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 your host, 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 CFO and Interim President, Antonio Migliarese, our Chief Medical Officer and Head of Business Development, Dr. Scott Kelly, and our Senior Director of Research and Development, Dr. Christopher Recknor. 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 reports filed with the Securities and Exchange Commission for more information about the risks and uncertainties that could cause actual results to differ materially versus our current expectations. I will now turn the webcast over to Antonio Migliarese.
Thank you, Cristina. Good afternoon, all, and thank you for joining us today for CytoDyn's quarterly update webcast. On today's call, we would like to provide you with a quarterly company update on past and future happenings with the company, followed by a brief Q&A session. Tanya and I will start off by providing an overall corporate strategy and business update, followed by Doctors Scott Kelly and Chris Recknor providing clinical R&D and business development related updates. This will then be followed by the Q&A session. I would like to briefly remind folks that as noted during our last investment community webcast at the end of March, we are now conducting regular quarterly webcasts to update the investment community. We continue to evaluate and refine our communication strategy to follow a more traditional cadence. We believe this will aid the company in rebuilding credibility.
Although we are not updating the market as frequently, we continue to work tirelessly to advance the organization. During our last call in March, we talked about our six-month strategy at the time being shaped around addressing the challenges facing the organization, restoring credibility, and determining our most advantageous path forward with the goal of maximizing shareholder value. We have executed on these initiatives over the last quarter by enhancing leadership with the board, president, CEO search, and scientific advisory board. We've continued to restore credibility with the scientific community. For example, Dr. Jay Lalezari recently agreed to re-engage with the company as a scientific advisor. The board continues to seek additional qualified board candidates with relevant experience. Lastly, Tanya will provide an update regarding the president CEO search. We also have been focused on addressing legal and financial issues.
We continue to seek to resolve legal issues such as the non-cash settlement of the litigation with the company's former CMO, Dr. Richard Pestell. We recently concluded a PIPE financing with Paulson Investment Company, resulting in net proceeds of approximately $19 million. We will also discuss today the need for additional authorized shares to allow the company to continue to have flexibility in obtaining capital if non-dilutive alternatives are unavailable. We have been addressing the clinical holds received for HIV and COVID-19 and strengthening our clinical operations and prioritizing patient safety. We have a strong project team in place and will provide an update on progress towards addressing the clinical holds. We will also provide an update on the paused COVID-19 resilient trials. We continue to analyze HIV data received from Amarex and revamping the timeline and activities needed for a successful BLA.
We will also provide an update on where the BLA stands. We recently presented final NASH data results at the EASL Congress in London, and Scott and Chris will further elaborate on this. Lastly, we have been identifying potential strategic partnerships to advance our development efforts and value creation with minimal investment from the company. Scott will provide an update on various programs and talk about some recent positive news with regards to HIV cure and an NIH grant. In addition, over the next quarter, the company will be focused on developing its future strategy beyond the six-month strategy we have been currently executing on, which has been primarily focused on stabilizing the organization and addressing existing challenges. We plan on announcing this at the next quarterly investment call. I will now pass the mic to Tanya, who will provide updates from the board.
Thank you, Antonio, and hello, everyone. Since our last call, the board has worked closely with executive management in an effort to refine the company's objectives with an emphasis on those needing to be achieved in the short and medium-term. During this time, the Company, led by the executive management team, has worked diligently and leveraged substantial resources in an effort to prepare the requisite deliverables for the FDA with a view toward lifting the partial clinical hold in HIV and the clinical hold in COVID-19. Other members of the board and I have been in frequent and direct communication with management to understand the clinical hold project management plan as it has been driven forward. Further, we have been working with management to understand financial and budgetary issues with an emphasis on paths to achieving financial efficiencies.
We serve to support management in its efforts to secure the recent financing. The board has also continued to interview potential candidates for the board of directors in an ongoing effort to supplement existing proficiencies with synergistic skills and thereby strengthen the board's overall capabilities. We have interviewed a number of potential candidates. It has been a pleasure to meet with such qualified and passionate professionals, and we look forward to the opportunity to announce the addition of the right talent. The CEO search committee has also been working since late January to identify the critical attributes we sought in this company's next leader. We hoped to identify a well-rounded leader who possessed several critical qualities, including a strong ethos, someone who would be dedicated to continuing the commitment to strong and responsible corporate and governance practices with a view to further strengthening the company's credibility.
