TEL AVIV - SciSparc Ltd. (NASDAQ: SPRC), a pharmaceutical company specializing in central nervous system disorders, has announced the submission of an Investigational New Drug application to the U.S. Food and Drug Administration for a phase IIb clinical trial of its drug candidate SCI-110, aimed at treating Tourette Syndrome (TS). The trial is set to take place at three leading institutions: the Yale Child Study Center at the Yale School of Medicine in the United States, Hannover Medical School in Germany, and Tel Aviv Sourasky Medical Center in Israel.
This trial follows the company's announcement on August 23, 2024, and will evaluate the efficacy, safety, and tolerability of SCI-110 in adults aged 18 to 65. Participants will be randomized to receive either the drug or a placebo, with the primary efficacy measure being the change in tic severity based on the Yale Global Tic Severity Scale at 12 and 26 weeks of the double-blind phase.
SciSparc has secured the necessary Institutional Review Board approvals from all three clinical sites, as well as the Israeli Ministry of Health's approval for the trial at Sourasky, and the Federal Institute for Drugs and Medical Devices in Germany for the Hannover Medical School site.
The company, which is also engaged in developing treatments for Alzheimer's disease, agitation, Autism Spectrum Disorder (ASD), and status epilepticus, emphasizes that its focus is on cannabinoid pharmaceuticals. It also holds a controlling interest in a subsidiary selling hemp seed oil-based products on Amazon (NASDAQ:AMZN) Marketplace.
The press release includes forward-looking statements, which are subject to risks and uncertainties. These statements should not be seen as guarantees of future performance, and actual results may vary. SciSparc has made it clear that past scientific research and clinical trials do not necessarily predict future outcomes.
The information for this article is based on a press release statement from SciSparc Ltd.
In other recent news, SciSparc Ltd. has extended an additional $1.85 million bridge loan to AutoMax Motors Ltd., bringing the total loan amount to $4.25 million, according to their amended agreement. This development negates the need for previously agreed closing financing in the merger plan between the two entities. Moreover, SciSparc has signed an exclusive patent license agreement with Polyrizon Ltd. for the out-licensing of its SCI-160 program aimed at treating pain, in a deal that could see SciSparc receive $3 million in Polyrizon securities and potential milestone fees of approximately $3 million in cash.
SciSparc has also initiated a clinical trial for its proprietary SCI-210 therapy, aimed at treating symptoms of autism spectrum disorder in children, at Soroka Medical Center in Israel. In addition, the company and AutoMax Motors Ltd. are moving forward with their merger plans, with an extended deadline for finalizing the merger to November 30, 2024.
In collaboration with Clearmind Medicine Inc., SciSparc reported promising results from a joint study aimed at combating obesity and metabolic syndrome. The company also announced the appointment of Professor Nir Peled, a renowned oncologist, to the scientific advisory board of its cancer-focused venture, MitoCareX Bio Ltd. These are the recent developments in the company's operations.
InvestingPro Insights
As SciSparc Ltd. (NASDAQ: SPRC) embarks on its phase IIb clinical trial for SCI-110, the company's financial health and market performance provide a backdrop for investors considering the stock. According to InvestingPro, a noteworthy aspect of SciSparc's financial position is that it holds more cash than debt on its balance sheet, which could offer some stability as it funds ongoing clinical trials. Furthermore, analysts predict that the company will be profitable this year, which is a positive sign for potential investors looking at the long-term prospects of the company.
InvestingPro data shows that SciSparc has a market capitalization of $0.94 million, indicating its status as a micro-cap stock that could be subject to higher volatility and risk. The company's revenue for the last twelve months as of Q4 2023 was $2.88 million, with a substantial growth rate of 113.73%. However, it's important to note that there was a quarterly revenue decline of -32.67% in Q4 2023, which may raise concerns about the sustainability of its revenue growth. The gross profit margin stands at a healthy 76.28%, yet the operating income margin was -200.52%, reflecting significant operational costs relative to its gross profit.
The stock's performance has been underwhelming, as the price has fallen significantly over the last year, with a one-year price total return of -92.52%. This aligns with the InvestingPro Tip that the stock has fared poorly over the last month, with additional details available on InvestingPro, which lists a total of 15 tips for SciSparc Ltd. These insights can help investors gauge the risk and potential of SciSparc's stock amidst its clinical developments.
For those interested in a deeper analysis, additional InvestingPro Tips can be found at the dedicated SciSparc page on InvestingPro: https://www.investing.com/pro/SPRC.
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