Greetings. Welcome to the CytoDyn investment community webcast. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. You may submit a question via the web at any time by using the Ask a Question feature on the side of your screen. Please note this conference is being recorded. I will now turn the conference over to Cristina De Leon. Thank you. You may begin.
Hello, everyone, and thank you for joining us today. This is Cristina De Leon with CytoDyn. Joining us on today's webcast is our board chair, Tanya Urbach, our president, Cyrus Arman, our CFO, Antonio Migliarese, and our chief medical officer and head of business development, Dr. Scott Kelly. Before we begin, it is essential that we provide you with important cautionary language related to 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, among other matters, statements regarding leronlimab's potential efficacy 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 that appear promising in early trials may not subsequently 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 report filed with the Securities and Exchange Commission for more information about the risks and uncertainties that could cause actual results to differ materially from our current expectations. I will now turn the webcast over to Tanya Urbach.
Thank you, Cristina, and good afternoon, everyone. In recent months, among the board's priorities has been to continue to add existing board members in an effort to strengthen the overall board of directors. Procedurally, the board laid the foundation for its recruitment efforts by working through a traditional board matrix process, outlining the ideal broader makeup of the board and subsequently identifying the critical experience and skills we felt would add the most additional value to the board's existing competencies. Qualified candidates have been interviewed by members of the board and ultimately, only after a rigorous background check process is a new member appointed to the board.
In early 2022, the board had identified the need to recruit a board member with substantial audit experience, ideally a mix of big firm audit and chief financial officer experience, who could leverage his or her professional background on behalf of the board and who could chair the audit committee. A culmination of these efforts was the announcement on August 30, 2022, of Ryan Dunlap's appointment to the CytoDyn board of directors. Early in his career, Mr. Dunlap held various financial and operational leadership roles in large multinational organizations and spent 11 years with various public accounting firms, including PricewaterhouseCoopers, KPMG, and Moss Adams, where he provided business assurance and advisory services to both public and private companies, including companies in the life sciences industry.
He has over 25 years experience in finance and operations leadership at both public and private companies, developing significant expertise in strategy setting, improving operational efficiency and effectiveness, fundraising and investor relations, financial reporting and compliance, and risk management. He is currently the Chief Financial Officer at Gurobi Optimization LLC, which provides a mathematical optimization solver to solve business problems for customers. Prior to joining Gurobi, he spent several years as the CFO and COO for a growth equity-backed molecular diagnostics company. Before that, he served for 4 years as the CFO of a publicly traded biotechnology and pharmaceutical sales company. Ryan has already added tremendous value in his short tenure and has demonstrated the type of thorough and thoughtful excellence you would expect from a board member. As importantly, Ryan is known for his high ethical standards and shares our commitment to a corporate culture of excellence.
Going forward, the board will continue in its recruitment efforts, focusing current attention on attracting and retaining persons with substantial experience as biotech industry C-suite level operators. The board has also been working with management in typical fashion on corporate strategic initiatives. Chief among Dr. Arman's priorities as he joined as president of CytoDyn was to assess CytoDyn's existing clinical programs, their associated data and relevant market data, and to recommend a go forward strategy to the board. He delivered on his promise to do so, and the board and executive management have engaged in rigorous discussion, debate and collaboration, resulting in a well thought out improvement in the company's go forward strategy. Further details are properly the province of Dr. Arman to discuss. With that, I will turn it over to Cyrus Arman.
Thank you, Tanya, and good afternoon, everyone. A moral obligation to generate therapies to improve people's lives. A focused and disciplined clinical development strategy. A value generating path resulting in economic returns for our investors. This is CytoDyn's mission, and I'm excited to be here and to lead the company into its next phase of evolution. I wanna send a thank you to both Antonio and Tanya for their stewardship during the critical period when the company was looking for new strategic leadership. I also wanna extend a special thank you to the numerous shareholders who have reached out to me and offered their support for both me and the company over the last couple of months. I want you to know that I've heard all of your comments and suggestions, and I'm grateful for your participation and continued belief in the company.
I know that many of you wanted to hear from both the company and from myself earlier. However, as we get to know each other better, I know you'll find that I'm a firm believer in action and not just talk. As such, I wanted to ensure that our first conversation was filled with meaningful and salient points. Now, that being said, I wanna take an opportunity to share with you my own journey and my decision in choosing to join CytoDyn. I've spent my entire career in biotech, and over the last 15 years I've worked at both large and small companies. During my time as a consultant, I worked with nearly all of the top 40 large cap and mid cap biopharmaceutical developers.