We sought someone trained by Big Pharma, but with the ability to thrive in a more entrepreneurial environment. A person strong operationally and with a deep understanding of the science. A skilled communicator capable of speaking to the company stakeholders, including the FDA, potential partners, vendors, and shareholders like you. We felt it important that the person have a strong physical discipline and the ability to identify and recruit for any gaps in the company's management. The search committee also recognized that over the past several years, the company successfully developed substantial valuable data and identified several meaningful opportunities for its core technology, leronlimab. Data in hand, we know CytoDyn needs to focus and prioritize resources on the best prospects for leronlimab.
With this understanding, the search committee was intense on identifying a well-rounded leader with the previous described attributes, but who also stood out as an exceptional strategic thinker from both a business and clinical perspective. One candidate immediately separated himself from his competition, particularly with respect to the thorough level of due diligence he brought to bear on the opportunity. He personally spent countless hours meeting with management and reviewing and assessing the data in an effort to understand leronlimab's potential, the business, and the existing management's core capabilities. Further, as we proceeded through his interview process, it became clear that he is the embodiment of each of the attributes the committee sought and thus exactly what we believe this company needs to take it to the next level.
It is my true pleasure to announce that Dr. Cyrus Arman, PhD, has been named President of CytoDyn. Dr. Arman is anticipated to advance to chief executive officer and to join the company's board of directors within six months. During his initial term as president, Dr. Arman will devote substantial focus to the immediate operational needs of the company and to further developing and refining the company's strategic plans. Antonio Migliarese, who has served as interim president as well as chief financial officer since late January, will continue to serve as chief financial officer. Dr. Arman's employment with CytoDyn will begin July 9, 2022. Dr. Arman is reputed to be an exceptional first principle thinker, able to work through both scientific and commercial considerations to evaluate probabilities of success and sizing the market to develop different criteria for forced ranking opportunities.
Throughout his career, he has repeatedly led war game events where clients had to role-play as their own competitors in an effort to understand how the decisions fit in the larger context of their markets. He is known to be a quick learner, to be analytical and methodical in thought processes, a tireless worker, and to have an incomparable sense of duty. The board could not be more excited about Dr. Arman's incoming leadership, and he has our unanimous full support. Dr. Arman most recently has served as Chief Business Officer for Nimble Therapeutics, a peptide therapeutics drug development company, where he was responsible for leading transactions, finance acquisitions, and corporate strategy. Dr. Arman has 15 years of experience in corporate, clinical, and commercial strategy for biotechnology companies, including advising C-level management and boards of directors on strategy, transactional opportunities, financing, and risk management.
Arman's prior experience was as the Vice President of Corporate Development and Strategy at NEUVOGEN, Inc., an early-stage immuno-oncology company where he was responsible for corporate development, business operations, and corporate strategy functions. Prior to NEUVOGEN, he was a director in Amgen's corporate strategy unit. Dr. Arman began his career as a management consultant, where he advised clients in complex strategic projects involving multi-billion-dollar business development investments and partnerships in both the biopharma and diagnostic sectors. He has an MBA from the University of California, Los Angeles, a PhD in Neuroscience, and an MS in Biomedical Engineering from the University of Southern California, and a BS in Biopsychology from the University of California, San Diego. About his impending start with the company, Dr. Arman said, "I am very excited to be joining CytoDyn.
I believe the company has extremely promising prospects with leronlimab that will benefit patients and create shareholder value. I look forward to working with the team to elucidate a disciplined go-forward strategy and then execute on it. Finally, I would be remiss if I did not thank Antonio Migliarese for his capable and tireless leadership as our Interim President. Thank you, Antonio. With that, I will turn it back over to you.
Thank you, Tanya. I was going to provide a brief update on legal and financial issues, but prior to that, I just wanted to make a few comments regarding Dr. Arman. I had the opportunity to spend quite a bit of time with Cyrus over the last couple of months, both in person and virtually. Cyrus was by far the most impressive candidate, not just from an intellect and experience standpoint, but also from a character perspective. After personally sitting in the interim president role for the last five months and experiencing firsthand what skills the company will most benefit from, I am confident that Cyrus has the perfect skill set, experience, and track record which CytoDyn needs today to advance the organization to the next level. From a cultural perspective, he is humble and a person of high moral integrity, making him a strong leader.
