Instead of reporting on the great advancements that CytoDyn Inc. (OTCMKTS: CYDY) has just announced the completion of enrollment in its first randomized clinical trial for mild to moderate COVID-19 patients, we feel compelled to talk about Adam Feuerstein’s (AF) fishing expedition which is getting ready to dump its stinky load of fish on the market. We have received a number of accounts that AF has attempted to talk to CYDY management and consultants. In addition, there are reports that AF has contacted proponents of CYDY which include doctors conducting clinical trials, interviewers, and even COVID-19 survivors. This may seem innocuous to some, but CYDY has almost weekly investor updates and affords AF the opportunity to ask direct questions of management. Yi Chen an analyst at HC Wainwright seems to be a fixture on these calls but AF has yet to grace the investors with his presence on any investor call so all this snooping around gives rise to question his motives. After 3 consecutive attacks investors have to ask what’s his angle? Most investors want to follow the dirty money, but that has been a losing proposition because all AF’s SEC inquiries and lawsuits have not resulted in a finding of any wrongdoing. The only thin AF seems to be guilty of is reprehensible and vile journalism.
Four Attacks in a Row – Go Fish
May 5th –
May 7th –
May 8th –
AF rarely attacks the same company two articles in a row, but CYDY holds AF’s new record for the most consecutive bashes at three. Technically it was four because Ed Silverman his colleague, wrote a blurb the day after he wrote his third hit piece. Some people are asking what Dr Pourhassan the CEO of CYDY did to upset AF because it seems personal, or is it simply just about the money that AF isn’t getting from the shorts to do their dirty work.
Manufacturing a Manufacturing Issue AF Style
AF tweeted during the conference call that the submission to the FDA is being held up due to outstanding manufacturing issues. How a person can take expected questions, during an expected procedural event, and twist it as a delay. Only AF and his followers could understand this irrational type of logic.
Here is a partial transcript from the conference call narrated by Dr. Nader Pourhassan.
“The FDA had indicated they would give us the PDUFA date by July 10th if they don’t have any issues with any other items. They did have another issue with manufacturing and on that issue they have given us until tomorrow to answer the six questions or so. As of today we already have finished all that. Dr Nitya Ray, our chief technology officer submitted that to Amerex. It will go to the FDA today or tomorrow and then we will be waiting to see if we get that PDUFA date sooner or by July 10th.”
Reading from the transcript it is clear there are no manufacturing issues. There is no delay as AF contends, there are simply questions about their manufacturing process. Dr Pourhassan hinted that it could be “sooner.” The fact that the FDA is asking about manufacturing was a shining point not a negative as AF contends. The reason for this is that the FDA will want to ensure capacity before awarding a Breakthrough Therapy Designation (BTD). Although BTD was not a question on the conference call, it should have been discussed, because this is a very real possibility.
AF’s Next Attack – Paid Promotions/ Dilution
Surely all this recent snooping activity is going to culminate in an article or tweet which are his usual mediums of attack. Normally if you are going to call up a doctor you ask medical questions like trial design not questions about compensation or credentials. The next attack will likely feature someone who was “compensated” by the company. They will try to find some newsletter writer that was paid or take an unpaid newsletter writer and use their standard disclaimer as proof of a front for payment. For the sake of argument, let’s assume everyone was compensated. Investors have to decide the relevancy of the alleged compensation over the almost undeniable fact that the drug works. To be fair, investors should also consider the relevancy of a suspected report that indicated AF was paid by the shorts.
The perennial favorite topic of shorts is dilution. The recent proxy filing to increase the shares by 100 million will no doubt be raised. The company still has 100 million warrants deep in the money that still needs to be exercised. These warrants could bring an additional $65 million into the company and preclude the company from even using any of the authorized shares for fundraising. The dilution scare tactic would be a farce, this increase in authorized is just a cautionary measure to keep the companies options open with respect to a contingency plan for an uplisting.
Conference Call Recap
- Trial Delay Explained:
Dr Chris Rectnor is a contact of CytoDyn Chairman Scott Kelly. He tested COVID-19 positive and started to deteriorate and was able to get an emergency IND and then clinically improved and then he continued to help enrolling many other COVID-19 patients. Dr. Kelly recalled.
“He was grateful for CYDY’s efforts. He has been a tremendous asset in enrolling our mild to moderate COVID-19 trial. We have been very impressed with his work and Dr. Rectnor has agreed to assist CytoDyn and Amerax in all trials going forward in a number of indications.” During the Q&A portion Dr. Pourhassan explained that the enrollment criteria suggested by the FDA was hampering their clinical trial recruitment and that by relaxing the enrollment criteria they would be able to finish enrolling in the trial.
A quick reveal of the exclusion criteria disqualifies many patients with these underlying conditions that leronlimab has actually demonstrated efficacy in. It makes no sense to exclude cancer patients after leronlimab showed such powerful efficacy by reducing circulating tumor cells (CTCs) to zero. The preprint article from Medrxiv demonstrated remarkable efficacy in kidney transplant patients. Eliminating people with liver problems make no sense in light of their approval to begin a phase 2 trial in NASH. The HIV exclusion made no sense whatsoever given that leronlimab was primarily developed to treat HIV. Its refreshing that management stood up to the FDA and negotiated with them because they probably saved many lives by doing so. It’s completely understandable how this exclusion criteria could have stymied enrollment and been a huge contributing factor to the 75+ compassionate use EIND’s.
