Cranford, NJ-based Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) has received a notice from Nasdaq indicating the company's failure to comply with the minimum bid price requirement, potentially leading to delisting from the Nasdaq Capital Market.
The trouble began on September 12, 2023, when Citius first learned it did not meet Nasdaq's minimum bid price rule, which requires a stock to maintain a bid price of at least $1.00 per share. Despite being granted an initial 180-day period to regain compliance, and a subsequent extension through September 9, 2024, the company's efforts did not result in meeting the necessary bid price threshold.
On Monday, September 10, 2024, Citius received a formal determination of delisting. In response, the company plans to request a hearing before a Nasdaq Hearing Panel, which will delay any delisting action until the hearing and any further extension period granted by the Panel concludes. The Panel could allow up to an additional 180 days for Citius to comply with the listing requirements.
There is no certainty that the Panel will grant an extension or that Citius can meet the continued listing criteria. The company has expressed its intention to present a plan to regain compliance at the hearing.
Citius, formerly known as Trail One, Inc., with a fiscal year ending on September 30, is headquartered at 11 Commerce Drive, 1st Floor, Cranford, NJ, and incorporated in Nevada. The company's recent challenges underscore the ongoing risks faced by pharmaceutical companies in maintaining financial and regulatory standards for stock market listings.
In other recent news, Citius Pharmaceuticals has received FDA approval for its cutaneous T-cell lymphoma (CTCL) therapy, LYMPHIR, marking the company's first FDA-approved product. The novel immunotherapy, expected to launch within the next five months, aims to provide a new treatment option for approximately 40,000 CTCL patients in the U.S.
The approval is based on a Phase 3 study that showed an Objective Response Rate (ORR) of 36% and a reduction in skin disease in 84% of patients.
In addition, Citius Pharmaceuticals has announced a merger with TenX Keane Acquisition, which is expected to conclude soon. This strategic move will result in Citius Pharma holding approximately 90% of the newly formed entity, Citius Oncology, Inc., enhancing the potential commercialization of LYMPHIR.
Furthermore, Citius Pharmaceuticals reported successful Phase 3 trials of Mino-Lok, an antibiotic lock solution. The trial met its primary endpoint, demonstrating a higher overall treatment success rate compared to the control group.
EF Hutton has initiated coverage on Citius Pharmaceuticals, issuing a Buy rating and highlighting the company's two late-stage therapeutics, Mino-Lok and LYMPHIR. Finally, Citius Pharmaceuticals has outlined upcoming milestones for its product candidates, following positive topline results from the Phase 3 Mino-Lok trial and the anticipation of commercializing LYMPHIR if approved by the FDA.
InvestingPro Insights
With Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) facing delisting concerns due to non-compliance with Nasdaq's minimum bid price requirement, it's essential to look at the company's financial health and market performance to understand the broader context. According to InvestingPro data, Citius has a market capitalization of approximately $95.6 million and is dealing with significant financial challenges, as indicated by a negative P/E ratio of -2.13, reflecting investor concerns about profitability.
InvestingPro Tips suggest that Citius holds more cash than debt, which could be a positive sign in terms of liquidity and financial stability. However, the company suffers from weak gross profit margins, which could be a contributing factor to its financial difficulties. Additionally, the stock has experienced a notable decline over the last month, with a 31.01% drop in price total return, pointing to high volatility and investor skepticism about the company's future performance.
For those considering investment opportunities with Citius, it is worth noting that analysts do not anticipate the company will be profitable this year, and the stock does not pay a dividend to shareholders. With these considerations in mind, investors may want to explore the full range of 7 InvestingPro Tips available at https://www.investing.com/pro/CTXR to make more informed decisions.
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