In addition to his leadership values, the company will greatly and immediately benefit from Cyrus's strategic abilities in maximizing value regarding ranking various opportunities and indications, determining the clinical development path forward to advance the indication, and identifying partners to fund and advance the program. He is also a great fit as he has the experience working in big pharma, but is very entrepreneurial and has thrived at growing organizations, which is the key to being successful at a pre-revenue biotech startup organization such as CytoDyn. I am quite excited that Cyrus will be leading CytoDyn into the future. Next, with regards to legal matters, in May, we announced a non-cash legal settlement with regards to an ongoing litigation with the company's former CMO, Dr. Richard Pestell, and are pleased to be able to restore the company's relationship with him as well.
With regards to the ongoing SEC and DOJ investigations, the company is fully cooperating. With regards to the Amarex dispute, we obtained our data from Amarex, and an independent audit has been performed of the services which Amarex was contracted to perform. This dispute is currently ongoing, and at the recommendation of our legal counsel, we are unable to comment on the status at this time. We are also currently working with Samsung Biologics regarding past due amounts and the related purported breach of contract. We are in negotiations to restructure the outstanding past due amounts, and in the interim, we are making monthly payments in addition to prepaying future services. We are doing our best to expeditiously and efficiently wrap up these and other various legal matters of the company.
With regards to company finances, since the change in leadership, we have spent a significant amount of time and effort going through a strategic planning and budgeting process. As part of this process, we created a plan and budget that is focused on aligning spend with the immediate and necessary objectives of the company previously described. During this process, we have gone through various budget iterations, which include the reduction of expenditures and resources to ensure that we are focusing our spending on areas that are essential to the company and its current objectives. Included in these expense reductions is the reduction of executive management cash salaries by 25% and issuing equity in lieu. We recently completed a PIPE financing round with Paulson Investment Company, which resulted in net proceeds of approximately $19 million to the company.
We are focused on stretching and making funds raised last as long as possible and are focused on various types of minimal and non-dilutive financing. After the completion of this latest financing round, the company will need to seek shareholder approval of additional authorized shares to not only resolve and address existing and future financial obligations, but also to have the flexibility to raise capital if non-dilutive alternatives are unavailable. Similar to all other pre-revenue biotech companies, we require significant capital to support our future success. The current board and management are committed to using shares responsibly by raising capital at the most advantageous times and terms available, and by using the capital raised to support focused execution of well-planned business objectives, which we believe will result in maximum value creation.
I will now pass it along to Dr. Scott Kelly, who will provide updates with regards to clinical R&D and business development.
Thank you, Antonio. I'd like to begin by addressing the partial clinical hold in our HIV program and clinical hold on our COVID-19 program. The revised project management timeline for submitting the necessary materials is September of this year.
Our initial time frame of 8-12 weeks was dependent on us being provided data from our former CRO according to industry standard. In the process of analyzing the data in conjunction with our pharmacovigilance experts, we realized we needed to convert the data into industry standard format. To be clear, we have the data. It is really a data conversion issue. Unforeseen data quality and other data-related issues remain a risk that could impact the timeline. Antonio, do you want to add some color on this?
Sure. Thanks, Scott. One of the things we just wanted to highlight is that addressing the clinical hold is our number one priority as an organization, and this is an all-hands on deck effort. As we mentioned earlier, we have a strong project team in place, which is led internally by our two top performers who have vast industry experience, including an internal project manager. This is led by our Senior Director of Clinical Operations, Joseph Meidling, and our Vice President of Project Management, Bernie Cunningham. We've additionally engaged a clinical research organization that has deep experience and resources in the areas of pharmacovigilance, safety base, safety database management analysis. We also have a regulatory consulting firm assisting us with the preparation and review of the various regulatory communications. Lastly, we have begun to work with an overall regulatory strategy advising group.
This group is one of the most reputable FDA regulatory consulting firms led by former FDA regulators. To provide a little more color on our project management, this team has a line-by-line detailed project plan with tasks, timelines, and milestones for which various team members are accountable. Our team holds a series of meetings designed to check in and discuss progress towards milestones, roadblocks, and risks to the critical path. These meetings occur at various intervals throughout the week and the month. This allows us to identify issues as quickly as possible to troubleshoot and identify ways to overcome them and the impacts on our overall timeline. Further, this also allows us to identify opportunities to bring in additional resources and where, and if possible, to expedite progress and timelines. Scott.
