UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM8-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): February 25, 2020
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 Avenue
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 Form8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule14a-12 under the Exchange Act (17 CFR240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule13e-4(c) under the Exchange Act (17 CFR240.13e-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 Rule12b-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 | 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 Form8-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 withmoderate-to-severe osteoarthritis (“OA”) of the knee is now fully enrolled. Both12- and24-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 with12-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”) enablingnon-clinical toxicology studies. Both senolytic molecules are inhibitors of particular members of theBcl-2 family of apoptosis regulatory proteins which have shown distinct pharmacokinetic profiles in preclinical studies. UNITY intends to completeIND-enabling studies for both molecules prior to selecting the first molecule to advance to afirst-in-human study to explore safety and tolerability of this novel mechanism of action forage-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 multipleage-related diseases of the eye, such asage-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 inage-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 ongoingpre-clinical studies of UBX1325 and UBX1967; the timing of initiation of the first Phase 1 study of UBX1325 or UBX1967 inage-related eye diseases; the potential scope of UNITY’s overall clinical program inage-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 Form10-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.
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: February 25, 2020 | By: | /s/ Robert C. Goeltz II | ||||
| Robert C. Goeltz II | ||||||
| Chief Financial Officer | ||||||