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CytoDyn Describes Stunning Results for COVID-19 Treatment with Leronlimab; Drug Ends “Cytokine Storms,” Restores Lung Function, & Reduces Plasma Viral Load; Ventilated Patients Achieve Rapid Improvement & Some Can Be Ex-Tubated 48 Hours After Treatment


--Results described in CytoDyn Investor Community Conference Call on Monday, April 27, 2020.
--CytoDyn scientists believe their studies show that powerful immune modulator RANTES drives the pathogenic process of COVID-19.
--RANTES is chemoactive chemokine, expressed by many hematopoietic and non-hematopoietic cell types, that plays key role in controlling homing and migration of effector and memory T-cells during acute infections.
--RANTES receptor (CCR5) is co-receptor for HIV and a major target of anti-HIV drugs based on blocking viral entry.
--RANTES levels are highly elevated in COVID-19 patients and RANTES fundamentally drives the COVID-19 pathogenic process via binding of RANTES to CCR5.
--CytoDyn’s drug, a humanized monoclonal antibody called leronlimab, blocks CCR5, denying binding access to RANTES.
--Levels of RANTES return to normal very quickly after single sub-cutaneous injection of leronlimab
--Disease-associated high levels of interleukin-6, and of other chemokines, are quickly reduced to normal.
--Lung function is restored.
--Plasma viral load is reduced.
--Drug delivered by one subcutaneous injection.

On Monday, April 27, 2020, CytoDyn, Inc. (OTC.QB: CYDY), a late-stage, Vancouver, Washington-based, biotechnology company that is developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications –including in HIV/AIDS, cancer, COVID-19, GvHD (graft versus host disease), and NASH (non-alcoholic steato-hepatitis (NASH)--held an investment community conference call to provide a comprehensive update on several recent developments. The chief focus was description of seemingly stunning breakthroughs achieved in the treatment of COVID-19 with leronlimab, in some cases allowing critically ill patients on ventilators to improve rapidly, enabling them to be removed from the ventilators within 48 hours after one sub-cutaneous inoculation of leronlimab, a humanized monoclonal antibody that blocks the CCR5 receptor and prevents the binding of RANTES, a master immune-modulator molecule that normally binds to CCR5.

A detailed report of the exciting clinical results in COVID-19 were presented by Bruce K. Patterson, MD, a CytoDyn consultant pathologist, and Founder & CEO of IncellDx (https://incelldx.com/), a single cell diagnostic company that has contracted with CytoDyn to run its clinical tests. In his remarks, Dr. Patterson noted that “RANTES drives the pathologic process of COVID-19,” and that, among its many salutary effects, “Leronlimab reduces the plasma viral load.”

These results were then amplified on by Jacob Lalezari, MD, interim Chief Science Officer at CytoDyn, who, in his comments, said “There’s no doubt in my mind anymore about how important a drug this is going to be for COVID-19.”

In addition to his work with CytoDyn, Dr. Lalezari is Chief Executive Officer and Director of Quest Clinical Research (https://www.questclinical.com/) in San Francisco, and he has served as a principal investigator for Phase I, II, and III clinical studies of new therapies for viral diseases including HIV/AIDS, CMV, HPV, HSV, hepatitis B &C, influenza, RSV, and cancer. Dr. Lalezari also serves as a leading clinician for CytoDyn’s HIV and mTNBC (metastatic triple-negative breast cancer) trials with leronlimab.

At the outset of the call, CytoDyn Director, President, & CEO & Nader Pourhassan, PhD (Mechanical Engineering), provided an update on completion of the biologics license application (BLA) to the FDA for leronlimab as a combination therapy, with HAART (highly active antiretroviral therapy),** for highly-treatmented HIV patients, BLA (txt tbd) filing for HIV, timeline for potential approval of treatment for COVID-19 patients, and two publications.

Below this introduction is a transcript of the presentations provided by Dr. Pourhassan, Dr. Patterson, and Dr. Lalezari. This transcription was prepared by BioQuick News Editor & Publisher Mike O’Neill, who monitored the conference call.

