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 March 16, 2023, Spruce Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the full year ended December 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 (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
Exhibit Number |
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Description |
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99.1 |
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Press Release of Spruce Biosciences, Inc., dated March 16, 2023 |
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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 16, 2023 |
By: |
/s/ Samir Gharib |
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Samir Gharib |
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Exhibit 99.1
Spruce Biosciences Reports Full Year 2022 Financial Results and Provides Corporate Updates
CAHmelia-203 in Adult Classic CAH Surpasses 50% Enrollment
Private Placement Financing of $53.6 million in Gross Proceeds with Top-Tier Healthcare Investors
Strategic Partnership and Exclusive Licensing Agreement with Kaken Pharmaceutical to Develop and Commercialize Tildacerfont for CAH in Japan
Private Placement Proceeds and Kaken Upfront Payment Expected to Extend Cash Runway Into 1H 2025
South San Francisco, Calif. – March 16, 2023 – 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 year ended December 31, 2022 and provided corporate updates.
“In 2022, we made significant progress across the board heading into 2023, which we believe will be a pivotal year for Spruce,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “In 2023, we remain focused on delivering data for a number of our ongoing clinical programs, including topline data from our CAHmelia-203 study in adult classic congenital adrenal hyperplasia (CAH), which surpassed 50% enrollment.”
Dr. Szwarcberg continued, “We’ve had a very strong start to the year. In January, we announced a strategic collaboration and exclusive license agreement with Kaken Pharmaceutical (Kaken) to develop and commercialize tildacerfont for CAH in Japan. In February, we closed a private placement financing with top-tier healthcare investors for gross proceeds of $53.6 million, which, together with the Kaken upfront payment of $15.0 million, enables us to fund operating and capital expenditures into the first half of 2025, beyond topline results for CAHmelia-204 which are anticipated in the second half of 2024.”
Recent Corporate Updates
Anticipated Upcoming Milestones
Spruce affirms the following anticipated upcoming milestones:
Full Year 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). 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 and presentation of topline data from the same; research and development plans; Spruce’s planned operations, including its expectations regarding operating and capital expenditures being funded into the first half of 2025, and responsibilities of Spruce and Kaken pursuant to the exclusive license agreement. 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”, “enable”, “expect”, “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 other 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.
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, 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.
SPRUCE BIOSCIENCES, INC.
BALANCE SHEETS
(in thousands, except share and per share amounts)
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December 31, |
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2022 |
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2021 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
24,487 |
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$ |
42,748 |
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Short-term investments |
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54,590 |
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46,221 |
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Prepaid expenses |
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3,320 |
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2,530 |
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Other current assets |
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1,211 |
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396 |
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Total current assets |
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83,608 |
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91,895 |
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Long-term investments |
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— |
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32,459 |
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Operating lease right-of-use asset |
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1,400 |
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1,479 |
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Other assets |
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640 |
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653 |
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Total assets |
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$ |
85,648 |
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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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$ |
1,426 |
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$ |
2,823 |
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Accrued expenses and other current liabilities |
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9,399 |
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6,048 |
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Term loan, current portion |
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1,622 |
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— |
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Total current liabilities |
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12,447 |
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8,871 |
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Operating lease liability, net of current portion |
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1,261 |
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1,293 |
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Term loan, net of current portion |
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3,293 |
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4,878 |
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Other liabilities |
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161 |
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73 |
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Total liabilities |
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17,162 |
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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 and |
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— |
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— |
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Common stock, $0.0001 par value; 200,000,000 shares authorized as of |
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3 |
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3 |
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Additional paid-in capital |
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218,354 |
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214,685 |
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Accumulated other comprehensive loss |
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(558 |
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(184 |
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Accumulated deficit |
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(149,313 |
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(103,133 |
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Total stockholders’ equity |
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68,486 |
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111,371 |
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Total liabilities and stockholders’ equity |
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$ |
85,648 |
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$ |
126,486 |
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SPRUCE BIOSCIENCES, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
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Year Ended December 31, |
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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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$ |
35,198 |
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$ |
30,698 |
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General and administrative |
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12,085 |
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11,368 |
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Total operating expenses |
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47,283 |
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42,066 |
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Loss from operations |
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(47,283 |
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(42,066 |
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Interest expense |
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(420 |
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(345 |
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Interest and other income, net |
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1,523 |
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119 |
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Net loss |
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(46,180 |
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(42,292 |
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Other comprehensive loss, net of tax: |
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Unrealized loss on available for sale securities |
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(374 |
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(184 |
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Total comprehensive loss |
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$ |
(46,554 |
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$ |
(42,476 |
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Net loss per share, basic and diluted |
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$ |
(1.96 |
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$ |
(1.81 |
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Weighted-average shares of common stock outstanding, |
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23,527,116 |
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23,361,416 |
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SPRUCE BIOSCIENCES, INC.
RECONCILIATION OF TOTAL OPERATING EXPENSES TO NON-GAAP TOTAL OPERATING EXPENSES
(unaudited)
(in thousands)
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Year Ended December 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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$ |
47,283 |
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$ |
42,066 |
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Adjustments: |
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Depreciation |
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37 |
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22 |
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Stock-based compensation |
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3,631 |
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3,958 |
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Non-GAAP total operating expenses |
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$ |
43,615 |
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$ |
38,086 |
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Media
Will Zasadny
Evoke Canale
(619) 961-8848
will.zasadny@evokecanale.com
media@sprucebiosciences.com
Investors
Xuan Yang
Solebury Strategic Communications
(415) 971-9412
xyang@soleburystrat.com
investors@sprucebiosciences.com