Full Press Release Details
Spruce Biosciences Reports Third Quarter 2021 Financial Results and Provides Corporate Updates
Planned Initiation of Phase 2 Programs in Pediatric Classic CAH and Polycystic Ovary Syndrome
Late-Stage CAHmelia Program in Adult Classic CAH Expanded to Sites in Australia and Canada
Cash, Cash Equivalents and Investments of $131.3 Million as of September 30, 2021
San Francisco, Calif. - November 15, 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 third quarter ended September 30, 2021 and provided a corporate update.
We continue to make progress in advancing tildacerfont for the treatment of patients with rare endocrine disorders with the planned initiation of a Phase 2 clinical trial for children with classic congenital adrenal hyperplasia (CAH), as well as a proof-of-concept clinical trial for women with a rare form of polycystic ovary syndrome (PCOS)," said Mike Grey, Executive Chairman of Spruce Biosciences, who has taken on the role of Interim Chief Executive Officer following the retirement of Richard King as separately announced today. "While we have recently seen an encouraging upward trend in the pace of site activation and patient enrollment across our CAHmelia studies in adults with classic CAH, the continued variability of the impact of the COVID-19 pandemic across sites throughout the United States and Europe has impacted enrollment and we now expect to report topline results from the CAHmelia-203 study in 2023."
Corporate & Pipeline Updates in Q3 2021
Third Quarter 2021 Financial Results
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 and announcements regarding the same. 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 expect," "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.
Use of Non-GAAP Financial Measures
Spruce has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included herein include non-GAAP total operating expenses and non-GAAP G&A expenses, both of which exclude depreciation and stock-based compensation. Spruce excludes depreciation and stock-based compensation because management believes the exclusion of these items is helpful to investors to evaluate Spruce's recurring operational performance. Spruce management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results.
SPRUCE BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share amounts)
| September 30, 2021 | December 31, 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 58,363 | $ | 157,150 | ||||
| Short-term investments | 33,957 | - | ||||||
| Prepaid expenses | 1,301 | 2,971 | ||||||
| Other current assets | 301 | 276 | ||||||
| Total current assets | 93,922 | 160,397 | ||||||
| Restricted cash | 216 | 216 | ||||||
| Right-of-use assets, net | 1,559 | 1,793 | ||||||
| Long-term investments | 38,975 | - | ||||||
| Other assets | 415 | 477 | ||||||
| Total assets | $ | 135,087 | $ | 162,883 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,128 | $ | 3,628 | ||||
| Term loan, current portion | - | 2,554 | ||||||
| Accrued expenses and other current liabilities | 5,924 | 2,496 | ||||||
| Accrued compensation and benefits | 1,009 | 1,085 | ||||||
| Total current liabilities | 9,061 | 9,763 | ||||||
| Term loan, net of current portion | 4,867 | 1,922 | ||||||
| Lease liability, net of current portion | 1,388 | 1,653 | ||||||
| Other liabilities | 51 | 118 | ||||||
| Total liabilities | 15,367 | 13,456 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value, 10,000,000 shares authorized, and no shares issued and outstanding as of September 30, 2021 and December 31, 2020 | - | - | ||||||
| Common stock, $0.0001 par value, 200,000,000 shares authorized, 23,379,887 and 23,260,399 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 3 | 2 | ||||||
| Additional paid-in capital | 213,682 | 210,266 | ||||||
| Accumulated other comprehensive loss | (16 | ) | - | |||||
| Accumulated deficit | (93,949 | ) | (60,841 | ) | ||||
| Total stockholders' equity | 119,720 | 149,427 | ||||||
| Total liabilities and stockholders' equity | $ | 135,087 | $ | 162,883 |
SPRUCE BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 8,607 | $ | 7,769 | $ | 24,440 | $ | 18,040 | ||||||||
| General and administrative | 2,793 | 1,790 | 8,491 | 3,041 | ||||||||||||
| Total operating expenses | 11,400 | 9,559 | 32,931 | 21,081 | ||||||||||||
| Loss from operations | (11,400 | ) | (9,559 | ) | (32,931 | ) | (21,081 | ) | ||||||||
| Interest expense | (88 | ) | (79 | ) | (257 | ) | (245 | ) | ||||||||
| Other income, net | 41 | 51 | 80 | 125 | ||||||||||||
| Net loss | $ | (11,447 | ) | $ | (9,587 | ) | $ | (33,108 | ) | $ | (21,201 | ) | ||||
| Unrealized gain/(loss) on available for sale securities | 13 | - | (16 | ) | - | |||||||||||
| Comprehensive loss | $ | (11,434 | ) | $ | (9,587 | ) | $ | (33,124 | ) | $ | (21,201 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.49 | ) | $ | (12.35 | ) | $ | (1.42 | ) | $ | (27.54 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 23,367,140 | 776,159 | 23,330,399 | 769,766 |
SPRUCE BIOSCIENCES, INC.
Reconciliation of Total Operating Expenses to Non-GAAP Total Operating Expenses
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Total operating expenses | $ | 11,400 | $ | 9,559 | $ | 32,931 | $ | 21,081 | ||||||||
| Adjustments: | ||||||||||||||||
| Depreciation | 5 | 1 | 14 | 2 | ||||||||||||
| Stock-based compensation | 1,031 | 218 | 3,161 | 346 | ||||||||||||
| Non-GAAP total operating expenses | $ | 10,364 | $ | 9,340 | $ | 29,756 | $ | 20,733 |
Reconciliation of G&A Expenses to Non-GAAP G&A Expenses
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| G&A expenses | $ | 2,793 | $ | 1,790 | $ | 8,491 | $ | 3,041 | ||||||||
| Adjustments: | ||||||||||||||||
| Depreciation | 5 | 1 | 14 | 2 | ||||||||||||
| Stock-based compensation | 777 | 129 | 2,297 | 208 | ||||||||||||
| Non-GAAP G&A expenses | $ | 2,011 | $ | 1,660 | $ | 6,180 | $ | 2,831 |
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