SPRB Spruce Biosciences Inc.

15.58
-0.52  -3%
Previous Close 16.1
Open 16.24
52 Week Low 14.18
52 Week High 31.94
Market Cap $363,043,166
Shares 23,301,872
Float 17,616,631
Enterprise Value $224,388,139
Volume 12,380
Av. Daily Volume 47,722
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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
Classic Congenital Adrenal Hyperplasia
Phase 2
Phase 2
Phase 2 data presented at ENDO March 20, 2021.
Tildacerfont
Pediatric Classic Congenital Adrenal Hyperplasia
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.

Latest News

  1. Oversubscribed fund to continue investing in high-impact biopharma and medical device innovation

    RiverVest Venture Partners, a leading venture capital firm, announced today the closing of its RiverVest Venture Fund V, L.P. ("Fund V"), with $275 million of capital commitments in an oversubscribed fundraise. Fund V brings the firm's total assets under management to more than $1.6 billion.

    RiverVest invests in early-stage biopharma and medical device companies addressing significant unmet medical needs and has delivered consistently strong results to investors. Fund V is RiverVest's largest fund to date, reflecting commitments from a wide range of institutional investors, as well as family offices and individual investors. Fund V's limited partners…

    Oversubscribed fund to continue investing in high-impact biopharma and medical device innovation

    RiverVest Venture Partners, a leading venture capital firm, announced today the closing of its RiverVest Venture Fund V, L.P. ("Fund V"), with $275 million of capital commitments in an oversubscribed fundraise. Fund V brings the firm's total assets under management to more than $1.6 billion.

    RiverVest invests in early-stage biopharma and medical device companies addressing significant unmet medical needs and has delivered consistently strong results to investors. Fund V is RiverVest's largest fund to date, reflecting commitments from a wide range of institutional investors, as well as family offices and individual investors. Fund V's limited partners include most major investors from earlier RiverVest funds and several new institutional investors, enabled by the larger fund size.

    "With RiverVest Venture Fund V, we will continue our investment strategy grounded in close collaboration with entrepreneurs and academic investigators to develop products for the most pressing challenges patients face today," said Jay Schmelter, RiverVest's co-founder and managing director. "Fund V's larger size will enable RiverVest to participate more fully in later equity rounds of portfolio companies which have the greatest potential."

    RiverVest has a 20-year track record of success. Of the 55 companies in which RiverVest has invested, 18 have been successfully sold and eight have gone public, including Allakos (NASDAQ:ALLK), Mirum Pharmaceuticals (NASDAQ:MIRM) and most recently Spruce Biosciences (NASDAQ:SPRB) in October 2020. Having founded 15 companies to date, RiverVest is adept at founding companies with technology that originates from academic labs or that has been spun out from larger companies. RiverVest joins syndicates with peer venture firms globally to propel early-stage companies.

    Today, there are at least 27 commercial products treating patients and many in development from companies in which RiverVest has invested. They include drugs such as Lokelma, a treatment for hyperkalemia, a life-threatening condition caused by elevated potassium levels, developed by ZS Pharma and commercialized by AstraZeneca in 2018, and medical devices such as the Supera™ stent, used to treat peripheral artery disease, developed by IDEV Technologies and acquired by Abbott in 2013.

    "RiverVest approaches each investment in our concentrated portfolio with high conviction," said Schmelter. "Working as a team, we aggressively identify and create investment opportunities, we are thorough in our due diligence, and we aim to provide our portfolio companies collaborative scientific, operational, financial and business development expertise."

    With its disciplined investment approach, RiverVest will continue to create value for patients, entrepreneurs and investors. Headquartered in St. Louis and with offices in San Diego and Cleveland, RiverVest is at the intersection of outstanding medical research universities and flourishing innovation ecosystems, reviewing a diverse opportunity set and investing nationally.

    About RiverVest

    RiverVest is a leading venture capital firm building life science companies to address significant unmet needs of patients and deliver consistently strong returns to investors. With headquarters in St. Louis and offices in San Diego and Cleveland, RiverVest accesses forward-thinking research and clinical expertise at leading institutions across the country to found and fund biopharma and medical device companies.

