UNITY Biotechnology, Inc. Reports First Quarter 2024 Financial Results and Business Updates
UNITY Biotechnology (NASDAQ: UBX) reported its Q1 2024 financial results and business updates on May 14, 2024. The company focuses on therapies to combat aging-related diseases. Significant progress was made in the Phase 2b ASPIRE study of UBX1325 for diabetic macular edema, expanding the study to 50 patients and extending it to 36 weeks for better efficacy assessment. Financials show cash equivalents of $38.3 million, with a net loss of $5.8 million, slightly higher than the $5.3 million in Q1 2023. Cash used in operations decreased significantly from $11.3 million to $5.2 million. R&D and G&A expenses also declined due to study completions, reduced headcount, and sublease income.
- Phase 2b ASPIRE study of UBX1325 expanded to 50 patients and extended to 36 weeks.
- 24-week and 36-week data from Phase 2b ASPIRE study expected in Q1 and Q2 2025, respectively.
- Cash used in operations decreased from $11.3 million to $5.2 million.
- Research & development expenses decreased by $2.1 million to $3.7 million.
- General & administrative expenses decreased by $0.9 million to $3.9 million.
- Net loss for Q1 2024 increased to $5.8 million from $5.3 million in Q1 2023.
- Cash, cash equivalents, and marketable securities decreased to $38.3 million from $43.2 million.
Insights
UNITY Biotechnology's financial results for Q1 2024 demonstrate a solid cash position with $38.3 million in cash, cash equivalents and marketable securities, which is sufficient to fund operations into Q3 2025. However, the
Investors should keep an eye on the Phase 2b ASPIRE study results, as these will significantly impact UNITY's valuation.
The Phase 2b ASPIRE study on UBX1325 (foselutoclax) for diabetic macular edema (DME) is a critical focus for UNITY. This trial, comparing UBX1325 to aflibercept, aims to validate a new mechanism of action to potentially reverse vision loss. Extending the study to 50 patients and increasing the duration to 36 weeks to assess UBX1325’s durability is a strategic move that could provide comprehensive efficacy data. If successful, UBX1325 could offer a differentiated treatment option, which is highly desirable in the ophthalmology market.
Key upcoming milestones include the 24-week and 36-week data in 2025, which will be pivotal in determining the drug's market potential and could significantly influence stock performance.
SOUTH SAN FRANCISCO, Calif., May 14, 2024 (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 first quarter ended March 31, 2024.
"Our team remains focused on the enrollment and execution of our Phase 2b ASPIRE study in diabetic macular edema, comparing UBX1325 (foselutoclax) against aflibercept," said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. "We were pleased to not only have been able to upsize our ASPIRE study to 50 patients as previously announced, but we also were able to extend the duration of the study to 36 weeks in order to better assess the durability of UBX1325 compared to aflibercept after final dosing at week 16. Patients and practitioners could benefit greatly from UBX1325 as a potentially new treatment option leveraging a new mechanism of action to help stave off or even reverse the vision loss from diabetic macular edema."
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 comparison to aflibercept. It is expected to enroll about 50 subjects, with 24-week data expected in the first quarter of 2025 and 36-week 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 the first quarter of 2025
- UBX1325 36-week safety and efficacy data from the Phase 2b ASPIRE DME study expected in the second quarter of 2025
First Quarter Financial Results
Cash, cash equivalents and marketable securities totaled
Net loss for the three months ended March 31, 2024 was
Research and development expenses decreased by
General and administrative expenses decreased by
About UNITY
UNITY 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 Twitter and LinkedIn.
Forward-Looking Statements
This 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 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 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 | |||||||
| March 31, | |||||||
| 2024 | 2023 | ||||||
| (Unaudited) | |||||||
| Operating expenses: | |||||||
| Research and development | 3,721 | 5,760 | |||||
| General and administrative | 3,878 | 4,798 | |||||
| Total operating expenses | 7,599 | 10,558 | |||||
| Loss from operations | (7,599 | ) | (10,558 | ) | |||
| Interest income | 513 | 855 | |||||
| Interest expense | — | (1,002 | ) | ||||
| Gain (loss) on warrant liability | 1,376 | 5,491 | |||||
| Other income (expense), net | (80 | ) | (65 | ) | |||
| Net loss | (5,790 | ) | (5,279 | ) | |||
| Other comprehensive gain (loss) | |||||||
| Unrealized gain (loss) on marketable debt securities | (14 | ) | 101 | ||||
| Comprehensive loss | $ | (5,804 | ) | $ | (5,178 | ) | |
| Net loss per share, basic and diluted | $ | (0.34 | ) | $ | (0.37 | ) | |
| Weighted-average number of shares used in computing net loss per share, basic and diluted | 16,785,090 | 14,312,887 | |||||
| Unity Biotechnology, Inc. | |||||||
| Condensed Balance Sheets | |||||||
| (In thousands) | |||||||
| March 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 7,430 | $ | 19,803 | |||
| Short-term marketable securities | 28,902 | 23,398 | |||||
| Prepaid expenses and other current assets | 2,187 | 3,404 | |||||
| Total current assets | 38,519 | 46,605 | |||||
| Property and equipment, net | 4,851 | 5,082 | |||||
| Operating lease right-of-use assets | 12,441 | 12,981 | |||||
| Long-term marketable securities | 1,952 | — | |||||
| Long-term restricted cash | 896 | 896 | |||||
| Other long-term assets | 204 | 126 | |||||
| Total assets | $ | 58,863 | $ | 65,690 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 1,398 | $ | 1,380 | |||
| Accrued compensation | 1,154 | 1,841 | |||||
| Accrued and other current liabilities | 5,180 | 4,619 | |||||
| Total current liabilities | 7,732 | 7,840 | |||||
| Operating lease liability, net of current portion | 22,606 | 23,539 | |||||
| Warrant liability | 4,537 | 5,913 | |||||
| Total liabilities | 34,875 | 37,292 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Common stock | 2 | 2 | |||||
| Additional paid-in capital | 514,167 | 512,773 | |||||
| Accumulated other comprehensive gain | (38 | ) | (24 | ) | |||
| Accumulated deficit | (490,143 | ) | (484,353 | ) | |||
| Total stockholders’ equity | 23,988 | 28,398 | |||||
| Total liabilities and stockholders’ equity | $ | 58,863 | $ | 65,690 | |||
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Investor Contact
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FAQ
What is UNITY Biotechnology's latest financial update for Q1 2024?
What progress has been made in the Phase 2b ASPIRE study?
When is the data from the Phase 2b ASPIRE study expected?
What were the changes in research and development expenses for UNITY in Q1 2024?
How did UNITY Biotechnology's cash used in operations change in Q1 2024?
