Transcription of Conference Call 3/31/22
Migliarese, 4:00: we are facing challenges which will change our strategy for next 6 months. we will be focused on restoring credibility and determining our most advantageous paths forward with the goal of maximizing shareholder value. We plan on 1) Strengthening our clinical operations and prioritizing patient safety. 2) Addressing the concerns in the partial clinical hold letter received for HIV and for Covid 19, 3) Enhancing leadership with the board, CEO and scientific advisory board, 4) Addressing legal and financial issues, 5) Analyzing HIV data received from Amarex, 6) Revamping the timelines necessary for a successful BLA submission, 7) Releasing final NASH data results,
Identifying partnerships necessary to enhance our develop efforts value creation with minimal investment from the company.
Tanya Urbach, 5:00: 1) prioritizing the company's clinical development and regulatory objectives, 2) supplementing the board with professionals whose skill sets are synergistic with & serve to reinforce the breath of the boards existing capabilities and conducting a broad search for the company's next CEO; the board has worked closely with management to focus the company clinical development program to identify the potential to enhance that program and then to develop a program to further the progress of the clinical development program with a view towards commercialization of LL (is this lady for real?) , 3) the board has worked and continues to work to identify and recruit highly qualified professionals directors, whose core competencies will serve to buttress capabilities of those already serving on the board, to that end, the company announced yesterday, subject to successful completion of her background check, the addition of the company's board of directors Dr. Karen J. Bronke PHD in microbiology, vp of corporate and business development at Jaguire Health, and she should be able to evaluate assets and consider the potential from both a biological and commercial standpoint. The board is also actively working to identify a financial expert as well as additional individuals capital markets & FDA regulatory expertise. The board has formed a CEO search committee working with 2 executive search firms as well as with corporate partners, to source and identify a ceo candidate. The are excited about the candidate pool.
Migliarese 8:15: We recently closed a $6.5 million bond, w/regards to the Amarex dispute which allowed us to download data from trials and have allowed the company to audit the data and the services provided performed by Amarex. This will guide us in determining the status of the Amarex data aiding in the resolution of the Amarex dispute & updating the timelines in the BLA resubmission. We are currently working with Samsung in regards to a plan to resolve past due amounts in inventory manufacturing. We are planning on implementing a judicious budget with focused spending.
Scott Kelly 9:00: 2 cardiac events led to pausing CD16. they don't know if these patients are LL or placebo. They want to pause the trial b/c our experience w/LL was in healthy volunteers and not in critically ill Covid 19 population of sick individuals. They have a preplanned DSMC meeting data safety monitoring committee in early April for both studies. So upon clearance of the DSMC we plan on removing the pause. We are in communication with ANVISA and the FDA and reported the events to each agency, but this was CytoDyn's decision. Full clinical hold on US IND Covid 19, and partial clinical hold for IND for HIV. The FDA wants aggregated safety data across all indications as our prior CRO was not aggregating safety data. We will correct this. We believe this is a solvable problem. We have contracted with a new pharmaco-vigilance CRO to move forward. So we expect about an 8-12 week, (June-July 2022), timeline and seek advice from the FDA.
​
Chris Recknor11:25: Re-evaluation of the BLA timelines, we will have a delay in the clinical activities for the BLA while we are performing the pharmaco-vigilance evaluations through the new contracted CRO. Bond was posted with Amerex, and data was obtained for all of our trials, including trial master file, and we will use this to move the BLA forward. On NASH, we completed Phase 2a for NASH during 2021, and announced preliminary results in January, we are in process of conducting final analysis of the data and plan to release the updated trial results in the near future and we are real excited about these results of this trial including the MRI findings the pdff and ct1 as well as biomarker data. No approved drug for NASH and liver disease is the leading cause of death in HIV patients. They are looking for partners.