The CytoDyn presentations were followed by 20 minutes of Q&A from the investment community. Highlights of the Q&A session will be added to this text at a later time. Following the transcription of the presentations are short summaries of the backgrounds of Dr. Pourhassan, Dr. Patterson, and Dr. Lalazari. At the end of the text are a number of links to related informative information, including links to eight different lay press articles on different severely ill COVID-19 patients discussing their recovery aided by treatment with leronlimab.

PRESENTATION BY DR. POURHASSAN [begins at 2:45]

“Today, we have some exciting news for the use of leronlimab in treating patients infected with COVID-19. Dr. Bruce Patterson will address this news shortly. The format of today’s update is, first, the BLA submission update; second, the cancer update; and third, the exciting news about what Dr. Patterson has discovered from the blood sample analysis of the patients who were enrolled by (Dr. Harish Seethamraju) at Montefiore Medical Center (in New York City).”

“The first update is the BLA submission, which is a historical achievement for CytoDyn. As everyone knows that the BLA timeline was pushed back constantly. These push-backs were all due to CytoDyn’s success. The first success with higher-dose of leronlimab in monotherapy; then it got pushed back because of the success of leronlimab application in corona virus and overwhelming interest from hospitals and patients to get leronlimab, which led to initiation of two new clinical trials which take tremendous amount of work from our CRO and our CytoDyn team. Then it got pushed back because of the corona virus shut-down of the lab site and even the manufacturing of leronlimab that showed us the availability of, or stability, data from [AGC-tbd].”

“Our success with cancer also contributed to our delay of BLA. Initiating two trials for over 20 different cancers is not an easy task. Ask anyone in this field and they will inform you.”

“The good news is that CytoDyn just filed the full BLA last night without slowing down our cancer programs, without slowing down our impressive work in corona virus, and without blinking on the tremendous financial pressure from everywhere.”

“Congratulations to [name tbd] [5:14] for not letting down all our shareholders and many patients in great need of leronlimab. Special thanks goes to Dr. Chris [check name tbd] Doty and the main person at [text tbd], and the CytoDyn team, especially our Chief Technology Officer Dr. Nitya Ray, who took the CMC-shattered pieces and successfully put it back together in an artistic fashion and, in doing so, he also finalized a superb deal for CytoDyn with Samsung Biologics (link).”

“So, in short, ladies and gentlemen, the BLA is submitted.”

“Second update is about our cancer program. Nearly all the cancer patients, more than 12 or so end up having 0 CTCs (circulating tumor cells), after 3-6 weeks of treatment with leronlimab. While most patients were not able to give us blood samples for CTC analysis during the last few months, due to the travel ban because of COVID-19.”

“I can report to you in regard to my own family member who is on leronlimab and has breast cancer, HER2-positive, with metastasis to the liver, lung, and brain.”

“Just in regard to the metastasis to her brain, the latest MRI has indicated very positive result. Her doctor told my wife about her mother’s condition last week that, and I’m quoting, he ‘never imagined her situation to be like it is today.' Furthermore, he indicated that all the credit for not having brain metastases all over her brain goes to leronlimab.”

“She still has a spot and lesions, but overall, she is doing fantastic. My mother-in-law wanted me thank all the shareholders of Cytodyn for making leronlimab available to patients like herself. She believes she’s alive today because of CytoDyn shareholders.”

“But her testimony about her life being saved with leronlimab is not the only testimony from cancer patients, and it is certainly not the only indication that lives are being saved by leronlimab. There are a few testimonies like this in our current war against COVID-19, but a solution against COVID-19 is to save humanity from a powerful plague, a plague that is taking lives by thousands every day.”

“And that brings us to today’s most powerful news of CytoDyn history. In the past, I thought the day we filed the BLA, after all the tremendous obstacles, that the BLA filing would be the biggest news of CytoDyn history, but, thank god, it is not the case. We have news that is by far much larger than the BLA.” [8:22]

“So, allow me to update you on our fight against COVID-19 with leronlimab.”

“Blood sample analysis of the first ten patients who were enrolled in emergency IND at Montefiore Medical Center were analyzed by [pathologist] Dr. Bruce Patterson at day 0, 3, 7, 14, 21, and, in some cases, day 28—whatever availability date they have---revealed some exciting news and Dr. Patterson will address them.”