    Select Commercial Products Developed by RiverVest's Portfolio Companies:

    • Lokelma – Treatment for adults with elevated potassium levels (ZS Pharma/AstraZeneca)
    • Vfend – Treatment for fungal infections (CyDex Pharmaceuticals/Pfizer)
    • Quinsair – Treatment for cystic fibrosis (Mpex Pharmaceuticals/Horizon)
    • Margenza – Treatment for breast cancer (MacroGenics)
    • Lutonix – Drug-coated angioplasty balloon (Lutonix/Bard)
    • Supera – Peripheral Stent System (IDEV Technologies/Abbott)
    • Emblem – Leadless Implantable Cardioverter Defibrillator (Cameron Health/Boston Scientific)

     

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  2. Late-Stage CAHmelia Program in Adult Classic CAH Advancing with Majority of Study Sites Active

    CAHmelia Program Enhanced Following Discussions with FDA - Primary Data Expected in 2022

    Amended Debt Facility with SVB Provides Access Up to Additional $25 Million in Non-Dilutive Financing

    New Drug Application (NDA) Filing for Tildacerfont in Adult Classic CAH Targeted for 2023

    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, 2020 and provided a corporate update.

    "2020 was a transformative year for Spruce…

    Late-Stage CAHmelia Program in Adult Classic CAH Advancing with Majority of Study Sites Active

    CAHmelia Program Enhanced Following Discussions with FDA - Primary Data Expected in 2022

    Amended Debt Facility with SVB Provides Access Up to Additional $25 Million in Non-Dilutive Financing

    New Drug Application (NDA) Filing for Tildacerfont in Adult Classic CAH Targeted for 2023

    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, 2020 and provided a corporate update.

    "2020 was a transformative year for Spruce Biosciences, as we firmly established our company as an emerging leader in the development of groundbreaking therapies for rare endocrine disorders," said Richard King, Chief Executive Officer, Spruce Biosciences. "The initiation of our CAHmelia program in adult classic congenital adrenal hyperplasia (CAH) moves us one step closer to changing the treatment paradigm for patients living with this chronic and potentially life-threatening disease. Following the completion of our upsized IPO in October 2020, we are also preparing to expand the utility of tildacerfont through studies in children with classic CAH and in women living with a rare form of polycystic ovary syndrome (PCOS), with Phase 2 programs in both indications on track to initiate in the second half of 2021. We also remain focused on clinical study execution: we have the majority of our CAHmelia study sites now active across 2 continents and are encouraged by the level of patient interest registered with our study investigators and at CAHstudy.com."

    King continued, "Following discussions with U.S. Food and Drug Administration, we have decided to increase the open label extension period for CAHmelia-203 by 18 weeks and for CAHmelia-204 by 24 weeks. In addition, we have increased the size of CAHmelia-204 from 60 patients to 90 patients. We believe that these changes will result in a more robust data package. With these program enhancements, together with the impact of the ongoing COVID-19 pandemic, we now expect primary data from CAHmelia-203 in the first half of 2022 and CAHmelia-204 in the second half of 2022. Assuming positive study outcomes, we continue to target an NDA filing for tildacerfont in adult classic CAH in 2023."

    Recent Operating Highlights

    • Presentation of Phase 1 and 2 Data of Tildacerfont at Endocrine's Society's 2021 Annual Meeting (ENDO 2021): In March 2021, data from the company's Phase 1 and 2 programs of tildacerfont in classic CAH were presented at ENDO 2021. The presentation highlighted several datasets, including data from the company's SPR001-202 study, 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 study and without increases to daily steroid doses has not been reported to date with any other investigational product candidate.



    • Submission of Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMA): Spruce has submitted a PIP to the Pediatric Committee of the EMA regarding a registrational program in pediatric classic CAH.



    • Patent Issuance Extends Tildacerfont Exclusivity Through 2038: In December 2020, the United States Patent and Trademark Office 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, builds on existing composition of matter patents, and further extends exclusivity through 2038.



    • Addition to Russell 2000®, 3000®, and Microcap® Indexes: In December 2020, the company was added to the Russell 2000®, 3000®, and Microcap® indexes as part of Russell's quarterly additions of selected initial public offering (IPOs). The additions increase overall awareness and visibility of the company within the investment community and may broaden its institutional shareholder base.



