SPRB Spruce Biosciences Inc.

4.31
-0.24  -5%
Previous Close 4.55
Open 4.42
52 Week Low 4.41
52 Week High 31.94
Market Cap $100,710,343
Shares 23,377,517
Float 17,692,276
Enterprise Value $3,818,702
Volume 99,544
Av. Daily Volume 49,125
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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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Tildacerfont
Pediatric Classic Congenital Adrenal Hyperplasia
Phase 2
Phase 2
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Tildacerfont
Polycystic Ovary Syndrome
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Tildacerfont
Classic Congenital Adrenal Hyperplasia
Phase 2
Phase 2
Phase 2 data presented at ENDO March 20, 2021.

Latest News

  1. 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 announced that company management will participate in four upcoming investor conferences taking place virtually throughout the month of September:

    • H.C. Wainwright 23rd Annual Global Investment Conference
      Date:
      September 13 – 14, 2021
      Format: Company presentation (available September 13 at 7:00 am ET) and 1x1 meetings
    • Baird 2021 Global Healthcare Conference
      Date:
      September 14 – 15, 2021
      Format: Company presentation (September 15 at 1:25 pm ET) and 1x1 meetings
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
      Date:
      September…

    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 announced that company management will participate in four upcoming investor conferences taking place virtually throughout the month of September:

    • H.C. Wainwright 23rd Annual Global Investment Conference

      Date:
      September 13 – 14, 2021

      Format: Company presentation (available September 13 at 7:00 am ET) and 1x1 meetings
    • Baird 2021 Global Healthcare Conference

      Date:
      September 14 – 15, 2021

      Format: Company presentation (September 15 at 1:25 pm ET) and 1x1 meetings
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

      Date:
      September 20 – 22, 2021

      Format: Company presentation (September 21 at 11:35 am ET) and 1x1 meetings
    • SVB Leerink CybeRx Series: Neuromuscular, Rare Diseases & Genetic Medicines 1x1 Event

      Date:
      September 22 – 23, 2021

      Format: 1x1 meetings

    Interested parties can access the webcast for each conference presentation from the Events section of the company's investor relations website.

    About Spruce Biosciences

    Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years. Spruce is also developing tildacerfont for women suffering from a rare form of polycystic ovary syndrome (PCOS) with primary adrenal androgen excess. To learn more, visit www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio, LinkedIn, Facebook and YouTube.

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  2. Phase 2 Program in Pediatric Classic Congenital Adrenal Hyperplasia (CAH) on Track to Initiate in 2021 with Data Expected by 1H 2023

    Phase 3 Registrational Program in Pediatric Classic CAH Expected to Initiate in 2023

    R&D Day Webcast Featuring Spruce Management, KOL Panel Discussion and Q&A Begins Today at 11:00 am ET

    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 announced that it will discuss the details of its Phase 2 clinical program for tildacerfont in pediatric classic CAH during the company's virtual Research and Development (R&D) Day. The webcast will begin today at 11:00…

    Phase 2 Program in Pediatric Classic Congenital Adrenal Hyperplasia (CAH) on Track to Initiate in 2021 with Data Expected by 1H 2023

    Phase 3 Registrational Program in Pediatric Classic CAH Expected to Initiate in 2023

    R&D Day Webcast Featuring Spruce Management, KOL Panel Discussion and Q&A Begins Today at 11:00 am ET

    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 announced that it will discuss the details of its Phase 2 clinical program for tildacerfont in pediatric classic CAH during the company's virtual Research and Development (R&D) Day. The webcast will begin today at 11:00 am ET.

    "We are pleased to initiate our Phase 2 clinical program of tildacerfont in children with classic CAH, a rare endocrine disorder where a significant unmet medical need exists for a non-steroidal treatment approach, this year," said Richard King, Chief Executive Officer of Spruce Biosciences. "The clinical profiles of, and goals of therapy for children with classic CAH vary between pre- and post-pubertal stages of development. Our program responds to these different clinical paradigms dependent on a child's stage of development."

    The Phase 2 open-label study will utilize a sequential 3 cohort design to evaluate the safety, pharmacokinetics, and exploratory pharmacodynamics of tildacerfont in children aged 6 to 17 with classic CAH for up to 3 weight-adjusted doses, equivalent to adult doses of 50 mg, 100 mg, or 200 mg once daily of tildacerfont, for a duration of 2 weeks. Cohort 1 will include children between 11 and 17 years of age, at a dose of 50 mg once a day. Cohort 2 will also include children between 11 and 17 years of age, at a dose of up to 200mg once daily. Cohort 3 will include children between 6 and 10 years of age, at a dose of up to 200 mg once daily. The study drug will be dosed with an evening meal and will be formulated as granules to be sprinkled over food.

