SANA
Sana BiotechnologyDDocument history
Earnings documents stored for SANA.
Investor releaseQuarter not tagged2026-08-10Sana: Q2 Earnings Snapshot
Associated Press
Sana: Q2 Earnings Snapshot
SEATTLE (AP) — SEATTLE (AP) — Sana Biotechnology Inc. (SANA) on Monday reported a loss of $63.6 million in its second quarter. On a per-share basis, the Seattle-based company said it had a loss of 22 cents. Losses, adjusted for non-recurring costs, were 13 cents per share. The results surpassed Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 15 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on SANA at https://www.zacks.com/ap/SANA
Investor releaseQuarter not tagged2026-08-10Sana Biotechnology Reports Second Quarter 2026 Financial Results and Business Updates
GlobeNewswire
Sana Biotechnology Reports Second Quarter 2026 Financial Results and Business Updates
Continued progress toward starting SC451 Phase 1/2 trial, including GLP toxicology studies, SC451 process transfer to the contract manufacturer, and clinical trial readiness Continued progress toward starting clinical study for SG293 in non-Hodgkin lymphoma and generating initial clinical data, including manufacturing and clinical trial readiness Announced follow-on publication in The New England Journal of Medicine (NEJM) highlighting long-term data and durability of hypoimmune-modified islet cell transplantation with UP421 without immunosuppression in type 1 diabetes Announced upcoming symposium presentation highlighting UP421 clinical data at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 on October 2 Advancing strategic collaboration with Mayo Clinic, focused on improving care in type 1 diabetes and accelerating development of SC451 Presented SG293 surrogate preclinical data demonstrating specificity and potency in non-human primates at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting Continued progress with SG227, a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make BCMA-directed CAR T cells, as a potential treatment for patients with multiple myeloma; expect to begin clinical study as early as mid-2027 Q2 2026 cash position of $160.5 million; expected cash runway into mid-2027 SEATTLE, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the second quarter 2026. “Our team is executing on our goals of beginning clinical studies soon for both SC451 in type 1 diabetes and SG293 in non-Hodgkin lymphoma,” said Steve Harr, President and Chief Executive Officer. “Proof of concept data for these programs, including the recent update for UP421 in The New England Journal of Medicine and for an SG293 surrogate at the ASGCT meeting, are encouraging. If all goes as we anticipate, we expect to gain valuable insight into the clinical profiles and potential of both SC451 and SG293 over the next 6-9 months, and we look forward to sharing our progress.” Corporate Highlights Continued progress toward beginning clinical trials for SC451 and SG293 SC451, an O-negative, hypoimmune (HIP)-modified, iPSC-derived pancreatic islet cell ther…Read full documentShow less
Continued progress toward starting SC451 Phase 1/2 trial, including GLP toxicology studies, SC451 process transfer to the contract manufacturer, and clinical trial readiness Continued progress toward starting clinical study for SG293 in non-Hodgkin lymphoma and generating initial clinical data, including manufacturing and clinical trial readiness Announced follow-on publication in The New England Journal of Medicine (NEJM) highlighting long-term data and durability of hypoimmune-modified islet cell transplantation with UP421 without immunosuppression in type 1 diabetes Announced upcoming symposium presentation highlighting UP421 clinical data at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 on October 2 Advancing strategic collaboration with Mayo Clinic, focused on improving care in type 1 diabetes and accelerating development of SC451 Presented SG293 surrogate preclinical data demonstrating specificity and potency in non-human primates at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting Continued progress with SG227, a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make BCMA-directed CAR T cells, as a potential treatment for patients with multiple myeloma; expect to begin clinical study as early as mid-2027 Q2 2026 cash position of $160.5 million; expected cash runway into mid-2027 SEATTLE, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the second quarter 2026. “Our team is executing on our goals of beginning clinical studies soon for both SC451 in type 1 diabetes and SG293 in non-Hodgkin lymphoma,” said Steve Harr, President and Chief Executive Officer. “Proof of concept data for these programs, including the recent update for UP421 in The New England Journal of Medicine and for an SG293 surrogate at the ASGCT meeting, are encouraging. If all goes as we anticipate, we expect to gain valuable insight into the clinical profiles and potential of both SC451 and SG293 over the next 6-9 months, and we look forward to sharing our progress.” Corporate Highlights Continued progress toward beginning clinical trials for SC451 and SG293 SC451, an O-negative, hypoimmune (HIP)-modified, iPSC-derived pancreatic islet cell therapy which uses the same HIP technology as UP421, is being developed as a one-time treatment for patients with type 1 diabetes with a goal of long-term normal blood glucose without the need for any insulin therapy or immunosuppression. Sana is conducting activities to prepare for SC451 investigational new drug application (IND) submission and Phase 1/2 trial start, including near-term completion of GLP toxicology studies, advancement of SC451 technology transfer to the contract manufacturer, and clinical trial readiness. Sana expects to file an IND and begin a Phase 1/2 clinical trial for SC451 as early as this year. SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. SG293 has been designed to minimize potential toxicities related to in vivo CAR T cells, including peri-infusion reactions and off-target delivery to tissues such as the liver. Preclinical data presented at the ASGCT 2026 Annual Meeting demonstrate that a SG293 surrogate, which is active in non-human primates, achieves 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. Sana expects to generate first-in-human data for SG293 in non-Hodgkin lymphoma as early as this year. If successful, the company intends to expand clinical development into B cell-mediated autoimmune diseases as well. Shared updated, positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with HIP technology, into a patient with type 1 diabetes without the use of any immunosuppression. UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator. Results of the study through 14 months after cell transplantation demonstrated the survival and function of pancreatic beta cells in a patient as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increased with mixed meal tolerance tests (MMTT) performed over the course of the study, consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 were comparable to those observed in the first six months of the study. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study has identified no safety issues, and the HIP-modified islet cells have evaded immune detection. Announced that The New England Journal of Medicine published a peer-reviewed Letter to the Editor titled “Long-Term Survival of Hypoimmune Allogeneic Islets without Immunosuppression” (DOI: 10.1056/NEJMc2604408), which discusses 14-month results from this study. 14-month data from the study were presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting in July 2026, and additional data from the IST will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 on October 2. Announced strategic collaboration with Mayo Clinic to advance development of SC451, a HIP-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes. The purpose of the collaboration is to draw on Mayo Clinic’s multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments. In connection with the collaboration, Mayo Clinic made a $25.0 million equity investment in the company, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes. Advanced preclinical pipeline SG227, a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells, is being developed as a potential treatment for patients with multiple myeloma. 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. Sana is preparing to begin clinical testing as early as mid-2027, contingent upon the early clinical profile of SG293. Raised aggregate net proceeds of $93.3 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and Mayo Clinic investment in the second quarter; expected cash runway into mid-2027. Raised net proceeds of $93.3 million in the second quarter from sales of common stock through Sana’s ATM and equity financing. Second Quarter 2026 Financial Results GAAP Results Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2026 were $160.5 million compared to $138.4 million as of December 31, 2025. The increase of $22.1 million was primarily due to net proceeds from equity financings of $93.3 million, partially offset by cash used in operations of $70.2 million and cash used for the purchase of property and equipment of $1.9 million. Research and Development Expenses: For the three and six months ended June 30, 2026, research and development expenses, inclusive of non-cash expenses, were $30.7 million and $59.4 million, respectively, compared to $29.8 million and $67.0 million for the same periods in 2025. The increase of $0.9 million for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to increased research, laboratory, and clinical development costs for our SC451 and SG293 programs and increased third-party manufacturing costs at contract development and manufacturing organizations (CDMOs) for our SC451 and SG293 programs, partially offset by lower personnel and other facility and allocated costs. The decrease of $7.6 million for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to lower personnel-related expenses, including non-cash stock-based compensation, lower facility and other allocated costs, and decreased third-party manufacturing costs at CDMOs due to costs incurred in the first half of 2025 for the suspended allogeneic CAR T programs that did not recur in 2026. These decreases were partially offset by increased third-party manufacturing costs at CDMOs for our SC451 and SG293 programs. Research and development expenses include non-cash stock-based compensation of $3.2 million and $6.3 million for the three and six months ended June 30, 2026, respectively, compared to $4.2 million and $8.8 million for the same periods in 2025. Research and Development Related Success Payments and Contingent Consideration: For the three and six months ended June 30, 2026, Sana recognized non-cash expenses of $23.9 million and $32.3 million, respectively, compared to $10.3 million and $12.2 million for the same periods in 2025, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities may fluctuate significantly with changes to the probabilities of achieving clinical development or regulatory milestones with respect to a fusosome product candidate, and Sana’s market capitalization and stock price. General and Administrative Expenses: General and administrative expenses for the three and six months ended June 30, 2026, inclusive of non-cash expenses, were $10.8 million and $22.2 million, respectively, compared to $10.3 million and $21.8 million for the same periods in 2025. 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. General and administrative expenses include non-cash stock-based compensation of $2.2 million and $4.7 million for the three and six months ended June 30, 2026, respectively, compared to $2.4 million and $4.8 million for the same periods in 2025. Impairment of Long-Lived Assets: For each of the three and six months ended June 30, 2025, non-cash impairment of long-lived assets was $44.6 million. There was no impairment of long-lived assets for the three and six months ended June 30, 2026. The non-cash impairment in 2025 was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. In the second quarter of 2025, because of increased availability of manufacturing capacity at third-party CDMOs for cell and gene therapy products, together with progress in understanding our near-term manufacturing needs, we determined that CDMOs could meet our manufacturing requirements. Accordingly, we suspended further build-out of our internal manufacturing capabilities and continue to rely on CDMOs to meet our manufacturing needs at present. Net Loss: Net loss for the three and six months ended June 30, 2026 was $63.6 million, or $0.22 per share, and $110.8 million, or $0.39 per share, respectively, compared to $93.8 million, or $0.39 per share, and $143.2 million, or $0.60 per share, for the same periods in 2025. Non-GAAP Measures Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the six months ended June 30, 2026 was $69.3 million compared to $79.0 million for the same period in 2025. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, costs related to portfolio prioritizations, and the purchase of property and equipment. Non-GAAP Net Loss: Non-GAAP net loss for the three and six months ended June 30, 2026 was $39.7 million, or $0.13 per share, and $78.5 million, or $0.27 per share, respectively, compared to $38.9 million, or $0.16 per share, and $86.4 million, or $0.36 per share, for the same periods in 2025. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities and non-cash impairment losses recorded in 2025. A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.” About Sana Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including with respect to the substance and timing of potential INDs, the commencement of clinical trials and generation of clinical data, and potential indications for and the potential impact and benefits of its platforms and product candidates; expectations regarding the impact of the Company’s activities on its ability to start clinical studies for SC451 and SG293, including with respect to GLP toxicology studies, manufacturing, including technology transfer, and clinical trial readiness; the potential benefits of, plans for, and activity under the Company’s strategic collaboration with Mayo Clinic; the potential ability for SC451 to be a one-time treatment for patients with type 1 diabetes that achieves long-term normal blood glucose without insulin therapy or immunosuppression; the potential ability for SG293 to minimize potential toxicities related to in vivo CAR T cells; timing and other expectations for, and the potential significance and impact of data from, preclinical studies and clinical trials of the Company’s product candidates and technologies, including future studies and trials, and an IST utilizing HIP-modified primary pancreatic islet cells; expectations for the presentation at the EASD Annual Meeting 2026, including the content of such presentation; expectations regarding the Company’s cash runway; and statements made by the Company’s President and Chief Executive Officer. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others: risks inherent in drug development such as those associated with the initiation, cost, timing, progress, and results of the Company’s current and future research and development programs and preclinical and clinical trials, including that the timing of development activities, including IND submissions and initiation of clinical trials, is subject to change, IND acceptance is subject to the discretion of the U.S. Food and Drug Administration, acceptance of an IND and initiation of a clinical trial are not predictive of clinical trial results or whether the Company will successfully enroll or dose patients, preclinical data may not be predictive of clinical trial results, and clinical results from one product candidate may not be predictive of clinical results from another product candidate; the risk that the collaboration with Mayo Clinic may not achieve its anticipated benefits; and risks associated with economic, market, and social conditions and disruptions, which could cause delays in Sana’s business plans, impede Sana’s access to additional capital, and impede the clinical development of its product candidates, among other things. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Quarterly Report on Form 10-Q dated August 10, 2026. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Investor Relations & Media:Nicole [email protected]@sana.com Non-GAAP Financial Measures To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana’s management believes that these non-GAAP financial measures are helpful in understanding Sana’s financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sana’s management utilizes non-GAAP operating cash burn, non-GAAP research and development expense, non-GAAP general and administrative expense, and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the company’s actual ongoing costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and certain one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity. Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provide investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies. These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Sana’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana’s business and make operating decisions. In addition, Sana’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana’s results from period to period and allow for greater transparency with respect to key financial metrics Sana uses in making operating decisions. The following are reconciliations of GAAP to non-GAAP financial measures:
Investor releaseQuarter not tagged2026-07-16Sana Biotechnology (SANA) Publishes 14 Month Diabetes Cell Therapy Results In NEJM
Simply Wall St.
Sana Biotechnology (SANA) Publishes 14 Month Diabetes Cell Therapy Results In NEJM
Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. Sana Biotechnology (NasdaqGS:SANA) reported long term follow up data from an investigator sponsored study of its HIP modified islet cell therapy for type 1 diabetes. Results published in The New England Journal of Medicine highlighted safety and durable islet cell function over 14 months without the use of immunosuppressive drugs. The transplanted cells were observed to survive, evade immune rejection, and maintain glucose regulating activity through the follow up period. Sana Biotechnology focuses on cell and gene engineering therapies, with its hypoimmune platform aimed at creating cells that can be used off the shelf without immunosuppression. For investors tracking NasdaqGS:SANA, this publication adds clinical context to a company positioned around stem cell derived treatments for serious diseases such as type 1 diabetes. The NEJM article gives investors a reference point for assessing how Sana's hypoimmune technology might fit into the broader efforts to treat autoimmune and chronic conditions using cell based approaches. While it is still early stage and subject to further clinical testing and regulatory review, the durability and safety profile reported over 14 months may inform how you think about long run risk, the scientific backdrop, and the potential addressable market for cell therapies targeting diabetes. Stay updated on the most important news stories for Sana Biotechnology by adding it to your watchlist or portfolio. Alternatively, explore our Community to discover new perspectives on Sana Biotechnology. 0 things going right for Sana Biotechnology that this headline doesn't cover. The NEJM publication gives Sana Biotechnology something concrete for investors to anchor on, because it links the company’s hypoimmune, or HIP, platform to sustained real world biological activity in a person with type 1 diabetes over 14 months. The investigator-sponsored study used donor derived islet cells rather than Sana’s own product candidate, but the core concept is the same: engineered cells that evade immune rejection while still producing insulin. For a pre revenue cell and gene therapy company with four analyst flagged risks and no identified rewards, externally generated, peer reviewed clinical observations like these can be an important part of ho…Read full documentShow less
Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. Sana Biotechnology (NasdaqGS:SANA) reported long term follow up data from an investigator sponsored study of its HIP modified islet cell therapy for type 1 diabetes. Results published in The New England Journal of Medicine highlighted safety and durable islet cell function over 14 months without the use of immunosuppressive drugs. The transplanted cells were observed to survive, evade immune rejection, and maintain glucose regulating activity through the follow up period. Sana Biotechnology focuses on cell and gene engineering therapies, with its hypoimmune platform aimed at creating cells that can be used off the shelf without immunosuppression. For investors tracking NasdaqGS:SANA, this publication adds clinical context to a company positioned around stem cell derived treatments for serious diseases such as type 1 diabetes. The NEJM article gives investors a reference point for assessing how Sana's hypoimmune technology might fit into the broader efforts to treat autoimmune and chronic conditions using cell based approaches. While it is still early stage and subject to further clinical testing and regulatory review, the durability and safety profile reported over 14 months may inform how you think about long run risk, the scientific backdrop, and the potential addressable market for cell therapies targeting diabetes. Stay updated on the most important news stories for Sana Biotechnology by adding it to your watchlist or portfolio. Alternatively, explore our Community to discover new perspectives on Sana Biotechnology. 0 things going right for Sana Biotechnology that this headline doesn't cover. The NEJM publication gives Sana Biotechnology something concrete for investors to anchor on, because it links the company’s hypoimmune, or HIP, platform to sustained real world biological activity in a person with type 1 diabetes over 14 months. The investigator-sponsored study used donor derived islet cells rather than Sana’s own product candidate, but the core concept is the same: engineered cells that evade immune rejection while still producing insulin. For a pre revenue cell and gene therapy company with four analyst flagged risks and no identified rewards, externally generated, peer reviewed clinical observations like these can be an important part of how you think about the long term market opportunity and potential for eventual revenue from programs such as SC451. ⚠️ Sana Biotechnology currently generates less than US$1m in revenue and remains in the development stage, so progress on HIP based diabetes treatments may not translate into near term cash flows. ⚠️ Shareholders have experienced substantial dilution over the past year and analysts expect earnings to decline by an average of 6.4% per year over the next 3 years, which can weigh on existing holders even as clinical data advances. 🎁 The 14 month follow up suggests HIP modified islet cells can survive and function without immunosuppression, which may support the commercial logic for an off the shelf, stem cell derived product like SC451. 🎁 A therapy that targets long term insulin independence in type 1 diabetes without chronic immunosuppression speaks to a large addressable patient pool and could position Sana as a differentiated player next to diabetes focused peers. Following this update, focus on how Sana Biotechnology translates these UP421 findings into its own SC451 program, including regulatory interactions, trial design, and any early safety or biomarker data once patients are dosed. Investors may also want to track the company’s funding decisions, given limited current revenue and prior dilution, to see how it balances capital needs with potential partnership or licensing activity around the hypoimmune platform. To ensure you're always in the loop on how the latest news impacts the investment narrative for Sana Biotechnology, head to the community page for Sana Biotechnology to never miss an update on the top community narratives. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include SANA. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-05-12Sana: Q1 Earnings Snapshot
Associated Press
Sana: Q1 Earnings Snapshot
SEATTLE (AP) — SEATTLE (AP) — Sana Biotechnology Inc. (SANA) on Monday reported a loss of $47.2 million in its first quarter. The Seattle-based company said it had a loss of 17 cents per share. Losses, adjusted for non-recurring costs, came to 14 cents per share. The results surpassed Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 15 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on SANA at https://www.zacks.com/ap/SANA
Investor releaseQuarter not tagged2026-05-12Sana Biotechnology Reports First Quarter 2026 Financial Results and Business Updates
GlobeNewswire
Sana Biotechnology Reports First Quarter 2026 Financial Results and Business Updates
