UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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:
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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.
Item 2.02 Results of Operations and Financial Condition.
On August 10, 2022, Spruce Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2022 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 (“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 |
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Description |
99.1 |
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Press Release of Spruce Biosciences, Inc., dated August 10, 2022 |
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104 |
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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.
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SPRUCE BIOSCIENCES, INC. |
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Date: |
August 10, 2022 |
By: |
/s/ Samir Gharib |
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Samir Gharib |
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Exhibit 99.1
Spruce Biosciences Reports Second Quarter 2022 Financial Results and Provides Corporate Update
Abstract Accepted for Oral Presentation at International Congress of Endocrinology (ICE 2022)
Appointment of P.J. Ramtin as Senior Vice President of Business Operations
Expansion of Tildacerfont Patent Portfolio Estate with Key Method of Use Patents
San Francisco, Calif. – August 10, 2022 – 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, 2022, and provided corporate updates.
“Throughout the second quarter of 2022, we continued to remain focused on clinical study execution. We were pleased to have recently surpassed 25% enrollment in our CAHmelia-203 study and are approaching 25% enrollment in our CAHmelia-204 study,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “I am also pleased to welcome P.J. Ramtin as our Senior Vice President of Business Operations as we continue to expand our development and operational capabilities. With her extensive background in implementing business solutions and bridging real-world insights across all phases of clinical development, we believe that P.J.'s expertise will enrich our ongoing clinical programs for patients and study investigators.”
Recent Corporate Updates
Details are as follows:
Title: Association between glucocorticoid dose with BMI and glucocorticoid-related comorbidities: Data from tildacerfont Phase 2a trials in classic congenital adrenal hyperplasia
Paper Number: 179
Paper Reference: OP-3-6
Session Date & Time: 1:10 p.m. - 2:40 p.m. SGT on August 27, 2022
Presenter: Will Charlton, MD, Chief Medical Officer of Spruce Biosciences
Authors: Mimi Kim, Chris Barnes, and Will Charlton
Anticipated Upcoming Milestones
Second Quarter 2022 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). Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years. Spruce is also developing tildacerfont for women suffering from polycystic ovary syndrome (PCOS) with primary adrenal androgen excess. 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; and Spruce’s planned operations. 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”, “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 other 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.
Use of Non-GAAP Financial Measures
This release and the reconciliation tables included herein include non-GAAP total operating expenses, which excludes 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 this non-GAAP financial measure to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. This non-GAAP financial measure 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
(unaudited)
(in thousands, except share and per share amounts)
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June 30, |
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December 31, |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
47,210 |
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$ |
42,748 |
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Short-term investments |
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46,085 |
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46,221 |
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Prepaid expenses |
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2,821 |
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2,530 |
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Other current assets |
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390 |
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396 |
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Total current assets |
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96,506 |
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91,895 |
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Restricted cash |
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216 |
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216 |
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Right-of-use assets, net |
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1,314 |
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1,479 |
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Long-term investments |
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5,805 |
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32,459 |
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Other assets |
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674 |
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437 |
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Total assets |
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$ |
104,515 |
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$ |
126,486 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,445 |
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$ |
2,823 |
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Term loan, current portion |
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811 |
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— |
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Accrued expenses and other current liabilities |
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6,953 |
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4,613 |
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Accrued compensation and benefits |
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893 |
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1,435 |
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Total current liabilities |
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10,102 |
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8,871 |
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Term loan, net of current portion |
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4,077 |
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4,878 |
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Lease liability, net of current portion |
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1,098 |
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1,293 |
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Other liabilities |
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117 |
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73 |
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Total liabilities |
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15,394 |
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15,115 |
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Stockholders’ equity: |
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Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of June 30, 2022 and December 31, 2021 |
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— |
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— |
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Common stock, $0.0001 par value, 200,000,000 shares authorized, 23,560,250 and 23,491,881 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively |
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3 |
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3 |
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Additional paid-in capital |
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216,731 |
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214,685 |
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Accumulated other comprehensive loss |
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(845 |
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(184 |
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Accumulated deficit |
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(126,768 |
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(103,133 |
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Total stockholders’ equity |
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89,121 |
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111,371 |
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Total liabilities and stockholders’ equity |
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$ |
104,515 |
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$ |
126,486 |
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SPRUCE BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended |
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Six Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
9,060 |
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$ |
9,119 |
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$ |
17,568 |
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$ |
15,833 |
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General and administrative |
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2,822 |
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2,595 |
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6,048 |
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5,698 |
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Total operating expenses |
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11,882 |
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11,714 |
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23,616 |
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21,531 |
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Loss from operations |
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(11,882 |
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(11,714 |
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(23,616 |
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(21,531 |
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Interest expense |
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(94 |
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(80 |
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(181 |
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(169 |
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Other income, net |
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104 |
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20 |
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162 |
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39 |
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Net loss |
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$ |
(11,872 |
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$ |
(11,774 |
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$ |
(23,635 |
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$ |
(21,661 |
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Unrealized loss on available for sale securities |
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(152 |
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(29 |
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(661 |
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(29 |
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Comprehensive loss |
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$ |
(12,024 |
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$ |
(11,803 |
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$ |
(24,296 |
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$ |
(21,690 |
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Net loss per share, basic and diluted |
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$ |
(0.51 |
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$ |
(0.50 |
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$ |
(1.01 |
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$ |
(0.93 |
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Weighted-average shares of common stock outstanding, basic and |
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23,493,613 |
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23,329,756 |
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23,492,960 |
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23,306,708 |
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SPRUCE BIOSCIENCES, INC.
Reconciliation of Total Operating Expenses to Non-GAAP Total Operating Expenses
(unaudited)
(in thousands)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Total operating expenses |
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$ |
11,882 |
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$ |
11,714 |
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$ |
23,616 |
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$ |
21,531 |
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Adjustments: |
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Depreciation |
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9 |
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5 |
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18 |
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9 |
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Stock-based compensation |
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905 |
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1,010 |
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2,046 |
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2,130 |
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Non-GAAP total operating expenses |
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$ |
10,968 |
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$ |
10,699 |
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$ |
21,552 |
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$ |
19,392 |
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Media Contact:
Will Zasadny
Evoke Canale
(619) 961-8848
will.zasadny@evokegroup.com
media@sprucebiosciences.com
Investors
Xuan Yang
Solebury Trout
(415) 971-9412
xyang@soleburytrout.com
investors@sprucebiosciences.com