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.

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  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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  6. Tildacerfont was Evaluated in Two Phase 2 Open-Label Studies in Adults with Classic Congenital Adrenal Hyperplasia (CAH)

    Data Demonstrated Normalization or Trend to Normalization in Key Hormone Biomarkers

    Tildacerfont is First CRF1 Receptor Antagonist Studied Beyond 2 Weeks in CAH

    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 publication of the results from two Phase 2 clinical studies investigating tildacerfont in adult patients with classic CAH in the Journal of Clinical Endocrinology and Metabolism.

    "The data published in the Journal of Clinical Endocrinology

    Tildacerfont was Evaluated in Two Phase 2 Open-Label Studies in Adults with Classic Congenital Adrenal Hyperplasia (CAH)

    Data Demonstrated Normalization or Trend to Normalization in Key Hormone Biomarkers

    Tildacerfont is First CRF1 Receptor Antagonist Studied Beyond 2 Weeks in CAH

    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 publication of the results from two Phase 2 clinical studies investigating tildacerfont in adult patients with classic CAH in the Journal of Clinical Endocrinology and Metabolism.

    "The data published in the Journal of Clinical Endocrinology and Metabolism demonstrates the potential of tildacerfont to reduce androgen excess without increasing the total daily glucocorticoid dose in patients with classic CAH," said Kyriakie Sarafoglou, MD, Associate Professor, Department of Pediatrics – Divisions of Endocrinology and Genetics & Metabolism at the University of Minnesota Medical School.

    SPR001-201 was an open-label, multi-dose, Phase 2a dose-escalation study which evaluated the ability of tildacerfont to lower adrenocorticotropic hormone (ACTH), 17-hydroxyprogesterone (17-OHP), and androstenedione (A4) at doses ranging from 200mg daily to 1,000mg daily in patients with congenital adrenal hyperplasia due to 21-hydroxylase deficiency. 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 ACTH, 17-OHP, and A4 over a 12-week dosing period. SPR001-201 and SPR001-202 comprised the entire Phase 2a clinical development program for tildacerfont in adult classic CAH. In the studies, efficacy was evaluated by changes from baseline in ACTH, 17-OHP, and A4 according to baseline A4 ≤2x upper limit of normal (ULN), denoted as baseline good disease control, or A4 >2x ULN, denoted as baseline poor disease control. Safety was evaluated using adverse events and laboratory assessments.

    The results of the studies showed that tildacerfont reduced key hormone biomarkers towards normal levels in the baseline poor disease control group, including normalization of ACTH and A4 in 60% and 40% of patients, respectively. In patients with baseline good disease control, these hormones were maintained near or below normal levels. Tildacerfont was generally safe and well-tolerated. The findings from these studies support the ongoing global late-stage studies of tildacerfont in adults with classic CAH – CAHmelia-203 (assessing the ability of tildacerfont to reduce excessive adrenal androgens in patients with poor disease control) and CAHmelia-204 (assessing the ability of tildacerfont to reduce glucocorticoid usage in patients with good disease control while maintaining control of androgens).

    "Classic CAH is a serious and potentially life-threatening condition that has not benefited from new effective treatment options in approximately 50 years," said Rosh Dias, M.D., MRCP, Chief Medical Officer of Spruce Biosciences. "People living with classic CAH must grapple with the difficult balance of managing their adrenal androgen excess and supraphysiologic dosing of glucocorticoids, the existing standard of care therapy. In our Phase 2a studies, I was pleased to see that tildacerfont was able to produce meaningful reductions in highly elevated hormones in classic CAH patients, including in some cases normalization of these hormones, over a 12-week period without increases to daily steroid doses. This has not been reported to date with any other investigational product candidate."

