May 24, 2024

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UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

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Unity Biotechnology, Inc.Unity Biotechnology, Inc.

Unity Biotechnology, Inc.

SOUTH SAN FRANCISCO, Calif., April 15, 2024 (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 fourth quarter and full year ended December 31, 2023.

“On the heels of positive BEHOLD data, our team is currently single-mindedly focused on the enrollment and execution of our Phase 2b ASPIRE study in diabetic macular edema, comparing UBX1325 (foselutoclax) against aflibercept” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “I am pleased to note that thanks to the team’s financial and operational discipline we have been able to upsize our ASPIRE study to 50 patients to maximize the ability to differentiate UBX1325 from the current standard of care.”

The Phase 2b ASPIRE study in DME is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept. It is expected to enroll about 50 subjects, with 16-week data expected in the fourth quarter of 2024 and 24-week data expected in the first quarter of 2025. More information about ASPIRE (NCT06011798) can be found here.

Recent and Upcoming Milestones

  • In January, the Company published new research in Nature Medicine, “Therapeutics targeting of cellular senescence in diabetic macular edema: preclinical and phase 1 trial results” discussing the potential of UBX1325 to target senescence cells and thereby leading to long-lasting, disease-modifying intervention for DME

  • UBX1325 16-week safety and efficacy data from the Phase 2b ASPIRE DME study expected in the fourth quarter of 2024

  • UBX1325 24-week safety and efficacy data from the Phase 2b ASPIRE DME study expected in the first quarter of 2025

Fourth Quarter and Full Year Financial Results

Cash, cash equivalents and marketable securities totaled $43.2 million as of December 31, 2023 compared with $94.8 million as of December 31, 2022. UNITY believes that current cash, cash equivalents and marketable securities are sufficient to fund operations into the third quarter of 2025.

Net loss for the twelve months ended December 31, 2023 was $39.9 million compared to $44.5 million for the twelve months ended December 31, 2022. Cash used in operations during the year ended December 31, 2023 was $36.2 million compared to $51.0 million for the twelve months ended December 31, 2022. Total net loss for the fourth quarter of 2023 was $4.3 million compared to $7.4 million for the fourth quarter of 2022. Cash used in operations during the fourth quarter of 2023 was $6.7 million compared to $10.4 million for the fourth quarter of 2022.

Research and development expenses decreased by $16.8 million, to $20.1 million for the year ended December 31, 2023 from $36.9 million for the year ended December 31, 2022. The decrease was primarily due to decreases of $7.3 million in direct research and development expenses mainly due to the completion of our UBX1325 BEHOLD and ENVISION studies, $7.2 million in personnel costs due to our reduced headcount and reduction in force, $2.0 million in facilities-related costs primarily due to the sublease of our East Grand facility, and $0.3 million in laboratory. Research and development expenses decreased by $4.5 million, to $3.3 million for the fourth quarter of 2023 from $7.8 million for the fourth quarter of 2022. The decrease was due to decreases of $2.8 million in direct research and development expenses primarily due to the completion of our UBX1325 BEHOLD and ENVISION studies, $1.4 million in personnel-related costs due to reduced headcount, and $0.3 million in facilities-related costs and depreciation.

General and administrative expenses decreased by $1.9 million, to $19.0 million for the year ended December 31, 2023 from $21.0 million for the year ended December 31, 2022. The decrease was primarily due to decreases of $2.5 million in personnel-related expenses due to the Company’s reduced headcount, partially offset by an increase of $0.6 million in professional fees. General and administrative expenses decreased by $0.9 million, to $4.4 million for the fourth quarter of 2023 from $5.3 million for the fourth quarter of 2022. The decrease was primarily due to decreases of $0.8 million in personnel-related costs due to lower headcount and $0.1 million in facilities-related costs.