Yeah. Thanks, Antonio. I'd like to begin by addressing the pausing for our COVID-19 Brazil trials and the consideration to potentially 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 Data Safety Monitoring Board (DSMB) had a scheduled predetermined date to evaluate safety within a few weeks. The DSMB evaluated the safety portion only of the trial, not the efficacy, but the recommendation was to continue the trial with ongoing monitoring and interim analysis according to the trial protocol. We are currently waiting to hear from Anvisa. As we wait for approval to proceed with the trial, 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.
Regarding the unblinding of the data, we have had many people ask us about the potential to unblind the data early. We are considering all options and are working with our team, including our own statistician, our Einstein clinical team in Brazil, Einstein statisticians, as well as our partner, Biomm. Updates on our clinical programs regarding HIV. First, in regards to the HIV BLA, there's been some concerns that we are abandoning the BLA for HIV. To be clear, we are not abandoning the HIV BLA. We're currently working to achieve the deliverables required by the FDA to lift the clinical hold. We have requested a Type C meeting with the FDA to gain further guidance with respect to completion of the BLA.
Once we achieve the lift on clinical hold and receive further clarity from our Type C meeting request from the FDA, we'll be in a better position to provide an updated timeline and analysis. Now, as Antonio mentioned, we do have some very exciting news regarding an NIH grant for HIV cure. We will be announcing this shortly, but OHSU has received an approximately $5 million grant from the National Institutes of Health or the NIH, to evaluate the role of leronlimab in HIV cure. The project director is Dr. Jonah Sacha. As you are aware, only three people have ever been cured of HIV, and they received immune cells void of the CCR5 receptor, which is the same receptor that leronlimab blocks. What's unique about this grant centers around the technology. We'll be using an AAV vector, which delivers a gene-encoded leronlimab into immune cells.
Adenovirus is a promising vector platform due to the safety and ability to stimulate immune responses in multiple species. This is essentially a gene therapy designed to induce the body to produce leronlimab, and if successful, this work could lead to a single injection that suppresses HIV replication long term without needing antiretroviral therapy. This is one of the many projects we are working on to obtain non-dilutive capital financing of trials. We'll keep you up to date as these progress. Regarding long-acting leronlimab, we believe that the future of HIV treatment is long-acting injectables. We know that leronlimab can persist for three months, and we believe this could impact the pre-exposure prophylaxis market as well as the combination therapy market. This could obviously be a game changer in HIV.
For HIV and NASH, you know, HIV and NASH patients have multiple risk factors, including inflammation from HIV infection, heart therapy, as well as bacterial translocation. Liver disease is 13%-18% of all-cause mortality in HIV-infected patients. Liver disease is one of the leading causes of non-AIDS related death. Many of these HIV patients are excluded from the current NASH trials due to hepatic limitations, and it's hypothesized that the HIV virus may cause direct injury to the liver. I'll now turn it over to Dr. Chris Recknor, who will give us some other updates on R&D as well as NASH. Dr. Recknor?
Thanks, Dr. Kelly, and thanks for the investors calling in. We've made good progress on investigating the mechanism of action of leronlimab and wanted to give an update. We believe leronlimab may work in several different ways, and understanding how leronlimab works informs us about potential clinical development and helps us to identify key strategic partners with synergistic opportunities looking for key biomarkers and mechanisms of action. Dr. Kelly mentioned the issues that HIV patients have with liver inflammation, and it is significant. The mechanism for preventing HIV for viral entry for leronlimab is thought to be related to coating or binding of CCR5 to prevent HIV from entering the cells.
In our Phase III HIV trial CD03, we showed a reduction in plasma HIV with leronlimab 350 mg versus placebo with a p-value of 0.0032 that extended to a 24-week extension phase, whereby 80% of patients remaining in follow-up had HIV RNA levels less than 50 copies per mL. The interesting thing is they also had improved CD4 counts. In addition to viral entry inhibition, leronlimab appears to work as an immunomodulator such that at lower doses may reduce inflammation, but yet at higher doses may affect the immune system by increasing CD8 and natural killer cells. This places our company in the unique position to be able to look at both pathways where most drugs aren't able to perform.