“I want to emphasize here that without Dr. Harish Seethamraju's heroic, bold action to use leronlimab in COVID-19 patients, none of these discoveries would have been possible.”

“And many thanks to Dr. Patterson for his tireless efforts in discovery and laboratory analysis to assist CytoDyn in saving patient lives.”

“It is very important, as the CytoDyn story gets unfolded, that shareholders realize the value that one man has brought to us and he is CytoDyn’s Chairman of the Board and Chief Medical Officer Dr. Scott Kelly. One of his many supports for CytoDyn was the introduction of Dr. Bruce Patterson to Cytodyn. He is also the man who has pushed all the non-HIV indications of leronlimab forward and supported me in has supported me in this difficult task without any limits. [9:57] As the CEO of CytoDyn, I went through a lot of challenges in the last eight years, and without Dr. Kelly, most of our victories would not have been possible and I would probably not be here today, enjoying this wonderful success with you shareholders.” [10:15]

“Go back to the update with corona virus. The blood sample analyses by Dr. Patterson are all taking place at IncellDx (http://www.incelldx.com), the diagnostic laboratory that Dr. Bruce Patterson is Founder and CEO of. CytoDyn had signed an agreement with IncellDx to conduct all tests needed for all COVI-19 patients and, perhaps in the future, our cancer patients. His results are impressive and we expect several publications surrounding to probably be out in the next few days and weeks.”

“As of this morning, Dr. Bruce Patterson believes he has discovered several very important facts about COVID-19 that could have a very strong impact on the war against COVID-19.”

“Dr. Bruce Patterson, could you please give those updates to shareholders?”

PRESENTATION BY DR. PATTERSON [11:16]

“Thank you, Nader. It is a real pleasure to be on this call, but most importantly it’s a pleasure to be able to reveal what we’ve discovered and how that could potentially help this horrible pandemic, and get people back to work, and save patients’ lives.”

“Most importantly, we’ve heard a lot about interleukin-6 as being the key to the ‘cytokine storm.’ What I am telling you today [is that] COVID-19 is a RANTES disease. RANTES is the protein that binds to CCR5 (cysteine-cysteine chemokine receptor 5) and it’s elevated to levels that are equivalent to, and even greater than, interleukin-6, both in mild-to-moderate patients and in critically ill patients.”

“RANTES has also been attributed to [associated with] renal failure, liver failure, and coagulation issues. So, there is nothing that RANTES hasn’t been involved in and that makes sense because RANTES coordinates the movement of cells throughout the body.”

“Second, treatment of leronlimab in these patients brought IL-6 down by 14 days to normal levels, which was truly amazing. And that, by a combination of inhibiting the sequestration of macrophages in the lungs, and also the change in the production of IL-6, the repolarization that we’ve heard about and changing macrophages away from pro-inflammatory phenotype.”

“In addition, leronlimab restored immune cells and the horrible immune suppression so that by day 14, the CD4 to CD8 ratios that were used also to measure immunosuppression in HIV/AIDS were restored to normal, over 14 days.”

Most importantly, and this was all we could hope for, because we knew that we blocked T regulatory cells which inhibit the immune response, as well as other factors, leronlimab decreases plasma viral load.

“We are the first to report the ability to quantify virus in the plasma and this is the first report that this immune modulator (RANTES), not an anti-viral, is responsible for reductions in plasma virus as if it were an anti-viral. That is remarkable--for one drug to restore the immune system and decrease the viral burden in these patients.”

“That is what gives us great hope and great excitement about leronlimab going forward in these trials.”

“The cautionary aspect of that finding is that we have to be concerned about our blood supply. Corona virus now exists in blood, not just the lungs, and current testing for the blood supply, including units given to patients, plasma, has not been determined and has not been addressed appropriately.” [15:00]

“So, these findings are dramatic; they are all very exciting and unreported in COVID infections; and the upregulation of RANTES can account for a role in just about all the co-morbidities in COVID infection, and the use of leronlimab, our hope is that in addition to restoring lung function, will also reduce the co-morbities in these infections.”

