Topline Safety Data from Cohort 1 of Phase 2
Pediatric Classic CAH Study Expected by 1H 2023
Will Charlton, M.D., M.A.S., Appointed Chief
Medical Officer
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, 2021 and provided a
corporate update.
“Over the last quarter, we have made notable 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 (CAH) and polycystic ovary syndrome
(PCOS),” said Javier Szwarcberg, M.D., M.P.H., Chief Executive
Officer of Spruce Biosciences. “We are expanding the number of
study sites globally and rolling out updated protocols for the
CAHmelia-203 and CAHmelia-204 clinical trials in adult classic CAH,
which we expect will accelerate patient enrollment. We were also
pleased to initiate our Phase 2 clinical trials in patients with
pediatric classic CAH and PCOS and expect topline results from both
studies by the first half of 2023.”
Corporate Updates
- Topline Safety Data from Cohort 1 of Phase 2 Pediatric
Classic CAH Study Expected by 1H 2023: Spruce is investigating
tildacerfont for the treatment of classic CAH in children and
recently initiated a Phase 2 clinical trial. There is a significant
unmet medical need to bring androgen-lowering and
glucocorticoid-sparing therapies to pediatric classic CAH patients
to reduce the risk of premature puberty and the adverse effects of
glucocorticoids, including stunted growth resulting in short
stature as adults. The Phase 2 open-label clinical trial will
utilize a sequential 3 cohort design to evaluate the safety and
pharmacokinetics of tildacerfont in children six to 17 years of age
with classic CAH.
- Will Charlton, M.D., M.A.S., Appointed Chief Medical
Officer: In March 2022, Will Charlton, M.D., M.A.S, was
appointed Chief Medical Officer of Spruce Biosciences, and will
lead the company’s clinical development and global drug development
strategy. Dr. Charlton is a board-certified pediatric
endocrinologist with two decades of experience as a clinician and
industry executive building successful programs across clinical
development, medical affairs and drug safety. He joins Spruce from
89bio, Inc., where he served as Vice President, Clinical
Development, and was responsible for clinical development,
pharmacology and pharmacovigilance across multiple therapeutic
areas.
Anticipated Upcoming
Milestones
- Completion of enrollment from the Phase 2 proof of concept
clinical trial in PCOS by the end of 2022 and topline results by
the first half of 2023
- Topline safety results from cohort 1 of the Phase 2 pediatric
classic CAH clinical trial by the first half of 2023
- Topline results from the Phase 2 CAHmelia-203 clinical trial in
adult classic CAH patients with poor disease control by the second
half of 2023
- Topline results from the Phase 2 CAHmelia-204 clinical trial in
adult classic CAH patients with good disease control by the second
half of 2024
Fourth Quarter and Full Year 2021
Financial Results
- Cash, Cash Equivalents and Investments: Cash, cash
equivalents and investments as of December 31, 2021, were $121.4
million, which management anticipates funds the company into the
second quarter of 2024.
- Research and Development (R&D) Expenses: R&D
expenses for the fourth quarter and full year ended December 31,
2021 were $6.3 million and $30.7 million, respectively, compared to
$5.8 million and $23.9 million for the same periods in 2020,
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,
2021 were $2.9 million and $11.4 million, respectively, compared to
$2.5 million and $5.6 million for the same periods in 2020,
respectively. 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 fourth quarter and full year ended December 31, 2021 were $9.1
million and $42.1 million, respectively, compared to $8.3 million
and $29.4 million for the same periods in 2020, respectively.
Stock-based compensation expense for the three and twelve months
ended December 31, 2021 was $0.8 million and $4.0 million,
respectively. When excluding depreciation and stock-based
compensation expenses, total operating expenses for the three
months and full year ended December 31, 2021 were $8.3 million and
$38.1 million, respectively.
- Net Loss: Net loss for the fourth quarter and full year
ended December 31, 2021 was $9.2 million and $42.3 million,
respectively, compared to $8.3 million and $29.5 million for the
same periods in 2020, respectively.