There are two places that leronlimab can bind to CCR5, and the inflammation or immunomodulation may work by one leronlimab binding simultaneously to two regions on CCR5 to alter the geometry of the receptor and hence its function. If you have higher doses or amounts of leronlimab, individual binding in a one-to-one ratio, in other words, one leronlimab for each binding site, may lock the receptor in place without a conformational change. We're investigating how this works in the lab, but it's interesting because we are looking at different doses and seeing different ways that leronlimab can work. On June 25th, Dr. Mazen Noureddin, a NASH key opinion leader, presented a poster at EASL, the EASL conference about NASH01, which was an exploratory phase two clinical study of leronlimab in patients with a diagnosis of NASH and baseline MRI showing fatty liver and fibroinflammation.
The main part of the study, part one, was randomized comparing treatment of leronlimab 700 mg to placebo. There was also a non-randomized open label part of the study, part two, that after completion of enrollment in the randomized phase, enrolled additional patients according to the same inclusion/exclusion criteria, but assigned them to 350 mg of leronlimab, allowing us the opportunity to compare 700 versus placebo and 350 to placebo and to look at the effects of biomarkers. The primary and secondary endpoints, MRI liver fat by PDFF and MRI liver fibroinflammation cT1, were not met for the 700 mg group in part one in this exploratory study of leronlimab for the treatment of NASH. However, in part two, PDFF and cT1 were reduced in the 350 mg group compared to placebo.
Additionally, these reductions correlated with reductions in key biomarkers known to be associated with NASH. There are genetic differences in CCR5 that have been studied as related to the risk for HIV and HIV progression. In some CCR5 haplotypes overproduce CCR5, thus increasing the risk for HIV because there's more CCR5 that the virus can enter. Since these patients have increased CCR5 from these HIV studies, we hypothesized that they may need more leronlimab in the NASH study, and an exploratory analysis showed a 28% reduction in MRI PDFF with corresponding reductions in MRI cT1 fibroinflammation for patients with overexpressed CCR5 haplotypes when treated with 700 mg of leronlimab. The numbers of patients were small, representing only 23% of those in the 700 mg group.
We noticed key distinct changes in biomarkers for this haplotype group, perhaps suggestive that these CCR5 haplotype patients may have a different etiology for NASH, but further exploratory studies need to be performed. Leronlimab binding to CCR5 is thought to be potentially associated with alterations in CCL5 or RANTES. In NASH, this exploratory biomarker analyses showed that the leronlimab reduces CCL5 and other chemokines, CCL2, 3, 11, and 18. These chemokines act as a beacon to attract other cells into the area. This is really big because we thought we just worked on CCL5, but we're also working on CCL2, 3, 11, and 18. In NASH studies, we can see correlations between CCL3, which is macrophage inflammatory protein alpha one levels, and they increase with the severity of NASH on biopsies.
Patients with full-blown NASH show the highest CCL3 levels, but leronlimab reduced mean CCL3 with 350 mg compared to placebo from baseline to week 14. CCL2 is another one that moves monocytes called monocyte chemotactic protein, and is a key biomarker associated with NASH. Leronlimab reduced mean CCL2 from baseline to week 14 in the 350 mg group compared to placebo. Now, when Dr. Kelly was talking about HIV and NASH, this has great application because CCL2 applied to the treatment of HIV patients is important because lower CCL2 levels correlates with less viral replication in effective macrophages, less rapid seeding of the latent HIV viral reservoir, and less chance, very importantly, of HIV central nervous system invasion.
The ability to reduce CCL2 may have application to HIV and NASH and may really position leronlimab very effectively to help patients. One other key biomarker is VCAM or vascular cell adhesion molecule. This is very important because VCAM allows immune cells to migrate through blood vessel walls. We did not know leronlimab reduces VCAM until NASH, but we have now observed a reduction from mean change to baseline in week 14 for the NASH 350-mg group for VCAM. This is very important because it has application to other inflammatory markers that are reduced. Further trials need to be conducted with larger numbers, but the exploratory biomarker analyses may be very relevant for informing about future research in other disease states, including cancer. Dr. Kelly, can you provide an update on oncology?
Yes. Chris left with the perfect thing about VCAM, because we do believe that VCAM is very important for oncology and leronlimab. What we're doing now is we're currently evaluating opportunities with our KOLs moving forward in the metastatic triple-negative breast cancer program for leronlimab, in combination with the current standard of care as well as a colon cancer trial. We have animal and human data for metastatic triple-negative breast cancer, as well as animal data on the effects of leronlimab on colon cancer. We are very encouraged by the exploratory biomarker data from NASH at the 350 mg dose, as many of the biomarkers that leronlimab appear to affect in NASH are important for our oncology program, and this exploratory data may inform future trials in oncology. Regarding our COVID-19 long haulers program, I wanted to provide an update.