​
Scott Kelly 12:45: We've been contacted by academic institutions interested in doing studies with LL. A researcher from a top university in Boston. CAR T research. CAR T not working as well against solid tumors as was hoped. For this study we will need to supply molecule only, (they will do trial). It is believed that the tumor micro environment is contributing to the lack of effectiveness of CAR T progress against solid tumors and we can control the tumor micro environment we may be able to enhance the effectiveness of CAR T Therapy. We have been contacted by the department of neurological surgery at a major academic center in NYC. and they are planning to evaluate LL in glioblastoma multiforme which is a very aggressive brain tumor. Again, we will supply LL and they've expressed their interest that if successful, in this non-clinical model, that they would pay for a human trial. In the study in the use of check point inhibitors, which is funded by CytoDyn, it may represent another potential opportunity in immunotherapy and is moving forward. We have been in contact in London with the university and foundation to further evaluate the potential of LL as a treatment in Alzheimer's. Their interest is in the role of neuro inflammation. It is similar to the role of cancer where initially people did not believe that cancer had an inflammatory component. I think the same is true in a number of central nervous system disorders. We are also considering the potential of LL acting as a long acting HIV prep agent in macaques. If successful, we are very excited about this. This has the potential to turn LL into a once every 3 month injection from once per week. This could be future of HIV treatment with Prep as a long acting injectable. Possibility of a grant funded Phase 2 clinical trail in LL with HIV patients with NASH & NAFLD, where we supply LL, but do not pay for the trial. Publications and presentations: We think that this will help with the credibility with CytoDyn. We have a poster presentation at American Association for Cancer Research on April 11, 2022. Dan Athens at Creative Microtech will be presenting. Dan Athens office submitted another poster presentation to another prominent oncology meeting this year. We presented our mTNBC data at San Antonio breast conference in December, 2021 and we believe that was well received. We are also processing 3 articles for publication in peer reviewed journals. 1st in on HIV monotherapy. 2) HIV multidrug resistance. 3) Covid 19 Long Haulers program. Potential Partnerships: regarding HRD? looking both internationally and domestically; for 1) HIV Prep, we hope to use long acting LL, pending results of macaque study currently being done for once every 3 months injection, looking for partners in 2) Multidrug resistant HIV, 3) partners to complete the BLA submission with Inhouse BLA expertise, we are looking at partnerships in 4) HIV combo both internationally and domestically. partnerships with 5) existing agents that LL would be a great add on agent. and also with 6) HIV and 7) NASH looking to do a phase 2 clinical trial for obvious reasons. For HIV patients, they have increased risk of NAFLD and NASH compared to general population. Looking at combo therapy for NASH with LL and existing agent. Market is growing at 58.64% annually. Expected to be $180.9billion by 2028. In oncology, we are pursuing partnerships in unmet medical needs and quicker paths to approval. We do know that CCR5 is present on many tumors that are unmet medical needs as well as the tumor micro environment. Cancer immunotherapy is projected to be $277billion by 2030 growing by 12.6%. Focus is on Partnerships for immunotherapy combination.
Migliarese 20:35: Amarex audit is wrapping up. Amarex arbitration slated for mid-April 2022.
Kelly 22:22, so we are in discussions, we have companies under NDA right now. we are advancing the discussions for multiple different applications for LL. But we will have to comment on that when it is publicly available to everybody at the same time.
Migliarese, 4:00: we are facing challenges which will change our strategy for next 6 months. we will be focused on restoring credibility and determining our most advantageous paths forward with the goal of maximizing shareholder value. We plan on 1) Strengthening our clinical operations and prioritizing patient safety. 2) Addressing the concerns in the partial clinical hold letter received for HIV and for Covid 19, 3) Enhancing leadership with the board, CEO and scientific advisory board, 4) Addressing legal and financial issues, 5) Analyzing HIV data received from Amarex, 6) Revamping the timelines necessary for a successful BLA submission, 7) Releasing final NASH data results,
Identifying partnerships necessary to enhance our develop efforts value creation with minimal investment from the company. Tanya Urbach, 5:00: 1) prioritizing the company's clinical development and regulatory objectives, 2) supplementing the board with professionals whose skill sets are synergistic with & serve to reinforce the breath of the boards existing capabilities and conducting a broad search for the company's next CEO; the board has worked closely with management to focus the company clinical development program to identify the potential to enhance that program and then to develop a program to further the progress of the clinical development program with a view towards commercialization of LL (is this lady for real?) , 3) the board has worked and continues to work to identify and recruit highly qualified professionals directors, whose core competencies will serve to buttress capabilities of those already serving on the board, to that end, the company announced yesterday, subject to successful completion of her background check, the addition of the company's board of directors Dr. Karen J. Bronke PHD in microbiology, vp of corporate and business development at Jaguire Health, and she should be able to evaluate assets and consider the potential from both a biological and commercial standpoint. The board is also actively working to identify a financial expert as well as additional individuals capital markets & FDA regulatory expertise. The board has formed a CEO search committee working with 2 executive search firms as well as with corporate partners, to source and identify a ceo candidate. The are excited about the candidate pool.
Migliarese 8:15: We recently closed a $6.5 million bond, w/regards to the Amarex dispute which allowed us to download data from trials and have allowed the company to audit the data and the services provided performed by Amarex. This will guide us in determining the status of the Amarex data aiding in the resolution of the Amarex dispute & updating the timelines in the BLA resubmission. We are currently working with Samsung in regards to a plan to resolve past due amounts in inventory manufacturing. We are planning on implementing a judicious budget with focused spending.
