Spruce Biosciences(SPRB) - 2024 Q1 - Quarterly Report

Clinical Trials and Development - Tildacerfont is being developed as a potential first non-steroidal therapy for classic congenital adrenal hyperplasia (CAH), with over 200 subjects administered in clinical trials and no serious adverse events reported[76]. - The CAHmelia-203 trial enrolled 96 adult patients with a mean baseline androstenedione level of 1,151 ng/dL, but did not achieve the primary efficacy endpoint, showing a placebo-adjusted reduction of -2.6%[77]. - The CAHmelia-204 trial is ongoing with 100 adult patients, and topline results are expected in Q3 2024[78]. - The CAHptain-205 trial for children aged 2 to 17 years showed that 73% of patients met the efficacy endpoint of A4 or glucocorticoid reduction at 12 weeks[79]. - A pediatric investigational plan for tildacerfont has been submitted to the European Medicines Agency, with a waiver granted for patients under one year[81]. - The company is exploring tildacerfont's potential in treating polycystic ovary syndrome (PCOS) and has completed a Phase 2 trial showing promising interim results[82]. Financial Performance - As of March 31, 2024, the company reported net losses of $11.6 million and an accumulated deficit of$208.9 million[86]. - Cash and cash equivalents as of March 31, 2024, were $81.2 million, expected to fund operations for at least 12 months[89]. - Collaboration revenue for Q1 2024 was$2.0 million, a slight increase from $1.964 million in Q1 2023, reflecting a change of$38,000[119]. - Total operating expenses decreased to $14.635 million in Q1 2024 from$15.163 million in Q1 2023, a reduction of $528,000[119]. - Research and development expenses were$10.317 million in Q1 2024, down from $11.712 million in Q1 2023, showing a decrease of$1.395 million[119]. - General and administrative expenses increased to $4.318 million in Q1 2024 from$3.451 million in Q1 2023, an increase of $867,000[119]. - Net loss for Q1 2024 was$11.625 million, an improvement compared to a net loss of $12.791 million in Q1 2023, reflecting a decrease in loss of$1.166 million[119]. - Interest expense decreased to $97,000 in Q1 2024 from$131,000 in Q1 2023, a reduction of $34,000[119]. - Interest and other income, net increased to$1.105 million in Q1 2024 from $539,000 in Q1 2023, an increase of$566,000[119]. - As of March 31, 2024, the accumulated deficit was $208.9 million, up from$197.2 million as of December 31, 2023[125]. - Cash and cash equivalents decreased to $81.2 million as of March 31, 2024, from$96.3 million as of December 31, 2023[125]. - Net cash used in operating activities increased by $3.2 million to$15.0 million for the three months ended March 31, 2024, compared to $11.8 million in the same period of 2023[141]. - Net cash provided by investing activities was nil for the three months ended March 31, 2024, compared to$10.5 million in the same period of 2023[143]. - Net cash used in financing activities was $0.2 million for the three months ended March 31, 2024, primarily due to principal payments on the Term Loan[144]. - The company anticipates needing additional capital to fund operations and develop tildacerfont, with future funding requirements dependent on various factors[130]. - For the three months ended March 31, 2023, net cash provided by financing activities was$50.5 million, primarily from a private placement of $51.0 million, offset by principal payments on the Term Loan of$0.4 million[145]. - As of March 31, 2024, cash and cash equivalents totaled $81.2 million in bank deposits and money market funds, with no excessive risk anticipated[151]. - The company does not expect a hypothetical 1$293.1 million since inception, including $15.0 million from Kaken Pharmaceutical for the development of tildacerfont in Japan[88]. - The Kaken License Agreement includes potential milestone payments of up to approximately$65.0 million upon achieving specified milestones related to tildacerfont in Japan[98]. - The company has retained all rights to tildacerfont in all geographies outside Japan, while Kaken is responsible for regulatory approvals in Japan[96]. - The company expects significant additional spending to progress tildacerfont through clinical development and potential regulatory approval[113].