SPRB Spruce Biosciences Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
Tildacerfont - CAHmelia-203
Congenital Adrenal Hyperplasia (poor disease control)
|
Phase 2b
Phase 2b
|
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|
|
Tildacerfont - CAHmelia-204
Congenital Adrenal Hyperplasia (good disease control)
|
Phase 2b
Phase 2b
|
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Tildacerfont
Polycystic Ovary Syndrome
|
Phase 2
Phase 2
|
Phase 2 trial to be initiated 2H 2021.
|
|
Tildacerfont
Pediatric Classic Congenital Adrenal Hyperplasia
|
Phase 2
Phase 2
|
Phase 2 trial to be initiated 2H 2021.
|
Latest News
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-CAHmelia Adult Classic CAH Program Underway in U.S. and Europe-
-Initiation of Phase 2 Pediatric Classic CAH Program Anticipated in Second Half of 2021-
-Initiation of Phase 2 Polycystic Ovary Syndrome Program Anticipated in Second Half of 2021-
-New Patent Issuance Extends Tildacerfont Patent Exclusivity through 2038-
Spruce Biosciences, Inc. (NASDAQ:SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need, today provided a corporate update and shared anticipated milestones for 2021.
"Our vision is to deliver groundbreaking therapies to patients living with rare endocrine disorders with significant unmet medical need," said Richard King, Chief Executive Officer of Spruce Biosciences. "As we enter the new year, we are entirely focused on clinical study execution. Our potential registration-enabling CAHmelia program for tildacerfont in adult classic congenital adrenal hyperplasia (CAH) is underway. In parallel, we are preparing to advance tildacerfont into the clinic for the treatment of pediatric classic CAH and a rare form of polycystic ovary syndrome (PCOS)."
Mr. King continued, "Following our initial public offering in October 2020, we have sufficient resources to continue to advance our pipeline through major milestones. This includes the completion of our CAHmelia program and, dependent on trial results and subsequent interactions with regulatory agencies, potential submission of our first new drug application for tildacerfont for adults with classic CAH. At the same time, we expect 2021 to be a year of notable progress as we expand our portfolio of indications. Through this, we hope to deliver on the full potential of tildacerfont to bring therapeutic benefit to patients suffering from endocrine disorders driven by excess secretion of, or hyperresponsiveness to, adrenocorticotropic hormone (ACTH)."
Potential Registration-Enabling Phase 2 CAHmelia Program in Adult Classic CAH
Spruce Biosciences is focused on advancing tildacerfont in potential registration-enabling programs, dependent on clinical trial results, for the treatment of adult patients with CAH. Based on analyses of the company's clinical data to date, the company has chosen to target two distinct groups of classic CAH patients with either good disease control or poor disease control. These two groups have differing disease challenges centered on the harmful effects of excessive glucocorticoid usage or excessive adrenal androgen levels respectively, both of which have the potential to be addressed by treatment with tildacerfont, if approved.
The company has initiated CAHmelia-203 in adult CAH patients with poor disease control and CAHmelia-204 in adult CAH patients with good disease control focused on glucocorticoid reduction. Study sites across the United States and Europe for both studies are active.
Phase 2 Program in Pediatric Classic CAH
Spruce Biosciences plans to investigate tildacerfont for the treatment of classic CAH in children. There is an urgent 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 growth inhibition and short-stature as adults. Feedback received from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) has been incorporated into the company's Phase 2 development program.
The company plans to achieve the following milestones in 2021:
- Initiation of a Phase 2 clinical program in children in the second half of 2021; and
- Finalization of a Pediatric Investigational Plan to the Pediatric Committee of the EMA regarding a registrational program in pediatrics.
Phase 2 Program in a Rare Form of PCOS
PCOS is a hormonal disorder common among females of reproductive age typically characterized by elevated levels of androgens, irregular periods, and cysts in the ovaries. While the underlying causes of the disease are unknown, elevated levels of androgens may be due to a hyper-responsiveness to ACTH in a subset of women with PCOS. Tildacerfont has the potential to reduce ACTH and adrenal androgens, thereby reducing overall ACTH hyperresponsiveness. Tildacerfont may provide a therapeutic option for females with this rare form of PCOS, representing 3-5% of females with the disorder1, which is estimated to be 150,000 to 200,000 patients in the United States.
