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
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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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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 March 23, 2021, Unity Biotechnology, Inc. (the “Company”) announced its financial results for the fourth quarter and full year ended December 31, 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: March 23, 2021 |
By: |
/s/ Anirvan Ghosh |
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Anirvan Ghosh, Ph.D. |
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Chief Executive Officer |
Exhibit 99.1
UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2020 Financial Results
and Business Updates
SOUTH SAN FRANCISCO, Calif., March 23, 2021 (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 fourth quarter and full year ended December 31, 2020.
“Over the past six months, we have made significant progress in advancing our lead ophthalmology program, having initiated a Phase 1 study of UBX1325 in patients with diabetic macular edema or age-related macular degeneration. We anticipate receiving initial results from the Phase 1 study and initiating a Phase 2a proof of concept study in the first half of this year,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “Supported by the strength of the underlying biology and preclinical evidence implicating senescent cell burden as a key molecular pathway associated with progression of age-related diseases, we continue to build a portfolio of programs aimed at providing transformative treatment options for patients with ophthalmologic and neurologic diseases.”
Key Business Highlights
Ophthalmology – UBX1325
In October 2020, UNITY announced that the first patient was dosed in the Phase 1 clinical trial of UBX1325, an investigational senolytic, small molecule inhibitor of the anti-apoptotic Bcl-2 family member called Bcl-xL, in patients with diabetic macular edema (DME) or age-related macular degeneration (AMD).
Initial results from the Phase 1 safety study are expected in the first half of 2021. Following assessment of the data, UNITY plans to initiate a Phase 2a proof of concept study to evaluate the safety and efficacy of UBX1325 in patients with DME in the first half of 2021, with preliminary results expected in the first half of 2022.
In February 2021, UNITY announced that its researchers and collaborators published a study in the peer-reviewed journal Cell Metabolism featuring a novel mechanism – Bcl-xL inhibition – for treating age-related eye diseases by restoring vascular health in the retina. By selectively eliminating the senescent cells accumulating in diseased blood vessels of the eye, researchers identified a way to target diseased vasculature while leaving healthy blood vessels intact, thus enabling the retina to repair itself. The study is featured in the April issue of Cell Metabolism and is currently available online.
Operational Highlights
In December 2020, UNITY announced that Gilmore O’Neill, M.B., had been appointed to the board of directors and as the chair of the science committee. This evolution of UNITY’s board composition reflects a continued focus on building a clinical-stage drug development company to advance its ophthalmology and neurology programs.
In February 2021, UNITY announced the appointment of Przemyslaw (Mike) Sapieha, Ph.D., as chief scientific advisor. Dr. Sapieha is a world leader in the fundamental biology of age-related diseases of the eye.
UNITY also announced the appointment of Jason Damiano, Ph.D., as vice president of translational biology, and Nathan Guz, Ph.D., as vice president of operations.
In March 2021, UNITY announced Alexander Nguyen had been appointed general counsel, bringing extensive operational and regulatory experience.
Fourth Quarter and Full Year Financial Results
Cash, cash equivalents and marketable securities totaled $115.6 million as of December 31, 2020 compared with $125.0 million as of December 31, 2019. UNITY believes that current cash, cash equivalents and marketable securities are sufficient to fund operations into the second half of 2022.
Operating loss for the twelve months ended December 31, 2020 was $93.9 million compared to $89.7 million for the twelve months ended December 31, 2019. Cash used in operations during the year ended December 31, 2020 was $78.3 million compared to $72.4 million for the twelve months ended December 31, 2019. Total operating loss for the fourth quarter of 2020 was $18.8 million compared to $23.1 million for the fourth quarter of 2019. Cash used in operations during the fourth quarter of 2020 was $16.7 million compared to $15.7 million for the fourth quarter of 2019.
Research and development expenses decreased by $3.6 million, to $67.3 million for the year ended December 31, 2020 from $71.0 million for the year ended December 31, 2019. The decrease was primarily due to a decrease of $5.3 million in direct research and development expenses mainly due to lower pre-clinical research and development activities and contract manufacturing costs, partially offset by higher costs from clinical programs started in late 2019. Laboratory supplies decreased by $1.9 million and facilities-related costs increased by $2.2 million. Personnel-related expenses increased by $1.4 million, of which a $1.6 million increase was related to non-cash stock compensation expense partially offset by a decrease in payroll due to the corporate restructuring and other costs such as travel, due to employees working from home. Research and development expenses decreased by $5.1 million, to $13.1 million for the fourth quarter of 2020 from $18.2 million for the fourth quarter of 2019. The decrease was due to decreases of $2.6 million in direct research and development expenses primarily due to the termination of osteoarthritis (OA) studies, $1.6 million in personnel-related costs driven by the reduction-in-force during the fourth quarter of 2020, $0.5 million in facilities-related costs and $0.4 million in laboratory purchases.
