Full Press Release Details
SAN FRANCISCO, May 08, 2019 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today reported first quarter 2019 financial results.
UNITY also announced the last study visit for the last subject enrolled in the Phase 1 study of UBX0101 in patients with osteoarthritis of the knee occurred in April 2019. UNITY remains on track to report initial study results in the second quarter of 2019.
"We continue to make solid progress across our preclinical pipeline including advancing our first clinical candidate for ophthalmologic indications towards an IND filing early next year," said Keith Leonard, chairman and chief executive officer of UNITY. “We look forward to reporting data during the second quarter from our Phase 1 study. This is an important step in assessing the role that a senolytic agent may play in the treatment of osteoarthritis.”
First Quarter Financial Results
Cash, cash equivalents and investments totaled $150.2 million as of March 31, 2019 compared with $171.1 million as of December 31, 2018.
Operating loss for the three months ended March 31, 2019 was $19.7 million compared with $16.5 million for the same period in 2018. Cash used for operations during the first quarter of 2019 was $20.6 million.
Research and development expenses were $16.5 million during the first quarter of 2019 compared with $13.0 million for the first quarter of 2018. The increase was attributable to an increase in personnel-related expenses of $1.5 million, $2.1 million for direct research and development activities and $0.1 million for facilities-related costs. The increase was partially offset by $0.2 million decrease in consulting expenses.
General and administrative expenses were $4.5 million during the first quarter of 2019 compared with $3.5 million for the first quarter of 2018. The increase was predominantly due to $1.5 million in personnel-related expenses, of which $0.6 million was related to non-cash stock-based compensation expense. This was partially offset by a decrease of $0.4 million in professional fees.
The change in estimated fair value of contingent consideration expense of $1.2 million during the first quarter of 2019 was driven by the decrease in stock price from December 31, 2018.
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, progress in our preclinical pipeline, timing for filing an IND application for ophthalmologic indications, 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 most recent Annual Report on Form 10-K and any subsequent current and periodic reports filed with the Securities and Exchange Commission.
Unity Biotechnology, Inc.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2019 | 2018 | |||||||
| Operating expenses: | ||||||||
| Research and development | 16,505 | 13,025 | ||||||
| General and administrative | 4,477 | 3,457 | ||||||
| Fair value of contingent consideration | (1,245 | ) | — | |||||
| Total operating expenses | 19,737 | 16,482 | ||||||
| Operating loss | (19,737 | ) | (16,482 | ) | ||||
| Interest income | 1,006 | 352 | ||||||
| Other expense, net | (36 | ) | (3 | ) | ||||
| Net loss | (18,767 | ) | (16,133 | ) | ||||
| Other comprehensive loss | ||||||||
| Unrealized gain (loss) on marketable securities, net of tax | 114 | (34 | ) | |||||
| Comprehensive loss | $ | (18,653 | ) | $ | (16,167 | ) | ||
| Net loss per share, basic and diluted | $ | (0.44 | ) | $ | (4.69 | ) | ||
| Weighted-average number of shares used in computing net loss per share, basic and diluted | 42,190,457 | 3,437,345 |
Unity Biotechnology, Inc.
Condensed Balance Sheets
| March 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 34,249 | $ | 15,399 | ||||
| Short-term marketable securities | 115,949 | 155,736 | ||||||
| Prepaid expenses and other current assets | 1,642 | 1,830 | ||||||
| Total current assets | 151,840 | 172,965 | ||||||
| Property and equipment, net | 5,880 | 6,238 | ||||||
| Restricted cash | 1,446 | 550 | ||||||
| Other long-term assets | 1,631 | 1,622 | ||||||
| Total assets | $ | 160,797 | $ | 181,375 | ||||
| Liabilities, convertible preferred stock, and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,071 | $ | 4,847 | ||||
| Accrued compensation | 1,674 | 3,791 | ||||||
| Accrued and other current liabilities | 4,920 | 4,990 | ||||||
| Settlement liability | - | 2,059 | ||||||
| Contingent consideration liability, current portion | 446 | 895 | ||||||
| Total current liabilities | 11,111 | 16,582 | ||||||
| Deferred rent, net of current portion | 2,265 | 2,467 | ||||||
| Contingent consideration liability, net of current portion | 792 | 1,588 | ||||||
| Other non-current liabilities | 26 | 45 | ||||||
| Total liabilities | 14,194 | 20,682 | ||||||
| Convertible preferred stock | — | — | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 4 | 4 | ||||||
| Additional paid-in capital | 329,226 | 324,663 | ||||||
| Related party promissory notes for purchase of common stock | (201 | ) | (201 | ) | ||||
| Employee promissory notes for purchase of common stock | (400 | ) | (400 | ) | ||||
| Accumulated other comprehensive loss | 19 | (95 | ) | |||||
| Accumulated deficit | (182,045 | ) | (163,278 | ) | ||||
| Total stockholders' equity | 146,603 | 160,693 | ||||||
| Total liabilities, convertible preferred stock, and stockholders' equity | $ | 160,797 | $ | 181,375 |