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Sana Biotechnology, Inc.

For the period ended Sep 30, 2026. Filed Nov 5, 2026.

View on SEC.gov

About 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.

Sep 30, 2026 · Filed Nov 5, 2026

SANA$2.37+1.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

The 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 116 previous paragraphs and 113 current paragraphs.

74 unchanged; 32 reworded; 7 added; 8 removed; 2 previous and 0 current paragraphs rearranged.

Tables are not compared: 7 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 and nine months ended September 30, 2026 and 2025

Current report

a net $2.0 million increase in third-party manufacturing costs at CDMOs reflecting increased costs related to our SC451 and SG293 programs, partially offset by costs associated with the suspended allogeneic CAR T programs incurred in the three months ended September 30, 2025 that did not recur in 2026; and

Current report

a $1.9 million increase in laboratory costs related to our SC451 program.

Current report

This increase was partially offset by a net $0.5 million decrease in clinical development costs reflecting costs associated with the suspended allogeneic CAR T programs incurred in the three months ended September 30, 2025 that did not recur in 2026, partially offset by increased costs related to our SC451 and SG293 programs.

Current report

a $3.0 million decrease in facility and other allocated costs.

Current report

This decrease was partially offset by:

Current report

a $4.7 million increase in laboratory costs related to our SC451 program; and
Removed paragraphs (8)

Previous report

Comparison of the three and six months ended June 30, 2026 and 2025

Previous report

an increase of $2.4 million in research, laboratory, and clinical development costs related to the SC451 and SG293 programs; and

Previous report

an increase of $1.4 million in third-party manufacturing costs at CDMOs for SC451 and SG293.

Previous report

These increases were partially offset by:

Previous report

a decrease of $1.1 million in facility and other allocated costs primarily related to depreciation, allocated personnel, and other allocated costs.

Previous report

a decrease of $3.2 million in facility and other allocated costs primarily related to depreciation, allocated personnel, and other allocated costs; and

Previous report

These decreases were partially offset by an increase of $2.4 million in cost for research, laboratory, and clinical development for SC451 and SG293.

Previous report

(1) Management is continuing to evaluate options to optimize its real estate footprint, which includes the potential amendment of a facility lease to reduce square footage. If finalized, we expect that this amendment would reduce each of our operating lease ROU assets and long-term lease liabilities by approximately $12.0 million and result in a one-time fee of approximately $3.8 million within the current fiscal year.
Reworded paragraphs (32)

Previous wording

Type 1 Diabetes: Almost ten million people suffer from type 1 diabetes (T1D) worldwide, and there has been limited progress in treatments for this disease since the advent of insulin injections over 100 years ago. We are 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. Through a first-in-human investigator-sponsored study (IST), we have shown that UP421, an allogeneic, primary islet cell therapy engineered with our HIP technology, can survive and function for 14 months post-transplant in a patient with T1D without the need for immunosuppression. We have incorporated this HIP technology into a more scalable manufacturing platform with SC451 and expect to file an investigational new drug application (IND) as well as begin a Phase 1/2 clinical trial for this therapy as early as this year.

Current wording

Type 1 Diabetes: Almost ten million people suffer from type 1 diabetes (T1D) worldwide, and there has been limited progress in treatments for this disease since the advent of insulin injections over 100 years ago. We are 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. Through a first-in-human investigator-sponsored study (IST), we have shown that UP421, an allogeneic, primary islet cell therapy engineered with our HIP technology, can survive and function for 14 months post-transplant in a patient with T1D without the need for immunosuppression. We have incorporated this HIP technology into a more scalable manufacturing platform with SC451 and expect to file an investigational new drug application (IND) and begin a Phase 1/2 clinical trial for this therapy as early as this year.

Previous wording

SG293 is a CD8-targeted fusosome that delivers genetic material to CD8+ T cells, which enables these cells to become CD19-targeting CAR T cells while avoiding potentially problematic delivery to tissues such as the liver and gonads. We plan to develop SG293 in a range of B cell cancers and B cell mediated autoimmune diseases and expect to generate initial clinical data in patients with non-Hodgkin lymphoma as early as this year.

