CytoDyn’s Vyralogix to fight COVID-19. On Thursday CytoDyn management hosted a community conference call and broke their silence. On Monday they announced that they were initiating a phase 2 IND to treat stage 2 and 3 COVID-19 patients. Below is the raw transcripts of their conference call.
CYTODYN INC. (OTCMKTS: CYDY) COMMUNITY CONFERENCE CALL – THE TRANSCRIPT
- March 5, 2020
- 4PM EDT
- Unofficial Transcription
A live audio webcast may also be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download and install any necessary software. The webcast can also be accessed via the following link:
A replay of the conference call will be available until April 5, 2020. To access the replay, interested parties may dial 877-660-6853 (US) / 201-612-7415 (international) and enter conference identification number 13695017.
(OPENING DISCLAIMER – Not Transcribed)
Nader Pourhassan: Before I update everyone I would like to take a brief three to four minutes to give a brief introduction to everyone about what you the shareholders and CytoDyn team have done in the last eight years. On September 12, 2012 about eight years ago you the shareholders selected me to run your company CytoDyn. At that time I had less than 30 days to come up with $3.5 million dollars to purchase this amazing product which was called at that time PRO 140. Now it is called leronlimab and soon in a commercial setting will be called Vyralogix. At that time in 2012, I raised seven million dollars in less than 30 days mainly because of one man with a powerful vision and that man was Mr. David Callahan. He trusted me and he
convinced his friends to trust me. On October 10th, 2012 less than 30 days after I became the CEO of CytoDyn we had the down payment to purchase PRO 140 which was $3.5 million dollars. In my wildest dreams I could have never imagined that we could be blessed to have a product like PRO 140 called leronlimab with the potential to have indications in over 30 different
diseases. Today, I am a 12-year experienced biotech CEO but back in 2012 you the shareholders trusted me over all the top biotech wizards who had invented PRO 140. After they spent about $200 million dollars and about ten years later the top scientists and big powerful names in biotech space had given up on PRO 140. Therefore PRO 140 was shelved and soon to be forgotten. If it was not because of you the shareholders of CytoDyn to decide on a management team. You shareholders decided to accept my plea that me and my team at CytoDyn can change PRO 140’s future a task that at that time seemed almost impossible.
Soon after we paid the down payments for PRO 140 we realized the funds needed for this project was is in hundreds of millions and not just a few million. This is when another man this time a Wall Street investment banker who knows how to do very deep due diligence trusted me and my team at CytoDyn. This man’s name was Thomas Parigian one of the partners at Paulson. He also along with his two partners trusted our vision and our projections for PRO 140’s future. To make the long story short in 2012 at the time when we purchased Progenics, all their top biotech experts gave up on the PRO 140 program fully and they indicated the reason was that they needed to concentrate on their cancer program. The path to approval for PRO 140 was very long and costly. Little Cyto Dyn and its shareholders bought this product with $3.5 million dollars down payment and in the next 8 years we raised about two hundred and fifty million dollars. Today there is no doubt with our current stock price and unbelievable potential future in NASH, GvHD, HIV treatment, HIV prevention, and cancer, that our shareholders were right to trust CytoDyn management. Progenics fully diluted market cap is now about $450 million dollars. While CytoDyn’s fully diluted market cap as of today is about $600 million. I congratulate all our shareholders for trusting the CytoDyn team for trusting the fundamentals, for trusting the truth today. We are so proud that we are blessed to try to save a few lives in cancer and maybe a lot more very soon.
So with that introduction please allow me to first update you on one of the most important tasks for CytoDyn and that is the BLA biologic license application submission to the FDA. Now we already have said to the shareholders that we need to submit two sections and it gets delayed and delayed and delayed as one of the cause of the shareholders send me an email saying that please finish something. You’re starting things you don’t finish it. So I’d like to address that first.
When you start a trial that is completely different than every path that the FDA has given you have to go by their what they tell you I have chosen as your CEO to make sure I am 100% clear with you at all times that means when you ask me a question I don’t say no comments I give you the projections and those projections sometimes is a lot1 better than what it comes out to the end. Sometime it’s a lot worse in this case the clinical trial was ready to be submitted in 2018 as we know the 700 milligrams surprised us with a great result and that delayed everything all the while had to be changed as different measurement and all that. We were going to submit that for BLA with 50 patients for 700 milligram dose however after we finished that and we were ready to submit the FDA indicated that now you have a CDO-03 program which has your monotherapy data for safety give us all of that when we were ready to give that we realized that the 2 trials have different virologic failure and enrollment criteria this means the program that FDA will use to analyze your one trial for approval that now has to go with two different criteria so we have to submit something based upon either criteria A or criteria B. We did it both. We spent more money and funding to AMEREX and we made sure both of them are done and we submitted both of those about ten days or so ago to the FDA and FDA now would tell us that they want to go with A or B as soon as they do within three days we will form a we will formally will submit the clinical trial so we have complete the clinical section we are waiting for FDA to tell us which path do they want to go and we can do exactly that within three to four days since all the work has been done. In regards to manufacturing when you will depend on other companies to give you data you have to continuously work with them and in AGC they have delayed our stability data and they were indicating that this could be delayed till June of this year, however after meeting with them ferociously many times and they’ll see all coming to our rescue we are now able to get all of the data and we have received all of the stability data for 3 months one month stability two months with 3 month1 stability and three months all of them has been received. They look very good, everything aligns perfect and our clinical or Chief Technology Officer Nitiya Rae has indicated at the end of this month March we will be able to do that sort of very tough task that we took five and a half years ago. Started this is going to be completed most likely by the end of March yes. There are delays always when you work with the FDA if you don’t have everything the way they want you have to do exactly what they tell you and we have done that.