We were very excited that we recently published a paper in Clinical Infectious Diseases. We do think that there is a real opportunity in COVID-19 long haulers, but we also recognize some challenges, such as trial design and the path to regulatory approval. We're actively trying to identify appropriate government grant opportunities to fund the study. We've also had some questions about patents that I'd like to address because there's been some confusion. I want people to understand that we have a highly qualified boutique firm that has handled our IP portfolio for many years. Now, since leronlimab is a biologic, it will receive 12 years of exclusivity, if approved.
Now, the original patent filed for composition of matter does expire in 2023, but the concentrated protein formulation does not expire until 2031, and this is what is being used in all of our clinical studies. We will also pursue methods of use patents, which is using leronlimab in a novel way across many indications. For partnerships, we will continue to pursue partnerships both internationally and domestically for pharma companies, academic institutions, and government funding. We're doing this across multiple indications, and we will announce any progress to investors when appropriate. Regarding presentations and publications, this has been very exciting for scientific credibility. We did have a poster presentation at the San Antonio Breast Cancer Symposium in December of 2021.
We had a poster presentation at the American Association of Cancer Research on April 11, 2022 by Dan Adams of Creatv MicroTech. We had a poster presentation at EASL, the International Liver Congress in London on June 25, 2022, for which I was present. It was a walking poster tour with the chairman, and we are submitting more data to other conferences. We also had an online abstract at ASCO, which is the American Society of Clinical Oncology, regarding leronlimab by Dan Adams of Creatv MicroTech. Regarding publications, we published an HIV monotherapy paper, which was entitled Suppression of Human and Simian Immunodeficiency Virus Replication with the CCR5 specific antibody leronlimab in two different species. We also submitted a paper on HIV MDR regarding our CD02 trial, and we're awaiting response.
We did also have the COVID-19 long haulers paper, which many of you are aware of, which was published in Clinical Infectious Diseases. With that, Cristina, let's proceed with Q&A, please.
Thank you, Scott. The first question. I am hopeful to hear some positive news on the science and want to understand the impacts of ongoing clinical holds as well as the HIV BLA process. I honestly expected this submittal last year, and I'm seriously concerned that while we have a molecule that appears to work based on the mechanism of action, in vitro, et cetera. Can you please speak to impacted time frames and list future expected dates for hiring a CEO and any pertinent corporate actions?
Sure. I'll take the positive news on the science first. We are very encouraged by the effect of leronlimab on the biomarkers in NASH. Many of these same biomarkers are supported by the literature to be important in our oncology program, including CCL2, CCL5, CCL18, VCAM, and VEGF. Some of these biomarkers also correlate with the potential to decrease metastasis, control the tumor microenvironment, and correlate with anti-fibrosis in NASH. We're also seeing some potential benefits of certain biomarkers in cardiovascular disease. We're working diligently to lift the clinical holds by providing the necessary materials to the FDA and request of the Type C meeting. Tanya has already addressed the CEO position or President CEO position, and we are very pleased with our choice.
Next question. Why isn't the company publicizing presentations and studies? Has NASH data attracted partnerships? Has the Amarex issue permanently damaged the BLA application?
Okay, I'll begin with the first question. We certainly acknowledge being more metered and conservative in our publicity, but we will be announcing important presentations and studies on a going-forward basis. Regarding the NASH, people have asked about how NASH has attracted partnerships. We just presented the PDFF, cT1 and biomarker data at EASL in London. Just to shed some color on the importance of the EASL meeting, there were over 7,000 delegates present or online from 114 countries. There were 1,722 abstracts presented. There were only four poster presentations selected for a walking tour of the chairman of EASL, and we were one of those four. I was present and can tell you it was well received by the scientific community.
We can't comment on potential partnerships, but we believe there's multiple opportunities for NASH and HIV.
With regards to the Amarex question.
Yeah, Antonio.
At the recommendation of our legal team, we're unable to comment on the Amarex dispute at this time.
Okay, thank you.
Okay.
When will the interim analysis of the Brazil COVID trial be released? How much cash is on hand? Any plans for future funding? Are any partnerships soon to be announced? Where are you on any breakthrough designations?
