– Completed enrollment in BEHOLD, the Phase 2 clinical trial of UBX1325 in DME; BEHOLD remains on track with 12-week safety and efficacy data expected by mid-2022-
-Dose the first patient in ENVISION, the Phase 2 clinical trial of UBX1325 in age-related wet macular degeneration; ENVISION remains on track with 16-week results expected in Q4 2022-
– As of March 31, 2022, UNITY had approximately $ 79.2 million in cash, cash equivalents and negotiable securities, extending the track through the first quarter of 2023 –
SOUTH SAN FRANCISCO, California, May 10, 2022 (GLOBE NEWSWIRE) – UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX]a biotech company developing therapies to slow, stop or reverse the diseases of aging, today announced its financial results for the first quarter ending March 31, 2022.
“The start of 2022 was marked by important advances in our ongoing clinical development program for UBX1325, such as the successful completion of enrollment in BEHOLD, our Phase 2 clinical trial of UBX1325 in patients with diabetic macular edema ( DME), as well as the initiation of ENVISION, our Phase 2 clinical trial of UBX1325 in patients with age-related wet macular degeneration (wAMD), ”said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “We are encouraged by the growing evidence highlighting the role cellular senescence plays in eye disease and believe we are well positioned to build on the results of the promising Phase 1 study of UBX1325, which we recently presented at the ARVO 2022 Annual Meeting. , we remain on track to provide several upcoming catalysts, including 12-week data from our DME study by mid-2022. We appreciate the support and enthusiasm we have received from patients and KOLs, and will continue to pursue our mission to address the urgent need for innovative therapeutic alternatives beyond anti-VEGFs for key ophthalmological conditions “.
Upcoming milestones
-
UBX1325 12-week safety and efficacy data from BEHOLD, the Phase 2a clinical trial in DME (study UBX1325-02) by mid-2022, as well as 24-week safety and efficacy data before the end of 2022
-
UBX1325 Safety and efficacy data at 16 weeks from ENVISION, the phase 2 clinical study wAMD (study UBX1325-03) expected in the fourth quarter of 2022
-
Tie2 / VEGF bispecific preclinical data to support advanced candidate selection by mid-2022
Financial results for the first quarter
Cash, cash equivalents and negotiable securities amounted to $ 79.2 million as of March 31, 2022, compared to $ 90.1 million as of December 31, 2021. UNITY believes that current liquidity, cash equivalents and marketable securities are sufficient to finance operations during the first quarter of 2023.
The operating loss for the three months ending March 31, 2022 was $ 18.9 million compared to $ 15.8 million for the three months ending March 31, 2021. Cash used in operations during the first quarter of 2022 is was $ 15.0 million compared to $ 15.1 million in the first quarter of 2021.
Research and development expenses increased by $ 3.8 million, to $ 12.5 million for the three months ending March 31, 2022, from $ 8.7 million for the three months ending March 31, 2021 The increase was primarily due to increases of $ 3.5 million in direct research and development expenses mainly due to the progress of the UBX1325 studies and $ 1.2 million in personnel costs due to the reduction in effect and $ 0.4 million retention bonus accruals, offset by $ 0.7 million decreases in facilities costs due to the allocation to general and administrative expenses of net expenses on the Brisbane and East Grand facilities that were sublet, $ 0.2 million in employee share-based compensation lost from the reduction in effect and $ 0.4 million in laboratory supplies.
General and administrative expenses decreased by $ 0.4 million, to $ 5.8 million for the three months ending March 31, 2022, from $ 6.2 million for the three months ending March 31, 2021. The decrease was primarily due to decreases of $ 0.6 million in facilities costs, $ 0.3 million in hiring expenses and $ 0.2 million in professional fees, offset by $ 0.4 increases in personnel costs mainly due to military reductions and $ 0.2 million in retention bonus accruals and $ 0.1 million in insurance expenses.
