing is required, we may not be able to raise it on terms that are acceptable to us or at all. Our ability to raise additional financing may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from public health crises, the conflicts in Ukraine and the Middle East, or other regions, changes in inflation, interest rate uncertainty, disruptions in global trade caused by political tensions and conflicts between countries, and other factors creating market risk. Bank failures have also caused increased concerns about liquidity in the broader financial services industry, and our business, business partners, or industry as a whole may be adversely impacted in ways that we cannot predict at this time. If we raise additional funds through the issuance of equity or convertible debt securities, existing stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing, if available, may result in increased fixed payment obligations, and the existence of securities with rights that may be senior to those of our common stock, and involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, or acquiring, selling, or licensing intellectual property rights or assets, which could adversely impact our ability to conduct our business. If we raise funds through strategic collaborations or licensing or other arrangements, we may have to relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from various factors beyond our control. If we are unable to raise additional capital when desired, our business, results of operations, and financial condition would be adversely affected.

Current wording

Until such time, if ever, as we can generate significant revenue from product sales, we expect to finance our operations with our existing cash, cash equivalents, and marketable securities, proceeds from any future equity or debt financings, and milestone, royalty, and other payments received under any future licenses, collaborations, or other arrangements. In the event that additional financing is required, we may not be able to raise it on terms that are acceptable to us or at all. Our ability to raise additional financing may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from public health crises, the conflicts in Ukraine and the Middle East, or other regions, changes in inflation, interest rate uncertainty, disruptions in global trade caused by political tensions and conflicts between countries, and other factors creating market risk. Bank failures have also caused increased concerns about liquidity in the broader financial services industry, and our business, business partners, or industry as a whole may be adversely impacted in ways that we cannot predict at this time. If we raise additional funds through the issuance of equity or convertible debt securities, existing stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing, if available, may result in increased fixed payment obligations, and the existence of securities with rights that may be senior to those of our common stock, and involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, or acquiring, selling, or licensing intellectual property rights or assets, which could adversely impact our ability to conduct our business. If we raise funds through strategic collaborations or licensing or other arrangements, we may have to relinquish significant rights or grant licenses on terms that are not favorable to us. If we are unable to raise additional capital when desired, our business, results of operations, and financial condition would be adversely affected.

Previous wording

During the six months ended June 30, 2025, net cash used in operating activities was $81.8 million, consisting primarily of net loss of $143.2 million and the change in net operating assets and liabilities of $14.2 million, offset by non-cash adjustments of $75.6 million. The non-cash adjustments of $75.6 million consisted of $44.6 million for impairment of long-lived assets, $13.7 million of non-cash stock-based compensation, expenses of $8.2 million and $4.1 million for revaluation of our contingent consideration and success payment liabilities, respectively, and depreciation expense of $6.5 million, partially offset by other non-cash adjustments of $1.5 million.

Current wording

During the nine months ended September 30, 2025, net cash used in operating activities was $111.2 million, consisting primarily of net loss of $185.3 million and the change in net operating assets and liabilities of $13.6 million, offset by non-cash adjustments of $87.7 million. The non-cash adjustments of $87.7 million consisted of $44.6 million for impairment of long-lived assets, $19.1 million of non-cash stock-based compensation, expenses of $9.2 million and $6.2 million for revaluation of our success payment liabilities and contingent consideration, respectively, and depreciation expense of $9.7 million, partially offset by other non-cash adjustments of $1.1 million.

Previous wording

During the six months ended June 30, 2024, net cash used in operating activities was $124.2 million, consisting primarily of net loss of $157.8 million and the change in net operating assets and liabilities of $5.1 million, offset by non-cash adjustments of $38.7 million. The non-cash adjustments of $38.7 million consisted of $20.5 million of non-cash stock-based compensation, expenses of $8.0 million and $2.0 million for revaluation of our success payment liabilities and contingent consideration, respectively, and depreciation expense of $7.6 million, offset by other non-cash adjustments of $0.6 million.

Current wording

During the nine months ended September 30, 2024, net cash used in operating activities was $176.0 million, consisting primarily of net loss of $217.7 million and the change in net operating assets and liabilities of $5.5 million, offset by non-cash adjustments of $47.2 million. The non-cash adjustments of $47.2 million consisted of $31.2 million of non-cash stock-based compensation, depreciation expense of $11.7 million, and expenses of $2.3 million for revaluation of each of our success payment liabilities and contingent consideration, offset by other non-cash adjustments of $0.3 million.