CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Greetings, and welcome to CytoDyn's Investment Community Webcast. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Cristina De Leon. Please go ahead.

Hello, everyone. Thank you for taking the time to meet with us today. This is Cristina De Leon with CytoDyn. Joining us on today's call from CytoDyn is our CFO and Interim President, Antonio Migliarese; Tanya Urbach, Board Chair; Dr. Scott Kelly, CMO and Head of Business Development; and Dr. Chris Recknor, Senior Executive Vice President of Clinical Operations. Before we begin today, we will provide you with important cautionary language related to certain federal securities laws. Remarks during today's webcast will include forward-looking statements. Forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are difficult to predict. Actual results may be materially different from any future results expressed or implied by such forward-looking statements. These risks and uncertainties include, among other matters, statements regarding leronlimab's potential effectiveness in certain immunology and oncology indications; the company's ongoing ability to raise additional new capital; that clinical trials may not commence or proceed as planned; products may not ultimately prove to be viable on safety or efficacy grounds; products may not receive regulatory approval or market acceptance; competition may reduce the commercial potential of our products; we may experience product recalls, manufacturing issues or product liability; and our patents may be challenged or unenforceable. Although forward-looking statements help to provide complete information about the company, forward-looking statements may be less reliable than historical information. The company undertakes no obligation to update publicly these forward-looking statements, except as required by law. Please refer to our recent quarterly and annual reports filed with the Securities and Exchange Commission for more information about the risks and uncertainties that could cause the actual results to differ materially from our current expectations. I will now turn the webcast over to Antonio Migliarese.

Thank you, Cristina. Good morning, everyone, and thank you for taking the time to join us today. On today's call, we would like to provide you with current updates and also an insight into our future plans, followed by a brief Q&A where we will answer questions submitted to the best of our knowledge. Tanya and I will start off by providing an overall corporate and strategy update, followed by Dr. Scott Kelly and Dr. Chris Recknor providing clinical, R&D and business development related updates. Over the last 9 years, CytoDyn has made great strides involving leronlimab from a single indication molecule into a platform with the potential for multiple therapeutics. This has been done through investment in resource-intensive clinical trials. During this time, we have generated valuable data, informing us how leronlimab may be used in HIV, oncology, NASH and COVID-19. During this time, we also successfully transferred our manufacturing capabilities and technologies to 2 different contract manufacturers, Samsung BioLogics and AGC Biologics. This has provided us with the ability to manufacture at commercial scale. However, despite such achievements in a relatively short amount of time, we are currently facing some challenges, which will shape our plans for the immediate future in next 6 months. We will be focused on setting up the company for future success by restoring credibility and determining our most advantageous path forward with the goal of maximizing shareholder value. We plan on doing this by strengthening our clinical operations and prioritizing patient safety; addressing the concerns noted in the partial clinical hold letter received for HIV and the full clinical hold letter received for COVID-19; enhancing leadership with the Board, CEO and Scientific Advisory Board; addressing legal and financial issues; analyzing HIV data received from Amarex and revamping the time line and activities needed for a successful BLA resubmission; releasing final NASH data results; and identifying partnerships to advance our development efforts and value creation with minimal investment from the company. I will now turn it over to Tanya, who will touch on our leadership initiatives.

Thank you, Antonio, and hello, everyone. From the Board of Directors' perspective, I would like to echo Antonio's comments. With those goals in mind, the Board has been laser-focused on strengthening CytoDyn and supporting management's efforts. Chief among the Board's responsibilities have been prioritizing the company's clinical development and regulatory objectives, supplementing the Board with professionals whose skills sets are synergistic with and serve to reinforce the breadth of the Board's existing capabilities and conducting a broad search for the company's next Chief Executive Officer. The Board has worked closely with management to focus the company's clinical development program to identify the potential to enhance that program and then to develop a plan to further the progress of the clinical development programs with a view toward commercialization of leronlimab. The Board has also worked and continues to work to identify and recruit highly qualified professionals as directors whose core competencies will serve to buttress the capabilities of those already serving on the Board. To that end, the company announced yesterday, subject to successful completion of a background check, the addition of a new member of the company's Board of Directors, Dr. Karen J. Brunke. Dr. Brunke has a PhD in microbiology and is presently Executive Vice President of Corporate and Business Development at Jaguar Health. She has a strong network in the venture space, which combined with a substantial science background allows her to evaluate assets and consider their potential from both biological and commercial standpoint. The Board is also actively working to identify a financial expert as well as additional individuals with capital markets and FDA regulatory expertise. The Board has formed a CEO search committee, which has worked with 2 executive search firms as well as with investors and corporate partners to source, identify and interview potential CEO candidates. We're excited about the overall quality of the candidate pool and will continue in our efforts to identify the company's next Chief Executive Officer. And finally, I would like to turn it over to Dr. Scott Kelly to discuss his work in recommending to the Board a number of highly qualified members to our Scientific Advisory Board.

Thank you, Tanya. So in regards to the Scientific Advisory Board, we are strengthening our position. We know we have good experience in HIV, NASH, immunology and rheumatology. But now in addition, we're adding more experts in neuroinflammatory diseases, pulmonary critical care and oncology. And we'll be able to leverage the experience of the Scientific Advisory Board to enhance our scientific activities at CytoDyn. Antonio?

Thanks, Scott. With regards to the legal and financial issues, we're fully cooperating with the ongoing SEC and DOJ investigations, and we are doing our best to expeditiously wrap up the various other legal matters of the company. We recently posted a $6.5 million bond with regards to the Amarex dispute, which has allowed us to download data from trials and has allowed the company to begin an audit of the data and the services performed by Amarex. This will guide us in further determining the status of the Amarex data, aiding us in the resolution of the Amarex dispute and updating the time line for the BLA resubmission. With regards to Samsung, we are currently working with Samsung with regards to a plan to resolve past due amounts related to our inventory manufacturing. And as we look forward, we have been focused on planning and implementing a judicious budget with focused spending. Scott will now provide us with an update with regards to clinical, R&D and business development.

Yes. So regarding clinical activities, we elected to pause our Brazil COVID-19 trial due to safety events in the critical COVID population. This is in the CD16 clinical trial, which studies IV leronlimab versus IV placebo. I want people to understand that these patients are incredibly sick patients with both cardiac and pulmonary manifestations of COVID-19 being extremely common in this population. There were 2 clinical cardiac events. And since the trial is blinded, we don't know if these patients received placebo or leronlimab for these very sick patients. So we discussed this in depth with the physician investigators in Brazil who have extensive pulmonary and critical care expertise. And they believe the events were consistent with the natural course of COVID and nothing out of the ordinary of their experience in prior COVID-19 trials. So out of an abundance of caution, we elected to pause the trial as our experience with IV leronlimab prior to the CD16 trial was in healthy volunteers. It was not in the critically ill COVID-19 population. We also knew that we had a preplanned DSMC meeting, and that's the Data Safety Monitoring Committee meeting, in early April for both studies. So upon clearance of the DSMC, we plan on removing the pause. We're in communication with ANVISA and the FDA and reported the events to each agency. But I want to be clear that this was our decision, and we thought it was the right thing to do. Now regarding our full clinical hold on the U.S. IND for COVID-19 and the partial clinical hold on IND for HIV. There have been no trials ongoing in the United States for COVID-19, and we're not enrolling any patients at this time. We are currently not enrolling new patients for HIV. And we're closing our long-term HIV extension trials after obtaining data in some patients for over 6 to 7 years. The FDA wants aggregated safety data across all indications as our prior CRO was not aggregating safety data. We will correct this, and we believe this is a solvable problem. We have contracted with a new pharmacovigilance CRO to move forward. So we expect about an 8- to 12-week time line, and then we will seek advice from the FDA. And now I'll have Chris update in regards to the BLA and NASH. Chris?

Thanks, Scott. Regarding the reevaluation of the BLA time lines, we're going to have a delay in the clinical activities for the BLA while we are performing a pharmacovigilance evaluation through the new contracted CRO. The bond was posted with Amarex -- for the Amarex and data was obtained for all of our trials, including trial master file. And we're going to use this to move the BLA forward. Regarding NASH, we completed our Phase IIa clinical trial for NASH during 2021 and announced preliminary results in January. We're in the process of conducting final analysis of the data and plan to release the updated final results in the near future. And we're real excited about the results of this trial, including the MRI findings for PDFF and CT1 as well as biomarker data. There's currently no approved drug for NASH, and liver disease is one of the leading causes of age-related -- of non-age related deaths in HIV patients. The company is identifying the next steps in clinical development, and we're exploring potential business opportunities to accelerate the investigation of the potential for our therapy to address this unmet need. Scott, if you can announce research activities.

