UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
UNITY BIOTECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification Number) |
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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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.
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Item 2.02 |
Results of Operations and Financial Condition. |
On July 31, 2020, Unity Biotechnology, Inc. (the “Company”) announced its financial results for the second quarter ended June 30, 2020. 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.
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Item 9.01 |
Financial Statements and Exhibits. |
Reference is made to the Exhibit Index attached hereto.
EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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104 |
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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.
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UNITY BIOTECHNOLOGY, INC. |
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Date: July 31, 2020 |
By: |
/s/ Robert C. Goeltz II |
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Robert C. Goeltz II |
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Chief Financial Officer |
Exhibit 99.1
UNITY Biotechnology, Inc. Reports Second Quarter 2020 Financial Results and Clinical Program Updates
SOUTH SAN FRANCISCO, Calif., July 31, 2020 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today reported financial results for the second quarter ended June 30, 2020.
“We are pleased with the progress we are making on advancing programs that target senescent cells to alter the course of diseases of aging,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “The second half of 2020 is a very important period for UNITY, with our topline 12-week Phase 2 data readout from the UBX0101 program in osteoarthritis expected in the third quarter, as well as the commencement of our initial clinical program in ophthalmology later in the second half of the year.”
Clinical Program Updates
Osteoarthritis – UBX0101
In July 2020, UNITY announced that it expects to announce topline 12-week results from its Phase 2 study of UBX0101 in the third quarter of 2020. Consistent with prior guidance, 24-week results are also expected by the end of 2020. The company previously announced completion of enrollment of a Phase 2 study of UBX0101 in patients with moderate-to-severe osteoarthritis (OA) of the knee in February 2020. The study is randomized, double-blind, and placebo-controlled and will evaluate three doses (0.5 mg, 2.0 mg and 4.0 mg) of UBX0101 administered via a single intra-articular injection.
UNITY is also conducting a Phase 1b study of UBX0101 in patients with moderate-to-severe OA of the knee. Enrollment in this study was completed in March 2020. The study is randomized, double-blind, and placebo-controlled and will explore the safety, tolerability and initial efficacy of a single 8.0 mg dose or multiple doses (two 4.0 mg doses separated by one month) of UBX0101. Consistent with prior guidance, both 12- and 24-week results are expected in the second half of 2020.
Ophthalmology – UBX1325
In July 2020, UNITY announced that it has completed Investigational New Drug application (IND) -enabling studies with UBX1325, an investigational senolytic, small molecule inhibitor of the anti-apoptotic Bcl-2 family member, Bcl-xL. Assuming clinical sites are able to recruit and retain investigators and study staff and screen and enroll patients during the ongoing COVID-19 pandemic, UNITY expects to initiate a Phase 1 safety study for UBX1325 in the second half of 2020 and obtain initial results from the study in 2021. The overall clinical program is directed at multiple age-related diseases of the eye, such as diabetic macular edema, diabetic retinopathy and age-related macular degeneration.
UNITY believes that current cash, cash equivalents and marketable securities are sufficient to fund operations into the second half of 2021.
Second Quarter Financial Results
Cash, cash equivalents and marketable securities totaled $111.8 million as of June 30, 2020 compared with $125.0 million as of December 31, 2019.
Operating loss for the three months ended June 30, 2020 was $23.3 million compared to $24.5 million for the three months ended June 30, 2019. Cash used in operations during the six months ended June 30, 2020 was $44.4 million compared to $39.9 million for the six months ended June 30, 2019.
Research and development expenses decreased by $2.3 million, to $16.1 million for the three months ended June 30, 2020 from $18.5 million for the three months ended June 30, 2019. The decrease was primarily due to a decrease of $5.3 million in pre-clinical and manufacturing expenses partially offset by a $1.8 million increase in clinical study related costs, driven by progression of UBX0101 to clinical stage, and increases of $1.2 million in personnel-related costs, of which $1.0 million was related to non-cash stock compensation expense.
General and administrative expenses increased by $1.4 million, to $6.3 million for the three months ended June 30, 2020 from $5.0 million for the three months ended June 30, 2019. The increase was primarily due to increases of $1.2 million in non-cash stock compensation expense, and $0.2 million in facilities-related fees.