I've seen the drug development process from end to end, and I've had the opportunity to look at over 1,000 clinical development programs across hundreds of different molecules. Importantly, I've had the benefit of time to see how these programs have actually played out, either in the clinic or in the markets. I've looked at these molecules through the lens of an investor, a developer, a competitor, or in some cases, as an acquirer. Through those experiences, I've learned extensively about what the hallmarks are for a clinical stage therapeutic to get to market, to help patients, and importantly, to generate economic returns for shareholders.
After examining all of the data surrounding leronlimab, I've concluded that this is indeed a unique therapeutic, and I have a very high conviction that with the proper leadership and execution in place, leronlimab can not only achieve success through development and benefit patients, but in doing so, I strongly believe that it will generate value for shareholders. Since doing my diligence on CytoDyn prior to joining in July, I've developed a very clear vision for how leronlimab can achieve the goals I just described. However, that vision by itself isn't gonna be enough. We also have to have the right talent and the right capabilities in order to deliver.
I and other key stakeholders within the company will continue to evaluate our staffing needs on an ongoing basis to ensure that we have the right personnel at all levels of the organization in order to deliver on the promise of leronlimab. That does leave the question of the company's financial position and ongoing questions related to the various government agencies that we're currently engaged with. In performing my diligence and reviewing the governance and financial considerations around the company, I've come to the conclusion that each of these situations is addressable and that, again, with the right leadership, the company will successfully work through these items. Now, with regard to financing, as this group is no doubt aware, we've recently had a share increase authorized at the shareholder meeting at the end of August.
Antonio and I are actively working on identifying and evaluating financing initiatives that will allow the company to continue to service its outstanding debt while maintaining operating and development capital that's gonna be required for us to reach our next value inflection point. Fundamentally, this is why I chose to join CytoDyn. The core of the technology is solid, and in the drug development business, the hardest part of the process is creating a well-tolerated and clinically active, molecule. Quite literally everything else will come down to leadership, vision, experience, and most importantly, the ability to execute. I wanna be clear that achieving everything I just described is gonna take a new level of focus, and more importantly, a new level of discipline that the company has not had before, but that I am completely committed to executing on.
This newfound discipline is not just gonna be limited to development strategy or to resource allocation, but it's a core theme of how our business now operates. To put it simply, what got us here today is not what will lead us into the future. Now, before diving into the company's future development strategy, I wanted to address a couple high priority initiatives that the company is working on. Many of the questions that we received were related to the ongoing clinical holds for HIV and COVID treatment, as well as the rolling submission BLA for the HIV multidrug-resistant or MDR population. With regard to the clinical hold, we believe we now have the required data from Amarex to address the FDA's concerns.
However, as we previously communicated in the last quarterly call, the data from Amarex was not coded in an industry standard format. While this barrier extended our desired response timelines to the FDA, it has recently been mitigated by actions from leadership. I'm pleased to announce that during the month of September, the first of a series of documents has gone into publishing for submission to the FDA, and we continue to move as quickly as possible on the remaining items. It's important to note that substantially all of the data requested by the FDA to lift the clinical hold are items that Amarex was contracted by CytoDyn to prepare, but failed to do so. As a result, CytoDyn has taken on all of these responsibilities internally over the last six months.
Along these lines, we've also recently completed the warning letter closeout process with the Office of Prescription Drug Promotion, and we look forward to continuing to improve our relationship with the FDA at all levels. Turning now to the BLA for HIV. Over the course of the last few months, we had the chance to get a much clearer look at the state of the clinical data collected by Amarex. This led us to perform an internal feasibility assessment on the clinical portion of the BLA, with the key question of understanding if the data would withstand what is commonly referred to as a good clinical practice or GCP audit, which is precisely what we would expect the FDA to perform during the BLA review process.
As a result of our internal assessment, we decided to engage an external high caliber regulatory consultancy to perform an external audit of that same data. We expect to receive those results of that audit in the near term, and those results will inform our next steps with the BLA. I wanna make clear that this audit is not a question of the performance of leronlimab in clinical trials. Rather, it's an assessment of the quality of data collection and monitoring performed by Amarex. We are performing this work purely to assess the probability that if the BLA submission is completed, that it would pass an FDA-type GCP audit. Now, turning to the future development strategy of the company. Going forward, we're gonna have a much more focused and a much more disciplined clinical development strategy.