    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 171 patients across seven 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 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", "demonstrates", "may" 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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  7. Richard Auchus, MD, PhD, Presents Phase 2 Data of Tildacerfont in Adult Classic CAH

    Tildacerfont Demonstrates Normalization of Elevated Hormone Levels Without Increases to Daily Steroid Doses

    CAHmelia Clinical Program in Adult Classic CAH Underway to Assess Hormone and Steroid Reduction

    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 presented data from its Phase 2 clinical trial of tildacerfont in adults with classic congenital adrenal hyperplasia (CAH) at the European Society of Endocrinology's 23rd European Congress of Endocrinology (ECE 2021), taking place virtually May 22…

    Richard Auchus, MD, PhD, Presents Phase 2 Data of Tildacerfont in Adult Classic CAH

    Tildacerfont Demonstrates Normalization of Elevated Hormone Levels Without Increases to Daily Steroid Doses

    CAHmelia Clinical Program in Adult Classic CAH Underway to Assess Hormone and Steroid Reduction

    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 presented data from its Phase 2 clinical trial of tildacerfont in adults with classic congenital adrenal hyperplasia (CAH) at the European Society of Endocrinology's 23rd European Congress of Endocrinology (ECE 2021), taking place virtually May 22 – 26, 2021.

    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-hydroxyprogesterone (17-OHP), and androstenedione (A4) over a 12-week dosing period. These hormones are used by physicians as a means of measuring the severity of CAH. Patients were classified into two groups based on disease control using these baseline hormone levels, defined as either poor disease control or good disease control.

    Patients with poor disease control upon study entry had mean baseline levels of ACTH, 17-OHP and A4 that were significantly above the upper limit of normal. Administration of tildacerfont to these patients resulted in mean maximum reductions of 84% in ACTH, 80% in 17-OHP, and 79% in A4 compared to baseline across the study period. This enabled reduction in the levels of these key hormones to normal or near normal levels, including normalization of ACTH levels in 60% and normalization of A4 levels in 40% of poor disease control patients during month three. Normalization of these highly elevated hormones in classic CAH patients without increases to daily steroid doses has not been reported to date with any other investigational product candidate. Patients with good disease control upon study entry, achieved by supraphysiologic glucocorticoid dosing, had mean baseline levels of ACTH, 17-OHP and A4 that were below the upper limit of normal. Administration of tildacerfont to these patients did not lead to significant changes in these levels. While this study did not evaluate the ability of tildacerfont to reduce the need for high glucocorticoid dosing in patients with good disease control, this objective is an important unmet need due to the long-term and serious side effects associated with chronic use of high doses of glucocorticoids and is currently being evaluated in the CAHmelia-204 study.

    "It is encouraging to see that tildacerfont, an oral, once-daily, and non-steroidal investigational therapy, produced meaningful reductions in highly elevated hormone levels for classic CAH patients, including, in some cases, normalization of these hormone levels over twelve weeks," said Richard Auchus, MD, PhD, the study's lead investigator and Professor of Internal Medicine and Pharmacology, University of Michigan, Ann Arbor. "The data suggest that tildacerfont has the potential to improve the adverse consequences of androgen excess and to reduce the burden of daily glucocorticoid dosing for these patients. Patients with classic CAH should benefit from new treatment options, which effectively manage their disease, yet reduce the complications derived from chronic glucocorticoid exposure as the existing standard of care."

    Spruce's CAHmelia program in adult classic CAH patients is underway and actively enrolling in sites within the United States and Europe. CAHmelia-203 is assessing the ability of tildacerfont to reduce excessive adrenal androgens in patients with poor disease control, while CAHmelia-204 is assessing the ability of tildacerfont to reduce glucocorticoid usage in patients with good disease control while maintaining control of androgens.

    The presentation is on display in ECE 2021's virtual poster hall. Learn more about the full program and how to access the poster presentation details on the ECE 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 (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 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 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, 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", "suggests", "demonstrates", "may" 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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  8. 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 Richard King, Chief Executive Officer, will participate in a virtual fireside chat at the RBC Capital Markets Global Healthcare Conference on May 19, 2021 at 5:25pm EDT.

    Interested parties can access the live webcast for the conference from the Events section of the company's investor relations website at https://investors.sprucebiosciences.com. An archived replay of the webcast will be available after the conclusion of the live presentation for approximately 30 days.

    About Spruce Biosciences

    Spruce Biosciences is a…

    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 Richard King, Chief Executive Officer, will participate in a virtual fireside chat at the RBC Capital Markets Global Healthcare Conference on May 19, 2021 at 5:25pm EDT.

