25% Enrollment Achieved in CAHmelia-203 Study
for Adult Classic CAH; On Track to Report Topline Data in 2H
2023
Debt Facility with Silicon Valley Bank Amended
to Provide Up to $10 Million Credit Line in 2022
Tildacerfont Patent Portfolio Estate Expanded
with Key Method of Use Patents
Libbie Mansell, Ph.D., M.B.A., R.A.C.,
Appointed Chief Regulatory and Quality 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 first
quarter ended March 31, 2022 and provided corporate updates.
“Throughout the first quarter of 2022, we continued to drive our
clinical and business objectives forward, with key progress made in
our lead program for adults with classic congenital adrenal
hyperplasia (CAH), expansion of our executive leadership team, and
through potential access to non-dilutive sources of capital. We
were pleased to achieve the recent milestone of 25% enrollment in
our CAHmelia-203 study for adult classic CAH, which keeps us on
track to meet topline data readout for the study in the second half
of 2023,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive
Officer of Spruce Biosciences. “The enhanced protocols we
rolled-out for the CAHmelia-203 and 204 studies have been
well-received by study investigators across our global trial sites
and have streamlined screening activities. We look forward to
continuing this momentum and providing further enrollment updates
over the course of the year.”
Recent Corporate & Pipeline
Updates
- 25% Enrollment Achieved in CAHmelia-203 Study for Adult
Classic CAH: Spruce Biosciences recently achieved 25%
enrollment in the company’s CAHmelia-203 clinical study and is on
track to report topline data in the second half of 2023.
CAHmelia-203 is a randomized, double-blind, placebo-controlled,
dose-ranging study evaluating the safety and efficacy of
tildacerfont in adult patients with classic CAH and is designed to
enroll approximately 72 patients with high levels of
androstenedione (A4) on their current glucocorticoid regimen. Study
sites are now enrolling under the amended protocol, which is
anticipated to accelerate patient enrollment.
- Enrollment in CAHmelia-204 Progressing Under Amended
Protocol: CAHmelia-204 is a randomized, double-blind,
placebo-controlled study evaluating the safety and efficacy of
tildacerfont in adult patients with classic CAH. The study is
designed to enroll approximately 90 patients on supraphysiologic
doses of glucocorticoids at or above 30 mg/d hydrocortisone
equivalent with normal or near normal levels of A4. Study sites are
now enrolling under the amended protocol, which removed the
glucocorticoid conversion requirement. Enrollment is progressing as
planned and the company plans to share enrollment updates over the
course of the year.
- Debt Facility with Silicon Valley Bank (SVB) Amended to
Provide $10 Million Credit Line in 2022: Spruce Biosciences has
amended its debt facility with SVB to provide a credit line of up
to $10 million (“Tranche 2”) in 2022, subject to the satisfaction
of certain financial and operating conditions. The amendment also
reduces the current variable interest rate on the outstanding debt
of $5 million by 50 basis points and on Tranche 2 by 250 basis
points. Additionally, subject to potential drawdowns under Tranche
2 occurring, the interest-only period for outstanding term debt
will be extended from December 31, 2022 to June 30, 2023. No
warrants were issued in connection with the amended debt
facility.
- Tildacerfont Patent Portfolio Estate Expanded with Key
Method of Use Patents: Spruce Biosciences continues to expand
its patent portfolio for its wholly-owned product candidate
tildacerfont to supplement its issued composition of matter patent
and market exclusivity afforded by orphan drug designation in the
United States and Europe for CAH, if approved. In April 2022, the
United States Patent and Trademark Office issued U.S. Patent Number
11,304,950 titled “Methods of treating testicular and ovarian
adrenal rest tumors,” and U.S. Patent Number 11,311,549 titled
“Corticotropin release factor receptor antagonists.” The newly
issued patents cover broad claims regarding the use of a CRF-1
receptor antagonist for the treatment of adrenal rest tumors and
use of tildacerfont to reduce androstenedione in patients with CAH.
These patents expand existing patent exclusivity through 2038.
- Libbie Mansell, Ph.D., M.B.A., R.A.C., Appointed Chief
Regulatory and Quality Officer: In April 2022, Libbie Mansell,
Ph.D., M.B.A., R.A.C. was appointed Chief Regulatory and Quality
Officer of Spruce Biosciences, and will lead the company’s global
regulatory affairs and quality strategy. Dr. Mansell is a seasoned
regulatory affairs professional, with over 30 years of industry
experience in serious and rare diseases. She joins Spruce from
Asklepios BioPharmaceutical (AskBio), where she served as Senior
Vice President of Regulatory Affairs. Dr. Mansell’s appointment
follows the March 2022 appointment of Will Charlton, M.D., M.A.S.,
as Chief Medical Officer.
Upcoming Corporate Access
Events
- RBC Capital Markets Global Healthcare Conference Date:
May 17-18, 2022 Format: Fireside chat (May 17 at 10:00 a.m.
