UNITY Biotechnology presents clinical data at the 2022 Annual Meeting of the Association for Research in Vision & Ophthalmology (ARVO)

UNITY Biotechnology, Inc. reports first quarter 2022 financial results and company updates

Unity Biotechnology, Inc.

– 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
calculation of net loss per share, basis e
diluted

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

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