Like all clinical stage biotechs, we have limited resources, and we must focus our energy on the initiatives that have the potential to maximize value generation and have a clear path to potential economic returns for investors. While at the same time still honoring our moral obligation as drug developers to generate therapies that can improve people's lives. During the months of July and August, I led the team through a corporate strategy assessment that examined the future commercial and clinical development options for leronlimab. Our approach considered many factors, including, one, our current clinical data. Two, pertinent intellectual property considerations. Three, our pre-feasibility assessment of the HIV MDR BLA, and the projected valuation of that increasingly narrow HIV MDR indication within the larger HIV treatment space.
Compared that to the valuation of other potential disease areas we could pursue, and then considered the associated development cost of each of those options. We went through the strategic assessment with the goal of identifying our highest probability options within indications where we believe we have a clear path to generating what I refer to as unequivocal clinical data that could both address unmet needs for patients, and if successful, would result in a strategic investment from a partner. We felt that it was critical to build on the positive signals that we've already generated in the clinic and not take on new biological risk or further delay development by picking a new indication. We employed net present valuation, or NPV, as a tool to help frame the potential economic returns to shareholders on a risk-adjusted basis.
For those who are unaware of what NPV analysis is, it's essentially a form of a discounted cash flow method that's frequently used as a decision support tool when evaluating the potential risk-adjusted economic returns of a variety of different investment projects that a company could potentially pursue. The benefit of using this kind of an approach is that it allows us as the organization to consider multiple variables in tandem, such as disease epidemiology, patient segmentation, projected market share, probability of clinical success, pricing and reimbursement among other factors, all into a single model. This is a very standard method that I've used in the past at both large and small companies, particularly when we were trying to determine what projects we should pursue or in determining the price or the value of a potential transaction.
Following this line of reasoning, we determined at the end of our assessment that in addition to our efforts in HIV, the clinical signals that we generated in NASH and oncology are the most promising and will be the focus of future clinical development for leronlimab. Specifically, the opportunity in NASH will be a priority from an organizational resourcing and investment standpoint. We believe that the NASH market has many attractive features, and in our assessment, our most promising clinical signal is in NASH. Even on a risk-adjusted basis for probability of success in the clinic, the NASH market represents a multi-billion dollar valuation opportunity for leronlimab on its own. In addition to the broader NASH population, leronlimab may also be in a unique position to address a subpopulation of NASH patients with both HIV and NASH.
In a moment, Scott will be describing what that particular opportunity looks like in more detail. The near-term financing requirements for the company will be focused on re-entering clinical trials for NASH as expeditiously as possible. Now, while we do plan to continue development in oncology, our focus is gonna be narrowed to certain solid tumors to ensure that we can collect sufficient data in enough patients within select indications, mainly colorectal cancer, breast cancer and potentially in non-small cell lung cancer as a combination agent. Within colorectal cancer or CRC, we're gonna be looking at the metastatic microsatellite stable population. This represents about 85% of all the diagnosed cases of CRC. This particular segment of CRC hasn't seen any meaningful therapeutic advancements in nearly a decade. Excuse me. Yet the survival rates in our population have considerable room for improvement.
Similarly, within breast cancer, rather than focusing only on the triple-negative breast cancer population, which really only represents about 15% of the total breast cancer market and has seen increased competition with recent advancements for both checkpoint inhibitors and antibody drug conjugates, we're gonna expand our focus into hormone receptor-positive and HER2 negative population, which transfer roughly about 70% of the total market. We believe that metastatic CRC and breast cancer each represent large opportunities for leronlimab, and we believe that the mechanistic rationale for using the drug in those populations is quite strong for a CCR5 inhibitor. Let me be clear that we intend to run these cancer studies over a sufficient period of time that again, we can generate a robust and meaningful clinical data set that a potential partner would find compelling.
In order to bolster our capabilities in both NASH and oncology, we've added additional scientific advisory board members, Doctors Jordan Lake and Naoto Ueno, who are experts in NASH and oncology respectively. Additionally, Dr. Stefan Glück, formerly of Celgene and Regeneron, has come in as both an SAB member and as an advisor to the company. Scott will be speaking more about these additions shortly. Internally, we're seeking to bring in additional capabilities, specifically within clinical, medical, and quality functions. Now, strategy is all about making trade-offs, and in order for this strategy to work, we cannot, and really we must not, continue to pursue every possible indication in tandem. I wanna be clear that in the near term, the company will not be pursuing COVID treatment, either in the acute setting or in the long hauler setting. We will not be pursuing graft versus host disease.