Our second update is Leronimab used in coronavirus and cancer, before I update you in regards to cancer and lead on leronlimab’s potential application in coronavirus, I would like to clearly explain the mechanism of action of leronlimab. First for cancer through a series of question that I will ask Dr.Bruce Patterson who is a former Stanford University professor a medical doctor, and is currently the CEO of Incell DX. Dr. Patterson is an expert on CCR5’s role in cancer and has many publications in peer-reviewed journals. So we have a person who we can trust with respect to this explanation of the mechanism of action clearly and carefully. Then we will give you an update of what we have done in regards to coronavirus and where we are with the cancer. So the mechanism of action in cancer it’s amazing and we had never been seen anything like that in our opinion. That’s what Dr. Bruce Patterson believed. The first mechanism of action is something that we were told before. The cancer tumors cannot metastasize unless the cell comes out of the tumor and goes to the other part of the body and then it will kill the patient those cells that come out have CCR5 on them and Dr. Patterson will explain that. Dr. Patterson could you please explain that mechanism of action
Patterson: Yes, So metastasis of cancer number one yes so metastasis of
cancer is driven by the expression of CCR5 on the surface of either the cancer
cell or a composite of the cancer cell with a macrophage is so-called EMT where
macrophages which are scavenging cancer cells become part of a complex and that
complex can metastasize into tissues in response to
CCL5 the be ligand for CCR5 that drives a migration of these cells into tissues.
Nader Pourhassan: Thank you so much. The second mechanism of action leronlimab reprogrammed macrophages. I don’t think you have anybody have seen anything like that I haven’t I haven’t heard of it but this means the bad macrophages will turn to good macrophages because macrophages have CCR5 in the last five years there are major publication papers about the role of CCR5 in metastasis of tumors cancer so which we just explained. When we found out about this great potential for leronlimab Dr. Patterson at that time argued with our scientists that the main mechanism of action is even much much better than that metastasis that you guys are hanging onto. When all the patients lab results came in we clearly saw that he was a hundred percent right if we did not have his insights to this and if we did not change the criteria of enrollment we were delayed one year for enrollment it would have been another couple of years probably and we wouldn’t get patients because the patient that we are getting now mostly have CCR5 on the macrophages leukocytes in frustration around the tumor so without Dr.Patterson this would have been very very long trial Dr. Patterson single-handedly solved our enrollment problem and opens our eyes to a very important fact that our scientist has not been aware Dr. Patterson could explain this second mechanism of action?
Bruce Patterson: Yes sure. Based on our work at Incell DX and other publications it became clear that the immune response to the tumor was heavily dependent on what’s called the tumor microenvironment (TME) in the tumor microenvironment resides lymphocytes macrophages cells that are responsible for fighting off the tumor and what’s very clear is there’s two very important cell types the macrophage and the T regulatory cell which we’ll talk about in a moment, but in particular the macrophage or tumor associate macrophages they’re called TAM’s and TAM’s come into the tumor via the blood monocytes migrate into the tumor and initially they are Pro tumor they make they make all kinds of compounds including a compound called veg F which is vascular endothelial growth factor (VEGF) which causes vascularization of the tumor so it can survive and grow it also produces certain compounds that cause proliferation of the tumor when CCR5 is cross-linked by leronlimab that macrophage changes polarization from M2 to M1 and all of a sudden gains a phenotype or a type of macrophage that is fighting off the tumor with the arrest with the rest of the immune system so the effects on macrophages as you’ll see in all the applications that we’re talking about with leronlimab are very important components of its mechanism of action
Nader Pourhassan: Thank you Dr. Patterson so the third mechanism of action on cancer is called angiogenesis these findings will be published very soon Dr. Daniel Linder in Cleveland Clinic told us that NASA had come up with a device that they could actually get pictures of this phenomena you know sw480 colon carcinoma cancer study he came up with this amazing result that leronlimab had and the picture which is in front of me shows that the number of vessels that feed the tumor cell in that study reduced from about 70 of them got reduced to 10. .that means the feeding of the tumor that is in the body will it stop being fed that’s why we see such a great result dr. Patterson could you elaborate on this
Bruce Patterson: I think you know that in order to have this this mechanism action of neovascularization or the creation of blood vessels to feed the tumor to allow it to grow again can be traced back to the macrophage producing this veg F which is a factor that promotes blood vessel growth that wasn’t shown distinctly in this particular study but the amazing thing in this study was that it was shown that the number of vessels goes down with leronlimab treatment and I think it’s very much related to activities of the macrophages
Nader Pourhassan: Thank you so much. The fourth which is the last, but not least is T regulatory T regulatory shut down the immune cell killing of tumor cells before the tumor is eliminated so when the T regulatory stop the immune system from killing the tumor the tumor stays there and cancer we will have Dr. Patterson collaborate on that one.
Bruce Patterson: The T regulatory cell was a very important part of a study that Incell DX embarked on looking at lung cancer where we looked at signatures of the primary tumor to look at factors that promoted metastasis and one of those factors was an increase in T regulatory cells and when we looked further those T regulatory cells expressed CCR5 and could be inhibited by leronlimab. In fact, we’ve now produced a receptor occupancy assay much like in HIV, but a receptor occupancy assay or T regulatory cells where we can actually measure how much leronlimab is bound to T regulatory cells in cancer to ensure that we’re at the proper dose for efficacy. T regulatory cells have been a very important part of our cancer research at Incell DX and I think the mechanism is much aligned with using leronlimab for therapy for cancer and has been very effective to date.
