Form 8-K - Current report

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): August 8, 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 August 8, 2023, Unity Biotechnology, Inc. (the “Company”) announced its financial results for the second quarter ended June 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 August 8, 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: August 8, 2023	By:	/s/ Anirvan Ghosh
		Anirvan Ghosh, Ph.D.
		Chief Executive Officer

Exhibit 99.1

UNITY Biotechnology, Inc. Reports Second Quarter 2023 Financial Results

and Business Updates

SOUTH SAN FRANCISCO, Calif., August 8, 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 second quarter ended June 30, 2023.

“We are focused on rapidly advancing UBX1325 (foselutoclax) into the next clinical study to help patients suffering from diabetic macular edema who receive suboptimal benefit from the current anti-VEGF standard of care,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “Our Phase 2b ASPIRE study is a head-to-head trial comparing UBX1325 against aflibercept in patients with DME and follows our positive data from the Phase 2 BEHOLD study in which patients showed a statistically significant and clinically meaningful improvement in visual acuity that was sustained through 48 weeks after just a single injection of UBX1325. We are also looking forward to continuing to learn about potential efficacy of UBX1325 in combination with aflibercept from Part B of the Phase 2 ENVISION study in patients with wet AMD.”

The Company expects to disclose 48-week data from Part B of the ENVISION Phase 2 study in patients with AMD in the third quarter. Also in the third quarter, the Company expects to activate clinical trial sites in ASPIRE with the first patient dosed shortly thereafter. The ASPIRE study 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.

Second Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities totaled $71.0 million as of June 30, 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 fourth quarter of 2024.

Operating loss for the three months ended June 30, 2023 was $12.0 million compared to $12.3 million for the three months ended June 30, 2022. Cash used in operations during the first and second quarters of 2023 was $22.4 million compared to $29.8 million for the first and second quarters of 2022.

Research and development expenses decreased by $1.1 million, to $6.5 million for the three months ended June 30, 2023 from $7.6 million for the three months ended June 30, 2022. The decrease was primarily due to decreases of $0.4 million in personnel costs due to our reduced headcount related to out reduction in force, and $0.7 million in operating costs due to reduced fixed assets depreciation and reduced office space.

General and administrative expenses increased by $0.5 million, to $5.4 million for the three months ended June 30, 2023 from $4.9 million for the three months ended June 30, 2022. The increase was primarily due to increases of $0.3 million in personnel-related expenses due to increased stock-based compensation from the new May 2023 awards, director refresh awards and option repricing true up expense, and $0.3 million in professional fees and accounting service fees, partially offset by $0.1 million decrease in operating costs mainly from the sublease income of the Company's 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 June 30, 2023, filed with the Securities and Exchange Commission on August 8, 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						Six Months Ended
	June 30,						June 30,
	2023			2022			2023			2022
	(Unaudited)
Licensing revenue - Related Party	$	—		$	236		$	—		$	236

Operating expenses:
Research and development		6,529			7,553			12,364			20,014
General and administrative		5,433			4,941			10,252			10,747
Total operating expenses		11,962			12,494			22,616			30,761
Loss from operations		(11,962	)		(12,258	)		(22,616	)		(30,525	)
Interest income		805			58			1,660			87
Interest expense		(979	)		(894	)		(1,981	)		(1,702	)
Other income (expense), net		(69	)		(43	)		(133	)		88
Net loss		(12,205	)		(13,137	)		(23,070	)		(32,052	)
Other comprehensive gain (loss)
Unrealized gain (loss) on marketable debt securities		14			(11	)		115			(143	)
Comprehensive loss	$	(12,191	)	$	(13,148	)	$	(22,955	)	$	(32,195	)
Net loss per share, basic and diluted	$	(0.85	)	$	(1.90	)	$	(1.61	)	$	(4.69	)
Weighted-average number of shares used in computing net loss per share, basic and diluted		14,425,775			6,924,782			14,369,643			6,839,293

Unity Biotechnology, Inc.

Condensed Balance Sheets

(In thousands)


	June 30,			December 31,
	2023			2022
	(Unaudited)
Assets
Current Assets:
Cash and cash equivalents	$	19,118		$	12,736
Short-term marketable securities		49,974			82,059
Prepaid expenses and other current assets		3,874			1,740
Total current assets		72,966			96,535
Property and equipment, net		7,181			7,825
Operating lease right-of-use assets		18,061			19,042
Long-term marketable securities		1,899			—
Long-term restricted cash		896			896
Other long-term assets		5			52
Total assets	$	101,008		$	124,350
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,449		$	1,790
Accrued compensation		1,652			3,020
Accrued and other current liabilities		5,417			5,334
Current portion of long-term debt		13,704			9,476
Total current liabilities		22,222			19,620
Operating lease liability, net of current portion		25,297			26,991
Long-term debt, net of current portion		4,082			10,891
Total liabilities		51,601			57,502
Commitments and contingencies
Stockholders’ equity:
Common stock		1			1
Additional paid-in capital		532,563			527,049
Accumulated other comprehensive gain		(136	)		(251	)
Accumulated deficit		(483,021	)		(459,951	)
Total stockholders’ equity		49,407			66,848
Total liabilities and stockholders’ equity	$	101,008		$	124,350

Media

Evoke Canale

Jason Spark

jason.spark@evokegroup.com

Investor Contact
LifeSci Advisors, LLC
Joyce Allaire
jallaire@lifesciadvisors.com

Document And Entity Information	Aug. 09, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 08, 2023
Entity Registrant Name	UNITY BIOTECHNOLOGY, INC.
Entity Central Index Key	0001463361
Entity Emerging Growth Company	true
Securities Act File Number	001-38470
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-4726035
Entity Address, Address Line One	285 East Grand Ave.
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	(650)
Local Phone Number	416-1192
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	UBX
Security Exchange Name	NASDAQ