SPRB Spruce Biosciences Inc

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 14, 2023

 

 

Spruce Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware			001-39594	81-2154263
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
611 Gateway Boulevard, Suite 740
South San Francisco, California				94080
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 415-655-4168

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

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:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		SPRB		Nasdaq Global Select Market

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. ☐

 

 

 

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Item 2.02 Results of Operations and Financial Condition.

On August 14, 2023, Spruce Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the second quarter ended June 30, 2023 and providing corporate updates that included interim results from the Company’s Phase 2 POWER proof-of-concept clinical trial evaluating its product candidate tildacerfont for the treatment of polycystic ovary syndrome (“PCOS”). 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 8.01 Other Events.

As noted in Item 2.02, on August 14, 2023, the Company issued a press release providing corporate updates that included interim results from the Company’s Phase 2 POWER proof-of-concept clinical trial evaluating its product candidate tildacerfont for the treatment of PCOS. The POWER clinical trial is a randomized, placebo-controlled, dose-escalation trial to evaluate the safety and efficacy of tildacerfont titrated to 200 mg QD compared to placebo at 12 weeks of treatment in subjects with PCOS and elevated adrenal androgens as measured by dehydroepiandrosterone sulfate (“DHEAS”) levels at baseline. The Company conducted an analysis of interim data from 20 patients (13 on tildacerfont and 7 on placebo) through the 12-week treatment period for the POWER clinical trial. The study enrolled 27 patients in total. The interim data from the POWER clinical trial support target engagement and suggest that DHEAS may be reduced with tildacerfont treatment in women suffering from PCOS. Tildacerfont was well-tolerated, with a safety profile that is consistent with past studies. Most adverse events were classified as mild-moderate, balanced between treatment arms, unrelated to study drug and single event occurrences. No serious adverse reactions or dose toxicities were observed, and there was no evidence of adrenal insufficiency. Final data from the POWER clinical trial will be presented at a future medical conference.

Forward Looking Statements

This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the “safe harbor” provisions 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 the Company’s clinical trials; the receipt and presentation of topline data from the same; research and development plans; the Company’s planned operations, including its expectations regarding operating and capital expenditures being funded into the first half of 2025; the implications of the interim data from the POWER study; tildacerfont’s potential to become a first-in-class therapy for PCOS; the Company’s expectations to further engage regulatory authorities regarding tildacerfont; and the ability of tildacerfont to provide a therapeutic option to treat the underlying cause of disease through reductions of ACTH. 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”, “expect”, “may,” “plan,” “will”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company’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, the risk that interim data from the POWER study will differ from final data once available, along with risks and uncertainties associated with the Company’s business in general, the impact of geopolitical and macroeconomic events, and other risks and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, its subsequently filed Quarterly Reports on Form 10-Q, and the other documents the Company files from time to time with the U.S. Securities and Exchange Commission. These forward-looking statements speak only as of the date of this Current Report on Form 8-K, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description
99.1		Press Release of Spruce Biosciences, Inc., dated August 14, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

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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.

			SPRUCE BIOSCIENCES, INC.
Date:	August 14, 2023	By:	/s/ Samir Gharib
			Samir Gharib President and Chief Financial Officer

 

2

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Exhibit 99.1

Spruce Biosciences Reports Second Quarter 2023 Financial Results and Provides Corporate Updates

 

Spruce Reports Interim Data from Phase 2 POWER Proof-of-Concept Study in Polycystic Ovary Syndrome (PCOS)

CAHmelia Program in Adult Classic Congenital Adrenal Hyperplasia (CAH) Surpasses 75% Enrollment in CAHmelia-203 and Approaches 75% Enrollment in CAHmelia-204

Screening Underway for Cohort 3 in CAHptain Study for Pediatric Classic CAH

 

South San Francisco, Calif. – August 14, 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 second quarter ended June 30, 2023 and provided corporate updates.

 

“Our goal with the POWER study is to assess the ability of tildacerfont to reduce dehydroepiandrosterone sulfate (DHEAS) in women with PCOS, and the interim results support target engagement and suggest that DHEAS may be reduced with tildacerfont treatment” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “With a significant unmet medical need for new PCOS treatments and no FDA-approved therapies today, we are eager to analyze and present the full data set at an upcoming medical conference.”