    Interested parties can access the live webcast for the conference from the Events section of the company's investor relations website at https://investors.sprucebiosciences.com. An archived replay of the webcast 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 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, Facebook and YouTube.

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  9. Presentation of Phase 2 Data of Tildacerfont at 23rd Annual European Congress of Endocrinology

    Cash and Cash Equivalents of $148.6 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 first quarter ended March 31, 2021 and provided a corporate update.

    "Throughout the first quarter of 2021, Spruce Biosciences made substantial progress in our efforts to advance new treatment options for people living with rare endocrine disorders and to maximize the potential of tildacerfont as a therapeutic to treat people living with classic congenital adrenal…

    Presentation of Phase 2 Data of Tildacerfont at 23rd Annual European Congress of Endocrinology

    Cash and Cash Equivalents of $148.6 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 first quarter ended March 31, 2021 and provided a corporate update.

    "Throughout the first quarter of 2021, Spruce Biosciences made substantial progress in our efforts to advance new treatment options for people living with rare endocrine disorders and to maximize the potential of tildacerfont as a therapeutic to treat people living with classic congenital adrenal hyperplasia, or CAH, and other diseases impacted by ACTH," said Richard King, Chief Executive Officer of Spruce Biosciences. "We continue to advance enrollment into our late-stage CAHmelia program in adult classic CAH and remain encouraged with the level of patient interest registered with our study investigators. Looking ahead, we remain on track to initiate our Phase 2 program in children with classic CAH in the second half of this year. In the pediatric classic CAH population, the imbalance between excess adrenal androgens and glucocorticoids can lead to irreversible impacts on childhood development. Tildacerfont has the potential to ease the disease and steroid burden for children, which may enable normal growth progression through childhood and adolescence."

    Corporate Highlights

    • Presentation of Phase 2 Data of Tildacerfont at European Society of Endocrinology's 23rd Annual European Congress of Endocrinology (ECE 2021): On May 24, 2021, Richard Auchus, MD, PhD, Professor of Internal Medicine and Pharmacology, University of Michigan, Ann Arbor, will present data from the company's Phase 2 program of tildacerfont in classic CAH at ECE 2021. The presentation will highlight data from the company's SPR001-202 clinical trial, 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 trial and without increases to daily steroid doses, to the company's knowledge, has not been publicly reported with any other investigational product candidate to date.

    • Cash and Cash Equivalents of $148.6 Million: Based on the company's current operating plan, the company is well capitalized to advance its pipeline through key milestones, including primary data readout from its CAHmelia studies and initiation of Phase 2 programs in pediatric classic CAH and a rare form of polycystic ovary syndrome (PCOS).

    Anticipated Upcoming Milestones

    • Submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for PCOS in the first half of 2021, and initiation of a Phase 2 proof-of-concept clinical trial in the second half of 2021

    • Initiation of a Phase 2 clinical program 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

    First Quarter 2021 Financial Results

    Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2021, were $148.6 million.

    Research and Development (R&D) Expenses: R&D expenses for the first quarter ended March 31, 2021 were $6.7 million compared to $4.6 million for the same period in 2020. 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 first quarter ended March 31, 2021 were $3.1 million compared to $0.5 million for the same period in 2020. 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 quarter ended March 31, 2021 were $9.8 million compared to $5.1 million for the same period in 2020. Stock-based compensation for the first quarter ended March 31, 2021 was $1.1 million. When excluding depreciation and stock-based compensation, total operating expenses for the quarter ended March 31, 2021 were $8.7 million.