Nader Pourhassan: Thank you so much. Four mechanisms of action in cancer and we stopped metastasis potentially. We changed the bad macrophages to good macrophages and the feeding of the tumor cells gets stopped and the T regulatory cell will not shut down the immune system from killing the tumor. That’s why we seeing such a great results and to add to that we have nine patient interviews in HIV but they all said inflammation had gone down that has gone down the body is not bloated anymore they feel like they were taking a break from something that was so heavier on them. When ex-Giliead had experienced folks ask us “has anybody on your monotherapy lasted a year?” CytoDyn had 215 patients that went a year on monotherapy and five patient that have gone over five years it had any of them asked to go back on pills getting tired of having weekly sub-q simple injections. We said no absolutely no doctor Kush Doty reported at zero now with all that with the inflammation being one of the major component of what leronlimab works on right now in coronavirus two to three percent die in America right now that number is higher why do they die why do those few patients only die and not all of them because those few patient get ARDS acute respiratory distress syndrome in lung and guess what can stop that well PRO 140 leronlimab we believe can have effects on that dr. Patterson could you explain that
Bruce Patterson: Sure again it’s a recurring theme and that’s you know a lot of people ask me well how can leronlimab be this effective against this many different indications and the fact is these indications have a common theme amongst all of them. Everything from Nash to corona virus to cancer all of them involve the immune system and in particular they involve macrophages and what happens in coronavirus infection is you have this massive influx of macrophages and immune cells into areas of infection the coronavirus infects epithelial cells and the respiratory tract and lung it produces chemicals or cytokines that bring in an influx of these immune cells and these immune cells also produce other cytokines that in turn bring in more cells and bring in and can actually stimulate virus replication so what we’re doing with leronlimab is breaking that cycle of immune cells coming in and producing basically cytokines that damage the tissue and I think the other fact is t-regulatory cells also inhibit the innate immune response so in infections that the body has never seen before you don’t have the immune memory that you would if you have a cold or and you know any other infection that you’ve had before your body’s immune systems remember that and are able to fight that off that’s the whole basis of vaccines With something that the world has never seen before the first line of defense is called the innate immune response. One of the big inhibitors of the innate immune response or T regulatory cells again common theme to leronlimab’s action and then of course being able to reprogram macrophages from producing these very toxic cytokines into macrophages that would have more of an effector function in clearing some of the virally infected cells is a very important topic in coronavirus infection. It’s much like when we treat shingles when we treat shingles 2 drugs you get are an antiviral and steroids well the steroids are used because they inhibit the damage caused by the immune response and the damage to the nerve cells and the pain that’s associated with shingles we’re looking at the same type of mechanism for corona virus where we don’t use an immunosuppressive like steroids but we using an immune modulator like leronlimab to redirect the immune response to enhance the innate immune response against the virus while at the same time limiting the amount of damage that the immune response does to the lungs to create Acute Respiratory Distress Syndrome so we’re very excited about the novelty of what leronlimab does in targeting the morbidity mortality factors in coronavirus.
Nader Pourhassan: Thank you so much Dr. Patterson so in that regard now I will update you what we are doing at CytoDyn to get people who are stricken with coronavirus especially the ones that are in very big trouble with organ failures get leronlimab. As of an hour ago I have verified with our regulatory team that our expedition of the filing of the IND initial new drug application and protocol for coronavirus have been completed. We are expected to file the protocol to the FDA by tomorrow and we will make announcement on Monday with all the details. I have quest clinical in San Francisco all getting ready to set up to inject the first patient whoever is in California can be enrolled. Doctors from New York Presbyterian Brooklyn Methodist Hospital already got hold of us they want to enroll patients doctors Stefano Rossconni in Italy wants to work with us and he has already worked with us on the HIV and wants to enroll patients for us too. We will update everyone as those programs proceed.
Our next update is about breakthrough designation (BTD) application
that we filed for triple negative breast cancer (TNBC). We filed the application
on January 10th, we updated our data on February 6 according to FDA
guidelines sixty-day will be off in about five days or so if FDA chooses to
reset the clock for February 6 then they’re delayed then the results will be 30
days delay. Number five update is about expected timing of the company’s filings for a new request for breakthrough designation (BTD) for multiple cancers our basket trial is about to initiate the first patient to be enrolled and in that regard we have already got IRB approved and San Francisco clinical trials Dr. Laurazari who’s known for clinical studies has just received his IRB approval. We have two different patients in our group that we have right now which is one with her to breast cancer and one with triple negative breast cancer if we get one more that’s three different cancer that we work and if the mechanism of action is in place that means we can file breakthrough designation with that. We are hoping to file breakthrough designation for 22 different solid tumor cancers based upon mechanism of action just a side note when we send these results the data I mean there’s a lab samples to our laboratory our laboratory doctor called me several time now and the first time when he called after a few months of seeing samples. I never seen results like this you definitely have a responded this just from the doctors will take care of the results of the CTC and EMT and camel.
The next update is in regard to the anticipated timing of potential approval for TFDA Taiwan’s FDA of leronolimab for the treatment of cancer HIV and corona virus we have already signed a letter of intent and NDA and the 30 days have already started with a company which we are not naming at this time in Taiwan. The company that takes care of all of our clinical trial is named AMEREX’s it happens that AMEREX’s three years ago has opened a branch in Taiwan and it’s a very big branch. Me and the CEO of AMEREX talked about that often and he now has the data from here in Unite States and shares it with their branch over there so their data to the TFDA will be expedited for breakthrough designation for chance and for HIV obviously they would want to see some patients from that region so we will be updating that as we get more information. The next update is about doing the same kind of thing in China that we talked about in Taiwan we already have translated all of our documents that we gave to Longen Group and they already indicated that they have submitted it to ask so things and that record have already progress. The next update was about testimony from cancer patient and I wanted to have testimony but we had to get regulatory approval first well that’s what happens for patients to talk and once they gave us that so for them to talk to you god it was too late some of these patients are in overseas they are sending us their testimony on the email and we will read it to the investor at it at a different time.
I will now update you on what we have with their cancer. The patients that was injected in September 27th this patient now has completely zero everything CTC EMT and CAML this has not been seen by the laboratory people who called me the same laboratory doctor I’ll just talk about call me says we never seen anything like this that everything is zero this is amazing. That patient has now been on live on the map for about more than five months and carboplatin Dr. Massimo Christospher Finale had told us before the study to start that if you have any patient that can go six months without changing carboplatin and proven forty live on the map this is amazing it’s groundbreaking news that’s what he told us and all we think the first patient which in those timelines the second patient I was injected in November 25th this patient is a HER-2 breast cancer metastasized to the liver lung and brain and now we see that the CTC after ten weeks of the only map has dropped to zero that means CTC an EMTbeing zero that means the metastases in this patient that was having terrible time other stuff patient injected on January we were awaiting results from this patient this session is an overseas but this patient sent pictures of her tumor cells and her chest that was growing from whole year and their doctor was documenting that by taking picture every step of the way every month or so for the first time they’re saying that the tumor now has not increased and some part of the tumors seemed like it shrunk the patient had said and I wanted that patient to be on the call but we couldn’t we will next time hopefully and that patient said that I feel the tumor has decreased and she’s in very good mood for that. The patient injected in February third CTC dropped to zero right after just two injections of leronlimab, patient 7 got injected yesterday patient 8 will be injected Friday. Patient 9 and 10 passed the screening will be injected. We are assigning the date for them and 11 and 12 are both in the Phase 1b/2a patient group and they will be injected in Houston site the sight that we have just added. Dr. Patterson could you elaborate on all these results which you have been very much involved on analyzing?