    • Amended Debt Facility with Silicon Valley Bank (SVB) Provides Access to $25 Million in Non-Dilutive Financing: The company has amended its debt facility with SVB to increase the aggregate principal amount of the term loan commitment by SVB from $4.5 million to $30 million. The amendment refinances and delays repayment of principal of the existing $4.5 million term loan to 2023 and provides access up to $25 million in additional non-dilutive financing for general corporate purposes.



    • Cash and Cash Equivalents of $157.2 Million at 2020 Year End: Following the IPO in October 2020, the company is well capitalized to advance its pipeline through major milestones, including primary data readout from its late-stage CAHmelia program and Phase 2 programs in pediatric classic CAH and a rare form of PCOS.

    Anticipated Upcoming Milestones

    • Filing of an Investigational New Drug (IND) application in the first half of 2021 in PCOS
    • Initiation of a Phase 2 proof-of-concept clinical trial in the second half of 2021 in PCOS
    • Initiation of a Phase 2 clinical program in pediatric classic CAH in the second half of 2021

    Financial Highlights

    • Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2020, were $157.2 million.



    • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter and full year ended December 31, 2020 were $5.8 million and $23.9 million compared to $2.8 million and $10.8 million for the same periods in 2019, 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, 2020 were $2.5 million and $5.6 million, compared to $0.3 million and $2.3 million for the same periods in 2019, respectively. The overall increase in G&A expenses was primarily driven by an increase in costs related to operation as a public company.



    • Net Loss: Net loss for the fourth quarter and full year ended December 31, 2020 was $8.3 million and $29.5 million, compared to $3.2 million and $13.1 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 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, representing 3-5% of females with PCOS (estimated to be 150,000 to 200,000 patients in the United States). To learn more, visit www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio, LinkedIn and Facebook.

    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 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.

     

    SPRUCE BIOSCIENCES, INC.

    BALANCE SHEETS

    (in thousands, except share amounts)

     

     

     

    December 31,

     

     

    2020

     

     

    2019

     

    ASSETS

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    157,150

     

     

    $

    3,924

     

    Prepaid expenses

     

     

    2,971

     

     

     

    215

     

    Other current assets

     

     

    276

     

     

     

    513

     

    Total current assets

     

     

    160,397

     

     

     

    4,652

     

    Restricted cash

     

     

    216

     

     

     

     

    Right-of-use assets

     

     

    1,793

     

     

     

     

    Other assets

     

     

    477

     

     

     

    40

     

    Total assets

     

    $

    162,883

     

     

    $

    4,692

     

    LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    3,628

     

     

    $

    1,878

     

    Term loan, current portion

     

     

    2,554

     

     

     

    1,252

     

    Accrued expenses and other current liabilities

     

     

    2,496

     

     

     

    265

     

    Accrued compensation and benefits

     

     

    1,085

     

     

     

    908

     

    Total current liabilities

     

     

    9,763

     

     

     

    4,303

     

    Term loan, net of current portion

     

     

    1,922

     

     

     

    3,193

     

    Lease liability, net of current portion

     

     

    1,653

     

     

     

     

    Other liabilities

     

     

    118

     

     

     

    20

     

    Total liabilities

     

     

    13,456

     

     

     

    7,516

     

    Series A redeemable convertible preferred stock, $0.0001 par value; 0 shares and 28,000,000 shares authorized, issued and outstanding as of December 31, 2020 and 2019, respectively; liquidation preference of $0 and $28,000 as of December 31, 2020 and 2019, respectively

     

     

     

     

     

    27,813

     

    Stockholders' equity (deficit):

     

     

     

     

     

     

    Preferred stock, $0.0001 par value; 10,000,000 shares and 0 shares authorized as of December 31, 2020 and 2019, respectively; 0 shares issued and outstanding as of December 31, 2020 and 2019

     

     

     

     

     

     

    Common stock, $0.0001 par value; 200,000,000 shares and 41,000,000 shares authorized as of December 31, 2020 and 2019, respectively; 23,260,399 shares and 764,408 shares issued and outstanding as of December 31, 2020 and 2019, respectively

     

     

    2

     

     

     

    1

     

    Additional paid-in capital

     

     

    210,266

     

     

     

    664

     

    Accumulated deficit

     

     

    (60,841

    )

     

     

    (31,302

    )

    Total stockholders' equity (deficit)

     

     

    149,427

     

     

     

    (30,637

    )

    Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)

     

    $

    162,883

     

     

    $

    4,692

     

     

    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,

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    5,813

     

