Spruce Biosciences Q2 2024 Financial Results and Corporate Updates

SOUTH SAN FRANCISCO, Calif.--Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company, has released its financial results for the second quarter ending June 30, 2024, along with corporate updates.

Chief Executive Officer Javier Szwarcberg, M.D., M.P.H., emphasized the company's dedication to advancing the development of tildacerfont, a promising treatment for congenital adrenal hyperplasia (CAH). The company aims to report primary efficacy and safety data by the fourth quarter of 2024 from the CAHmelia-204 study. This study focuses on glucocorticoid reduction in adult CAH patients, potentially leading to a registrational endpoint. Additionally, Spruce plans to release topline data from the CAHptain-205 study, which explores different dosages of tildacerfont in adults, adolescents, and children with CAH.

Spruce Biosciences has entered into a strategic collaboration with HMNC to develop a personalized treatment for major depressive disorder (MDD). Under this agreement, HMNC will fund and conduct a Phase 2 study of tildacerfont using HMNC’s Cortibon Genetic Selection Tool. If successful, Spruce holds an option to acquire exclusive rights to Cortibon for future developments.

At the ENDO 2024 Annual Meeting, several significant findings were presented:

1. Phase 2 POWER Study for PCOS: Ricardo Azziz, M.D., M.B.A., M.P.H., from the University of Alabama at Birmingham, showcased the final results demonstrating that tildacerfont significantly reduced dehydroepiandrosterone sulfate levels over 12 weeks in women with polycystic ovary syndrome (PCOS). The study also noted an increase in serum sex hormone-binding globulin, which may help lower levels of free testosterone. Tildacerfont was well-tolerated, with no major safety concerns reported.

2. Healthcare Utilization in CAH: Prasanth Surampudi, M.D., from the U.C. Davis School of Medicine, highlighted the critical need for improved collaboration between primary care physicians and endocrinologists. His presentation underscored the importance of educating CAH patients and advocacy groups to enhance biochemical outcomes and reduce morbidity and mortality risks.

3. Endocrinology Practices in CAH: Wenyu Huang, M.D., Ph.D., from Northwestern University and Amir Hamrahian, M.D., from Johns Hopkins University, presented findings on the health risks associated with CAH, especially concerning hyperandrogenemia and long-term glucocorticoid use. Their research indicates the necessity for improved biochemical management practices in treating adult CAH patients.

Spruce Biosciences expects several upcoming milestones:
- Topline results from the CAHmelia-204 study in the fourth quarter of 2024.
- Topline results from the CAHptain-205 study, also anticipated in the fourth quarter of 2024.
- An end-of-Phase-2 meeting with the FDA in the first half of 2025.

Financially, Spruce Biosciences reported $69.7 million in cash and cash equivalents as of June 30, 2024. Collaboration revenue amounted to $1.6 million for the quarter and $3.6 million for the first half of the year. Research and development expenses were $8.1 million for the quarter, a decrease from the previous year, primarily due to the completion of various studies. General and administrative expenses were $3.6 million for the quarter. Total operating expenses for the first half of 2024 were $26.3 million, leading to a net loss of $20.8 million for the same period.

In summary, Spruce Biosciences continues to focus on developing tildacerfont for various endocrine and neurological disorders, including CAH, PCOS, and MDD. With multiple studies underway and significant financial resources, the company remains committed to addressing unmet medical needs and advancing its clinical programs.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!