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:
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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 May 11, 2022, Spruce Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2022 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 (“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 May 11, 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: |
May 11, 2022 |
By: |
/s/ Samir Gharib |
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Samir Gharib |
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Exhibit 99.1
Spruce Biosciences Reports First Quarter 2022 Financial Results and Provides Corporate Update
25% Enrollment Achieved in CAHmelia-203 Study for Adult Classic CAH; On Track to Report Topline Data in 2H 2023
Debt Facility with Silicon Valley Bank Amended to Provide Up to $10 Million Credit Line in 2022
Tildacerfont Patent Portfolio Estate Expanded with Key Method of Use Patents
Libbie Mansell, Ph.D., M.B.A., R.A.C., Appointed Chief Regulatory and Quality Officer
San Francisco, Calif. – May 11, 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 first quarter ended March 31, 2022 and provided corporate updates.
“Throughout the first quarter of 2022, we continued to drive our clinical and business objectives forward, with key progress made in our lead program for adults with classic congenital adrenal hyperplasia (CAH), expansion of our executive leadership team, and through potential access to non-dilutive sources of capital. We were pleased to achieve the recent milestone of 25% enrollment in our CAHmelia-203 study for adult classic CAH, which keeps us on track to meet topline data readout for the study in the second half of 2023,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “The enhanced protocols we rolled-out for the CAHmelia-203 and 204 studies have been well-received by study investigators across our global trial sites and have streamlined screening activities. We look forward to continuing this momentum and providing further enrollment updates over the course of the year.”
Recent Corporate & Pipeline Updates
Upcoming Corporate Access Events
Date: May 17-18, 2022
Format: Fireside chat (May 17 at 10:00 a.m. ET) and 1x1 meetings
Date: May 23-26, 2022
Format: Company presentation (May 25 at 4:00 p.m. ET) and 1x1 meetings
Upcoming Medical Conferences
Date: May 21-24, 2022
Date: June 11-14, 2022
Anticipated Upcoming Milestones
First Quarter 2022 Financial Results
237695947 v1
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 and announcements regarding the same, and the funding of Spruce’s operations. 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,” “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 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 Measures
Spruce has presented certain non-GAAP financial measures in this release. This release and the reconciliation table included herein include non-GAAP total operating expenses, which excludes 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 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.
237695947 v1
SPRUCE BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share amounts)
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March 31, |
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December 31, |
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ASSETS |
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(unaudited) |
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Current assets: |
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Cash and cash equivalents |
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$ |
23,343 |
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$ |
42,748 |
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Short-term investments |
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68,005 |
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46,221 |
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Prepaid expenses |
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3,423 |
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2,530 |
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Other current assets |
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325 |
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396 |
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Total current assets |
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95,096 |
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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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Right-of-use assets, net |
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1,397 |
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1,479 |
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Long-term investments |
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17,601 |
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32,459 |
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Other assets |
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678 |
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437 |
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Total assets |
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$ |
114,988 |
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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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$ |
1,109 |
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$ |
2,823 |
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Term loan, current portion |
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405 |
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— |
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Accrued expenses and other current liabilities |
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6,457 |
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4,613 |
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Accrued compensation and benefits |
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998 |
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1,435 |
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Total current liabilities |
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8,969 |
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8,871 |
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Term loan, net of current portion |
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4,485 |
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4,878 |
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Lease liability, net of current portion |
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1,196 |
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1,293 |
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Other liabilities |
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95 |
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73 |
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Total liabilities |
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14,745 |
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15,115 |
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Stockholders’ equity: |
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Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of March 31, 2022 and December 31, 2021 |
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— |
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— |
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Common stock, $0.0001 par value, 200,000,000 shares authorized, 23,492,873 and 23,491,881 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively |
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3 |
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3 |
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Additional paid-in capital |
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215,828 |
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214,685 |
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Accumulated other comprehensive loss |
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(693 |
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(184 |
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Accumulated deficit |
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(114,895 |
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(103,133 |
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Total stockholders’ equity |
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100,243 |
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111,371 |
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Total liabilities and stockholders’ equity |
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$ |
114,988 |
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$ |
126,486 |
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237695947 v1
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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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
8,508 |
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$ |
6,714 |
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General and administrative |
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3,225 |
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3,103 |
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Total operating expenses |
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11,733 |
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9,817 |
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Loss from operations |
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(11,733 |
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(9,817 |
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Interest expense |
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(87 |
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(89 |
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Other income, net |
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58 |
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19 |
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Net loss |
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$ |
(11,762 |
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$ |
(9,887 |
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Unrealized loss on available for sale securities |
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(509 |
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— |
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Comprehensive loss |
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$ |
(12,271 |
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$ |
(9,887 |
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Net loss per share, basic and diluted |
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$ |
(0.50 |
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$ |
(0.42 |
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Weighted-average shares of common stock outstanding, basic and |
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23,492,295 |
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23,283,658 |
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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 March 31, |
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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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$ |
11,733 |
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$ |
9,817 |
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Adjustments: |
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Depreciation |
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9 |
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4 |
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Stock-based compensation |
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1,141 |
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1,120 |
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Non-GAAP total operating expenses |
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$ |
10,583 |
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$ |
8,693 |
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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