8-K
false 0001463361 00014633612023-11-132023-11-13

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 13, 2023

 

 

UNITY BIOTECHNOLOGY, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

001-38470

26-4726035

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification Number)

285 East Grand Ave.

South San Francisco, CA 94080

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 416-1192

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

UBX

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


Item 2.02 Results of Operations and Financial Condition.

On November 13, 2023, Unity Biotechnology, Inc. (the “Company”) announced its financial results for the third quarter ended September 30, 2023. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K, including the attached Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

Reference is made to the Exhibit Index attached hereto.

 

EXHIBIT INDEX

Exhibit No.

Description

 

 

 

99.1

Press release dated November 13, 2023.

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

UNITY BIOTECHNOLOGY, INC.

 

 

 

Date: November 13, 2023

By:

/s/ Anirvan Ghosh

 

 

Anirvan Ghosh, Ph.D.

 

 

Chief Executive Officer

 


EX-99.1

Exhibit 99.1

UNITY Biotechnology, Inc. Reports Third Quarter 2023 Financial Results

and Business Updates

SOUTH SAN FRANCISCO, Calif., November 13, 2023 (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, 2023.

 

“Following positive efficacy and safety data at 48 weeks from a single injection of UBX1325 (foselutoclax) in patients with diabetic macular edema, we are working to quickly and efficiently advance UBX1325 (foselutoclax) into our Phase 2b ASPIRE study which is a head-to-head trial comparing UBX1325 against aflibercept,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “Our patients and practitioners need treatment options with statistically significant, clinically meaningful, and over time sustainable improvement in visual acuity, and UBX1325 could potentially be that option.”

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 40 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.

Third Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities, following the Company's full repayment of its remaining loan balance of $15.0 million on the Hercules Loan Facility on September 6, 2023, totaled $45.9 million as of September 30, 2023 compared with $94.8 million as of December 31, 2022. UNITY believes that current cash, cash equivalents and marketable securities and following the cash exercise by certain holders of existing warrants are sufficient to fund operations into the third quarter of 2025.

Operating loss for the three months ended September 30, 2023 was $15.3 million compared to $13.7 million for the three months ended September 30, 2022. Cash used in operations during the nine quarters of 2023 was $29.5 million compared to $40.7 million for the nine quarters of 2022.

Research and development expenses decreased by $3.3 million, to $4.9 million for the three months ended September 30, 2023 from $8.2 million for the three months ended September 30, 2022. The decrease was primarily due to decreases of $1.0 million in personnel costs due to our reduced headcount related to our reduction in force, $2.0 million in direct research and development expenses mainly due from the completion of the Phase 2 BEHOLD study in patients with DME and the near completion of the Phase 2 ENVISION study of UBX1325 in patients with AMD, and $0.3 million in operating costs due to reduced fixed assets depreciation and reduced office space.

General and administrative expenses decreased by $0.5 million, to $4.4 million for the three months ended September 30, 2023 from $4.9 million for the three months ended September 30, 2022. The decrease was primarily due to decreases of $0.5 million in personnel-related expenses due to reduced headcount and the higher bonus and severance amounts paid in 2022, and $0.3 million in professional fees and accounting service fees, partially offset by $0.3 million increase in operating costs mainly from the discontinuation of sublease income generated from the former Brisbane property.


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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the Securities and Exchange Commission on November 13, 2023, 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

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

(Unaudited)

 

 

 

 

 

 

 

Licensing revenue - Related Party

 

$

 

 

$

 

 

$

 

 

$

236

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,901

 

 

 

8,208

 

 

 

17,266

 

 

 

28,222

 

General and administrative

 

 

4,428

 

 

 

4,922

 

 

 

14,681

 

 

 

15,669

 

Impairment of long-lived assets

 

 

5,602

 

 

 

 

 

 

5,602

 

 

 

 

Total operating expenses

 

 

14,931

 

 

 

13,130

 

 

 

37,549

 

 

 

43,891

 

Loss from operations

 

 

(14,931

)

 

 

(13,130

)

 

 

(37,549

)

 

 

(43,655

)

Interest income

 

 

689

 

 

 

329

 

 

 

2,349

 

 

 

416

 

Interest expense

 

 

(470

)

 

 

(866

)

 

 

(2,451

)

 

 

(2,568

)

Other income (expense), net

 

 

(577

)

 

 

(41

)

 

 

(711

)

 

 

49

 

Net loss

 

 

(15,289

)

 

 

(13,708

)

 

 

(38,362

)

 

 

(45,758

)

Other comprehensive gain (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable debt securities

 

 

81

 

 

 

(88

)

 

 

196

 

 

 

(231

)

Comprehensive loss

 

$

(15,208

)

 

$

(13,796

)

 

$

(38,166

)

 

$

(45,989

)

Net loss per share, basic and diluted

 

$

(1.05

)

 

$

(1.36

)

 

$

(2.66

)

 

$

(5.77

)

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

 

 

14,598,218

 

 

 

10,072,077

 

 

 

14,446,672

 

 

 

7,928,729

 

 


Unity Biotechnology, Inc.

Condensed Balance Sheets

(In thousands)

 

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

7,876

 

 

$

12,736

 

Short-term marketable securities

 

 

38,063

 

 

 

82,059

 

Prepaid expenses and other current assets

 

 

3,599

 

 

 

1,740

 

Total current assets

 

 

49,538

 

 

 

96,535

 

Property and equipment, net

 

 

5,314

 

 

 

7,825

 

Operating lease right-of-use assets

 

 

13,522

 

 

 

19,042

 

Long-term restricted cash

 

 

896

 

 

 

896

 

Other long-term assets

 

 

 

 

 

52

 

Total assets

 

$

69,270

 

 

$

124,350

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,149

 

 

$

1,790

 

Accrued compensation

 

 

2,226

 

 

 

3,020

 

Accrued and other current liabilities

 

 

5,258

 

 

 

5,334

 

Current portion of long-term debt

 

 

 

 

 

9,476

 

Total current liabilities

 

 

8,633

 

 

 

19,620

 

Operating lease liability, net of current portion

 

 

24,431

 

 

 

26,991

 

Long-term debt, net of current portion

 

 

 

 

 

10,891

 

Total liabilities

 

 

33,064

 

 

 

57,502

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

534,570

 

 

 

527,049

 

Accumulated other comprehensive gain

 

 

(55

)

 

 

(251

)

Accumulated deficit

 

 

(498,310

)

 

 

(459,951

)

Total stockholders’ equity

 

 

36,206

 

 

 

66,848

 

Total liabilities and stockholders’ equity

 

$

69,270

 

 

$

124,350

 

 


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