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Jun 30, 2023
Sana Q2 2023 Earnings Report
Sana Biotechnology reported financial results and business highlights.
Key Takeaways
Sana Biotechnology reported its Q2 2023 financial results, highlighting the continued progress in their clinical programs, particularly the ARDENT trial for SC291 in B-cell malignancies, and the expectation of initial data from two clinical studies later in the year. The company's cash position is expected to support activities through multiple data readouts and last into 2025.
Continued enrollment in the ARDENT Phase 1 study evaluating SC291 in patients with B-cell malignancies, with initial data expected this year.
Expect initial data later this year from an investigator-sponsored trial with hypoimmune-modified primary human islet cells for type 1 diabetes patients.
Goal to submit INDs this year for both SC262 and SG299 in hematologic cancers.
Strengthened R&D leadership with the addition of Dr. Doug Williams as President of Research and Development and Dr. Gary Meininger as Chief Medical Officer.
Sana
Sana
Forward Guidance
Sana Biotechnology is focused on creating and delivering engineered cells as medicines for patients. They anticipate progress in their clinical programs, particularly the ARDENT trial for SC291 in B-cell malignancies, and the expectation of initial data from two clinical studies later in the year.
Positive Outlook
- Enrollment in the ARDENT Phase 1 study continued.
- SC291 has the potential to serve as clinical proof-of-platform for other hypoimmune-modified CAR T cell candidates using clinically-validated or commercially-approved CAR constructs in development at Sana for hematological malignancies, such as SC262 (CD22) and SC255 (BCMA).
- Sana expects initial data later this year from an investigator-sponsored trial transplanting hypoimmune-modified primary human islet cells into type 1 diabetes patients.
- Sana’s goal is to file an IND for SC451 in 2024.
- Hypoimmune-modified iPSCs were differentiated into pancreatic islet cells. Transplantation of hypoimmune-modified iPSC-derived pancreatic cells into allogeneic diabetic mice with a humanized immune system showed immune evasion after transplantation for the duration of the studies (4 weeks) and amelioration of diabetes and normalization of blood glucose levels.
Challenges Ahead
- The value of these potential liabilities may fluctuate significantly with changes in Sana’s market capitalization and stock price.
- Net loss for the three months ended June 30, 2023 was $114.0 million, or $0.59 per share
- The company's future performance is 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.
- The company's cash position decreased by $108.1 million compared to December 31, 2022.
- Research and Development Related Success Payments and Contingent Consideration: For the three months ended June 30, 2023, we recognized expenses of $26.7 million in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate, compared to gains of $17.9 million for the same periods in 2022.