About Us | ScientistSPRB Spruce Biosciences Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Tildacerfont - CAHmelia-203
Congenital Adrenal Hyperplasia (poor disease control)
|
Phase 2b
Phase 2b
|
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|
|
Tildacerfont - CAHmelia-204
Congenital Adrenal Hyperplasia (good disease control)
|
Phase 2b
Phase 2b
|
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Tildacerfont
Pediatric Classic Congenital Adrenal Hyperplasia
|
Phase 2
Phase 2
|
Phase 2 trial to be initiated 2H 2021.
|
|
Tildacerfont
Polycystic Ovary Syndrome
|
Phase 2
Phase 2
|
Phase 2 trial to be initiated 2H 2021.
|
|
Tildacerfont
Classic Congenital Adrenal Hyperplasia
|
Phase 2
Phase 2
|
Phase 2 data presented at ENDO March 20, 2021.
|
Latest News
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210624005125/en/
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210621005255/en/
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210524005276/en/
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Spruce Biosciences, Inc. (NASDAQ:SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210513005039/en/
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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
View source version on businesswire.com: https://www.businesswire.com/news/home/20210512005829/en/
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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.