     

    $

    2,847

     

     

    $

    23,854

     

     

    $

    10,817

     

    General and administrative

     

     

    2,521

     

     

     

    286

     

     

     

    5,562

     

     

     

    2,290

     

    Total operating expenses

     

     

    8,334

     

     

     

    3,133

     

     

     

    29,416

     

     

     

    13,107

     

    Loss from operations

     

     

    (8,334

    )

     

     

    (3,133

    )

     

     

    (29,416

    )

     

     

    (13,107

    )

    Interest expense

     

     

    (79

    )

     

     

    (60

    )

     

     

    (323

    )

     

     

    (65

    )

    Other income, net

     

     

    75

     

     

     

    12

     

     

     

    200

     

     

     

    84

     

    Net loss

     

    $

    (8,338

    )

     

    $

    (3,181

    )

     

    $

    (29,539

    )

     

    $

    (13,088

    )

    Net loss per share, basic and diluted

     

    $

    (0.39

    )

     

    $

    (4.16

    )

     

    $

    (4.93

    )

     

    $

    (17.12

    )

    Weighted-average shares of common stock outstanding, basic and diluted

     

     

    21,542,045

     

     

     

    764,408

     

     

     

    5,991,213

     

     

     

    764,408

     

     

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  3. Tildacerfont Led to Significant Reductions in Disease Biomarkers Over 12 Weeks

    Tildacerfont is First CRF1 Antagonist Studied Beyond Two Weeks in CAH

    CAHmelia Program Underway and Enrolling Patients in U.S. and Europe

    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, presented data from its Phase 1 and 2 programs of tildacerfont in adults with classic congenital adrenal hyperplasia (CAH) from the Endocrine Society's 2021 Annual Meeting, taking place virtually March 20 – 23, 2021.

    "As an investigator in the SPR001-202 trial, I was pleased to see that the reductions of biomarkers with tildacerfont…

    Tildacerfont Led to Significant Reductions in Disease Biomarkers Over 12 Weeks

    Tildacerfont is First CRF1 Antagonist Studied Beyond Two Weeks in CAH

    CAHmelia Program Underway and Enrolling Patients in U.S. and Europe

    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, presented data from its Phase 1 and 2 programs of tildacerfont in adults with classic congenital adrenal hyperplasia (CAH) from the Endocrine Society's 2021 Annual Meeting, taking place virtually March 20 – 23, 2021.

    "As an investigator in the SPR001-202 trial, I was pleased to see that the reductions of biomarkers with tildacerfont treatment were not only sustained during the 12 weeks but often progressively greater at the later time points, without any new safety concerns during prolonged treatment," said Rich Auchus, MD, PhD, Professor of Internal Medicine and Pharmacology, University of Michigan, Ann Arbor. "These results support ongoing extended studies of tildacerfont for the treatment of classic 21-hydroxylase deficiency."

    Dose Escalating and Bioavailability Phase 1 Studies Assessing Safety and Tolerability and Pharmacokinetics of Tildacerfont, A Small-Molecule Oral CRF1 Receptor Antagonist

    Poster Session: P04, Adrenal - Basic and Translational Aspects

    Abstract Number: 4140

    In both single ascending dose and multiple ascending dose studies, tildacerfont was generally safe and well tolerated in healthy adults in single doses up to 800mg as well as in multiple doses up to 200mg once daily, for 14 days. Approximate steady-state exposures were attained within 14 days of dosing.

    Further, in a separate bioavailability study, tildacerfont formulated as a tablet provided for a more consistent and more predictable pharmacokinetic profile, as well as demonstrating bioequivalence in overall exposure, compared to a capsule formulation.

    Assessment of Steroid Hormones in Both Saliva and Blood During a Phase 2 Clinical Trial for the Use of Tildacerfont in Adults with Classic Congenital Adrenal Hyperplasia

    Poster Session: P54, Hormone Actions in Tumor Biology: From New Mechanisms to Therapy

    Abstract Number: 4305

    SPR001-201 was an open-label, multi-dose, dose-escalation study which evaluated the ability of tildacerfont to reduce adrenal hormones and androgens at doses ranging from 200mg daily to 1,000mg daily in patients with congenital adrenal hyperplasia due to 21-hydroxylase deficiency. Participants in the study underwent concurrent salivary and serum concentration measurements of androstenedione (A4), 17-hydroxyprogesterone (17-OHP) and testosterone (T). Both serum and saliva samples were measured using liquid chromatography-tandem mass spectrometry.