Yes. So I'll update everybody on the research and development activities. So we've had some exciting developments. We've had -- we've been contacted by academic institutions interested in doing studies with leronlimab. We were just recently contacted by a researcher at a top academic university in Boston regarding CAR-T research with leronlimab. What we found is that CAR-T is not working as well as had been hoped against solid tumors. For this study, we will need to supply molecule only. And it's believed that the tumor microenvironment is contributing to the lack of effectiveness of CAR-T products against solid tumors. And if we can assist in controlling the tumor microenvironment, we may be able to enhance the effectiveness of CAR-T therapies going forward. We've also been contacted by the Department of Neurological Surgery at a major academic center in New York City, and they're planning to evaluate leronlimab and glioblastoma multiforme, which is a very aggressive brain tumor in a nonclinical model. Again, we will supply leronlimab, and they've even expressed their interest that if this is successful in this nonclinical model that they would pay for a human trial. And in our study involving the use of checkpoint inhibitors, which is funded by CytoDyn, may represent another potential opportunity in immunotherapy and is moving forward. We've also been in contact in London with a university and foundation to further evaluate the potential of leronlimab as a treatment in Alzheimer's. Their interest is the role of neuroinflammation in Alzheimer's. It's very similar to the role of cancer where initially people do not believe that cancer was -- had a significant inflammatory component, but now they've embraced that concept. And I think the same is happening in a number of central nervous system disorders. So we're also studying the potential of leronlimab as a long-acting HIV PrEP agent in macaques is successful, and we're very excited about this. This has the potential to turn leronlimab into a once-every-3-month injection from once-a-week. This felt that the future of HIV treatment and PrEP is long-acting injectables. We've also been exploring the possibility of a grant-funded Phase II clinical trial for leronlimab in HIV patients with NASH and NAFLD where we supply leronlimab, but do not pay for the trial. And I'd like to turn to publications and presentations. We think that this will help with the credibility with CytoDyn. We have a poster presentation at the American Association for Cancer Research on April 11, 2022. Dan Adams of Creatv MicroTech will be presenting. Dan Adams has also submitted another poster presentation to another prominent oncology meeting this year. In addition, as you all know, we presented our metastatic TNBC data at San Antonio Breast conference in December of 2021, and we believe that was very well received. We're also processing 3 articles for publication in peer-reviewed journals. The first is on HIV monotherapy. We also have another paper on HIV multidrug resistance. And we're also looking to publish a paper on our COVID-19, the long-haulers program. So I'd like to turn the attention to our potential partnership opportunities. As we all know, to do clinical trials, it's very costly, but we believe we can leverage the experience of others that are experts in each chosen field. So regarding HIV, we're looking for the following opportunities, both internationally and domestically. For HIV PrEP, we hope to use a long-acting leronlimab in a clinical trial, pending the results of our macaques studies that are currently being done for a once-every-3-month injection. We also are looking for partners in multidrug resistance for partners to complete with the BLA submission with in-house BLA expertise. We're looking at partnerships in HIV combo, both internationally and domestically for partnership with existing agents. We believe that leronlimab would be a great add-on agent. And also with HIV and NASH, we're looking to do a Phase II clinical trial for obvious reasons. And I want people to know that in the HIV population, they have an increased risk of NAFLD as well as fibrosis compared to the general population. And if you look at patients who have elevated aminotransferases with a liver biopsy, NAFLD can be as high as 45% in this patient with significant fibrosis than 22%. We're also looking at combination therapy in NASH with leronlimab. We believe that the future of NASH treatment will probably be not monotherapy, but also adding a drug to an existing agent. And this is a market that's growing at a rate of 58.64% on a compound annual growth rate. It's expected to be $180.9 billion by 2028. In oncology, we're pursuing partnerships in unmet medical needs, which is a quicker path to approval. We do know that CCR5 is present on many tumors with unmet medical needs as well as the tumor microenvironment. And the cancer immunotherapy market is projected to be approximately $277 billion by 2030, and it's growing at a compound annual growth rate of 12.6%. So the opportunity is there. Now we can turn it over for questions.

Okay. Perfect. The first question, can you please provide an update on the following, and I'll list the studies, and we can update after each one. The first one, COVID-19 Brazil enrollment.

Yes. I'll address that. As of today, the CD16 critical trial has 16 critically ill COVID-19 patients. We had 30 sites -- 38 sites activated. The CD17 trial has 77 patients with 39 sites activated. I want people to understand, in Brazil, that 80.7% of the population in Brazil has received their first vaccination dose. 72.9% have completed vaccination and 31.7% have received their first booster vaccine. Brazil is credited with one of the more successful vaccination programs in the world. So we'll continue to monitor the COVID-19 outbreak closely as it transitions from the pandemic to endemic phase.

COVID-19 long-hauler enrollment?

Yes, I'll address that one as well. We're currently not enrolling for long-haulers, but we are looking for partnership opportunities to pursue that indication.

The next one, NASH study?

Chris?

Yes, I can take that one, Cristina. Yes, for NASH, we've released previous results, and we really continue to be optimistic. The final results of the top line will be announced shortly.

The basket trial study?

Yes. We're interested in pursuing partnerships for a basket trial. We think that, as I said before, that CCR5 is present on a lot of these tumors as well as in the tumor microenvironment, but we'd like to preserve capital and pursue potential partnership opportunities for immunotherapy combination.

And lastly, mTNBC study?

Yes. So for the mTNBC study, I mean, we were very encouraged by our preliminary results, and that's something we will be progressing with as well. We have Fast Track designation, as everybody knows. So that's something we're looking forward to pursuing.

The next question, will CytoDyn have an interim CEO until the CEO search is over?

So an interim CEO is something we're certainly considering, but we would like to have a full-time CEO to progress the clinical program forward.

The next question, what is the status of the Amarex litigation?

This is Antonio. I'll take that. So we're in the process of wrapping up the independent audit of Amarex after we posted the bond. And the arbitration is rescheduled to start in mid-April.

Will there be any opportunities for patients to be treated with leronlimab for lung cancer or other cancers? If so, would there be a listing of where those trials might be taking place?

Yes. This is Scott. So we are pursuing a number of different indications, including lung cancer. Lung cancer tends to be one with a very high CCR5 expression as well as colon cancer, breast cancer, bladder cancer, et cetera. So we are looking to pursue this opportunity. We're looking for partnerships to advance the program forward.

Did the company update and submit the TNBC data by adding the surviving patients to the Breakthrough technology application?

Yes. For Breakthrough designation -- and during 2021, we closed and reported data from the first 28 patients for mTNBC. Now these are patients that had failed at 2 lines of previous therapy. They were from our compassionate use program, the Phase Ib/II clinical trial and the basket trial. Now upon closure of that trial, there were some patients remaining on leronlimab, but there's a very high bar for a Breakthrough designation, and we don't believe that, that's enough data. So we will be progressing this molecule forward for mTNBC and be looking for more development opportunities.

On one of the prior calls, a mention was made of partnerships with other pharmaceutical companies. What is the status of partnering with another company?

Yes. So we are in discussions. We have companies under NDA right now, and we are advancing those discussions for multiple different applications for leronlimab. But we will have to comment on that when it is publicly available to everybody at the same time.

And can we expect CytoDyn to provide at least quarterly conference call updates?

Yes. So we expect to provide at least quarterly conference call updates in the future in addition to providing updates through our 10-Qs and 10-Ks on a quarterly and annual basis. We have implemented a shift in the cadence of our communications with stakeholders. And we have hired a professional investor and public relations firm to assist with this. Cristina, do we have any more questions?

That's all the questions that we have.

Dr. Kelly, would you like to provide some closing remarks?

Yes, sure. Thanks, Antonio. So in closing, we want to thank you for your time. We are moving forward on all fronts. We believe the challenges before us are solvable, and we look forward to the many opportunities in front of us. So thank you for your time. We appreciate it. Thank you.

This concludes today's conference. You may disconnect at this time. Thank you for your participation.