Full Press Release Details
Spruce Biosciences Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Recent Corporate Updates
Late-Stage CAHmelia Program in Adult Classic CAH Advancing with Majority of Study Sites Active
CAHmelia Program Enhanced Following Discussions with FDA - Primary Data Expected in 2022
Amended Debt Facility with SVB Provides Access Up to Additional $25 Million in Non-Dilutive Financing
New Drug Application (NDA) Filing for Tildacerfont in Adult Classic CAH Targeted for 2023
San Francisco, Calif. - March 22, 2021 - 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 fourth quarter and full year ended December 31, 2020 and provided a corporate update.
"2020 was a transformative year for Spruce Biosciences, as we firmly established our company as an emerging leader in the development of groundbreaking therapies for rare endocrine disorders," said Richard King, Chief Executive Officer, Spruce Biosciences. "The initiation of our CAHmelia program in adult classic congenital adrenal hyperplasia (CAH) moves us one step closer to changing the treatment paradigm for patients living with this chronic and potentially life-threatening disease. Following the completion of our upsized IPO in October 2020, we are also preparing to expand the utility of tildacerfont through studies in children with classic CAH and in women living with a rare form of polycystic ovary syndrome (PCOS), with Phase 2 programs in both indications on track to initiate in the second half of 2021. We also remain focused on clinical study execution: we have the majority of our CAHmelia study sites now active across 2 continents and are encouraged by the level of patient interest registered with our study investigators and at CAHstudy.com."
King continued, "Following discussions with U.S. Food and Drug Administration, we have decided to increase the open label extension period for CAHmelia-203 by 18 weeks and for CAHmelia-204 by 24 weeks. In addition, we have increased the size of CAHmelia-204 from 60 patients to 90 patients. We believe that these changes will result in a more robust data package. With these program enhancements, together with the impact of the ongoing COVID-19 pandemic, we now expect primary data from CAHmelia-203 in the first half of 2022 and CAHmelia-204 in the second half of 2022. Assuming positive study outcomes, we continue to target an NDA filing for tildacerfont in adult classic CAH in 2023."
Recent Operating Highlights
Anticipated Upcoming Milestones
Financial Highlights
Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2020, were $157.2 million.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter and full year ended December 31, 2020 were $5.8 million and $23.9 million compared to $2.8 million and $10.8 million for the same periods in 2019, respectively. The overall increase in R&D expenses was primarily related to the advancement of tildacerfont into late-stage clinical development.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter and full year ended December 31, 2020 were $2.5 million and $5.6 million, compared to $0.3 million and $2.3 million for the same periods in 2019, respectively. The overall increase in G&A expenses was primarily driven by an increase in costs related to operation as a public company.
Net Loss: Net loss for the fourth quarter and full year ended December 31, 2020 was $8.3 million and $29.5 million, compared to $3.2 million and $13.1 million for the same periods in 2019, respectively.
About Spruce Biosciences
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 results, conduct, progress and timing of Spruce's clinical trials, the regulatory approval path for tildacerfont, the strength of Spruce's balance sheet and the adequacy of Spruce's cash position. 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 "plans", "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 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.
(in thousands, except share amounts)
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 157,150 | $ | 3,924 | ||||
| Prepaid expenses | 2,971 | 215 | ||||||
| Other current assets | 276 | 513 | ||||||
| Total current assets | 160,397 | 4,652 | ||||||
| Restricted cash | 216 | - | ||||||
| Right-of-use assets | 1,793 | - | ||||||
| Other assets | 477 | 40 | ||||||
| Total assets | $ | 162,883 | $ | 4,692 | ||||
| LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,628 | $ | 1,878 | ||||
| Term loan, current portion | 2,554 | 1,252 | ||||||
| Accrued expenses and other current liabilities | 2,496 | 265 | ||||||
| Accrued compensation and benefits | 1,085 | 908 | ||||||
| Total current liabilities | 9,763 | 4,303 | ||||||
| Term loan, net of current portion | 1,922 | 3,193 | ||||||
| Lease liability, net of current portion | 1,653 | - | ||||||
| Other liabilities | 118 | 20 | ||||||
| Total liabilities | 13,456 | 7,516 | ||||||
| Series A redeemable convertible preferred stock, $0.0001 par value; 0 shares and 28,000,000 shares authorized, issued and outstanding as of December 31, 2020 and 2019, respectively; liquidation preference of $0 and $28,000 as of December 31, 2020 and 2019, respectively | - | 27,813 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares and 0 shares authorized as of December 31, 2020 and 2019, respectively; 0 shares issued and outstanding as of December 31, 2020 and 2019 | - | - | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares and 41,000,000 shares authorized as of December 31, 2020 and 2019, respectively; 23,260,399 shares and 764,408 shares issued and outstanding as of December 31, 2020 and 2019, respectively | 2 | 1 | ||||||
| Additional paid-in capital | 210,266 | 664 | ||||||
| Accumulated deficit | (60,841 | ) | (31,302 | ) | ||||
| Total stockholders' equity (deficit) | 149,427 | (30,637 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ | 162,883 | $ | 4,692 |
SPRUCE BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,813 | $ | 2,847 | $ | 23,854 | $ | 10,817 | ||||||||
| General and administrative | 2,521 | 286 | 5,562 | 2,290 | ||||||||||||
| Total operating expenses | 8,334 | 3,133 | 29,416 | 13,107 | ||||||||||||
| Loss from operations | (8,334 | ) | (3,133 | ) | (29,416 | ) | (13,107 | ) | ||||||||
| Interest expense | (79 | ) | (60 | ) | (323 | ) | (65 | ) | ||||||||
| Other income, net | 75 | 12 | 200 | 84 | ||||||||||||
| Net loss | $ | (8,338 | ) | $ | (3,181 | ) | $ | (29,539 | ) | $ | (13,088 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.39 | ) | $ | (4.16 | ) | $ | (4.93 | ) | $ | (17.12 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 21,542,045 | 764,408 | 5,991,213 | 764,408 |
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