8-K
false000168355300016835532025-11-102025-11-10
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
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Date of Report (Date of earliest event reported): November 10, 2025 |
Spruce Biosciences, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-39594 |
81-2154263 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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611 Gateway Boulevard, Suite 740 |
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South San Francisco, California |
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94080 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 415-655-4168 |
(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:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ 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
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Trading
Symbol(s) |
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share |
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SPRB |
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Nasdaq Capital 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 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 November 10, 2025, Spruce Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 2025 and providing 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 (the "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
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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SPRUCE BIOSCIENCES, INC. |
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Date: |
November 10, 2025 |
By: |
/s/ Samir Gharib |
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Samir Gharib
President and Chief Financial Officer |
EX-99.1
Spruce Biosciences Reports Third Quarter 2025 Financial Results and Provides Corporate Updates
Granted Breakthrough Therapy Designation for Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfillipo Syndrome Type B (MPS IIIB)
Biologics License Application Submission of TA-ERT for the Treatment of MPS IIIB on Track for the First Quarter of 2026
Completed $50.0 Million Private Placement Financing Backed by Dedicated Healthcare Investors
South San Francisco, Calif. – November 10, 2025 – Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today reported financial results for the third quarter ended September 30, 2025 and provided corporate updates.
“We have made significant progress this year with the receipt of Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for our tralesinidase alfa enzyme replacement therapy (TA-ERT), followed by the syndication of a $50 million private placement financing backed by an impressive group of healthcare investors. These important corporate milestones underscore the transformative moments in our collective efforts to advance TA-ERT as potentially the first disease-modifying therapy to treat children with MPS IIIB,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “The recent financing provides the capital resources to advance TA-ERT well beyond a biologics license application (BLA) submission expected in the first quarter of 2026.”
Dr. Szwarcberg continued, “I am very proud of our team for the advancements we have made this year, appreciative of the unwavering support from our Board and investors, and grateful to the patients and families who took part in the TA-ERT clinical trials. We look forward to an impactful 2026 as we move towards bringing to market a new, life-changing treatment option for children affected by MPS IIIB.”
Corporate Updates
•$50.0 Million Private Placement Financing Backed by Dedicated Healthcare Investors. In October 2025, the company entered into a definitive securities purchase agreement for a private placement that resulted in gross proceeds of approximately $50.0 million, before deducting offering expenses. Under the securities purchase agreement, the investors purchased 502,181 shares of the company’s common stock. In lieu of shares of common stock, as a portion of their investment, certain investors purchased prefunded warrants to purchase up to 233,144 shares of common stock. The prefunded warrants are exercisable for a period of five years following the date of issuance.
•U.S. FDA Breakthrough Therapy Designation Granted to TA-ERT for the Treatment of MPS IIIB. Granted to Spruce in October 2025, the FDA Breakthrough Therapy Designation is designed to expedite the development and regulatory review of promising therapies for serious or life-threatening conditions where preliminary clinical evidence suggests the potential for substantial improvement over existing treatments. The designation facilitates more intensive FDA guidance, cross-disciplinary collaboration, and eligibility for rolling submission and priority review.
•Relisted “SPRB” on the Nasdaq Capital Market. In September 2025, the company resumed trading on the Nasdaq Capital Market under the ticker symbol “SPRB” and CUSIP 85209E 208, following a one-for-75 reverse stock split.
Third Quarter 2025 Financial Results
•Cash and Cash Equivalents: Cash and cash equivalents as of September 30, 2025, were $10.7 million, which does not include approximately $50.0 million in gross proceeds from the October 2025 private placement financing. Cash and cash equivalents as of September 30, 2025, plus proceeds from the October 2025 private placement financing are expected to fund the company’s current operating plan into the fourth quarter of 2026.
•Research and Development (R&D) Expenses: R&D expenses for the three and nine months ended September 30, 2025, were $5.0 million and $15.4 million, respectively, compared to $6.6 million and $25.0 million for the same periods in 2024. The decrease in R&D expenses was primarily related to the cessation of development activities of tildacerfont for the treatment of congenital adrenal hyperplasia (CAH), offset by development activities related to TA-ERT for the treatment of MPS IIIB.
•General and Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2025, were $3.2 million and $10.0 million, respectively, compared to $3.5 million and $11.3 million for the same periods in 2024, primarily driven by a decrease in stock-based compensation expense.