We will not be pursuing stroke, and we will not be pursuing multiple sclerosis. By not pursuing these indications in the near term, it's gonna allow us to focus on the higher value opportunities that we have with NASH and oncology. Going forward, our external persona and corporate brand is gonna evolve to align with our new strategy, and I look forward to sharing more about that with you in the future. This is our mission, a moral obligation to generate therapies to improve people's lives. A focused and disciplined clinical development strategy. A value-generating path resulting in economic returns for our investors. I wanna thank you all for your continued support, and now I'll turn it over to Scott.
Thank you, Cyrus Arman. Before I begin introducing the new scientific advisory board members, I wanna address a recurring question I've received from investors regarding our new leadership. You know, when we first began our search for a new CEO, the board of directors at CytoDyn was focused on finding a unique individual with experience in corporate strategy and development, capital markets, licensing agreements, corporate governance with a firm scientific background, and the ability to be a strategic thinker. We needed someone who would not only understand the potential opportunities of leronlimab, but would execute on those opportunities. We believe we have found that person in Dr. Arman. I work with Dr. Arman on a daily basis. He's an analytical and methodical thinker. He is focused, and he works tirelessly.
He has a unique ability to understand the science, but can switch on a moment's notice to evaluate the business principles to support further advancement of an idea into a clear clinical path forward. He has chosen leronlimab after much due diligence. We believe leronlimab is now in the best of hands. One of the things that Dr. Arman and I agree on wholeheartedly is to focus and surround ourselves with people that we believe will make leronlimab a success with our current focus and initiatives. Under the leadership of Dr. Arman, I can tell you we believe our team has never been stronger, and the work we are currently doing is placing CytoDyn and leronlimab on the best potential path for success. As Dr. Arman mentioned, we do believe that leronlimab's role in HIV NASH is a unique opportunity.
We have the potential to assist with controlling the viral load while possibly helping to reduce steatosis and fibrosis. NASH is a complex disease, but it's even more complex in the HIV population. People living with HIV may have multiple comorbidities. The HIV virus may directly cause inflammation and fibrosis, while hepatotoxicity is associated with antiviral agents and steatosis. In addition, HIV causes leakiness in the gut barrier, resulting in increased levels of endotoxin reaching the liver through the portal circulation. There is evidence that HIV itself may even bind to hepatocytes with the CCR5 via the CCR5 receptor and trigger downstream cytokine responses that are both pro-inflammatory and pro-fibrotic in nature. In people living with HIV, the rate of NAFLD is approximately 50%, and the NASH rates are almost double the general population.
Due to the underlying diagnosis of HIV, most of these patients are excluded from clinical trials for NASH, and this represents an unmet medical need. Now I would like to introduce you to the newest members of our scientific advisory board that Dr. Arman had mentioned. We are very proud of this. Dr. Stefan Glück is the former Vice President of Global Medical Affairs at Celgene Corporation since October 2014 until its acquisition by Bristol-Myers Squibb for $74 billion in 2019. He then served as the VP and the Head of Global Franchise Oncology for Regeneron from March 2020 through March 2022. Prior to Celgene, he was a professor in the Department of Medicine at the University of Miami in Florida.
As VP of Global Medical Affairs at Celgene, he oversaw breast, ovarian, and bladder cancer activities worldwide for the Celgene Corporation as well as the Immuno-Oncology Program. He has been the principal investigator for 37 clinical studies in breast cancer. He has authored or co-authored over 250 articles. In addition, Dr. Glück has written or co-written a number of book chapters and numerous journal abstracts, and he has presented more than 350 papers at national and international meetings. He will be assisting us with identifying partnership opportunities, trial design, identifying collaborations, and solid tumor opportunities. I would now like to introduce you to Dr. Naoto Ueno. Dr. Naoto Ueno has a strong background in translational breast cancer research in the areas of cancer biology and molecular therapeutics.