Dr Patterson: Yeah again I think the most compelling data from all the patients, and again being the one seeing the data come off the machines is a unique position, but I think the remarkable aspect of all these patients is this pattern of response. In other words we’re seeing both a shrinkage of the primary tumor. We’re seeing shrinkage of any metastatic tumors, and we’re also seeing a dramatic reduction in circulating cells or pieces of cells in the peripheral blood. Now you know we see all the patients have gone down to zero circulating tumor cells, and you have to remember that these are stage four patients and we’ve seen this in both breast cancer and in lung cancer. They could just as easily have their CTC’s go up to 20 or 40. In some of these lung cancer patients that we looked at 80 or above. So you know it almost looks a little bit mundane over time with these patients because everybody is going to zero, but the impact of that is remarkable and shouldn’t be lost just because you know they all look like they’re behaving the same. Like I said, I’ve seen CTC’s go the other direction in these end-stage patients and go to levels that we’ve never seen before.
Nader Pourhassan: Thank you so much, and to that effect I just want to add one quick comment that just a few days ago an analyst called us and they were not very happy with me saying such a powerful statement at setting such a large expectation. As he was talking I caught Dr. Patterson. I brought him on the call, and he said that he doesn’t believe in this. After Dr. Patterson explained everything to him he was very apologetic and was very very surprised that we had such a powerful product. So I’ve seen firsthand how the naysayers got turned around when they know the science of the product. The next up update is an overview of doing licensing opportunities. We having licensing opportunities with several countries so in regards to Longen China group, which we announced, we signed a LOI Letter of Intent and NDA. Nine days from today the letter of intent will expire. So they are trying to finish up the final agreement, final term sheet and agreement which we have seen. We are working with them to finish as much as we can, fast as we can. If that process gets delayed, I will let the shareholders know. If that process ends up not happening I will let the shareholders know, and if it does happen I will let the shareholders know. So in regards to the licensing agreement with another company which is a very solid company with financial background located in Taiwan. We will be announcing something shortly with them. We have signed LOI and NDA with them all so now both of these companies are right now talking to us to buy every bit of leronlimab that we have in commercial vials which is 24,000 vials commercial grade I’m sorry not commercial by commercial grade. We also are receiving 600,000 more thanks to our Samsung deal that Dr. Nitya Rae secured for us. That 24,000 now two different entity wants to purchase it and they want to also enter into an agreement to purchase the rest of that. This will come to the point where we will be short of the wild especially with coronavirus if we have positive results in the next few weeks hopefully. So these two opportunities to show how very very important the efforts of Bruce Patterson has been for us. It is not the two company that I have found. These two company were brought to us by Dr. Bruce Patterson, and he had communication and professional relationships with them and I would ask him now to elaborate on both these points. Dr. Patterson could you talk about these two companies without naming names.
Dr. Patterson: Yes sure I think you know the good thing is when the corona virus outbreak hit in south Korea had three deals in China and one of the deals in China one of the deals in Taiwan involved large pharmaceutical companies and Icell DX was making companion diagnostics for their either party. Therapies or current cancer therapies when I met with these companies we discussed or on the map the potential for leronlimab to be used in combination with CAR-T and other cancer therapies, but I thought the best thing that came out of these meetings and again I was in China in January was that we developed a relationship and they were pleased to be able to talk to CytoDyn and not hear about the possibility of bringing leronlimab over to China and now Taiwan as part of from first you know to address the coronavirus situation but ultimately as they learn more and more about CytoDyn I think they became very impressed with obviously the HIV data and the cancer data. All of which has been submitted to both the CFDA in China and the TFDA in Taiwan as part of an ongoing process to get drug approval over there for coronavirus. So we’re very pleased to have this unique relationship with these two companies in China through Incell D X and obviously our work with CytoDyn on the companion diagnostic side has really made. You know the opportunity come to fruition so we’re like nod or said we’re very close to agreements with these companies and we’ll be shipping drug to one other or the other or both in an effort to combat corona and ultimately cancer.
Nader Pourhassan: Thank you for that so that’s this is under forward-looking a statements obviously our tenth update is graft-versus-host disease this update was not on our press list but we’d happen that we also filed for Graft Versus Host’s Disease (GvHD). We finally got the RIC reduced intensity care population nailed down. Dr. David Porter has injected this and they’re very interested it what happens. After five patient if there is no GvHD, and 40 percent usually get GvHD we will be able to file for breakthrough therapy designation if that happens. The next thing is the American Association of Cancer Research. We will try to present the data at that conference if we get accepted. We will let the public know when we are allowed to talk about that, but that’s the next the conference that we are looking at the next update is in regard to our commercial name that’s going to be Vyrologix we have received conditional approval from FDA for this name Dr. Scott Kelly our chairman of the board worked on that project. He’s also the chief science officer and the next update is our MS protocol and IND. Due to this very strong result that we had in MS, multiple sclerosis we wanted the data to go to the FDA immediately, but even though the protocol and IND is ready to go, we will probably will be filing it in a week or two not right away.
The last update is in regards to fundraising so everybody says where is it where do these people get the money to do what they want to do and in the past we always been criticized that we didn’t want to dilute the shareholders back in December 16 we could have sold another hundred million shares and gotten 20 million dollars at 25 cents or 20 cents. We did not do that and we had an offer now for $20 million dollars at the price of 15 to 20 percent lower than the VWAP twenty days average plus warrants. We rejected that. We had another offer from an institutional bank $30 million dollars registered direct. We rejected it. The next offer was $32 million dollars registered direct. Rejected it. Another offer for convertible note for $15 million dollars at a dollar-fifty conversion with ratchet down exercisable in six months. We rejected that. Now what have not rejected or have come to do is the non-dilutive opportunity that we always talked about. This was a very tough process I will have gone through. We have received a conditional approval for 45 conditional term sheet for $45 million dollars non-dilutive debt deal. There is interest to give us a term sheet non-binding in the next week or two one for $60 million one for $75 million and $100 million dollars. We obviously do not want to put our IP as a collateral unless if the number is highest and that’s a hundred million dollars now Mr.Craig Eastwood has done a tremendous amount of work in the last eight we should say 16 weeks four months. Mr. Eastwood would please explain a little bit about what you have been doing on this project.