“So, I’ll turn it back over to Nader at this point.” [15:41]

DR. NADER INTRODUCES DR. LALEZARA

“Thank you very much, Dr. Patterson. Next speaker for us is Dr. Jacob Lalezari. He’s known for conducting many clinical trials with new potential drugs. He knows the process very well. Dr. Lalezar is very familiar with all the data that is coming out of Dr. Patterson’s lab and all the clinical outcomes of our emergency IND patients and what he has seen until now has convinced him, 100%, that the war against COVID-19 has the potential of victory to leronlimab. Dr. Lalezari, please tell us your thoughts so far.”

PRESENTATION BY JACOB LALEZARI, MD

“Thank you, Nader. Good morning, everyone."

“It is a great relief to be able to speak plainly and openly now. (16:28) For the last two to three weeks, Nader and Bruce and the core team and I have been sitting on these data that point to remarkable proof-of-concept, remarkable work that Bruce has done, and not being able to share it, while we see the carnage on TV, has been agonizing.”

“I’d like to just start by again saying that I don’t have any equity or stock in this company, so I’m as much as possible an impartial broker. It will be plenty for me to get a good night’s sleep when this is over.”

“Talk about forward-looking statements, my focus for Cytodyn, with CytoDyn now, is really three things. I would like to see…..and I’ll circle back in a minute to say why these are my priorities…..I would like to see some sort of compassionate use access for ICU patients, doctors, nurses, respiratory therapists, who are all in an impossible situation.”

“It’s clear this drug is working’ it’s working better than we could have ever imagined. I’ll get back to that in a minute. And the sooner we bring relief to these people in those critical situations, the better.”

“I’m obviously hoping that the manufacturing of this drug gets ramped up as soon as possible, because we’re going to have to address a world-wide need for this. And to that end, I’ve already made contact with folks at World Health and engaged at the Clinton Foundation to begin the conversation.”

“This has really been an amazing story. I’ll just touch on four points.” [18:04]

“On March 20, we wrote the FDA suggesting that instead of an emergency IND process, we do a compassionate use because it would be too much paper work and too complicated. And that was based on seeing two of four patients at the Montefiore ICU be ex-tubated within 48 hours, which seemed like a remarkable result, although an anecdote at best, but still.”

“And, at that point, we said let’s do a compassionate use and not have these doctors who were so busy do all these IND applications.”

“We wrote them again on March 27, and said we would like to have a compassionate use protocol because we now see that in 4 of 4 of these patients [18:48] from the ICU that Dr. Patterson is showing us this rapid balancing of the immune system CD4/CD8 counts and rapid decreases in IL-6 and other cytokines—and that’s a 1 in 16 chance of getting four wins in a row. But they said ‘No.’”[19:09]

"Then, the key day was on April 8, when we wrote back to them again, and said the situation has become morally perilous in that we now see 7 of 7 patients having these incredible laboratory responses that Bruce is showing, and, moreover, we now know that if they seem too good, they’re not too good to be true—because now we know that RANTES is driving the disease.”

“It was incredible good luck for Cytodyn. It was born of good intentions that we could try to influence migration of regulatory T-cells and the polarization of macrophages and, thereby affect clinical outcomes in COVID-19.”

“But what we didn’t know, and what was incredibly lucky for Cytodyn, and I think for all of humanity, is that this process is fundamentally being driven by RANTES, and RANTES’ job in life is fundamentally to bind to CCR5, so when we interrupt that access, we are breaking the basic pathogenesis of the disease, and that explains these extraordinary laboratory findings, where seriously, critically ill patients are showing return of immune homeostasis within days of a single sub-cutaneous injection."

"I mean that, in itself, is astonishing. And it seemed too astonishing, really, until we understood that RANTES was driving the disease.”

“And then the last time we asked the FDA for compassionate use, when Bruce remarkably showed that viral load decreases in all patients.”

“This has been an incredible story. It’s been fortunate in that it’s all come through this hodge-podge of emergency INDs. We’re obviously trying to enroll the clinical studies as fast as we can, but, in the meantime, there’s no doubt in my mind anymore about how important a drug this is going to be for COVID-19.”

