SAN DIEGO - Ensysce Biosciences, Inc. (NASDAQ:ENSC), a clinical-stage pharmaceutical company, has been granted an extension to continue listing on The Nasdaq Capital Market. The Nasdaq notification, dated November 5, 2024, provides Ensysce with an extension until November 14, 2024, to meet the equity requirement as per Listing Rule 5550(b)(1), with the condition of filing its Form 10-Q by that date.
Furthermore, the company has until December 19, 2024, to demonstrate compliance with the Minimum Bid Price requirement outlined in Listing Rule 5550(a)(2) and to meet other applicable requirements as well as certain interim conditions.
Ensysce specializes in developing safer prescription drugs for severe pain management, with a focus on reducing the potential for opioid abuse and overdose. Its proprietary technology platforms, Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®), aim to create tamper-proof pain treatments. These treatments are designed to minimize the risk of drug abuse and overdose, providing safer options for patients in severe pain and aiding in the prevention of medication abuse-related deaths.
The company's product candidates are currently in clinical stages and are not yet approved. There is no guarantee that the clinical programs will successfully demonstrate safety and efficacy, that Ensysce will not face delays in clinical development, or that any product will receive regulatory approval or be successfully commercialized.
Ensysce's management acknowledges the inherent uncertainties in their forward-looking statements, which are subject to various risks and uncertainties that could cause actual results to differ significantly from expectations.
This news is based on a press release statement by Ensysce Biosciences, Inc. The company's most recent quarterly report on Form 10-Q and current reports on Form 8-K are publicly available for review at the SEC's website.
In other recent news, Ensysce Biosciences has made significant strides in its operations. The pharmaceutical firm has amended its bylaws to reduce the quorum requirement for stockholder meetings, facilitating governance and shareholder participation. Concurrently, Ensysce has successfully met Nasdaq's stockholders' equity requirements, ensuring its continued listing on the Nasdaq Capital Market.
Further, the company has secured substantial funding, including a $5 million financing transaction and a $14 million grant from the National Institutes of Health. These funds are set to bolster the development of Ensysce's opioid products, PF614 and PF614-MPAR, which are currently in clinical stages.
As part of its strategy to expedite the commercialization of its safer opioid alternatives, Ensysce has formed strategic partnerships and plans to submit a New Drug Application by 2026. The company has also initiated non-clinical studies for PF614-MPAR, with patient enrollment expected to start later this quarter.
In the realm of clinical trials, Ensysce has submitted a Phase 3 Protocol for PF614, a treatment for post-abdominoplasty pain, to the FDA. The results of this pivotal study are anticipated in late 2025. These developments highlight Ensysce's commitment to advancing its clinical trials and meeting regulatory standards.
InvestingPro Insights
As Ensysce Biosciences (NASDAQ:ENSC) navigates its Nasdaq listing extension, recent InvestingPro data provides additional context to the company's financial situation. With a market capitalization of just $7.63 million, Ensysce is operating in a challenging environment. The company's revenue for the last twelve months as of Q2 2024 stood at $1.44 million, with a significant revenue decline of 51.96% over the same period.
InvestingPro Tips highlight that Ensysce "holds more cash than debt on its balance sheet," which could be crucial as the company works to meet Nasdaq's equity requirements. However, the tip that the "stock generally trades with high price volatility" aligns with the company's struggle to maintain the minimum bid price for Nasdaq listing.
Despite these challenges, Ensysce has shown a strong return of 150.25% over the last month, according to InvestingPro data. This recent performance might be encouraging for investors watching the company's efforts to maintain its listing status.
For those seeking a deeper understanding of Ensysce's financial health and market position, InvestingPro offers 11 additional tips, providing a more comprehensive analysis of the company's prospects.
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