Spruce Biosciences Expands Tildacerfont Portfolio with Potential Treatment for Polycystic Ovary Syndrome

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

Late-stage biopharmaceutical company Spruce Biosciences Inc SRPB reported financial results for the second quarter ended June 30, 2021 and announced that it has submitted an investigational new drug application (IND) for tildacerfont in the treatment of polycystic ovary syndrome (PCOS), which has recently been cleared by the FDA.

Tildacerfont is an investigational oral medication that binds to CRF1 receptors on the pituitary gland, preventing excessive production of adrenocorticotropic hormone (ACTH). Spruce is currently investigating tildacerfont in adult classic congenital adrenal hyperplasia in late-stage studies and believes it may also be a suitable treatment option for a subset of women suffering from PCOS. 

PCOS is a condition that affects nearly 115 million women around the world, and despite its prevalence, its physiological origins remain unclear to scientists. Clinically, PCOS presents with irregular periods, cysts in the ovaries and hyperandrogenism, or elevated androgen levels. Although the majority of women with PCOS demonstrate an ovarian source for their high androgen elevation, some women present with androgen levels that are entirely or partly sourced from their adrenal glands. Adrenal androgen excess may be the result of a generalized hyperresponsivity to ACTH stimulation, which is tildacerfont’s directed mechanism of action. 

According to Richard King, chief executive officer of Spruce Biosciences, there are currently no therapies approved to treat hyperandrogenism due to adrenal dysfunction in women with PCOS. In fact, treatments today comprise of only symptomatic relief. Ultimately, Spruce Biosciences believes tildacerfont may provide a therapeutic intervention for adrenal hyperandrogenism that addresses the underlying cause of disease for some women suffering from PCOS. 

With clearance of its IND, Spruce remains on track to initiate a Phase 2 proof-of-concept study later this year, and anticipates data from this study by the first half of 2023. 

Second Quarter Financial Results:

• Cash, cash equivalents and investments for Spruce Biosciences as of June 30, 2021, were $139.0 million. 
• Research and development expenditures for three and six months of 2021 were $9.1 million and $15.8 million, respectively, due to tildacerfont’s progressing late-stage development. In 2020, the same time periods showed $5.7 million and $10.3 million in expenditures.
• General and administrative expenditures for three and six months of 2021 were $2.6 million and $5.7 million, respectively, due to an increase in costs related to operating a public company. In 2020, the same time periods showed $0.7 million and $1.3 million.
• Total operating expenses for three and six months of 2021 were $11.7 million and $21.5 million, respectively. Excluding depreciation and stock-based compensation, they were $10.7 million and $19.4 million. 
• Net loss was $11.8 million and $21.7 million for three and six months of 2021, respectively. 
• Price Action: SRPB closed at $7.91 on Aug. 10. 

Check out Spruce Biosciences here for more information on its work. 

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.