Current wording

SG293 is a CD8-targeted fusosome that delivers genetic material to CD8+ T cells, which enables these cells to become CD19-targeting CAR T cells while avoiding potentially problematic delivery to tissues such as the liver and gonads. We plan to develop SG293 in a range of B cell cancers and B cell mediated autoimmune diseases and have the potential to share first-in-human data for this therapy in non-Hodgkin lymphoma as early as the first half of 2027.

Previous wording

SG227 is a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells. SG227 delivers a BCMA CAR that has been validated in the autologous CAR T setting for patients with multiple myeloma in a product that is currently approved in China. We plan to develop SG227 as a potential treatment for patients with multiple myeloma and are preparing to begin clinical testing as early as mid-2027, contingent upon the early clinical profile of SG293.

Current wording

SG227 is a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells. SG227 delivers a BCMA CAR that has been validated in the autologous CAR T setting for patients with multiple myeloma in a product that is currently approved in China. We plan to develop SG227 as a potential treatment for patients with multiple myeloma and are preparing to begin clinical testing as early as 2027, contingent upon the early clinical profile of SG293.

Previous wording

With respect to ourex vivo cell engineering efforts, in July 2026, The New England Journal of Medicine published a peer-reviewed Letter to the Editor highlighting 14-month follow-up data from the IST, which demonstrated in a patient the continued safety of the transplanted pancreatic beta cells, as well as continued survival and function of these cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increased during a mixed meal tolerance test, showing appropriate function of the transplanted islet cells. We continue preclinical development of SC451, which is currently completing nonclinical testing, manufacturing transfer, and clinical trial preparation.

Current wording

With respect to ourex vivo cell engineering efforts, in July 2026, The New England Journal of Medicine published a peer-reviewed Letter to the Editor highlighting 14-month follow-up data from the IST, which demonstrated in a patient the continued safety of the transplanted pancreatic beta cells, as well as continued survival and function of these cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increased during a mixed meal tolerance test, showing appropriate function of the transplanted islet cells.

Previous wording

With respect to ourin vivo cell engineering efforts, at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting in May 2026, we presented data from a preclinical study using a surrogate for SG293 that delivers a CD20 CAR capable of targeting non-human primate (NHP) B cells incynomolgus macaques in the absence of lymphodepletion. A single intravenous injection of the SG293 surrogate to these NHPs resulted in robustin vivo generation of CAR T cells and deep B cell depletion in the peripheral blood and lymph nodes. The B cell depletion was further confirmed by lymph node biopsies showing clearance of B cells as well as by “reset” of the NHPs’ B cell repertoire toward naïve B cells. We believe that deep B cell depletion in this preclinical model is the most significant biomarker for potential efficacy in patients with B cell cancers and B cell mediated autoimmune diseases. Separately, in vitro studies using SG293 have shown selective gene delivery to CD8+ T cells with no detectable off-target transduction in tissues such as the liver and gonadal tissue, supporting the specificity of SG293. We are currently completing nonclinical testing, manufacturing transfer, and clinical trial preparation for SG293.

Current wording

With respect to ourin vivo cell engineering efforts, at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting in May 2026, we presented data from a preclinical study using a surrogate for SG293 that delivers a CD20 CAR capable of targeting non-human primate (NHP) B cells incynomolgus macaques in the absence of lymphodepletion. A single intravenous injection of the SG293 surrogate to these NHPs resulted in robustin vivo generation of CAR T cells and deep B cell depletion in the peripheral blood and lymph nodes. The B cell depletion was further confirmed by lymph node biopsies showing clearance of B cells as well as by “reset” of the NHPs’ B cell repertoire toward naïve B cells. We believe that deep B cell depletion in this preclinical model is the most significant biomarker for potential efficacy in patients with B cell cancers and B cell mediated autoimmune diseases. Separately, in vitro studies using SG293 have shown selective gene delivery to CD8+ T cells with no detectable off-target transduction in tissues such as the liver and gonadal tissue, supporting the specificity of SG293.

