COMPANY PROFILE / iPS CELLS & REGENERATIVE MEDICINE
Sana Biotechnology
A company narrowed to iPS-derived islet cells that "hide" from the immune system, and a delivery technology that makes CAR-T cells inside the body
Sana Biotechnology spans iPS cell and cell therapy and gene therapy that rewrites cells directly inside the body, with the former as its main business. Using "hypoimmune (HIP)" cells that are harder for the immune system to detect, it aims to transplant cells from another person without immunosuppressive drugs. Its lead programme is SC451, iPS-derived islet cells for type 1 diabetes. In November 2025 it stopped its own allogeneic CAR-T programmes and narrowed its focus to SC451 and a delivery technology that makes CAR-T cells inside the body (fusogen-based, candidate SG293). Cash and investments were US$160.5 million at the end of June 2026, but both the 10-K and the 10-Q state substantial doubt about the company's ability to continue as a going concern. This profile sets out what it makes, whom it works with, how far it has got and what remains unconfirmed, using only the company's statutory filings and ClinicalTrials.gov.
- Sana Biotechnology in 30 seconds, and where it stands in iPS cells and regenerative medicine
- The logo and how the name is written
- Where the company sits in iPS cells and regenerative medicine
- Scale
- Resources committed to iPS cells and regenerative medicine
- Track record so far
- Plans ahead
- What the company is aiming for in iPS cells and regenerative medicine
- Partnership map for iPS cells and regenerative medicine
- Technology, products and services on offer
- The risks this company carries
- Glossary, references and claim-to-source audit
1. Sana Biotechnology in 30 seconds, and where it stands in iPS cells and regenerative medicine
Gene therapy (secondary)Also has a membrane-fusion technology for in vivo delivery (fusogen)
modified to be hypoimmune (HIP)Aims for transplantation without immunosuppressive drugs
Cell transplantation for type 1 diabetes faces two walls: there are not enough donors, and patients must take immunosuppressive drugs for life so that the transplanted cells are not rejected. Sana's answer is two-stage: use iPS cells as the raw material (the supply wall) and add a modification that removes HLA molecules and over-expresses CD47 (HIP) (the rejection wall) Sourced. The idea was tested in humans in an investigator-initiated study in which islet cells from a deceased donor (UP421) were transplanted into the forearm muscle of one patient, and the company says the cells have survived and functioned for 14 months without immunosuppressive drugs. This is, however, the result of a single patient, and the dose was about 7% of what would be needed to make a patient insulin-independent. It is no guarantee of a therapeutic effect.
2. The logo and how the name is written
A note on names: the legal entity is Sana Biotechnology, Inc., a Delaware corporation. "SC451", "SG293", "UP421" and the like are development code names, not the names of approved drugs. UP421 was used in an investigator-initiated study run by Uppsala University Hospital and consists of islet cells from a deceased donor, not from iPS cells, with the HIP modification added. In this article "HIP" stands for hypoimmune.
Official site: https://sana.com/3. Where the company sits in iPS cells and regenerative medicine
Among companies that all use cells from another person, the way they deal with rejection differs. Sana's approach is to "hide" cells from the patient's immune system with a modification (HIP) that eliminates expression of the cell's HLA (tissue type) and over-expresses CD47 so that NK cells do not attack it. Related ideas are covered in our explainers on MHC and universal donors, iPS cells, cell therapy for diabetes, CAR-T cells, viral vectors and lipid nanoparticles.
4. Scale
This is a clinical-stage company, so the figures to watch are R&D spending and cash on hand rather than sales Sourced. Amounts are in US dollars. The company has no product sales or collaboration income.
| Metric (US$ million) | FY2024 (year to December 2024) | FY2025 (year to December 2025) | January to June 2026 |
|---|---|---|---|
| Research and development expense (excluding success-based payments and similar) | 215.7 | 132.0 | 59.4 |
| Change in R&D-related success-based payments and contingent consideration | (8.9) | 29.4 | 32.3 |
| General and administrative expense | 64.0 | 44.3 | 22.2 |
| Impairment of fixed assets | 1.9 | 44.6 | 0 |
| Net loss | – | (244.2) | (110.8) |
| Item | Detail | As of |
|---|---|---|
| Cash and investments (cash and marketable securities) | US$138.4 million | 31 December 2025 |
| Cash and investments (cash and marketable securities) | US$160.5 million | 30 June 2026 |
| Funding outlook (company) | Cash may not last more than a year from the filing date, creating substantial doubt about the company's ability to continue as a going concern | 10-K and 10-Q |
| Employees | 142 (104 in R&D; 83 with a master's degree, doctorate or similar) | 31 December 2025 |
| Accumulated deficit | About US$2.0 billion | 30 June 2026 |
The company states plainly that it needs to raise additional funds within the next 12 months, and says there is substantial doubt about its ability to continue as a going concern Sourced. In 2026 it received net proceeds of about US$68.6 million in the second quarter through its ATM (at-the-market share offering) and about US$25.0 million from an investment by the Mayo Clinic. The Mayo Clinic has an option to buy a further US$25.0 million or so, which had not been exercised when the 10-Q was filed. In the second quarter of 2025 it recorded impairments of about US$44.6 million on its manufacturing site and other assets, and it has shifted from its own plant to a set-up centred on a contract development and manufacturing organisation (CDMO).
5. Resources committed to iPS cells and regenerative medicine
We give amounts only where they have been disclosed, and write "not confirmed" where they have not.
| Type of resource | Detail | Category |
|---|---|---|
| People | 142 employees (end of December 2025): 104 in R&D and 83 with a master's degree, doctorate or similar | Sourced |
| Research and manufacturing sites | Seattle (headquarters; about 22,188 plus 25,898 square feet), South San Francisco (about 66,075 square feet; research and manufacturing) and Cambridge (about 24,386 square feet and more). The manufacturing facility at Bothell, Washington (about 79,565 square feet) was impaired in the second quarter of 2025 | Sourced |
| Money: R&D expense | US$132.0 million in FY2025 (US$215.7 million the year before). US$59.4 million in January to June 2026 | Sourced |
| Manufacturing | For SC451 it has completed a master cell bank and is transferring the Phase 1 clinical manufacturing process to a partner CDMO. The CDMO is not named | Sourced |
| In-licensing from outside | Harvard (March 2019), UCSF (January 2019), Washington University (November 2019 and September 2020), FCDI (February 2021; non-exclusive iPS cell lines), Beam (October 2021; Cas12b editing technology), NIH (January 2022; CD22 CAR), UCLA (March 2019; fusogen-related) and a Mayo Clinic affiliate (April 2026) | Sourced |
| Outside investments and acquisitions | Acquired Cobalt Biomedicine in February 2019 (36.4 million preferred shares, valued at US$136.0 million). This brought in the fusogen technology | Sourced |
| Investment from outside | In April 2026 the Mayo Clinic bought 7.5 million shares (US$3.33 each, about US$25.0 million). In August 2025 a public offering raised net proceeds of about US$80.6 million | Sourced |
| Universities and research institutions | Uppsala University Hospital (the investigator-initiated study of UP421). Harvard, UCSF and Washington University (patents) | Sourced |
| Public funding and grants | The 10-K lists no government grants (the relationship with NIH is a licence agreement only) | Not confirmed |
The 10-K explains that multiple genetic modifications are made at the pluripotent stem cell (PSC) stage and that a modified master cell bank has been completed Sourced. On the materials side, what matters is the quality of the media and growth factors that drive differentiation, the uniformity of the size of the cell aggregates (islet-like clusters), the cryopreservation medium, and an environment that supports survival at the transplant site. The UP421 transplant was into muscle, but this article cannot confirm the route of administration for SC451 or details of any device that encapsulates the cells Not yet confirmed.
6. Track record so far
The timeline is limited to what we could confirm in statutory filings and ClinicalTrials.gov.