Announced strategic collaboration with Mayo Clinic, focused on improving care in type 1 diabetes and accelerating development of SC451 Continued progress toward starting SC451 Phase 1 trial later this year, including manufacturing readiness, non-clinical testing, and clinical trial preparation Announced positive clinical results at 14 months from ongoing clinical trial transplanting UP421 without any immunosuppression into a patient with type 1 diabetes, showing ongoing survival and function Continued progress toward starting clinical study for SG293 in non-Hodgkin lymphoma later this year, including manufacturing readiness, non-clinical testing, and clinical trial preparation Will present SG293 surrogate preclinical data demonstrating specificity and potency in non-human primates at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on May 12 Progress with SG227, a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make BCMA-directed CAR T cells, as a potential treatment for patients with multiple myeloma; expect to begin clinical study as early as mid-2027 Q1 2026 cash position of $101.1 million and pro forma cash position of $128.9 million, including approximately $25.0 million equity investment from Mayo Clinic collaboration and recent at the market offering facility (ATM) activity; expected cash runway into 2027 SEATTLE, May 11, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the first quarter 2026. “We remain focused on execution in 2026 and are on track with both SC451 and SG293,” said Steve Harr, President and Chief Executive Officer. “We are working to file our IND and begin a Phase 1 trial later this year for SC451, our gene-modified, stem cell-derived pancreatic islet cell product candidate designed for patients with type 1 diabetes with the goal of a single treatment leading to long-term normal blood glucose without the need for any insulin therapy or immunosuppression. We are pleased to have recently entered into a strategic collaboration with Mayo Clinic, whose multidisciplinary expertise we expect will help accelerate the development, standardization of delivery for, and access to SC451. We also continue to advance SG293, our in vivo CAR T cell produc…Read full documentShow less
Announced strategic collaboration with Mayo Clinic, focused on improving care in type 1 diabetes and accelerating development of SC451 Continued progress toward starting SC451 Phase 1 trial later this year, including manufacturing readiness, non-clinical testing, and clinical trial preparation Announced positive clinical results at 14 months from ongoing clinical trial transplanting UP421 without any immunosuppression into a patient with type 1 diabetes, showing ongoing survival and function Continued progress toward starting clinical study for SG293 in non-Hodgkin lymphoma later this year, including manufacturing readiness, non-clinical testing, and clinical trial preparation Will present SG293 surrogate preclinical data demonstrating specificity and potency in non-human primates at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on May 12 Progress with SG227, a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make BCMA-directed CAR T cells, as a potential treatment for patients with multiple myeloma; expect to begin clinical study as early as mid-2027 Q1 2026 cash position of $101.1 million and pro forma cash position of $128.9 million, including approximately $25.0 million equity investment from Mayo Clinic collaboration and recent at the market offering facility (ATM) activity; expected cash runway into 2027 SEATTLE, May 11, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the first quarter 2026. “We remain focused on execution in 2026 and are on track with both SC451 and SG293,” said Steve Harr, President and Chief Executive Officer. “We are working to file our IND and begin a Phase 1 trial later this year for SC451, our gene-modified, stem cell-derived pancreatic islet cell product candidate designed for patients with type 1 diabetes with the goal of a single treatment leading to long-term normal blood glucose without the need for any insulin therapy or immunosuppression. We are pleased to have recently entered into a strategic collaboration with Mayo Clinic, whose multidisciplinary expertise we expect will help accelerate the development, standardization of delivery for, and access to SC451. We also continue to advance SG293, our in vivo CAR T cell product candidate, which has the potential to offer a one-time, off-the-shelf treatment without conditioning chemotherapy to patients with blood cancers or B cell-mediated autoimmune disorders. We are making meaningful progress toward our goal of beginning clinical testing later this year. We are also preparing to begin a clinical trial for SG227, an in vivo BCMA-targeted CAR T cell therapy, by as early as mid-2027 assuming positive early safety and efficacy data for SG293. This near-term operational focus has the potential to generate meaningful proof of concept data across multiple programs over the coming 12-18 months, and we look forward to building on this momentum.” Corporate Highlights Announced strategic collaboration with Mayo Clinic to advance development of SC451, a hypoimmune (HIP)-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes. The collaboration will draw on Mayo Clinic’s multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments. In connection with the collaboration, Mayo Clinic made an approximately $25.0 million equity investment in the company, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes. The organization also has the option to make an additional approximately $25.0 million equity investment. Shared updated, positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with HIP technology, into a patient with type 1 diabetes without the use of any immunosuppression. UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator. Results of the study through 14 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 increased with mixed meal tolerance tests (MMTT) performed over the course of the study, consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 are comparable to those observed in the first six months of the study. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study has identified no safety issues, and the HIP-modified islet cells have evaded immune detection. Continued progress toward beginning clinical trials later this year for SC451 and SG293 SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy which uses the same HIP technology as UP421, is being developed as a one-time treatment for patients with type 1 diabetes with a goal of long-term normal blood glucose without the need for any insulin therapy or immunosuppression. Sana is currently conducting nonclinical testing, manufacturing transfer to contract manufacturers, and clinical trial preparation. Sana expects to file an IND and begin a Phase 1 clinical trial for SC451 as early as this year. SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. Sana is currently conducting nonclinical testing, manufacturing transfer to a contract manufacturer, and clinical trial preparation. The fusogen technology used in SG293 has been designed to minimize potentially troublesome toxicities related to in vivo CAR T cells, including off-target delivery to tissues such as the liver and peri-infusion reactions. Preclinical data demonstrate that a SG293 surrogate, which is active in non-human primates, achieves 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. Details from this study will be presented at the upcoming ASGCT Annual Meeting on May 12. Sana intends to explore SG293 initially in non-Hodgkin lymphoma and expects to generate first-in-human data as early as this year. If successful, the company intends to expand clinical development into B cell-mediated autoimmune diseases as well. Advanced preclinical pipeline SG227, a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells, is being developed as a potential treatment for patients with multiple myeloma. 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. Sana is preparing to begin clinical testing as early as mid-2027, contingent upon the early clinical profile of SG293. Strengthened leadership with the appointment of new Chief Financial Officer Appointed Brian Piper as Executive Vice President, Chief Financial Officer. Mr. Piper has decades of experience in financial management within the biotechnology sector – including CFO roles at Scorpion Therapeutics, Antares Therapeutics, and Prelude Therapeutics – and has successfully led financings and worked with companies to maximize their assets. First Quarter 2026 Financial Results GAAP Results Cash Position: Cash, cash equivalents, and marketable securities as of March 31, 2026 were $101.1 million compared to $138.4 million as of December 31, 2025. The decrease of $37.3 million was primarily driven by cash used in operations of $37.4 million. Research and Development Expenses: For the three months ended March 31, 2026, research and development expenses, inclusive of non-cash expenses, were $28.7 million compared to $37.2 million for the same period in 2025. The decrease of $8.5 million was primarily due to lower personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount, a decrease in third-party manufacturing costs at contract development and manufacturing organizations primarily related to the suspension of Sana’s allogeneic CAR T programs, and lower facility and other allocated costs primarily related to depreciation, allocated personnel, and other costs. Research and development expenses include non-cash stock-based compensation of $3.1 million and $4.6 million for the three months ended March 31, 2026 and 2025, respectively. Research and Development Related Success Payments and Contingent Consideration: For the three months ended March 31, 2026, Sana recognized non-cash expenses of $8.4 million compared to $2.0 million for the same period in 2025, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price. General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2026, inclusive of non-cash expenses, were $11.5 million, unchanged from the same period in 2025. For the three months ended March 31, 2026, legal fees increased $0.2 million, offset by decreased personnel-related costs of $0.2 million, compared to the same period in 2025. General and administrative expenses include non-cash stock-based compensation of $2.6 million and $2.4 million for the three months ended March 31, 2026 and 2025, respectively. Net Loss: Net loss for the three months ended March 31, 2026 was $47.2 million, or $0.17 per share, compared to $49.4 million, or $0.21 per share, for the same period in 2025. Non-GAAP Measures Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the three months ended March 31, 2026 was $37.0 million compared to $46.6 million for the same period in 2025. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding costs related to portfolio prioritizations and the purchase of property and equipment. Non-GAAP Net Loss: Non-GAAP net loss for the three months ended March 31, 2026 was $38.8 million, or $0.14 per share, compared to $47.4 million, or $0.20 per share, for the same period in 2025. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities. A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.” About Sana Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including with respect to the substance and timing of potential INDs, the commencement of clinical trials and generation of clinical data, and potential indications for and the potential impact and benefits of its platforms and product candidates; expectations with respect to nonclinical testing, manufacturing transfer to contract manufacturers, and clinical trial preparation for SC451 and SG293; the potential for SG293 to offer a one-time, off-the-shelf treatment without the use of conditioning chemotherapy to patients with blood cancers or B cell-mediated autoimmune disorders; the potential benefits of, plans for, and activity under the Company’s strategic collaboration with Mayo Clinic; the potential ability for SC451 to be a one-time treatment for patients with type 1 diabetes that achieves long-term normal blood glucose without insulin therapy or immunosuppression; expectations for and the potential significance and impact of data from preclinical studies and clinical trials of the Company’s product candidates and technologies, including future studies and trials, and an IST utilizing HIP-modified primary pancreatic islet cells; expectations for the Company’s participation in and presentation at ASGCT, including the content of such presentation; expectations regarding the Company’s cash runway; and statements made by the Company’s President and Chief Executive Officer. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others: risks inherent in drug development such as those associated with the initiation, cost, timing, progress, and results of the Company’s current and future research and development programs and preclinical and clinical trials, including that the timing of an IND submission is subject to change, IND acceptance is subject to the discretion of the U.S. Food and Drug Administration, acceptance of an IND and initiation of a clinical trial are not predictive of clinical trial results or whether the Company will successfully enroll or dose patients, preclinical data may not be predictive of clinical trial results, and clinical results from one product candidate may not be predictive of clinical results from another product candidate; the risk that the collaboration with Mayo Clinic may not achieve its anticipated benefits; and risks associated with economic, market, and social conditions and disruptions, which could cause delays in Sana’s business plans, impede Sana’s access to additional capital, and impede the clinical development of its product candidates, among other things. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Quarterly Report on Form 10-Q dated May 11, 2026. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Investor Relations & Media: Nicole Keith [email protected] [email protected] Non-GAAP Financial Measures To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana’s management believes that these non-GAAP financial measures are helpful in understanding Sana’s financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sana’s management utilizes non-GAAP operating cash burn, non-GAAP research and development expense, non-GAAP general and administrative expense, and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the company’s actual ongoing costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and certain one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity. Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provide investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies. These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Sana’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana’s business and make operating decisions. In addition, Sana’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana’s results from period to period and allow for greater transparency with respect to key financial metrics Sana uses in making operating decisions. The following are reconciliations of GAAP to non-GAAP financial measures:
Investor releaseQuarter not tagged2026-03-13Sana Biotechnology Announces Continued Positive Clinical Results Through 14 Months from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression
GlobeNewswire
Sana Biotechnology Announces Continued Positive Clinical Results Through 14 Months from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression
Groundbreaking First-in-Human Study Demonstrates Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression 14-Month Follow-up Data Show Hypoimmune (HIP)-Modified Islets are Safe, Evade Detection by the Immune System, Survive Long-Term, and Continue to Produce Insulin C-Peptide Levels at Month 14 Comparable to Initial Six Months of Study; Results Highlight the Importance of Improved Glycemic Control on Islet Function Full 14-Month Data to Be Presented Today at the Advanced Technologies & Treatments for Diabetes (ATTD) Conference Sana is Leveraging Validated HIP Technology to Develop SC451, a HIP-Modified, Stem Cell-Derived Therapy, Designed as a One-Time Treatment for Patients with Type 1 Diabetes, with a Goal of Normal Blood Glucose without Insulin or Immunosuppression Sana Expects to File Investigational New Drug (IND) Application for SC451 in Type 1 Diabetes and Initiate Phase 1 Trial as Early as This Year SEATTLE, March 13, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced 14-month follow-up results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana’s hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without any immunosuppression. The study is being conducted in partnership with Uppsala University Hospital. Results from more than 1 year after cell transplantation demonstrate sustained survival and function of pancreatic beta cells, as measured by the presence of circulating C-peptide, a biomarker of endogenous insulin production by the transplanted beta cells. C-peptide levels also increase in response to a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 are comparable to those observed in the first six months of the study and exceed levels measured at months 9 and 12. Between months 12 and 14, the patient achieved tighter glycemic control, and the improved insulin secretion at month 14 underscores the importance of glucose control in optimizing pancreatic beta cell function. No safety issues were identified in the study. “We are pleased to share the results through 14 months from this first-in-…Read full documentShow less
Groundbreaking First-in-Human Study Demonstrates Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression 14-Month Follow-up Data Show Hypoimmune (HIP)-Modified Islets are Safe, Evade Detection by the Immune System, Survive Long-Term, and Continue to Produce Insulin C-Peptide Levels at Month 14 Comparable to Initial Six Months of Study; Results Highlight the Importance of Improved Glycemic Control on Islet Function Full 14-Month Data to Be Presented Today at the Advanced Technologies & Treatments for Diabetes (ATTD) Conference Sana is Leveraging Validated HIP Technology to Develop SC451, a HIP-Modified, Stem Cell-Derived Therapy, Designed as a One-Time Treatment for Patients with Type 1 Diabetes, with a Goal of Normal Blood Glucose without Insulin or Immunosuppression Sana Expects to File Investigational New Drug (IND) Application for SC451 in Type 1 Diabetes and Initiate Phase 1 Trial as Early as This Year SEATTLE, March 13, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced 14-month follow-up results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana’s hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without any immunosuppression. The study is being conducted in partnership with Uppsala University Hospital. Results from more than 1 year after cell transplantation demonstrate sustained survival and function of pancreatic beta cells, as measured by the presence of circulating C-peptide, a biomarker of endogenous insulin production by the transplanted beta cells. C-peptide levels also increase in response to a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 are comparable to those observed in the first six months of the study and exceed levels measured at months 9 and 12. Between months 12 and 14, the patient achieved tighter glycemic control, and the improved insulin secretion at month 14 underscores the importance of glucose control in optimizing pancreatic beta cell function. No safety issues were identified in the study. “We are pleased to share the results through 14 months from this first-in-human study transplanting hypoimmune-modified primary islet cells into a patient with type 1 diabetes,” said Per-Ola Carlsson, MD, Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. “These findings build upon previously presented data and continue to show no safety issues, along with continued immune evasion, survival, and function of the transplanted cells. Importantly, the results demonstrate the positive impact of improved glucose control on beta cell function and the dynamic functional capacity of beta cells transplanted in a single low dose without immunosuppression. This work suggests that the hypoimmune technology has the potential to enable a functional cure for type 1 diabetes without immunosuppression, and we look forward to working with Sana as it brings forward SC451, a more scalable approach, at higher doses.” “These data continue to highlight the potential for HIP-modified cells to survive, function, and evade immune detection long-term in people post-transplant, a finding that we believe could have broad impact in type 1 diabetes and beyond,” said Steve Harr, MD, Sana’s President and CEO. “The data presented today also demonstrate how improvement in glycemic control – which is anticipated with higher doses of hypoimmune islets – can further enhance the function of these cells. We remain focused on advancing SC451, a HIP-modified stem cell-derived islet cell therapy, into the clinic and expect to file an investigational new drug application (IND) and initiate a Phase 1 trial as early as this year. Our goal is to offer patients a single treatment that delivers durable, normal blood glucose without the need for exogenous insulin or immunosuppression, and we look forward to continuing our collaboration with Dr. Carlsson and his colleagues at Uppsala University to advance this vision.” Primary islet cell transplantation with immunosuppression is an established procedure in type 1 diabetes in which allogeneic pancreatic islet cells are isolated from a deceased donor’s pancreas and transplanted into a patient with a goal of normal blood glucose and insulin independence. As with whole-organ transplants, suppression of the patient’s immune system has historically been required to prevent immune rejection of allogeneic transplanted cells and resurgence of the inciting autoimmune attack. Sana’s HIP technology is designed to overcome immunologic rejection of allogeneic cells and, in type 1 diabetes, to also evade autoimmune rejection of pancreatic beta cells. UP421 was derived from the islet cells of a deceased donor and transplanted with no immunosuppression, and the survival of the UP421 cells provides evidence that they evade both allogeneic and autoimmune detection. About the Uppsala University Hospital Investigator-Sponsored Study of UP421 in Type 1 Diabetes The investigator-sponsored study of UP421 is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust. The study evaluates whether HIP-modified insulin-producing pancreatic cells can be transplanted safely and help to regain insulin production in individuals with type 1 diabetes without need of simultaneous treatment with immunosuppressive medicines. To do this, UP421 is engineered using Sana’s HIP platform at Oslo University Hospital. The study involves intramuscular surgical transplantation of HIP-modified primary islet cells into the forearm of patients with type 1 diabetes. The primary objective of the study is to investigate the safety of UP421 transplantation in patients with type 1 diabetes, with secondary endpoints including cell survival, immune evasion, and C-peptide production. Circulating C-peptide is a measure of endogenous insulin production. This first-in-human study examines a low dose of HIP-modified primary islets to initially establish the safety and function of HIP-modified islets without immunosuppression and, as a result, is not intended to show improvement in glycemia and/or reduction in exogenous insulin administration. Results of the study at 14 months after islet 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 during an MMTT, consistent with insulin secretion in response to a meal. At baseline, the patient had undetectable C-peptide both fasting and during an MMTT. 52-week PET-MRI scanning also demonstrated islet cells at the transplant site, a forearm muscle. The HIP platform has not only achieved proof-of-concept in humans but has also shown continuation of effect with long-term evasion of immune recognition, supporting its potential broad application for allogeneic transplantation without immunosuppression. About the Sana Biotechnology Hypoimmune (HIP) Platform Sana’s HIP platform is designed to generate cells ex vivo that can evade the patient’s immune system to enable the transplantation of allogeneic cells without the need for immunosuppression. We are applying our HIP technology to develop therapeutic candidates at scale, including pluripotent stem cells, which can then be differentiated into multiple cell types, including pancreatic islet cells. We and our collaborators have generated significant foundational intellectual property in the area. Early clinical data from Phase 1 trials and preclinical data published in peer-reviewed journals demonstrate across a variety of cell types that these transplanted allogeneic cells can evade both the adaptive and innate arms of the immune system while retaining their activity. Sana’s most advanced program using this platform is its stem cell-derived pancreatic islet cell program for type 1 diabetes. About Sana Biotechnology Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA. For more information about Sana Biotechnology, please visit https://sana.com/. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including the potential timing of INDs and clinical trials for its SC451 program and the dose levels to be evaluated; the potential ability of SC451 to be administered as a one-time treatment for patients with type 1 diabetes, to provide a more scalable approach, and to achieve durable, normal blood glucose without exogenous insulin or immunosuppression; the potential impact and significance of data from the UP421 study of islet cell transplantation without immunosuppression in a patient with type 1 diabetes (“Study”), including the potential to transplant insulin-secreting cells and develop a functional cure for the treatment of type 1 diabetes without immunosuppression; expectations regarding the presentation at the Advanced Technologies & Treatments for Diabetes conference; the ability of the HIP platform to generate cells ex vivo that can evade the patient’s immune system to enable the transplantation of allogeneic cells without the need for immunosuppression and, in type 1 diabetes, enable pancreatic beta cells to overcome autoimmune rejection, to have broad application for allogeneic transplantation without immunosuppression, including in diabetes, and to be applied to develop therapeutic candidates at scale, including pluripotent stem cells that can be differentiated into multiple cell types; the potential safety and long-term survival, function, and evasion of immune detection of HIP-modified cells with no immunosuppression, including the potential impact of glycemic control on islet and beta cell function and the dynamic functional capacity of beta cells transplanted in a single low dose without immunosuppression; expectations with respect to the impact of the dose level of hypoimmune islets on glycemic control; the potential application of the learnings from the Study to the Company’s SC451 program; and statements made by Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital, and by the Company’s President and CEO. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market, and social disruptions. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Annual Report on Form 10-K dated March 3, 2026. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Investor Relations & Media: Nicole Keith [email protected] [email protected]
