Spruce Biosciences(SPRB)
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Spruce Biosciences(SPRB) - 2023 Q3 - Quarterly Report
2023-11-13 21:22
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ____________ Commission File Number: 001-39594 Spruce Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 81- ...
Spruce Biosciences(SPRB) - 2023 Q2 - Quarterly Report
2023-08-14 20:20
(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ____________ Commission File Number: 001-39594 Spruce Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 81-21542 ...
Spruce Biosciences (SPRB) Investor Presentation - Slideshow
2023-05-18 15:20
Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and Spruce's own internal estimates and research. While Spruce believes these third-party studies, publications, surveys and other data to be reliable as of the date of this presen ...
Spruce Biosciences(SPRB) - 2023 Q1 - Quarterly Report
2023-05-15 12:20
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ____________ Commission File Number: 001-39594 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR Spruce Biosciences, Inc. (Exact name of registrant as specified in its charter ...
Spruce Biosciences(SPRB) - 2022 Q4 - Annual Report
2023-03-16 20:11
Financial Performance - The company reported a net loss of $46.180 million for the year ended December 31, 2022, compared to a net loss of $42.292 million in 2021, indicating an increase in losses of about 9.0%[651] - For the year ended December 31, 2022, the company reported a net loss of $46.2 million, compared to a net loss of $42.3 million in 2021, reflecting an increase in losses of approximately 2.1%[658] - The basic and diluted net loss per share for the year ended December 31, 2022, was $(1.96), compared to $(1.81) in 2021, with a net loss of $46.18 million in 2022[759] Assets and Liabilities - As of December 31, 2022, total assets decreased to $85.648 million from $126.486 million in 2021, reflecting a decline of approximately 32.3%[648] - As of December 31, 2022, the company had total liabilities of $17.162 million, an increase from $15.115 million in 2021[648] - As of December 31, 2022, the company had an accumulated deficit of $149.3 million, up from $103.1 million at the end of 2021, representing a 44.8% increase[664] Cash Flow - Cash and cash equivalents decreased to $24.487 million in 2022 from $42.748 million in 2021, a decline of approximately 42.5%[648] - The company used $41.7 million in cash for operating activities in 2022, up from $35.9 million in 2021, indicating a 16.5% increase in cash used[658] - The company reported a net cash decrease of $18.2 million in 2022, compared to a decrease of $114.4 million in 2021, indicating a significant reduction in cash outflow[658] Research and Development - Research and development expenses rose to $35.198 million in 2022, up from $30.698 million in 2021, representing an increase of approximately 14.9%[651] - Total operating expenses for 2022 were $47.283 million, compared to $42.066 million in 2021, marking an increase of about 12.5%[651] - Accrued research and development expenses increased to $7,449 thousand in 2022 from $3,837 thousand in 2021, indicating a focus on clinical trials and drug supply manufacturing[711] Financing and Future Needs - The company anticipates continued significant net losses as it progresses with clinical development and seeks regulatory approvals for its product candidate, tildacerfont[14] - The company expects to require substantial additional financing to develop tildacerfont and implement its operating plans[14] - The company anticipates needing to raise substantial additional financing in the future to support its operations, which may involve issuing additional equity or debt[665] Product Development and Risks - The company currently relies entirely on the success of tildacerfont, which is its only product candidate, and any delays in its clinical development could materially harm the business[14] - The company is subject to risks related to regulatory approvals and potential delays in clinical trials due to external factors such as the COVID-19 pandemic and macroeconomic uncertainties[670][671] - The company is focused on developing tildacerfont as a potential first non-steroidal therapy for classic congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS)[660] Stock and Compensation - The company incurred stock-based compensation expenses of $3.6 million in 2022, down from $4.0 million in 2021, reflecting a decrease of approximately 10.3%[658] - The total stock-based compensation expense for the year ended December 31, 2022, was $3.631 million, a decrease from $3.958 million in 2021[744] - The company has a total of $7.2 million of unrecognized stock-based compensation expense expected to be recognized over an estimated weighted-average vesting term of 2.4 years[744] Tax and Deferred Tax Assets - The federal statutory income tax rate for the company is 21.0%, with an effective tax rate of 0% for the years ended December 31, 2022, and 2021[749] - The Company recorded a valuation allowance against its U.S. net deferred tax assets, which increased by $17.0 million in 2022 due to an increase in net operating loss and capitalization of research costs[750] - The total gross deferred tax assets as of December 31, 2022, amounted to $50.75 million, with a valuation allowance of $50.36 million[750] Agreements and Collaborations - The Company entered into a Collaboration and License Agreement with Kaken Pharmaceutical, granting exclusive rights for tildacerfont in Japan, with an upfront payment of $15.0 million and potential milestone payments of up to $65.0 million[760] - The company is required to pay up to $23.0 million in milestone payments to Eli Lilly upon achieving certain clinical development and commercial sales milestones[746] Market and Investment Strategy - The Company utilizes a fair value hierarchy for financial instruments, classifying inputs into three levels: Level 1 (quoted prices in active markets), Level 2 (observable inputs), and Level 3 (unobservable inputs) [679] - The estimated fair value of the term loan is based on market observable interest rates, classified as Level 2 fair value measurement [679] - The Company has not recorded any impairment charges on securities related to other-than-temporary declines in fair value, indicating a stable investment strategy[708]
Spruce Biosciences (SPRB) Investor Presentation - Slideshow
2022-12-02 14:12
SPI'UCEBIOSCIENCES Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need Corporate Presentation November 10, 2022 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements about Spruce Biosciences, Inc. ("we," "Spruce" or the "Company"). All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements about our strategy, our expectations rega ...