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 enrollment and 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 the Company in general, see UNITY’s most recent Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on April 15, 2024, 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
(In thousands, except share and per share amounts)

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Year Ended

 

 

 

December 31,

 

 

December 31,

 

 

 

2023

 

 

2022 (Restated)

 

 

2023

 

 

2022 (Restated)

 

 

 

(Unaudited)

 

 

 

 

 

 

 

Licensing revenue – Related Party

 

$

 

 

$

 

 

$

 

 

$

236

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,271

 

 

 

7,759

 

 

 

20,099

 

 

 

36,859

 

General and administrative

 

 

4,406

 

 

 

5,280

 

 

 

18,966

 

 

 

20,949

 

Impairment of long-lived assets

 

 

 

 

 

 

 

 

5,602

 

 

 

 

Total operating expenses

 

 

7,677

 

 

 

13,039

 

 

 

44,667

 

 

 

57,808

 

Loss from operations

 

 

(7,677

)

 

 

(13,039

)

 

 

(44,667

)

 

 

(57,572

)

Interest income

 

 

525

 

 

 

804

 

 

 

2,874

 

 

 

1,220

 

Interest expense

 

 

 

 

 

(990

)

 

 

(2,452

)

 

 

(3,558

)

Unrealized gain on warrant liability

 

 

3,932

 

 

 

5,869

 

 

 

6,215

 

 

 

16,843

 

Other expense, net

 

 

(1,119

)

 

 

(66

)

 

 

(1,830

)

 

 

(1,402

)

Net loss

 

 

(4,339

)

 

 

(7,422

)

 

 

(39,860

)

 

 

(44,469

)

Other comprehensive gain (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable debt securities

 

 

31

 

 

 

24

 

 

 

227

 

 

 

(207

)

Comprehensive loss

 

$

(4,308

)

 

$

(7,398

)

 

$

(39,633

)

 

$

(44,676

)

Net loss per share, basic and diluted

 

$

(0.28

)

 

$

(0.52

)

 

$

(2.70

)

 

$

(4.68

)

Weighted-average number of shares used in
   computing net loss per share, basic and
   diluted

 

 

15,743,772

 

 

 

14,140,520

 

 

 

14,773,612

 

 

 

9,494,421

 

Unity Biotechnology, Inc.
Condensed Balance Sheets
(In thousands)

 

 

 

 

 

 

 

 

 

December 31,

 

 

December 31,

 

 

 

2023

 

 

2022 (Restated)

 

Assets

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

19,803

 

 

$

12,736

 

Short-term marketable securities

 

 

23,398

 

 

 

82,059

 

Prepaid expenses and other current assets

 

 

3,404

 

 

 

1,740

 

Total current assets

 

 

46,605

 

 

 

96,535

 

Property and equipment, net

 

 

5,082

 

 

 

7,825

 

Operating lease right-of-use assets

 

 

12,981

 

 

 

19,042

 

Long-term restricted cash

 

 

896

 

 

 

896

 

Other long-term assets

 

 

126

 

 

 

52

 

Total assets

 

$

65,690

 

 

$

124,350

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,380

 

 

$

1,790

 

Accrued compensation

 

 

1,841

 

 

 

3,020

 

Accrued and other current liabilities

 

 

4,619

 

 

 

5,334

 

Current portion of long-term debt

 

 

 

 

 

9,476

 

Total current liabilities

 

 

7,840

 

 

 

19,620

 

Operating lease liability, net of current portion

 

 

23,539

 

 

 

26,991

 

Long-term debt, net

 

 

 

 

 

10,891

 

Warrant liability

 

 

5,913

 

 

 

10,764

 

Total liabilities

 

 

37,292

 

 

 

68,266

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock

 

 

2

 

 

 

1

 

Additional paid-in capital

 

 

512,773

 

 

 

500,827

 

Accumulated other comprehensive gain

 

 

(24

)

 

 

(251

)

Accumulated deficit

 

 

(484,353

)

 

 

(444,493

)

Total stockholders’ equity

 

 

28,398

 

 

 

56,084

 

Total liabilities and stockholders’ equity

 

$

65,690

 

 

$

124,350

 

Media
Inizio Evoke Comms
Jason Spark
[email protected]

Investor Contact
LifeSci Advisors, LLC
Joyce Allaire
[email protected]

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