UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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(650) 770-0077 Registrant’s telephone number, including area code |
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(Former name or former address, if changed since last report)
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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Trading |
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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.
Item 2.02 Results of Operations and Financial Condition
On March 24, 2022, Vera Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2021, and providing recent corporate updates. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and shall not be incorporated by reference in any filing 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
99.1 |
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Press Release of Vera Therapeutics, Inc., dated March 24, 2022. |
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, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Vera Therapeutics, Inc. |
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Date: |
March 24, 2022 |
By: |
/s/ Sean Grant |
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Sean Grant, Chief Financial Officer |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Vera Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results
2H-2022
BRISBANE, Calif., March 24, 2022 – Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the fourth quarter and full year ended December 31, 2021.
“2021 was a defining period for our company, as we executed against our business strategy and accomplished a number of key objectives. We have built a world class team, completed our initial public offering, and both advanced and expanded the Vera pipeline, with two programs currently in Phase 2 clinical trials. We believe this initial progress is being recognized by our investors, as Vera finished the year as the top performing biotech IPO in 2021,” said Marshall Fordyce, MD, Founder and CEO of Vera Therapeutics.
“At the start of 2022, we strengthened our balance sheet by completing an equity offering with net proceeds of approximately $80.2 million. Looking ahead, we expect to achieve several clinical milestones in 2022. At the forefront of our pipeline is atacicept for IgA nephropathy, currently in the Phase 2b ORIGIN study. This study is expected to complete enrollment in mid-2022 and announce topline results in the fourth quarter. We expect these data to support initiation of a pivotal Phase 3 clinical trial of atacicept in 2023. In addition, we recently announced a positive meeting with the FDA evaluating the development program for atacicept to treat lupus nephritis. As a result, we are planning to advance this program into a Phase 3 pivotal clinical trial later this year.
“At the end of 2021, we acquired a promising new clinical stage program, MAU868, to treat patients with BK Virus infections, a population that currently lacks an effective therapeutic option. MAU868 is being studied in an ongoing Phase 2 study in patients with BKV reactivation after kidney transplant, and we plan on presenting the full interim data from this study in mid-2022, and initiating a Phase 2b or Phase 3 clinical trial of MAU868 in kidney transplant patients with BK Virus reactivation in 2023. To help educate the market about the clinical importance of BK Virus reactivation and the opportunity for MAU868, we have scheduled an event that will
include a presentation from world-renowned transplant nephrologist and pioneering kidney transplant researcher, Stanley C. Jordan, M.D., FASN, FAST,” concluded Dr. Fordyce.
Fourth Quarter and Recent Business Highlights
Upcoming Milestones
Expect to announce topline data in the fourth quarter of 2022 for the Phase 2b ORIGIN clinical trial, a dose-ranging study evaluating the safety and efficacy of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression.
Financial Results for the Year Ended December 31, 2021
For the three months ended December 31, 2021, the company reported a net loss of $16.8 million, or a net loss per diluted share of $0.79, compared to a net loss of $42.9 million, or a net loss per diluted share of $137.63, for the same period last year. Outstanding shares of redeemable convertible preferred stock were excluded from the computation of net loss per diluted share for periods prior to the conversion of those shares to common stock in May 2021.
During the year ended December 31, 2021, net cash used in operating activities was $23.7 million, compared to $34.8 million for the same period last year.
Vera reported approximately $79.7 million in cash and cash equivalents as of December 31, 2021. Subsequent to the end of the quarter, the company raised approximately $80.2 million in net proceeds from a public offering of Class A Common Stock that was completed in February 2022. In addition, the company has secured a credit facility through Oxford with a remaining borrowing capacity of up to $45 million.
Conference Call and Webcast
Vera’s management team will host a webcast today at 8:00 a.m. ET to discuss a financial results and recent corporate developments. The dial-in number for the webcast is 1-877-423-9813 for domestic participants and 1-201-689-8573 for international participants, with Conference ID #13727899. A live webcast of the conference call can be accessed at (click here) or through the Investors section of the Vera website at https://ir.veratx.com/news-events/investor-calendar. A replay will be available on this website shortly after conclusion of the event for approximately 90 days.
