Spruce Biosciences(US:SPRB)2024-11-12 11:10Clinical Trials and Efficacy - Tildacerfont, an oral antagonist of the CRF1 receptor, is being developed for classic congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS), and major depressive disorder (MDD) with over 400 subjects administered in clinical trials[54] - In the CAHmelia-203 trial, 96 subjects had a mean baseline androstenedione (A4) level of 1,151 ng/dL, but the primary efficacy endpoint was not achieved, showing a placebo-adjusted reduction of -2.6% at week 12[54] - The CAHmelia-204 trial is ongoing with 100 adult patients, and topline results are expected in December 2024, with a mean baseline A4 level of 224 ng/dL[54] - In the CAHptain-205 trial for pediatric patients, 73% of 30 children met the efficacy endpoint of A4 or glucocorticoid reduction at 12 weeks[54] - Tildacerfont showed significant reduction in DHEAS levels in women with PCOS, with a p-value of 0.020, and an increase in sex hormone binding globulin (SHBG) with a p-value of 0.012[54] - A license agreement with HMNC Holding GmbH was established for a Phase 2 study of tildacerfont in MDD patients, utilizing the Cortibon Genetic Selection Tool[54] - The Pediatric Committee of the European Medicines Agency endorsed the proposed pediatric investigational plan for tildacerfont in children with classic CAH[56] Financial Performance and Revenue - The company has not generated any product revenue to date and continues to incur significant research and development expenses[54] - The company incurred net losses of $29.5 million and $38.0 million for the nine months ended September 30, 2024 and 2023, respectively, with cash used in operations of $35.3 million and $22.1 million[58] - As of September 30, 2024, the company had an accumulated deficit of $226.7 million, up from $197.2 million as of December 31, 2023[58] - The company raised aggregate gross proceeds of $293.1 million since inception, including $15.0 million from the Kaken License Agreement in April 2023[58] - The company expects to continue incurring significant losses and does not anticipate positive cash flows from operations for the foreseeable future[58] - Collaboration revenue for the three months ended September 30, 2024, was $0.6 million, down from $3.1 million in the same period of 2023, a decrease of $2.5 million[71] - For the nine months ended September 30, 2024, collaboration revenue was $4.2 million, down from $7.2 million in the same period of 2023, a decrease of $2.99 million[73] Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $10.0 million, a decrease of $6.7 million compared to $16.7 million in the same period of 2023[70] - Research and development expenses decreased by $6.9 million to $6.6 million for the three months ended September 30, 2024, primarily due to reduced clinical development and manufacturing expenses[71] - General and administrative expenses increased by $0.2 million to $3.5 million for the three months ended September 30, 2024, mainly due to higher legal professional services[72] - Total operating expenses for the nine months ended September 30, 2024, were $36.3 million, a decrease of $11.7 million compared to $48.0 million in the same period of 2023[73] - Research and development expenses for the nine months ended September 30, 2024, were $25.0 million, down $13.4 million from $38.3 million in the same period of 2023[74] Cash Position and Funding - As of September 30, 2024, the company had cash and cash equivalents of $60.1 million, down from $96.3 million as of December 31, 2023[58] - The company anticipates that its cash and cash equivalents will be sufficient to fund operations for at least 12 months following the issuance date of the financial statements[76] - The company has entered into a Loan Agreement with Silicon Valley Bank, with an outstanding principal of $2.2 million as of September 30, 2024[65] - The company reported a net cash used in operating activities of $35.3 million for the nine months ended September 30, 2024, an increase of $13.2 million compared to the same period in 2023[85] - The company had no net cash provided by investing activities for the nine months ended September 30, 2024, compared to $46.5 million in the same period in 2023[85] - As of September 30, 2024, cash and cash equivalents amount to $60.1 million, primarily in bank deposits and money market funds[91] - The company has not generated any revenues from the commercial sale of approved products and does not expect to do so in the foreseeable future[66] - The company anticipates significant increases in research and development expenses as it advances clinical trials for tildacerfont, particularly for classic CAH[79] - Future funding requirements will depend on various factors, including clinical trial progress and regulatory approval timelines[81] Regulatory and Strategic Plans - Plans to build a specialized commercial organization for tildacerfont's potential commercialization in the U.S. are underway, targeting endocrinologists and specialists[54] - The company aims to leverage strategic collaborations for resources in relevant disease areas and geographies outside the U.S.[54] - Under the Kaken License Agreement, the company is entitled to receive up to approximately $65.0 million upon achieving specified milestones related to tildacerfont in Japan[62] - The company will receive tiered double-digit royalties on net sales of tildacerfont in Japan, with rates potentially reaching the mid-twenties[62] Economic Factors - The company does not expect inflation to have a material effect on its business or financial condition in future reporting periods[93] - Inflation has increased costs related to labor and clinical trials, but is not expected to materially affect future financial results[93] - The company anticipates continued record inflation due to geopolitical and macroeconomic events, but does not expect significant impacts on business operations[93] - A hypothetical 1% change in interest rates would not have a material effect on the financial statements as of September 30, 2024, and December 31, 2023[91] - The company does not currently engage in hedging transactions to manage exposure to interest rate risk[91] - There was no material impact on operating results due to foreign currency exchange rate fluctuations[92]