Spruce Biosciences Reports First Quarter 2021 Financial Results and Provides Corporate Updates
Presentation of Phase 2 Data of Tildacerfont at 23rd Annual
Cash and Cash Equivalents of
“Throughout the first quarter of 2021,
Corporate Highlights
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Presentation of Phase 2 Data of Tildacerfont at
European Society of Endocrinology’s 23rd AnnualEuropean Congress of Endocrinology (ECE 2021): OnMay 24, 2021 ,Richard Auchus , MD, PhD, Professor of Internal Medicine and Pharmacology,University of Michigan, Ann Arbor , will present data from the company’s Phase 2 program of tildacerfont in classic CAH at ECE 2021. The presentation will highlight data from the company’s SPR001-202 clinical trial, which demonstrated the ability of tildacerfont to reduce and normalize key disease biomarkers over a 12-week period. Normalization of highly elevated hormones in classic CAH patients over a 12-week trial and without increases to daily steroid doses, to the company’s knowledge, has not been publicly reported with any other investigational product candidate to date.
-
Cash and Cash Equivalents of
$148.6 Million: Based on the company’s current operating plan, the company is well capitalized to advance its pipeline through key milestones, including primary data readout from its CAHmelia studies and initiation of Phase 2 programs in pediatric classic CAH and a rare form of polycystic ovary syndrome (PCOS).
Anticipated Upcoming Milestones
-
Submission of an Investigational New Drug (IND) application with the
U.S. Food and Drug Administration for PCOS in the first half of 2021, and initiation of a Phase 2 proof-of-concept clinical trial in the second half of 2021
-
Initiation of a Phase 2 clinical program in pediatric classic CAH in the second half of 2021
-
Results from CAHmelia-203 in adult classic CAH patients with poor disease control the first half of 2022
- Results from CAHmelia-204 in adult classic CAH patients with good disease control in the second half of 2022
First Quarter 2021 Financial Results
Cash and Cash Equivalents: Cash and cash equivalents as of
Research and Development (R&D) Expenses: R&D expenses for the first quarter ended
General and Administrative (G&A) Expenses: G&A expenses for the first quarter ended
Total Operating Expenses: Total operating expenses for the quarter ended
Net Loss: Net loss for the three months ended
About
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
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.
CONDENSED BALANCE SHEETS (unaudited) (in thousands, except share amounts) |
||||||||
|
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2021 |
|
|
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, |
|
|
— |
|
|
|
— |
|
Common stock, |
|
|
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 |
|
CONDENSED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except share and per share amounts) |
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|
Three Months Ended
|
|
|||||
|
|
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 |
|
Reconciliation of Total Operating Expenses to Non-GAAP Total Operating Expenses (unaudited) (in thousands) |
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|
Three Months Ended |
|
|||||
|
|
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 (unaudited) (in thousands) |
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|
Three Months Ended |
|
|||||
|
|
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 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210512005829/en/
Media Contact:
(619) 961-8848
will@canalecomm.com
media@sprucebiosciences.com
Investors:
Solebury Trout
(415) 971-9412
xyang@soleburytrout.com
investors@sprucebiosciences.com
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