CytoDyn Joins The Stock Day Podcast to Discuss Phase 3 Trials for Their HIV Program.
Jolly began the interview by asking about the progress of the Company's current HIV program. Dr. Pourhassan explained that CytoDyn's HIV program consists of three branches. The first branch involves the use of leronlimab in combination with standard anti-retroviral therapies for unmet medical HIV population. This division of the Company has already completed Phase 3 trials and could potentially gain final approval in the near future, which would allow for its release by the second quarter of next year. Second branch of CytoDyn's HIV program involves the use of leronlimab as a once-weekly monotherapy program for HIV-infected patients, which has also completed one investigative Phase 3 clinical trial and is meeting with the FDA to finalize a final trial for approval as label expansion.
Jolly then asked about the potential of the HIV market. Dr. Pourhassan explained that this market is currently valued around $10 billion. Dr. Pourhassan then explained that the Company is close to the final approval of their HIV program and already has close to $60 million worth of commercial product ready for launch. "When we get approval, we have assets that we will be able to use," stated Dr. Pourhassan.
Dr. Pourhassan then expanded on the Company's third branch of their HIV program, lead by Dr. Jonas Sacha. This aspect of the Company was designed to explore the potential of leronlimab (PRO 140) in HIV Pre-Exposure Prophylaxis (PrEP) and cure, and has had great success. Dr. Pourhassan shared that new results from Dr. Jonas Sacha will be released later this year and he believes it will have a significant impact on the HIV industry. CytoDyn has already signed an Memorandum of Understanding with Thai Red Cross for a PrEP study funded outside of CytoDyn.
Dr. Pourhassan then expanded on the Company's plans to fund the launch of their HIV program. He shared that the Company has been offered one substantial opportunity and working on a second one also, which will include significant upfront and milestone payments. "We're eager to get one of those deals signed and let our shareholders know that we're really entering the revenue era soon", said Dr. Pourhassan.
Jolly then asked about the Company's non-HIV programs. Dr. Pourhassan explained that the Company is currently entering Phase 2 trials for the use of leronlimab in treating metastatic triple-negative breast cancer. He shared that animal studies were extremely successful, which if replicated in humans then it could represent massive value in the treatment of cancer. The Company is also adapting their program to help with the treatment of fibrosis, as well as colon cancer.
Jolly asked about the Company's plans for potential partnerships or licensing. Dr. Pourhassan shared that the Company is very close to signing a licensing agreement, which represents an important step towards the production of their HIV program.
To close the interview, Jolly noted that the Company is exceptionally undervalued and represents a great opportunity for investors interested in this space.
To hear Nader Pourhassan's entire interview, follow the link to the podcast here: https://audioboom.com/posts/7348426-cytodyn-joins-the-stock-day-podcast-to-discuss-phase-3-trials-for-their-hiv-program
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CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as graft-vs-host disease (GvHD) and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (PRO 140) can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
CONTACTSInvestors:Nader Pourhassan, Ph.D.President & CEO email@example.com
Marek Ciszewski, J.D. firstname.lastname@example.org
About The "Stock Day" Podcast
Founded in 2013, Stock Day is the fastest growing media outlet for Nano-Cap and Micro-Cap companies. It educates investors while simultaneously working with penny stock and OTC companies, providing transparency and clarification of under-valued, under-sold Micro-Cap stocks of the market. Stock Day provides companies with customized solutions to their news distribution in both national and international media outlets. The Stock Day Podcast is the number one radio show of its kind in America. Stock Day recently launched its Video Interview Studio located in Phoenix, Arizona.
SOURCE:Stock Day Media602-441-3474
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/47148
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|Publication:||Financial News Releases|
|Date:||Aug 22, 2019|
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