AI Analysis | Feedback

• Moderna, but for 'off-the-shelf' cell therapies designed to be invisible to the immune system.
• CRISPR Therapeutics, but focused on using gene editing to make therapeutic cells universally accepted by the body.

AI Analysis | Feedback

• SC291: An allogeneic chimeric antigen receptor (CAR) T cell therapy candidate for B-cell malignancies, designed for off-the-shelf use.
• SC451: An *in vivo* gene therapy program aimed at enabling immune protection for transplanted cells by expressing PD-L1.
• SC379: An *in vivo* gene therapy candidate targeting Type 1 Diabetes, designed to generate functional insulin-producing cells.
• SC412: An *in vivo* gene therapy candidate for Hypoparathyroidism, intended to restore parathyroid hormone production.

AI Analysis | Feedback

Sana Biotechnology (SANA) is a clinical-stage biotechnology company focused on developing and delivering engineered cells as medicines. As a clinical-stage company, it does not yet have commercial products approved for sale directly to individuals (patients) or healthcare providers. Therefore, it does not have "customers" in the traditional sense who purchase its products off the shelf.

Sana Biotechnology's revenue is primarily generated through strategic collaborations, licensing agreements, and grant funding. Based on its recent financial disclosures (e.g., 2023 10-K filing), its major customer and source of collaboration revenue is:

• Bayer AG (primarily through its subsidiary BlueRock Therapeutics). Bayer AG is a public company. Its symbol is BAYRY (traded as ADRs on the OTCPK in the U.S.) or BAYN (Frankfurt Stock Exchange). This collaboration represents a significant portion of Sana's revenue.

Sana also receives revenue from grant funding, such as from the California Institute for Regenerative Medicine (CIRM), which provides significant financial support for its research and development but is not a commercial customer purchasing products or services.

AI Analysis | Feedback

• FUJIFILM Holdings Corporation (TSE: 4901, OTC: FUJIY)

AI Analysis | Feedback

Steve Harr, MD President and Chief Executive Officer

Steve Harr is a co-founder of Sana Biotechnology and has served as its President and Chief Executive Officer since September 2018. Prior to co-founding Sana, Dr. Harr was the Chief Financial Officer and Head of Corporate Development for Juno Therapeutics, Inc., until its acquisition by Celgene Corporation in March 2018. He also co-founded JW Therapeutics Co. Ltd., a public cell therapy company in China, and was a member of its Board of Directors. Additionally, Dr. Harr served on the Board of Directors of Loxo Oncology, Inc. before its acquisition by Eli Lilly and Company in early 2019. Before his roles at Juno, he was a Managing Director and Head of Biotechnology Investment Banking at Morgan Stanley. He previously served as the Lead Biotech Research Analyst and Co-head of Global Healthcare Research at Morgan Stanley.

Susan Wyrick Acting Chief Financial Officer, Treasurer, and Principal Accounting Officer

Susan Wyrick has been promoted to Acting Chief Financial Officer, Treasurer, and Principal Accounting Officer. She previously served as Senior Vice President. Her experience in the biotech sector includes previous roles at Juno Therapeutics and OncoGenex Pharmaceuticals.

Gary Meininger, MD Executive Vice President and Chief Medical Officer

Gary Meininger is the Executive Vice President and Chief Medical Officer at Sana Biotechnology. Before joining Sana, Dr. Meininger served as Senior Vice President and Head of Clinical Development at Vertex Cell and Genetic Therapies (VCGT), where he oversaw all aspects of clinical development. His prior experience also includes more than eight years at Janssen, where he was Vice President, Franchise Medical Leader in the Cardiovascular-Metabolism Therapeutic Area, and leadership roles at Merck.

Dhavalkumar Patel, MD, PhD Executive Vice President and Chief Scientific Officer

Dhavalkumar Patel is the Executive Vice President and Chief Scientific Officer of Sana Biotechnology, joining in 2024. Before Sana, Dr. Patel served as Executive Vice President and Chief Scientific Officer of UCB, a multinational biopharmaceutical company, where his teams contributed to the registration of several medicines.

Snehal Patel Executive Vice President and Chief Technical Officer

Snehal Patel is the Executive Vice President and Chief Technical Officer at Sana Biotechnology. He brings extensive experience in leading roles in Technical Operations, Technology, and Quality Assurance across Biologics, Small Molecules, and Cell Therapy. Prior to Sana, he was the Global Head and Vice President for Cell Therapy at an undisclosed company.

AI Analysis | Feedback

1. Financial Instability and Dependence on Capital: As a pre-revenue company, Sana Biotechnology is entirely reliant on its existing cash reserves and its ability to secure additional capital to fund extensive research and development efforts, as well as ongoing clinical trials. This creates substantial financial risk, making the company vulnerable to market volatility and investor sentiment. Any setbacks in clinical trials or delays in regulatory approvals could severely hinder its ability to raise future funding. The company has a high cash burn rate, and analyses indicate a high probability of financial distress within 24 months.

2. Clinical Trial and Regulatory Uncertainty: Sana's cell engineering platforms are based on novel, unproven technologies, and there is no guarantee that they will result in approvable or marketable products. The process of preclinical and clinical testing is inherently unpredictable, and positive early results may not be indicative of success in later, larger studies. Bringing a product to market requires navigating extensive and complex regulatory hurdles, making it difficult to predict the timelines and costs involved. Additionally, stem cell-based product candidates carry potential safety risks, such as oncogenic transformations or other adverse effects from undifferentiated cells.

3. Rapid Technological Advancement and Competition: The field of engineered cell therapy is characterized by rapid innovation, with new technologies and approaches constantly emerging. Sana Biotechnology faces the risk that by the time its therapies reach the market, they may encounter competition from next-generation treatments with potentially improved efficacy or safety profiles. The scalability of its core allogeneic hypoimmune (HIP) technology also remains unproven, posing manufacturing and logistical challenges for widespread commercialization.

AI Analysis | Feedback

The rapid advancement and clinical validation of in vivo gene editing and delivery technologies by other companies present a clear emerging threat to Sana Biotechnology. Sana's core strategy includes its Fusogen-Enabled Delivery (FEND) and Gene Delivery Particle (GDLP) platforms, which aim to engineer cells in vivo by delivering genetic payloads to specific cell types such as T-cells and hematopoietic stem cells. Companies like Verve Therapeutics (VERV) and Beam Therapeutics (BEAM) are at the forefront of developing similar in vivo gene editing capabilities. Verve Therapeutics, for example, has recently demonstrated positive early human data for its in vivo base editing program (Heart-1 trial), showcasing the feasibility and potential efficacy of delivering genetic material directly into the body to edit target cells. While Verve's current focus is not directly competitive in Sana's immediate therapeutic areas, its success, and that of other companies developing robust in vivo delivery systems, validate and accelerate the broader technological landscape. If these or other emerging platforms prove to be superior, more efficient, or safer for delivering genetic material to the specific cell types Sana is targeting (e.g., T-cells for oncology or HSCs for inherited diseases), they could significantly undermine the differentiation and future market potential of Sana's in vivo cell engineering platforms by offering alternative, potentially more advanced, solutions to achieve similar therapeutic goals.

AI Analysis | Feedback

Sana Biotechnology (SANA) is focused on developing engineered cells as medicines, with their most advanced programs targeting Type 1 Diabetes and B-cell related diseases, including cancers and autoimmune conditions.

The addressable markets for Sana Biotechnology's main products and services are as follows:

