Analyst Conference Summary

biotechnology

release date: November 2, 2022
for quarter ending: September 30, 2022 (third quarter, Q3)

Forward-looking statements

Overview: Sana expects filing its first IND with the FDA in 2022.

Basic data (GAAP):

Revenue was $0, flat sequentially from $0, and flat from $0 year-earlier.

Net Income was negative $85 million, down sequentially from negative $72 million, and down from negative $83 million year-earlier.

Earnings Per Share (EPS), diluted were negative $0.45, down sequentially from negative $0.39, and up from negative $0.46 year-earlier.

Guidance:

Cash runway into 2025

Conference Highlights:

Steve Harr, CEO, said: "For SC291, we expect to generate tumor response data and CAR T cell persistence data, which have the potential to highlight differentiation from current CAR T programs and provide generalizable insights on how preclinical results for our hypoimmune platform (HIP) will translate into patients. For SG295, our scientists have developed a second-generation process that is many times more potent and has the potential to lead to better efficacy, safety, and manufacturability. Given the promise and potential of this program, we will take more time to implement these changes and now expect to file the IND in 2023."

SC291 (HIP-modified CD19-targeted allogeneic CAR T) remains on track to file an IND in 2022. Preclinical data continue to highlight the potential for the HIP platform to hide our allogeneic cells from immune detection, creating the potential for longer CAR T cell persistence and higher durable complete response rates in cancer patients. Sana intends to study this therapy in a range of B cell malignancies and report data beginning next year.

SC451 is an islet cell product candidate for the treatment of type 1 diabetes has a goal of filing an IND in 2024.

SG295 is now planned for an IND in 2023. It uses retargeted fusosomes for in vivo delivery of genetic payloads to various cells, including CD8+ T cells, CD4+ T cells, and human hepatocytes.

SC276 (HIP-modified, CD22/CD19-targeted allogeneic CAR T) remains on track for an IND in 2023. Targets CD22 and/or CD19 expressing cells. Intended for patients with B cell malignancies who have either failed previous CAR T therapies or are naive to CAR T therapy.

In Q2 2022 Sana announced it would move its manufacturing plant from Fremont, CA to Bothell, WA, resulting in approximately $100 million in expected cost savings over the next three years. Sana signed a lease agreement to develop an approximately 80,000 square foot manufacturing facility in Bothell, WA. The facility will be designed to support the late-stage clinical and early commercial manufacturing of multiple product candidates across the portfolio.

At the end of the quarter cash and equivalents were $512 million, down sequentially from $580 million

Operating expenses were $86 million, consisting of: $77 million for R&D; $16 million for SG&A; offset by $6 million from R∧D success and contingent payments. Interest income was $1 million. Other expense $0.1 million.

Q&A:

none

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