CytoDyn Inc. (CYDY)

CytoDyn Inc. (CYDY) is a biotechnology company focused on the clinical development and potential commercialization of a new class of HIV/AIDS therapeutics or viral-entry inhibitors intended to protect healthy cells from viral infection. The company's pipeline includes its lead product, PRO 140 for multiple indications among which are human immunodeficiency virus (HIV), graft-versus-host disease (GvHD), colon cancer, and multiple sclerosis (MS), each in various stages of development. CytoDyn's first approval is focused on HIV indications for two different HIV populations.

PRO 140 is a humanized monoclonal antibody directed at CCR5, a molecular portal that HIV uses to enter T-cells. PRO 140 works by blocking the predominant HIV (R5) subtype entry into T-cells by masking this required co-receptor, CCR5.

CytoDyn has completed one pivotal phase 3 clinical trials of PRO 140 use in combination with current drugs for population that has limited treatment options. PRO 140 is also currently in another phase 3 (investigative trial) for a second approval for another HIV population. HIV continues to be a major global public health issue. There is no cure for the disease that has claimed more than 35 million lives to date, according to the World Health Organization ("WHO"). In 2017, 940,000 people around the world died from HIV-related causes. There were approximately 36.9 million people living with HIV at the end of 2017 with 1.8 million people becoming newly infected during that same year. The WHO estimates there were 21.7 million people globally receiving antiretroviral therapy ("ART") in 2017.

HIV targets the immune system and weakens the body's defense systems against infections and some types of cancer. As the virus destroys and impairs the function of immune cells, infected individuals gradually become immunodeficient which results in increased susceptibility to a wide range of infections, cancers and other diseases that people with healthy immune systems can fight off. The most advanced stage of HIV infection is Acquired Immunodeficiency Syndrome (AIDS), which can take from 2 to 15 years to develop depending on the individual.

PRO 140 functions by blocking the HIV co-receptor CCR5, a molecular portal HIV uses to enter T-cells, thus preventing the HIV virus from entering the cell. CCR5 is a protein located on the surface of white blood cells that normally serves as a receptor for chemicals that attract immune cells to the site of inflammation. Clinical trials to date indicate PRO 140 does not interfere with these normal CCR5 functions. Results from phase 1 and phase 2 human clinical trials have shown PRO 140 significantly reduces viral burden in people infected with HIV. Importantly, in a recent phase 2b clinical trial, PRO 140 demonstrated it can allow a subset of R5 strain of HIV population to replace their current HIV regimen (Highly Active Antiretroviral Therapy or "HAART.") by a simple sub-cutaneous self-injectable dose of PRO 140 which is administered once a week. Some of those patients have received PRO 140 as their only therapy for almost four years.

The PRO 140 antibody appears to be a powerful antiviral agent with hardly any side effects, toxicity. More than 500 patients have used PRO 140 in clinical trial and no resistance has ever been developed in any patients including patients in monotherapy of PRO 140 for almost four years.

PRO 140, which is taken as an easy-to-use, weekly, subcutaneous self-administered dose, has almost no side effects or toxicity with no report of any serious adverse event related to PRO 140 in more than 500 patients in eight different clinical trial.

As we indicated earlier patients given PRO 140 showed no drug resistance on monotherapy for some almost four years while 76% of HAART patients developed a resistance to some portion of the lifetime drug regimen. Patient compliance with HAART is also the main reason why only 35% of HIV patients in US reporting complete viral load (VL) suppression which is VL<50 cp/mL.

In addition to its research into the powerful potential of PRO 140 for use in HIV patients, CytoDyn is pursuing PRO 140 as a therapeutic anti-viral agent in other non-HIV indications that could benefit from PRO 140's ability to block CCR5. These immunologic indications include new reactions to cancer, transplantation rejection, autoimmune diseases and chronic inflammation such as Multiple Sclerosis. The company sees the significant potential for multiple pipeline opportunities for PRO 140.

The U.S. Food and Drug Administration has designated PRO 140 as a "fast track" product for HIV and granted Orphan Drug Designation to it for the prevention of GvHD in transplant patients. CytoDyn has initiated its first clinical trial with PRO 140 in an immunological indication for GvHD in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are undergoing bone marrow stem cell transplantation. The company is also investigating PRO 140 in animal models of cancer progression and autoimmunity with positive results and has published its animal study results in GvHD in peer-reviewed journal.

CytoDyn president and CEO Nader Z. Pourhassan, Ph.D. joined the company in 2008 and is credited for purchasing PRO 140 from Progenics in 2012 and has taken a new path to approval for the product. He is the co-inventor of monotherapy path for PRO 140. He has taken PRO 140 development from phase 2 to Completed successful phase 3 in about four years. He now has more than 10 years of drug development experience and has overseen the rapid clinical development of PRO 140 as a therapy for HIV into two phase 3 for two different indications. He also initiated PRO 140 first immunological indication in GvHD (currently in phase 2). He is also involved in preclinical and clinical development of PRO 140 in additional immunological indications. Dr. Pourhassan, who has more than 20 years of business development experience, has led CytoDyn's capital market activities since joining the company in 2008. He received his Bachelor of Science from Utah State University, Master of Science from Brigham Young University, and his Ph.D. in Mechanical Engineering from the University of Utah and is the author of three books.