“And I’ll leave it there.” [21:05]

ADDITIONAL UPDATES FROM DR. NADER

“Thank you very much, Dr. Lalezari. Just a few more updates.”

“Over 50 emergency INDs have been approved by the FDA so far, to CytoDyn. Most of these patients have been injected, not all. Data out of the patients in treatment with leronlimab in emergency INDs are anecdotal, but some had remarkable results.”

“Our Phase 2 COVID-19 enrollment is going very well. And we are now more than one-third enrolled, and we believe the other two-thirds will be much faster because now we have more sites enrolled.”

“Our Phase 2b/3 COVID-19 enrollment is at 12 patients and we’re hoping to do interim analysis at 50. Again, the sites are set, so we believe this could go pretty fast, faster than the initial 12.”

“The next update is that the FDA approved the name “Vyrologix,” for our product leronlimab. So hopefully in commercialization, leronlimab will be under ‘Vyrologix’ name.”

“In regards to fund-raising, I just have a few words. And I cannot count how many times in the past, I have told our Board that I will not raise large funds at 30 cents because we believe we can get to a much higher level in our stock price. That’s what we were hoping for and believe in.”

“Mr. Jordan Nxxxx and Dr. Scott Kelly were amongst the main supporters of me in this regard all through these years. And today, I am still thinking the same way [22:43]. We are way under-valued to raise large funds, unless we can up this.”

“We will update everyone about all these very soon, how we’re going forward with our fund-raising. As everyone knows, our last fund-raising was at $4.50, without any warrants.”

“So, with that, allow us to go to Q&A.” [23:10]

Q & A (HIGHLIGHTS TO BE REPORTED LATER]

BACKGROUNDS OF SPEAKERS

NADER Z. POURHASSAN, PHD, DIRECTOR, PRESIDENT, & CEO, CYTODYN

Dr. Pourhassan received his Bachelor of Science from Utah State University in 1985, his Master’s of Science from Brigham Young University in 1990, and his PhD in Mechanical Engineering from the University of Utah in 1998. Dr. Pourhassan has authored three books.

His 20 years of business development experience set the stage for him to transform a publicly traded biotech company on the brink of bankruptcy, into a company on the cusp of potentially obtaining FDA approval for its first drug. If granted approval, the drug called leronlimab (PRO 140) could change the treatment paradigms in both HIV and metastatic cancer.

Dr. Pourhassan joined CytoDyn (CYDY) in 2008 as Chief Operating Officer and by September, 2012, he was appointed President and CEO. He was responsible for identifying significant opportunities for leronlimab, and single-handedly raised enough capital for CytoDyn to complete an acquisition of leronlikab (PRO 140) from Progenics Pharmaceuticals.

Dr. Pourhassan has overseen the rapid preclinical and clinical developments of leronlimab (PRO 140) as a therapy for HIV, from Phase 2 development into successful completion of Phase 3 trials. This includes oversight of the development of trial protocols and interaction with the Food and Drug Administration.

Dr. Pourhassan also opened the door for exploring leronlimab (PRO 140) for other indications, most notably, he has been involved in the preclinical and clinical developments of leronlimab in indications for triple-negative breast cancer, colon cancer, GvHD, NASH, and, most recently COVID-19.

To advance the drug development of leronlimab, Dr. Pourhassan has raised capital for CytoDyn of approximately $200 million over the last 5 years.

BRUCE PATTERSON, MD, ADVISOR FOR CYTODYN, CEO & FOUNDER OF INCELLDX

Bruce Petterson, MD, is the CEO & Founder of IncellDx (https://incelldx.com/) and an advisor to CytoDyn. Dr. Patterson received his undergraduate training in molecular biology from the University of Michigan in Ann Arbor. He then went on to Northwestern University Medical School for training in medicine. During the early stages of the AIDS epidemic, Dr. Patterson began investigating cellular reservoirs of HIV-1, using molecular and in situ technology patented in his laboratory.

Dr. Patterson went on to a residency in Pathology, focusing on viral pathogenesis. While in his residency, Dr. Patterson determined that enough HIV virus was present in infected individuals to account for the massive destruction of the immune system. This paradigm-altering work was published in Science in 1993 (https://www.ncbi.nlm.nih.gov/pubmed/8493534). Dr. Patterson was later named Chief Resident of Pathology at Northwestern Memorial Hospital.

