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UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates

1. UNITY expects 24-week data from Phase 2b ASPIRE study in Q1 2025. 2. UBX1325 could provide a novel treatment for diabetic macular edema. 3. Net loss decreased to $26 million in 2024, improving from 2023. 4. Company's cash reserves are sufficient to fund operations till Q4 2025. 5. Research expenses fell significantly, signaling cost control efforts.

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Positive anticipation of ASPIRE study data can drive market interest. Historical examples show that trial results impact biotech stock prices significantly.

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The article discusses critical upcoming data and financial health, which significantly affects investor sentiment and stock performance.

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SAN FRANCISCO, March 07, 2025 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today reported financial results for the fourth quarter and full year ended December 31, 2024. “We expect to receive 24-week topline data from our Phase 2b ASPIRE study in diabetic macular edema (DME) in this quarter,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “DME remains a significant unmet need, and we believe UBX1325 (foselutoclax) has the potential to provide a differentiated treatment option for patients who continue to experience vision loss despite current standard-of-care therapies. With its novel mechanism of action and durable therapeutic profile, UBX1325 could offer meaningful advantages over existing anti-VEGF treatments. The 24-week data as well as the 36-week data will be instrumental in shaping our plans for a potential pivotal trial and advancing our program.” UBX1325 (foselutoclax) is designed as a novel and durable therapeutic option in DME that acts via a senolytic mechanism of action, with the potential to address shortcomings of the current standard of care, such as high treatment burden and sub-optimal response to treatment. UNITY anticipates receiving 24-week primary endpoint data in the first quarter of 2025 and 36-week data in the second quarter of 2025. The Phase 2b ASPIRE study in DME is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in a head-to-head comparison to aflibercept. More information about ASPIRE (NCT06011798) can be found here. Fourth Quarter and Full Year Financial Results Cash, cash equivalents and marketable securities totaled $23.2 million as of December 31, 2024 compared with $43.2 million as of December 31, 2023. UNITY believes that current cash, cash equivalents and marketable securities are sufficient to fund operations into the fourth quarter of 2025. Net loss for the twelve months ended December 31, 2024 was $26.0 million compared to $39.9 million for the twelve months ended December 31, 2023. Cash used in operations during the year ended December 31, 2024 was $20.9 million compared to $37.1 million for the twelve months ended December 31, 2023. Total net loss for the fourth quarter of 2024 was $8.4 million compared to $4.3 million for the fourth quarter of 2023. Cash used in operations during the fourth quarter of 2024 was $5.9 million compared to $6.7 million for the fourth quarter of 2023. Research and development expenses decreased by $7.1 million, to $13.0 million for the year ended December 31, 2024 from $20.1 million for the year ended December 31, 2023. The decrease was primarily due to decreases of $3.5 million in personnel costs due to our reduced headcount and the reduction in force, $2.7 million in direct research and development expenses mainly due to the completion of our UBX1325 BEHOLD and ENVISION studies, and $0.9 million in facilities-related costs primarily due to the sublease of our East Grand facility. Research and development expenses decreased by $0.2 million, to $3.1 million for the fourth quarter of 2024 from $3.3 million for the fourth quarter of 2023. The decrease was due to decreases of $0.5 million in personnel-related costs due to reduced headcount, partially offset by a increase of $0.3 million in direct research and development expenses primarily due to the ongoing UBX1325 ASPIRE study. General and administrative expenses decreased by $3.5 million, to $15.5 million for the year ended December 31, 2024 from $19.0 million for the year ended December 31, 2023. The decrease was primarily due to decreases of $2.5 million in personnel costs due to our reduced headcount and reduction in force, $0.4 million in professional fees, and $0.6 million in facilities-related costs primarily due to the sublease of our East Grand facility. General and administrative expenses decreased by $0.1 million, to $4.3 million for the fourth quarter of 2024 from $4.4 million for the fourth quarter of 2023. The decrease was primarily due to decreases of $0.2 million in personnel-related costs due to lower headcount, partially offset by increases of $0.1 million in professional and consulting fees. About UNITYUNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on X and LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt, or reverse diseases of aging, including for ophthalmologic and neurologic diseases, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of enrollment and results of the clinical trials in UBX1325, and UNITY’s expectations regarding the sufficiency of its cash runway. 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 related to delay or disruption in the enrollment of patients in clinical trials, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY’s understanding of senescence biology. We may not actually 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 could 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, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing 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 further 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 business of the Company in general, see UNITY’s most recent Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 7, 2025, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.   Unity Biotechnology, Inc. Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts)     Three Months Ended  Year Ended   December 31,  December 31,   2024  2023  2024  2023   (Unaudited)       Operating expenses:            Research and development $3,035  $3,271  $13,006  $20,099 General and administrative  4,251   4,406   15,460   18,966 Impairment of long-lived assets  2,705   —   2,705   5,602 Total operating expenses  9,991   7,677   31,171   44,667 Loss from operations  (9,991)  (7,677)  (31,171)  (44,667)Interest income  309   525   1,733   2,874 Interest expense  —   —   —   (2,452)Gain on warrant liability  1,306   3,932   3,713   6,215 Other expense, net  (64)  (1,119)  (265)  (1,830)Net loss  (8,440)  (4,339)  (25,990)  (39,860)Other comprehensive gain (loss)            Unrealized gain (loss) on marketable debt securities  (24)  31   39   227 Comprehensive loss $(8,464) $(4,308) $(25,951) $(39,633)Net loss per share, basic and diluted $(0.50) $(0.28) $(1.54) $(2.70)Weighted-average number of shares used in computing net loss per share, basic and diluted  16,857,810   15,743,772   16,827,038   14,773,612  Unity Biotechnology, Inc. Condensed Balance Sheets (In thousands)     December 31,  December 31,   2024  2023 Assets      Current Assets:      Cash and cash equivalents $7,580  $19,803 Short-term marketable securities  15,650   23,398 Prepaid expenses and other current assets  1,037   3,404 Total current assets  24,267   46,605 Property and equipment, net  3,456   5,082 Operating lease right-of-use assets  8,900   12,981 Long-term restricted cash  896   896 Other long-term assets  143   126 Total assets $37,662  $65,690 Liabilities and Stockholders’ Equity      Current liabilities:      Accounts payable $997  $1,380 Accrued compensation  2,096   1,841 Accrued and other current liabilities  6,167   4,619 Total current liabilities  9,260   7,840 Operating lease liability, net of current portion  19,709   23,539 Warrant liability  2,199   5,913 Total liabilities  31,168   37,292 Commitments and contingencies      Stockholders’ equity:      Common stock  2   2 Additional paid-in capital  516,820   512,773 Accumulated other comprehensive gain  15   (24)Accumulated deficit  (510,343)  (484,353)Total stockholders’ equity  6,494   28,398 Total liabilities and stockholders’ equity $37,662  $65,690   Media Inizio Evoke CommsKatherine Smithkatherine.smith@inizioevoke.com Investor Contact LifeSci Advisors, LLCJoyce Allairejallaire@lifesciadvisors.com

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