Craig Eastwood: Thank You Nader. Thank you very much for the very insightful updates only medical therapeutic and scientific front and thank you to Dr. Bruce Patterson. I just wanted to cover two areas. First of all, I’ll just cover our cash position at the end of the quarter. Our third quarter ended on February 20 and as will be disclosed in our upcoming 10-Q filing we ended the quarter with just over seven million dollars in cash on hand this is a substantial improvement compared to previous quarters looking back last quarter we ended with approximately $1.2 million which included around seven hundred ninety thousand dollars in restricted cash the prior quarter. We ended with $1.8 million and the quarter before that we ended with almost three and a half million dollars which is approximately eight hundred fifty-three thousand was restricted cash this substantial improvement as of this last quarter end was strongly bolstered by natural warrant exercises totaling approximately $5.1 million during the quarter. This last quarter which occurred on the advent of Saturday and recent buoyancy in the stock price this strong cash position has achieved in addition to making significant progress on our previously reported accounts payable balance as of the last reported quarter as well as clearing the floating rate debt off our balance sheet through a series of cash repayments and lender conversions. As a housekeeping note we wanted to inform investors that if they have any questions about warrant exercises or need to know where to submit their notices of exercise CytoDyn set up a link on its website under the section entitled warrant exercise inquiries. In addition any investors with questions about restricted stock will also be able to find a link entitled restricted stock inquiries under the investor section we have support staff in place to assist with questions and process any transactions related to these two areas coming to funding and as Nader had mentioned earlier. I’ll just give a brief backdrop over the last few weeks of activity as we look forward to the remainder of this year a key component of our funding will be focusing on attracting significant non-dilutive debt financing balanced with an appropriate mix of equity.
As mentioned on our previous call, our goal is to achieve a balanced capital structure and provide leverage opportunity for our shareholders and minimizing unnecessary dilution as we move closer to our goal to provide therapeutics to HIV patients in the latter half of this year. We are routinely aware of the commercialization efforts necessary to support that which we forecasted internally starting in the middle of last year. We may also receive positive news with regards to mTNBC that Nader mentioned which if occurred would obviously accelerate these commercialization efforts with respect to debt financing. We progressed well in our discussions and received several non-binding indications of interest in our workings. The details of those, a quick synopsis of where we’ve been with this and where we are now as it’s followed. Firstly we started this process in late 2019 and met with several investors in San Francisco on the heels of the JPMorgan conference. As we entered 2020 we were successfully able to de-risk our balance sheet by paying down and encouraging conversion of a major convertible note holder. While we were grateful for the financing that we received back in mid-2018 and early 2019 when it was sorely needed we know how important to a prospective debt financier it is to clear the deck of floating rate debt. Next we set up a data room and spend a lot of time populating that with core materials everything from an updated investor deck the strategic milestone plan the financial forecast and the clinical data files that show the critical endpoints of our trials and other important data that speaks to the efficacy and safety of leronlimab. In the weeks following that we conducted one-on-one meetings with each of the investors working through their questions primarily on the financial model and the clinical data we still have a couple more to complete. At this juncture, we have for investors at the ongoing evaluation stage and have received five conditional LOI’s from other investors, that Nader briefly ran through currently the indications of interest range in size from between 25 to 100 million dollars and one of the investors is suggesting a syndicated arrangement which is a common method of financing. In summary, as we continue to progress forward we will maintain our dialogue with these debts and answers and at the appropriate time work through the normal negotiations and detailed due diligence processes. We will provide updates to our shareholders at meaningful points in time.
With the financing overview complete, we’re now going to turn to the Q&A section of the call before we turn the live Q&A. We first wanted to address a couple of pre call Q&A questions received. The first one Nader I think you addressed was a question about the CMC manufacturing portion of the BLA and the second one was with regards to offers from Big Pharma for HIV franchises so that into the my update comments and not all headed back to you.
Nader Pourhassan: Thank You Craig appreciated in regard to CMC I’ve obviously answered that so why don’t we just go to a live Q&A please
Moderator: Thank you at this time we will be conducting a question and answer session if you would like to ask a question please press star 1 on your telephone keypad a confirmation tone will indicate your line is in the questioning queue you may press star 2 if you would like to remove your question from the queue for participants using speaker equipment it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Your first question comes from line of E Chen with HC Wainwright please proceed with your question.
HC Wainwright: Thank you for taking my questions. Nader could you please elaborate on the exact clinical data requirement by the FDA regarding completion of a completing BLA submission because your mentioned there seems to be two different sets of data required by the FDA and you’re still waiting for the FDA to have their final opinion on which data to submit is that right?
Nader Pourhassan: That’s correct thank you for your question so what’s happening is when you submitted protocol for approval there is a program that they have to run it through. Now that that trial that you’re trying to get approval for would evaluate everything based upon the criteria’s. For example in this study we had the virologic failure after the viral load goes over 50 copy per mil then if it was to increase in viral load post that over 200 copy per mil where they one with monotherapy was different. So when you have different criteria’s we went ahead and manually did all of one of the trials according to the other condition that so they all be will condition a let’s say and then if we did it again vice versa and it became condition number B we gave order to the FDA so we’re all done with the clinical trial section but we just need to have them tell us which one do they want. The criteria A which is the first trial or criteria B which is the second trial. Now once we hear which one they want, it would take about three to four days according to AMAREX in order to formally submit that part. All the work that we had to do has been completed. Did you want me to talk about manufacturing also or just about clinical?
HC Wainwright: That’s fine because you mentioned the manufacturing stability today that could be attained being within March right?
Nader Pourhassan: That’s correct within the next I would say ten days we supposed to have that which then it would take us another week or two to finalize putting it in a date into the you know to the file. As you would know filing manufacturing for first approval, these are major major milestones and people think sometime that these are just one step and then the next step in it should be done but this this is just a tremendous file the clinical section has some modifier they told me had 12,000 columns I mean just gigantic files but go ahead yes.
