UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates
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Insights
The reporting of financial results by UNITY Biotechnology, Inc. represents a moment of transparency that permits investors to gauge the health of the company. The spotlight on the Phase 2b ASPIRE study and the expansion to 50 patients strengthens investor confidence, as it indicates a belief in the potential efficacy and differentiation of UBX1325 (foselutoclax). It's vital to note that financial and operational discipline, as mentioned by the CEO, suggests effective resource allocation which may provide resilience against market volatility.
Investors should pay attention to the burn rate, cash on hand and the timeline for clinical trials. These factors are critical in understanding the runway available to UNITY before requiring additional capital. Any delay or deviation in the trials could impact the stock due to the speculative nature of biotech investments, where market sentiment can sway significantly with clinical outcomes.
The progression of UBX1325 into a Phase 2b study for diabetic macular edema (DME) is a significant milestone. The comparison against aflibercept, an established standard of care, could either bolster the drug's profile or raise concerns on its efficacy. UBX1325's success in this study could lead to a paradigm shift in DME treatment, which would be a large market opportunity.
However, investors should be aware of the intrinsic risks associated with clinical trials. The data cited (BEHOLD) must translate into statistically significant results in larger, more definitive trials like ASPIRE. Efficacy and safety outcomes will be critical in determining the drug's regulatory path and market potential. Any setbacks could lead to volatility in UNITY's stock price.
SOUTH SAN FRANCISCO, Calif., April 15, 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 fourth quarter and full year ended December 31, 2023.
"On the heels of positive BEHOLD data, our team is currently single-mindedly 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. "I am pleased to note that thanks to the team’s financial and operational discipline we have been able to upsize our ASPIRE study to 50 patients to maximize the ability to differentiate UBX1325 from the current standard of care."
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 16-week data expected in the fourth quarter of 2024 and 24-week data expected in the first quarter of 2025. More information about ASPIRE (NCT06011798) can be found here.
Recent and Upcoming Milestones
- In January, the Company published new research in Nature Medicine, "Therapeutics targeting of cellular senescence in diabetic macular edema: preclinical and phase 1 trial results" discussing the potential of UBX1325 to target senescence cells and thereby leading to long-lasting, disease-modifying intervention for DME
- UBX1325 16-week safety and efficacy data from the Phase 2b ASPIRE DME study expected in the fourth quarter of 2024
- UBX1325 24-week safety and efficacy data from the Phase 2b ASPIRE DME study expected in the first quarter of 2025
Fourth Quarter and Full Year Financial Results
Cash, cash equivalents and marketable securities totaled
Net loss for the twelve months ended December 31, 2023 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 the risk that the COVID-19 worldwide pandemic may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or disrupting 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, 2023, filed with the Securities and Exchange Commission on April 15, 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 | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 (Restated) | 2023 | 2022 (Restated) | |||||||||||||
| (Unaudited) | ||||||||||||||||
| Licensing revenue - Related Party | $ | — | $ | — | $ | — | $ | 236 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,271 | 7,759 | 20,099 | 36,859 | ||||||||||||
| General and administrative | 4,406 | 5,280 | 18,966 | 20,949 | ||||||||||||
| Impairment of long-lived assets | — | — | 5,602 | — | ||||||||||||
| Total operating expenses | 7,677 | 13,039 | 44,667 | 57,808 | ||||||||||||
| Loss from operations | (7,677 | ) | (13,039 | ) | (44,667 | ) | (57,572 | ) | ||||||||
| Interest income | 525 | 804 | 2,874 | 1,220 | ||||||||||||
| Interest expense | — | (990 | ) | (2,452 | ) | (3,558 | ) | |||||||||
| Unrealized gain on warrant liability | 3,932 | 5,869 | 6,215 | 16,843 | ||||||||||||
| Other expense, net | (1,119 | ) | (66 | ) | (1,830 | ) | (1,402 | ) | ||||||||
| Net loss | (4,339 | ) | (7,422 | ) | (39,860 | ) | (44,469 | ) | ||||||||
| Other comprehensive gain (loss) | ||||||||||||||||
| Unrealized gain (loss) on marketable debt securities | 31 | 24 | 227 | (207 | ) | |||||||||||
| Comprehensive loss | $ | (4,308 | ) | $ | (7,398 | ) | $ | (39,633 | ) | $ | (44,676 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.28 | ) | $ | (0.52 | ) | $ | (2.70 | ) | $ | (4.68 | ) | ||||
| Weighted-average number of shares used in computing net loss per share, basic and diluted | 15,743,772 | 14,140,520 | 14,773,612 | 9,494,421 | ||||||||||||
| Unity Biotechnology, Inc. Condensed Balance Sheets (In thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 (Restated) | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 19,803 | $ | 12,736 | ||||
| Short-term marketable securities | 23,398 | 82,059 | ||||||
| Prepaid expenses and other current assets | 3,404 | 1,740 | ||||||
| Total current assets | 46,605 | 96,535 | ||||||
| Property and equipment, net | 5,082 | 7,825 | ||||||
| Operating lease right-of-use assets | 12,981 | 19,042 | ||||||
| Long-term restricted cash | 896 | 896 | ||||||
| Other long-term assets | 126 | 52 | ||||||
| Total assets | $ | 65,690 | $ | 124,350 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,380 | $ | 1,790 | ||||
| Accrued compensation | 1,841 | 3,020 | ||||||
| Accrued and other current liabilities | 4,619 | 5,334 | ||||||
| Current portion of long-term debt | — | 9,476 | ||||||
| Total current liabilities | 7,840 | 19,620 | ||||||
| Operating lease liability, net of current portion | 23,539 | 26,991 | ||||||
| Long-term debt, net | — | 10,891 | ||||||
| Warrant liability | 5,913 | 10,764 | ||||||
| Total liabilities | 37,292 | 68,266 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock | 2 | 1 | ||||||
| Additional paid-in capital | 512,773 | 500,827 | ||||||
| Accumulated other comprehensive gain | (24 | ) | (251 | ) | ||||
| Accumulated deficit | (484,353 | ) | (444,493 | ) | ||||
| Total stockholders’ equity | 28,398 | 56,084 | ||||||
| Total liabilities and stockholders’ equity | $ | 65,690 | $ | 124,350 | ||||
Media
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Jason Spark
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Investor Contact
LifeSci Advisors, LLC
Joyce Allaire
jallaire@lifesciadvisors.com
FAQ
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