On May 8, 2024 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the first quarter 2024 (Press release, Sana Biotechnology, MAY 8, 2024, View Source [SID1234642891]).
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"We have four ongoing clinical trials in seven indications, and we remain on track to share initial data from each of these studies in 2024," said Steve Harr, Sana’s President and Chief Executive Officer. "We strengthened our capital position with the financing in the first quarter, enabling us to share readouts from multiple clinical studies with our current balance sheet. 2024 is a year of execution at Sana with a goal of better understanding our hypoimmune platform, its potential to treat a number of prevalent diseases, and the impacts of clinical data on our longer-term plans."
Recent Corporate Highlights
Advancing four clinical programs across seven indications, including an allogeneic CAR T program targeting CD19+ cancers, an allogeneic CAR T program for B-cell mediated autoimmune diseases, an allogeneic CAR T program targeting CD22+ cancers, and a primary islet cell therapy in type 1 diabetes:
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SC291 is a hypoimmune (HIP)-modified CD19-directed allogeneic CAR T for patients with B-cell malignancies and B-cell mediated autoimmune diseases.
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The ARDENT trial evaluates SC291 in patients with B-cell malignancies. Early SC291 data from the ongoing ARDENT trial suggest the ability to dose safely, the desired immune evasion profile, and early clinical efficacy. Enrollment in this study continues, and Sana expects to share more data in 2024.
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The GLEAM trial evaluates SC291 in patients with B-cell mediated autoimmune diseases including lupus nephritis, extrarenal lupus, and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The trial has begun enrollment, and Sana expects to share initial data in 2024.
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The VIVID trial evaluates SC262, a HIP-modified CD22-directed allogeneic CAR T, in patients with relapsed or refractory B-cell malignancies. The VIVID trial initially investigates SC262 in patients who have received prior CD19-directed CAR T therapy. The trial has begun enrollment, and Sana expects to share initial data in 2024.
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UP421 is a primary human HIP-modified islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial is to understand survival and immune evasion of allogeneic islet cells in patients with autoimmunity and without immunosuppression. The Clinical Trial Application (CTA) cleared in 4Q 2023, and Sana expects to share initial data in the first half of 2024.
Published preclinical data in Cell Stem Cell demonstrating that HIP-modified allogeneic islet cells provided lasting endocrine function in a fully immunocompetent non-human primate with type 1 diabetes, enabling the achievement of exogenous insulin independence without immunosuppression for six-month study duration:
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Sana developed HIP-modified allogeneic islet cells, which cluster into effective endocrine organoids termed "pseudo islet grafts" (p-islets). HIP p-islets engrafted and provided stable endocrine function, enabling insulin independence without immunosuppression.
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The allogeneic HIP p-islet graft survived for the six-month duration of the study with no indication of immune recognition of the HIP p-islet engraftment at any time.
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To demonstrate that there was no regeneration or recovery of an endogenous islet cell population in the diabetic NHP, HIP p-islets were eliminated using an anti-CD47 antibody, demonstrating proof of principle of CD47 overexpression and a potential safety switch.
Completed financing with gross proceeds of approximately $189.8 million to further support activities to enable multiple data readouts:
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Closed on an upsized public offering in February 2024 of 21.8 million shares of Sana’s common stock, which includes the full exercise of the underwriter’s option, and pre-funded warrants to purchase 12.7 million shares of Sana’s common stock. The gross proceeds from this offering were approximately $189.8 million before deducting underwriting discounts and commissions and estimated offering expenses.
First Quarter 2024 Financial Results
GAAP Results
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Cash Position: Cash, cash equivalents, and marketable securities as of March 31, 2024 were $311.1 million compared to $205.2 million as of December 31, 2023. The increase of $105.9 million was primarily driven by net proceeds from equity financings of $181.5 million during the three months ended March 31, 2024, partially offset by cash used in operations of $65.6 million and cash used for the purchase of property and equipment of $15.8 million.
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Research and Development Expenses: For the three months ended March 31, 2024, research and development expenses, inclusive of non-cash expenses, were $56.4 million compared to $67.2 million for the same period in 2023. The decrease of $10.8 million was primarily due to lower personnel-related costs, including non-cash stock-based compensation, and laboratory costs due to a decrease in headcount related to the strategic repositioning in the fourth quarter of 2023, decreased research costs, and lower costs for third-party manufacturing at contract development and manufacturing organizations. These decreases were partially offset by increased clinical development costs. Research and development expenses include non-cash stock-based compensation of $5.8 million and $6.0 million for the three months ended March 31, 2024 and 2023, respectively.
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Research and Development Related Success Payments and Contingent Consideration: For the three months ended March 31, 2024, Sana recognized a non-cash expense of $38.0 million compared to $0.1 million for the same period in 2023, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuate significantly with changes in Sana’s market capitalization and stock price.
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General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2024, inclusive of non-cash expenses, were $16.3 million compared to $16.8 million for the same period in 2023. The decrease of $0.5 million was primarily due to lower personnel-related costs due to a decrease in headcount related to the strategic repositioning in the fourth quarter of 2023, and a decrease in costs related to Sana’s previously planned manufacturing facility in Fremont, California. These decreases were partially offset by an increase in patent and other legal fees. General and administrative expenses include non-cash stock-based compensation of $3.2 million and $2.8 million for the three months ended March 31, 2024 and 2023, respectively.
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Net Loss: Net loss for the three months ended March 31, 2024 was $107.5 million, or $0.49 per share, compared to $82.1 million, or $0.43 per share for the same period in 2023.
Non-GAAP Measures
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Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the three months ended March 31, 2024 was $58.7 million compared to $74.8 million for the same period in 2023. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, cash outflows from business development, non-recurring items, and the purchase of property and equipment.
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Non-GAAP Net Loss: Non-GAAP net loss for the three months ended March 31, 2024 was $69.5 million, or $0.32 per share, compared to $82.0 million, or $0.43 per share, for the same period in 2023. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities.