UNITY Biotechnology, Inc. Reports First Quarter 2024 Financial Results and Business Update

SOUTH SAN FRANCISCO, Calif., May 14, 2024 (GLOBE NEWSWIRE) — UNITY Biotechnology, Inc. [NASDAQ:UBX]a biotechnology company that develops therapies to slow, stop or reverse diseases of aging, today released financial results for the first quarter ended March 31, 2024.

“Our team remains focused on enrolling and executing our Phase 2b ASPIRE study in diabetic macular edema, comparing UBX1325 (foselutoclax) with aflibercept,” said Anirvan Ghosh, Ph.D., executive director of UNITY. “We were pleased not only to have been able to scale up our ASPIRE study to 50 patients as previously announced, but also to have been able to extend the study duration to 36 weeks in order to better evaluate the durability of UBX1325 compared to aflibercept after final dosing at week 16. Patients and providers could greatly benefit from UBX1325 as a potentially new treatment option, leveraging a new mechanism of action to help prevent or even reverse vision loss caused by diabetic macular edema.”

The Phase 2b ASPIRE study in DME is a multicenter, randomized, double-blind, active-controlled study designed to evaluate the safety and efficacy of UBX1325 compared to aflibercept. Approximately 50 individuals are expected to enroll, with 24 weeks of data expected in the first quarter of 2025 and 36 weeks of data expected in the second quarter of 2025. More information about ASPIRE (NCT06011798) can be found here.

Recent and upcoming milestones

• UBX1325 24-Week Safety and Efficacy Data from the Phase 2b ASPIRE DME Study Expected in Q1 2025

• UBX1325 36-Week Safety and Efficacy Data from the Phase 2b ASPIRE DME Study Expected in Q2 2025

First quarter financial results

Cash, cash equivalents and marketable securities totaled $38.3 million as of March 31, 2024, compared to $43.2 million as of December 31, 2023. UNITY believes that current cash, cash equivalents of cash and marketable securities are sufficient to finance operations in the third quarter of 2025.

Net loss for the three months ended March 31, 2024 was $5.8 million compared to $5.3 million for the three months ended March 31, 2023. Cash used in operations during the three months ended March 31, 2024 was $5.2 million compared to $11.3 million for the three months ended March 31, 2023.

Research and development expenses decreased by $2.1 million to $3.7 million for the three months ended March 31, 2024, from $5.8 million for the three months ended March 31, 2023 . The decrease was primarily due to reductions of $1.6 million in direct research and development expenses, primarily due to the completion of our UBX1325 BEHOLD and ENVISION studies, with sole emphasis on our UBX1325 ASPIRE, $0.4 study. million in facilities-related costs, primarily due to the sublease of our East Grand facility, and $0.1 million in personnel costs due to our reduced headcount and force reduction.

The story continues

General and administrative expenses decreased by $0.9 million to $3.9 million for the three months ended March 31, 2024, from $4.8 million for the three months ended March 31, 2023. The decrease was primarily due to reductions of $0.4 million in personnel-related expenses due to reductions in the Company’s headcount, partially, $0.3 million in professional fees and accounting services fees, and U.S. $0.2 million in operating costs, primarily from continued sublease income generated by the East Grand property.

About UNIT

UNITY is developing a new class of therapeutics to slow, halt or reverse diseases of aging. UNITY’s current focus is creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefits in age-related ophthalmological and neurological diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter It is LinkedIn.

Forward-looking statements

This press release contains forward-looking statements, including statements regarding UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, UNITY’s potential to develop therapeutics to slow, halt or reverse diseases of aging, including for diseases ophthalmological and neurological. diseases, the potential for UNITY to successfully initiate and complete clinical trials of UBX1325 for DME, AMD and other ophthalmic diseases, the expected timing of enrollment and results of clinical trials in UBX1325, and UNITY’s expectations regarding the sufficiency of its pipeline Of box. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including risks relating to delay or interruption in enrolling patients in clinical trials, risks related to the uncertainties inherent in the drug development process, and risks related to UNITY’s understanding of the biology of senescence. In fact, we may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events may differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, although we may choose to update these forward-looking statements at some point in the future, we have no current intention to do so, except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this release. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business generally, see UNITY’s most recent Quarterly Report on Form 10- Q for the quarter ended March 31, 2024, filed with the Securities and Exchange Commission on May 14, 2024, as well as such other documents as may be filed by UNITY from time to time with the Securities and Exchange Commission.

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Joyce Allaire
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