| When | What happened | Why it matters |
|---|---|---|
| July 2018 | Incorporated in Delaware, headquartered in Seattle | A concept of turning engineered cells into medicines |
| January to March 2019 | Licensed hypoimmune-cell patents from UCSF (January) and Harvard (March). Acquired Cobalt Biomedicine in February | The foundation for HIP and the fusogen |
| November 2019 and September 2020 | Licensed hypoimmune-cell and beta-cell patents from Washington University | Patents for making islet cells |
| February and October 2021 | Licence for iPS cell lines from FCDI. Option and licence for editing technology (Cas12b) from Beam | Brought in iPS cells and an editing tool |
| January 2022 | Licensed patents for a CD22-targeting CAR from NIH | For B-cell malignancies |
| June 2022 | Leased a manufacturing facility of about 79,565 square feet in Bothell, Washington (initial term to February 2039) | The idea of its own plant (later impaired) |
| March and December 2024 | A study of HIP islet cells began at Uppsala University Hospital (March). In December, UP421 was transplanted into the forearm of one patient | The first attempt to test transplantation without immunosuppressive drugs in a human |
| January to September 2025 | Four-week results announced in January. Twelve-week data published in the New England Journal of Medicine in September | Published after external peer review |
| March 2025 | Shareholders filed a class action against the company and former executives (U.S. District Court in Seattle) | The outcome is not yet known |
| Q2 2025 | Impairments at the Bothell and Seattle facilities and elsewhere (about US$44.6 million) | A scaling back of in-house manufacturing |
| November 2025 | Stopped its allogeneic CAR-T programmes (SC291, SC262) and moved to end the GLEAM and VIVID trials. Concentrated on SC451 and SG293 | Narrowing of the business |
| January and May 2026 | Preclinical data in which surrogates of SG293 deeply depleted B cells in monkeys (January, May) | The preclinical basis for in vivo CAR-T |
| April 2026 | The Mayo Clinic invested about US$25.0 million and an affiliate took a licence to SC451 | Outside funding and expertise for islet cells |
| July 2026 | Fourteen-month follow-up of UP421 published in the New England Journal of Medicine | The long-term result for one patient |
7. Plans ahead
The detailed design of the SC451 Phase 1/2 trial (number of patients, route of administration, primary endpoint) is not stated in the primary sources as of this article Not yet confirmed.
None of the following is stated in the primary sources Not yet confirmed.
The specific start date and size of the SC451 trial; the date of the first SG293 dosing; the name of the contract manufacturer (CDMO); the manufacturing scale for each programme; the expected price; and the timing of approval. This article does not assert timing such as "approval will come at X".
8. What the company is aiming for in iPS cells and regenerative medicine
This chapter includes points the company does not state directly. We set out inferences that can be read from the primary sources, together with the grounds for each.
| What can be read from the sources | Primary-source basis | Category |
|---|---|---|
| The centre of gravity of the business has narrowed from allogeneic CAR-T to two pillars: islet cells and in vivo CAR-T | SC291 and SC262 were stopped in November 2025. In the 10-Q the lead programmes are SC451, SG293 and SG227 | Sourced |
| It is moving from in-house manufacturing to contract manufacturing | The Bothell manufacturing facility and others were impaired in Q2 2025. SC451 manufacturing is being transferred to a CDMO | Inference |
| The in vivo CAR-T approach is a counter-proposal to the limits of making cells in a factory | The 10-K explains that in vivo delivery can give the benefits of autologous CAR-T while avoiding conditioning chemotherapy and manufacturing complexity | Sourced |
| In islet cells an outside investor (the Mayo Clinic) is becoming more involved | The Mayo Clinic invested in April 2026 and an affiliate took a licence. Its use is limited to SC451 | Sourced |
| 2026 to 2027 is a year for reaching the clinic, not a year for approval | SC451 and SG293 are both expected to enter the clinic "as early as 2026". SG227 is mid-2027 at the earliest | Inference |
The evidence in humans that the company weighs most heavily is the result of transplanting deceased-donor islet cells with the HIP modification (UP421) into one patient Sourced. In that study, the transplanted cell population mixed unmodified cells, cells with only HLA removed, and HIP-modified cells, and the company reports that only the HIP cells escaped an immune response. We read these data as the core of the case for SC451's approach (adding HIP to iPS cells), and the company's explanation of its funding also depends on them. However, UP421 was not derived from iPS cells, involves a single patient (n=1) and used a small dose, so it has not been confirmed that SC451 will behave in the same way Not yet confirmed.
9. Partnership map for iPS cells and regenerative medicine
10. Technology, products and services on offer
There are no products yet. What the company offers is its development candidates, which are islet cells modified to be hypoimmune (HIP) and a delivery technology that makes CAR-T cells inside the body (fusosomes) Sourced.
| Programme | Description | Target | Stage (as of August 2026) |
|---|---|---|---|
| SC451 | iPS-derived islet cells with the HIP modification | Type 1 diabetes | Preclinical. The IND and start of a Phase 1/2 trial are described as "as early as 2026" |
| SG293 | A fusosome that reaches CD8-positive T cells (carries the gene for a CD19 CAR) | B-cell malignancies, autoimmune disease | Preclinical. Initial clinical data in non-Hodgkin lymphoma "as early as 2026" |
| SG227 | A fusosome that reaches CD8-positive T cells (carries the gene for a BCMA CAR) | Multiple myeloma | Clinical trial expected from mid-2027 at the earliest |
| UP421 (for reference) | HIP-modified islet cells from a deceased donor (Uppsala University Hospital) | Type 1 diabetes | Investigator-initiated study (NCT06239636). One patient transplanted. Planned enrolment 2 |
| SC291 / SC262 | HIP-modified allogeneic CAR-T | Autoimmune disease / oncology | Discontinued in November 2025. GLEAM (NCT06294236) stopped new enrolment |
What has been reported for UP421 (HIP-modified islet cells)
The cells were transplanted into the forearm of one patient, a 42-year-old with type 1 diabetes of more than 30 years' duration, in December 2024. No immunosuppressive drugs or steroids were used. The primary endpoint was safety, and the company states that no drug-related adverse events were reported and that C-peptide (a marker of insulin secretion), which was undetectable before transplantation, was detectable at 12 and 14 months and rose in a meal-tolerance test. The dose is described as "about 7% of the amount normally needed to become insulin-independent".