He trained as a medical oncologist at MD Anderson and simultaneously learned how to conduct clinical research and perform data analysis related to breast cancer and ovarian cancer. He is now a practicing physician who has experience in conducting both targeted and gene therapy clinical trials. He has a strong interest in triple-negative breast cancer, inflammatory breast cancer, metastasis, cancer stem cells, and drug resistance of cancer cells. He will be assisting CytoDyn with trial design and identifying opportunities for collaboration and partnership. Next, I would like to introduce you to Dr. Jordan Lake. Dr. Lake is an Associate Professor of Medicine at UTHealth Houston. She completed both medical school and internal medicine residency at Baylor College of Medicine in Houston, Texas, followed by an infectious disease fellowship and Master of Science in Clinical Research degree program at UCLA. Dr.
Lake's outpatient practice focuses on HIV-infected adults. Her translational research portfolio, which is funded by the NIH and industry, focuses on the treatment of metabolic and aging-related complications of HIV and antiretroviral therapy, including optimization of care for HIV-infected individuals. Dr. Lake also serves as chair of the NIH Multicenter AIDS Cohort Study Metabolic Working Group, is an active member of the NIH-funded AIDS Clinical Trials Group, including service on multiple ACTG scientific committees and protocol leadership teams. Dr. Lake will also be assisting us with trial design for HIV and NASH and identifying collaborative opportunities. Antonio.
Thanks, Scott. I will be providing a brief update with regards to legal and financial today. With regards to legal matters, the company recently began mediation discussions with plaintiffs on the class action and derivative litigation. The company continues to cooperate with regulatory authorities with regards to the ongoing SEC and DOJ investigations. The Amarex dispute continues to be ongoing and at the recommendation of our legal counsel, we are unable to comment beyond that we have obtained our data from Amarex and an independent audit has been performed of the services which Amarex was contracted to perform. We continue ongoing discussions with Samsung to restructure outstanding past due amounts. In the interim, we continue to make monthly payments to Samsung for past due, current, and future services. We are doing our best to expeditiously and efficiently resolve the various legal matters facing the company.
When or if material events unfold, the company will appropriately update the public. As Cyrus described earlier, we have spent a significant amount of time and effort going through a planning process. We continue to stay focused on aligning spend with the immediate necessary objectives of the company, identifying areas for the reduction of expenditures, and focusing on stretching and making funds last as long as possible. At the end of August, the company's shareholders approved an increase to authorized shares. This increase not only allows the company to be able to continue to resolve and address some of our existing and future financial obligations, but also to have the flexibility to raise capital when non-dilutive alternatives are unavailable. Similar to other pre-revenue biotech companies, we require significant capital to support our success.
The current board and management are committed to using shares responsibly by raising capital at the most advantageous times and terms available at that time, and to use the capital raised to support focused execution of well-planned business objectives that we believe will promote maximum value creation. This concludes the presentation portion of today's webcast.
Thank you. At this time, we will be conducting a question and answer session. As a reminder, you may submit questions via the web by using the Ask a Question feature on the side of your screen. I will now turn the call over to Cristina De Leon.
Thank you. First question, the HIV combination therapy indication has a Fast Track designation and two of the three sections have been submitted to the FDA. Have you received any feedback on those pursuant to a rolling review?
Yes. We've taken advantage of the line of communication that we have with the FDA as it relates to the BLA for the HIV MDR population. The FDA has been very responsive with us through that channel. As mentioned earlier, we're performing an external audit of the collection and documentation of that clinical data. The results from that audit will inform our next steps with the BLA.
Thank you. The next question is a two-part question. When will you announce the data from the COVID Brazil trial? Why were Brazil trials in critical and severe COVID-19 shut down and is there a plan to restart them?
Yeah. We are working with our colleagues in Brazil to determine the proper time to unblind the data. The trials in Brazil were never put on clinical hold. CytoDyn's clinical team decided to pause the COVID-19 trials in Brazil as the DSMC had a scheduled predetermined date to evaluate safety within a few weeks. The DSMC met on April 1, 2022, and evaluated the safety portion only of the trial, not the efficacy portion. Their recommendation was to continue the trial with ongoing monitoring and interim analysis according to the trial protocol. We will continue to analyze the dynamics of the COVID-19 landscape as it unfolds with a particular emphasis on the critical COVID-19 population.
We've been in close contact with our colleagues in Brazil, and they do not believe at this time there's enough hospitalized patients in the severe and critical population to recommend continuing the trial at this time.
Next question, why weren't our oncology trial patients tracked beyond the date of their original breakthrough designation submission, as that would have allowed us to submit a follow-up submission based on the FDA's feedback?