Investor releaseQuarter not tagged2026-03-04Sana: Q4 Earnings Snapshot
Associated Press Finance
Sana: Q4 Earnings Snapshot
SEATTLE (AP) — SEATTLE (AP) — Sana Biotechnology Inc. (SANA) on Tuesday reported a loss of $58.8 million in its fourth quarter. The Seattle-based company said it had a loss of 21 cents per share. Losses, adjusted for non-recurring costs, came to 16 cents per share. The results fell short of Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 13 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on SANA at https://www.zacks.com/ap/SANA
Investor releaseQuarter not tagged2026-03-04Sana Biotechnology Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates
GlobeNewswire
Sana Biotechnology Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates
Shared 12-month clinical results of ongoing UP421 type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression are safe and well-tolerated, evade detection by the immune system, and continue to function one year post-transplant New England Journal of Medicine published positive 12-week clinical results of the UP421 type 1 diabetes study Incorporating the tested hypoimmune technology to develop SC451, a hypoimmune-modified, stem cell-derived therapy, as a one-time treatment for patients with type 1 diabetes, with a goal of normal blood glucose, with no insulin and no immunosuppression Made significant progress with SC451 across manufacturing, regulatory, and clinical trial preparedness, including the non-clinical testing plan and manufacture of the master cell bank Expect to file investigational new drug application (IND) for SC451 in type 1 diabetes and begin Phase 1 trial as early as this year Expect to generate first-in-human data in blood cancers as early as this year for the next-generation in vivo CAR T product candidate, SG293, a CD8-targeted fusosome that delivers a CD19-directed CAR Demonstrated deep B-cell depletion and immune reset with a single treatment in non-human primates with surrogate SG293 Raised aggregate gross proceeds of $133.7 million from sales of common stock through Sana’s at the market offering facility (ATM) and equity financing in 2025 Q4 2025 cash position of $138.4 million and expected cash runway into late 2026 SEATTLE, March 03, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the fourth quarter and year ended December 31, 2025. “Meaningful scientific and operational progress in 2025 has positioned us well to generate human proof-of-concept data over the next 12-18 months for SC451 in type 1 diabetes and SG293 in blood cancers,” said Steve Harr, Sana’s President and Chief Executive Officer. “Clinical data for UP421, a study which is now out beyond a year, provide the first known example of transplanting an allogeneic cell therapy for the treatment of type 1 diabetes without any immunosuppression. These results, when combined with progress in the field of transplanting pancreatic islets, make us optimistic that SC451, whi…Read full documentShow less
Shared 12-month clinical results of ongoing UP421 type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression are safe and well-tolerated, evade detection by the immune system, and continue to function one year post-transplant New England Journal of Medicine published positive 12-week clinical results of the UP421 type 1 diabetes study Incorporating the tested hypoimmune technology to develop SC451, a hypoimmune-modified, stem cell-derived therapy, as a one-time treatment for patients with type 1 diabetes, with a goal of normal blood glucose, with no insulin and no immunosuppression Made significant progress with SC451 across manufacturing, regulatory, and clinical trial preparedness, including the non-clinical testing plan and manufacture of the master cell bank Expect to file investigational new drug application (IND) for SC451 in type 1 diabetes and begin Phase 1 trial as early as this year Expect to generate first-in-human data in blood cancers as early as this year for the next-generation in vivo CAR T product candidate, SG293, a CD8-targeted fusosome that delivers a CD19-directed CAR Demonstrated deep B-cell depletion and immune reset with a single treatment in non-human primates with surrogate SG293 Raised aggregate gross proceeds of $133.7 million from sales of common stock through Sana’s at the market offering facility (ATM) and equity financing in 2025 Q4 2025 cash position of $138.4 million and expected cash runway into late 2026 SEATTLE, March 03, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the fourth quarter and year ended December 31, 2025. “Meaningful scientific and operational progress in 2025 has positioned us well to generate human proof-of-concept data over the next 12-18 months for SC451 in type 1 diabetes and SG293 in blood cancers,” said Steve Harr, Sana’s President and Chief Executive Officer. “Clinical data for UP421, a study which is now out beyond a year, provide the first known example of transplanting an allogeneic cell therapy for the treatment of type 1 diabetes without any immunosuppression. These results, when combined with progress in the field of transplanting pancreatic islets, make us optimistic that SC451, which incorporates the same hypoimmune gene edits into a more scalable manufacturing platform, can lead to a functional cure for people with type 1 diabetes, meaning normal blood glucose, no more insulin injections, and no immunosuppression. Moving to the fusogen platform, we made improvements to our in vivo CAR T platform with our next‑generation SG293 candidate, offering the potential for a simple, one-time, off-the-shelf treatment without the use of conditioning chemotherapy for the treatment of B cell cancers and B cell-mediated autoimmune diseases. We look forward to beginning clinical trials for both of these therapies this year. With two powerful platforms advancing in parallel, we look to drive meaningful clinical benefit for patients.” Corporate Highlights Published positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression. UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) was to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator. Results of the study through one year 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 mixed meal tolerance tests performed over the course of the study, consistent with insulin secretion in response to a meal. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection. The New England Journal of Medicine (NEJM) published a journal article titled “Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression” (DOI: 10.1056/NEJMoa2503822). The article discusses 12-week results from this study. NEJM also published an accompanying editorial that further describes both the Sana technology and progress in the field (DOI: 10.1056/NEJMe2507578). Advancing our focused pipeline across two platforms: Hypoimmune Platform – Type 1 diabetes – Sana continues development of SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy, which uses the same HIP technology as UP421. Sana has had multiple interactions with regulators over the last year, including FDA INTERACT and Pre-IND meetings, the results of which increase confidence in its manufacturing process, manufacturing controls, nonclinical testing plan, and clinical trial plan. Sana expects to file an IND and begin a Phase 1 clinical trial for SC451 as early as this year. Fusogen Platform – In vivo CAR T cells – Sana continues to develop its next-generation in vivo CAR T product candidate, SG293, which uses Sana’s proprietary fusogen delivery-based technology. 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. Preclinical data demonstrate that a SG293 surrogate achieves 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. Sana intends to explore SG293 in both B-cell cancers and B-cell mediated autoimmune diseases and expects to generate first-in-human data as early as this year. Published preclinical data in Nature Biotechnology demonstrating potent in vivo gene editing of hematopoietic stem cells (HSCs) in the bone marrow with systemic delivery in preclinical murine models using fusogen technology: The article describes a study that evaluated a systemically delivered virus-like particle (VLP) using the fusogen technology to target and gene edit HSCs in vivo. Results show potent and cell-specific in vivo delivery and gene editing of HSCs in the bone marrow in several murine models, with stable gene editing of long-term HSCs. This broadens the application of fusogen technology beyond T cells to a second cell type, HSCs, and underscores the ability to deliver diverse payloads, including CRISPR gene-editing and base-editing machinery. Raised aggregate gross proceeds of $133.7 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in 2025; expected cash runway into late 2026. Closed public offering in August 2025 of 24.3 million shares of Sana’s 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 Sana’s common stock. The gross proceeds from this offering were $86.3 million before deducting underwriting discounts and commissions and offering expenses. Raised gross proceeds of $47.4 million in 2025 from sales of common stock through Sana’s ATM. Strengthened leadership with the appointment of new Chief Financial Officer In the first quarter of 2026, appointed Brian Piper as Executive Vice President, Chief Financial Officer. Mr. Piper has decades of experience in financial management within the biotechnology sector – including CFO roles at Scorpion Therapeutics, Antares Therapeutics, and Prelude Therapeutics – and has successfully led financings and worked with companies to maximize their assets. Fourth Quarter 2025 Financial Results GAAP Results Cash Position: Cash, cash equivalents, and marketable securities as of December 31, 2025 were $138.4 million compared to $152.5 million as of December 31, 2024. The decrease of $14.1 million was primarily driven by cash used in operations of $143.8 million, partially offset by net proceeds from equity financings of $126.4 million, proceeds from stock option exercises and Sana’s employee stock purchase plan of $2.7 million, and other cash inflows. Research and Development Expenses: For the three and twelve months ended December 31, 2025, research and development expenses, inclusive of non-cash expenses, were $34.9 million and $132.0 million, respectively, compared to $45.1 million and $215.7 million for the same periods in 2024. The decreases of $10.2 million and $83.7 million for the three and twelve months ended December 31, 2025 compared to the same periods in 2024, respectively, were primarily due to the portfolio prioritization announced in the fourth quarter of 2024, which resulted in a reduction of the scope of research, laboratory, and clinical development activities, lower personnel-related costs, including non-cash stock-based compensation, and a decrease in facility and other allocated costs. Research and development expenses include non-cash stock-based compensation of $3.2 million and $15.2 million, respectively, for the three and twelve months ended December 31, 2025, and $3.9 million and $23.4 million for the same periods in 2024. Research and Development Related Success Payments and Contingent Consideration: For the three and twelve months ended December 31, 2025, Sana recognized non-cash expenses of $14.1 million and $29.4 million, respectively, compared to non-cash gains of $13.4 million and $8.9 million for the same periods in 2024, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price. General and Administrative Expenses: General and administrative expenses for the three and twelve months ended December 31, 2025, inclusive of non-cash expenses, were $12.2 million and $44.3 million, respectively, compared to $17.3 million and $64.0 million for the same periods in 2024. The decrease of $5.1 million for the three months ended December 31, 2025 compared to the same period in 2024 was primarily due to personnel-related costs incurred in connection with the portfolio prioritization announced in the fourth quarter of 2024. The decrease of $19.7 million for the twelve months ended December 31, 2025 compared to the same period in 2024 was primarily due to lower personnel-related costs, including non-cash stock-based compensation, due to a decrease in headcount in connection with the portfolio prioritization announced in the fourth quarter of 2024, and decreased legal and consulting fees. General and administrative expenses include non-cash stock-based compensation of $3.2 million and $10.3 million for the three and twelve months ended December 31, 2025, respectively, compared to $2.5 million and $14.3 million for the same periods in 2024. Impairment of Long-Lived Assets: For the twelve months ended December 31, 2025, non-cash impairment of long-lived assets was $44.6 million, compared to $1.9 million for the same period in 2024. The non-cash impairment of $44.6 million recorded in the second quarter of 2025 was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. Because of the increased availability of manufacturing capacity at third-party contract development and manufacturing organizations (CDMOs) for cell and gene therapy products as well as progress in understanding its near-term manufacturing needs, Sana expects to use CDMOs to meet its manufacturing needs at present and has suspended further build-out of internal manufacturing capabilities. Impairment of long-lived assets in 2024 consists of non-cash losses recognized for the impairment of certain laboratory equipment and leasehold improvements as a result of the portfolio prioritization in the fourth quarter of 2024. Net Loss: Net loss for the three and twelve months ended December 31, 2025 was $58.8 million, or $0.21 per share, and $244.2 million, or $0.96 per share, respectively, compared to $49.1 million, or $0.21 per share, and $266.8 million, or $1.16 per share, for the same periods in 2024. Non-GAAP Measures Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the twelve months ended December 31, 2025 was $138.5 million compared to $195.1 million for the same period in 2024. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, costs related to portfolio prioritizations, and the purchase of property and equipment. Non-GAAP General and Administrative Expenses: Non-GAAP general and administrative expenses for the three and twelve months ended December 31, 2025 were $12.2 million and $44.3 million, respectively, compared to $11.4 million and $58.2 million for the same periods in 2024. Non-GAAP general and administrative expense excludes personnel-related costs related to the portfolio prioritization in the fourth quarter of 2024. Non-GAAP Net Loss: Non-GAAP net loss for the three and twelve months ended December 31, 2025 was $44.7 million, or $0.16 per share, and $170.1 million, or $0.67 per share, respectively, compared to $54.8 million, or $0.23 per share, and $263.1 million, or $1.14 per share, for the same periods in 2024. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities, and non-cash impairment losses recorded in 2025 and 2024. A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.” About Sana Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including with respect to the substance and timing of potential INDs, the commencement of clinical trials and generation of human data, and potential indications for and the potential impact and benefits of its platforms and product candidates; expectations with respect to the impact of regulatory interactions and the ability to move forward with the Company’s SC451 manufacturing process, manufacturing controls, nonclinical testing plan, and clinical trial plan; the potential ability for SG293 to be a simple, one-time, off-the-shelf treatment without the use of conditioning chemotherapy; expectations with respect to manufacturing and scalability of SC451 and the potential ability for SC451 in type 1 diabetes to be a single treatment that restores normal blood glucose without insulin or immunosuppression and lead to a functional cure for people with type 1 diabetes; expectations regarding the significance and impact of data from preclinical studies and clinical trials of the Company’s product candidates and technologies, including the potential breadth of application and ability of the fusogen technology to deliver diverse payloads, and an IST utilizing HIP-modified primary pancreatic islet cells; expectations regarding the Company’s cash runway; expectations regarding the use of CDMOs; and statements made by the Company’s President and Chief Executive Officer. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market, and social disruptions. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Annual Report on Form 10-K dated March 3, 2026. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Investor Relations & Media: Nicole Keith [email protected] [email protected] Non-GAAP Financial Measures To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana’s management believes that these non-GAAP financial measures are helpful in understanding Sana’s financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sana’s management utilizes non-GAAP operating cash burn, non-GAAP research and development expense, non-GAAP general and administrative expense, and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the company’s actual ongoing costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and certain one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity. Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provide investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies. These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Sana’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana’s business and make operating decisions. In addition, Sana’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana’s results from period to period and allow for greater transparency with respect to key financial metrics Sana uses in making operating decisions. The following are reconciliations of GAAP to non-GAAP financial measures:
Investor releaseQuarter not tagged2025-11-07Sana Biotechnology Reports Third Quarter 2025 Financial Results and Business Updates
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Sana Biotechnology Reports Third Quarter 2025 Financial Results and Business Updates
Announced increased focus on type 1 diabetes and in vivo CAR T programs Regulatory interactions increase confidence in moving forward with GMP master cell bank for SC451, nonclinical testing plan, and path to filing SC451 Investigational New Drug Application (IND) as early as 2026 The New England Journal of Medicine published positive 12-week clinical results of ongoing type 1 diabetes study with UP421, which demonstrate that Sana’s hypoimmune-modified pancreatic islet cells are safe and well-tolerated, survive, evade detection by the immune system, and produce insulin in the patient Next-generation in vivo CAR T product candidate, SG293, demonstrates deep B-cell depletion and immune reset with a single treatment in non-human primates; expect to file IND for SG293 in B-cell cancers and/or B-cell mediated autoimmune diseases as early as 2027 To focus resources on SC451 and SG293, suspended enrollment and further internal investment in allogeneic CAR T studies Raised aggregate gross proceeds of $115.8 million from sales of common stock through Sana’s at the market offering facility (ATM) and equity financing in the third quarter of 2025 Q3 2025 cash position of $153.1 million and $170.5 million pro forma cash balance including recent ATM activity; expected cash runway into late 2026 SEATTLE, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the third quarter 2025. Sana announced it will prioritize future development activity for SC451, a HIP-modified stem cell-derived pancreatic islet cell therapy for type 1 diabetes, and for SG293, an in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR. The company continues to see meaningful progress in its type 1 diabetes program, particularly in advancing SC451 toward an IND. In addition, Sana improved the potency and manufacturability of its next-generation in vivo CAR T product platform, and the company is incorporating these updates into SG293 and expects to file an IND for this program as early as 2027. The company has suspended development of its two allogeneic cell therapy CAR T programs – SC291 in B-cell mediated autoimmune diseases and SC262 in oncology. “Given our recent progress and the potentially transformative impact with SC451 in…Read full documentShow less
Announced increased focus on type 1 diabetes and in vivo CAR T programs Regulatory interactions increase confidence in moving forward with GMP master cell bank for SC451, nonclinical testing plan, and path to filing SC451 Investigational New Drug Application (IND) as early as 2026 The New England Journal of Medicine published positive 12-week clinical results of ongoing type 1 diabetes study with UP421, which demonstrate that Sana’s hypoimmune-modified pancreatic islet cells are safe and well-tolerated, survive, evade detection by the immune system, and produce insulin in the patient Next-generation in vivo CAR T product candidate, SG293, demonstrates deep B-cell depletion and immune reset with a single treatment in non-human primates; expect to file IND for SG293 in B-cell cancers and/or B-cell mediated autoimmune diseases as early as 2027 To focus resources on SC451 and SG293, suspended enrollment and further internal investment in allogeneic CAR T studies Raised aggregate gross proceeds of $115.8 million from sales of common stock through Sana’s at the market offering facility (ATM) and equity financing in the third quarter of 2025 Q3 2025 cash position of $153.1 million and $170.5 million pro forma cash balance including recent ATM activity; expected cash runway into late 2026 SEATTLE, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the third quarter 2025. Sana announced it will prioritize future development activity for SC451, a HIP-modified stem cell-derived pancreatic islet cell therapy for type 1 diabetes, and for SG293, an in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR. The company continues to see meaningful progress in its type 1 diabetes program, particularly in advancing SC451 toward an IND. In addition, Sana improved the potency and manufacturability of its next-generation in vivo CAR T product platform, and the company is incorporating these updates into SG293 and expects to file an IND for this program as early as 2027. The company has suspended development of its two allogeneic cell therapy CAR T programs – SC291 in B-cell mediated autoimmune diseases and SC262 in oncology. “Given our recent progress and the potentially transformative impact with SC451 in type 1 diabetes, as well as with our in vivo CAR T platform across a range of diseases, now is the time to concentrate our efforts in these programs,” said Steve Harr, President and CEO of Sana. “Our goal for SC451 in type 1 diabetes is a single treatment leading to normal blood glucose with no need for further insulin treatment or immunosuppression, and the past several quarters of clinical results, manufacturing progress, and regulatory developments have solidified our confidence that this is possible. Additionally, as we progress toward our goals of filing an IND and beginning our Phase 1 clinical trial next year, we believe now is the time to free up resources to invest in scaling this important therapy. Separately, we have increased the potency of in vivo CAR T platform, and based upon preclinical data, believe we have the opportunity to develop best-in-class therapies with a single treatment and no conditioning chemotherapy for a range of B-cell cancers and B-cell mediated autoimmune diseases. Based upon our momentum and given the resources required to fully exploit these opportunities, we have made the difficult decision to suspend our allogeneic CAR T programs, including SC291 and SC262. While these programs increased our confidence in our HIP platform, we believe the impact we can have for patients and shareholders is now greater with increased focus on SC451 and in vivo CAR T cells.” Recent Corporate Highlights Published positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression. UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into type 1 diabetes patients without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator. Results of the study through 6 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 at these timepoints, consistent with insulin secretion in response to a meal. 12-week PET-MRI scanning demonstrated islet cells at the transplant site. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection. The New England Journal of Medicine (NEJM) published a journal article titled “Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression” (DOI: 10.1056/NEJMoa2503822). The article discusses 12-week results from this study. NEJM also published an accompanying editorial that further describes both the Sana technology and progress in the field (DOI: 10.1056/NEJMe2507578). Sana and Uppsala University Hospital expect to report additional data from the IST, including longer-term follow-up. Advancing our focused pipeline across two platforms: Hypoimmune Platform – Type 1 diabetes – Sana continues pre-clinical development of SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy, which uses the same HIP technology as UP421. Sana has had multiple interactions with regulators over the past several months, including an FDA INTERACT meeting, the results of which increase confidence in moving forward with our HIP-edited master cell bank for GMP manufacturing and our nonclinical testing plan. Sana expects to file an IND and begin our Phase 1 clinical trial for SC451 as early as 2026. Fusogen Platform – In vivo CAR T cells – SG293 is the next-generation version of our prior SG299 product candidate and 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. Sana intends to explore SG293 in both B-cell cancers and B-cell mediated autoimmune diseases. The company expects to file an IND for SG293 as early as 2027. SC291 (HIP-modified CD19-directed allogeneic CAR T) in autoimmune diseases and SC262 (HIP-modified CD22-directed allogeneic CAR T) in oncology – Sana recently published in the journal Cell Stem Cell an article titled “Hypoimmune CD19 CAR T cells evade allorejection in patients with cancer and autoimmune disease,” which provides additional clinical data showing how HIP-modified cells avoid immune attack (doi.org/10.1016/j.stem.2025.07.009). Nevertheless, as the company seeks to further prioritize resources and follow promising data in the SC451 and fusogen programs, Sana has suspended enrollment and further internal investment in the respective Phase 1 trials. Raised aggregate gross proceeds of $133.2 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in the third and fourth quarters of 2025; expected cash runway into late 2026. Closed public offering in August 2025 of 24.3 million shares of Sana’s 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 Sana’s common stock. The gross proceeds from this offering were $86.3 million before deducting underwriting discounts and commissions and offering expenses. Raised gross proceeds of $29.5 million in the third quarter of 2025 and an additional $17.4 million in the fourth quarter of 2025 from sales of common stock through Sana’s ATM. Third Quarter 2025 Financial Results GAAP Results Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2025 were $153.1 million compared to $152.5 million as of December 31, 2024. The increase of $0.6 million was primarily driven by net proceeds from equity financings of $109.7 million and other cash inflows of $2.4 million, partially offset by cash used in operations of $111.2 million. Research and Development Expenses: For the three and nine months ended September 30, 2025, research and development expenses, inclusive of non-cash expenses, were $30.1 million and $97.1 million, respectively, compared to $53.2 million and $170.5 million for the same periods in 2024. The decreases of $23.1 million and $73.5 million for the three and nine months ended September 30, 2025 compared to the same periods in 2024, respectively, were primarily due to the portfolio prioritization announced in the fourth quarter of 2024, which resulted in lower research, laboratory, and clinical development costs, lower personnel-related costs, including non-cash stock-based compensation, and a decrease in facility and other allocated costs. Research and development expenses include non-cash stock-based compensation of $3.2 million and $12.0 million, respectively, for the three and nine months ended September 30, 2025, and $6.5 million and $19.5 million for the same periods in 2024. Research and Development Related Success Payments and Contingent Consideration: For the three and nine months ended September 30, 2025, Sana recognized non-cash expenses of $3.1 million and $15.3 million, respectively, compared to a non-cash gain of $5.5 million and a non-cash expense of $4.6 million for the same periods in 2024, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price. General and Administrative Expenses: General and administrative expenses for the three and nine months ended September 30, 2025, inclusive of non-cash expenses, were $10.3 million and $32.1 million, respectively, compared to $14.1 million and $46.8 million for the same periods in 2024. The decreases of $3.8 million and $14.7 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024 were primarily due to lower personnel-related costs, including non-cash stock-based compensation, due to a decrease in headcount in connection with the portfolio prioritization announced in the fourth quarter of 2024, and decreased legal and consulting fees. General and administrative expenses include non-cash stock-based compensation of $2.3 million and $7.1 million for the three and nine months ended September 30, 2025, respectively, compared to $4.3 million and $11.8 million for the same periods in 2024. Impairment of Long-Lived Assets: For the nine months ended September 30, 2025, non-cash impairment of long-lived assets was $44.6 million, compared to zero for the same period in 2024. The non-cash impairment, recorded in the second quarter of 2025, was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. Because of the increased availability of manufacturing capacity at third-party contract development and manufacturing organizations (CDMOs) for cell and gene therapy products as well as progress in understanding its near-term manufacturing needs, Sana expects to use CDMOs to meet its manufacturing needs at present and has suspended further build-out of internal manufacturing capabilities. Net Loss: Net loss for the three and nine months ended September 30, 2025 was $42.2 million, or $0.16 per share, and $185.3 million, or $0.75 per share, respectively, compared to $59.9 million, or $0.25 per share, and $217.7 million, or $0.95 per share, for the same periods in 2024. Non-GAAP Measures Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the nine months ended September 30, 2025 was $108.0 million compared to $153.1 million for the same period in 2024. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, costs related to the portfolio prioritizations in the fourth quarters of 2024 and 2023, and the purchase of property and equipment. Non-GAAP Net Loss: Non-GAAP net loss for the three and nine months ended September 30, 2025 was $39.0 million, or $0.15 per share, and $125.4 million, or $0.51 per share, respectively, compared to $64.7 million, or $0.27 per share, and $208.3 million, or $0.91 per share, for the same periods in 2024. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities, and non-cash impairment losses recorded in 2025. A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.” About Sana Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including with respect to the substance and timing of potential INDs, the commencement of clinical trials, and potential indications for and the potential impact of its product candidates; expectations with respect to the Company’s areas of focus and program prioritization; expectations with respect to the impact of regulatory interactions and the ability to move forward with the Company’s HIP-edited master cell bank for GMP manufacturing, nonclinical testing plan, and path to filing an IND for SC451; expectations with respect to the benefits of SG293, including with respect to B-cell depletion, immune reset, potency, cell-specific delivery, and manufacturability; expectations with respect to the Company’s allogeneic cell therapy CAR T platform and programs, including SC291 and SC262; the potential ability to develop best-in-class in vivo CAR T therapies with a single treatment and no conditioning chemotherapy for a range of B-cell cancers and B-cell mediated autoimmune diseases; the potential ability to deliver on our goal for SC451 in type 1 diabetes to be a single treatment leading to normal blood glucose with no need for further insulin treatment or immunosuppression; expectations regarding the timing, substance, significance, and impact of data from preclinical studies and clinical trials of the Company’s product candidates and technologies and an IST utilizing HIP-modified primary pancreatic islet cells, including expectations for reporting of additional data from the IST; expectations regarding the Company’s cash runway, investment in the Company’s pipeline, the Company’s allocation and prioritization of resources, and the potential impact for patients and shareholders; expectations regarding the use of CDMOs; and statements made by the Company’s President and Chief Executive Officer. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market, and social disruptions. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Quarterly Report on Form 10-Q dated November 6, 2025. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Investor Relations & Media: Nicole Keith [email protected] [email protected] Non-GAAP Financial Measures To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana’s management believes that these non-GAAP financial measures are helpful in understanding Sana’s financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sana’s management utilizes non-GAAP operating cash burn, non-GAAP research and development expense and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the company’s actual ongoing costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and certain one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity. Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provides investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies. These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Sana’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana’s business and make operating decisions. In addition, Sana’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana’s results from period to period and allows for greater transparency with respect to key financial metrics Sana uses in making operating decisions. The following are reconciliations of GAAP to non-GAAP financial measures:
Investor releaseQuarter not tagged2025-11-07Sana: Q3 Earnings Snapshot
Associated Press Finance
Sana: Q3 Earnings Snapshot
SEATTLE (AP) — SEATTLE (AP) — Sana Biotechnology Inc. (SANA) on Thursday reported a loss of $42.2 million in its third quarter. On a per-share basis, the Seattle-based company said it had a loss of 16 cents. Losses, adjusted for non-recurring costs, came to 15 cents per share. The results beat Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 18 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on SANA at https://www.zacks.com/ap/SANA
Investor releaseQuarter not tagged2025-08-12Sana: Q2 Earnings Snapshot
Associated Press Finance
Sana: Q2 Earnings Snapshot
SEATTLE (AP) — SEATTLE (AP) — Sana Biotechnology Inc. (SANA) on Monday reported a loss of $93.8 million in its second quarter. The Seattle-based company said it had a loss of 39 cents per share. Losses, adjusted for non-recurring costs, came to 16 cents per share. The results beat Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 20 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on SANA at https://www.zacks.com/ap/SANA
Investor releaseQuarter not tagged2025-08-12Sana Biotechnology Reports Second Quarter 2025 Financial Results and Business Updates
GlobeNewswire
Sana Biotechnology Reports Second Quarter 2025 Financial Results and Business Updates
Presented positive 6-month clinical results of ongoing type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression overcome immune recognition, while continuing to function and persist with stable C-peptide New England Journal of Medicine published positive 12-week clinical results of the type 1 diabetes study Recent FDA INTERACT meeting increases confidence in moving forward with GMP master cell bank for SC451 and in filing SC451 Investigational New Drug Application (IND) as early as 2026 Expect to file IND for SG299 in a B-cell related disease as early as 2026 Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases and VIVID trial for SC262 in relapsed/refractory B-cell malignancies; expect to report clinical data from both studies in 2025 Raised aggregate gross proceeds of approximately $105 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in July and August 2025; expected cash runway into the second half of 2026 Q2 2025 cash position of $72.7 million and pro forma Q2 2025 cash position of $177.2 million including gross proceeds from sales of common stock through the ATM and equity financing in July and August 2025 SEATTLE, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the second quarter 2025. “We are pleased with the progress with the type 1 diabetes program, including recent FDA feedback on our HIP-edited GMP master cell bank and non-clinical testing plan for SC451, positive UP421 6-month clinical results presented at an invited talk at the American Diabetes Association Annual Meeting and World Transplant Congress 2025, and UP421 3-month clinical results published in the New England Journal of Medicine,” said Steve Harr, Sana’s President and Chief Executive Officer. “Type 1 diabetes affects over 9 million people worldwide, and we are positioned to deliver on our goal of a broadly accessible single treatment with no immunosuppression leading to long-term normal blood glucose without exogenous insulin in patients with type 1 diabetes. We expect to file the IND for SC451 as early as next year, and we also look forward to continuing progress in the…Read full documentShow less
