13:05: Turning now to the BLA for HIV, During the course of

Quote:

13:05: Turning now to the BLA for HIV, During the course of last few months, we have had the chance to get a much clearer look at the state of the clinical data collected by Amarex. This showed us to perform an internal feasibility assessment, on the clinical portion of the BLA, With a key question of understanding, if the data would withstand, what is commonly referred to as a good clinical practice, or a GCP audit, which is precisely what we would expect the FDA to perform during the BLA review Process. And as a result of our internal assessment, we decided to gauge an external audit and as a result of internal assessment we decided to perform external audit of that same data and we expect to receive those results of that audit in near term. And those results will inform our next steps with the BLA. I want to make clear, that this audit is not a question of the performance of Leronlimab in clinical trials. Rather, it is an assessment of the quality of the data collection and monitoring performed by Amarex. And We are performing this purely To assess the probability that if the BLA submission had been completed, that it would pass an FDA type GCP audit .

Quote:

2:53: Thank you Christina. Good Morning Everyone and thank you for joining us. As many of you know, since July of 2021, CytoDyn has worked on resubmitting parts of its BLA for Leronlimab and HIV multidrug resistant or MDR population. As part of our rolling submission, CytoDyn completed and submitted sections of the BLA related to the non-clinical studies and the product and manufacturing information or CMP / CNC? section.

And Thus, in November, (2021), we have worked on completing the clinical study section of the application and we have been trying to do this, despite not having full access to the electronic database from the CRO engaged, managed studies. As we have previously discussed, we have filed a claim against the CRO, seeking damages resulting from the breach of the Master Services Agreement.

3:38: Due to our concerns with the CRO, we commissioned 3 independent audits of the clinical data, in addition to our own internal feasibility assessments of the same data. Each of these audits, including the investigation of the CRO's performance and Data Management, Monitoring and Quality. We found that these multiple audits, we have concluded that, a BLA faces a severe risk of receiving a complete (negative?) response letter from the FDA, which means non approval.

4:05: Now, with that being said, we are confident that the primary findings of the study are sound. Since these assessments did not find any serious integrity issues at the level of the clinical trial sites, and due to the CRO's inadequate process and performance around the Monitoring and Oversight of the Data , there are significant challenges to meeting the high bar of passing an FDA GCP Audit.

4:27: In light of these factors, and the substantial costs associated with remediating the data, or in conducting entirely new trials in this population, we decided to voluntarily withdraw the BLA for the HIV MDR population. We notified the FDA of this decision on October 25, 2022. Given the considerable financial resources that the company has put into the clinical development program for this indication, we did not make this decision lightly.

4:54: It was only after an extensive review of the assessment by the External Auditors, our own Internal Assessment, Expertise from our Board and Advice from our Regulatory Consultants, that we came to this decision.

5:06: Now, we realize that this may be dissapointing to some, however, it is critical to note that, this decision does not under cut the drugs performance in clinical trials, as the audit results do not change the fact that the Primary Endpoint was met . By the time we publish those positive results in the Peer Reviewed Journal soon, which we believe will help others in the medical and clinical communities further understand the enormous potential of Leronlimab.

5:30: Leronlimab has been studied in over 1,500 patients, many of whom have received the therapy for multiple years, and the drug appear to be well tolerated across many indications studied to date. Now, before joining the company, and while performing my independent due diligence on Leronlimab and CytoDyn, I became aware of the issues the company was facing with the CRO and the BLA. I fully understood that there was a possibility that the BLA might need to be withdrawn, and even while being fully aware of this possibility, I decided to join the organization because I viewed the company as having real long term potential for significant value creation in Oncology, NASH, and other HIV related indications.

6:09: I believed and still believe, that given the promise of other potential indications, we will be able to overcome the situation regarding the HIV MDR BLA. And in fact, I wouldn't be here today, and believe this would be a very different story, if we did not have solid clinical signals in other indications. Our assessment of the data collected from the clinical trials with Leronlimab, led us to conclude that our Top Line End Point Results are valid . This gives us the appropriate confidence to continue to pursue certain clinical programs, such as NASH and Oncology and other HIV related indications. Where there remains substantial unmet clinical needs and where Leronlimab's generated Compelling clinical signals to date.

Quote:

04:51: So turning now to our primary topic: which is the status of the partial clinical hold from the FDA. As a reminder, for everyone on the call, in March of 2022, just over a year ago, the FDA's division of AntiVirals within the offices of Infectious Diseases placed a partial clinical hold on the Company IND HIV program and a full clinical hold on a separate IND for our Covid 19 program. Though, at the time, CytoDyn was not actively enrolling new patients under either the INDs that were placed on Hold, and we choose to voluntarily withdraw the INDs for the Covid 19 program. We subsequently made the business decision to no longer develop leronlimab in Covid 19 patients. Since March 2022, we have been working diligently to resolve the partial clinical hold on the HIV program, and also taking time to insure that we were putting in the appropriate care and attention required to address the FDA's concerns. Part of this entailed successfully working through data access, data formatting issues, related to the CRO that was responsible for collecting and managing the clinical data, that we actually needed to address the FDA's concerns.

