Spruce Biosciences Q1 2024 Financial Results and Corporate Updates

Spruce Biosciences, Inc. has shared its financial results for the first quarter ending March 31, 2024, alongside significant corporate updates. The company, listed on Nasdaq under SPRB, is focused on developing therapies for rare endocrine disorders that have significant unmet medical needs. CEO Javier Szwarcberg highlighted the encouraging outcomes from the CAHmelia-203 trial, targeting adult patients with severe hyperandrogenemia. In this trial, the investigational drug tildacerfont showed promising results, reducing adrenocorticotropic hormone (ACTH) levels by up to 45%, indicating successful engagement with its pituitary target.

The study further revealed that patients who had higher baseline doses of glucocorticoids (GC) and exhibited better compliance with the study drug, showed larger reductions in androstenedione (A4) levels. Dr. Szwarcberg emphasized that these results showcase the difficulties in treating severe hyperandrogenemia and suggest that tildacerfont might show even greater benefits in the upcoming CAHmelia-204 study, which will evaluate GC reduction in a more controlled setting.

In the CAHmelia-203 study, participants with higher baseline GC doses experienced more significant reductions in A4 levels. For instance, participants with a baseline GC dose of 55mg hydrocortisone equivalents (HCe) saw a 27% decrease in A4 after 12 weeks of treatment, compared to an 18% increase in those with a baseline dose of 15mg HCe. Compliance with the study medication also played a crucial role, with fully compliant participants experiencing a 14% reduction in A4 levels after 12 weeks, compared to no reduction in those with lower compliance rates.

Spruce Biosciences also presented research at the Pediatric Endocrine Society (PES) 2024 Annual Meeting, where baseline characteristics from the CAHmelia program in adults and the CAHptain-205 study in pediatric patients were showcased. Paul Thornton, a medical director, discussed the baseline data from the CAHmelia program, indicating that current treatments are inadequate in achieving long-term goals for height and weight optimization in pediatric CAH patients. The CAHptain-205 study, led by Dr. Mimi S. Kim, highlighted that managing androgen levels in children often requires high doses of GCs, with tildacerfont showing promise in reducing both A4 and GC doses.

Looking forward, Spruce Biosciences plans to release results from the CAHmelia-204 study and further dose-ranging data from the CAHptain-205 study in the third quarter of 2024. They also anticipate a meeting with the U.S. Food and Drug Administration (FDA) in early 2025 to discuss the future of tildacerfont for treating classic CAH.

Financially, Spruce Biosciences reported cash and cash equivalents of $81.2 million as of March 31, 2024, expected to support operations through the end of 2025. Collaboration revenue remained steady at $2.0 million for the first quarters of both 2024 and 2023, stemming from a partnership with Kaken Pharmaceutical. Research and development expenses decreased by $1.4 million from the previous year, totaling $10.3 million, due to the completion of enrollments in ongoing CAH programs and a phase 2 study in polycystic ovary syndrome (PCOS). General and administrative expenses rose to $4.3 million, up from $3.5 million in the same period the previous year. Total operating expenses for the quarter were $14.6 million, resulting in a net loss of $11.6 million, an improvement from the $12.8 million loss reported in the first quarter of 2023.

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