• SC451 (Stem-cell derived pancreatic islet cell program for Type 1 Diabetes):
  • The global diabetes stem cell therapy market was valued at approximately USD 5.4 billion in 2024 and is projected to reach about USD 14.6 billion by 2034, exhibiting a compound annual growth rate (CAGR) of 10.8% during the forecast period from 2025 to 2034. North America is expected to hold a significant revenue share in this market.
• SG293 (In vivo CAR T program for B-cell related diseases, including B-cell cancers and autoimmune diseases):
  • For B-cell Cancers (CAR T Therapy): The global CAR T-cell therapy market size was estimated at USD 4.3 billion in 2024 and is projected to grow at a CAGR of 30.5% from 2025 to 2034. Another estimate places the global CAR T-Cell therapy market size at USD 15.75 billion in 2024, projected to surpass USD 223.9 billion by 2034, with North America holding 41% of the market share in 2024. The lymphoma segment within the CAR T-cell therapy market generated USD 2.4 billion in revenue in 2024. The global B-cell lymphoma market, which CAR T therapy targets, is calculated at USD 5.44 billion in 2025 and is forecasted to reach around USD 10 billion by 2034. The North American B-cell lymphoma market size was USD 1.98 billion in 2024 and is expanding at a CAGR of 7.15%.
  • For B-cell Mediated Autoimmune Diseases (Cell Therapy): The global autoimmune disease therapeutics market reached USD 79.76 billion in 2025 and is projected to reach USD 103.01 billion by 2030, with a CAGR of 5.25%. The global cell therapy market, which includes autoimmune diseases, was valued at USD 6.40 billion in 2024 and is projected to grow to USD 94.26 billion by 2032, exhibiting a CAGR of 40.15%.

AI Analysis | Feedback

1. Advancement and Potential Regulatory Progress of SC451 for Type 1 Diabetes (T1D): Sana Biotechnology is prioritizing SC451, a hypoimmune (HIP)-modified, stem cell-derived pancreatic islet cell therapy for Type 1 Diabetes. The company has reported positive clinical results from a related program (UP421) demonstrating the survival and function of hypoimmune-modified pancreatic islet cells without immunosuppression, which validates the platform for SC451. Sana expects to file an Investigational New Drug (IND) application for SC451 as early as 2026, which would enable the initiation of clinical trials and represent a significant step towards future commercialization and revenue generation.
2. Clinical Progression of SC291 for B-cell Mediated Autoimmune Diseases: Sana has strategically refocused SC291, a HIP-modified allogeneic CD19-directed CAR T cell therapy, towards B-cell mediated autoimmune diseases such as systemic lupus erythematosus and ANCA-associated vasculitis. The company anticipates reporting clinical data from the GLEAM trial for SC291 in B-cell autoimmune diseases in 2025. Positive clinical readouts could significantly advance this program, attracting further investment or partnerships, and moving it closer to market, thereby driving future revenue.
3. Development of In Vivo CAR T Programs, particularly SG293: Sana is advancing its in vivo CAR T program, with SG293 being a key candidate using CD8-targeted fusogen delivery of a CD19-directed CAR for B-cell cancers and/or B-cell mediated autoimmune diseases. Preclinical data for SG293 (also referred to as SG299 in some reports) has demonstrated deep B-cell depletion and immune reset in non-human primates. Sana expects to file an IND for SG293 as early as 2027. Continued progress in this innovative platform and subsequent entry into clinical trials would be a significant driver of future value and potential revenue.
4. Strategic Collaborations and Licensing Agreements: Sana Biotechnology has explicitly stated its intention to seek licensing partners for certain deprioritized programs, such as SC291 in oncology and its glial progenitor cell program. Successful execution of such partnerships could provide immediate revenue through upfront payments, research funding, and milestone payments, as well as future royalty streams, thereby contributing to the company's financial growth.

AI Analysis | Feedback

Share Repurchases

• Sana Biotechnology has not undertaken any significant share repurchase programs over the last 3-5 years.

Share Issuance

• In February 2021, Sana Biotechnology completed its initial public offering (IPO), raising approximately $675.6 million in gross proceeds, including the full exercise of the underwriters' option to purchase additional shares.
• The company closed an upsized public offering in February 2024, generating approximately $189.75 million in gross proceeds from the sale of common stock and pre-funded warrants.
• In August 2025, Sana Biotechnology priced another underwritten public offering of common stock and pre-funded warrants, with expected gross proceeds of approximately $75 million.

Inbound Investments

• Prior to its IPO, Sana Biotechnology raised a significant amount of capital, including a Series D round on June 25, 2020, which totaled $821 million from various investors.
• Before going public, the company had raised more than $700 million while privately held.

Outbound Investments

• Sana Biotechnology made a Later Stage VC investment in Repairon on January 1, 2021.

Capital Expenditures

• In the last 12 months leading up to November 2025, Sana Biotechnology reported capital expenditures of approximately -$501,000.
• The company has incurred and subsequently decreased costs related to its previously planned manufacturing facility in Fremont, California.