Important limitations: there was only one patient; the cells came from a deceased donor (not from iPS cells); it is not reported that blood glucose was normalised; and the observation period is up to 14 months Sourced.
HIP is a design of cell-surface molecules: removal of HLA class I and II and over-expression of CD47. The fusogen used in in vivo CAR-T is a virus-derived protein placed on the outer membrane of the carrier, which fuses with the target cell's membrane to deliver the contents, and surface proteins decide which cells it reaches (SG293 goes to CD8-positive T cells). On the materials and process side, the stability of the carrier, storage conditions, lot-to-lot reproducibility and the composition of the outer membrane govern quality Not yet confirmed. The company has not disclosed its control values, so this is a general discussion.
11. The risks this company carries
| Risk | Details | Category |
|---|---|---|
| Funding | Substantial doubt about its ability to continue as a going concern. Additional funds are needed within the next 12 months. Cash and investments were US$160.5 million at the end of June 2026 | Sourced |
| Clinical stage | All three lead programmes are preclinical. The only human evidence is one patient in UP421 (islet cells from a deceased donor) | Sourced |
| Translation to iPS-derived cells | It is unconfirmed whether the UP421 result applies directly to SC451 (iPS-derived) | Sourced |
| Transfer of manufacturing | It has impaired its own plant and is transferring technology to a CDMO. A delay in the transfer could delay entry to the clinic | Sourced |
| Class action | In March 2025 shareholders filed a class action against the company and former executives. The claims allege false or misleading statements about the business and outlook | Sourced |
| Burden of contingent consideration | Contingent consideration from the Cobalt acquisition (up to US$500.0 million) and success-based payments (up to US$500.0 million). The fair value of the contingent consideration at the end of June 2026 was US$150.8 million | Sourced |
| Competition | The 10-K says that many companies are working on cell and gene therapy, including islet cells and CAR-T | Sourced |
| Shrunken organisation | After the narrowing of the business and impairments in 2025, it is expected to execute on its two lead programmes | Inference |
12. Glossary
- HIP (hypoimmune)
- A modification that makes cells harder for the immune system to detect, by removing HLA class I and II and over-expressing CD47.
- Allogeneic
- Made from the cells or iPS cell lines of another person. Rejection by the immune system is the challenge.
- Islet (beta cell)
- A cell in the islets of the pancreas that produces insulin. In type 1 diabetes it is destroyed by the immune system.
- C-peptide
- A fragment made in the same amount as insulin. A marker of whether the body is making its own insulin.
- Fusogen / fusosome
- A virus-derived membrane-fusion protein (the fusogen), placed on a carrier such as a gene-therapy vector or a lipid vesicle, makes a fusosome. It is designed to suit the target cell.
- In vivo CAR-T
- A method in which, instead of modifying cells outside the body, an injected carrier delivers the CAR gene into T cells inside the body.
- Master cell bank
- A frozen store of a cell line whose quality has been checked.
- CDMO
- Contract development and manufacturing organisation, a company that develops and manufactures medicines under contract.
- IND
- Investigational New Drug application. The filing made to the FDA to begin a clinical trial in the U.S.
- Investigator-initiated study (IST)
- A clinical study run by a university or physicians, not by a pharmaceutical company.
- ATM
- At-the-market offering. A way of raising money by selling shares gradually at market prices.
- Going concern
- The assumption that a company can keep operating. Where there is substantial doubt, it is disclosed in a note to the financial statements.
