Sana Biotechnology

Seattle cell-engineering company that raised ~$1.6B. After cutting its clinical CAR-T programs, it now bets on hypoimmune islet cells for type 1 diabetes, and its 10-Q carries a going-concern warning.

1. Core Product / Service

Sana was incorporated in Delaware on 2018-07-13 and launched publicly in January 2019 with about $700M [1][4]. It works on two engineering platforms:

Hypoimmune (HIP) gene edits, which let donor or iPSC-derived cells evade immune rejection without immunosuppression.
Fusosomes, which deliver genes in vivo. This platform came from the Cobalt Biomedicine acquisition in 2019.

Candidate	What it is	Stage (October 2026)
SC451	HIP-edited, iPSC-derived islet cells for type 1 diabetes	Pre-IND; filing described as "imminent" in September 2026 [5]
UP421	HIP-edited primary islet cells, run as an investigator-sponsored study in Uppsala	One patient with graft function at 14 months without immunosuppression (proof of concept) [2]
SG293	In vivo CD19 CAR-T delivered by fusosome	First human data slipped to 1H 2027 [5]
SG227	In vivo BCMA CAR-T	Clinic targeted mid-2027 [2]

In November 2025 Sana wound down its allogeneic CAR-T programs SC291 (autoimmune) and SC262 (oncology) [1].

2. Target Users & Pain Points

Patients: people with type 1 diabetes. Islet transplants work today but need lifelong immunosuppression; HIP-edited cells aim to remove that need.
Oncology and autoimmune patients: in vivo CAR-T would avoid autologous cell manufacturing and lymphodepletion.

3. Competitive Landscape

Player	Approach	Note
Vertex (zimislecel)	Stem-cell islets with immunosuppression	Most advanced competitor in T1D
CRISPR Therapeutics	Gene-edited islet cells	Earlier stage
lyell-immunopharma	Autologous CAR-T made in its own plant	Same 2018 ARCH cohort; opposite choice on manufacturing

4. Unique Observations

Wet lab and manufacturing: it built a plant, then walked away from it.
- In June 2022 Sana signed a 16-year lease on 79,565 sq ft of lab and manufacturing space in Bothell, WA [1].
- In 2025 it suspended the build-out, citing "increased availability of manufacturing capacity at third-party contract development and manufacturing organizations", and moved to sublease the site. It booked $44.6M of impairments, and construction in progress fell to zero [1].
- As of mid-2026 the Bothell lease (to 2039) had not been subleased [2].
- Manufacturing now goes to unnamed CDMOs. SC451 is "transferring technology to a contract manufacturer" [5].
- Sana still leases about 99,000 sq ft of lab and manufacturing space in South San Francisco, plus sites in Cambridge, MA and Seattle [1].
- Headcount was 142 at end-2025, 104 of them in R&D [1].
It pays more for facilities than for manufacturing. FY2025 R&D was $132.0M. "Facility and other allocated" costs were $46.0M of that, against only $7.6M for third-party manufacturing [1].
The market prices the islet option, not the cash. Sana has an accumulated deficit of about $2.0B and a going-concern warning in its Q2 2026 10-Q [2]. Its equity value in August 2026 was still roughly $0.9–1.2B, well above Lyell's, on the strength of the UP421 data.

5. Financials / Funding

Private rounds (2018–2020) [3], totalling $705.5M gross preferred:
- Series A-1: $45.9M
- Series A-2: $216.1M plus $7.9M
- Series B: $435.6M (June 2020)
IPO: February 2021, Nasdaq SANA, 27.0M shares at $25, $675.6M gross with the option exercised [3].
Follow-ons: $181.0M net (2024); $80.6M net offering (August 2025); Mayo Clinic bought $25M of stock (April 2026); ATM program [1][2].
Cash: $160.5M at 2026-06-30; the company guides runway into mid-2027 [2].

6. People & Relationships

Co-founder and CEO: Steven Harr (former Juno CFO) [1].
Co-founder: Hans Bishop (Juno founder; President of altos-labs).
CFO: Brian Piper (since February 2026) [2].
Investors: ARCH, Flagship, F-Prime, CPPIB, Baillie Gifford, GV, Bezos Expeditions; Mayo Clinic (strategic) [2][4].
Acquisitions: Cobalt Biomedicine, Cytocardia, Oscine.

Sources

[1] Sana Biotechnology, Form 10-K FY2025, SEC EDGAR, filed 2026-03-03 (accessed 2026-10-14)
[2] Sana Biotechnology, Form 10-Q for Q2 2026, SEC EDGAR, filed 2026-08-10 (accessed 2026-10-14)
[3] Sana IPO prospectus (424B4), 2021-02-05, and press release on IPO closing (accessed 2026-10-14)
[4] BioSpace, "Sana secures $700M in initial financing", January 2019 (accessed 2026-10-14)
[5] Sana at the Citi BioPharma summit, transcript via Investing.com, September 2026 (accessed 2026-10-14)