Spruce Biosciences(SPRB) - 2022 Q3 - Quarterly Report
2022-11-10 21:33
Clinical Trials and Development - Tildacerfont achieved approximately 80% reductions in key adrenal hormone indicators in a 12-week Phase 2a clinical trial for classic CAH patients [81]. - The company initiated CAHmelia-203 and CAHmelia-204 Phase 2b clinical trials, with topline results expected in the second half of 2023 and 2024, respectively [82]. - A Phase 2 open-label clinical trial for tildacerfont in children aged 6 to 17 with classic CAH is underway, with topline safety results anticipated in the first half of 2023 [83]. - Tildacerfont is also being investigated for potential use in treating polycystic ovary syndrome (PCOS), with a Phase 2 proof-of-concept trial initiated [84]. - The company anticipates significant increases in research and development expenses as tildacerfont advances in late-stage studies for classic CAH in adult patients [128]. Financial Performance - As of September 30, 2022, the company reported a net loss of $35.0 million and an accumulated deficit of $138.2 million [87]. - The company incurred a net loss of $11.401 million for the three months ended September 30, 2022, compared to a net loss of $11.447 million for the same period in 2021, showing an improvement of $46,000 [112]. - For the nine months ended September 30, 2022, net cash used in operating activities was $29.9 million, compared to $26.1 million for the same period in 2021 [139][141]. - The company has not generated any revenue and does not expect to do so until regulatory approval and commercialization of tildacerfont or future product candidates [127]. Expenses and Cash Flow - The company reported total operating expenses of $11.557 million for the three months ended September 30, 2022, compared to $11.400 million for the same period in 2021, reflecting an increase of $157,000 [112]. - Research and development expenses for the three months ended September 30, 2022, were $8.791 million, an increase of $184,000 from $8.607 million in the same period in 2021 [114]. - For the nine months ended September 30, 2022, total operating expenses were $35.173 million, an increase of $2.242 million from $32.931 million in the same period in 2021 [118]. - The company expects to continue incurring significant losses and does not anticipate positive cash flows from operations in the foreseeable future [87]. - The company expects to require substantial additional capital to fund operations and development efforts, with the timing and amount depending on various factors [129]. Capital and Funding - The company has raised a total of $224.5 million since inception, including $93.4 million from its IPO in October 2020 [88]. - The company has raised aggregate gross proceeds of $224.5 million since inception, including $103.5 million from its IPO in October 2020 [123]. - The company plans to build a specialized commercial organization to support the potential commercialization of tildacerfont in the U.S. and Europe [85]. Operational Risks - The ongoing COVID-19 pandemic and macroeconomic uncertainties may adversely affect the company's clinical trials and overall business operations [92]. - Inflation has increased labor and clinical trial costs, but the company does not expect significant impacts on future financial results due to inflation [153]. - The ongoing military conflict between Ukraine and Russia, along with related sanctions, is contributing to record inflation, yet the company anticipates no material effect on its business [153]. - The company relies on third parties for the manufacture and distribution of tildacerfont, which allows for a more efficient operational structure [86]. Financial Obligations - The company has obligations under a License Agreement that may require up to $23.0 million in milestone payments upon achieving specified milestones [137]. - Future payments of principal and interest on the Term Loan, commencing in January 2023, total $5.6 million [134]. - As of September 30, 2022, the company had total lease liabilities of $1.4 million for non-cancelable operating leases [135]. Cash Position - The company had cash, cash equivalents, and investments of $90.4 million as of September 30, 2022, down from $121.4 million as of December 31, 2021 [123]. - Cash provided by investing activities for the nine months ended September 30, 2022, was $9.1 million, primarily from proceeds of $43.0 million from maturities of investments [142]. - The company holds $90.4 million in cash, cash equivalents, and short-term investments as of September 30, 2022 [150]. Interest and Currency Risks - Interest and other income, net increased by $225,000 to $266,000 for the three months ended September 30, 2022, compared to $41,000 in the same period in 2021 [112]. - A hypothetical 1% change in interest rates would not have a material effect on the company's financial statements as of September 30, 2022 [151]. - The company's operations are exposed to foreign currency exchange rate fluctuations, but there was no material impact on results for the periods presented [152].
Spruce Biosciences (SPRB) Investor Presentation - Slideshow
2022-08-14 18:22
SPI'UCEBIOSCIENCES Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need Corporate Presentation August 10, 2022 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements about Spruce Biosciences, Inc. ("we," "Spruce" or the "Company"). All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements about our strategy, our expectations regard ...
Spruce Biosciences(SPRB) - 2022 Q2 - Quarterly Report
2022-08-10 20:22
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ____________ Commission File Number: 001-39594 Spruce Biosciences, Inc. (Exact name of registrant as specified in its charter) ...
Spruce Biosciences (SPRB) Investor Presentation - Slideshow
2022-05-18 13:41
spruceBlosciences Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need Corporate Presentation May 11, 2022 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements about Spruce Biosciences, Inc. ("we," "Spruce" or the "Company"). All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements about our strategy, our expectations regarding ...