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): November 13, 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 November 13, 2023, Spruce Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 2023 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		Description
99.1		Press Release of Spruce Biosciences, Inc., dated November 13, 2023
104		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.

			SPRUCE BIOSCIENCES, INC.
Date:	November 13, 2023	By:	/s/ Samir Gharib
			Samir Gharib President and Chief Financial Officer

 

2

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Exhibit 99.1

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

 

Enrollment Completed in CAHptain-205 Study in Pediatric Classic Congenital Adrenal Hyperplasia (CAH)

 

Target Enrollment Completed in CAHmelia-203 Study in Adult Classic CAH

 

CAHmelia-204 Study in Adult Classic CAH on Track to Complete Enrollment in Early Q1 2024

 

South San Francisco, Calif. – November 13, 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 third quarter ended September 30, 2023 and provided corporate updates.

 

“Achieving completion of enrollment milestones in the CAHptain-205 and CAHmelia-203 studies underscores the strong execution of our key clinical objectives and the momentum within our adult and pediatric classic CAH programs,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “We continue to make notable progress in our efforts to advance tildacerfont as a potentially novel therapeutic option for people living with CAH and are eager to report topline data from CAHmelia-203 and CAHptain-205 in the first quarter of 2024.”

 

Recent Corporate Updates
 

 

 

 

Anticipated Upcoming Milestones

 

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Third Quarter 2023 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). 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 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; and Spruce’s planned operations, including its expectations regarding operating and capital expenditures being funded into the first half of 2025. 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

 

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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.

 

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SPRUCE BIOSCIENCES, INC.

CONDENSED BALANCE SHEETS

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

 

		September 30,				December 31,
		2023				2022
ASSETS
Current assets:
Cash and cash equivalents		$	98,801			$	24,487
Short-term investments			9,231				54,590
Prepaid expenses			2,687				3,320
Other current assets			419				1,211
Total current assets			111,138				83,608
Right-of-use assets			1,240				1,400
Other assets			607				640
Total assets		$	112,985			$	85,648
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	3,152			$	1,426
Accrued expenses and other current liabilities			11,616				9,399
Term loan, current portion			1,622				1,622
Deferred revenue, current portion			7,798				—
Total current liabilities			24,188				12,447
Lease liabilities, net of current portion			1,083				1,261
Term loan, net of current portion			2,113				3,293
Other liabilities			220				161
Total liabilities			27,604				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 September 30, 2023 and December 31, 2022			—				—
Common stock, $0.0001 par value; 200,000,000 shares authorized as of    September 30, 2023 and December 31, 2022; 40,710,692 and 23,601,004 shares    issued and outstanding as of September 30, 2023 and December 31, 2022, respectively			4				3
Additional paid-in capital			272,662				218,354
Accumulated other comprehensive loss			(3	)			(558	)
Accumulated deficit			(187,282	)			(149,313	)
Total stockholders’ equity			85,381				68,486
Total liabilities and stockholders’ equity		$	112,985			$	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 September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Collaboration revenue		$	3,073			$	—			$	7,202			$	—
Operating expenses:
Research and development			13,494				8,791				38,332				26,359
General and administrative			3,237				2,766				9,699				8,814
Total operating expenses			16,731				11,557				48,031				35,173
Loss from operations			(13,658	)			(11,557	)			(40,829	)			(35,173	)
Interest expense			(119	)			(110	)			(377	)			(291	)
Interest and other income, net			1,423				266				3,237				428
Net loss			(12,354	)			(11,401	)			(37,969	)			(35,036	)
Other comprehensive gain (loss), net of tax:
Unrealized gain (loss) on available for sale securities			52				(28	)			555				(689	)
Total comprehensive loss		$	(12,302	)		$	(11,429	)		$	(37,414	)		$	(35,725	)
Net loss per share, basic and diluted		$	(0.30	)		$	(0.48	)		$	(1.01	)		$	(1.49	)
Weighted-average shares of common stock outstanding,    basic and diluted			40,710,692				23,560,250				37,751,865				23,515,651

 

 

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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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v3.23.3

Document and Entity Information	Nov. 13, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 13, 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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