CYDY expects to produce 1.5 million vials of leronlimab in the next half of 2020 for 375,000 patients. This is expected to generate $2.5 billion in sales this year with an estimated 6 million vials in 2021 which could translate into $9.0 billion in revenue if leronlimab receives regulatory approval. This is in line with wall street estimates from SVB Leerlink that suggest remdesivir could fetch $6.7 billion in revenue assuming a $5000 treatment. CYDY also indicated it is in the final stages of discussion with its distribution partner and hopes to have a definitive agreement soon.
3. Disease Indications: (10 phase 2 Trials in 2020)
Cancer – Recruitment in the trials is picking up. Approximately 20 people are enrolled in the various cancer trials at this time. Since CTC’s are zero for leronlimab cancer patients Dr. Lelazari has been flooded with clinical trial requests and has an additional 5 in the process of enrollment. This activity should lead to a resumption of the recruitment trend. The company is compiling the data and believes that it will make a compelling argument at an upcoming meeting with the FDA to discuss the preliminary Breakthrough Therapy Designation (BTD) discussion.
NASH – CYDY announced that it received the greenlight to begin a phase 2 NASH clinical trial. The trial will dose 90 patients in a multi-center, double blind, placebo controlled phase 2 three arm study (placebo, 525 mg, 700 mg) of the safety and efficacy of NASH for a total of 22 weeks. Dr. Kelly with the help of liver specialists theorized that the stellate and hypatocytes cells in the liver secrete Rantes (CCL5). Since the stellate cells produce the scar tissue in the liver blocking their migration could stop the pathogenesis of the disease.
Multiple Sclerosis – Animal models were very convincing so CYDY is preparing a phase 2 IND and plans to enroll “as quickly as possible.” MS is a disease whereby the immune system attacks the central nervous system. MOA is to block the CCR5 effector cells from crossing the blood brain barrier and destroying myelin. In COIVD-19 trials we learned that rantes disrupts the blood brain barrier could be helpful with Alzheimer’s.
Alzheimer’s Disease / Traumatic Brain Injury/ Stroke – Professor at Montefiore Medical Center wants to initiate a phase 2 trial in Alzheimer’s disease and has readily available 400 patients. CYDY expects to begin this Alzheimers’ disease study very soon.
4. Partners and Licensing deals
CYDY is currently in discussion with Asia, Bangladesh, India, South America, China, Europe and Big Pharma in the USA. Discussions are on all indications that include HIV, Cancer, NASH, COVID-19. Big pharma in the USA indicated that it is waiting to see the readout from the COVID-19 trials before taking action.
5. Fundraising and Uplisting
The company initiated a 6 week uplisting program. It is in week two of the process and has been making a lot of progress. The first stage is the eligibility which typically takes two weeks. Afterwards the company then responds to comments. After the response they would get an approval letter to uplist subject to certain contingencies. The company has a good idea of what these contingencies are and they are ready to address them quickly.
CYDY signed an engagement letter with a top investment bank but according to disclosure issues they are unable to talk about the details. The company went out of it’s way to stress that no agreement was made with them to raise money and that as a management they were extremely sensitive to dilution concerns. Pourhassan mentioned they turned down a number of deals that were $25 million at $3.00 with no warrants. So no fund raising is going on except the warrant exercises. Management pointed out that 100 million warrants at a .65 strike were deep in the money and that if the stock appreciated on any regulatory news they could see continued warrant exercises.
Social media has been firmly negative against AF’s attacks because they have no merit. None of AF’s arguments attack the science and most of the investors believe the science is sound. The results speak for themselves. Dr. Patterson said people coming off life support for 30 days are not anecdotal. It’s very clear that leronlimab works and even clearer that the results will confirm what was seen in the 75+ EIND trials. Dr. Patterson paper that coins COVID-19 a Rantes disease is spot on in its assessment. Leronlimab stops the trafficking of immune cells to the site of infection thereby quieting the cytokine storm that could eventually kill people. The drug has a broad spectrum of use from mild to moderate and includes severe patients.
It’s astonishing how undervalued this stock seems to be. In the conference call Dr. Pourhassan said in his opinion the stock is “way way undervalued.” Hundreds of thousands of people have died from COVID-19 and if the masses found out there was a drug that was non-toxic and returned homeostasis of the immune system the social outcry alone would get the drug approval. The FDA has sent a very strong signal that approval is weeks away. There is a chance it could take longer, but given the incredibly weak data that won remdesivir an FDA emergency approval it’s reasonable to think that this is a shoe in. With close to $12 billion in revenues likely in the next 1.5 years investors need to ask why the stock is trading at a 90% discount to just one times sales. Simple, people need to stop listening to AF and his meaningless drivel and look at the facts. If AF continues to attack CYDY he will go down as the biggest stooge on the planet. This is in pole position to be the first FDA approved drug to treat COVID-19.
- The drug is non-toxic (dosed in over 1000 ppl)
- The BLA is filed and has a 98% likelihood of approval for HIV
- The drug stops people from dying with COVID-19 and pulls some right out of a coma
- $12 billion in 1.5 years is a lot of revenue
- The fear of dying from this disease evaporates upon drug is approved
- This drug allows the world economy to open back up again
Is all this only worth $3.00? You Decide!
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