About UNITS
UNITY is developing a new class of therapies to slow, stop or reverse the diseases of aging. UNITY’s current goal is to create drugs to selectively eliminate or modulate senescent cells and thereby provide transformative benefits in age-related ophthalmological and neurological 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 regarding UNITY’s understanding of cellular senescence and the role it plays in the diseases of aging, the potential for UNITY to develop therapies to slow, stop or reverse the diseases of aging, including for use ophthalmic and neurological diseases, the potential for UNITY to successfully initiate and complete clinical trials of UBX1325 for DME, AMD and other ophthalmological diseases, the timescales for enrollment and clinical trial results in UBX1325, and UNITY’s expectations in this regard to the sufficiency of its cash track. These statements involve known and unknown risks, uncertainties and other material factors that could cause our actual results, business levels, performance or results to differ materially from the information expressed or implied in these forward-looking statements, including the risk that the global pandemic COVID-19 may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or discontinuing patient enrollment in clinical trials, risks related to uncertainties inherent in the drug development process, and risks related to UNITY’s understanding of the biology of senescence. We may not actually realize 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 contained in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will change our views. However, while we may decide to update these forward-looking statements in the future, we have no intention of doing so except to the extent required by applicable law. Therefore, you should not rely on these forward-looking statements as representing our views at any date after 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 UNITY’s business in general, see UNITY’s most recent quarterly report on Form 10 -Q for the quarter ended March 31, 2022, filed with the Securities and Exchange Commission on May 10, 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.
Operating reports and global loss
(In thousands, excluding quotas and amounts per share)
Three months finished |
||||||||
31 March |
||||||||
2022 |
2021 |
|||||||
(not certified) |
||||||||
Operating expenses: |
||||||||
Research and development |
12,461 |
8,717 |
||||||
General and administrative |
5,806 |
6,226 |
||||||
Total operating costs |
18,267 |
14,943 |
||||||
Loss from operations |
(18.267 |
) |
(14,943 |
) |
||||
Interest income |
29 |
36 |
||||||
Passive interests |
(808 |
) |
(775 |
) |
||||
Other income (expenses), net |
131 |
(74 |
) |
|||||
Net loss |
(18.915 |
) |
(15,756 |
) |
||||
Other overall gain (loss) |
||||||||
Unrealized gain (loss) on negotiable debt securities |
(132 |
) |
10 |
|||||
Complete loss |
$ |
(19,047 |
) |
$ |
(15,746 |
) |
||
Net loss per share, basic and diluted |
$ |
(0.28 |
) |
$ |
(0.29 |
) |
||
Weighted average number of shares used in |
67,528,552 |
54.169.349 |
||||||
Unity Biotechnology, Inc.
Condensed budgets
(In thousands)
31 March |
December 31st |
|||||||
2022 |
2021 |
|||||||
(not certified) |
||||||||
Resources |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ |
16,446 |
$ |
32.905 |
||||
Short-term negotiable securities |
62.717 |
55.170 |
||||||
Prepayments and other current assets |
1,770 |
1,879 |
||||||
Limited cash |
550 |
550 |
||||||
Total current assets |
81,483 |
90.504 |
||||||
Real estate and equipment, net |
9.308 |
9.942 |
||||||
Assets for right of use in operational lease |
20,706 |
21,286 |
||||||
Long-term negotiable securities |
– |
1.993 |
||||||
Long-term tied cash |
896 |
896 |
||||||
Other long-term assets |
76 |
91 |
||||||
Total assets |
$ |
112,469 |
$ |
124.712 |
||||
Liabilities and Net Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ |
3,323 |
$ |
1.985 |
||||
Compensation accrued |
2,837 |
4,028 |
||||||
Accruals and other current liabilities |
6,692 |
6,370 |
||||||
Deferred revenue |
216 |
216 |
||||||
Derivative liability relating to debt |
– |
963 |
||||||
Current share of long-term debt |
4,837 |
3,055 |
||||||
Total current liabilities |
17.905 |
16,617 |
||||||
Liabilities for operating leases, net of the current portion |
29,339 |
30,094 |
||||||
Long-term debt, net |
14,534 |
18.409 |
||||||
Other long-term liabilities |
– |
23 |
||||||
Total passivity |
61,778 |
65.143 |
||||||
Commitments and contingencies |
||||||||
Net assets: |
||||||||
Joint action |
7 |
6 |
||||||
Additional paid-up capital |
469.799 |
459.631 |
||||||
Accumulated other overall loss |
(176 |
) |
(44 |
) |
||||
Accumulated deficit |
(418.939 |
) |
(400,024 |
) |
||||
Total equity |
50,691 |
59,569 |
||||||
Total liabilities and shareholders’ equity |
$ |
112,469 |
$ |
124.712 |
CONTACT: Media Canale Communications Jason Spark jason.spark@canalecomm.com Investor Contact LifeSci Advisors, LLC Joyce Allaire jallaire@lifesciadvisors.com
