Full Press Release Details
Spruce Biosciences Reports First Quarter 2021 Financial Results and Provides Corporate Updates
Presentation of Phase 2 Data of Tildacerfont at 23rd Annual European Congress of Endocrinology
Cash and Cash Equivalents of $148.6 million
San Francisco, Calif. - May 12, 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 first quarter ended March 31, 2021 and provided a corporate update.
"Throughout the first quarter of 2021, Spruce Biosciences made substantial progress in our efforts to advance new treatment options for people living with rare endocrine disorders and to maximize the potential of tildacerfont as a therapeutic to treat people living with classic congenital adrenal hyperplasia, or CAH, and other diseases impacted by ACTH," said Richard King, Chief Executive Officer of Spruce Biosciences. "We continue to advance enrollment into our late-stage CAHmelia program in adult classic CAH and remain encouraged with the level of patient interest registered with our study investigators. Looking ahead, we remain on track to initiate our Phase 2 program in children with classic CAH in the second half of this year. In the pediatric classic CAH population, the imbalance between excess adrenal androgens and glucocorticoids can lead to irreversible impacts on childhood development. Tildacerfont has the potential to ease the disease and steroid burden for children, which may enable normal growth progression through childhood and adolescence."
Corporate Highlights
Anticipated Upcoming Milestones
First Quarter 2021 Financial Results
Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2021, were $148.6 million.
Research and Development (R&D) Expenses: R&D expenses for the first quarter ended March 31, 2021 were $6.7 million compared to $4.6 million for the same period in 2020. 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 first quarter ended March 31, 2021 were $3.1 million compared to $0.5 million for the same period in 2020. The overall increase in G&A expenses was primarily driven by an increase in costs related to operation as a public company.
Total Operating Expenses: Total operating expenses for the quarter ended March 31, 2021 were $9.8 million compared to $5.1 million for the same period in 2020. Stock-based compensation for the first quarter ended March 31, 2021 was $1.1 million. When excluding depreciation and stock-based compensation, total operating expenses for the quarter ended March 31, 2021 were $8.7 million.
Net Loss: Net loss for the three months ended March 31, 2021 was $9.9 million compared to $5.1 million for the same period in 2020.
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.
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)
| March 31, 2021 | December 31, 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 148,627 | $ | 157,150 | ||||
| Prepaid expenses | 2,687 | 2,971 | ||||||
| Other current assets | 272 | 276 | ||||||
| Total current assets | 151,586 | 160,397 | ||||||
| Restricted cash | 216 | 216 | ||||||
| Right-of-use assets | 1,716 | 1,793 | ||||||
| Other assets | 473 | 477 | ||||||
| Total assets | $ | 153,991 | $ | 162,883 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,566 | $ | 3,628 | ||||
| Term loan, current portion | - | 2,554 | ||||||
| Accrued expenses and other current liabilities | 3,558 | 2,496 | ||||||
| Accrued compensation and benefits | 727 | 1,085 | ||||||
| Total current liabilities | 6,851 | 9,763 | ||||||
| Term loan, net of current portion | 4,843 | 1,922 | ||||||
| Lease liability, net of current portion | 1,566 | 1,653 | ||||||
| Other liabilities | 8 | 118 | ||||||
| Total liabilities | 13,268 | 13,456 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value, 10,000,000 shares authorized, and no shares issued and outstanding as of March 31, 2021 and December 31, 2020 | - | - | ||||||
| Common stock, $0.0001 par value, 200,000,000 shares authorized, 23,301,872 and 23,260,399 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 2 | 2 | ||||||
| Additional paid-in capital | 211,449 | 210,266 | ||||||
| Accumulated deficit | (70,728 | ) | (60,841 | ) | ||||
| Total stockholders' equity | 140,723 | 149,427 | ||||||
| Total liabilities and stockholders' equity | $ | 153,991 | $ | 162,883 |
SPRUCE BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 6,714 | $ | 4,610 | ||||
| General and administrative | 3,103 | 523 | ||||||
| Total operating expenses | 9,817 | 5,133 | ||||||
| Loss from operations | (9,817 | ) | (5,133 | ) | ||||
| Interest expense | (89 | ) | (74 | ) | ||||
| Other income, net | 19 | 39 | ||||||
| Net loss | $ | (9,887 | ) | $ | (5,168 | ) | ||
| Net loss per share, basic and diluted | $ | (0.42 | ) | $ | (6.76 | ) | ||
| Weighted-average shares of common stock outstanding, basic and diluted | 23,283,658 | 764,408 |
SPRUCE BIOSCIENCES, INC.
Reconciliation of Total Operating Expenses to Non-GAAP Total Operating Expenses
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Total operating expenses | $ | 9,817 | $ | 5,133 | ||||
| Adjustments: | ||||||||
| Depreciation | 4 | - | ||||||
| Stock-based compensation | 1,120 | 32 | ||||||
| Non-GAAP total operating expenses | $ | 8,693 | $ | 5,101 |
Reconciliation of G&A Expenses to Non-GAAP G&A Expenses
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| G&A expenses | $ | 3,103 | $ | 523 | ||||
| Adjustments: | ||||||||
| Depreciation | 4 | - | ||||||
| Stock-based compensation | 856 | 22 | ||||||
| Non-GAAP G&A expenses | $ | 2,243 | $ | 501 |
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