The company plans to achieve the following milestones in 2021:
- Filing of an Investigational New Drug (IND) application in the first half of 2021; and
- Initiation of a Phase 2 proof-of-concept clinical trial in the second half of 2021.
Intellectual Property
Spruce Biosciences continues to expand its patent portfolio for tildacerfont to supplement its issued composition of matter patent that has an expiry date in 2027, and if tildacerfont is approved, will be eligible for patent term extension of up to 5 years. Upon regulatory approval, tildacerfont is also entitled to market exclusivity afforded by orphan drug designation of tildacerfont in the U.S. and Europe for CAH.
In December 2020, the United States Patent and Trademark Office (USPTO) issued US Patent Number 10,849,908 titled "Corticotrophin releasing factor antagonists." This newly issued patent covers broad claims regarding the use of a CRF1 receptor antagonist for the treatment of CAH and further extends exclusivity through 2038.
Financial Update
As of December 31, 2020, Spruce Biosciences had unaudited cash and cash equivalents of approximately $157 million. Spruce Biosciences had 23,260,399 shares of common stock outstanding as of December 31, 2020.
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 need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy to offer markedly improved disease control and reduce steroid burden for patients suffering from classic CAH. Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years.
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. 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", "potential", "anticipates" 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.
1 Rosenfield RL, et al. (2016) Endocrine Reviews; 37(5):467–520.
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Spruce Biosciences, Inc. (NASDAQ:SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need, today announced that it will be added to the Russell 2000®, 3000® and Microcap® Indexes effective December 21, 2020, following Russell's quarterly additions of select initial public offerings.
"Our inclusion in the Russell indexes reflects the meaningful progress we continue to make toward our goal of changing the treatment paradigm for people living with congenital adrenal hyperplasia," said Richard King, Chief Executive Officer of Spruce Biosciences. "We believe that this important milestone will increase the overall awareness and visibility of our company within the investment community and broadens our institutional shareholder base."
Russell indexes are part of FTSE Russell, a leading global index provider. FTSE Russell determines membership for its Russell Indexes primarily by objective, market-capitalization rankings and style attributes. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes.
The Russell 2000® Index measures the performance of the small-cap segment of the U.S. equity market and is a subset of the Russell 3000®, representing approximately 10 percent of the total market capitalization of that index. Membership in the Russell 2000® Index includes automatic inclusion in the appropriate growth and style indexes. The Russell Microcap® Index measures the performance of the microcap segment of the U.S. equity market.
About FTSE Russell
FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.
FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $16 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.
A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by London Stock Exchange Group.
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 need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy to offer markedly improved disease control and reduce steroid burden 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.
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. 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 "will", "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.
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–Successful Initiation of Late-Stage CAHmelia Program in Adult Classic CAH–
–FDA and EMA Scientific Advice Support Plans in Pediatric Classic CAH Program–
–IPO Results in Pro Forma Cash and Cash Equivalents of $168.4 Million–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 third quarter ended September 30, 2020, and provided a corporate update.
Recent Accomplishments and Progress Toward Milestones
-
Successful Initiation of the Late-Stage CAHmelia Program in Adult Classic Congenital Adrenal Hyperplasia (CAH). CAHmelia-203 will assess the impact of tildacerfont, a CRF-1 receptor antagonist, on biomarker control and reducing clinical effects of disease in adult classic CAH patients with poor disease control. CAHmelia-204 will assess the effect of tildacerfont on glucocorticoid reduction and the clinical impact of that reduction in adult classic CAH patients with good disease control. Spruce believes that its two-study strategy may allow it to observe more clinically meaningful outcomes with fewer total patients studied. Screening activities are underway and substantial patient interest for participation in both studies has been registered at CAHstudy.com.