06:13: From the original Partial Hold Letter, that we received in March 2022, the FDA had identified various items that needed to be addressed as part of a complete response to that clinical hold. I'll go through those items now. and Provide you an update on the status, where we are at. So the FDA requested an updated investigator brochure , there was a request to come to compliance with annual reporting requirements for all the active INDs with adequate quality annual reports which we agreed with the FDA to address through annual development safety update reports, SARS . There has been a further request for a safety management and pharmacovigilance program , to find a place for an aggregate safety data analysis which included an analysis of all cardio vascular events across all the clinical trials that involved Leronlimab. This was further expanded to include all system that we had data on and also the benefits / risks assessment for the HIV population being studied as part of that indication.

07:42: It is important to note, that with the exception of the benefits/risk analysis for the HIV indication, we took the items that had been requested by the FDA, really needed to be addressed regardless of the indication for or the disease being studied. During the 3rd fiscal quarter which ended at the end of February 2023, we submitted the documents that were requested by the FDA, in the original March 2022 partial clinical hold letter. Subsequently, the FDA responded to us, through written communication, requesting some additional information and clarification regarding the benefits / risk assessment for the HIV population and made an additional supplemental requests that we, the company, also provide a general investigational plan for the HIV program IND going forward. So, in March 2023, just last month, we responded and submitted the additional information , and the clarifications requested for those 2 items. The FDA then responded back with a 3rd further written communication to us, again relating to the benefit / risk assessment as well as requesting submission of a new Protocol for HIV indication to be studied once the Partial Hold is lifted or some clarification that CytoDyn may not continue to develop Leronlimab in that indication.

09:24: So, at the end of March 2023, just last month, we had, an informal meeting with the FDA, where the agency clarified some of our more specific questions with respect to the information that we would like to see addressed. The risk / benefit portion, of the clinical hold and work on finalizing the supplemental submissions to address the items that we discussed with the agency during that informal meeting and we remain fully committed to the submission of the complete response to lift the partial clinical hold for that indication .

Quote:

21:28: In our most recent 10Q filing, filed yesterday, we demonstrated a continued support of investors through financing and fund raising activities and the company's continued focus on aligning the availability of capital with the needs of the business while continuing to judiciously manage and reduced expenses with focused spending. We posted the cash collateral required for the Amarex surety bond which will remain classified as restricted cash until the Amarex litigation is resolved. Most importantly, this resulted in the release of the liens on the company's patents which were previously secured by the cash collateral posted by an investor which has now been replaced. Having this restricted cash sitting on our balance sheet strengthens it.

Quote:

21:28: In our most recent 10Q filing, filed yesterday, we demonstrated a continued support of investors through financing and fund raising activities and the company's continued focus on aligning the availability of capital with the needs of the business while continuing to judiciously manage and reduced expenses with focused spending. We posted the cash collateral required for the Amarex surety bond which will remain classified as restricted cash until the Amarex litigation is resolved. Most importantly, this resulted in the release of the liens on the company's patents which were previously secured by the cash collateral posted by an investor which has now been replaced. Having this restricted cash sitting on our balance sheet strengthens it.

Quote:

Christina: Has the safety hold been lifted? If not, then Why? What are the current trial plans?

Cyrus: At the current time, the partial clinical hold for HIV remains in place. Based on our most recent interactions with the FDA, we believe that we do have a clearer understanding of the information requests regarding the benefit / risk assessment for the HIV MDR population in question. As well as the additional forward looking general investigation planned along with a full clinical protocol that has been requested by the agency. As I mentioned earlier, we are working on finishing that supplemental submission to address those items.

Christina: If the hold is not lifted, is it a vital part for proceeding with any of the other indications including HIV and NASH?

Cyrus: So the IND for the NASH clinical program is issued through a different division of the FDA, and it is technically, not directly impacted, by the existing partial clinical hold. For HIV, there are certain small term reporting requirement for any clinical trial to proceed and some of those requirements included the type of documentation that we were asked to prepare as part of the complete response to the clinical hold. So with that in mind, we are currently preparing materials for re-initiation clinical trials in NASH as well as the complete response on the HIV side. So these things are happening in tandem. Simultaneously.

Quote:

Christina: Any update with Arbitration with Amarex? And the Damage claim against Amarex?

Cyrus: We anticipated that this would be a question that would come up. I'll take a moment to provide who Amarex is, and what happened and what our company's relationship is with Amarex. Amarex previously served as CRO for CytoDyn starting in or around 2014 providing management and consulting services for nearly all of CytoDyn's clinical trials involving Leronlimab and during that time Amarex managed about 20 different CytoDyn sponsored studies. Among other issues, following the discovery of certain specific oversights associated with a prior submission to the FDA, it became increasingly apparent to CytoDyn that Amarex is not performing its services on par with industry standards or in some cases not at all. Over the past 12 months, we were able to obtain a 3rd party audit, which we discussed previously, which confirms these suspicions and uncovered significant non performance and under performance by Amarex. We believe that this conduct and underperformance results in a clear breach of contractural agreements between the 2 parties. We are in the process of seeking damages related to that breach of contract. In terms of where we are from a proceeding stand point. We have already filed the claim against Amarex. In those proceedings, among other claims for damages, we would be seeking reimbursement for services that were invoiced by Amarex and simply never performed and services that were negligent or services that were performed well below industry standard. We continue to pursue that. this case and we look forward to the opportunity to present more fully, but do to the fact that this is still pending legal matter, there is not much more we can say at this time.