    The Phase 2 program in pediatric classic CAH remains on track to initiate later this year with data expected by the first half of 2023. The Phase 3 registrational program in pediatric classic CAH is expected to initiate in 2023.

    Spruce Biosciences R&D Day Webcast Details: Tildacerfont for Adult & Pediatric Classic CAH

    Date: Wednesday, August 25, 2021

    Time: 11:00 am – 1:00 pm ET

    Registration and Webcast Link

    Richard King, Chief Executive Officer of Spruce Biosciences, will be joined by members of the company's management team, as well as leading endocrinologists, Richard Auchus, MD, PhD, the James A. Shayman and Andrea S. Kevrick Professor of Translational Medicine at the University of Michigan, and Professor of Internal Medicine and Professor of Pharmacology at the University of Michigan Medical School, and Paul Thornton, MD, Medical Director, Endocrine and Diabetes Program, Cook Children's Medical Center.

    Interested parties may also access the webcast from the Events section of the company's investor relations website. An archived replay of the webcast will be available after the conclusion of the presentation.

    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 (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 235 patients across eight clinical trials in which it has been generally well tolerated. No drug-related serious adverse events 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 medical need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years. Spruce is also developing tildacerfont for women suffering from a rare form of polycystic ovary syndrome (PCOS) with primary adrenal androgen excess. To learn more, visit www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio, LinkedIn, Facebook and YouTube.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the results, conduct, progress and timing of Spruce's clinical trials. 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.

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  3. Presentations from Spruce leadership team & KOL panel discussion featuring Richard Auchus, MD, PhD and Paul Thornton, MD

    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 announced that the company will host its inaugural virtual Research and Development (R&D) Day on Wednesday, August 25, 2021 from 11:00 am to 1:00 pm ET.

    The event will include an overview of Spruce's clinical development programs for tildacerfont in adult and pediatric classic congenital adrenal hyperplasia (CAH). The event will also feature a KOL panel discussion and Q&A session with company management.

    Richard King…

    Presentations from Spruce leadership team & KOL panel discussion featuring Richard Auchus, MD, PhD and Paul Thornton, MD

    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 announced that the company will host its inaugural virtual Research and Development (R&D) Day on Wednesday, August 25, 2021 from 11:00 am to 1:00 pm ET.

    The event will include an overview of Spruce's clinical development programs for tildacerfont in adult and pediatric classic congenital adrenal hyperplasia (CAH). The event will also feature a KOL panel discussion and Q&A session with company management.

    Richard King, Chief Executive Officer of Spruce Biosciences, will be joined by members of the company's management team, as well as leading endocrinologists, Richard Auchus, MD, PhD, Professor of Internal Medicine and Pharmacology at the University of Michigan, and Paul Thornton, MD, Medical Director, Endocrine and Diabetes Program, Cook Children's Medical Center.

    Spruce Biosciences R&D Day Webcast Details: Tildacerfont for Adult & Pediatric Classic CAH

    Date: Wednesday, August 25, 2021

    Time: 11:00 am – 1:00 pm ET

    Registration and Webcast Link

    Interested parties may also access the webcast from the Events section of the company's investor relations website. An archived replay of the webcast will be available after the conclusion of the presentation.

    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 (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 235 patients across eight clinical trials in which it has been generally well tolerated. No drug-related serious adverse events 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 medical need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years. Spruce is also developing tildacerfont for women suffering from a rare form of polycystic ovary syndrome (PCOS) with primary adrenal androgen excess. To learn more, visit www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio, LinkedIn, Facebook and YouTube.

    View Full Article Hide Full Article
  4. Clearance of IND for Treatment of Polycystic Ovary Syndrome

    New Patent Broadens Tildacerfont Intellectual Property Estate in Congenital Adrenal Hyperplasia

    Publication of Tildacerfont Phase 2 Data in the Journal of Clinical Endocrinology and Metabolism

    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, 2021 and provided a corporate update.

    "As we continue to progress the execution of the CAHmelia clinical program in adults with classic congenital adrenal hyperplasia (CAH), we were also pleased with the FDA's clearance…

    Clearance of IND for Treatment of Polycystic Ovary Syndrome

    New Patent Broadens Tildacerfont Intellectual Property Estate in Congenital Adrenal Hyperplasia

    Publication of Tildacerfont Phase 2 Data in the Journal of Clinical Endocrinology and Metabolism

    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, 2021 and provided a corporate update.

