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:
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.
Item 2.02 Results of Operations and Financial Condition.
On March 14, 2022, Spruce Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2021 and providing 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 |
99.1 |
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Press Release of Spruce Biosciences, Inc., dated March 14, 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: |
March 14, 2022 |
By: |
/s/ Samir Gharib |
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Samir Gharib |
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Exhibit 99.1
Spruce Biosciences Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Updates
Topline Safety Data from Cohort 1 of Pediatric Classic CAH Study Expected by 1H 2023
Will Charlton, M.D., M.A.S., Appointed Chief Medical Officer
San Francisco, Calif. – March 14, 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 fourth quarter and full year ended December 31, 2021 and provided a corporate update.
“Over the last quarter, we have made notable progress in our efforts to advance new treatment options for people living with rare endocrine disorders and to maximize the potential of tildacerfont as a therapeutic to treat people living with classic congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS),” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “We are expanding the number of study sites globally and rolling out updated protocols for the CAHmelia-203 and CAHmelia-204 clinical trials in adult classic CAH, which we expect will accelerate patient enrollment. We were also pleased to initiate our Phase 2 clinical trials in patients with pediatric classic CAH and PCOS and expect topline results from both studies by the first half of 2023.”
Corporate Updates
Anticipated Upcoming Milestones
Fourth Quarter and Full Year 2021 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 a rare form of 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 results, conduct, progress and timing of Spruce’s clinical trials and announcements regarding the same. 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 expect,” “plans”, “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 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.
237695947 v1
Use of Non-GAAP Financial Measures
Spruce has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included herein include non-GAAP total operating expenses and non-GAAP G&A expenses, both of which exclude depreciation and stock-based compensation. Spruce excludes depreciation and stock-based compensation because management believes the exclusion of these items is helpful to investors to evaluate Spruce's recurring operational performance. Spruce management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures 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.
237695947 v1
SPRUCE BIOSCIENCES, INC.
BALANCE SHEETS
(in thousands, except share amounts)
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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 |
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$ |
42,748 |
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$ |
157,150 |
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Short-term investments |
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46,221 |
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— |
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Prepaid expenses |
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2,530 |
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2,971 |
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Other current assets |
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396 |
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276 |
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Total current assets |
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91,895 |
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160,397 |
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Restricted cash |
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216 |
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216 |
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Right-of-use assets |
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1,479 |
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1,793 |
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Long-term investments |
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32,459 |
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— |
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Other assets |
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437 |
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477 |
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Total assets |
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$ |
126,486 |
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$ |
162,883 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,823 |
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$ |
3,628 |
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Term loan, current portion |
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— |
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2,554 |
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Accrued expenses and other current liabilities |
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4,613 |
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2,496 |
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Accrued compensation and benefits |
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1,435 |
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1,085 |
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Total current liabilities |
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8,871 |
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9,763 |
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Term loan, net of current portion |
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4,878 |
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1,922 |
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Lease liability, net of current portion |
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1,293 |
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1,653 |
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Other liabilities |
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73 |
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118 |
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Total liabilities |
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15,115 |
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13,456 |
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Stockholders’ equity: |
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Preferred stock, $0.0001 par value; 10,000,000 shares and 0 shares authorized as of |
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— |
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— |
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Common stock, $0.0001 par value; 200,000,000 shares authorized as of |
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3 |
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2 |
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Additional paid-in capital |
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214,685 |
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210,266 |
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Accumulated other comprehensive loss |
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(184 |
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— |
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Accumulated deficit |
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(103,133 |
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(60,841 |
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Total stockholders’ equity |
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111,371 |
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149,427 |
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Total liabilities, and stockholders’ equity |
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$ |
126,486 |
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$ |
162,883 |
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237695947 v1
SPRUCE BIOSCIENCES, INC.
STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended |
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Twelve Months Ended |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
6,258 |
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$ |
5,814 |
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$ |
30,698 |
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$ |
23,854 |
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General and administrative |
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2,877 |
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2,521 |
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11,368 |
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5,562 |
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Total operating expenses |
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9,135 |
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8,335 |
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42,066 |
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29,416 |
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Loss from operations |
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(9,135 |
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(8,335 |
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(42,066 |
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(29,416 |
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Interest expense |
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(88 |
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(78 |
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(345 |
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(323 |
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Other income, net |
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39 |
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75 |
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119 |
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200 |
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Net loss |
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$ |
(9,184 |
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$ |
(8,338 |
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$ |
(42,292 |
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$ |
(29,539 |
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Net loss per share, basic and diluted |
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$ |
(0.39 |
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$ |
(0.39 |
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$ |
(1.81 |
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$ |
(4.93 |
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Weighted-average shares of common stock outstanding, |
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23,453,793 |
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21,542,045 |
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23,361,416 |
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5,991,213 |
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237695947 v1
SPRUCE BIOSCIENCES, INC.
Reconciliation of Total Operating Expenses to Non-GAAP Total Operating Expenses
(unaudited)
(in thousands)
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Three Months Ended December 31, |
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Twelve Months Ended |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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Total operating expenses |
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$ |
9,135 |
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$ |
8,335 |
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$ |
42,066 |
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$ |
29,416 |
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Adjustments: |
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Depreciation |
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8 |
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3 |
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22 |
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4 |
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Stock-based compensation |
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797 |
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410 |
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3,958 |
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754 |
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Non-GAAP total operating expenses |
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$ |
8,330 |
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$ |
7,922 |
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$ |
38,086 |
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$ |
28,658 |
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Reconciliation of G&A Expenses to Non-GAAP G&A Expenses
(unaudited)
(in thousands)
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Three Months Ended December 31, |
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Twelve Months Ended |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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G&A expenses |
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$ |
2,877 |
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$ |
2,521 |
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$ |
11,368 |
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$ |
5,562 |
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Adjustments: |
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Depreciation |
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6 |
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3 |
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20 |
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4 |
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Stock-based compensation |
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616 |
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221 |
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2,913 |
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428 |
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Non-GAAP G&A expenses |
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$ |
2,255 |
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$ |
2,297 |
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$ |
8,435 |
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$ |
5,130 |
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237695947 v1
Media Contact:
Will Zasadny
Canale Communications
(619) 961-8848
will@canalecomm.com
media@sprucebiosciences.com
Investors
Xuan Yang
Solebury Trout
(415) 971-9412
xyang@soleburytrout.com
investors@sprucebiosciences.com
237695947 v1