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
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
- Abstract Accepted for Oral Presentation at ICE 2022: A
submitted abstract was accepted for oral presentation at the
International Society of Endocrinology’s ICE 2022 taking place
virtually August 25 – 28, 2022. ICE 2022 will be held jointly with
the 18th Asia Oceania Congress of Endocrinology (AOCE) and the 21st
ASEAN Federation of Endocrine Societies Congress (AFES). The
presentation will highlight data from the company’s Phase 2a
clinical trials in adults with classic congenital adrenal
hyperplasia (CAH) demonstrating an association between
glucocorticoid dose with BMI and other glucocorticoid-related
comorbidities. 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
- Appointment of P.J. Ramtin as Senior Vice President of
Business Operations: As Senior Vice President of Business
Operations, Ms. Ramtin oversees clinical operational excellence and
patient engagement. Ms. Ramtin is a seasoned industry executive
with over two decades of experience directing and leading
commercial and clinical organizations in roles of increasing
responsibility across biotech and global pharmaceutical companies.
She joins Spruce from BridgeBio, where she served as Vice
President, Business Operations. Prior to BridgeBio, Ms. Ramtin held
various roles at Regeneron, Genentech, InterMune, AVEO Oncology,
and GlaxoSmithKline.
- 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. In the second quarter, the United
States Patent and Trademark Office issued U.S. Patent Number
11,344,557 titled “Corticotropin releasing factor receptor
antagonists,” and U.S. Patent Number 11,351,177 titled
“Corticotropin releasing factor receptor antagonists.” The newly
issued patents cover broad claims regarding the use of a CRF-1
receptor antagonist to reduce 17-hydroxyprogesterone and
adrenocorticotropic hormone (ACTH) concomitantly from baseline in
patients with CAH and the use of tildacerfont to reduce ACTH from
baseline. These patents expand existing patent exclusivity through
2038.
Anticipated Upcoming
Milestones
- Topline results from the Phase 2 proof of concept clinical
trial in polycystic ovary syndrome (PCOS) 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 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 in the second half of
2024
Second Quarter 2022 Financial
Results
- Cash, Cash Equivalents and Investments: Cash, cash
equivalents and investments as of June 30, 2022, were $99.1
million.
- Research and Development (R&D) Expenses: R&D
expenses for the three and six months ended June 30, 2022, were
$9.1 million and $17.6 million, respectively, compared to $9.1
million and $15.8 million, respectively, for the same periods in
2021. The overall increase in R&D expenses was primarily
related to 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 three and six months ended June 30, 2022, were
$2.8 million and $6.0 million, respectively, compared to $2.6
million and $5.7 million, respectively, for the same periods in
2021.
- Total Operating Expenses: Total operating expenses for
the three and six months ended June 30, 2022, were $11.9 million
and $23.6 million, respectively, compared to $11.7 million and
$21.5 million, respectively, for the same periods in 2021.
Stock-based compensation expense for the three and six months ended
June 30, 2022, was $0.9 million and $2.0 million, respectively,
compared to $1.0 million and $2.1 million, respectively, for the
same periods in 2021. When excluding depreciation and stock-based
compensation expenses, total non-GAAP operating expenses for the
three and six months ended June 30, 2022, were $11.0 million and
$21.6 million, respectively, compared to $10.7 million and $19.4
million for the same periods in 2021.
- Net Loss: Net loss for the three and six months ended
June 30, 2022, was $11.9 million compared to $23.6 million,
respectively, compared to $11.8 million and $21.7 million,
respectively, for the same periods 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; 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)
June 30, 2022
December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents
$
47,210
$
42,748
Short-term investments
46,085
46,221
Prepaid expenses
2,821
2,530
Other current assets
390
396
Total current assets
96,506
91,895
Restricted cash
216
216
Right-of-use assets, net
1,314
1,479
Long-term investments
5,805
32,459
Other assets
674
437
Total assets
$
104,515
$
126,486
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
1,445
$
2,823
Term loan, current portion
811
—
Accrued expenses and other current
liabilities
6,953
4,613
Accrued compensation and benefits
893
1,435
Total current liabilities
10,102
8,871
Term loan, net of current portion
4,077
4,878
Lease liability, net of current
portion
1,098
1,293
Other liabilities
117
73
Total liabilities
15,394
15,115
Stockholders’ equity:
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
—
—
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
3
3
Additional paid-in capital
216,731
214,685
Accumulated other comprehensive loss
(845
)
(184
)
Accumulated deficit
(126,768
)
(103,133
)
Total stockholders’ equity
89,121
111,371
Total liabilities and stockholders’
equity
$
104,515
$
126,486
SPRUCE BIOSCIENCES,
INC.
CONDENSED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except share
and per share amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Operating expenses:
Research and development
$
9,060
$
9,119
$
17,568
$
15,833
General and administrative
2,822
2,595
6,048
5,698
Total operating expenses
11,882
11,714
23,616
21,531
Loss from operations
(11,882
)
(11,714
)
(23,616
)
(21,531
)
Interest expense
(94
)
(80
)
(181
)
(169
)
Other income, net
104
20
162
39
Net loss
$
(11,872
)
$
(11,774
)
$
(23,635
)
$
(21,661
)
Unrealized loss on available for sale
securities
(152
)
(29
)
(661
)
(29
)
Comprehensive loss
$
(12,024
)
$
(11,803
)
$
(24,296
)
$
(21,690
)
Net loss per share, basic and diluted
$
(0.51
)
$
(0.50
)
$
(1.01
)
$
(0.93
)
Weighted-average shares of common stock
outstanding, basic and diluted
23,493,613
23,329,756
23,492,960
23,306,708
SPRUCE BIOSCIENCES,
INC.
Reconciliation of Total
Operating Expenses to Non-GAAP Total Operating Expenses
(unaudited)
(in thousands)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Operating expenses:
Total operating expenses
$
11,882
$
11,714
$
23,616
$
21,531
Adjustments:
Depreciation
9
5
18
9
Stock-based compensation
905
1,010
2,046
2,130
Non-GAAP total operating expenses
$
10,968
$
10,699
$
21,552
$
19,392
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version on businesswire.com: https://www.businesswire.com/news/home/20220810005698/en/
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
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