Dr. Patterson has authored over 100 manuscripts and book chapters and he continues his work on HIV-1 pathogenesis and reservoirs at Stanford University School of Medicine. Dr. Patterson was the Medical Director of Diagnostic Virology at Stanford University Hospitals and Clinics.

JACOB LALEZARI, MD, INTERIM CHIEF SCIENCE OFFICER OF CYTODYN, CEO OF QUEST CLINICAL RESEARCH

Dr. Lalezari is currently leading CytoDyn’s immediate preparations to initiate a coronavirus (COVID-19) clinical trial and the Company recently filed a modified trial protocol.

Dr. Lalezari is also currently Chief Executive Officer and Director of Quest Clinical Research (https://www.questclinical.com/) in San Francisco. He has served as a principal investigator for Phase I, II, and III clinical studies of new therapies for many viral diseases--including HIV/AIDS, CMV, HPV, HSV, hepatitis B &C, influenza, RSV, and cancer.

Dr. Lalezari also serves as a leading clinician for CytoDyn’s HIV and mTNBC (metastatic triple-negative breast cancer) trials with leronlimab.

Prior to joining Quest Clinical Research, Dr. Lalezari was Co-Director, HIV Clinical Research Center, Mt. Zion Medical Center at the University of California, San Francisco (UCSF). He has published several research papers and presented research at numerous international conferences. Dr. Lalezari holds an MA degree from the University of Virginia and earned his MD at the University of Pennsylvania.

Dr. Lalezari commented, “I am excited to join the CytoDyn team in a leadership role to advance the therapeutic opportunities of leronlimab for so many potential indications. I have been deeply involved with CytoDyn for several years and most recently in its cancer studies, which are now producing unique and compelling results. We are also accelerating the opportunity to evaluate leronlimab as a treatment for corona virus patients and are hopeful to initiate treatment to patients in the very near future.”

Nader Pourhassan, PhD, president and Chief Executive Officer of CytoDyn, stated: “We are very pleased that Dr. Lalezari has joined our Company at a very exciting time. Based upon his years of clinical experience working with leronlimab, he has a comprehensive understanding of the patient data from our HIV clinical trials for combination and monotherapy, and importantly, our current clinical trials with cancer patients. This understanding is of the highest importance to us.”

[CytoDyn press release, 4-30-20]
[CytoDyn press release, 4-30-20, PDF]
[YouTube Video Interview (Dr.Pourhassan & Dr. Patterson), 4-30-20]
[CytoDyn Press Release, 4-27-20]
[CytoDyn Investment Community Conference Call, 4-27-2020]
[CytoDyn]
[About CytoDyn]
[CytoDyn Science]
[Upcoming CytoDyn Wall Street Reporters' Press Conference on "Strong Results," 5-1-20]

["Vancouver Biotech Company Tests COVID-19 Treatment--The Drug Is Called Leronlimab," KOIN-6 TV (Portland) article (April 25, 2020)]
["SF Doc Sees Promise in HIV Drug As Treatment for COVID-19," Bay Area Reporter (April 21, 2020)]
["COVID-19 Patient Credits Recovery to Drug Developed by Vancouver Biotech Company," KGW8 TV (Portland) article (April 15, 2020)]
["Southern California’s Race for a COVID-19 Cure Is Moving at ‘Lightning Speed,'" NBC4 TV (Southern California) article (April 13, 2020)]
["Coronavirus Survivor Credits Artificial Antibody Experimental Treatment for Recovery," NBC4 TV (Southern California) article (April 10, 2020)]
["Coronavirus Survivor Credits Artificial Antibody Experimental Treatment for Recovery," KCAL9 CBS TV (Los Angeles) article (April 10, 2020)]
["CytoDyn Enrolls First Two Patients in Phase 2 COVID-19 Trial with Leronlimab," RTTNews (April 6, 2020)]
["HIV Drug Leronlimab, Which Successfully Treats Coronavirus, Moving to Phase 2 Trials," NY Post (April 4, 2020)]