    "As we continue to progress the execution of the CAHmelia clinical program in adults with classic congenital adrenal hyperplasia (CAH), we were also pleased with the FDA's clearance of our investigational new drug (IND) application for polycystic ovary syndrome (PCOS). This milestone allows us to continue fulfilling our strategy of advancing tildacerfont as a potential treatment for patients with rare endocrine disorders with significant unmet medical need," said Richard King, Chief Executive Officer of Spruce Biosciences. "We believe that tildacerfont may provide a therapeutic option to treat the underlying pathophysiology of disease through reduction of adrenocorticotropic hormone (ACTH) and therefore adrenal hyperandrogenism in this population. With no therapies currently approved in the U.S. to treat hyperandrogenism due to adrenal dysfunction in females with PCOS, the clearance of our IND brings us one step closer to developing a potential new treatment option for these patients."

    Corporate & Pipeline Highlights in Q2 2021

    • Clearance of IND for Treatment of Polycystic Ovary Syndrome: During the second quarter, Spruce completed a meeting with and submitted an IND application to the FDA for the study of tildacerfont, a potent and highly selective, non-steroidal CRF1 receptor antagonist, in females with PCOS. PCOS is a hormonal disorder common among women of reproductive age and is characterized by an overproduction of androgens, which can result in irregular menses, infertility, hirsutism, male pattern baldness and acne. Adrenal androgen excess in PCOS may result from an enhanced adrenal responsivity to ACTH. With clearance of the IND, Spruce remains on track to initiate a Phase 2 proof of concept study later this year.
    • Issuance of Patent Broadens Tildacerfont Intellectual Property Estate in CAH: The United States Patent and Trademark Office issued U.S. Patent 11,007,201 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 and method of use patents, and broadens tildacerfont's patent exclusivity through 2038.
    • Publication of Tildacerfont Phase 2 Data in the Journal of Clinical Endocrinology and Metabolism: In June 2021, Spruce announced the publication of the results from two Phase 2 clinical trials investigating tildacerfont in adult patients with classic CAH in the Journal of Clinical Endocrinology and Metabolism. The results of the trials showed that, in subjects with elevations of ACTH and androstenedione, at baseline, tildacerfont reduced these key hormone biomarkers, with normalization in 60% and 40% of subjects, respectively. Tildacerfont was generally safe and well-tolerated.
    • Cash, Cash Equivalents, and Investments of $139 Million: Based on Spruce's current operating plan, Spruce believes it is well capitalized to advance its pipeline beyond key milestones, including primary data readout from its CAHmelia trials and Phase 2 programs in pediatric classic CAH and PCOS.

    Anticipated Upcoming Milestones

    Spruce reaffirms the following previously issued clinical development program milestones:

    • Initiation of a Phase 2 proof-of-concept clinical trial in PCOS in the second half of 2021
    • Initiation of a Phase 2 clinical trial in pediatric classic CAH in the second half of 2021
    • Results from CAHmelia-203 in adult classic CAH patients with poor disease control the first half of 2022
    • Results from CAHmelia-204 in adult classic CAH patients with good disease control in the second half of 2022

    Spruce now confirms the following clinical development program milestone:

    • Results from the Phase 2 proof-of-concept clinical trial in PCOS in the first half of 2023

    Second Quarter 2021 Financial Results

    • Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of June 30, 2021, were $139.0 million.
    • Research and Development (R&D) Expenses: R&D expenses for the three and six months ended June 30, 2021 were $9.1 million and $15.8 million, respectively, compared to $5.7 million and $10.3 million for the same periods in 2020, respectively. The overall increase in R&D expenses was primarily related to the advancement of tildacerfont into late-stage clinical development.
    • General and Administrative (G&A) Expenses: G&A expenses for the three and six months ended June 30, 2021 were $2.6 million and $5.7 million, respectively, compared to $0.7 million and $1.3 million for the same periods in 2020, respectively. The overall increase in G&A expenses was primarily driven by an increase in costs related to operation as a public company.
    • Total Operating Expenses: Total operating expenses for the three and six months ended June 30, 2021 were $11.7 million and $21.5 million, respectively, compared to $6.4 million and $11.5 million for the same periods in 2020, respectively. Stock-based compensation for the three and six months ended June 30, 2021 was $1.0 million and $2.1 million, respectively. When excluding depreciation and stock-based compensation, total operating expenses for the three and six months ended June 30, 2021 were $10.7 million and $19.4 million, respectively.
    • Net Loss: Net loss for the three and six months ended June 30, 2021 was $11.8 million and $21.7 million, respectively, compared to $6.4 million and $11.6 million for the same periods in 2020, respectively.

