UNITY Biotechnology, Inc. Reports Second Quarter 2019 Financial Results and Program Updates
"During the second quarter, we announced promising results from our Phase 1 study of UBX0101 in patients with OA of the knee. We believe these results provide strong support for the broad potential of our therapies directed against senescent cells," said
Recent Highlights and Program Updates
Osteoarthritis – UBX0101
In
UNITY recently announced plans to initiate a Phase 2 study of UBX0101 in patients with moderate-to-severe OA of the knee. The trial is expected to enroll approximately 180 patients with initiation expected in the fourth quarter of 2019 and initial 12-week results expected in the second half of 2020. UNITY also announced plans to study the safety, tolerability and initial effectiveness of both a new higher dose and repeat doses in a parallel Phase 1B study. Details of that study will be forthcoming.
Ophthalmology
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Alpha-Klotho
In
Second Quarter 2019 Financial Results
Cash, cash equivalents and investments totaled
Operating loss for the three months ended
Research and development expenses were
General and administrative expenses were
The change in estimated fair value of contingent consideration expense was
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: statements related to UNITY’s understanding of cellular senescence and the role cellular senescence plays in diseases of aging; UBX101’s potential to selectively eliminate senescent cells in patients with OA of the knee; the potential benefits, activity, effectiveness and safety of UBX0101; the design of UNITY’s planned Phase 2 OA trial; and timing of initiation of and data read out from UNITY’s Phase 2 OA trial; and UNITY’s ability to successfully complete ongoing pre-clinical studies of UBX1967 and UBX1325 and the potential timing of any future filings of any IND applications. 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. 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 recently filed Quarterly Report on Form 10-Q for the quarter ended
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 18,468 | 15,198 | 34,973 | 28,223 | ||||||||||||
| General and administrative | 4,970 | 3,842 | 9,447 | 7,299 | ||||||||||||
| Change in fair value of contingent consideration | 1,032 | 1,758 | (213 | ) | 1,758 | |||||||||||
| Total operating expenses | 24,470 | 20,798 | 44,207 | 37,280 | ||||||||||||
| Loss from operations | (24,470 | ) | (20,798 | ) | (44,207 | ) | (37,280 | ) | ||||||||
| Interest income (expense), net | 900 | 826 | 1,906 | 1,178 | ||||||||||||
| Other expense, net | (103 | ) | (30 | ) | (139 | ) | (33 | ) | ||||||||
| Net loss | (23,673 | ) | (20,002 | ) | (42,440 | ) | (36,135 | ) | ||||||||
| Other comprehensive loss | ||||||||||||||||
| Unrealized gain (loss) on marketable securities, net of tax | 94 | 61 | 208 | 27 | ||||||||||||
| Comprehensive loss | $ | (23,579 | ) | $ | (19,941 | ) | $ | (42,232 | ) | $ | (36,108 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.56 | ) | $ | (0.76 | ) | $ | (1.00 | ) | $ | (2.41 | ) | ||||
| Weighted-average number of shares used in computing net loss per share, basic and diluted |
42,442,886 | 26,298,666 | 42,311,040 | 15,003,493 | ||||||||||||
Condensed Balance Sheets
(In thousands)
| June 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 23,113 | $ | 15,399 | ||||
| Short-term marketable securities | 104,889 | 155,736 | ||||||
| Prepaid expenses and other current assets | 2,775 | 1,830 | ||||||
| Tenant improvement receivable | 10,650 | — | ||||||
| Total current assets | 141,427 | 172,965 | ||||||
| Property and equipment, net | 5,658 | 6,238 | ||||||
| Long-term marketable securities | 4,040 | — | ||||||
| Restricted cash | 1,446 | 550 | ||||||
| Other long-term assets | 1,639 | 1,622 | ||||||
| Total assets | $ | 154,210 | $ | 181,375 | ||||
| Liabilities, convertible preferred stock, and stockholders' equity |
||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,381 | $ | 4,847 | ||||
| Accrued compensation | 2,741 | 3,791 | ||||||
| Accrued and other current liabilities | 4,840 | 4,990 | ||||||
| Settlement liability | — | 2,059 | ||||||
| Contingent consideration liability | 2,270 | 895 | ||||||
| Total current liabilities | 15,232 | 16,582 | ||||||
| Deferred rent, net of current portion | 11,921 | 2,467 | ||||||
| Contingent consideration liability, net of current portion | - | 1,588 | ||||||
| Other non-current liabilities | 7 | 45 | ||||||
| Total liabilities | 27,160 | 20,682 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 4 | 4 | ||||||
| Additional paid-in capital | 333,252 | 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 | 113 | (95 | ) | |||||
| Accumulated deficit | (205,718 | ) | (163,278 | ) | ||||
| Total stockholders' equity | 127,050 | 160,693 | ||||||
| Total liabilities, convertible preferred stock, and stockholders' equity |
$ | 154,210 | $ | 181,375 | ||||
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Source: Unity Biotechnology, Inc.