SPRB 8-K
Spruce Biosciences, Inc. (SPRB)
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 May 13, 2024, Spruce Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the first quarter ended March 31, 2024 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 May 13, 2024 |
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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 13, 2024 |
By: |
/s/ Samir Gharib |
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Samir Gharib |
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Exhibit 99.1
Spruce Biosciences Reports First Quarter 2024 Financial Results and Provides Corporate Updates
Analyses of Data from CAHmelia-203 in Adult Congenital Adrenal Hyperplasia (CAH) Demonstrate Correlation Between Tildacerfont Response and Baseline Glucocorticoid (GC) Dose and Drug Compliance
Posters Highlighting Baseline Characteristics from the CAHmelia Program in Adult CAH and CAHptain-205 Study in Pediatric CAH Presented at the Pediatric Endocrine Society (PES) 2024 Annual Meeting
Topline Data from the CAHmelia-204 Study in Adult CAH and Additional Dose-Ranging Data from Adults and Children with CAH in CAHptain-205 Anticipated in Q3 2024
South San Francisco, Calif. – May 13, 2024 – 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, 2024 and provided corporate updates.
“We are encouraged by key learnings from analyses of data from our CAHmelia-203 clinical trial in adult CAH patients with severe hyperandrogenemia,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer, Spruce Biosciences. “In the open-label portion of the study, tildacerfont demonstrated a maximum mean reduction in adrenocorticotropic hormone (ACTH) of 45%, suggesting pituitary target engagement and direct evidence of its mechanism of action. Additionally, we observed that higher GC doses at baseline as well as higher rates of study drug compliance were associated with larger placebo-adjusted reductions from baseline in androstenedione (A4).”
Dr. Szwarcberg added, “These findings underscore the challenges of treating severe hyperandrogenemia within this patient population and reinforce our belief that tildacerfont may have a greater benefit in CAHmelia-204, which is assessing GC reduction in a controlled and more compliant population of adult CAH patients. We look forward to reporting data from the CAHmelia-204 study in the third quarter of this year.”
Analyses of Data from CAHmelia-203 in Adult CAH
Other Corporate Updates
Anticipated Upcoming Milestones
Upcoming Investor Conferences
Company management will participate in two upcoming investor conferences taking place in May.
Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer, will participate in a fireside chat at the JMP Securities Life Sciences Conference on May 14, 2024 at 10:30 a.m. ET and in a fireside chat at the RBC Capital Markets Global Healthcare Conference on May 15, 2024 at 8:30 a.m. ET. Company management will also be hosting 1x1 meetings at each conference.
The live webcast for each conference presentation can be accessed on the events section of the company’s investor relations website and will be available for replay after the conclusion of the live presentations for approximately 90 days.
First Quarter 2024 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) and other endocrine disorders. To learn more, visit www.sprucebio.com and follow us on Twitter/X @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 design, results, conduct, progress and timing of Spruce’s clinical trials; Spruce’s expectations regarding reporting results of its clinical trials in 2024; Spruce’s plans to meet with the FDA to discuss the potential registrational path forward of tildacerfont for adult and pediatric classic CAH; upcoming investor conferences; and Spruce’s product candidate, strategy and regulatory matters. 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”, “suggest”, “plan” 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.
SPRUCE BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands, except share and per share amounts)
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March 31, |
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December 31, |
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2024 |
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2023 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
81,154 |
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$ |
96,339 |
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Prepaid expenses |
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3,100 |
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3,876 |
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Other current assets |
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1,611 |
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1,968 |
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Total current assets |
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85,865 |
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102,183 |
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Right-of-use assets |
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1,121 |
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1,181 |
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Other assets |
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553 |
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582 |
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Total assets |
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$ |
87,539 |
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$ |
103,946 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,891 |
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$ |
3,332 |
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Accrued expenses and other current liabilities |
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11,973 |
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14,600 |
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Term loan, current portion |
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1,622 |
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1,622 |
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Deferred revenue |
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2,908 |
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4,911 |
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Total current liabilities |
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18,394 |
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24,465 |
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Lease liabilities, net of current portion |
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950 |
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1,019 |
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Term loan, net of current portion |
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1,321 |
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1,717 |
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Other liabilities |
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250 |
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236 |
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Total liabilities |
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20,915 |
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27,437 |
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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, $0.0001 par value; 200,000,000 shares authorized as of |
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4 |
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4 |
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Additional paid-in capital |
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275,477 |
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273,737 |
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Accumulated deficit |
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(208,857 |
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(197,232 |
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Total stockholders’ equity |
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66,624 |
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76,509 |
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Total liabilities and stockholders’ equity |
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$ |
87,539 |
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$ |
103,946 |
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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 March 31, |
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2024 |
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2023 |
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Collaboration revenue |
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$ |
2,002 |
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$ |
1,964 |
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Operating expenses: |
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Research and development |
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10,317 |
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11,712 |
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General and administrative |
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4,318 |
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3,451 |
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Total operating expenses |
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14,635 |
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15,163 |
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Loss from operations |
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(12,633 |
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(13,199 |
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Interest expense |
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(96 |
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(131 |
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Interest income and other expense, net |
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1,105 |
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539 |
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Net loss |
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(11,624 |
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(12,791 |
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Other comprehensive gain (loss), net of tax: |
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Unrealized gain on available for sale securities |
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— |
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370 |
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Total comprehensive loss |
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$ |
(11,624 |
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$ |
(12,421 |
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Net loss per share, basic and diluted |
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$ |
(0.28 |
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$ |
(0.40 |
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Weighted-average shares of common stock outstanding, |
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41,096,231 |
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31,900,160 |
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Media
Katie Beach Oltsik
Inizio Evoke Comms
(937) 232-4889
[email protected]
[email protected]
Investors
Samir Gharib
President and CFO
Spruce Biosciences, Inc.