About UNITY
UNITY is developing a new class of therapeutics to slow, halt or reverse diseases of aging. UNITY's initial focus is on creating senolytic medicines to selectively eliminate senescent cells and thereby provide transformative benefit in age-related diseases, such as osteoarthritis, eye diseases, neurological diseases and pulmonary diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter.
Forward-Looking Statements
This press release contains forward-looking statements including statements related to the potential for UNITY to develop therapeutics to extend healthspan, the timing of certain regulatory filings, expectations regarding the results of its clinical studies and timing of announcements of such results and the sufficiency of its cash, cash equivalents and marketable securities. 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. 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, 2020, filed with the Securities and Exchange Commission on July 31, 2020, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Operating expenses: |
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Research and development |
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$ |
16,123 |
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$ |
18,468 |
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$ |
35,388 |
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$ |
34,973 |
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General and administrative |
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6,320 |
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4,970 |
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12,273 |
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9,447 |
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Change in fair value of contingent consideration |
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906 |
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1,032 |
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685 |
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(213 |
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Impairment of long-lived assets |
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— |
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— |
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2,159 |
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— |
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Total operating expenses |
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23,349 |
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24,470 |
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50,505 |
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44,207 |
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Loss from operations |
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(23,349 |
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(24,470 |
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(50,505 |
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(44,207 |
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Interest income |
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340 |
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900 |
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867 |
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1,906 |
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Other income (expense), net |
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4,342 |
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(103 |
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2,933 |
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(139 |
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Net loss |
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(18,667 |
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(23,673 |
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(46,705 |
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(42,440 |
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Other comprehensive loss |
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Unrealized gain (loss) on marketable debt securities, net of tax |
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(141 |
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94 |
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142 |
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208 |
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Comprehensive loss |
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$ |
(18,808 |
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$ |
(23,579 |
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$ |
(46,563 |
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$ |
(42,232 |
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Net loss per share, basic and diluted |
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$ |
(0.38 |
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$ |
(0.56 |
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$ |
(0.96 |
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$ |
(1.00 |
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Weighted-average number of shares used in computing net loss per share, basic and diluted |
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49,659,153 |
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42,442,886 |
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48,606,768 |
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42,311,040 |
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Condensed Balance Sheets
(In thousands)
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June 30, |
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December 31, |
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2020 |
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2019 |
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(Unaudited) |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
39,592 |
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$ |
37,473 |
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Short-term marketable securities |
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72,176 |
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84,508 |
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Strategic investment |
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7,768 |
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5,507 |
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Prepaid expenses and other current assets |
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4,001 |
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1,999 |
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Total current assets |
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123,537 |
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129,487 |
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Property and equipment, net |
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14,226 |
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16,636 |
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Operating lease right of use asset |
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24,891 |
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— |
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Long-term marketable securities |
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— |
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3,025 |
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Restricted cash |
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1,446 |
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1,446 |
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Other long-term assets |
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598 |
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627 |
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Total assets |
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$ |
164,698 |
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$ |
151,221 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ |
3,952 |
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$ |
5,185 |
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Accrued compensation |
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3,651 |
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5,905 |
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Accrued and other current liabilities |
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6,250 |
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4,995 |
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Contingent consideration liability |
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1,816 |
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1,131 |
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Total current liabilities |
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15,669 |
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17,216 |
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Operating lease liability, net of current portion |
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36,770 |
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— |
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Deferred rent, net of current portion |
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— |
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13,298 |
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Total liabilities |
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52,439 |
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30,514 |
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Commitments and contingencies |
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Stockholders' equity: |
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Common stock |
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5 |
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5 |
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Additional paid-in capital |
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404,754 |
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366,695 |
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Related party promissory notes for purchase of common stock |
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(210 |
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(210 |
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Employee promissory notes for purchase of common stock |
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(362 |
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(418 |
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Accumulated other comprehensive income |
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232 |
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90 |
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Accumulated deficit |
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(292,160 |
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(245,455 |
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Total stockholders' equity |
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112,259 |
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120,707 |
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Total liabilities and stockholders' equity |
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$ |
164,698 |
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$ |
151,221 |
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Endurance Advisors
Peter Rahmer
prahmer@enduranceadvisors.com
Media
Canale Communications
Jason Spark
jason@canalecomm.com