Yeah. The patients that remain on leronlimab continue to be followed, but as we stated previously, we don't think it's enough of an adequate sample size to support a breakthrough designation.
On ClinicalTrials.gov, various trials of CytoDyn are mentioned with final completion data before today's webcast. CytoDyn should inform its shareholders regarding the results of these trials. One of these trials is a phase III trial in which leronlimab is prescribed as single agent therapy using 3 different dosages in 556 persons with HIV. More trials of CytoDyn are mentioned. Please inform us.
Yeah. Regarding the ClinicalTrials.gov, we are following our regulatory obligation to update ClinicalTrials.gov. Now, that monotherapy trial that you're referring to is not a pivotal trial. It was used to support really the safety of CD02. We've announced previously the results of the trials that have been completed.
What is the status of any lawsuit with Amarex, if there is one?
Yeah, I'll take that one. Under the advisement of our external counsel, we don't comment on ongoing legal matters.
Could you explain what you discovered about leronlimab and adverse side effects? I was under the impression that over the last three years in all the studies for COVID, mTNBC, NASH, and HIV, that one of the great advantages of leronlimab, it had an excellent record of very few side effects.
Yeah. When we look at the adverse event profile of leronlimab on a trial by trial basis, the therapy appears to be well-tolerated. As part of the ongoing work to lift the clinical hold, we're completing an aggregated safety analysis across all of the trials to determine if there's a pool safety signal.
Thank you. How does Patterson's recent patent for CCR5 blocking in long COVID-19 affect our efforts on that front? Are we still applying for that NIH grant for long COVID-19 research?
Yeah. Again, you know, given our redefined clinical development focus, which does not include COVID treatment in any setting, we don't see this as a concern to our business. Additionally, we do have other COVID-related IP that would protect leronlimab if we were to choose to do anything in that space in the near term. With regard to the NIH grant, our priority really is to complete our submission of all of the documentation for lifting the clinical hold before we would pursue any NIH opportunities for COVID.
How long does the FDA warning header need to be on the website?
Yeah. As mentioned earlier, we completed the warning letter closeout process and the header actually is no longer on the website as of at least a couple days.
Is the CytoDyn board and management just as open to a buyout as they are to a partnership?
Yeah. As fiduciaries of the company, we're committed to maximizing shareholder value, right? We would consider any buyout offer against the reasonable future valuation that we could expect. You know, ultimately, an acquisition would have to be approved by the shareholders anyway. I'll leave it at that.
Is the board happy with the company progress in their previously announced goal to streamline, organize, and reestablish confidence with outside agencies?
Hi, this is Tanya. I'll take that question. Yes, the board is pleased with the company's progress in rehabilitating its reputation with its key stakeholders. That said, we are aware that reputations are built on a foundation of not only communication, but also of actions that are consistent with the communicated principles. One key to cutting through barriers that might impede an organization's effort to reestablish confidence is senior leadership who are committed to the communicated ideals. When we hired him, we believe Dr. Arman shared the board's commitment to a strong corporate ethos. Throughout the first several months of his tenure, we have been pleased to witness Dr. Arman employ an unwavering commitment to strong and responsible corporate and governance practices. I guess I would just say also, as an athlete, I know that true strength comes from with time under tension.
To this end, we look forward to continuing to act in accordance with our stated principles to further increase stakeholder confidence.
Thank you, Tanya. Next question. Please provide an update on the glioblastoma indication.
Yeah, this is Scott. I'll take that. CytoDyn realizes that there are certain solid tumors such as GBM and pancreatic cancer that remain understudied by the drug development community, and we'll work with our KOLs to determine the appropriate path forward in those indications.
Thank you. This will be the final question on today's webcast. When will leronlimab be available for state or federal Right to Try or expanded access and compassionate use?
Yeah, I'll take that as well. This is something we are very proud of our efforts in Right to Try applications and compassionate use. That being said, we have been just absolutely overwhelmed with requests both internationally and domestically. We feel it is best for patients and our shareholders at this time to focus on the approval of leronlimab before we resume any other potential opportunities. Cyrus, would you like to provide closing remarks?
Yeah, sure. I, you know, I'd like to conclude by reiterating what I said earlier, that the future of the company is bright, and that I, along with the other key stakeholders, are committed to seeing leronlimab through to success, to helping patients, and to generating financial returns for all of our shareholders. Thank you.
Thank you. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.