    The study demonstrated good correlation between salivary and serum assessments of 17-OHP and A4, indicating that measurement of hormones in saliva may offer a promising, non-invasive approach to more frequently assessing response to therapy in patients with CAH.

    Tildacerfont for the Treatment of Patients with Classic Congenital Adrenal Hyperplasia: Results From a 12-week Phase 2 Clinical Trial in Adults with Classic CAH

    Poster Session: P25, Endocrine Disrupting Compounds: Mechanisms of Action and Clinical Implications

    Abstract Number: 4308

    SPR001-202 was an open-label, 12-week Phase 2a clinical trial, which assessed the ability of a daily dose of 400mg of tildacerfont to lower disease-driving hormones such as adrenocorticotropic hormone (ACTH), 17-OHP, and A4 over a 12-week dosing period. Patients were classified into two groups based on disease control using baseline biomarker levels.

    Tildacerfont-treated patients with poor disease control had mean maximum reductions of 84% in ACTH, 80% in 17-OHP, and 79% in A4 compared to baseline at 8:00 a.m. This enabled reduction in the levels of these key hormones that are used as targets for assessment of disease control in these patients to near normal levels. In addition, 60% of patients achieved normalization of ACTH levels, and 40% achieved normalization of A4 levels during month three. Normalization of these highly elevated hormones in classic CAH patients within 12 weeks and without increases to daily steroid doses has not been reported to date with any other investigational product candidate. Patients who were in good disease control upon entry to SPR001-202 had mean levels of ACTH, 17-OHP and A4 that were well below the target goal. Administration of tildacerfont to these patients did not lead to significant changes in these levels.

    In the Phase 2 program, comprising of studies SPR001-201 and SPR001-202, two homogenous patient groups were identified using ACTH and A4, which classified these patients as either having "poor disease control" or "good disease control." Patients with poor disease control had highly elevated ACTH and A4 levels at baseline, generally greater than twice the upper limit of normal (ULN) and, more commonly, greater than four times the ULN. These patients with poor disease control were on a stable mean daily supraphysiologic dose of approximately 25mg of hydrocortisone, or a dose of another glucocorticoid equivalent to 25mg of hydrocortisone. Patients with good disease control had elevated 17-OHP levels but had ACTH and A4 generally less than twice the ULN, and more commonly, within the normal bounds for ACTH and A4. These patients were on doses equivalent to a mean daily supraphysiologic dose 36mg of hydrocortisone, which was a 44% higher total daily dose than patients with poor disease control.

    "The findings from our Phase 2 program suggest that patients in the poor disease control patient group may have been receiving inadequate glucocorticoid doses to provide adequate control of their disease, possibly due to an inability to tolerate higher doses of glucocorticoids or unwillingness to accept the adverse outcomes attributed to chronic dosing of supraphysiologic glucocorticoids," said Richard King, Chief Executive Officer, Spruce Biosciences. "Our ongoing CAHmelia program is designed to assess both good disease and poor disease control patients. CAHmelia-203 is assessing the ability of tildacerfont to reduce excessive adrenal androgens in patients with poor disease control, while CAHmeila-204 is assessing the ability of tildacerfont to reduce glucocorticoid usage in patients with good disease control while maintaining control of androgens. We believe that our two-study strategy may allow us to observe more clinically meaningful outcomes."

    The presentations are now on display in ENDO 2021's virtual poster hall. Learn more about the full program and how to access the poster presentation details on the ENDO 2021 website.

    About Tildacerfont

    Tildacerfont is a potent and highly selective, non-steroidal, oral antagonist of the CRF1 receptor, which is the receptor for corticotropin-releasing factor, or CRF, a hormone that is secreted by the hypothalamus. The CRF1 receptor is abundantly expressed in the pituitary gland where it is the primary regulator of the HPA axis. By blocking the CRF1 receptor, tildacerfont has the potential to address the uncontrolled cortisol feedback regulatory pathway in CAH, and in turn reduce the production of ACTH in the pituitary, limiting the amount of androgen produced downstream from the adrenal gland. Tildacerfont has been evaluated in 171 patients across seven clinical trials in which it has been generally well tolerated. No drug-related SAEs have been reported related to tildacerfont treatment.

