Newsfile Corp. Newsfile Corp
Phoenix, Arizona–(Newsfile Corp. – October 10, 2019) – The Stock Day Podcast welcomed CytoDyn Inc. (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. President and CEO, Dr. Nader Pourhassan, joined Stock Day host Everett Jolly.
To begin the interview, Jolly asked about the Company’s primary goals. Dr. Pourhassan explained that the Company has been focused on achieving FDA approval for the use of leronlimab, formerly known as PRO 140, as a treatment for HIV. “However, along this path we have found that this product could have a lot of indications,” said Dr. Pourhassan. He further explained that leronlimab targets the CCR5 receptor, but may also be useful for the treatment of other immune-mediated illnesses and tumors.
Jolly then asked about the progress of the Company’s Phase 2 trials, as well as their Phase 1/b2 Clinical Trial with leronlimab for patients with triple negative breast cancer. “The FDA has informed us that they need to have data from the 700 milligram dose of our monotherapy with patients who have been treated for 24 weeks,” explained Dr. Pourhassan when addressing the HIV trials. He added that the Company expects to be completed its final application for final approval (BLA) by the end of this year.
Dr. Pourhassan then expanded on the Company’s work with cancer, which also uses leronlimab as a combination treatment method. Dr. Pourhassan shared that animal studies have shown that tumor metastasis can be suppressed by up to 98%, however clinical trials will help determine whether this is possible in humans. “It’s a very exciting time to see if we can save lives in a big way with this mechanism of action,” said Dr. Pourhassan.
Jolly then inquired about the Company’s revenue potential going forward. “We do have fast-track designations for HIV, which qualifies us for accelerated approval which is six months,” explained Dr. Pourhassan. “We hope to have our approval by the second quarter of next year, and then we will have revenue.”
Dr. Pourhassan then shared that the Company is in the process of licensing their products to a company with an established sales force for potential revenue from its HIV program. “We have signed a non-binding term sheet,” said Dr. Pourhassan. “We are hoping to have this wrapped-up very soon.”
“What about fundraising, what is the plan for that?” asked Jolly. Dr. Pourhassan shared that the Company is continually working to raise funds, while also ensuring that the dilution remains as low as possible. “We should be able to get this funding ourselves and get to the end of the year,” said Dr. Pourhassan.
“There are a lot of things going on and there is a lot of excitement with leronlimab for potential HIV prevention,” shared Dr. Pourhassan when discussing the Company’s work with HIV treatment and prevention. He then expanded on the Company’s additional indications for leronlimab, which include the treatment of breast cancer and tumors. “I believe we are at the very close vicinity of major victories.”
To close the interview, Dr. Pourhassan expressed his excitement for the Company’s current projects and shared that he looks forward to completing the licensing process of their HIV products. “But the most excitement will come when we get the results of the human data from the triple-negative breast cancer trials, which if successful could change the world of cancer forever,” added Dr. Pourhassan. He also noted that the stock is currently undervalued, and he expects appreciation of the stock with all the major milestones this year alone.
To hear Dr. Pourhassan’s entire interview, follow the link to the podcast here: https://audioboom.com/posts/7392365-ceo-of-cytodyn-dr-nader-pourhassan-shares-the-progress-of-the-company-s-leronlimab-trials-with
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 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 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 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.
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.
Stock Day Media
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/48672