Dr. Szwarcberg continued, “As we approach key topline data readouts, we continue to make meaningful progress across our adult and pediatric CAH programs. In our CAHmelia program in adult classic CAH, we’ve surpassed 75% enrollment in the CAHmelia-203 study and are approaching 75% enrollment in the CAHmelia-204 study. Cohort 2 in our CAHptain study for pediatric classic CAH is nearly fully enrolled, with screening in cohort 3 currently underway. Finally, as we continue building our seasoned leadership team for the pivotal year ahead, I am delighted to welcome Heidi Petersen, M.P.H., as our Senior Vice President of Regulatory and Quality. With more than 25 years of life sciences industry experience managing complex drug development programs, Ms. Petersen will be vital as we advance tildacerfont towards a potential registrational submission for classic CAH.”

 

Recent Corporate Updates

 

 

 

 

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Anticipated Upcoming Milestones

 

 

 

Second Quarter 2023 Financial Results

 

 

 

 

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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). 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; the implications of the interim data from the POWER study; tildacerfont’s potential to become a first-in-class therapy for PCOS; Spruce’s expectations to further engage regulatory authorities regarding tildacerfont; and the ability of tildacerfont to provide a therapeutic option to treat the underlying cause of disease through reductions of ACTH. 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”, “expect”, “may”, “plan”, “will”, “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, the risk that interim data from the POWER study will differ from final data once available, along with 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.

 

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SPRUCE BIOSCIENCES, INC.

CONDENSED BALANCE SHEETS

(unaudited)

(in thousands, except share and per share amounts)

 

		June 30,				December 31,
		2023				2022
ASSETS
Current assets:
Cash and cash equivalents		$	97,482			$	24,487
Short-term investments			23,041				54,590
Prepaid expenses			3,400				3,320
Other current assets			206				1,211
Total current assets			124,129				83,608
Right-of-use assets			1,297				1,400
Other assets			536				640
Total assets		$	125,962			$	85,648
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	945			$	1,426
Accrued expenses and other current liabilities			12,107				9,399
Term loan, current portion			1,622				1,622
Deferred revenue, current portion			8,060				—
Total current liabilities			22,734				12,447
Lease liabilities, net of current portion			1,147				1,261
Term loan, net of current portion			2,507				3,293
Deferred revenue, net of current portion			2,811				—
Other liabilities			202				161
Total liabilities			29,401				17,162
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized and    no shares issued or outstanding as of June 30, 2023 and December 31, 2022			—				—
Common stock, $0.0001 par value; 200,000,000 shares authorized as of    June 30, 2023 and December 31, 2022; 40,710,692 and 23,601,004 shares    issued and outstanding as of June 30, 2023 and December 31, 2022, respectively			4				3
Additional paid-in capital			271,540				218,354
Accumulated other comprehensive loss			(55	)			(558	)
Accumulated deficit			(174,928	)			(149,313	)
Total stockholders’ equity			96,561				68,486
Total liabilities and stockholders’ equity		$	125,962			$	85,648

 

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SPRUCE BIOSCIENCES, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

(in thousands, except share and per share amounts)

 

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
Collaboration revenue		$	2,165			$	—			$	4,129			$	—
Operating expenses:
Research and development			13,126				9,060				24,838				17,568
General and administrative			3,011				2,822				6,462				6,048
Total operating expenses			16,137				11,882				31,300				23,616
Loss from operations			(13,972	)			(11,882	)			(27,171	)			(23,616	)
Interest expense			(127	)			(94	)			(258	)			(181	)
Interest and other income, net			1,275				104				1,814				162
Net loss			(12,824	)			(11,872	)			(25,615	)			(23,635	)
Other comprehensive gain (loss), net of tax:
Unrealized gain (loss) on available for sale securities			133				(152	)			503				(661	)
Total comprehensive loss		$	(12,691	)		$	(12,024	)		$	(25,112	)		$	(24,296	)
Net loss per share, basic and diluted		$	(0.32	)		$	(0.51	)		$	(0.71	)		$	(1.01	)
Weighted-average shares of common stock outstanding,    basic and diluted			40,547,925				23,493,613				36,247,931				23,492,960

 

 

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Media

Will Zasadny
Evoke Canale
(619) 961-8848
will.zasadny@evokecanale.com
media@sprucebiosciences.com

 

Investors

Samir Gharib
President and CFO

Spruce Biosciences

investors@sprucebiosciences.com

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v3.23.2

Document and Entity Information	Aug. 14, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 14, 2023
Entity Registrant Name	Spruce Biosciences, Inc.
Entity Central Index Key	0001683553
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity File Number	001-39594
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	81-2154263
Entity Address, Address Line One	611 Gateway Boulevard
Entity Address, Address Line Two	Suite 740
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	415
Local Phone Number	655-4168
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	SPRB
Security Exchange Name	NASDAQ

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