    Net Loss: Net loss for the three months ended March 31, 2021 was $9.9 million compared to $5.1 million for the same period in 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 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, 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)

     

     

     

    March 31,

    2021

     

     

    December 31,

    2020

     

    ASSETS

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    148,627

     

     

    $

    157,150

     

    Prepaid expenses

     

     

    2,687

     

     

     

    2,971

     

    Other current assets

     

     

    272

     

     

     

    276

     

    Total current assets

     

     

    151,586

     

     

     

    160,397

     

    Restricted cash

     

     

    216

     

     

     

    216

     

    Right-of-use assets

     

     

    1,716

     

     

     

    1,793

     

    Other assets

     

     

    473

     

     

     

    477

     

    Total assets

     

    $

    153,991

     

     

    $

    162,883

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    2,566

     

     

    $

    3,628

     

    Term loan, current portion

     

     

     

     

     

    2,554

     

    Accrued expenses and other current liabilities

     

     

    3,558

     

     

     

    2,496

     

    Accrued compensation and benefits

     

     

    727

     

     

     

    1,085

     

    Total current liabilities

     

     

    6,851

     

     

     

    9,763

     

    Term loan, net of current portion

     

     

    4,843

     

     

     

    1,922

     

    Lease liability, net of current portion

     

     

    1,566

     

     

     

    1,653

     

    Other liabilities

     

     

    8

     

     

     

    118

     

    Total liabilities

     

     

    13,268

     

     

     

    13,456

     

    Stockholders' equity:

     

     

     

     

     

     

     

     

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

     

     

     

     

     

     

    Common stock, $0.0001 par value, 200,000,000 shares authorized, 23,301,872 and 23,260,399 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively

     

     

    2

     

     

     

    2

     

    Additional paid-in capital

     

     

    211,449

     

     

     

    210,266

     

    Accumulated deficit

     

     

    (70,728

    )

     

     

    (60,841

    )

    Total stockholders' equity

     

     

    140,723

     

     

     

    149,427

     

    Total liabilities and stockholders' equity

     

    $

    153,991

     

     

    $

    162,883

     

     

    SPRUCE BIOSCIENCES, INC.

    CONDENSED STATEMENTS OF OPERATIONS

    (unaudited)

    (in thousands, except share and per share amounts)

     

     

     

    Three Months Ended

    March 31,

     

     

     

    2021

     

     

    2020

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Research and development

     

    $

    6,714

     

     

    $

    4,610

     

    General and administrative

     

     

    3,103

     

     

     

    523

     

    Total operating expenses

     

     

    9,817

     

     

     

    5,133

     

    Loss from operations

     

     

    (9,817

    )

     

     

    (5,133

    )

    Interest expense

     

     

    (89

    )

     

     

    (74

    )

    Other income, net

     

     

    19

     

     

     

    39

     

    Net loss

     

    $

    (9,887

    )

     

    $

    (5,168

    )

    Net loss per share, basic and diluted

     

    $

    (0.42

    )

     

    $

    (6.76

    )

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

     

     

    23,283,658

     

     

     

    764,408

     

     

    SPRUCE BIOSCIENCES, INC.

    Reconciliation of Total Operating Expenses to Non-GAAP Total Operating Expenses

    (unaudited)

    (in thousands)

     

     

     

    Three Months Ended March 31,

     

     

     

    2021

     

     

    2020

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Total operating expenses

     

    $

    9,817

     

     

    $

    5,133

     

    Adjustments:

     

     

     

     

     

     

     

     

    Depreciation

     

     

    4

     

     

     

     

    Stock-based compensation

     

     

    1,120

     

     

     

    32

     

    Non-GAAP total operating expenses

     

    $

    8,693

     

     

    $

    5,101

     

     

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

    (unaudited)

    (in thousands)

     

     

     

    Three Months Ended March 31,

     

     

     

    2021

     

     

    2020

     

    Operating expenses:

     

     

     

     

     

     

     

     

    G&A expenses

     

    $

    3,103

     

     

    $

    523

     

    Adjustments:

     

     

     

     

     

     

     

     

    Depreciation

     

     

    4

     

     

     

     

    Stock-based compensation

     

     

    856

     

     

     

    22

     

    Non-GAAP G&A expenses

     

    $

    2,243

     

     

    $

    501

     

     

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  10. 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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  11. 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

     

     

    View Full Article Hide Full Article
  12. 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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  13. 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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  14. 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.

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  15. -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…

    -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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  16. 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…

    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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  17. 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…

    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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  18. 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…

    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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  19. 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…

    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 syndicate@svbleerink.com, 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 usa.prospectus@credit-suisse.com, 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.

    View Full Article Hide Full Article