An Old CytoDyn Introduction Video and Current Implications
This was an introduction video Nader made back in February 2020.
Near-Term Commercialization of New HIV Combination Therapy
0: 00: I am Dr. Nader Poorhassan. I am the president and CEO of CytoDyn. The product in CytoDyn is Leronlimab. We believe this product could have over 30 indications, but, the most important one would be HIV. For HIV, we have conducted a Phase 3 study, completed it, sent the results to the FDA. We hit the Primary Endpoint, finished the trial with a great result, 81% suppression of viral load, and the other companies who got approved, theirs was about 43%. So, 81% was much higher.
00.43: We have received Rolling Review granted to us by FDA so, the first section that we sent to the FDA, out of the 3 sections for the BLA is already perhaps reviewed, (by 2/19/2020, when this video was recorded); the other 2 sections should be submitted by the end of February 2020, and we believe that, since we have accelerated approval, we could get approved by 6 months later, (following complete submission of all 3 parts of BLA).
01:01: In regards to the problem that 2 products are being launched, needs to have with the launching of the product, a sales force needs to be ready to go and manufacturing of the product. Samsung Biologics have given us a great agreement where we had deferred payment agreement, so we didn't have to spend $70 million upfront. Launching the product, we have a licensing agreement with Vyera Pharmaceuticals which not only takes care of the launching of the $70 million, (and they have sales force already there), we also get $87.5 million worth of milestones; we get 50% of the net sales, and we also receive cost of goods plus 10%. We already signed that agreement and have received $4.5 million, which some of that were purchased as equity into our company.
01:48: So, with HIV, we feel next step is our HIV Monotherapy. The HIV population that could perhaps use this product without taking any other pill. Some patients take 3, 4 pills a day; and if this works for them, a simple sub-q injection under the skin, (2) injections, one after the other, once weekly, perhaps, 2 minutes weekly. So we are very excited with that.
02:16: Our prevention study, we signed the memorandum of understanding with Thailand Red Cross. 1,200 patient protocol we going to be submitted in Thailand and the funding for that is from third party, not us and there is a lot of belief in this product to be the future of Prevention.
02:30; On top of that, we have cancer and other auto-immune diseases. Our cancer has been very strong for us and the results are strong enough to send the results to the FDA and request breakthrough designation for mTNBC.
02:54: Now, that's not the only cancer; we also submitted for basket trial. Why, because the mechanism of action is recognized for all solid tumors we believe. Therefore, we have filed with the FDA, so we can enroll 22 different indications for cancer.
Thank you for listening to the introduction to our company CytoDyn. Ticker symbol is CYDY. Thanks again.
https://www.youtube.com/watch?v=zSsk4e6bDg4
I personally think a lot of this remains pertinent today. Right after he issued this video, the CRO at the time Amarex, produced a laughable, unsatisfactory 3rd part of BLA report which caused the denial and RTF of this BLA for HIV. CytoDyn currently is in arbitration with Amarex to settle this dispute, but the BLA is slated to be resubmitted again to the FDA by end of year 2022 without the need to repeat the HIV trial.
More than likely, the sales, marketing and distribution Vyera agreement CytoDyn had in 2020 remains intact and only awaits FDA approval for this indication.
As for Monotherapy, Thailand Red Cross, these may certainly become goals of the company following FDA approval on HIV combination.
We all know the outcome of mTNBC, where we beat SOC by 1/2 month, 12 months to our 12.5 months overall survivability, so BTC was denied, but our trial had continued. In June, ASCO will be presenting a discussion on our Breast Cancer trials, 3 of them. Comparisons with current treatments and their effectiveness will be made with Leronlimab's effectiveness. If a minimum of 14 of the 28 patients of the mTNBC trial remain alive by the date of that conference, Leronlimab will be sporting an overall survivability of 18 months. 1.5 years where SOC is only 12 months (and Gilead spent 3 years on that trial trying to maximize that overall survivability, but, 1 year was the best it could do, that's Trodelvy.).
The results of the Basket Trial have not yet been released. https://clinicaltrials.gov/ct2/show/NCT04504942
More than likely, it has been completed. We know that the mechanism of action of all solid tumors is roughly the same and it was for that reason why this study was put together. Since LL worked so well in mTNBC, we can assume, it will work just as well in the majority of other solid tumors. In addition, we know LL crosses the BBB, so, it was found also to cure brain metastasis and brain tumors. Tumors all over the body just shrink because the blood supply to them dwindles and they die off for lack of nourishment and lack of oxygenation.
Because we are under financial pressure, our new BoD have a new game plan which does not yet include this basket trial, so the cancer indications in this trial will be pursued in the future, but not in the next 6 months.
