UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 November 10, 2022, Spruce Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2022 and provided a corporate update. 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 Number |
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Description |
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99.1 |
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Press Release of Spruce Biosciences, Inc., dated November 10, 2022 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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, 2022 |
By: |
/s/ Samir Gharib |
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Samir Gharib |
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Exhibit 99.1
Spruce Biosciences Reports Third Quarter 2022 Financial Results and Provides Corporate Updates
CAHmelia-203 Approaching 50% Enrollment; CAHmelia-204 Recently Surpassed 25% Enrollment
Appointment of Saba Sile, M.D., as Vice President of Clinical Development
San Francisco, Calif. – November 10, 2022 – Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today reported financial results for the third quarter ended September 30, 2022 and provided corporate updates.
“The third quarter of 2022 was one of continuous execution and momentum on multiple fronts. We were pleased to have recently surpassed 25% enrollment in our CAHmelia-204 study and are approaching 50% enrollment in our CAHmelia-203 study,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “As we continue to advance our late-stage clinical pipeline of therapies for rare endocrine disorders, I am excited to welcome Dr. Saba Sile as our Vice President of Clinical Development. With her extensive background in directing clinical development across multiple rare disease programs, Dr. Sile will play a key role in delivering on the full potential of tildacerfont to bring therapeutic benefit to patients with congenital adrenal hyperplasia (CAH) and other endocrine disorders.”
Recent Corporate Update
Anticipated Upcoming Milestones
Third Quarter 2022 Financial Results
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years. Spruce is also developing tildacerfont for women suffering from polycystic ovary syndrome (PCOS) with primary adrenal androgen excess. To learn more, visit www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio, 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 enrollment, results, conduct, progress and timing of Spruce’s clinical trials; the receipt of topline data from the same; and Dr. Sile’s role as Vice President of Clinical Development. 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”, “believe”, “potential” 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, including the COVID-19 pandemic, 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.
Use of Non-GAAP Financial Measure
This release and the reconciliation tables included herein include non-GAAP total operating expenses, which excludes depreciation and stock-based compensation expenses. Spruce excludes depreciation and stock-based compensation expenses because management believes the exclusion of these items is helpful to investors to evaluate Spruce's recurring operational performance. Spruce management uses this non-GAAP financial measure to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. This non-GAAP financial measure should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results.
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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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
21,649 |
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$ |
42,748 |
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Short-term investments |
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68,751 |
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46,221 |
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Prepaid expenses and other current assets |
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2,786 |
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2,926 |
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Total current assets |
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93,186 |
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91,895 |
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Restricted cash |
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216 |
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216 |
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Operating lease right-of-use assets |
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1,229 |
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1,479 |
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Long-term investments |
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— |
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32,459 |
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Other assets |
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667 |
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437 |
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Total assets |
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$ |
95,298 |
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$ |
126,486 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,181 |
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$ |
2,823 |
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Term loan, current portion |
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1,216 |
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— |
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Accrued expenses and other current liabilities |
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8,604 |
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6,048 |
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Total current liabilities |
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12,001 |
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8,871 |
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Term loan, net of current portion |
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3,685 |
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4,878 |
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Operating lease liability, net of current portion |
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998 |
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1,293 |
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Other liabilities |
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139 |
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73 |
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Total liabilities |
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16,823 |
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15,115 |
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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 |
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— |
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— |
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Common stock, $0.0001 par value, 200,000,000 shares authorized as |
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3 |
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3 |
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Additional paid-in capital |
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217,514 |
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214,685 |
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Accumulated other comprehensive loss |
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(873 |
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(184 |
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Accumulated deficit |
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(138,169 |
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(103,133 |
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Total stockholders’ equity |
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78,475 |
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111,371 |
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Total liabilities and stockholders’ equity |
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$ |
95,298 |
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$ |
126,486 |
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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 |
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Nine Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
8,791 |
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$ |
8,607 |
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$ |
26,359 |
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$ |
24,440 |
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General and administrative |
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2,766 |
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2,793 |
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8,814 |
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8,491 |
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Total operating expenses |
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11,557 |
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11,400 |
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35,173 |
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32,931 |
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Loss from operations |
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(11,557 |
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(11,400 |
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(35,173 |
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(32,931 |
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Interest expense |
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(110 |
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(88 |
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(291 |
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(257 |
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Interest and other income, net |
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266 |
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41 |
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428 |
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80 |
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Net loss |
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$ |
(11,401 |
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$ |
(11,447 |
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$ |
(35,036 |
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$ |
(33,108 |
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Unrealized (loss) gain on available for sale |
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(28 |
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13 |
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(689 |
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(16 |
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Comprehensive loss |
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$ |
(11,429 |
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$ |
(11,434 |
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$ |
(35,725 |
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$ |
(33,124 |
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Net loss per share, basic and diluted |
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$ |
(0.48 |
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$ |
(0.49 |
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$ |
(1.49 |
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$ |
(1.42 |
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Weighted-average shares of common stock |
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23,560,250 |
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23,367,140 |
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23,515,651 |
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23,330,399 |
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SPRUCE BIOSCIENCES, INC.
Reconciliation of Total Operating Expenses to Total Non-GAAP Operating Expenses
(unaudited)
(in thousands)
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Three Months Ended |
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Nine Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Total operating expenses |
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$ |
11,557 |
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$ |
11,400 |
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$ |
35,173 |
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$ |
32,931 |
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Adjustments: |
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Depreciation |
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10 |
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5 |
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27 |
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14 |
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Stock-based compensation |
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783 |
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1,031 |
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2,829 |
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3,161 |
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Total non-GAAP operating expenses |
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$ |
10,764 |
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$ |
10,364 |
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$ |
32,317 |
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$ |
29,756 |
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Media Contact
Will Zasadny
Canale Communications
(619) 961-8848
will.zasadny@canalecomm.com
media@sprucebiosciences.com
Investors
Xuan Yang
Solebury Strategic Communications
(415) 971-9412
xyang@soleburystrat.com
investors@sprucebiosciences.com