•Total Operating Expenses: Total operating expenses for the three and nine months ended September 30, 2025, were $8.2 million and $25.4 million, respectively, compared to $10.0 million and $36.3 million for the same periods in 2024. Operating expenses include non-cash stock-based compensation expenses of $0.4 million and $0.9 million for the three and nine months ended September 30, 2025, respectively, compared to $1.1 million and $4.4 million for the same periods in 2024.
•Net Loss: Net loss for the three and nine months ended September 30, 2025, was $8.2 million and $24.3 million, respectively, compared to $8.7 million and $29.5 million for the same periods in 2024.
•Capital Structure: Common shares outstanding as of September 30, 2025, were 563,491, which excludes 25,512 outstanding restricted stock units and 28,118 outstanding prefunded warrants to purchase common stock. In connection with the October 2025 private placement financing, 502,181 shares of common stock and 233,144 prefunded warrants to purchase common stock were issued to certain investors.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. To learn more, visit www.sprucebio.com and follow us on X, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts 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 timing and likelihood of regulatory filings and approvals for TA-ERT, including the anticipated biologics license application submission of TA-ERT for MPS IIIB in the first quarter of 2026; TA-ERT’s potential to be the first disease-modifying therapy to treat MPS IIIB; TA-ERT’s potential to be a new, life-changing treatment option for children affected by MPS IIIB; and the Company’s ability to fund its operating plan into the fourth quarter of 2026. 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 “anticipate”, “will”, “potential”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’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 and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. 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. Spruce 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.
Contacts
Media
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com
Investors
Samir Gharib
President and CFO
Spruce Biosciences, Inc.
investors@sprucebio.com
+++ tables to follow +++
SPRUCE BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands, except share and per share amounts)
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September 30, |
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December 31, |
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2025 |
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2024 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
10,669 |
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$ |
38,753 |
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Prepaid expenses |
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932 |
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3,177 |
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Other current assets |
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2,915 |
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2,276 |
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Total current assets |
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14,516 |
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44,206 |
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Right-of-use assets |
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735 |
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934 |
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Other assets |
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62 |
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69 |
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Total assets |
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$ |
15,313 |
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$ |
45,209 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,386 |
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$ |
1,295 |
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Accrued expenses and other current liabilities |
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7,502 |
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12,329 |
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Term loan, current portion |
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539 |
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1,622 |
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Total current liabilities |
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9,427 |
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15,246 |
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Lease liabilities, net of current portion |
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500 |
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736 |
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Term loan, net of current portion |
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— |
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124 |
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Other liabilities |
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— |
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282 |
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Total liabilities |
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9,927 |
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16,388 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock, $0.0001 par value; 10,000,000 shares authorized
and no shares issued or outstanding as of September 30, 2025
and December 31, 2024 |
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— |
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— |
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Common stock, $0.0001 par value; 200,000,000 shares authorized as of
September 30, 2025 and December 31, 2024; 563,491 and 563,042
shares issued and outstanding as of September 30, 2025 and December 31,
2024, respectively |
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— |
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— |
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Additional paid-in capital |
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279,974 |
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279,089 |
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Accumulated deficit |
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(274,588 |
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(250,268 |
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Total stockholders’ equity |
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5,386 |
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28,821 |
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Total liabilities and stockholders’ equity |
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$ |
15,313 |
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$ |
45,209 |
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SPRUCE BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Collaboration revenue |
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$ |
— |
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$ |
602 |
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$ |
— |
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$ |
4,214 |
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Operating expenses: |
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Research and development |
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5,011 |
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6,554 |
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15,418 |
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24,961 |
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General and administrative |
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3,218 |
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3,456 |
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9,995 |
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11,330 |
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Total operating expenses |
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8,229 |
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10,010 |
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25,413 |
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36,291 |
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Loss from operations |
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(8,229 |
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(9,408 |
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(25,413 |
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(32,077 |
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Interest expense |
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(19 |
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(71 |
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(84 |
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(251 |
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Interest and other income, net |
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36 |
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808 |
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1,177 |
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2,851 |
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Net loss and comprehensive loss |
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(8,212 |
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(8,671 |
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(24,320 |
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(29,477 |
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Net loss per share, basic and diluted |
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$ |
(14.58 |
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$ |
(15.75 |
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$ |
(41.25 |
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$ |
(53.68 |
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Weighted-average shares of common stock
outstanding, basic and diluted |
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563,066 |
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550,645 |
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589,520 |
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549,116 |
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