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 a rare
form of 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 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.
BALANCE SHEETS
(in thousands, except share
amounts)
December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$
42,748
$
157,150
Short-term investments
46,221
—
Prepaid expenses
2,530
2,971
Other current assets
396
276
Total current assets
91,895
160,397
Restricted cash
216
216
Right-of-use assets
1,479
1,793
Long-term investments
32,459
—
Other assets
437
477
Total assets
$
126,486
$
162,883
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
2,823
$
3,628
Term loan, current portion
—
2,554
Accrued expenses and other current
liabilities
4,613
2,496
Accrued compensation and benefits
1,435
1,085
Total current liabilities
8,871
9,763
Term loan, net of current portion
4,878
1,922
Lease liability, net of current
portion
1,293
1,653
Other liabilities
73
118
Total liabilities
15,115
13,456
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value;
10,000,000 shares and 0 shares authorized as of December 31, 2021
and 2020, respectively; 0 shares issued and outstanding as of
December 31, 2021 and 2020
—
—
Common stock, $0.0001 par value;
200,000,000 shares authorized as of December 31, 2021 and 2020,
respectively; 23,491,881 shares and 23,260,399 shares issued and
outstanding as of December 31, 2021 and 2020, respectively
3
2
Additional paid-in capital
214,685
210,266
Accumulated other comprehensive loss
(184
)
—
Accumulated deficit
(103,133
)
(60,841
)
Total stockholders’ equity
111,371
149,427
Total liabilities and stockholders’
equity
$
126,486
$
162,883
SPRUCE BIOSCIENCES,
INC.
STATEMENTS OF
OPERATIONS
(unaudited)
(in thousands, except share
and per share amounts)
Three Months Ended December
31,
Twelve Months Ended December
31,
2021
2020
2021
2020
Operating expenses:
Research and development
$
6,258
$
5,814
$
30,698
$
23,854
General and administrative
2,877
2,521
11,368
5,562
Total operating expenses
9,135
8,335
42,066
29,416
Loss from operations
(9,135
)
(8,335
)
(42,066
)
(29,416
)
Interest expense
(88
)
(78
)
(345
)
(323
)
Other income, net
39
75
119
200
Net loss
$
(9,184
)
$
(8,338
)
$
(42,292
)
$
(29,539
)
Net loss per share, basic and diluted
$
(0.39
)
$
(0.39
)
$
(1.81
)
$
(4.93
)
Weighted-average shares of common stock
outstanding, basic and diluted
23,453,793
21,542,045
23,361,416
5,991,213
SPRUCE BIOSCIENCES,
INC.
Reconciliation of Total
Operating Expenses to Non-GAAP Total Operating Expenses
(unaudited)
(in thousands)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2021
2020
2021
2020
Operating expenses:
Total operating expenses
$
9,135
$
8,335
$
42,066
$
29,416
Adjustments:
Depreciation
8
3
22
4
Stock-based compensation
797
410
3,958
754
Non-GAAP total operating expenses
$
8,330
$
7,922
$
38,086
$
28,658
Reconciliation of G&A
Expenses to Non-GAAP G&A Expenses
(unaudited)
(in thousands)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2021
2020
2021
2020
Operating expenses:
G&A expenses
$
2,877
$
2,521
$
11,368
$
5,562
Adjustments:
Depreciation
6
3
20
4
Stock-based compensation
616
221
2,913
428
Non-GAAP G&A expenses
$
2,255
$
2,297
$
8,435
$
5,130
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version on businesswire.com: https://www.businesswire.com/news/home/20220314005738/en/
Media Contact: Will Zasadny Canale Communications (619)
961-8848 will@canalecomm.com media@sprucebiosciences.com
Investors Xuan Yang Solebury Trout (415) 971-9412
xyang@soleburytrout.com investors@sprucebiosciences.com
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