CytoDyn’s Adjust Course to Emphasize Philippine EUA and Long Haulers

Many CytoDyn Inc. (OTCMKTS: CYDY) shareholders have been waiting impatiently for an EUA from the US FDA and a BLA in HIV. Frustratingly, the EUA in the United States appears to be delayed until the CD16 trial can rapidly enroll patients outside the United States in Brazil, India, and Canada and provide more patient data in the critical patient population to the FDA. While waiting for results, in CYDY’s latest Proactive Investors video the CEO Nader Pourhassan indicated a shift in near-term strategy that could result in an Philippine Drug Products under Emergency Use (DEU) in the coming days to weeks, plus an emphasis on the large and growing number of long hauler patients. The company is anticipating short and medium term demand for the product will exceed its 1.2 million vials. The CEO attributes that this “bright future” is what enabled $50 million in fundraising over the past 3 weeks. The important point about the funding is that the company now clearly has enough funding to get to the point of generating substantial revenues. CytoDyn’s CEO, Nader Pourhassan said

“the $50 million in 3 weeks represents 1/8th of the total money raised in the past 10 years.”

[embed]https://www.youtube.com/watch?v=b5iXfHwFq7o[/embed]

The Philippines in Play

Rhetoric by Philippines Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera reached a crescendo this past week when they called for the expansion of the DEU to include Ivermectin and leronlimab. Their press release was titled “FDA taken to task by lawmakers over delay on drug approvals.” Lawmakers cited massive delays in the registration of the drugs with some sitting in the pending category since 2015. They also commented on how multinational pharmaceutical companies were leaving to manufacture outside the country. There also appears to be a lack of supply of the drugs currently under DEU like midazolam and tocilizumab. The FDA General Manager of the Philippines, Eric Domingo faced scathing criticism and was accused of “dribbling” on the issue of Ivermectin and Deputy Speaker Kito Atienza said the FDA chief was not fit for the job. The result of this hearing was House Resolution1711 which called for a congressional inquiry into the policies and guidelines for the registration, utilization, manufacture, distribution or sale of COVID-19 treatment drugs, which “appear to be detrimental to public interest.” The Philippine legislature still needs to move the process forward, but regardless of the hearings outcome leronlimab and Ivermectin have been singled out to be added to the list of DEU in order to give doctors more options in their toolbox. Although Ivermectin was granted a Compassionate Special Permit (CSP) in 3 hospitals the FDA head on April 15th indicated he had some reservations based on the safety of Ivermectin that came from “scientists in Australia” who indicated in their studies that there was a chance of “pulmonary problems while having neurologic and brain damage.” With no safety issues for leronlimab and its efficacy in end stage patients like ex-president Joseph Estrada it's reasonable to think that leronlimab is the top contender for Philippine DEU approval. Right now both leronlimab and Ivermectin are being sold in the Philippines under Compassionate Special Permit (CSP). Under pressure during the hearing, the FDA head Eric Domingo seemed to have softened his stance on both Ivermectin and Leronlimab. [embed]https://www.youtube.com/watch?v=0sxAbhv7xII&ab_channel=ANC24%2F7[/embed]

Long Haulers Potential

Anyone who watches Chris Cuomo knows what long haulers are because he talks about it almost daily, since he suffers from the syndrome. Many don't realize that Long Haulers is officially a disease, with two official names. Some call it Post-Acute Covid-19 Syndrome (PACS). The NIH launched a new initiative in February 2021 to study Long Haulers so it had to come up with an official disease name (which they refer to as PASC: Post-Acute Sequelae of SARS-CoV-2 infection). Perhaps surprisingly, it is now projected to be bigger than HIV. The lack of a standard available test makes it difficult to quantify but if you had a positive COVID-19 test and have symptoms of brain fog, headache, fatigue, muscle aches, shortness of breath, or loss of taste and smell then a long hauler diagnosis is very likely. Long Haulers are essentially patients with long term symptoms from COVID-19 that just don't go away. Since the disease is so hard to quantify, it's really difficult to estimate the size of the true market. Many estimates range between 10- 30% of all COVID-19 patients. The NIH director believes 1 in 10 healthcare workers is coping with at least one moderate to severe symptom eight months after exposure. Looking at the study he references in his blog 10% represents an extremely conservative estimate since the study showed “15% vs 30% reported at least 1 moderate to severe symptom lasting for at least 8 months (RR, 4.4 [95% CI, 2.9-6.7]).” This was drawn from a study of healthcare workers in Sweden and the director possibly factored in the confidence level to arrive at 10%. The percentage of seropositive (n = 323) and seronegative (n = 1072) participants reporting symptoms lasting at least 2 months and their related functional impairment in their work, social, and home life using the Sheehan Disability Scale (1-3, mild; 4-6, moderate; and 7-10, marked).A University of Washington study shows 30% of patients experience Long Haulers as much as 9 months after symptoms start. This was a small study of 234 participants.In the United States, alone using the most conservative estimate, at least 3.2 million either have Long Haulers or were affected by it. With 146.6 million infections worldwide it means that at least 14.6 million people might have been affected by Long Haulers. Long Haulers represent the Pandemic that only Cuomo seems to be talking about. This disease could quickly become the largest unmet medical need next to NASH. NASH represents 5% of the adult population or 16.5 million. For CytoDyn this market alone is dramatically larger than what they can supply in the way of drugs. They only have 1.2 million vials and there are easily might be 14.6 million afflicted worldwide. Their recent financing seems to suggest that they realize this and are doing everything in their power to secure more and supply even though they have sold very little. The demand will be dictated by the number of vials the Long Hauler needs before they feel normal again. For Long Haulers it's not just one or two shots and done, it could take months of treatment to get back to normal. These findings will be revealed in the CD15 study around the first week of June which is about 5 weeks from now.What is clear is that the anecdotal data from the CD15 study is very encouraging. The CEO of CytoDyn indicated in the Proactive video that people in wheelchairs were walking again. He was referring to teacher and active Marathon runner 27 year old Miranda Erlanson who was wheelchair bound after getting COVID-19.