13. References
- Sana Biotechnology Form 10-K for the year ended December 2025 (filed with the U.S. SEC on 3 March 2026). Business description, pipeline, collaborations, licences, finances, employees, facilities and going-concern doubt. https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm
- Sana Biotechnology Form 10-Q for the quarter ended 30 June 2026 (filed with the U.S. SEC on 10 August 2026). The agreement with the Mayo Clinic, the ATM, cash balance and pipeline updates. https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm
- U.S. National Library of Medicine ClinicalTrials.gov NCT06239636 (investigator-initiated study of the HIP-modified islet cells UP421, Uppsala University Hospital). https://clinicaltrials.gov/study/NCT06239636
- U.S. National Library of Medicine ClinicalTrials.gov NCT06294236 (SC291, Phase 1 trial GLEAM in autoimmune disease). https://clinicaltrials.gov/study/NCT06294236
- Sana Biotechnology Official website (used to check the logo and company overview). https://sana.com/
14. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Legal name (Sana Biotechnology, Inc.), head office location (Seattle), Nasdaq listing, incorporated in July 2018 | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm |
| 142 employees (104 in R&D, 83 with advanced degrees) | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm |
| Floor area and lease terms of the facilities (Seattle, South San Francisco, Cambridge and Bothell) | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm |
| R&D expense, G&A expense, impairment and net loss (FY2024 and FY2025) | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm |
| R&D expense and net loss for January to June 2026, cash and investments of US$160.5 million, accumulated deficit | Sourced | Reference 2 https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm |
| Cash and investments of US$138.4 million at the end of December 2025, and the going-concern doubt | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm |
| The need to raise additional funds within 12 months, and the going-concern doubt as of June 2026 | Sourced | Reference 2 https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm |
| The Mayo Clinic investment (April 2026, 7.5 million shares, US$3.33 each), the licence agreement and the option to buy more | Sourced | Reference 2 https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm |
| The ATM (up to US$150.0 million from March 2026; net US$68.6 million in the second quarter) and the August 2025 public offering (net US$80.6 million) | Sourced | Reference 2 https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm |
| Licence agreements with Harvard, UCSF, Washington University, FCDI, Beam, NIH and UCLA | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm |
| The acquisition of Cobalt Biomedicine (February 2019) and the contingent consideration and success-based payments | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm |
| The position of SC451, completion of the master cell bank, technology transfer to a CDMO, and the stated IND timing | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm |
| The UP421 transplant (December 2024), follow-up at 12 and 14 months, and the immune-response results for HIP cells | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm |
| Registration details of the UP421 investigator-initiated study (early Phase 1, planned enrolment 2) | Sourced | Reference 3 https://clinicaltrials.gov/study/NCT06239636 |
| Discontinuation of SC291 and SC262 (November 2025) and the halt to enrolment in the GLEAM trial | Sourced | References 1, 2 and 4 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm https://clinicaltrials.gov/study/NCT06294236 |
| SG293 preclinical data in monkeys, the clinical timing for SG227, and expected timing of SG293 clinical data | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm |
| Impairment of manufacturing facilities and other assets in Q2 2025 | Sourced | References 1 and 2 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm https://www.sec.gov/Archives/edgar/data/1770121/000119312526342395/sana-20260630.htm |
| The shareholder class action of March 2025 | Sourced | Reference 1 https://www.sec.gov/Archives/edgar/data/1770121/000119312526088215/sana-20251231.htm |
| The design of the SC451 trial (number of patients, route of administration, primary endpoint), the name of the CDMO, manufacturing scale, price and timing of approval | Not yet confirmed | Not stated in the primary sources. This article does not estimate them |
| National grants, and investments in start-ups | Not yet confirmed | Not mentioned in the 10-K. This article does not assert that they do not exist either |
| The reading that it is moving from in-house to contract manufacturing | Inference | This article's interpretation of the impairment disclosures and the technology transfer to a CDMO |
| The reading that 2026 to 2027 is a year for reaching the clinic, not for approval | Inference | This article's interpretation of the stated timing of entry to the clinic for each programme |
| The reading that the UP421 data are the core of the case for the SC451 approach | Inference | This article's interpretation of how much weight the 10-K gives to these data |
| The risk that execution is demanded after the narrowing of the business and impairments | Inference | This article's own interpretation |
| Materials challenges around differentiation, freezing and delivery | Not yet confirmed | A general discussion in this article. The company has not disclosed its control values |
Last updated 1 October 2026 / Troy Technical
Every figure in this article comes from the statutory filings Sana Biotechnology has made with the U.S. Securities and Exchange Commission (SEC) and from ClinicalTrials.gov. No research-firm estimates or press-based figures have been used. Passages marked "Inference" are this article's interpretation of the primary sources, not statements made by the company. This article does not recommend any particular treatment and is not medical advice.