    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 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, representing 3-5% of females with PCOS (estimated to be 150,000 to 200,000 patients in the United States). To learn more, visit www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio, LinkedIn and Facebook.

    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. 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 "potential", "assess" 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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  4. 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 data from its Phase 1 and 2 program of tildacerfont for the treatment of classic congenital adrenal hyperplasia will be shared at the Endocrine Society's 2021 Annual Meeting (ENDO 2021) taking place virtually from Saturday, March 20 to Tuesday, March 23.

    Full ePoster presentation details are listed below, and the full preliminary program is available online at the ENDO 2021 website. The presentations will be on display in ENDO 2021's virtual poster hall beginning on Saturday, March 20 at 8:00am PST / 11:00am EST.

    Tildacerfont

    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 data from its Phase 1 and 2 program of tildacerfont for the treatment of classic congenital adrenal hyperplasia will be shared at the Endocrine Society's 2021 Annual Meeting (ENDO 2021) taking place virtually from Saturday, March 20 to Tuesday, March 23.

    Full ePoster presentation details are listed below, and the full preliminary program is available online at the ENDO 2021 website. The presentations will be on display in ENDO 2021's virtual poster hall beginning on Saturday, March 20 at 8:00am PST / 11:00am EST.

    Tildacerfont for the Treatment of Patients with Classic Congenital Adrenal Hyperplasia: Results From a 12-week Phase 2 Clinical Trial in Adults with Classic CAH

    Presenter: Richard J. Auchus, MD, PhD

    Co-Authors: Richard J. Auchus, MD, PhD, Deborah P. Merke, MD, MS, Ivy-Joan Madu, MD, Samer Nakhle, MD, Kyriakie Sarafoglou, MD, Michael Huang, MD, David Moriarty, PhD, Chris N. Barnes, PhD, and Ron S. Newfield, MD

    Poster Session: P25, Endocrine Disrupting Compounds: Mechanisms of Action and Clinical Implications

    Abstract Number: 4308

    Assessment of Steroid Hormones in Both Saliva and Blood During a Phase 2 Clinical Trial for the Use of Tildacerfont in Adults with Classic Congenital Adrenal Hyperplasia

    Presenter: Chris N. Barnes, PhD

    Co-Authors: Brian Keevil, MSc FRCPath, Kyriakie Sarafoglou, MD, David Moriarty, PhD, Michael Huang, MD, Chris N. Barnes, PhD, and Wiebke Arlt, MD DSc FRCP FMedSci

    Poster Session: P54, Hormone Actions in Tumor Biology: From New Mechanisms to Therapy

    Abstract Number: 4305

    Dose Escalating and Bioavailability Phase 1 Studies Assessing Safety and Tolerability and Pharmacokinetics of Tildacerfont, A Small-Molecule Oral CRF1 Receptor Antagonist

    Presenter: Chris N. Barnes, PhD

    Co-Authors: Chris N. Barnes, PhD, Elliot Offman, PhD, Nora Darago, BS, and David Moriarty, PhD

    Poster Session: P04, Adrenal - Basic and Translational Aspects

    Abstract Number: 4140

    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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  5. 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 two upcoming investor conferences.

    10th Annual SVB Leerink Global Healthcare Conference

    Chief Executive Officer, Richard King, is scheduled to participate in a fireside chat on Wednesday, February 24 at 9:00am PST / 12:00pm EST.

    41st Cowen Annual Healthcare Conference

    Richard King is also scheduled to participate in a panel discussion on Tuesday, March 2 at 11:10am PST / 2:10pm EST.

    Interested parties can access the live webcast for each conference from the Investor Relations section of the company's…

    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 two upcoming investor conferences.

    10th Annual SVB Leerink Global Healthcare Conference

    Chief Executive Officer, Richard King, is scheduled to participate in a fireside chat on Wednesday, February 24 at 9:00am PST / 12:00pm EST.

    41st Cowen Annual Healthcare Conference

    Richard King is also scheduled to participate in a panel discussion on Tuesday, March 2 at 11:10am PST / 2:10pm EST.

    Interested parties can access the live webcast for each conference from the Investor Relations section of the company's website at www.sprucebiosciences.com. A replay of the webcasts 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.

    View Full Article Hide Full Article
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