Okay. First, the interim analysis. We're currently evaluating the landscape of the COVID-19 opportunity in Brazil, but have not made the decision regarding interim analysis. Regarding cash on hand, Antonio.
Yep. As of our last 10-Q for the quarter ended February twenty-eighth, we reported approximately $2.4 million in cash. As previously discussed, we recently completed a PIPE financing transaction, which resulted in approximately $19 million of net proceeds to the company. As we look forward, we will continue to evaluate all financing options, including minimal and non-dilutive alternatives if available.
Okay. Regarding the partnerships, as we discussed, we're unable to comment on the partnerships. In breakthrough designations, we don't have any breakthrough designation applications at this time, but we do have fast track status for both metastatic triple-negative breast cancer as well as the HIV multidrug-resistant population. Next.
How long until the Amarex dispute is completed?
Antonio.
I think as I mentioned earlier, we can't comment. What I can say is we've obtained the data from Amarex. An independent audit has been performed of the services which Amarex was contracted to perform. We have upcoming meetings with the FDA with regards to the BLA, and the dispute is ongoing, but outside of that, we can't comment on timelines, et cetera.
Okay.
Thank you. What precisely is the status of the attempt to get leronlimab approved for treatment of NASH? When can we expect those 700 mg results on NASH? If they are available, what are those results, and what is the pathway to approval by the FDA?
Okay, we've announced the 700 mg results already, and we are very encouraged that the 350 mg dose reduced PDFF and cT1 as well as the biomarker data. We will be working on the clinical development plan with the guidance of the FDA. Regarding metastatic triple-negative breast cancer, we plan on doing an investigational trial with the current standard of care. AACR will be intimately involved in this. Once we have these results, we will then request a meeting with the FDA for further clinical development plans for approval.
Thank you. Did Canada grant use to any patients with metastatic breast cancer? If so, how many? Are they included in the studies?
We did have one CSP patient in Canada that was not included in the trials. We've had a lot more requests, but due to overwhelming demand we did not proceed.
Why did the Philippines fall apart?
I wouldn't say that the Philippines fell apart. We maintain our relationship with interested parties in the Philippines and are considering other opportunities while we focus on lifting the clinical hold in the U.S.
Thank you. Next question. Are we still trying for a listing on a stock exchange? If so, which exchange?
Antonio.
Oh, yep. We currently are not actively seeking an uplist. However, we plan on revisiting this in the future when we are better positioned to be successful in such undertaking, including but not limited to resolving current legal and regulatory issues, seasoning of the company's stock price, and curing our going concern opinion and stockholders' deficit.
Thank you. Will the BLA be abandoned due to insurmountable flaws so the company can pursue more promising indications?
Yeah. We are not abandoning the HIV BLA, but we do have promising indications other than the HIV BLA, and those include oncology, NASH, among others.
There is a new initiative at the FDA Accelerated Cancer Program. Are there plans to approach the FDA regarding this program?
Yeah. I believe the question is centered around the concept of Project FrontRunner, which was initiated by the FDA Oncology Chief, Dr. Richard Pazdur. Normally, accelerated approvals for oncology drugs are reserved for later stages of treatment, and this initiative will push for accelerated approvals earlier in treatment. I truly applaud Dr. Pazdur for doing this, because the earlier you intervene in cancer, the less you might need the later line indications. My understanding is that it'll be later this year before it goes into effect. Yes, we will be pursuing this opportunity.
Brazil COVID cases are recently surging again. I understand CytoDyn have requested Anvisa to reinitiate the trials. What is the status? Is the company still intending to complete the trials there?
No. I would be in agreement with that COVID cases have recently been surging. That being said, the majority of cases have been milder and not the severe to critical population, which of course is where we believe leronlimab may have the most potential benefit. In Brazil, they have one of the top vaccination initiatives in the world, and it's been reported that the symptomatic cases of COVID-19 have dropped by 80% since the start of mass vaccination. Related hospitalizations have dropped by 86% and deaths by 95%. We have been in regular contact with our Brazilian colleagues and are monitoring the situation very closely.
Do we have to file a patent for each indication we use leronlimab on, or is one patent overreaching?
Yeah, that's a good question. Again, to emphasize, our protein concentration formula that has been used in all of our clinical trials lasts until 2031. Now, upon approval, biologics get 12 years of exclusivity, so we will continue to pursue methods of use patents, which is essentially patents for leronlimab in various indications based on mechanism of action.
