8-K

UNITY BIOTECHNOLOGY, INC.

Date: February 25, 2020

/s/ Robert C. Goeltz II

Robert C. Goeltz II

Chief Financial Officer

Item 2.02

Pipeline and Business Updates

On February 25, 2020, Unity Biotechnology, Inc., a Delaware corporation (“UNITY” or the “Company”), issued a press release announcing, among other things, UNITY’s cash, cash equivalents and investments (unaudited) as of December 31, 2019. The full text of the press release is furnished herewith as Exhibit 99.1.

The information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for 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, or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 8.01

Other Events

On February 25, 2020, UNITY announced that the its Phase 2 study of UBX0101 in patients with moderate-to-severe osteoarthritis (“OA”) of the knee is now fully enrolled. Both 12- and 24-week results are now expected in the second half of 2020. In addition, UNITY announced that it had dosed the first patients in a Phase 1b study to explore the safety, tolerability and initial efficacy of a higher dose (8.0 mg) and repeated doses (4.0 mg x 2, separated by 1 month) of UBX0101. The study is expected to enroll approximately 36 patients with 12-week results expected in the second half of 2020.

UNITY further announced that its lead ophthalmology candidates, UBX1325 and UBX1967, are currently in the final phases of Investigational New Drug (“IND”) enabling non-clinical toxicology studies. Both senolytic molecules are inhibitors of particular members of the Bcl-2 family of apoptosis regulatory proteins which have shown distinct pharmacokinetic profiles in preclinical studies. UNITY intends to complete IND-enabling studies for both molecules prior to selecting the first molecule to advance to a first-in-human study to explore safety and tolerability of this novel mechanism of action for age-related eye diseases. UNITY expects to initiate a Phase 1 safety study for this program in the second half of 2020. The overall clinical program is directed at multiple age-related diseases of the eye, such as age-related macular degeneration, diabetic retinopathy and diabetic macular edema.

Finally, UNITY announced that as of December 31, 2019, UNITY’s cash, cash equivalents and investments were $125.0 million (unaudited). UNITY believes that cash, cash equivalents and investments are sufficient to fund operations into the second half of 2021. UNITY expects to release its audited financial results for fiscal year 2019 on March 11, 2020.

Item 9.01

Financial Statements and Exhibits


Exhibit No.		Description

99.1		Press release dated February 25, 2020.

Forward-Looking Statements

To the extent that statements contained herein are not descriptions of historical facts regarding UNITY, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements related to UNITY’s understanding of cellular senescence and the role cellular senescence plays in age-related diseases; the potential for UNITY to develop medicines that eliminate senescent cells; the potential benefits, activity, effectiveness and safety of UBX0101 in patients with OA of the knee; the design of, pace of enrollment in, and timing of data read out from UNITY’s Phase 2 OA study; the design of, pace of enrollment in, and timing of data read out from UNITY’s Phase 1b OA study; the mechanism of action and pharmacokinetic profiles of UBX1325 and UBX1967; UNITY’s ability to successfully complete ongoing pre-clinical studies of UBX1325 and UBX1967; the timing of initiation of the first Phase 1 study of UBX1325 or UBX1967 in age-related eye diseases; the potential scope of UNITY’s overall clinical program in age-related eye diseases; and UNITY’s expectations with regard to the sufficiency of its cash runway. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. For a 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 reports filed with the Securities and Exchange Commission (“SEC”), including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 6, as well as other documents that may be filed by the Company from time to time with the SEC.