About Vera
Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger’s disease and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit www.veratx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the continued tolerability of Vera’s product candidates, research and clinical development plans and timing, the scope, progress, and results of developing Vera’s product candidates, strategy, and regulatory matters, including the timing and likelihood of success of obtaining drug approvals. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “will,” “expects,” “potential,” and similar expressions are intended to
identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, risks and uncertainties associated with Vera’s business in general, the impact of the COVID-19 pandemic, and the other risks described in Vera’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K expected to be filed with the Securities and Exchange Commission on March 25, 2022, particularly under the caption “Risk Factors.” All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
For more information, please contact:
Investor Contact:
Joyce Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com
Media Contact:
Kathy Vincent
Greig Communications, Inc.
kathy@greigcommunications.com
VERA THERAPEUTICS, INC.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
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Three Months Ended December 31, |
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For the Year Ended December 31, |
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2021 |
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2020 |
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2021 |
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2020 |
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(unaudited) |
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Operating expenses: |
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Research and development |
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$ |
12,753 |
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$ |
39,844 |
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$ |
22,484 |
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$ |
45,206 |
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General and administrative |
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3,832 |
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1,136 |
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11,918 |
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4,039 |
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Restructuring Costs |
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- |
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1,580 |
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- |
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2,996 |
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Total operating expenses |
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16,585 |
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42,560 |
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34,402 |
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52,241 |
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Loss from operations |
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(16,585 |
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(42,560 |
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(34,402 |
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(52,241 |
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Total other income (expense), net |
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(261 |
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(314 |
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1,794 |
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(1,171 |
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Provision for income taxes |
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(1 |
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(1 |
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(1 |
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(1 |
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Net loss and comprehensive loss |
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$ |
(16,847 |
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$ |
(42,875 |
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$ |
(32,609 |
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$ |
(53,413 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.79 |
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$ |
(137.63 |
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$ |
(2.43 |
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$ |
(166.93 |
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Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
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21,276,355 |
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311,522 |
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13,435,706 |
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319,963 |
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VERA THERAPEUTICS, INC.
Condensed Balance Sheets
(in thousands)
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December 31, |
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December 31, |
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2021 |
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2020 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
79,674 |
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$ |
53,654 |
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Restricted cash, current |
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- |
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50 |
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Prepaid expenses and other current assets |
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2,863 |
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557 |
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Total current assets |
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82,537 |
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54,261 |
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Restricted cash, noncurrent |
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293 |
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293 |
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Prepaid expenses and other current assets, noncurrent |
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51 |
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- |
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Non-marketable equity securities |
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867 |
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- |
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Total assets |
$ |
83,748 |
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$ |
54,554 |
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Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) |
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Current liabilities: |
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Accounts payable |
$ |
1,385 |
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$ |
909 |
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Restructuring liability, current |
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377 |
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962 |
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Accrued expenses and other current liabilities |
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5,928 |
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535 |
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Total current liabilities |
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7,690 |
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2,406 |
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Long term debt |
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4,923 |
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- |
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Restructuring liability, noncurrent |
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1,257 |
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1,634 |
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Accrued and other noncurrent liabilities |
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286 |
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286 |
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Total liabilities |
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14,156 |
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4,326 |
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Redeemable convertible preferred stock |
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- |
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139,576 |
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Stockholders' equity (deficit) |
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Common stock |
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21 |
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- |
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Additional paid-in-capital |
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193,627 |
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2,099 |
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Accumulated deficit |
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(124,056 |
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(91,447 |
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Total stockholders' equity (deficit) |
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69,592 |
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(89,348 |
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Total liabilities, redeemable convertible preferred stock and stockholders' equity |
$ |
83,748 |
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$ |
54,554 |
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