PHOENIX, AZ / ACCESSWIRE / July 10, 2019 / The Stock Day Podcast welcomed CytoDyn (CYDY) ("the Company"), a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CEO and President, Nader Pourhassan, Ph.D., joined Stock Day host Everett Jolly.
Jolly began the interview by asking about the Company's recent press release regarding a new addition to their team. Dr. Pourhassan explained that Dr. Jonah Sacha has been named the Company's Senior Science Advisor and adds extensive experience in HIV research to the team. Dr. Sacha will be exploring leronlimab (PRO 140) for its potential use in HIV prevention.
Dr. Pourhassan also explained that the Company will be exploring possible cures for HIV with the help of Dr. Sacha, and based on vast data from monotherapy clinical trial, they are confident in their abilities for this project.
Jolly then asked Dr. Pourhassan to share more information about the Company's preventative treatments for HIV. Dr. Pourhassan explained that the Company is close to developing a preventative treatment using the antibody, leronlimab (PRO 140), which works to prevent HIV from entering T-cells. "That is a very powerful concept," explained Dr. Pourhassan.
Jolly followed by asking about the Company's BLA (Biologics License Application). Dr. Pourhassan explained that the Company is still in the process of filing the rest of their BLA to the FDA, however, the outcome is looking positive. He explained that the Company might be able to complete their BLA by the end of August 2019 for clinical and end of September 2019 for their manufacturing, which makes achieving final approval by next year, first or second quarter very possible.
Jolly then asked about the Company's strategy for revenue. Dr. Pourhassan explained that raising the necessary funds and receiving FDA approval for their treatments are key to having revenue. "The strategy is to make sure we stand strong at this point," stated Dr. Pourhassan. He added that having revenue is not too far from us and will represent a significant step for our shareholders.
To hear Dr. Pourhassan's entire interview, follow the link to the podcast here:
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, including leronlimab's potential in HIV Pre-Exposure Prophylaxis (PrEP) and HIV cure. 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.
Nader Pourhassan, Ph.D.
President & CEO
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.
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