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Tuesday, August 3, 2021

CytoDyn Inc (OTCMKTS: CYDY) Gaining as Vyrologix (leronlimab-PRO 140) Top Line Data Looms

CytoDyn Inc (OTCMKTS: CYDY) is making an explosive move up the charts in recent weeks on a massive wave of buy volume and heavy accumulation from investors which is increasing rapidly. Recently the Company reported full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter. CytoDyn is simultaneously finalizing an EUA application with the Philippine FDA with patient data from CD10 and recent eINDs for severe-to-critical patients

Microcapdaily reported on CYDY on December 9 the last time because we saw the market change that day and CYDY had an energy it had not had since earlier this year on the way up to $10.01 per share. The massive accumulation that fueled that rise was back on December 9 and has been growing since than with CYDY now over $5 and well on its way to take out previous highs.

CytoDyn Inc (OTCMKTS: CYDY) is a biotechnology company focused on developing innovative treatments for multiple therapeutic indications. Its lead candidate Leronlimab (PRO 140) belongs to a new class of therapeutics called viral-entry inhibitors and is one of the most advanced experimental monoclonal antibodies for HIV treatment. Leronlimab is a wunderdrug that has turned Cytodyn fortunes around from a wanna be to the monster it is now.. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.

CYDY now has the same energy behind it that propelled the stock to $10 the last time and Investors are excited. JWR a respected biotech expert stated on Cytodyn yesterday:

  1. The run to $5 is a real run based on the growing Covid epidemic and completion of the CD12 trial. Those hoping to short this baby to make back their losses will be in panic mode as the price continues to trip up with more and more events.
  2. CD12 being statistically significant is a no-brainer brainer. DSMB gave strong hints in their interim review. While improving SOC is reducing mortality, it ain’t working for those that are put into a leronlimab trial and, therefore, will not significantly have an impact. Given the safety record with significantly less severe SAE’s than SOC, there is only upside. This combines with no penalty to the p-value needed means very high confidence. And…for a state the obvious refutement against those saying it actually is water: it ain’t.
  3. Leronlimab WILL get EUA by end of January in the US and UK. FDA/OWS is watching and well aware of leronlimab. You don’t need Columbo to follow the clues here. The addition of codes for leronlimab added to the CMS, the statements by NP that FDA has unblinded access as well as additional comments regarding OWS interest. The confirmation by TI and others on responses from Dr. Woodcock who heads thereapeutics for OWS. To state the obvious twice, FDA does not want to do EUA before trial completion as it compromises the ability to complete the trial. Now that the trial is complete…you may just be surprised.
  4. OWS will make a sizeable investment to ramp up production in the US. Dr. Woodcock has acknowledged in interviews that a vaccine is only part of the arsenal against Covid. It’s a no brainer that leronlimab needs to be in that arsenal.
  5. Leronlimab MAY get EUA approval in the Philippines by end of year depending on budget approval
  6. UPLIST will happen…and soon. Me thinks early January we will be up listed.
  7. HIV approval for US or UK has NOT been factored into the stock price. The BLA will get filed at least for the MHRA and possibly for US by end of January at the latest.
  8. Other applications have mammoth potential. Post viral syndrome (eg., long hauler), Stroke, NASH (and Crosby, Stills and Young), stroke, will be game changers and bring in bank.
  9. The risk profile of shorts has flip-flopped.
  10. All of my predictions will be between 30-60% wrong.

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CYDYOn December 15 CYDY announced it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter. On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of the patients were enrolled and completed a 42-day post-enrollment period. The Company has concluded it will be far more time efficient to forego the second interim analysis and to analyze the data on 390 patients and to provide final data to the U.S. Food and Drug Administration, Health Canada, U.K.’s MHRA, and Philippines FDA, as soon as it is available.

CytoDyn’s Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very thankful for the concerted efforts by so many healthcare professionals to reach full enrollment so quickly in these trying times. To the best of our knowledge, we are the first company to complete a Phase 3 trial for COVID-19 severe-to-critical population. Currently, there are hundreds of thousands of patients around the globe with an immediate need for a safe and efficacious therapeutic to combat this horrific pandemic. Since the Philippine FDA has relaxed the criteria of EUA for any safe drug with any efficacy data, we will file our EUA as soon as the presidential order is implemented by the Philippine FDA with all of the information we currently have available, which we believe could occur within the next couple of weeks. The Company is working diligently to ensure a sufficient supply of drug product is available to meet the urgent needs of patients.”

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Microcapdaily reported on CYDY on December 9 the last time because we saw the market change that day and CYDY had an energy it had not had since earlier this year on the way up to $10.01 per share. The massive accumulation that fueled that rise was back on December 9 and has been growing since than with CYDY now over $5 and well on its way to take out previous highs. We noted earlier this month that CMS recently provided a DRG Code for leronlimab so Medicare and Medicaid can reimburse for leronlimab starting after January 1 if it is approved which seems more and more likely every day. The FDA has been following the leronlimab trials carefully. The Company is serious about up-listing to a national exchange as announced in previous press and that coupled with possible FDA approval in January could prove catastrophic for shorts who are well aware we are once again rapidly closing in on $10.01 per share. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.

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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.

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