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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Spruce Biosciences Inc | NASDAQ:SPRB | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0052 | -0.68% | 0.7617 | 0.7616 | 0.7633 | 1,507 | 13:00:02 |
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
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
Anticipated Upcoming Milestones
Second 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.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.
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
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20230814328144/en/
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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