General and administrative expenses increased by $4.0 million, to $24.0 million for the year ended December 31, 2020 from $20.0 million for the year ended December 31, 2019. The increase was primarily due to increases of $2.0 million in personnel-related expenses, of which $1.4 million was related to non-cash stock compensation expense, $0.8 million in professional fees, $0.7 million in facilities-related costs and $0.5 million in insurance-related expense. General and administrative expenses increased by $0.3 million, to $5.2 million for the fourth quarter of 2020 from $4.9 million for the fourth quarter of 2019. The increase was primarily due to increases of $0.5 million in professional and consultant fees, $0.1 million in insurance-related expense and $0.1 million in facilities-related costs, offset by a $0.4 million decrease in personnel-related costs driven by the reduction-in-force during the fourth quarter of 2020.
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 initial results of the Phase 1 study of UBX1325, the timing of the expected commencement of the Phase 2a study of 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 Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 23, 2021, 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)
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2020 |
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2019 |
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2020 |
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2019 |
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(Unaudited) |
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Operating expenses: |
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Research and development |
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$ |
13,091 |
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$ |
18,207 |
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$ |
67,309 |
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$ |
70,957 |
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General and administrative |
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5,222 |
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4,907 |
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24,025 |
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20,046 |
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Change in fair value of contingent consideration |
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— |
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(24 |
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(33 |
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(1,352 |
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Impairment of long-lived assets |
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470 |
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— |
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2,629 |
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— |
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Total operating expenses |
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18,783 |
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23,090 |
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93,930 |
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89,651 |
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Loss from operations |
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(18,783 |
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(23,090 |
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(93,930 |
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(89,651 |
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Interest income |
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103 |
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627 |
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1,196 |
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3,289 |
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Interest expense |
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(793 |
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— |
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(1,292 |
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— |
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Other income (expense), net |
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(114 |
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4,436 |
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182 |
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4,185 |
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Net loss |
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(19,587 |
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(18,027 |
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(93,844 |
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(82,177 |
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Other comprehensive loss |
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Unrealized gain (loss) on marketable debt securities |
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(61 |
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(5 |
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(85 |
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185 |
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Comprehensive loss |
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$ |
(19,648 |
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$ |
(18,032 |
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$ |
(93,929 |
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$ |
(81,992 |
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Net loss per share, basic and diluted |
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$ |
(0.37 |
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$ |
(0.39 |
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$ |
(1.84 |
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$ |
(1.88 |
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Weighted-average number of shares used in computing net loss per share, basic and diluted |
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53,222,957 |
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45,975,828 |
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50,864,889 |
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43,624,807 |
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Unity Biotechnology, Inc.
Condensed Balance Sheets
(In thousands)
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December 31, |
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December 31, |
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2020 |
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2019 |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
17,807 |
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$ |
37,473 |
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Short-term marketable securities |
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79,892 |
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84,508 |
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Strategic investment |
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— |
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5,507 |
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Prepaid expenses and other current assets |
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3,167 |
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1,999 |
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Total current assets |
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100,866 |
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129,487 |
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Property and equipment, net |
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12,627 |
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16,636 |
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Operating lease right-of-use assets |
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23,509 |
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— |
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Long-term marketable securities |
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17,871 |
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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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— |
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627 |
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Total assets |
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$ |
156,319 |
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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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$ |
2,558 |
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$ |
5,185 |
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Accrued compensation |
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5,355 |
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5,905 |
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Accrued and other current liabilities |
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6,550 |
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4,995 |
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Contingent consideration liability |
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— |
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1,131 |
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Total current liabilities |
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14,463 |
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17,216 |
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Operating lease liability, net of current portion |
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34,468 |
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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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Long-term debt, net |
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24,508 |
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— |
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Total liabilities |
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73,439 |
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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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422,379 |
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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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— |
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(418 |
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Accumulated other comprehensive gain |
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5 |
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90 |
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Accumulated deficit |
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(339,299 |
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(245,455 |
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Total stockholders' equity |
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82,880 |
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120,707 |
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Total liabilities and stockholders' equity |
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$ |
156,319 |
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$ |
151,221 |
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Media
Canale Communications
Jason Spark
jason.spark@canalecomm.com