    About Spruce Biosciences

    Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need. Spruce is initially developing its wholly owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years. Spruce is also developing tildacerfont for women suffering from a rare form of polycystic ovary syndrome (PCOS) with primary adrenal androgen excess. To learn more, visit www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio, LinkedIn, Facebook and YouTube.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the results, conduct, progress and timing of Spruce's clinical trials, 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.

    Use of Non-GAAP Financial Measures

    Spruce has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included herein include non-GAAP total operating expenses and non-GAAP G&A expenses, both of which exclude depreciation and stock-based compensation. Spruce excludes depreciation and stock-based compensation because management believes the exclusion of these items is helpful to investors to evaluate Spruce's recurring operational performance. Spruce management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results.

    SPRUCE BIOSCIENCES, INC.

    CONDENSED BALANCE SHEETS

    (unaudited)

    (in thousands, except share amounts)

     

     

     

    June 30,

    2021

     

    December 31,

    2020

    ASSETS

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    78,278

     

     

    $

    157,150

     

    Short-term investments

     

     

    30,945

     

     

     

     

    Prepaid expenses

     

     

    1,799

     

     

     

    2,971

     

    Other current assets

     

     

    347

     

     

     

    276

     

    Total current assets

     

     

    111,369

     

     

     

    160,397

     

    Restricted cash

     

     

    216

     

     

     

    216

     

    Right-of-use assets

     

     

    1,638

     

     

     

    1,793

     

    Long-term investments

     

     

    29,768

     

     

     

     

    Other assets

     

     

    457

     

     

     

    477

     

    Total assets

     

    $

    143,448

     

     

    $

    162,883

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    1,113

     

     

    $

    3,628

     

    Term loan, current portion

     

     

     

     

     

    2,554

     

    Accrued expenses and other current liabilities

     

     

    4,894

     

     

     

    2,496

     

    Accrued compensation and benefits

     

     

    973

     

     

     

    1,085

     

    Total current liabilities

     

     

    6,980

     

     

     

    9,763

     

    Term loan, net of current portion

     

     

    4,855

     

     

     

    1,922

     

    Lease liability, net of current portion

     

     

    1,478

     

     

     

    1,653

     

    Other liabilities

     

     

    29

     

     

     

    118

     

    Total liabilities

     

     

    13,342

     

     

     

    13,456

     

    Stockholders' equity:

     

     

     

     

     

     

    Preferred stock, $0.0001 par value, 10,000,000 shares authorized, and no shares issued and outstanding as of June 30, 2021 and December 31, 2020

     

     

     

     

     

     

    Common stock, $0.0001 par value, 200,000,000 shares authorized, 23,370,070 and 23,260,399 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively

     

     

    3

     

     

     

    2

     

    Additional paid-in capital

     

     

    212,634

     

     

     

    210,266

     

    Accumulated other comprehensive loss

     

     

    (29

    )

     

     

     

    Accumulated deficit

     

     

    (82,502

    )

     

     

    (60,841

    )

    Total stockholders' equity

     

     

    130,106

     

     

     

    149,427

     

    Total liabilities and stockholders' equity

     

    $

    143,448

     

     

    $

    162,883

     

    SPRUCE BIOSCIENCES, INC. 

    CONDENSED STATEMENTS OF OPERATIONS

    (unaudited)

    (in thousands, except share and per share amounts)

     

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

     

    2021

     

    2020

     

    2021

     

    2020

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    9,119

     

     

    $

    5,662

     

     

    $

    15,833

     

     

    $

    10,272

     

    General and administrative

     

     

    2,595

     

     

     

    727

     

     

     

    5,698

     

     

     

    1,250

     

    Total operating expenses

     

     

    11,714

     

     

     

    6,389

     

     

     

    21,531

     

     

     

    11,522

     

    Loss from operations

     

     

    (11,714

    )

     

     

    (6,389

    )

     

     

    (21,531

    )

     

     

    (11,522

    )

    Interest expense

     

     

    (80

    )

     

     

    (92

    )

     

     

    (169

    )

     

     

    (166

    )

    Other income, net

     

     

    20

     

     

     

    35

     

     

     

    39

     

     

     

    74

     

    Net loss

     

    $

    (11,774

    )

     

    $

    (6,446

    )

     

    $

    (21,661

    )

     

    $

    (11,614

    )

    Unrealized loss on available for sale securities

     

     

    (29

    )

     

     

    -

     

     

     

    (29

    )

     

     

    -

     

    Comprehensive loss

     

    $

    (11,803

    )

     

    $

    (6,446

    )

     

    $

    (21,690

    )

     

    $

    (11,614

    )

    Net loss per share, basic and diluted

     

    $

    (0.50

    )

     

