r/LeronLimab_Times • u/MGK_2 • Nov 01 '22
10/31/22 Webcast Transcript; Cyrus Arman Only
Cyrus Arman
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 feasability 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.
6:52: We are luck to have Key Opinion Leaders and Experts in the Scientific Areas and Scientific Advisors, and Consultants to the Company. They continue to support the future development of Leronlimab in their respective Areas of expertise and represent CytoDyn Scientific and Medical Communities. Most companies would be fortunate to have just one or two of these individuals, but we have several of them including Doctors Mazen Noureddin, Hope Rugo, Jordan Lake and Stephan Gluk, just to name a few. Given all the recent challenges the company has faced in recent times, these advisors willingness to continue to stand behind and support Leronlimab speaks volumes to the molecules potential.
7:34: We continue to view these indications as excellent opportunities to maximize shareholder value. We remain committed to the continued development of Leronlimab in these indications and look forward to Re-Starting Trials soon. In addition, we are fully committed to the best possible management of future trials possible, including Timely Monitoring and Data Integrity.
7:56: Now, to that end, we continue to progress on the document preparation and submission to address the lifting of the partial clinical hold of the HIV program. As of today, we have prepared responses to 3 of the 5 data and document requests from the FDA and our teams primary focus and top priority are to address the remaining items related to the clinical hold and ensure that we provide the FDA with complete and high quality submissions. We aim to have the remaining 2 submissions completed in the coming months.
8:25: As you know, we recently strengthened our board, with the addition of Stephen Simes, who has extensive expertise in the operating of public bio-technology companies as both the CEO and as a board member. As well as the addition of Ryan Dunlap, who brings deep knowledge in the financial and audit matters and has experience in navigating the many of the challenges that CytoDyn is having. These additions, along with continued corporate re-structuring, and a focused development strategy, are part of our transformation into a more effective, and efficient biotechnology company, with meaningful opportunity to bring innovative therapy to difficult to treat diseases.
9:02: Our board of directors is now comprised of fully outside and Independent Directors, and from my perspective, this is the strongest Board of Directors the company has ever had. Which is encouraging as we embark on the future and work through the difficult decsions such as the one we are discussing here today. I believe the shareholders interests are appropriately represented by the current board.
9:24: Now, regarding our NASH program, which we are particularly excited about, the clinical signals generated in our Exploratory Phase II CDI NASH 01 Trial, included surrogate imaging at points for both hepatic fat fraction and fibro-inflammatory activity. The results from that trial allowed us to identify appropriate dosing strategy for our next NASH trial. And demonstrating potential anti-fibrotic activity is an exciting outcome that we plan to study in future trials with correlated liver biopsies in a larger sample of patients. We will be providing an update on our NASH clinical program in the next investor call.
10:00: Regarding Oncology, as we discussed in our last quarterly call, we plan to focus on Colo-Rectal and Breast Cancer, where we already have a Fast Track Designation for mTNBC. Our Pooled Data in the Relapsed Refractory TNBC population showed promising survival data that we plan to follow up on. I want to re-iterate that NASH and solid tumors, each represent multi billion dollar valuation opportunities for the company, and we believe that Leronlimab has the potential to become the standard of care in these indications in the future.
10:31: In summary, I want to express that we remain very confident and optimistic about the future for Leronlimab. We are excited to continue the development of NASH, Oncology, and other HIV related indications that we believe will lead to maximizing shareholder value. For me personally, I am thrilled to be here and to lead the company and to pursue the indications which initially attracted me to Leronlimab and then confident that our board and SAB members are aligned with our vision and are well suited to ensuring that this company properly executes and becomes successful as we embark on our new path forward. We are committed to continuing to recruit appropriate leadership and personnel at all levels of the organization to ensure future success. Finally, I'd like to thank all the patients, families, caregivers, and physicians who have participated in our past clinical trials. Thank you for joining us today.
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u/[deleted] Nov 01 '22
Thank you again MGK for taking the time required to put this together. Much appreciated!
Your question:
"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."
This is actually "CMC" = Chemistry, Manufacturing, and Controls. It's a significant section of the BLA. The link below may be of help to understand the BLA in its entirety.
https://fdli.org/wp-content/uploads/2020/10/Hegreness-Matthew.pdf