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, 2026 and 2025 were $110.8 million and $143.2 million, respectively. As of June 30, 2026, we had an accumulated deficit of $2.0 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, 2026 and 2025 were $90.4 million and $185.3 million, respectively. As of September 30, 2026, we had an accumulated deficit of $1.9 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 April 2026, we entered into a stock purchase agreement (SPA) with Mayo Clinic pursuant to which Mayo Clinic purchased 7.5 million shares (the Initial Shares) of our common stock at a price of $3.33 per share for gross proceeds of approximately $25.0 million, and may elect, on or prior to August 31, 2026, to purchase an additional 7.5 million shares (the Additional Shares) of our common stock at a price of $3.33 per share for additional gross proceeds of approximately $25.0 million. As of the filing of this Quarterly Report, Mayo Clinic has not elected to purchase the Additional Shares. Pursuant to the SPA, we agreed to use the net proceeds from the sale of the Initial Shares and, if applicable, the Additional Shares, for the development of products upon which an affiliate of Mayo Clinic has the right to receive royalties pursuant to a collaboration and license agreement, dated April 10, 2026, between us and such affiliate (the License Agreement), including SC451 and certain genetically modified stem-cell derived islet cell products, as set forth in the License Agreement.

Current wording

In April 2026, we entered into a stock purchase agreement (SPA) with Mayo Clinic pursuant to which Mayo Clinic purchased 7.5 million shares of our common stock (the Shares) at a price of $3.33 per share for gross proceeds of approximately $25.0 million. Pursuant to the SPA, we agreed to use the net proceeds from the sale of the Shares for the development of products upon which an affiliate of Mayo Clinic has the right to receive royalties pursuant to a collaboration and license agreement, dated April 10, 2026, between us and such affiliate (the License Agreement), including SC451 and certain genetically modified stem-cell derived islet cell products, as set forth in the License Agreement.

Previous wording

In March 2026, we entered into an amended and restated 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 shares of our common stock from time to time in a series of one or more at the market equity offerings, and filed a prospectus supplement with the SEC pursuant to which we may offer and sell up to $150.0 million of shares of our common stock pursuant to the Sales Agreement (collectively, the ATM facility). During the quarter ended June 30, 2026, we sold an aggregate of 21.6 million shares of common stock under the Sales Agreement for net proceeds of $68.6 million, after deducting commissions and expenses.

Current wording

In March 2026, we entered into an amended and restated 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 shares of our common stock from time to time in a series of one or more at the market equity offerings, and filed a prospectus supplement with the SEC pursuant to which we may offer and sell up to $150.0 million of shares of our common stock pursuant to the Sales Agreement (collectively, the ATM facility). During the quarter ended September 30, 2026, we did not sell any shares of common stock under the Sales Agreement.

Previous wording

As of June 30, 2026, we had cash, cash equivalents, and marketable securities of $160.5 million. We will need to raise additional capital within the next 12 months and in the future to fund our operations, including conducting 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.

Current wording

As of September 30, 2026, we had cash, cash equivalents, and marketable securities of $121.7 million. We will need to raise additional capital within the next 12 months and in the future to fund our operations, including conducting 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

Pursuant to the terms and conditions of the Cobalt acquisition agreement, we are obligated to pay to certain former Cobalt stockholders contingent consideration (Cobalt Contingent Consideration) of up to an aggregate of $500.0 million upon our achievement of certain specified development milestones and a success payment (Cobalt Success Payment) of up to $500.0 million, each of which is payable in cash or stock. The Cobalt Success Payment can become payable over a maximum of 20 years from the date of the acquisition, but this period could be shorter upon the occurrence of certain events. The Cobalt Success Payment is payable if our market capitalization equals or exceeds $8.1 billion, and we are advancing a product based on the fusogen technology in a clinical trial pursuant to an IND, or are in the process of filing or have filed for, or received approval for, a biologics license application or new drug application for a product based on the fusogen technology. The Cobalt Success Payment would alternatively be payable upon a change of control if at least one of our products based on the fusogen technology is the subject of an active research program at the time of such change of control. If our market capitalization is below $8.1 billion as of the date of such change of control, the amount of the potential Cobalt Success Payment will decrease, and the amount of potential Cobalt Contingent Consideration will increase. As of June 30, 2026, the Cobalt Success Payment had not been triggered.

