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): November 7, 2018
UNITY BIOTECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-38470 |
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26-4726035 |
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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) |
3280 Bayshore Blvd, Suite 100
Brisbane, CA 94005
(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:
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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)) |
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. ☐
On November 7, 2018, Unity Biotechnology, Inc. (the “Company”) announced its financial results for the third quarter ended September 30, 2018. 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.
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Exhibit No. |
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Description |
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99.1 |
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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: November 7, 2018 |
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 Third Quarter 2018 Financial Results
SAN FRANCISCO, Calif., November 7, 2018 (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 third quarter 2018 financial results.
"We finished the third quarter well-positioned to drive our clinical and pre-clinical senescence programs forward, while continuing to explore other mechanisms implicated in diseases of aging," said Keith Leonard, chairman and chief executive officer of UNITY. “Our Phase 1 clinical trial evaluating the safety and tolerability of UBX0101 in moderate to severe osteoarthritis of the knee is ongoing and on track to read out in the first quarter of next year.”
UNITY remains on schedule to file two additional Investigational New Drug (IND) applications in the second half of 2019. The most advanced pre-clinical candidates being evaluated for IND filings are targeted at ophthalmologic diseases.
Third Quarter Financial Results
Cash, cash equivalents and investments totaled $184.2 million as of September 30, 2018 compared with $92.2 million as of December 31, 2017.
Operating loss for the three months ended September 30, 2018 was $19.4 million compared with $12.1 million for the same period in 2017. The increase includes non-cash stock-based compensation expense of $2.2 million, non-cash contingent consideration of $0.6 million and depreciation expense of $0.1 million. Cash used for operations during the third quarter of 2018 was $13.9 million, which includes cash used for changes to our operating assets and liabilities of $1.1 million.
Research and development expenses were $14.4 million during the third quarter of 2018 compared with $9.6 million for the third quarter of 2017. The increase was attributable to an increase in personnel-related expenses of $2.8 million, of which $1.4 million was related to non-cash stock-based compensation expense, $1.6 million for direct research and development activities and $0.3 million for facilities-related costs.
General and administrative expenses were $4.4 million during the third quarter of 2018 compared with $2.5 million for the third quarter of 2017. The increase was predominantly due to $1.5 million in personnel-related expenses, of which $0.7 million was related to non-cash stock-based compensation expense and $0.5 million increase in expenses related to operating as a public company.
The change in estimated fair value of contingent consideration expense of $0.6 million during the third quarter of 2018 relates to the value of shares potentially issuable under two commercial agreements.
About UNITY
UNITY is developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging. UNITY's initial focus is on creating senolytic medicines to selectively eliminate senescent cells and thereby
treat age-related diseases, such as osteoarthritis, eye 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 but not limited to statements related to the expected timing for the data read out from our Phase 1 clinical study of UBX0101 and the filing of our next two INDs and our potential to bring medicines to market to treat age-related diseases and extend human healthspan. Such forward-looking statements involve substantial risks and uncertainties that could cause UNITY’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug discovery and development process, including UNITY’s early stage of development and our understanding of senescence biology and other fundamental biological processes associated with aging, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, UNITY’s ability to successfully protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations and the availability or commercial potential of UNITY’s product candidates. UNITY undertakes no obligation to update or revise any forward-looking statements. 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 recently filed Registration Statement on Form S-1 and any subsequent current and periodic reports filed 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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Nine Months Ended |
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September 30, |
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September 30, |
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2018 |
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2017 |
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2018 |
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2017 |
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Operating expenses: |
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Research and development |
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$ |
14,353 |
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$ |
9,599 |
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$ |
42,577 |
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$ |
25,782 |
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General and administrative |
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4,389 |
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2,484 |
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11,688 |
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7,040 |
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Fair value of contingent consideration |
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635 |
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— |
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2,393 |
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— |
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Total operating expenses |
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19,377 |
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12,083 |
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56,658 |
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32,822 |
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Operating loss |
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(19,377 |
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(12,083 |
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(56,658 |
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(32,822 |
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Interest income |
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1,068 |
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348 |
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2,246 |
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734 |
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Other expense, net |
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(37 |
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(15 |
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(70 |
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(25 |
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Net loss |
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(18,346 |
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(11,750 |
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(54,482 |
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(32,113 |
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Other comprehensive loss |
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Unrealized gain (loss) on marketable securities, net of tax |
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(42 |
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16 |
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(15 |
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(4 |
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Comprehensive loss |
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$ |
(18,388 |
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$ |
(11,734 |
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$ |
(54,497 |
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$ |
(32,117 |
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Net loss per share, basic and diluted |
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$ |
(0.45 |
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$ |
(3.63 |
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$ |
(2.29 |
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$ |
(10.17 |
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Weighted-average number of shares used in computing net loss per share, basic and diluted |
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41,057,861 |
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3,236,760 |
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23,762,450 |
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3,157,505 |
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Condensed Balance Sheets
(In thousands)
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September 30, |
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December 31, |
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2018 |
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2017 |
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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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$ |
28,897 |
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$ |
7,298 |
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Contribution receivable |
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— |
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1,382 |
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Short-term marketable securities |
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148,917 |
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79,212 |
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Prepaid expenses and other current assets |
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2,002 |
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988 |
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Total current assets |
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179,816 |
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88,880 |
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Property and equipment, net |
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6,345 |
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6,958 |
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Long-term marketable securities |
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6,386 |
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5,118 |
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Restricted cash |
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550 |
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550 |
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Other long-term assets |
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1,624 |
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518 |
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Total assets |
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$ |
194,721 |
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$ |
102,024 |
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Liabilities, convertible preferred stock, and stockholders' equity (deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
2,624 |
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$ |
2,378 |
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Accrued compensation |
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2,839 |
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2,181 |
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Accrued and other current liabilities |
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4,618 |
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3,338 |
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Contingent consideration liability, current portion |
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1,609 |
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— |
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Total current liabilities |
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11,690 |
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7,897 |
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Deferred rent, net of current portion |
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2,667 |
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3,166 |
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Contingent consideration liability, net of current portion |
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784 |
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— |
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Other non-current liabilities |
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64 |
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118 |
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Total liabilities |
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15,205 |
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11,181 |
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Convertible preferred stock |
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— |
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173,956 |
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Stockholders' equity (deficit): |
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Common stock |
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4 |
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1 |
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Additional paid-in capital |
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321,594 |
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4,072 |
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Related party promissory notes for purchase of common stock |
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(201 |
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(202 |
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Employee promissory notes for purchase of common stock |
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(400 |
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— |
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Accumulated other comprehensive loss |
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(119 |
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(104 |
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Accumulated deficit |
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(141,362 |
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(86,880 |
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Total stockholders' equity (deficit) |
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179,516 |
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(83,113 |
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Total liabilities, convertible preferred stock, and stockholders' equity (deficit) |
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$ |
194,721 |
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$ |
102,024 |
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Endurance Advisors
Elizabeth Broder
ebroder@enduranceadvisors.com
Media
Austine Graff
1-650-443-6725
austine.graff@unitybiotechnology.com