UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2018 Financial Results and Program Updates
“We ended 2018 in a strong position having made significant progress in our lead development programs,” said
Recent Highlights and Program Updates
Osteoarthritis – UBX0101
In
OA of the knee is believed to be a heterogeneous and multifactorial disease in which multiple SASP factors are implicated in pathogenesis. The Phase 1 study will evaluate the impact of UBX0101 on SASP factors (up to 24 in synovial fluid and up to 8 in plasma) believed to play a role in human OA. The factors were selected based on our Ph 0 OA biomarker study, pre-clinical data and an extensive literature review. These factors, which include cytokines and chemokines, proteases and protease inhibitors, and growth factors and adhesion molecules, will be measured for change from baseline to 12 weeks (in Part A) and baseline to 4 weeks (in Part B).
“As observed in diseases such as rheumatoid arthritis, the therapeutic suppression of just one factor has the ability to meaningfully alter the course of disease,” said
Ophthalmology – UBX1967
In
Corporate
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Fourth Quarter and Full Year 2018 Financial Results
Cash, cash equivalents and investments totaled $171.1 million as of December 31, 2018 compared with $91.6 million as of December 31, 2017.
Operating loss for the twelve months ended
Research and development expenses were
General and administrative expenses were
Estimated fair value of contingent consideration expense increased by
About UNITY
UNITY is developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging. UNITY's initial focus is on creating senolytic medicines to selectively eliminate senescent cells and thereby treat age-related diseases, such as osteoarthritis, eye diseases and pulmonary diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter.
Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to statements related to the expected timing for the data read out from our Phase 1 clinical study of UBX0101 and the filing of our next two INDs and our potential to bring medicines to market to treat age-related diseases and extend human healthspan. Such forward-looking statements involve substantial risks and uncertainties that could cause UNITY’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug discovery and development process, including UNITY’s early stage of development and our understanding of senescence biology and other fundamental biological processes associated with aging, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, UNITY’s ability to successfully protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations and the availability or commercial potential of UNITY’s product candidates. UNITY undertakes no obligation to update or revise any forward-looking statements. 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 recently filed Registration Statement on Form S-1 and any subsequent current and periodic reports filed with the
Unity Biotechnology, Inc. Condensed Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) |
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Three Months Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Contribution revenue | $ | — | $ | 1,382 | $ | — | $ | 1,382 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 16,331 | 11,592 | 58,907 | 37,373 | ||||||||||||
General and administrative | 4,328 | 2,577 | 16,016 | 9,617 | ||||||||||||
Fair value of contingent consideration | 2,149 | — | 4,542 | — | ||||||||||||
Total operating expenses | 22,808 | 14,169 | 79,465 | 46,990 | ||||||||||||
Operating loss | (22,808 | ) | (12,787 | ) | (79,465 | ) | (45,608 | ) | ||||||||
Interest income | 1,066 | 321 | 3,312 | 1,055 | ||||||||||||
Other expense, net | (175 | ) | (78 | ) | (245 | ) | (103 | ) | ||||||||
Net loss | (21,917 | ) | (12,544 | ) | (76,398 | ) | (44,656 | ) | ||||||||
Other comprehensive loss | ||||||||||||||||
Unrealized gain (loss) on marketable securities, net of tax | 24 | (100 | ) | 9 | (104 | ) | ||||||||||
Comprehensive loss | $ | (21,893 | ) | $ | (12,644 | ) | $ | (76,389 | ) | $ | (44,760 | ) | ||||
Net loss per share, basic and diluted | $ | (0.53 | ) | $ | (3.67 | ) | $ | (2.70 | ) | $ | (13.97 | ) | ||||
Weighted-average number of shares used in computing net loss per share, basic and diluted |
41,221,223 | 3,421,099 | 28,269,907 | 3,197,516 |
Unity Biotechnology, Inc. Condensed Balance Sheets (In thousands) |
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December 31, | December 31, | |||||||
2018 | 2017 | |||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 15,399 | $ | 7,298 | ||||
Contribution receivable | — | 1,382 | ||||||
Short-term marketable securities | 155,736 | 79,212 | ||||||
Prepaid expenses and other current assets | 1,830 | 988 | ||||||
Total current assets | 172,965 | 88,880 | ||||||
Property and equipment, net | 6,238 | 6,958 | ||||||
Long-term marketable securities | — | 5,118 | ||||||
Restricted cash | 550 | 550 | ||||||
Other long-term assets | 1,622 | 518 | ||||||
Total assets | $ | 181,375 | $ | 102,024 | ||||
Liabilities, convertible preferred stock, and stockholders' equity (deficit) |
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Current liabilities: | ||||||||
Accounts payable | $ | 4,847 | $ | 2,378 | ||||
Accrued compensation | 3,791 | 2,181 | ||||||
Accrued and other current liabilities | 4,990 | 3,338 | ||||||
Settlement liability | 2,059 | — | ||||||
Contingent consideration liability, current portion | 895 | — | ||||||
Total current liabilities | 16,582 | 7,897 | ||||||
Deferred rent, net of current portion | 2,467 | 3,166 | ||||||
Contingent consideration liability, net of current portion | 1,588 | — | ||||||
Other non-current liabilities | 45 | 118 | ||||||
Total liabilities | 20,682 | 11,181 | ||||||
Convertible preferred stock | — | 173,956 | ||||||
Stockholders' equity (deficit): | ||||||||
Common stock | 4 | 1 | ||||||
Additional paid-in capital | 324,663 | 4,072 | ||||||
Related party promissory notes for purchase of common stock |
(201 | ) | (202 | ) | ||||
Employee promissory notes for purchase of common stock |
(400 | ) | — | |||||
Accumulated other comprehensive loss | (95 | ) | (104 | ) | ||||
Accumulated deficit | (163,278 | ) | (86,880 | ) | ||||
Total stockholders' equity (deficit) | 160,693 | (83,113 | ) | |||||
Total liabilities, convertible preferred stock, and stockholders' equity (deficit) |
$ | 181,375 | $ | 102,024 | ||||
Investors & Media
650-443-6725
austine.graff@unitybiotechnology.com
Source: Unity Biotechnology, Inc.