Current wording

Pursuant to the terms and conditions of the Cobalt acquisition agreement, which was amended in August 2026, we are obligated to pay to certain former Cobalt stockholders contingent consideration (Cobalt Contingent Consideration) of up to an aggregate of $500.0 million and a success payment (Cobalt Success Payment) of up to $500.0 million, each of which is payable in cash or stock. The August 2026 amendment restructured the Cobalt Contingent Consideration to (i) expand the Cobalt Contingent Consideration triggers to include both the achievement of specified development milestones and the Company’s receipt of payments from business development transactions involving the fusogen technology and (ii) reduce or defer the payment of certain milestone amounts until a change of control. The Cobalt Success Payment would become payable if our market capitalization equals or exceeds $8.1 billion, and we are advancing a product developed using the fusogen technology in a clinical trial pursuant to an IND, or are in the process of filing or have filed for, or received approval for, a biologics license application or new drug application for such product. The Cobalt Success Payment may alternatively become payable upon a change of control if at least one product developed using the fusogen technology is the subject of an active research program at the time of such change of control. If our market capitalization is below certain threshold amounts as of the date of such change of control, the amount of the Cobalt Success Payment will decrease, and the amount of potential Cobalt Contingent Consideration will increase, as described in Note 4, Acquisitions included elsewhere in this Quarterly Report. As of September 30, 2026, no Cobalt Contingent Consideration or Cobalt Success Payment had been triggered. See Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations “—Critical accounting policies and significant judgments and estimates—Success payments” and “—Critical accounting policies and significant judgments and estimates—Contingent consideration” included in our 2025 Annual Report and Note 7, Fair value measurements located elsewhere in this Quarterly Report for more information on the accounting treatment of the Cobalt Success Payment and Cobalt Contingent Consideration.

Previous wording

Research and development related success payments and contingent consideration include the change in the estimated fair value of our Cobalt and Harvard Success Payment liabilities and Cobalt Contingent Consideration liability. The expense or gain associated with our research and development related success payments and contingent consideration is unpredictable, in part, because our success payments are impacted by changes in our common stock price and market capitalization at the end of each reporting period, and continues to vary significantly from quarter to quarter and year to year due to changes in the assumptions used in the calculations.

Current wording

Research and development related success payments and contingent consideration include the change in the estimated fair value of our Cobalt and Harvard Success Payment liabilities and Cobalt Contingent Consideration liability. The expense or gain associated with our research and development related success payments and contingent consideration is unpredictable, in part, because our success payments are impacted by changes in our common stock price and market capitalization at the end of each reporting period, and continues to vary significantly from quarter to quarter and year to year due to changes in the assumptions used in the calculations. The August 2026 amendment to the Cobalt acquisition agreement modified the Cobalt Contingent Consideration, including the applicable payment triggers and the timing and amount of certain payments, which had a material impact on the fair value of the Cobalt Contingent Consideration during the third quarter of 2026. For details regarding the impact of the amendment to the Cobalt acquisition agreement, see Note 4, Acquisitions included elsewhere in this Quarterly Report.

Previous wording

Research and development expenses were $30.7 million and $29.8 million for the three months ended June 30, 2026 and 2025, respectively. The increase of $0.9 million was primarily due to:

Current wording

Research and development expenses were $33.9 million and $30.1 million for the three months ended September 30, 2026 and 2025, respectively. The increase of $3.8 million was primarily due to:

Previous wording

Research and development expenses were $59.4 million and $67.0 million for the six months ended June 30, 2026 and 2025, respectively. The decrease of $7.5 million was primarily due to:

Current wording

Research and development expenses were $93.4 million and $97.1 million for the nine months ended September 30, 2026 and 2025, respectively. The decrease of $3.7 million was primarily due to:

Previous wording

a decrease of $2.2 million in personnel-related expenses, including non-cash stock-based compensation, primarily due to lower research and development headcount; and

Current wording

a $6.8 million decrease in personnel-related expenses, including non-cash stock-based compensation, primarily due to lower average research and development headcount; and

Previous wording

a decrease of $0.8 million in third-party manufacturing costs at CDMOs primarily related to costs incurred in the six months ended June 30, 2025 for the suspended allogeneic CAR T programs that did not recur in 2026, partially offset by an increase in third-party manufacturing at CDMOs for SC451 and SG293.

Current wording

a net $1.2 million increase in third-party manufacturing costs at CDMOs reflecting increased costs related to our SC451 and SG293 programs, partially offset by costs associated with the suspended allogeneic CAR T programs incurred in the nine months ended September 30, 2025 that did not recur in 2026.

