UNITY Biotechnology, Inc. Reports Third Quarter 2022 Financial Results and Business Updates
UNITY Biotechnology reported positive results from the Phase 2 BEHOLD study of UBX1325 for treating Diabetic Macular Edema, showing a 7.6-letter improvement in BCVA after 24 weeks. The drug demonstrated a favorable safety profile. UNITY's financial position improved, with cash and equivalents totalling $103.9 million as of September 30, 2022. This funding is expected to support operations into Q1 2024. A reduction in operating loss to $13.1 million, down from $14.8 million, reflects enhanced efficiency in operations.
- Positive 24-week data from Phase 2 BEHOLD study showing 7.6-letter improvement in BCVA.
- Favorable safety profile of UBX1325.
- Cash and equivalents increased to $103.9 million, sufficient to fund operations into Q1 2024.
- Reduced operating loss to $13.1 million from $14.8 million year-over-year.
- None.
- Announced positive 24-week data in Phase 2 BEHOLD Study of UBX1325 in Patients with Diabetic Macular Edema; single injection led to statistically significant and clinically meaningful improvement in BCVA with favorable safety profile through six months -
- 16-Week Data from Phase 2 ENVISION Study in wet Age-Related Macular Degeneration Expected in First Quarter of 2023 -
- As of September 30, 2022, UNITY had approximately
SOUTH SAN FRANCISCO, Calif., Nov. 08, 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 third quarter ended September 30, 2022.
“In the third quarter, we reported positive results from the Phase 2 BEHOLD study in patients with DME and strengthened our financial resources, which we believe will carry us through key value-driving milestones for our rapidly advancing lead program, UBX1325,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “The impressive 24-week results from BEHOLD demonstrate that a single injection of UBX1325, in addition to showing a favorable safety and tolerability profile, led to a statistically significant and clinically relevant improvement in Best Corrected Visual Acuity (BCVA) of 7.6 ETDRS letters compared to sham treatment, maintained stabilization of retinal structure, and improved the proportion of rescue-free patients compared to the sham-treated arm. These results, together with the growing dataset, position UBX1325 as a potential transformative, first-in-class and best-in-disease therapy, and underscore the opportunity for clinical utility of our senolytic approach. We look forward to further evaluating the durability of treatment effect through 48 weeks with our long-term extension of the BEHOLD study, with data expected in the second quarter of 2023. In parallel, we remain on track to report 16-week data from our Phase 2 ENVISION study in wet Age-Related Macular Degeneration (AMD) in the first quarter of 2023.”
Upcoming Milestones
- 16-week safety and efficacy data from Ph2 ENVISION study in wet AMD expected in Q1 2023
- 48-week long-term extension data from Ph2 BEHOLD study in DME expected in Q2 2023
- Full 24-week safety and efficacy data from Ph2 ENVISION study in wet AMD expected in Q2 2023
- 48-week long-term extension study data from Ph2 ENVISION study in wet AMD expected in Q4 2023
Third Quarter Financial Results
Cash, cash equivalents and marketable securities totaled
Operating loss for the three months ended September 30, 2022, 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 the 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 UNITY in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the Securities and Exchange Commission on November 8, 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
(Unaudited)
(In thousands, except share and per share amounts)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Licensing revenue - related party | $ | — | $ | — | $ | 236 | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 8,208 | 9,081 | 28,222 | 28,815 | ||||||||||||
| General and administrative | 4,922 | 5,747 | 15,669 | 17,952 | ||||||||||||
| Total operating expenses | 13,130 | 14,828 | 43,891 | 46,767 | ||||||||||||
| Loss from operations | (13,130 | ) | (14,828 | ) | (43,655 | ) | (46,767 | ) | ||||||||
| Interest income | 329 | 20 | 416 | 82 | ||||||||||||
| Interest expense | (866 | ) | (792 | ) | (2,568 | ) | (2,351 | ) | ||||||||
| Other income (expense), net | (41 | ) | (850 | ) | 49 | (996 | ) | |||||||||
| Net loss | (13,708 | ) | (16,450 | ) | (45,758 | ) | (50,032 | ) | ||||||||
| Other comprehensive (loss) gain | ||||||||||||||||
| Unrealized loss on marketable debt securities | (87 | ) | — | (230 | ) | — | ||||||||||
| Comprehensive loss | $ | (13,795 | ) | $ | (16,450 | ) | $ | (45,988 | ) | $ | (50,032 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.36 | ) | $ | (2.97 | ) | $ | (5.77 | ) | $ | (9.13 | ) | ||||
| Weighted-average number of shares used in computing net loss per share, basic and diluted | 10,072,076 | 5,543,644 | 7,928,729 | 5,482,648 | ||||||||||||
Unity Biotechnology, Inc.
Condensed Balance Sheets
(In thousands)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 22,576 | $ | 32,905 | ||||
| Short-term marketable securities | 76,364 | 55,170 | ||||||
| Prepaid expenses and other current assets | 3,234 | 1,879 | ||||||
| Restricted cash | 550 | 550 | ||||||
| Total current assets | 102,724 | 90,504 | ||||||
| Property and equipment, net | 8,202 | 9,942 | ||||||
| Operating lease right-of-use assets | 19,515 | 21,286 | ||||||
| Long-term marketable securities | 4,980 | 1,993 | ||||||
| Long-term restricted cash | 896 | 896 | ||||||
| Other long-term assets | 76 | 91 | ||||||
| Total assets | $ | 136,393 | $ | 124,712 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,444 | $ | 1,985 | ||||
| Accrued compensation | 2,961 | 4,028 | ||||||
| Accrued and other current liabilities | 4,593 | 6,370 | ||||||
| Deferred revenue | — | 216 | ||||||
| Derivative liability related to debt | — | 963 | ||||||
| Current portion of long-term debt | 6,776 | 3,055 | ||||||
| Total current liabilities | 16,774 | 16,617 | ||||||
| Operating lease liability, net of current portion | 27,792 | 30,094 | ||||||
| Long-term debt, net | 13,262 | 18,409 | ||||||
| Other long-term liabilities | — | 23 | ||||||
| Total liabilities | 57,828 | 65,143 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock | 1 | 1 | ||||||
| Additional paid-in capital | 524,623 | 459,636 | ||||||
| Accumulated other comprehensive loss | (275 | ) | (44 | ) | ||||
| Accumulated deficit | (445,784 | ) | (400,024 | ) | ||||
| Total stockholders’ equity | 78,565 | 59,569 | ||||||
| Total liabilities and stockholders’ equity | $ | 136,393 | $ | 124,712 | ||||
Media Contact
Evoke Canale
Jason Spark
jason.spark@evokegroup.com
Investor Contact
LifeSci Advisors, LLC
Joyce Allaire
jallaire@lifesciadvisors.com
FAQ
What are the results from UNITY's Phase 2 BEHOLD study for UBX1325?
What is the current financial status of UNITY Biotechnology?
When can we expect data from the ENVISION study on wet AMD?
How much did UNITY's operating loss decrease in Q3 2022?