HC Wainwright: What would it be reasonable to expect that the FDA should give you the feedback regarding which criteria and data said they would need to see fairly soon? waiting a couple days?
Nader Pourhassan: That’s correct we were hoping to get it today before the call, but unfortunately that didn’t happen.
HC Wainwright: Okay my second question regarding the coronavirus as you talked about potential partnership with companies in China and Taiwan. So I suppose after a deal is finalized they will start testing leronlimab in patients infected with the corona virus, but as we all know the corona virus has also started community spread in the US is there any chance that CytoDyn will test leronlimab against coronavirus infected patients in the US under some kind of emergency IND?
Nader Pourhassan: We are filing an IND for Phase 2 for coronavirus okay. Now that’s gonna happen tomorrow we are expected to file it tomorrow. With a new IND as you know this is a new disease so we have to have a new IND usually that takes about five six months to put together we did it in less than four weeks and I’m hoping that our shareholders are happy about the speed that we are showing everybody.
HC Wainwright: Would you only be tested which you only test leronlimab with patients exhibiting acute respiratory distress syndrome (ARDS) or any patients infected with the coronavirus with some kind of symptoms?
Nader Pourhassan: Three grades were described by our clinician and Dr. Patterson will explain a little bit more, but the first one was just the people who get coronavirus and they don’t require hospitalization the second one they require hospitalization they stay in hospital a third one they’re in ICU they are in respiratory failure, but Dr. Patterson would you like to explain a little bit about that also.
Bruce Patterson: yeah we’ve had several meetings where some you know use the UCSF clinicians that we’ve been working with for HIV indications and other biologists and what we came up with was a strategy to treat you know exposures in patients who have been hospitalized with coronavirus, but have not have not exhibited a ARDS yet. What is happening in the coronavirus epidemic is most of the patients who succumb to coronavirus are either the elderly or have some pre predisposed medical conditions and what we wanted to do was to see if we could intervene in this stage where they’re very sick. They do have a cough and respiratory symptoms but just prior to getting ARDS to keep them from getting ARDS and we think that by treating that patient group it’ll also be a cleaner background meaning they won’t have a lot of comorbidities that could complicate interpretation of the data
HC Wainwright: Got it thank you yep thank you so much
Nader Pourhassan: The next question please
Moderator: Your next question comes from line of Jeff Pfeifer a private investor. Please proceed with your question
Investor: Nader this was a great call, got a couple of my questions
already answered. I guess more
specifically on the non-dilutive funding. A little more insight about a timeline
it sounds like there’s a couple non-binding potentially on the deal on the
table. How long would it take to close
that? Secondly with all the good news,
has any big pharma been reaching out? I
find this is the hardest piece of the puzzle for me to figure out that Gilead is not knocking on your door or as well as all the others.
Pourhassan: You know I appreciate your question. First of all when you say when is the best I
mean what is your best guess I get in trouble when I give my best case 100% right
well 90% right are getting big trouble.
Because I want to be very true to all the shareholders I will give you
my best guess. I believe that we will
choose a term sheet within the next two to three
weeks and I believe four to six weeks later we should be able to complete that. Craig do you agree with what I’m saying?
Craig Eastwood: Yes I do.
Nader Pourhassan: Now I think you know if we continue to move forward with the things in front of us there’s no reason to believe that that couldn’t have. Yeah so the next thing is why doesn’t Gilead come in or anybody else when we submit data to the FDA. We really care about what the FDA says. Everybody else, we don’t really care about what they say, because their
model is sometimes completely different than all models their models. If the HIV is going for combination and it doesn’t have more than four or five billion dollar-a-year potential revenue which we’re not interested and I respect that, but we just can’t wait for them as a matter of fact. I’m hoping that’s in my hope that we don’t get an offer from Gilead until we get our breakthrough therapy designation (BTD) and get the other breakthrough designation for 22 cancer indications so the valuation of the company would be at the level that would be mind-blowing. In my opinion now if we get a deal right now and somebody offers something and all the shareholders vote for it and I respect that – thanks for your question. Next question please.
Moderator: Your next question comes from line of JP Arco private investor please proceed with your question.
Private Investor: Yes Nader and this follows up on the last question I believe it’s great to hear from you and great work at the company the question goes to the potential for up listing of the company I would assume that given the possibility of a significant capital infusion non diluted capital infusion there would be the possibility of uplisting. The company it’s been talked about certainly amongst the shareholders, on blogs and otherwise. Can you give us any insight into what the company’s intent is or thoughts are around that?
Nader Pourhassan: Absolutely yes. Thank you for your question. So please think about two different categories either Nasdaq or the New York Stock Exchange. We are in talks with the New York Stock Exchange of business the director of uplisting, Paul Dorfman and what he has told us is they need 18 month’s worth of cash that means our projected use of spending for 18 months they won’t give us credit for the revenue that we’re going to bring in because those are potential revenues. So if I was going to uplist to New York, if the company, I’m sorry if the company was going to obvious need the 18-months cash it has to be raised right now as in the past. We try to update they wanted that kind of thing and it would have delayed the company for 500 million shares we said no we will hang in there till we have better days and these are better days and December 16 and past so we’re not going to pursue New York Stock Exchange until we have perhaps a $100 million dollars debt deals done. In Nasdaq the amount of cash projection is for 12 months. You have to keep in mind that we signed a $60 million dollar agreement with Samsung this is the first payment but it is due in the next year or so and we are right now talking to selling that product for multiples of what it’s worth to other countries pre-made and even though it’s not made yet. The potential that we have here is just tremendous in my opinion and I just don’t suggest to anybody at this time for us to go and raise money even though people want us to raise money to meet that threshold of 18 months which could be $100 million dollars in the in case of 12 months $90 million dollars we will keep making publicity we will inject the first coronavirus patient, we will wait for our breakthrough designation, if the FDA says they need more patients we will give them more patients. We will go forward like we are standing a solid-gold because I think this company has really reached some major points. Craig, do you want to add anything to the obvious thing?
Eastwood: No thanks Nader. I would say that yes of course an uplist
remains a high priority of the company.