“I am in the Leronlimab clinical trial (Atlanta, Georgia) and had mild side effects that helped show me I am really receiving the drug and not the placebo!!”

Although this is anecdotal at this point in time this confirms what they saw in the CD10 trial when mild to moderate people with active disease and brain fog saw it dissipate after taking leronlimab. The CEO isn't the only one talking about this trial. Dr. Noman Gaylis has a specialized Long Hauler Clinic that recruited patients in the CD15 trial. He has testimonials that appear to be very genuine and powerful. There is a before and after of one patient Eli Musser who was incapacitated for a year. There were 54 patients dosed in this trial and half were placebo which means there will be about 27 patients that are going to be seeking an Open Label Extension (OLE to take the drug). The company has announce that they will continue to provide the drug after the trials ends to both treated and placebo. This will be a huge benefit to those patients. Positive data in the coming 5 weeks could really transform the company as investors start to fathom the sheer magnitude of this platform technology.The economics of treating this disease over HIV are very compelling. It is almost a positive that the HIV rollout was delayed so they could come up with a pricing that optimizes both indications. For some Long Haulers is a debilitating disease that precludes them from functioning. The only thing worse than Long Haulers is chronic pain and most of the population that experience chronic pain would pay almost any amount to get rid of it. This is why opioid abuse is at epidemic levels. This disease which is characterized by brain fog probably rates a step down from chronic pain but seems like it could command a very healthy price for CYDY.

Pricing

There are many numbers floating around on social media regarding the pricing of leronlimab. The company has not given any recent guidance except that it might be at a discount to remdesivir. What we do know is that the company as a minimum will charge 4-5 times the COGS. They have close to $100 million in inventory per the latest 10-Q. Each vial is 350 MG. Each dose is 2 vials. At $500/ vial that is $2000 per patient.

Coming Catalysts

• Philippine DEU Approval - Imminent
• Finish Protocol of CD16 Study - Imminent
• Shareholder Update - 1-2 weeks
• Start Enrollment in CD16 Study - May
• Breakthrough Therapy Designation (BTD) Request - May
• Rolling BLA Health Canada - May/June
• Long Haulers Trial Results - 1st week of June
• Case Studies - Cancer and Stroke - July / August
• Completion of CD16 Study - August
• BLA Filing in HIV (USA, Canada, MHRA, EUA) - Q3
• Cancer Basket Trial Results - Q4

The Proactive Video updated most of the milestones but there is a very powerful quote from the press release. Pourhassan said

“I wholeheartedly believe that the best is very close to come and by far much larger than what we have seen so far. In the last 3 weeks, this small bio-tech company raised over $50 million, which is a testimony to our dedication to never-failing leronlimab or CytoDyn.”

Investor Summary

The political heat in the Philippines to take action has reached a boiling point. When the top person in the legislature, the Philippine FDA, and the media are all aligned in expanding the drugs under DEU to include leronlimab it’s amazing that the stock price has not even remotely factored this approval into the price. The CSP is expected to bring in at least $68 million in revenue, but a DEU could be many multiples of what was expected under the CSP as doctors try it earlier in the disease state to manage ICU levels. It seems clear that a DEU in the Philippines is imminent. If that DEU is approved CYDY will have the revenues to support an even larger ramping of inventory of leronlimab to support the coming results of the long hauler trial expected to be released within the next 5 weeks. Anecdotal reports like a person getting up out of a wheelchair are trickling out of the trial and favor a positive read out. Even though the company is moving forward with its BLA submission in HIV this summer, CYDY seems to have its sights set on a bigger prize, the long haulers market. An DEU in the Philippines would also accelerate the pace of approval in Brazil and India as the position to get the remaining 1.0 million vials. CytoDyn is sitting in the pole position with the only new drug with no toxic side effects to treat a disease that cripples 1 out of 10 who develop COVID-19. There are 32.2 million people that have been infected with COVID-19 which means that 3.2 million Long Haulers that could be in need of treatment. There are 1.2 million people infected with HIV in the United States and most of them rely on Gilead Sciences (GILD) HIV drugs. Investors need to stop thinking small, and realize that taking on Gilead’s $17 billion a year HIV franchise may not be as lucrative as opening up a Long Haulers franchise almost triple the size.

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Disclosure: Insider Financial and its owners do not have a position in the stocks posted and have posted this article for free without editorial input. This article was written by a guest contributor and solely reflects his opinions.