Presented positive 6-month clinical results of ongoing type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression overcome immune recognition, while continuing to function and persist with stable C-peptide New England Journal of Medicine published positive 12-week clinical results of the type 1 diabetes study Recent FDA INTERACT meeting increases confidence in moving forward with GMP master cell bank for SC451 and in filing SC451 Investigational New Drug Application (IND) as early as 2026 Expect to file IND for SG299 in a B-cell related disease as early as 2026 Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases and VIVID trial for SC262 in relapsed/refractory B-cell malignancies; expect to report clinical data from both studies in 2025 Raised aggregate gross proceeds of approximately $105 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in July and August 2025; expected cash runway into the second half of 2026 Q2 2025 cash position of $72.7 million and pro forma Q2 2025 cash position of $177.2 million including gross proceeds from sales of common stock through the ATM and equity financing in July and August 2025 SEATTLE, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the second quarter 2025. “We are pleased with the progress with the type 1 diabetes program, including recent FDA feedback on our HIP-edited GMP master cell bank and non-clinical testing plan for SC451, positive UP421 6-month clinical results presented at an invited talk at the American Diabetes Association Annual Meeting and World Transplant Congress 2025, and UP421 3-month clinical results published in the New England Journal of Medicine,” said Steve Harr, Sana’s President and Chief Executive Officer. “Type 1 diabetes affects over 9 million people worldwide, and we are positioned to deliver on our goal of a broadly accessible single treatment with no immunosuppression leading to long-term normal blood glucose without exogenous insulin in patients with type 1 diabetes. We expect to file the IND for SC451 as early as next year, and we also look forward to continuing progress in the rest of our pipeline. We have raised over $100 million in new capital since the end of the second quarter, strengthening our balance sheet and allowing us to continue to invest appropriately in moving our pipeline forward.” Recent Corporate Highlights Announced positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression. UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into type 1 diabetes patients without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator. Results of the study through 6 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. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection. Announced that the New England Journal of Medicine published a journal article titled “Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression” (DOI: 10.1056/NEJMoa2503822). The article discusses 12-week results from this study. Sana and Uppsala University Hospital presented 6-month data at the 85th Annual American Diabetes Association (ADA) Scientific Sessions and the World Transplant Congress 2025, and expect to report additional data from the IST, including longer-term follow-up, as the year progresses. Advancing our pipeline across multiple indications and modalities: Type 1 Diabetes – The clinical study of gene-modified primary islet cells (UP421) continues to evaluate safety, survival, and function of these cells. Sana continues pre-clinical development of SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy, and a recent FDA INTERACT meeting increases our confidence in moving forward with our HIP-edited master cell bank for GMP manufacturing and our non-clinical testing plan. Sana expects to file an IND for SC451 as early as 2026. Allogeneic CAR T cells – Sana is enrolling patients in both the GLEAM and VIVID trials and expects to share data in 2025. The GLEAM trial is a Phase 1 study evaluating SC291, a HIP-modified CD19-directed allogeneic CAR T cell therapy, in patients with B-cell mediated autoimmune diseases, including refractory systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The VIVID trial is a Phase 1 study evaluating SC262, a HIP-modified CD22-directed allogeneic CAR T cell therapy, in patients with relapsed and/or refractory B-cell malignancies who have received prior CD19-directed CAR T therapy. In vivo CAR T cells – SG299, which uses our fusogen platform, allows for cell-specific, in vivo delivery of various payloads. SG299 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 areas such as the liver and gonadal tissue. Sana shared data showing that an SG299 surrogate with another component can lead to deep B-cell depletion in non-human primates without the use of any lymphodepleting chemotherapy. Sana expects to file an IND for SG299 as early as 2026, and we look forward to developing it in a range of B-cell cancers and B-cell mediated autoimmune diseases. Raised aggregate gross proceeds of approximately $105 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in July and August 2025; expected cash runway into the second half of 2026 Closed public offering in August 2025 of 20.9 million shares of Sana’s common stock and pre-funded warrants to purchase 1.5 million shares of Sana’s common stock. The gross proceeds from this offering were $75.0 million before deducting underwriting discounts and commissions and estimated offering expenses. Raised gross proceeds of $29.5 million in July and August 2025 from sales of common stock through Sana’s ATM. Second Quarter 2025 Financial Results GAAP Results Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2025 were $72.7 million compared to $152.5 million as of December 31, 2024. The decrease of $79.8 million was primarily driven by cash used in operations of $81.8 million. Research and Development Expenses: For the three and six months ended June 30, 2025, research and development expenses, inclusive of non-cash expenses, were $29.8 million and $67.0 million, respectively, compared to $60.9 million and $117.3 million for the same periods in 2024.The decreases of $31.1 million and $50.3 million for the three and six months ended June 30, 2025 compared to the same periods in 2024, respectively, were primarily due to lower research, laboratory, and clinical development costs related to the portfolio prioritization announced in the fourth quarter of 2024, lower personnel-related, costs, including non-cash stock-based compensation, a decrease in facility and other allocated costs primarily due to the portfolio prioritization announced in the fourth quarter of 2024, and lower third-party manufacturing costs. Research and development expenses include non-cash stock-based compensation of $4.2 million and $8.8 million, respectively, for the three and six months ended June 30, 2025 and $7.1 million and $13.0 million for the same periods in 2024. Research and Development Related Success Payments and Contingent Consideration: For the three and six months ended June 30, 2025, Sana recognized non-cash expenses of $10.3 million and $12.2 million, respectively, compared to a non-cash gain of $27.9 million and a non-cash expense of $10.1 million for the same periods in 2024, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price. General and Administrative Expenses: General and administrative expenses for the three and six months ended June 30, 2025, inclusive of non-cash expenses, were $10.3 million and $21.8 million, respectively, compared to $16.4 million and $32.7 million for the same periods in 2024. The decreases of $6.1 million and $10.9 million for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024 were primarily due to lower personnel-related costs, including non-cash stock-based compensation, due to a decrease in headcount in connection with the portfolio prioritization announced in the fourth quarter of 2024, and decreased legal and consulting fees. General and administrative expenses include non-cash stock-based compensation of $2.4 million and $4.8 million for the three and six months ended June 30, 2025, respectively, compared to $4.3 million and $7.5 million for the same periods in 2024. Impairment of Long-Lived Assets: For the three and six months ended June 30, 2025, non-cash impairment of long-lived assets was $44.6 million, compared to zero for the same periods in 2024. The non-cash impairment was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. Because of the increased availability of manufacturing capacity at third-party contract development and manufacturing organizations (CDMOs) for cell and gene therapy products as well as progress in understanding our near-term manufacturing needs, we expect to use CDMOs to meet our manufacturing needs at present and have suspended further build-out of our internal manufacturing capabilities. Net Loss: Net loss for the three and six months ended June 30, 2025 was $93.8 million, or $0.39 per share, and $143.2 million, or $0.60 per share, respectively, compared to $50.3 million, or $0.21 per share, and $157.8 million, or $0.70 per share, for the same periods in 2024. Non-GAAP Measures Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the six months ended June 30, 2025 was $79.0 million compared to $104.6 million for the same period in 2024. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, costs related to the portfolio prioritization in the fourth quarter of 2024 that were paid in 2025, and the purchase of property and equipment. Non-GAAP Net Loss: Non-GAAP net loss for the three and six months ended June 30, 2025 was $38.9 million, or $0.16 per share, and $86.4 million, or $0.36 per share, respectively, compared to $74.2 million, or $0.32 per share, and $143.6 million, or $0.64 per share, for the same periods in 2024. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities, and non-cash impairment losses recorded in 2025. A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.” About Sana Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including with respect to the substance and timing of potential INDs and potential indications for its product candidates; expectations with respect to the impact of the FDA INTERACT meeting and feedback and the ability to move forward with the Company’s HIP-edited master cell bank for GMP manufacturing and non-clinical testing plan; the potential ability to deliver on our goal of a broadly accessible single treatment with no immunosuppression leading to long-term normal blood glucose without exogenous insulin in patients with type 1 diabetes; expectations regarding the timing, substance, significance, and impact of data from clinical trials of the Company’s product candidates and technologies and an IST utilizing HIP-modified primary pancreatic islet cells, including expectations for reporting of additional data from the IST; expectations regarding the Company’s cash runway and the potential impact of the Company’s fundraising activities, including with respect to investment in the Company’s pipeline; and statements made by the Company’s President and Chief Executive Officer. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market, and social disruptions. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Quarterly Report on Form 10-Q dated August 11, 2025. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Investor Relations & Media: Nicole Keith [email protected] [email protected] Non-GAAP Financial Measures To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana’s management believes that these non-GAAP financial measures are helpful in understanding Sana’s financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sana’s management utilizes non-GAAP operating cash burn, non-GAAP research and development expense and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the company’s actual ongoing costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and certain one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity. Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provides investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies. These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Sana’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana’s business and make operating decisions. In addition, Sana’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana’s results from period to period and allows for greater transparency with respect to key financial metrics Sana uses in making operating decisions. The following are reconciliations of GAAP to non-GAAP financial measures:

