CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Greetings, and welcome to today's CytoDyn Investment Community Webcast. My name is Diego, and I will serve as your moderator today. [Operator Instructions] As a reminder, this call is being recorded today, March 5, 2024. I'd now like to turn the webcast over to Tyler Blok. You may begin.

Good morning, everyone, and thank you for joining us today. This is Tyler Blok with CytoDyn. Today's webcast is being hosted by our CEO, Dr. Jacob Lalezari. Before we begin, it is essential that we provide you with important cautionary language consistent with certain federal securities laws. Our 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 and relate to, among other things, statements regarding leronlimab's potential efficacy in certain indications, the status and potential consequences of regulatory actions and government investigations and inquiries, the company's ongoing ability to raise additional capital that clinical trials may not commence or proceed as planned, the products that appear promising in early trials may not subsequently prove to be viable on safety or efficacy ground, the products may not receive regulatory approval or market acceptance, that our patents may be challenged and/or enforceable, that competition may have reduced the commercial potential of our products and that the company may experience product recalls, manufacturing issues or other product-related liability. 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 publicly update these forward-looking statements, except as required by law. Please refer to our recent quarterly and annual reports as filed with the Securities and Exchange Commission for more information about the risks and uncertainties that could cause actual results to materially differ as compared to our current expectations. Once again, thank you for joining us today, and I will now turn the webcast over to Dr. Lalezari.

Thank you, Tyler, and greetings, everyone, again, and thank you for joining today's CytoDyn Shareholder call. It is a great privilege to be speaking with you now as your recently appointed full-time CEO. I would also like to acknowledge the great addition of Mitch Cohen as our new interim CFO. Mitch has deep prior public experience, public companies and has blended in perfectly and has been a wonderful addition to our executive team. On today's call, I'm pleased to provide an overview of encouraging recent developments towards CytoDyn. During our initial call in December, I made several specific commitments as follows. First, to oversee the revision and resubmission of the inflammation protocol in patients with HIV in an effort to remove the FDA's clinical hold on that study. Second, to pursue publication of our clinical data in cancer, HIV, NASH and COVID. And third, to prioritize opportunities for partnerships to extend investigations into leronlimab's potential applications, wherever that makes sense. I would now like to report on some of the progress we've made to achieving these goals. First, as you are probably aware, the FDA recently lifted the clinical hold on our protocol to study leronlimab in HIV-positive patients with chronic inflammation. So just to be clear, the FDA has now lifted both the previous partial clinical hold, which pertain to the overall development program, and the more recent full clinical hold, which was specific to the inflammation protocol. We are very pleased by these positive developments and are now focused on evaluating the next steps in our clinical development with leronlimab. I would also like to say a few words about the study in HIV-positive patients with chronic inflammation. As mentioned on the last call, this study represents an important pivot for CytoDyn, a way from leronlimab acting as an antiviral by simply blocking HIV entry, and towards leronlimab's potentially more significant activity, blocking chemokines signaling of the CCR5 receptor. It is this latter activity that forms the basis for the hope that leronlimab may provide clinical benefit for inflammation and other conditions that rely on chemokines signaling through CCR5. As currently designed, the inflammation study will be a randomized, double-blind, placebo-controlled trial, comparing 2 doses of leronlimab in 90 study subjects. The study will enroll 45 cisgender men and women, and 45 transgender women. But subjects will become eligible to participate in the study after demonstrating evidence of acquired inflammation of screening as determined by elevated levels of C-reactive protein or CRP. Eligible subjects will then be randomized to either 350 milligrams or 700 milligrams of weekly subcu leronlimab or placebo and treat it for 24 weeks. The current primary endpoints for the study are C-reactive protein and another biomarker of inflammation called EN-RAGE, both of which we believe showed earlier signs of responding to leronlimab during our NASH trial. Given the exploratory nature of this study, we will also be evaluating the effect of leronlimab and a host of other secondary biomarker endpoints as well. I believe the information study, as described, is the most cost-effective way to clearly establish leronlimab's biologic mechanism of action. If successful, I believe this proof-of-concept study would create the opportunity to intervene or partner in a host of other inflammatory conditions, establishing proof of leronlimab's activity as an anti-inflammatory could also create the opportunity for CytoDyn to study its potential to reduce heart attacks, strokes and other inflammatory vascular events, which remain the #1 cause of death in people with HIV. Turning now to the commitment to prioritize publication of our existing clinical data. I am pleased to announce that we are moving forward with the submission of 4 manuscripts in the coming weeks, including 2 papers with data from women with triple-negative breast cancer, a paper in patients with multidrug-resistant HIV, and a paper in patients with mild to moderate COVID-19. The first publication will report on the observation that 8 of 10 women are with third-line therapy for triple-negative breast cancer had either stable disease or a partial response after 6 months of combined treatment on leronlimab with a chemotherapy agent called carboplatin. This result compares favorably with historical controls. The second publication will report 2 further observations, suggesting leronlimab may have a role in the treatment of triple-negative breast cancer. First, in the pool analysis of 28 patients, there appears to be a signal of a dose response, with patients receiving the higher 5.5 milligram dose for leronlimab, having modestly improved progression-free and overall survival compared to the 350 dose. Second, and I think most provocatively, the pool of analysis showed that after receiving an initial dose of leronlimab, patients divided into 1 of 2 categories, about 25% of patients had an increase in circulating tumor cells or cells that are measured in the blood and can be referred to as CTCs. While about 75% of patients had a decrease or absence of the CTCs in the weeks following the first dose of leronlimab. That differentiation in CTC response in turn appear to identify which patients subsequently responded to leronlimab with improved progression-free and overall survival. Indeed, I believe the data on CTC response is perhaps the most compelling part of the leronlimab story in triple-negative breast cancer and could provide the basis for a screening test to identify which patients are most likely to respond to leronlimab in a follow-up study. Turning to our other manuscripts. We are pleased to announce that our Phase II/III study of leronlimab in a population of patients with HIV and multidrug-resistant virus will also shortly be submitted for review. This study did achieve a significant p-value for its primary endpoint, demonstrating the efficacy of leronlimab in the multi-drug-resistant population. Though we are choosing to prioritize other applications at this time, this study could support the pursuit of leronlimab as an HIV antiviral should that opportunity once again make sense. Finally, I'm pleased to announce that the manuscript for study in patients with mild to moderate COVID-19 will be submitted for peer review in the coming weeks. Although this study did not achieve its primary or secondary endpoints in a post-hoc analysis, the study did show a marked improvement on a metric called the National Early Warning Score for leronlimab compared to placebo. That score combines measures of heart rate, blood pressure, oxygen levels and other clinical measurements, and has been used to get which COVID patients are at the highest risk for subsequent pulmonary collapse. In retrospect, the real value of this COVID study may have been to help define the more advanced populate needed for a study of a proposed immunomodulator such as leronlimab in patients with COVID-19. Indeed, the results of our study in such patients with severe and critical COVID should be ready for submission in our next wave of manuscripts. That wave should also include a manuscript for our NASH/NASH study, and a manuscript highlighting the clinical endpoint of CytoDyn's long-haul COVID study. In terms of partnerships, I'd like to affirm our ongoing commitment: pursue partnerships and give leronlimab multiple shots on goal to prove itself. Board and management are currently evaluating several options on how to proceed as pertains to oncology, NASH and other potential indications. For example, we are acutely aware of the continuing and even growing interest in long COVID, and we'll continue our efforts to bring attention to leronlimab as a possible partner in long COVID treatment strategies. I would also like to note the growing body of evidence implicating the role of inflammation and specifically CCR5 in the pathogenesis of Alzheimer's disease. This is obviously an area of enormous and urgent unmet need. And given the well-tolerated safety profile of leronlimab to date, together with data from a recent preclinical study suggesting that blocking CCR5 can rescue memory deficits. I believe a pilot study in patients with Alzheimer's disease is now justified. The challenge, of course, is that CytoDyn is just emerging from a 2-year clinical hold and doesn't have the resources to do everything we'd like. We're also keenly aware of the need to stay focused and not try to do too much all at once. That said, the Board and management are working closely together to identify our priorities and the appropriate next steps to proceed. To that end, we will be taking steps to ensure the effective and efficient use of our resources while incorporating funding from third-party sources wherever possible. To be clear, we will be prioritizing opportunistic ways to develop and create value through various means for leronlimab, and employing strategies that are time and cost effective, including, for example, opportunities for nondilutive funding to services agreements to development initiatives and partnerships. So in closing, it's an honor to step in as CytoDyn's CEO, what remains a critical [indiscernible]. I want to thank the many shareholders who have graciously reached out to express their support and good wishes. We are generally pleased by recent progress here in CytoDyn, and look forward to keeping you informed as further events unfold. Until then, please take care, and thank you.

Thank you. This concludes today's conference. All parties may disconnect. Have a good day.