CEO Dr. Nader Pourhassan of CytoDyn Inc. (OTCQB: CYDY), rejoins the show to discuss recent additions to the board of directors, Pro 140’s impact on cancer treatment, and plans for 2019.
Uptick Newswire Hosts The President and CEO of CytoDyn Inc. to Discuss The Incredible Potential Breakthroughs The Company is Working Towards in HIV and Cancer Treatment
PHOENIX, Jan. 14, 2019 (GLOBE NEWSWIRE) — Uptick Newswire Stock Day Podcast welcomed CytoDyn Inc. (OTC.QB: CYDY) (the “company”), which is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection. Nader Z. Pourhassan, Ph.D., President and CEO, talked with Stock Day’s Everett Jolly.
At the start of the interview Jolly asked Pourhassan to bring listeners up to date on a few new board and management changes. Pourhassan said they’ve recently appointed Dr. Scott Kelly as chairman of the board. They also have a new board member, Dr. David Welch, and Dr. Nitya G. Ray is CytoDyn’s new Chief technology officer.
“We are surrounding ourselves with professionals who have a lot of experience for what we need at this point,” explained Pourhassan.
He then went on to explain that the company’s vision for 2019, which he describes as strong and says they are being hailed as one of the best stocks for 2019.
“People are really starting to see the future of CytoDyn as the future of cancer and HIV and that is really strong and the stock is totally undervalued. What we have done with HIV is, we said we would change the HIV paradigm by bringing a self-injectable antibody,” said Pourhassan.
He went on to say in the world of cancer, they are close to announcing some data that could bring us closer to making cancer potentially a chronic disease. He says the data could change cancer forever.
“The vision for 2019 is to finish our approval to get this (HIV injectable) in a commercial setting for 2020. Over $450 million in revenue potential and then let’s change the cancer paradigm.”
Jolly then asked how large the HIV and cancer market are at the moment and asked how much the company can take. Pourhassan says in regards to Cancer it depends on the data they are now gathering regarding their cancer treatment, leronlimab (PRO 140), which is currently in human trials for advanced breast cancer.
“If we can show this data, then it means that the mechanism working for any cancer that has CCR5, (50% of the breast cancer that metastasized have CCR5), will be effective. If we show that we can stop the metastasis, then, breast cancer, brain cancer, bone cancer, all cancers that metastasis will be effected by this product. The market for such product could be in trillions, not billions, but trillions,” said Pourhassan.
Jolly then asked how the company will fund its commercialization of the drug.
“We have been blessed by a tremendous investment bank helping us for the last 5 years and we have raised $120 million through them. I also raised money by myself, over $60 million. In the last 5 years we have never failed our company.” He went on to say, “We only need 10 or 15 percent more of what we’ve raised in the last 5 years to get to the finish line, in regards to BLA submission.”
CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on PRO 140 (leronlimab), a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor is also 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 PRO 140 in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. The Company plans to seek FDA approval for PRO 140 in combination therapy and plans to complete the filing of a Biological License Application (BLA) in the first quarter of 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with PRO 140 as a once-weekly monotherapy for HIV-infected patients, and plans to initiate a registration-directed study of PRO 140 monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that 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 PRO 140 monotherapy can prevent viral escape in HIV-infected patients, with some patients on PRO 140 monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate PRO 140 for the prevention of GvHD and expects to initiate clinical trials with PRO 140 in metastatic triple-negative breast cancer in 2018. More information is at www.cytodyn.com.
LHA Investor Relations
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding the proposed transaction with ProstaGene, the closing conditions and the likelihood of closing the proposed transaction with ProstaGene, the Company’s clinical focus, and the Company’s current and proposed trials. 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 differ materially from those contained in or expressed by such statements. In evaluating all such statements, the Company urges investors to specifically consider the various risk factors identified in the Company’s Form 10-K for the fiscal year ended May 31, 2018 in the section titled “Risk Factors” in Part I, Item 1A, and in our Form 10-Q for the quarterly period ended August 31, 2018 in the section titled “Risk Factors” in Part II, Item 1A, any of which could cause actual results to differ materially from those indicated by the Company’s forward-looking statements.
The Company’s forward-looking statements reflect its current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans. Investors should not place undue reliance on the Company’s forward-looking statements, which are subject to risks and uncertainties relating to, among other things: (i) the sufficiency of the Company’s cash position and the Company’s ongoing ability to raise additional capital to fund its operations, (ii) the Company’s ability to complete its Phase 2b/3 pivotal combination therapy trial for PRO 140 (CD02) and to meet the FDA’s requirements with respect to safety and efficacy to support the filing of a Biologics License Application, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (v) the Company’s ability to achieve approval of a marketable product, (vi) design, implementation and conduct of clinical trials, (vii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (viii) the market for, and marketability of, any product that is approved, (ix) the existence or development of vaccines, drugs, or other treatments for infection with HIV that are viewed by medical professionals or patients as superior to the Company’s products, (x) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xi) general economic and business conditions, (xii) changes in foreign, political, and social conditions, and (xiii) various other matters, many of which are beyond the Company’s control. Should one or more of these risks or uncertainties develop, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated by the Company’s forward-looking statements.
The Company intends that all forward-looking statements made in this press release will be subject to the safe harbor protection of the federal securities laws pursuant to Section 27A of the Securities Act of 1933, as amended, to the extent applicable. Except as required by law, the Company does not undertake any responsibility to update these forward-looking statements to take into account events or circumstances that occur after the date of this press release. Additionally, the Company does not undertake any responsibility to update investors upon the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.
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