UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates
"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
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
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
Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) |
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| Three Months Ended | Year Ended | |||||||||||||||
| 2023 | 2022 (Restated) | 2023 | 2022 (Restated) | |||||||||||||
| (Unaudited) | ||||||||||||||||
| Licensing revenue - |
$ | — | $ | — | $ | — | $ | 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 | ||||||||||||
Condensed Balance Sheets (In thousands) |
||||||||
| 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 | ||||
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Source: Unity Biotechnology, Inc.