We previously addressed this in other calls, but of course it brings
broader access to capital and expanded shareholder base visibility and
institutional interest, but in order I think very adequately characterized our
current standing on that thank you so much thank you Nader.
Nader Pourhassan: Next question pleas.
Moderator: Your next question comes from the line of a Steve Blake a private investor please proceed with your question.
Private Investor: Yes. Good afternoon gentlemen thank you very much for this very informative call. Thank you. My understanding is that there’s around 24,000 vials of commercial product available now, a hundred thousand vials potentially from Samsung in the next couple of months and then maybe another 500 thousand vials from Samsung by the end of the year. Not sure if those metrics are correct but my question for you is with so many indications and so many clinical trials going on and the coronavirus potentially requiring a substantial amount of product, if it shows efficacy. How does CytoDyn view allocating the available product especially in terms of its agreements that are anticipated with China and Taiwan, such that there’s enough product to actually treat patients that are stricken by coronavirus.
Nader Pourhassan: No, absolutely great question and thank you for your question. First of all the Taiwan and Chinese want all of the vials we have. We are not going to sell all of our stock, while we probably agree with 15,000 and keep 9,000 in regards to coronavirus. Our major focus are United States citizens and if we show that we can stop the killing, that means the patients who get coronavirus which is about 150 160 now they will get four injections of leronlimab, perhaps maximum eight which is eight weeks because the disease is mainly 28 days. So we should have plenty of products to take care of them because we will only need a couple thousand vials. Therefore United States once we prove the concept that we have this potential situation then I already have reached out to Samsung’s CEO. We had a call with his whole team and my team and what we said is that if we do want to expedite any of these we need Samsung to immediately jump on it. Keep in mind Samsung the productions of 20,000 leaders 3.5 kilograms yield per thousand liters and they have a special run that they can do with a hundred and eighty thousand liters they’ll see all guaranteed to me that if you just tell us go we would be able to expedite and get you every amount of leronlimab you want. I really am so thankful to meet Dr Nitiya Ray for getting such a situation where we are completely ready for it. Thank you for the question. Next please.
Moderator: Your next question comes from the line of Maureen Hydeck private investor please proceed with your question.
Private Investor: Thank you. Good afternoon Nader thank you for all this information. I’m curious, it’s the follow-up question to the one you just got. What do the potential sales of leronlimab equate to in terms of revenue for us.
Nader Pourhassan: So in regards to HIV we talked about that before, but in regards to the overseas we just can’t talk about that we’re under NDA right now. There is some information we cannot give out, but our cost of goods especially when we get it to the prefilled syringe, we would be in really great shape for our company and our shareholders. We would share all of those things that is at the right time allow us to have those information right now not public due to the negotiations that are going on. Thank you. Next question please.
Moderator: Your next question comes from line of Nick Cova with Tensoco capital. Please proceed with your question.
Tensoco Captial: I just wanted to find out the nature of the debt financing you’re looking at. We’re looking at a straight debt or we’re looking at a convertible kind of debt, what is your expectations on that front?
Nader Pourhassan: It’s a straight debt, but I let Craig Eastwood answer.
Craig Eastwood: I would be happy to answer that. We’re trying to get as benign debt on the balance sheet as possible obviously we want to steer away, as Nader I said early on the call, from any floating rate or convertible type of instruments and this was really to support the commercialization efforts that we’ve previously mentioned. okay thank our creations Ivy secured div’ secured by the IP we obviously want to give as little security as possible so you know we’re gonna try this we’re still looking at a number of indications of interest to see which ones are asking for security interest versus those that are not. We just don’t have enough conclusive information yet, but obviously we’re going to try to strike the best deal that we can. With regards to licensing or IP or any other type of security interests versus risk adjusted rate of return for non IP type of deals.
Tensoco Captial: The last question I have is I were you in terms of your Headroom for available shares and whether or not going to need to expand that sometime soon.
Nader Pourhassan: Nick thanks for the question. We have decided not to add any more shares at this time keep in mind that since June 2018 when I was in charge again we have only out used authorized share of hundred million prior to that in a year and a half we had authorized four hundred million shares so obviously I don’t my first and most important goal is no dilution to the company and that’s why I kept so strong even when the stock was at thirty cents when all the offers that came even when we had two three hundred thousand in our account I just did not give in to that and I believe at this time we also need to evaluate our situation very carefully. The BLA submission is a huge huge point for us. People will see that we’re gonna have revenue breakthrough designation, coronavirus, and deals with the China and Taiwan. and what we can get from them we need to make sure all of those are evaluated very carefully and as Craig said then we look at those and then we look at the debt deal that’s most likely gonna require IP collateral and Craig do you wanna add to anything to that?
Craig Eastwood: No thanks Nader. I obviously, I think we’ve got a number of strategic alternatives that we’re looking at you know it’s a question of the order of priority and the magnitude of priority that those milestones achieved so we have four looking strategic planning with a number of variables in mind and as these things come to fruition we’ll react accordingly.
Tensoco Captial: Thank you and keep up the good work.
Nader Pourhassan: Thank you and we appreciate it. Next question please.
Moderator: Your next question comes from line of Jessie Moskowitz private investor. Please proceed with your question.
Private Investor: Hi Dr. Patterson. My question, I’m a physician and the results that we’re seeing with leronlimab are very exciting. My question is for Dr. Patterson. It’s three parts one we talked about leronlimb as a prophylaxis, for HIV do you think it can play any role as a prophylaxis for developing cancer like tamoxifen. What’s the overall prognosis for stage four cancer patients with now that they’re on leronlimab?
Patterson: All those are great questions. The first one I’m very excited about because
published a lot of work in the mid to late 90s on the overwhelming predominance of CCR5 expression in the female genital tract and in the anus and in the foreskin as being a primary cause of HIV transmission and so I’m very excited about the work that’s being done by Dr. Jonas Sasha which kind of expands some of the stuff we were doing in the 90s he’s actually testing that on a monkey model, but I think pre-exposure prophylaxis is an absolute fantastic use of leronlimab. the safety profile, the fact that you can take it for a long period of time, go once a week dosing, where it’s basically an insulin shot once a week. I’m very excited about that application.