Scott Kelly 9:00: 2 cardiac events led to pausing CD16. they don't know if these patients are LL or placebo. They want to pause the trial b/c our experience w/LL was in healthy volunteers and not in critically ill Covid 19 population of sick individuals. They have a preplanned DSMC meeting data safety monitoring committee in early April for both studies. So upon clearance of the DSMC we plan on removing the pause. We are in communication with ANVISA and the FDA and reported the events to each agency, but this was CytoDyn's decision. Full clinical hold on US IND Covid 19, and partial clinical hold for IND for HIV. The FDA wants aggregated safety data across all indications as our prior CRO was not aggregating safety data. We will correct this. We believe this is a solvable problem. We have contracted with a new pharmaco-vigilance CRO to move forward. So we expect about an 8-12 week, (June-July 2022), timeline and seek advice from the FDA.
​
Chris Recknor11:25: Re-evaluation of the BLA timelines, we will have a delay in the clinical activities for the BLA while we are performing the pharmaco-vigilance evaluations through the new contracted CRO. Bond was posted with Amerex, and data was obtained for all of our trials, including trial master file, and we will use this to move the BLA forward. On NASH, we completed Phase 2a for NASH during 2021, and announced preliminary results in January, we are in process of conducting final analysis of the data and plan to release the updated trial results in the near future and we are real excited about these results of this trial including the MRI findings the pdff and ct1 as well as biomarker data. No approved drug for NASH and liver disease is the leading cause of death in HIV patients. They are looking for partners.
​
Scott Kelly 12:45: We've been contacted by academic institutions interested in doing studies with LL. A researcher from a top university in Boston. CAR T research. CAR T not working as well against solid tumors as was hoped. For this study we will need to supply molecule only, (they will do trial). It is believed that the tumor micro environment is contributing to the lack of effectiveness of CAR T progress against solid tumors and we can control the tumor micro environment we may be able to enhance the effectiveness of CAR T Therapy. We have been contacted by the department of neurological surgery at a major academic center in NYC. and they are planning to evaluate LL in glioblastoma multiforme which is a very aggressive brain tumor. Again, we will supply LL and they've expressed their interest that if successful, in this non-clinical model, that they would pay for a human trial. In the study in the use of check point inhibitors, which is funded by CytoDyn, it may represent another potential opportunity in immunotherapy and is moving forward. We have been in contact in London with the university and foundation to further evaluate the potential of LL as a treatment in Alzheimer's. Their interest is in the role of neuro inflammation. It is similar to the role of cancer where initially people did not believe that cancer had an inflammatory component. I think the same is true in a number of central nervous system disorders. We are also considering the potential of LL acting as a long acting HIV prep agent in macaques. If successful, we are very excited about this. This has the potential to turn LL into a once every 3 month injection from once per week. This could be future of HIV treatment with Prep as a long acting injectable. Possibility of a grant funded Phase 2 clinical trail in LL with HIV patients with NASH & NAFLD, where we supply LL, but do not pay for the trial. Publications and presentations: We think that this will help with the credibility with CytoDyn. We have a poster presentation at American Association for Cancer Research on April 11, 2022. Dan Athens at Creative Microtech will be presenting. Dan Athens office submitted another poster presentation to another prominent oncology meeting this year. We presented our mTNBC data at San Antonio breast conference in December, 2021 and we believe that was well received. We are also processing 3 articles for publication in peer reviewed journals. 1st in on HIV monotherapy. 2) HIV multidrug resistance. 3) Covid 19 Long Haulers program. Potential Partnerships: regarding HRD? looking both internationally and domestically; for 1) HIV Prep, we hope to use long acting LL, pending results of macaque study currently being done for once every 3 months injection, looking for partners in 2) Multidrug resistant HIV, 3) partners to complete the BLA submission with Inhouse BLA expertise, we are looking at partnerships in 4) HIV combo both internationally and domestically. partnerships with 5) existing agents that LL would be a great add on agent. and also with 6) HIV and 7) NASH looking to do a phase 2 clinical trial for obvious reasons. For HIV patients, they have increased risk of NAFLD and NASH compared to general population. Looking at combo therapy for NASH with LL and existing agent. Market is growing at 58.64% annually. Expected to be $180.9billion by 2028. In oncology, we are pursuing partnerships in unmet medical needs and quicker paths to approval. We do know that CCR5 is present on many tumors that are unmet medical needs as well as the tumor micro environment. Cancer immunotherapy is projected to be $277billion by 2030 growing by 12.6%. Focus is on Partnerships for immunotherapy combination.
Migliarese 20:35: Amarex audit is wrapping up. Amarex arbitration slated for mid-April 2022.
Kelly 22:22, so we are in discussions, we have companies under NDA right now. we are advancing the discussions for multiple different applications for LL. But we will have to comment on that when it is publicly available to everybody at the same time.
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