Tonix Pharmaceuticals stock halted ahead of FDA approval news
BOTHELL, Wash. - Cocrystal Pharma, Inc. (NASDAQ: COCP), a clinical-stage biotechnology company, has initiated the multiple-ascending dose (MAD) phase of their Phase 1 clinical trial for CDI-988. The drug, a broad-spectrum oral pan-viral protease inhibitor, is undergoing tests for its safety, tolerability, and pharmacokinetics in healthy adults.
The trial is taking place at a single research center in Australia, and follows a successful single-ascending dose (SAD) phase completed in July 2024, which reported no serious adverse events or severe treatment-emergent adverse events among participants. The current MAD study aims to build on these findings by further evaluating the compound's safety profile.
CDI-988 has been developed using Cocrystal's proprietary drug discovery technology and is being positioned as a first-in-class treatment for viral gastroenteritis and COVID-19, caused by noroviruses and coronaviruses, respectively. "We are delighted to advance the clinical evaluation of CDI-988, a novel direct-acting antiviral targeting the viral proteases of noroviruses and coronaviruses," stated Sam Lee, Ph.D., President and co-CEO of Cocrystal.
Noroviruses are a leading cause of gastroenteritis with symptoms such as vomiting and diarrhea. They are responsible for approximately 21 million cases of acute gastroenteritis annually in the U.S. alone, leading to significant hospitalizations and emergency department visits. Currently, there are no approved antiviral treatments or vaccines for norovirus infections.
Coronaviruses, including the SARS-CoV-2 virus and its variants, have historically ranged from asymptomatic to severe respiratory illnesses. By targeting viral replication enzymes and protease, Cocrystal aims to develop an effective treatment for all coronaviruses.
Topline results from the MAD portion of the CDI-988 study are expected in late 2024 or early 2025. The company's progress is particularly noteworthy as there remains a high unmet medical need for effective treatments against these viruses.
Cocrystal Pharma focuses on discovering and developing novel antiviral therapeutics for influenza, coronaviruses, noroviruses, and hepatitis C viruses. This announcement is based on a press release statement and contains forward-looking statements about the potential efficacy and market for CDI-988, subject to various risks and uncertainties, including those related to clinical trial processes and regulatory approvals.
In other recent news, Cocrystal Pharma's Phase 1 study for its pan-viral protease inhibitor, CDI-988, has yielded positive safety and tolerability results. The study, conducted with healthy volunteers, reported no serious adverse events or severe treatment-emergent adverse events. Furthermore, Cocrystal Pharma has announced a reduction in the number of authorized capital stock from 155 million to 101 million shares, marking a significant change in the company's capital structure.
In addition to these developments, H.C. Wainwright has revised its price target for Cocrystal Pharma to $7.00, maintaining a neutral rating on the stock. This adjustment follows the recent Phase 1 study results. Meanwhile, Noble Capital has retained its Outperform rating on the company, anticipating positive outcomes from the CC-42344 Influenza Virus Program.
These are recent developments in the company's operations and market position. As Cocrystal Pharma moves forward, the company is preparing for the multiple-ascending dose cohorts of the CDI-988 trial, with enrollment expected to begin soon.
InvestingPro Insights
As Cocrystal Pharma (NASDAQ: COCP) progresses with its Phase 1 clinical trial for CDI-988, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Cocrystal Pharma's market capitalization currently stands at a modest $17.6 million. Despite the potential promise of CDI-988, the company's financial metrics reflect some challenges, with a negative P/E ratio of -0.98 and a Price/Book ratio as of Q2 2024 at just under 1, at 0.99. These figures suggest that the market is cautious about the company's profitability.
InvestingPro Tips indicate that Cocrystal Pharma holds more cash than debt on its balance sheet, which could provide some financial flexibility as it continues to fund its clinical trials. However, the company is quickly burning through its cash reserves and has not been profitable over the last twelve months. Analysts have also revised their earnings expectations downwards for the upcoming period, indicating concerns about the company's near-term financial performance. Additionally, with weak gross profit margins and a valuation that implies a poor free cash flow yield, the financial outlook requires careful consideration from investors.
It's worth noting that Cocrystal Pharma does not pay a dividend, which is not uncommon for clinical-stage biotechnology companies where capital is often reinvested into research and development. For those interested in a deeper dive into the company's financials and future prospects, there are 6 additional InvestingPro Tips available on the InvestingPro platform, offering more detailed analysis and guidance. These tips could provide valuable insights for investors trying to navigate the complex landscape of biotech investing.
As the company awaits topline results from the multiple-ascending dose phase of the CDI-988 study, expected in late 2024 or early 2025, investors may want to stay informed on both the clinical and financial fronts. Keeping an eye on the InvestingPro platform could offer timely updates and expert analysis to help make more informed investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.