Previous wording

The expense related to the change in the estimated fair value of our Cobalt Success Payment was $7.2 million for the three months ended June 30, 2026, compared to $3.6 million for the same period in 2025. The changes in value were primarily 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 each of the three months ended June 30, 2026 and 2025. 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 $16.4 million for the three months ended June 30, 2026 compared to $6.3 million for the same period in 2025. 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 gain related to the change in the estimated fair value of our Cobalt Success Payment was $7.6 million for the three months ended September 30, 2026, compared to an expense of $4.8 million for the same period in 2025. The changes in value were primarily due to changes in our market capitalization during the relevant periods. The gain 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, 2026, compared to an expense of $0.3 million for the same period in 2025. 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 $55.5 million for the three months ended September 30, 2026, compared to $2.0 million for the same period in 2025. The change in value for the three months ended September 30, 2026 was primarily due to the impact of the August 2026 amendment to our Cobalt acquisition agreement, which modified the Cobalt Contingent Consideration, including the applicable payment triggers and timing and amount of certain payments. The change in value for the three months ended September 30, 2025 was primarily due to changes in the timing and probability of the achievement of milestones.

Previous wording

The following table summarizes the expenses associated with research and development related success payments and contingent consideration for the periods presented:

Current wording

The following table summarizes the expenses (gains) associated with research and development related success payments and contingent consideration for the periods presented:

Previous wording

The expense related to the change in the estimated fair value of our Cobalt Success Payment was $5.3 million for the six months ended June 30, 2026, compared to $3.7 million for the same period in 2025. The changes in value were primarily due to changes in our market capitalization during the relevant periods. The gain related to the change in the estimated fair value of our Harvard Success Payments was $0.1 million for the six months ended June 30, 2026, compared to an expense of $0.4 million for the same period in 2025. 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 $27.1 million for the six months ended June 30, 2026 compared to $8.2 million for the same period in 2025. 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 gain related to the change in the estimated fair value of our Cobalt Success Payment was $2.3 million for the nine months ended September 30, 2026, compared to an expense of $8.5 million for the same period in 2025. The changes in value were primarily due to changes in our market capitalization during the relevant periods. The gain related to the change in the estimated fair value of our Harvard Success Payments was $0.4 million for the nine months ended September 30, 2026, compared to an expense of $0.7 million for the same period in 2025. 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 $28.4 million for the nine months ended September 30, 2026, compared to an expense of $6.2 million for the same period in 2025. The change in value for the nine months ended September 30, 2026 was primarily due to the impact of the August 2026 amendment to our Cobalt acquisition agreement, which modified the Cobalt Contingent Consideration, including the applicable payment triggers and timing and amount of certain payments. The change in value for the nine months ended September 30, 2025 was primarily due to changes in the timing and probability of the achievement of milestones.

Previous wording

General and administrative expenses were $10.8 million and $22.2 million for the three and six months ended June 30, 2026, respectively, compared to $10.3 million and $21.8 million for the same periods in 2025, respectively.

Current wording

General and administrative expenses were $10.9 million and $33.2 million for the three and nine months ended September 30, 2026, respectively, compared to $10.3 million and $32.1 million for the same periods in 2025, respectively.

Previous wording

The increases for each of the three and six months ended June 30, 2026 and 2025 were primarily due to increases in facility and other allocated costs.

Current wording

The increases for each of the three and nine months ended September 30, 2026 and 2025 were primarily due to increases in facility costs.

Previous wording

Impairment of long-lived assets was $44.6 million for the three and six months ended June 30, 2025. There was no impairment of long-lived assets for the three and six months ended June 30, 2026. 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. There was no impairment of long-lived assets for the three and nine months ended September 30, 2026. 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 $1.1 million and $2.1 million for the three and six months ended June 30, 2026, respectively, compared to $0.6 million and $1.6 million for the same periods in 2025, respectively, and consisted primarily of interest earned on our cash and marketable securities balances.

Current wording

Interest income, net, was $1.2 million and $3.3 million for the three and nine months ended September 30, 2026, respectively, compared to $1.0 million and $2.6 million for the same periods in 2025, respectively, and consisted primarily of interest earned on our cash and marketable securities balances.

Previous wording

As of June 30, 2026, we had $160.5 million in cash, cash equivalents, and marketable securities. Since inception through June 30, 2026, we have raised an aggregate of approximately $1.8 billion in net proceeds from sales of our equity securities.