-
Pediatric Scientific Advice Meetings with FDA and European Medicines Agency (EMA) Completed. Spruce completed a scientific advice meeting with the EMA regarding its clinical development program of tildacerfont in children with classic CAH between the ages 2 and 17. Spruce plans to submit a Pediatric Investigational Plan (PIP) to the Pediatric Committee of the EMA regarding a Phase 3 registrational program in pediatrics. Scientific advice received from both the EMA and FDA also support Spruce's plans to initiate its planned Phase 2 pediatric clinical trial in the second half of 2021.
- Successful Completion of Initial Public Offering (IPO). Spruce closed its IPO in October 2020, resulting in net proceeds of $96.3 million, after deducting underwriting discounts and commissions of approximately $7.2 million and before deducting offering related expenses. When including net proceeds from the IPO, pro forma cash and cash equivalents as of September 30, 2020 were $168.4 million.
"The third quarter has been a transformational period for the company, marked by significant accomplishments. We have successfully initiated CAHmelia-203 and CAHmelia-204, our global late-stage development program in adult classic CAH, despite the challenges resulting from the COVID-19 pandemic," said Richard King, Chief Executive Officer. "With the successful completion of our IPO in October 2020, our strong cash position enables us to fund our CAHmelia program through completion and into applications for approval from regulatory authorities, assuming positive study outcomes. In addition, tildacerfont continues to progress towards evaluation in additional indications, including pediatric classic CAH and a rare form of polycystic ovary syndrome driven by a hyper-responsiveness to elevated levels of adrenocorticotropic hormone. We are focused on executing our clinical development plans and look forward to providing more updates in the future."
Financial Highlights
Cash and Cash Equivalents: Cash and cash equivalents as of September 30, 2020, were $72.2 million.
Research and Development (R&D) Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of tildacerfont. R&D expenses for the three and nine months ended September 30, 2020, were $7.8 million and $18.0 million compared to $2.1 million and $8.0 million for the same periods in 2019, respectively. The overall increase in R&D expenses was primarily related to an increase in clinical development, manufacturing, and personnel costs associated with advancement of tildacerfont into late-stage clinical development.
General and Administrative (G&A) Expenses: G&A expenses consist primarily of personnel costs, legal and other professional fees, insurance, and other administrative costs. G&A expenses for the three and nine months ended September 30, 2020, were $1.8 million and $3.0 million, compared to $0.5 million and $2.0 million for the same periods in 2019, respectively. The overall increase in G&A expenses was primarily driven by an increase in professional fees related to the IPO.
Net Loss: Net loss for the three and nine months ended September 30, 2020, was $9.6 million and $21.2 million, compared to $2.6 million and $9.9 million for the same periods in 2019, 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 need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy to offer markedly improved disease control and reduce steroid burden 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.
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", "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 Measure
To supplement our financial information, which is prepared and presented in accordance with generally accepted accounting principles in the United States of America ("GAAP"), we use the following non-GAAP financial measure: pro forma cash and cash equivalents, which include the net proceeds from the IPO, after deducting underwriting discounts and commissions and before deducting offering related expenses. Management believes the non-GAAP financial measure is helpful to investors to evaluate the company's financial position. The 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.
There are a number of limitations related to the use of non-GAAP financial measures. In light of these limitations, we provide specific information regarding the GAAP amounts included or excluded from these non-GAAP financial measures and evaluating these non-GAAP financial measures together with their relevant financial measures in accordance with GAAP.
For more information on these non-GAAP financial measures, please see the section titled "Reconciliation of Non-GAAP Measure" included at the end of this release.
