Spruce Biosciences(SPRB)

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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 ...
Spruce Biosciences(SPRB) - 2022 Q1 - Quarterly Report
2022-05-11 20:13
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, 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
2022-03-20 10:40
SPI'UCEBIOSCIENCES Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need Corporate Presentation March 14, 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 regardi ...
Spruce Biosciences(SPRB) - 2021 Q4 - Annual Report
2022-03-14 20:26
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 81-2154263 (State or ...
Spruce Biosciences(SPRB) - 2021 Q3 - Quarterly Report
2021-11-15 21:24
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 September 30, 2021 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 cha ...