Current wording

As of September 30, 2026, we had $121.7 million in cash, cash equivalents, and marketable securities. Since inception through September 30, 2026, we have raised an aggregate of approximately $1.8 billion in net proceeds from sales of our equity securities.

Previous wording

In April 2026, we entered into the SPA with Mayo Clinic pursuant to which Mayo Clinic purchased the Initial Shares at a price of $3.33 per share for gross proceeds of approximately $25.0 million, and may elect, on or prior to August 31, 2026, to purchase the Additional Shares at a price of $3.33 per share for additional gross proceeds of approximately $25.0 million. As of the filing of this Quarterly Report, Mayo Clinic has not elected to purchase the Additional Shares. Pursuant to the SPA, we agreed to use the net proceeds from the sale of the Initial Shares and, if applicable, the Additional Shares, for the development of products upon which an affiliate of Mayo Clinic has the right to receive royalties pursuant to the License Agreement, including SC451 and certain genetically modified stem-cell derived islet cell products, as set forth in the License Agreement.

Current wording

In April 2026, we entered into the SPA with Mayo Clinic pursuant to which Mayo Clinic purchased the Shares at a price of $3.33 per share for gross proceeds of approximately $25.0 million. Pursuant to the SPA, we agreed to use the net proceeds from the sale of the Shares for the development of products upon which an affiliate of Mayo Clinic has the right to receive royalties pursuant to the License Agreement, including SC451 and certain genetically modified stem-cell derived islet cell products, as set forth in the License Agreement.

Previous wording

In March 2026, we entered into the Sales Agreement with TD Cowen, acting as sales agent, and filed a prospectus supplement with the SEC, pursuant to which we may offer and sell up to $150.0 million of shares of our common stock from time to time under the ATM facility. During the quarter ended June 30, 2026, we sold an aggregate of 21.6 million shares of common stock under the Sales Agreement for net proceeds of $68.6 million, after deducting commissions and expenses.

Current wording

In March 2026, we entered into the Sales Agreement with TD Cowen, acting as sales agent, and filed a prospectus supplement with the SEC, pursuant to which we may offer and sell up to $150.0 million of shares of our common stock from time to time under the ATM facility. During the quarter ended September 30, 2026, we did not sell any shares of common stock under the Sales Agreement.

Previous wording

During the six months ended June 30, 2026, net cash used in operating activities was $70.2 million, consisting primarily of net loss of $110.8 million and the change in net operating assets and liabilities of $5.4 million, offset by non-cash adjustments of $46.0 million. The non-cash adjustments of $46.0 million consisted of expenses of $27.1 million and $5.2 million for revaluation of our contingent consideration and success payment liabilities, respectively, $11.0 million of non-cash stock-based compensation, and depreciation expense of $4.6 million, partially offset by other non-cash adjustments of $1.9 million.

Current wording

During the nine months ended September 30, 2026, net cash used in operating activities was $108.9 million, consisting primarily of net loss of $90.4 million, the change in net operating assets and liabilities of $11.6 million, and non-cash adjustments of $6.9 million. The non-cash adjustments of $6.9 million consisted of gains of $28.4 million and $2.7 million for revaluation of our contingent consideration and success payment liabilities, respectively, partially offset by $16.3 million of non-cash stock-based compensation, depreciation expense of $7.6 million, and other non-cash adjustments of $0.3 million.

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 the 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 the revaluation of our success payment and contingent consideration liabilities, respectively, and depreciation expense of $9.7 million, partially offset by other non-cash adjustments of $1.1 million.

Previous wording

Cash used in investing activities was $38.1 million during the six months ended June 30, 2026, and cash provided by investing activities was $24.3 million during the six months ended June 30, 2025. For the six months ended June 30, 2026, this consisted primarily of net purchases and maturities of marketable securities of $36.5 million and net purchases of property and equipment of $1.6 million. For the six months ended June 30, 2025, this consisted of net purchases and maturities of marketable securities of $23.7 million and net sales of property and equipment of $0.6 million.