This was an introduction video Nader made back in February 2020.
Near-Term Commercialization of New HIV Combination Therapy
0: 00: I am Dr. Nader Poorhassan. I am the president and CEO of CytoDyn. The product in CytoDyn is Leronlimab. We believe this product could have over 30 indications, but, the most important one would be HIV. For HIV, we have conducted a Phase 3 study, completed it, sent the results to the FDA. We hit the Primary Endpoint, finished the trial with a great result, 81% suppression of viral load, and the other companies who got approved, theirs was about 43%. So, 81% was much higher.
00.43: We have received Rolling Review granted to us by FDA so, the first section that we sent to the FDA, out of the 3 sections for the BLA is already perhaps reviewed, (by 2/19/2020, when this video was recorded); the other 2 sections should be submitted by the end of February 2020, and we believe that, since we have accelerated approval, we could get approved by 6 months later, (following complete submission of all 3 parts of BLA).
01:01: In regards to the problem that 2 products are being launched, needs to have with the launching of the product, a sales force needs to be ready to go and manufacturing of the product. Samsung Biologics have given us a great agreement where we had deferred payment agreement, so we didn't have to spend $70 million upfront. Launching the product, we have a licensing agreement with Vyera Pharmaceuticals which not only takes care of the launching of the $70 million, (and they have sales force already there), we also get $87.5 million worth of milestones; we get 50% of the net sales, and we also receive cost of goods plus 10%. We already signed that agreement and have received $4.5 million, which some of that were purchased as equity into our company.
01:48: So, with HIV, we feel next step is our HIV Monotherapy. The HIV population that could perhaps use this product without taking any other pill. Some patients take 3, 4 pills a day; and if this works for them, a simple sub-q injection under the skin, (2) injections, one after the other, once weekly, perhaps, 2 minutes weekly. So we are very excited with that.
02:16: Our prevention study, we signed the memorandum of understanding with Thailand Red Cross. 1,200 patient protocol we going to be submitted in Thailand and the funding for that is from third party, not us and there is a lot of belief in this product to be the future of Prevention.
02:30; On top of that, we have cancer and other auto-immune diseases. Our cancer has been very strong for us and the results are strong enough to send the results to the FDA and request breakthrough designation for mTNBC.
02:54: Now, that's not the only cancer; we also submitted for basket trial. Why, because the mechanism of action is recognized for all solid tumors we believe. Therefore, we have filed with the FDA, so we can enroll 22 different indications for cancer.
Thank you for listening to the introduction to our company CytoDyn. Ticker symbol is CYDY. Thanks again.
https://www.youtube.com/watch?v=zSsk4e6bDg4
I personally think a lot of this remains pertinent today. Right after he issued this video, the CRO at the time Amarex, produced a laughable, unsatisfactory 3rd part of BLA report which caused the denial and RTF of this BLA for HIV. CytoDyn currently is in arbitration with Amarex to settle this dispute, but the BLA is slated to be resubmitted again to the FDA by end of year 2022 without the need to repeat the HIV trial.
More than likely, the sales, marketing and distribution Vyera agreement CytoDyn had in 2020 remains intact and only awaits FDA approval for this indication.
As for Monotherapy, Thailand Red Cross, these may certainly become goals of the company following FDA approval on HIV combination.
We all know the outcome of mTNBC, where we beat SOC by 1/2 month, 12 months to our 12.5 months overall survivability, so BTC was denied, but our trial had continued. In June, ASCO will be presenting a discussion on our Breast Cancer trials, 3 of them. Comparisons with current treatments and their effectiveness will be made with Leronlimab's effectiveness. If a minimum of 14 of the 28 patients of the mTNBC trial remain alive by the date of that conference, Leronlimab will be sporting an overall survivability of 18 months. 1.5 years where SOC is only 12 months (and Gilead spent 3 years on that trial trying to maximize that overall survivability, but, 1 year was the best it could do, that's Trodelvy.).
The results of the Basket Trial have not yet been released. https://clinicaltrials.gov/ct2/show/NCT04504942
More than likely, it has been completed. We know that the mechanism of action of all solid tumors is roughly the same and it was for that reason why this study was put together. Since LL worked so well in mTNBC, we can assume, it will work just as well in the majority of other solid tumors. In addition, we know LL crosses the BBB, so, it was found also to cure brain metastasis and brain tumors. Tumors all over the body just shrink because the blood supply to them dwindles and they die off for lack of nourishment and lack of oxygenation.
Because we are under financial pressure, our new BoD have a new game plan which does not yet include this basket trial, so the cancer indications in this trial will be pursued in the future, but not in the next 6 months.
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