    $

    (8.43

    )

     

    $

    (0.93

    )

     

    $

    (15.15

    )

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

     

     

    23,329,756

     

     

     

    764,408

     

     

     

    23,306,708

     

     

     

    766,534

     

    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,

     

     

    2021

     

    2020

     

    2021

     

    2020

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Total operating expenses

     

    $

    11,714

     

    $

    6,389

     

    $

    21,531

     

    $

    11,522

    Adjustments:

     

     

     

     

     

     

     

     

     

     

     

     

    Depreciation

     

     

    5

     

     

     

     

    9

     

     

    Stock-based compensation

     

     

    1,010

     

     

    96

     

     

    2,130

     

     

    128

    Non-GAAP total operating expenses

     

    $

    10,699

     

    $

    6,293

     

    $

    19,392

     

    $

    11,394

    Reconciliation of G&A Expenses to Non-GAAP G&A Expenses

    (unaudited)

    (in thousands)

     

     

     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

     

    2021

     

    2020

     

    2021

     

    2020

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    G&A expenses

     

    $

    2,595

     

    $

    727

     

    $

    5,698

     

    $

    1,250

    Adjustments:

     

     

     

     

     

     

     

     

     

     

     

     

    Depreciation

     

     

    5

     

     

     

     

    9

     

     

    Stock-based compensation

     

     

    664

     

     

    57

     

     

    1,520

     

     

    79

    Non-GAAP G&A expenses

     

    $

    1,926

     

    $

    670

     

    $

    4,169

     

    $

    1,171

     

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  5. Dr. Ways' Expertise in Late-Stage Clinical Development in Therapeutics Areas of High Unmet Medical Meet Supports Spruce's Goal to Expand Portfolio of Indications for 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 medical need, today announced the appointment of Kirk Ways, M.D., Ph.D., to its board of directors.

    "We are excited to welcome Kirk to our board during an important time in Spruce's continued growth," said Mike Grey, Executive Chairman of Spruce Biosciences. "Kirk is an experienced endocrinologist and a recognized leader in the biopharmaceutical industry whose extensive clinical…

    Dr. Ways' Expertise in Late-Stage Clinical Development in Therapeutics Areas of High Unmet Medical Meet Supports Spruce's Goal to Expand Portfolio of Indications for 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 medical need, today announced the appointment of Kirk Ways, M.D., Ph.D., to its board of directors.

    "We are excited to welcome Kirk to our board during an important time in Spruce's continued growth," said Mike Grey, Executive Chairman of Spruce Biosciences. "Kirk is an experienced endocrinologist and a recognized leader in the biopharmaceutical industry whose extensive clinical development, research and medical experience will be instrumental as we execute on our clinical development program for tildacerfont and vision of delivering new medicines to people living with rare endocrine disorders."

    Dr. Ways brings more than 30 years of extensive pharmaceutical drug discovery and development experience to Spruce's board of directors. Until recently, Dr. Ways served as Chief Medical Officer of Nuvelution Pharma. Prior to joining Nuvelution, Dr. Ways headed several drug development units at Johnson & Johnson's Pharmaceutical Research and Development group, with focus on metabolic disease, women's health, cardiovascular disease, gastrointestinal disease and internal medicine. Prior to joining Johnson & Johnson, Dr. Ways served in leadership capacities at BioStratum Incorporated as Vice President and Chief Development Officer, Aventis as Senior Global Medical Leader and Project Team Leader and Lilly Research Laboratories as a Research Fellow with responsibilities for the preclinical and clinical development for agents treating the chronic complications of diabetes. Prior to joining the pharmaceutical industry, Dr. Ways served as Director of the Diabetes Center, Vice Chairman for the Department of Internal Medicine, Endocrinology Section Head and Professor of Medicine at East Carolina School of Medicine. An accomplished researcher, Dr. Ways has authored more than one hundred publications in the fields of diabetes and cancer.

    Dr. Ways earned his M.D. with honors and a Ph.D. in Pharmacology from the University of North Carolina and graduated with a B.A. Magna Cum Laude from Bridgewater College.

    "I am eager to work with the accomplished management team and board of directors of Spruce Biosciences to contribute to the clinical development strategy for tildacerfont," said Dr. Ways. "Spruce represents a differentiated opportunity to advance new and better treatment options for people living with rare endocrine disorders, including congenital adrenal hyperplasia and a rare form of polycystic ovary syndrome."

    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. To learn more, visit www.sprucebiosciences.com and follow us on Twitter @ Spruce_Bio, LinkedIn, Facebook and YouTube.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the results, conduct, progress and timing of Spruce's clinical trials. 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," "goal," 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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