Current wording

Cash used in investing activities was $15.7 million during the nine months ended September 30, 2026, compared to $23.7 million during the nine months ended September 30, 2025. For the nine months ended September 30, 2026, this consisted primarily of net purchases and maturities of marketable securities of $13.3 million and net purchases of property and equipment of $2.4 million. For the nine months ended September 30, 2025, this consisted of net purchases and maturities of marketable securities of $24.4 million and net sales of property and equipment of $0.7 million.

Previous wording

During the six months ended June 30, 2026 and 2025, cash provided by financing activities was $93.5 million and $1.5 million, respectively, and consisted primarily of net proceeds from issuance of common stock.

Current wording

During the nine months ended September 30, 2026 and 2025, cash provided by financing activities was $93.5 million and $111.1 million, respectively, and consisted primarily of net proceeds from issuance of common stock.

Previous wording

Other than as disclosed in the table above, the payment obligations under our license, collaboration, and acquisition agreements as of June 30, 2026 are contingent upon future events such as our achievement of specified development, regulatory, and commercial milestones or royalties on net product sales. See the section titled “Business—Key Intellectual Property Agreements” in Part I, Item 1 included in our 2025 Annual Report for more information about these payment obligations.

Current wording

Other than as disclosed in the table above, the payment obligations under our license, collaboration, and acquisition agreements as of September 30, 2026 are contingent upon future events such as the occurrence of specified development, regulatory, and commercial milestones, payments to us related to business development transactions involving the fusogen technology, and royalties on net product sales. See the section titled “Business—Key Intellectual Property Agreements” in Part I, Item 1 included in our 2025 Annual Report and Note 4, Acquisitions included elsewhere in this Quarterly Report for more information about these payment obligations. As of September 30, 2026, the timing and likelihood of the occurrence of such future events are uncertain, and therefore any related potential payments are not included in the table above.

Previous wording

We are also obligated to make a success payment to Cobalt of up to $500.0 million, payable in cash or stock, pursuant to the terms and conditions in the Cobalt acquisition agreement, and up to an aggregate of $175.0 million in success payments to Harvard, payable in cash. See Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations “—Critical accounting policies and significant judgments and estimates—Success payments” included in our 2025 Annual Report and Note 4, Acquisitions and Note 5, License and collaboration agreements to our condensed consolidated financial statements included elsewhere in this Quarterly Report for more information on the success payments. As of June 30, 2026, the timing and likelihood of achieving the milestones and success payments and generating future product sales are uncertain, and therefore any related payments are not included in the table above.

Current wording

We are also obligated to make a success payment to Cobalt of up to $500.0 million, payable in cash or stock, pursuant to the terms and conditions in the Cobalt acquisition agreement, and up to an aggregate of $175.0 million in success payments to Harvard, payable in cash. See Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations “—Critical accounting policies and significant judgments and estimates—Success payments” included in our 2025 Annual Report and Note 4, Acquisitions and Note 5, License and collaboration agreements to our condensed consolidated financial statements included elsewhere in this Quarterly Report for more information on the success payments. As of September 30, 2026, the timing and likelihood of achieving the success payments are uncertain, and therefore any related potential payments are not included in the table above.

Previous wording

Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Our significant accounting policies are described in more detail in the notes to our condensed consolidated financial statements as of June 30, 2026 and for the three and six months ended June 30, 2026 and 2025, and are consistent with those discussed in Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations “—Critical accounting policies and significant judgments and estimates” included in our 2025 Annual Report.

Current wording

Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Our significant accounting policies are described in more detail in the notes to our condensed consolidated financial statements as of September 30, 2026 and for the three and nine months ended September 30, 2026 and 2025, and are consistent with those discussed in Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations “—Critical accounting policies and significant judgments and estimates” included in our 2025 Annual Report.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

See Note 4, Acquisitions to our condensed consolidated financial statements included elsewhere in this Quarterly Report for details on the amount of the potential Cobalt Success Payment and potential Cobalt Contingent Consideration based on various thresholds for our market capitalization on the date of a change of control. See Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations “—Critical accounting policies and significant judgments and estimates—Success payments” and “—Critical accounting policies and significant judgments and estimates—Contingent consideration” included in our 2025 Annual Report for more information on the accounting treatment of the Cobalt Success Payment and Cobalt Contingent Consideration.

Previous report — wording carried elsewhere

a decrease of $6.9 million in personnel-related expenses, including non-cash stock-based compensation, primarily due to lower research and development headcount;