Cytodyn Inc (CYDY)

[BioInvestor4]

CONFERENCE CALL SUMMARY

-mTNBC- The results were a combination of phase 1b/2 patients and compassionate use patients. They have closed out the trial and will be speaking to the FDA about next steps. Hoping to get a phase 3 or possibly a breakthrough designation.

-Hiring a Cancer CRO to focus on those indications alone

-Dr Kelly read two AMAZING testimonials from cancer patients and discussed the MOA for cancer.

-In an animal model we showed a 97% reduction in Human Breast Cancer Metastisis.

-We have been given clearance to advance to phase 2 of mTNBC with 700mg dose due to safety.

-We have fast track status for mTNBC which is an unmet medical need

-We have opportunities in at least 23 different cancers

-Based on historical averages a BTD could be worth as much as 8.3 Billion. We have the opportunity in 23 different cancers as well as other indications

-Quote from Dr Kelly “One BTD puts you on the map to be acquired by big pharma. It is very rare for a company with two BTD’s to not be acquired”

-Will meet with FDA to find a clear path forward for BTD

-The longest patient in our basket trial had metastasis to lung, brain and liver. 18 months later the patient doesn’t have any lesions on liver and no new metastasis.

-Dr Recknor discussed the data from the long hauler trial in depth with charts and tables. Patients on Leronlimab improved in 21 of the 24 symptoms vs placebo patients

-We have made more progress in the last 3-4 months in terms of MOA than in all the previous years combined.

-Brazil- We meet twice a week on Monday’s and Thursday’s with the teams from Albert Einstein Research and Biomm working on every aspect of the regulatory submission of CD16 and CD17.

-All of the trial sites are now ready to go for CD16 and 17.

-There will be 316 in critical and 712 in severe. There will be an interim analysis at 40% of the enrollment.

-First injection will be any day now

-There Is no new information to report at this time in regards to the Phillippines. The company stands ready to fill any CSP’s.

-Cases have dropped in India. They have inquired about a long hauler trial there.

-BLA-We are still on target for Oct 15 submission. The biggest issue was the R/O assay. That draft has been submitted and we are awaiting FDA comments. The hardest part is done.

-NASH- 60 patients have been enrolled. We are going to add 30 more. Dr Recknor believes those 30 can be enrolled in 30-45 days.

-Diagnostic Labs- Dr Recknor is creating our own Diagnostic labs to make things easier for practioners. The company also plans to release what the FDA said about the prior RO tests.

-Our patent protections are growing rapidly. The company will aggressively defend any infringement. In a patent there are a number of people named who participated in the work, but the assignment of the patent goes to the company itself. There are NDA’s and contracts in place for people who work for the company obligating patent rights to the company.

-mTNBC results will be presented in a conference by the end of the year.

-Dr Jonas Sacha is working on a concentrated dose of Leronlimab and it is very encouraging

-Quote by Dr Kelly is regards to a partnership in the United States “It’s getting even more interesting”