UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2021 Financial Results and Business Updates
UNITY Biotechnology, Inc. (NASDAQ:UBX) reported its financial results for Q4 and the full year 2021, highlighting a refined pipeline strategy with a focus on UBX1325, designed to treat diabetic macular edema (DME) and age-related macular degeneration (AMD). The company posted a 2021 operating loss of $56.7 million, down from $93.9 million in 2020. Cash and equivalents stood at $90.1 million, expected to fund operations into Q1 2023. Upcoming milestones include Phase 2 safety and efficacy data for UBX1325 expected by mid and end of 2022.
- Decreased operating loss: $56.7 million in 2021 vs. $93.9 million in 2020.
- Cash balance of $90.1 million sufficient to fund operations into Q1 2023.
- Focus on UBX1325 showing promising preclinical data and Phase 1 results.
- Operating loss for Q4 2021 was $9.9 million, indicating ongoing financial challenges.
- Research and development expenses decreased significantly, reflecting reduced activity.
SOUTH SAN FRANCISCO, Calif., March 15, 2022 (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, 2021.
"In 2021, we sharpened the focus of our pipeline strategy and further underscored the therapeutic value of our lead candidate, UBX1325, a novel senolytic small molecule with disease-modifying potential, for the treatment of diabetic macular edema (DME) and age-related macular degeneration (AMD),” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “Supported by strong underlying biology as evidenced by preclinical data, and impressive results from our Phase 1 study in patients with DME or AMD, we believe UBX1325 has the potential to provide a meaningful therapeutic alternative to key ophthalmologic conditions beyond anti-VEGFs. Looking ahead, a key priority of 2022 will be to advance our Phase 2 proof-of-concept studies, and we are well positioned to deliver on exciting key milestones across our innovative ophthalmology clinical programs this year.”
Upcoming Milestones
- UBX1325 12-week safety and efficacy data from the Phase 2a DME study (UBX1325-02 Study) by mid-year 2022, as well as 24-week safety and efficacy data from that study before year-end 2022
- UBX1325 16-week safety and efficacy data from the Phase 2 wet AMD study (UBX1325-03 Study) before year-end 2022
- Tie2/VEGF bispecific preclinical data to support selection of advanced candidate by mid-year 2022
Fourth Quarter and Full Year Financial Results
Cash, cash equivalents and marketable securities totaled
Operating loss for the twelve months ended December 31, 2021 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, 2021, filed with the Securities and Exchange Commission on March 15, 2022, 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, | |||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||||||
| (Unaudited) | ||||||||||||||||||||
| Licensing revenue - Related Party | $ | 4,784 | $ | — | $ | 4,784 | $ | — | ||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | 9,579 | 13,091 | 38,393 | 67,309 | ||||||||||||||||
| General and administrative | 5,103 | 5,222 | 23,056 | 24,025 | ||||||||||||||||
| Change in fair value of contingent consideration | — | — | — | (33 | ) | |||||||||||||||
| Impairment of long-lived assets | — | 470 | — | 2,629 | ||||||||||||||||
| Total operating expenses | 14,682 | 18,783 | 61,449 | 93,930 | ||||||||||||||||
| Loss from operations | (9,898 | ) | (18,783 | ) | (56,665 | ) | (93,930 | ) | ||||||||||||
| Interest income | 18 | 103 | 100 | 1,196 | ||||||||||||||||
| Interest expense | (826 | ) | (793 | ) | (3,177 | ) | (1,292 | ) | ||||||||||||
| Other income (expense), net | 13 | (114 | ) | (983 | ) | 182 | ||||||||||||||
| Net loss | (10,693 | ) | (19,587 | ) | (60,725 | ) | (93,844 | ) | ||||||||||||
| Other comprehensive gain (loss) | ||||||||||||||||||||
| Unrealized loss on marketable debt securities | (49 | ) | (61 | ) | (49 | ) | (85 | ) | ||||||||||||
| Comprehensive loss | $ | (10,742 | ) | $ | (19,648 | ) | $ | (60,774 | ) | $ | (93,929 | ) | ||||||||
| Net loss per share, basic and diluted | $ | (0.18 | ) | $ | (0.37 | ) | $ | (1.09 | ) | $ | (1.84 | ) | ||||||||
| Weighted-average number of shares used in computing net loss per share, basic and diluted | 58,751,787 | 53,222,957 | 55,815,873 | 50,864,889 | ||||||||||||||||
Unity Biotechnology, Inc.
Condensed Balance Sheets
(In thousands)
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 32,905 | $ | 17,807 | ||||
| Short-term marketable securities | 55,170 | 79,892 | ||||||
| Prepaid expenses and other current assets | 1,879 | 3,167 | ||||||
| Restricted cash | 550 | — | ||||||
| Total current assets | 90,504 | 100,866 | ||||||
| Property and equipment, net | 9,942 | 12,627 | ||||||
| Operating lease right-of-use assets | 21,286 | 23,509 | ||||||
| Long-term marketable securities | 1,993 | 17,871 | ||||||
| Restricted cash | 896 | 1,446 | ||||||
| Other long-term assets | 91 | — | ||||||
| Total assets | $ | 124,712 | $ | 156,319 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,985 | $ | 2,558 | ||||
| Accrued compensation | 4,028 | 5,355 | ||||||
| Accrued and other current liabilities | 6,370 | 6,550 | ||||||
| Deferred revenue | 216 | — | ||||||
| Derivative liability related to debt | 963 | — | ||||||
| Current portion of long-term debt | 3,055 | — | ||||||
| Total current liabilities | 16,617 | 14,463 | ||||||
| Operating lease liability, net of current portion | 30,094 | 34,468 | ||||||
| Long-term debt, net | 18,409 | 24,508 | ||||||
| Other long-term liabilities | 23 | — | ||||||
| Total liabilities | 65,143 | 73,439 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock | 6 | 5 | ||||||
| Additional paid-in capital | 459,631 | 422,379 | ||||||
| Related party promissory notes for purchase of common stock | — | (210 | ) | |||||
| Accumulated other comprehensive gain | (44 | ) | 5 | |||||
| Accumulated deficit | (400,024 | ) | (339,299 | ) | ||||
| Total stockholders’ equity | 59,569 | 82,880 | ||||||
| Total liabilities and stockholders’ equity | $ | 124,712 | $ | 156,319 | ||||
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Jason Spark
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Investor Contact
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FAQ
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