ET) and 1x1 meetings
- H.C. Wainwright Global Investment Conference Date: May
23-26, 2022 Format: Company presentation (May 25 at 4:00
p.m. ET) and 1x1 meetings
Upcoming Medical
Conferences
- 24th European Congress of Endocrinology (ECE 2022)
Date: May 21-24, 2022
- 104th Annual Meeting of the Endocrine Society (ENDO
2022) Date: June 11-14, 2022
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 in
the first half of 2023
- Topline safety results from cohort 1 of the Phase 2 pediatric
classic CAH clinical trial in the first half of 2023
- Topline results from the CAHmelia-203 clinical trial in adult
classic CAH patients with elevated levels of A4 (labeled as in poor
disease control) in the second half of 2023
- Topline results from the CAHmelia-204 clinical trial in adult
classic CAH patients on supraphysiologic doses of glucocorticoids
with normal or near normal levels of A4 (labeled as in good disease
control) in the second half of 2024
First Quarter 2022 Financial
Results
- Cash, Cash Equivalents and Investments: Cash, cash
equivalents and investments as of March 31, 2022, were $108.9
million.
- Research and Development (R&D) Expenses: R&D
expenses for the quarter ended March 31, 2022 were $8.5 million
compared to $6.7 million for the same period in 2021. The overall
increase in R&D expenses was primarily related progressing
clinical development of tildacerfont in adult classic CAH and the
initiation of clinical programs in pediatric classic CAH and
polycystic ovary syndrome.
- General and Administrative (G&A) Expenses: G&A
expenses for the quarter ended March 31, 2022 were $3.2 million
compared to $3.1 million for the same period in 2021.
- Total Operating Expenses: Total operating expenses for
the quarter ended March 31, 2022 were $11.7 million, compared to
$9.8 million for the same period in 2021. Stock-based compensation
expense for the quarters ended March 31, 2022 and 2021 was $1.1
million and $1.1 million, respectively. When excluding depreciation
and stock-based compensation expenses, non-GAAP total operating
expenses for the quarters ended March 31, 2022 and 2021 were $10.6
million and $8.7 million, respectively.
- Net Loss: Net loss for the quarter ended March 31, 2022
was $11.8 million compared to $9.9 million for the same period in
2021.
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 and announcements
regarding the same, and the funding of Spruce’s 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 “expect,”
“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 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 table 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
(in thousands, except share
amounts)
March 31, 2022
December 31, 2021
ASSETS
(unaudited)
Current assets:
Cash and cash equivalents
$
23,343
$
42,748
Short-term investments
68,005
46,221
Prepaid expenses
3,423
2,530
Other current assets
325
396
Total current assets
95,096
91,895
Restricted cash
216
216
Right-of-use assets, net
1,397
1,479
Long-term investments
17,601
32,459
Other assets
678
437
Total assets
$
114,988
$
126,486
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
1,109
$
2,823
Term loan, current portion
405
—
Accrued expenses and other current
liabilities
6,457
4,613
Accrued compensation and benefits
998
1,435
Total current liabilities
8,969
8,871
Term loan, net of current portion
4,485
4,878
Lease liability, net of current
portion
1,196
1,293
Other liabilities
95
73
Total liabilities
14,745
15,115
Stockholders’ equity:
Preferred stock, $0.0001 par value,
10,000,000 shares authorized, no shares issued or outstanding as of
March 31, 2022 and December 31, 2021
—
—
Common stock, $0.0001 par value,
200,000,000 shares authorized, 23,492,873 and 23,491,881 shares
issued and outstanding as of March 31, 2022 and December 31, 2021,
respectively
3
3
Additional paid-in capital
215,828
214,685
Accumulated other comprehensive loss
(693
)
(184
)
Accumulated deficit
(114,895
)
(103,133
)
Total stockholders’ equity
100,243
111,371
Total liabilities and stockholders’
equity
$
114,988
$
126,486
SPRUCE BIOSCIENCES,
INC.
CONDENSED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except share
and per share amounts)
Three Months Ended March
31,
2022
2021
Operating expenses:
Research and development
$
8,508
$
6,714
General and administrative
3,225
3,103
Total operating expenses
11,733
9,817
Loss from operations
(11,733
)
(9,817
)
Interest expense
(87
)
(89
)
Other income, net
58
19
Net loss
$
(11,762
)
$
(9,887
)
Unrealized loss on available for sale
securities
(509
)
—
Comprehensive loss
$
(12,271
)
$
(9,887
)
Net loss per share, basic and diluted
$
(0.50
)
$
(0.42
)
Weighted-average shares of common stock
outstanding, basic and diluted
23,492,295
23,283,658
SPRUCE BIOSCIENCES,
INC.
Reconciliation of Total
Operating Expenses to Non-GAAP Total Operating Expenses
(unaudited)
(in thousands)
Three Months Ended March
31,
2022
2021
Operating expenses:
Total operating expenses
$
11,733
$
9,817
Adjustments:
Depreciation
9
4
Stock-based compensation
1,141
1,120
Non-GAAP total operating expenses
$
10,583
$
8,693
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version on businesswire.com: https://www.businesswire.com/news/home/20220511005912/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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