SPRUCE BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands, except share amounts)
September 30,
2020
December 31,
2019
ASSETS
Current assets:
Cash and cash equivalents
$
72,158
$
3,924
Prepaid expenses
1,233
215
Other current assets
209
513
Total current assets
73,600
4,652
Restricted cash
216
—
Right-of-use assets
1,869
—
Deferred offering costs
2,347
—
Other assets
453
40
Total assets
$
78,485
$
4,692
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts payable
$
4,002
$
1,878
Term loan, current portion
1,908
1,252
Accrued expenses and other current liabilities
3,469
265
Accrued compensation and benefits
707
908
Total current liabilities
10,086
4,303
Term loan, net of current portion
2,561
3,193
Lease liability, net of current portion
1,738
—
Other liabilities
95
20
Total liabilities
14,480
7,516
Series A redeemable convertible preferred stock, $0.0001 par value, 28,000,000 shares authorized, issued, and outstanding as of September 30, 2020 and December 31, 2019; liquidation preference of $28,000 as of September 30, 2020 and December 31, 2019
27,813
27,813
Series B redeemable convertible preferred stock, $0.0001 par value, 73,333,330 shares authorized, issued, and outstanding as of September 30, 2020 and 0 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $88,000 as of September 30, 2020 and $0 as of December 31, 2019
87,633
—
Stockholders' equity (deficit):
Common stock, $0.0001 par value, 130,518,922 and 41,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 822,022 and 764,408 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively
1
1
Additional paid-in capital
1,061
664
Accumulated deficit
(52,503
)
(31,302
)
Total stockholders' equity (deficit)
(51,441
)
(30,637
)
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)
$
78,485
$
4,692
SPRUCE BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except share and per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
Operating expenses:
Research and development
$
7,769
$
2,107
$
18,040
$
7,969
General and administrative
1,790
457
3,041
2,004
Total operating expenses
9,559
2,564
21,081
9,973
Loss from operations
(9,559
)
(2,564
)
(21,081
)
(9,973
)
Interest expense
(79
)
(5
)
(245
)
(5
)
Other income, net
51
18
125
72
Net loss
$
(9,587
)
$
(2,551
)
$
(21,201
)
$
(9,906
)
Net loss per share, basic and diluted
$
(12.35
)
$
(3.34
)
$
(27.54
)
$
(12.96
)
Weighted-average shares of common stock outstanding, basic and diluted
776,159
764,408
769,766
764,408
SPRUCE BIOSCIENCES, INC.
RECONCILIATION OF NON-GAAP MEASURE
(unaudited)
(in thousands)
September 30,
2020
Cash and cash equivalents
$
72,158
Adjustments:
Net IPO proceeds after deducting underwriting discounts and commissions and before deducting offering related expenses
96,255
Pro forma cash and cash equivalents
$
168,413
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Successful Initiation of the Late-Stage CAHmelia Program in Adult Classic Congenital Adrenal Hyperplasia (CAH). CAHmelia-203 will assess the impact of tildacerfont, a CRF-1 receptor antagonist, on biomarker control and reducing clinical effects of disease in adult classic CAH patients with poor disease control. CAHmelia-204 will assess the effect of tildacerfont on glucocorticoid reduction and the clinical impact of that reduction in adult classic CAH patients with good disease control. Spruce believes that its two-study strategy may allow it to observe more clinically meaningful outcomes with fewer total patients studied. Screening activities are underway and substantial patient interest for participation in both studies has been registered at CAHstudy.com.
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Spruce Biosciences, Inc. (NASDAQ:SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need, today announced that the company will participate in the Credit Suisse 29th Annual Virtual Healthcare Conference.
Chief Executive Officer, Richard King, is scheduled to present on Thursday, November 12 at 4:15 p.m. EST.
Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.sprucebiosciences.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.
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 need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy to offer markedly improved disease control and reduce steroid burden 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.
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Spruce Biosciences, Inc., a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need, today announced the closing of its initial public offering of 6,900,000 shares of its common stock, which includes 900,000 shares sold pursuant to the full exercise by the underwriters of their option to purchase additional shares, at a public offering price of $15.00 per share. The gross proceeds to Spruce from the offering, before deducting underwriting discounts, commissions and offering expenses, were $103.5 million. All of the shares in the offering were sold by Spruce.
Spruce's common stock began trading on the Nasdaq Global Select Market on October 9, 2020 under the ticker symbol "SPRB."
Cowen, SVB Leerink, Credit Suisse and RBC Capital Markets acted as joint book-running managers for the offering.
The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by e-mail at [email protected], or by phone at (800) 808-7525, ext. 6132; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by e-mail at [email protected], or by phone at (800) 221-1037; or from RBC Capital Markets, LLC, 200 Vesey Street, 8th Floor, New York, NY 10281, Attention: Equity Capital Markets, or by phone at (877) 822-4089.
Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 8, 2020. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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 need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy to offer markedly improved disease control and reduce steroid burden 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.
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