The second one is actually, I literally wrote an email to another clinician yesterday about you know what you said about tamoxifen or the aromatase inhibitors as being sort of an ongoing prophylaxis and breast cancer and I thought it was a great idea we were actually going to enroll some breast cancer patients under the under the Compassionate Use Agreement for leronolimab and in individuals who have CCR5 the pattern of CCR5 expression in breast with CTC’s despite the fact that they’ve been treated. Then follow those patients over time with only leronlimab so they wouldn’t have any other background which would which would be great data. To more directly answer your question about sort of ongoing chronic therapy with leronlimab and breast cancer I think that’s a fantastic idea and then the go ahead the last one well yeah what was the last question?
Private Investor: Yeah, I was wondering what do you think? You know Stage four is a terminal condition. So for stage four cancer, what do you think their overall median survival and also do you think you could change surgical indications because typically won’t operate on people with stage four cancer. With leronlimab do you think that could even change possible surgical indications?
Bruce Patterson: Well I mean I think the excitement is to look at you know overall survival and disease-free survival and survival without you know progression-free survival in in all of these patients who are admittedly very sick end stage. It’s miraculous like I said what’s been happening everything’s been stabilized or you know parameters are going down. I think it may create a different scenario and in some of the treatment programs where you might consider what to do after therapy. You might even consider surgery and then therapy but it may change the whole dynamic if we see longer overall survival rates. The other medications that are being used in these end stage patients.
Nader Pourhassan: Great thank you doctor and I’d like to add one thing to answer to your question their prognosis for this stage for so my mother-in-law who’s the patient number two has stage 4 cancer that was metastasized to the liver lung and brain and the doctor did say to her in June that they thought she probably one of two months left to live. She took it for a year and a half Herceptin and Perjeta and everybody knows that the Herceptin and Perjeta that the limit is about a year and a half so she practically was not taking anything when we gave her leronlimab. She had nothing since June she’s doing very well and we saw the latest result had CTC’s and EMT completely zero. So in that regard Dr. Bruce Patterson and other oncologists of all these patients we have enrolled are all meeting in San Francisco toward the end of March and we are going to have a plan of how to go forward perhaps in the best way possible what would you like to talk about that a little bit about the March 19. I believe or watch Tony admitting yeah you know it’s an exciting meeting where we’re pulling together everybody who’s been on every part of the patient management from the oncologist to the pathologist to the laboratory medicine people. What we’re going to do is I have a very open discussion about the mechanism of action and what these different groups of radiologists and oncologists have seen and whether their impressions are unprecedented. Is this to be expected, did you know typically what for instance do you see CDC’s going up to 20 or 30 typically after 5 months with ineffective therapy? I mean I think it’s a great opportunity for those of us who are all working on leronlimab to share our ideas and to come up with strategies that maybe we haven’t even thought about that would improve additional patients lives. So we’re very excited about that again a lot of the people cross over into infectious diseases as well.
Nader Pourhassan: yep thank you so much so let’s go to the last question it’s being a long call and so please go ahead be the last question.
Moderator: Your final question comes from line of Jason Fleming private investor please proceed with your question.
Private Investor: Thanks, good afternoon gentlemen. Before I ask my question I just wanted to preface it by thanking you guys for keeping our shareholders updated with frequent PR’s and videos and conference calls like this, H however many of us feel CytoDyn as a company and leronlimab need much broader exposure especially considering our stellar results that we just went over today for example just in the last few weeks I’ve read several articles posted on major news outlets listing companies working on either a coronavirus treatment or a vaccine and of course absolutely zero mention of CytoDyn I’m and the same can be said of articles talking about up and coming immuno oncology companies as well so with that said I’d like to know exactly what is CytoDyn’s plan to bring more attention to the company and to the stock going forward
Nader Pourhassan: Yes so we were just recently mentioned in one of the major articles. Dr. Patterson would you like to talk about that? You know what I’m talking about?
Bruce Patterson: Yes.
Nader Pourhassan: Okay go ahead. Please share your sentiment.
Bruce Patterson: For sure, I think it’s really a crime to see something that’s this effective not being mentioned in more detail, but finally in an article in a major journal effectors a few days ago that I sent CytoDyn we’re sited on was mentioned as one of the top 20 companies working on strategies for coronavirus and in you know the fact is when I looked at all of those companies it’s not a single one of them had anything that would be ready in the next three to nine months. They’re all vaccine related or antiviral related that they don’t even have animal testing there’s in vitro testing that need to be animal testing no one knows that they’re safe to deliver so in my mind I looked at all the 20 companies and basically 19 of them are well behind where we are with leronlimab with its known safety profile. So I share your sentiment, and the same with the Immune-Oncology. This is clearly an immuno-oncology drug and on the order of like CTLA-4 which is called your voice is a drug that has similar mechanisms here it’s my patient of t-regulatory cells but with some toxicity and clearly we should be mentioned at least in those categories of the next wave of immune-oncology drugs that are that are going to be at our fingertips for all of these cancers.
Nader Pourhassan: Thank you so much okay thank you. It’s great.
Moderator: Thank you everybody for dialing in for today’s call. In closing I will hand the call back to doctor Nader Pourhassan for closing remarks.
Nader Pourhassan: Thank You. Craig, so I hope everybody knows that the next few weeks are very very crucial for us. Finally we’re coming to the point of BLA submission and we are looking at HIV treatment, HIV prophylaxis. We are going forward with that and HIV mono therapy. Let’s not let that be lost as we are now getting so many other things in our plate Graft versus Host Disease is going on so there is also those whose data would be announced as we get it open labeled data open label study. I’m sorry and we will be sharing the data MS Multiple Sclerosis long waiting for us and we are going to get that moving we do have options of have paid for something there have been offered to pay for our trial so that’s something we are going to be working on and NASH we have gone forward full blast with that. We’re not slowing down we were hoping to get some kind of licensing deal for that before the end of the year and in regards to chance a triple negative breast cancer and 22 solid tumor cancers all of those will go forward and you know it regards to funding non-dilutive we will be announcing as soon as we get something major or any license agreement so with all that I want to thank all the shareholders for speaking with us for all this time and hopefully we would be producing some major results very soon. Thank you so much have a great day. Bye Bye.
Moderator: This concludes today’s conference.