Spruce Biosciences Inc

Spruce Biosciences, Inc. (NASDAQ: SPRB) is a late-stage biopharmaceutical company, which engages in developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need. It focuses on developing its wholly owned product candidate, Tildacerfont. The company was founded on November 13, 2014 and is headquartered in South San Francisco, CA.

Recent Business and Financial Updates

• Upcoming Clinical Data Releases: Spruce Biosciences anticipates reporting topline results from two critical Phase 2 studies evaluating tildacerfont for congenital adrenal hyperplasia (CAH) in December 2024. The CAHmelia-204 study focuses on adult CAH patients, assessing the efficacy of tildacerfont in reducing supraphysiologic glucocorticoid usage, while the CAHptain-205 study evaluates its safety, efficacy, and pharmacokinetics in both adult and pediatric patients. These results are expected to provide essential insights into the therapeutic potential of tildacerfont and its role in improving treatment outcomes for CAH patients.
• Clinical Trial Details: The CAHmelia-204 study is a Phase 2b, randomized, double-blind, placebo-controlled trial examining the impact of tildacerfont in 90 adult patients with classic CAH. The trial is designed to measure the absolute change in daily glucocorticoid dose over a 24-week period, with an additional 52-week open-label extension. Meanwhile, the CAHptain-205 study employs a sequential cohort design to investigate the effects of tildacerfont across different age groups. Pediatric patients receive weight-adjusted doses, with androgen level normalization and glucocorticoid dose reduction serving as primary efficacy measures. An optional extension period allows for long-term safety evaluation.
• Corporate and Regulatory Milestones: Beyond the upcoming clinical data releases, Spruce Biosciences expects to hold an End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) in the first half of 2025. This meeting will be a critical step toward advancing tildacerfont into late-stage development, facilitating discussions on the regulatory pathway for potential approval. These milestones underscore the company’s commitment to addressing the unmet medical needs of CAH patients through innovative therapeutic solutions.
• Financial Position and Cash Outlook: As of September 30, 2024, Spruce Biosciences reported cash and cash equivalents of USD60.1 million. This financial position is expected to sustain the company’s current operating plan through the end of 2025, supporting its ongoing clinical development efforts. Collaboration revenue for the quarter amounted to USD0.6 million, reflecting partial recognition of a USD15.0 million upfront payment received in April 2023 from Kaken Pharmaceutical under a licensing agreement.
• Operating Expenses and Net Loss: Total operating expenses for the third quarter of 2024 were USD10.0 million, a decrease from USD16.7 million in the same period of 2023, primarily due to reduced research and development (R&D) expenditures. R&D expenses declined to USD6.6 million, driven by the termination of the CAHmelia-203 study and completion of enrollment in the CAHmelia-204 study. General and administrative (G&A) expenses stood at USD3.5 million for the quarter. The company reported a net loss of USD8.7 million for the quarter, compared to USD12.4 million in the third quarter of 2023, reflecting the overall reduction in operating expenses.

Technical Observation (on the daily chart):

The Relative Strength Index (RSI) over a 14-day period stands at a value of 50.98, currently upward moving, with expectations of a consolidation or an upward momentum once USD 0.45-USD0.50 resistance is broken on the upside. Additionally, the stock's current positioning is below both the 50-period SMA and 200-period SMA, which may serve as dynamic short to medium-term resistance levels.

As per the above-mentioned price action, recent key business and financial updates, momentum in the stock over the last month, and technical indicators analysis, a ‘WATCH`’ rating has been given for Spruce Biosciences, Inc. (NASDAQ: SPRB) at the closing price of USD 0.3970 as of February 10, 2025. 

Individuals can evaluate the stock based on the support and resistance levels provided in the report in case of keen interest taking into consideration the risk-reward scenario. 

Markets are trading in a highly volatile zone currently due to certain macro-economic issues and prevailing geopolitical tensions. Therefore, it is prudent to follow a cautious approach while investing.

Related Risk: This report may be looked at from a high-risk perspective and a recommendation is provided for a short duration. This report is solely based on technical parameters, and the fundamental performance of the stocks has not been considered in the decision-making process. Other factors which could impact the stock prices include market risks, regulatory risks, interest rates risks, currency risks, social and political instability risks etc. 

Note 1: Past performance is not a reliable indicator of future performance.

Note 2: The reference date for all price data, currency, technical indicators, support, and resistance level is February 10, 2025. The reference data in this report has been partly sourced from REFINITIV.

Note 3: Investment decisions should be made depending on an individual's appetite for upside potential, risks, holding duration, and any previous holdings. An 'Exit' from the stock can be considered if the Target Price mentioned as per the Valuation and or the technical levels provided has been achieved and is subject to the factors discussed above.

Note 4: Target Price refers to a price level that the stock is expected to reach as per the relative valuation method and or technical analysis taking into consideration both short-term and long-term scenarios.

Note 5: ‘Kalkine reports are prepared based on the stock prices captured either from the New York Stock Exchange (NYSE), NASDAQ Capital Markets (NASDAQ), and or REFINITIV. Typically, all sources (NYSE, NASDAQ, or REFINITIV) may reflect stock prices with a delay which could be a lag of 15-20 minutes. There can be no assurance that future results or events will be consistent with the information provided in the report. The information is subject to change without any prior notice.