Is GlaxoSmithKline a good match for a leronlimab buyout as they roll out Haleon and their new Q-Block manufacturing plant for HIV?
I can't speak for GSK, but Haleon, as I understand it, is basically a way for GSK to separate its consumer healthcare business from GSK. I believe what they're doing is looking to increase their portfolio of brands. GSK has stated that it expects to deliver organic sales growth of at least 4%-6% through this new venture in the medium term. This does bring up a very important point. The entire biopharma industry is expected by Wall Street to have a 7.5% growth rate annually, but that growth rate is expected to drop to 2.6% by 2024. This anticipated drop in annual growth may well create greater opportunities for companies with late-stage assets as pharmaceutical companies explore more efficient paths to regulatory approval for new drugs.
Has CytoDyn seriously approached NIH, Department of Health and Human Services at all to consider a transfer of leronlimab directly to U.S. government under eminent domain acquisition?
Yeah, eminent domain in the United States refers to the power of a state or the federal government to take the private property for public use while requiring just compensation to be given to the original owner. We have not approached the government about this, but we do continue to explore other potential opportunities to work with the government where leronlimab is concerned.
What is the status of the investigational monotherapy trial?
This trial has been completed and the data is being used for safety for our HIV multi-drug resistance BLA.
Why were extended use of HIV leronlimab patients terminated by the FDA and forced to find another treatment, find other treatments when reportedly leronlimab was keeping them alive and many in remission? Did Charlie Sheen find new medication?
It was required by the FDA due to the partial clinical hold for HIV as other treatment options were available for these patients. I can't comment on Charlie Sheen.
Thank you. When will Scott Kelly's presentation on mTNBC and Dr. Mazen Noureddin's on NASH be available on the company's website?
Yeah. My presentation on metastatic triple-negative breast cancer was on the website from, I believe, April of 2021 until the beginning of this year. We just took it down while we were revising our website. Dr. Mazen Noureddin's presentation on NASH, which I believe he did a fantastic job, was not recorded, but was very well received by the scientific community.
Lastly, rumors are that management is taking compensation in equity or part equity. Can they elaborate on this topic and clarify what percentage, if any, is being distributed in stock and what type of restrictions are on the stock?
Antonio, you wanna take that?
Yep. As previously discussed earlier in the presentation, as part of cash expenditure reductions, executive management has agreed to reduce cash salaries by 25% and issuing stock in lieu of that from the company's equity incentive plan. These shares are unrestricted and are subject to Section 16 reporting requirements. This is beneficial to the company from a cash and equity availability standpoint, as it's cheaper than using funds raised as the stock is issued at current fair market value, and there's no warrant coverage associated with the issuances.
Thank you, Antonio.
That's it.
This has concluded the Q&A session. Scott, do you have any closing comments?
Yeah, sure. In closing, I just wanna thank you all for your time this afternoon. You know, we believe we've made significant progress on many fronts, including enhancing the independence of our board of directors, our president CEO search, and the progress of leronlimab. You know, a lot of people are asking questions regarding pursuing multiple opportunities for leronlimab, and I want people to understand our thinking behind this. I'll use Humira as an example. If you know, if you look at Humira, it stands for human monoclonal antibody in rheumatoid arthritis, and it's one of the best-selling drugs of all time. What AbbVie did that was so brilliant was they took the target tumor necrosis factor, and that target is important across multiple indications. They have 14 global and 10 U.S. approved indications, and we're trying to do exactly the same thing.
You know, it's a very cost-effective way to do drug development. Our target is the CCR5 receptor, and if one looks at the literature, you will find it has been implicated in many different indications, including HIV, NASH, and oncology. We will be actively pursuing partnerships to realize the true potential of leronlimab in these indications. Thank you again for your time. Antonio, do you have anything to add?
Yeah. Thank you, Scott, and I'll just have a quick closing comment. Thank you to our, all of our shareholders who took the time to join us today. We are excited about continuing to execute on our near-term objectives, which, as previously mentioned, have been primarily focused on stabilizing the organization and addressing the existing challenges. This ultimately sets the stage for Cyrus to lead CytoDyn into its next phase of success. Thank you for everybody's continued support, and this concludes today's webcast.
Thank you.
Thank you, everybody.
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