Migliarese is CEO now. His goal is to maximize sh

Migliarese is CEO now. His goal is to maximize shareholder value.

Migliarese, 4:00:

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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.

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COB Tanya Urbach is fulfilling #3, Enhancing leadership with the board.

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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

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Kelly & Migliarese on #4, the legal and financial issues.

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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.

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Recknor and CRO for Pharmaco-Vigilance is addressing #5, Analyzing HIV data received from Amarex and #6 the timelines necessary for a successful BLA submission : Chris Recknor11:25:

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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 Amarex, and data was obtained for all of our trials, including trial master file, and we will use this to move the BLA forward.

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Recknor handles #7, Releasing final NASH data results:

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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.

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#8 is being handled by Scott Kelly and Karen Brunke who is a 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." Kelly speaks about integrating Leronlimab with CAR T therapy, use in glioblastoma multi-forme; Using LL with check point inhibitors; pursuing Alzheimer's Disease as it reduces neuro inflammation; LL in Long Acting HIV injectable therapy, HIV Prep; LL for NASH/NAFLD in HIV patients;
Kelly discussed 3 articles for puplication in peer reviewed journals. 1st in on HIV monotherapy. 2) HIV multidrug resistance. 3) Covid 19 Long Haulers program. #3 was already released and was a huge success where we learned of the dual nature of LL.
Kelly's discussion on partnerships:

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Potential Partnerships: 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.

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Notice #5 is before #6, #7 & then comes #8.