7/24/23 Webcast Transcript:
3:12, Antonio Migliarese: Thank you Christina. Good Afternoon All and thank you for joining us today for CytoDyn's Quarterly Update Webcast. Before we get started, I do want to mention, that we had planned for Dr. Scott Hansen to join us today, however, unfortunately, he has been unable to join due to becoming ill. However on todays call, we will be providing you a company update covering both recent happenings and pitted developments in the coming months. We thank those of you who have submitted questions in advance of the call. We have received a number of question from investors and this webcast has been structured to cover as many of those questions as we are able to appropriately address at this time during the webcast.
3:55: As we get started today, I would like to spend a couple of minutes going over a couple of things. Over the last 18 months, CytoDyn has been going through a rebuilding and a transformation which starts with having the right people with the right values, the right processes, the right credibility and the right molecule. I will add that we believe we are lucky enough to be starting with a quite strong foundation as we believe and we continue to believe that LL is indeed a very, very special molecule. In addition, we have determined a short term, mid term and long term strategy which we have been executing against.
4:37: We have a new board of directors, a leadership team and group of advisors in addition to our team, who all have been aggressively hard at work, executing on these objectives. Although, it may not be immediately apparent, we have made immense progress and implemented changes that we believe have reset the foundation of the organization for success while bearing in mind that success doesn't happen overnight, rather success is an accumulation of changes and actions over periods of time. The objectives that we have been working on consist of the following which we will dive deeper into during today's webcast. We have strengthened the leadership of the organization and will continue to do so including our search for CEO. We believe we have the strongest team in place to date at the organization.
5:31: We have taken a major step in the Amarex litigation by filing a statement of claim and securing the necessary financing to pursue this case to the finish line, which we do believe will result in significant benefit to the company. We have and continue to reduce in the line expenditure and resources with key value creating objectives to the organization. We have made substantial progress on the HIV partial clinical hold including the hosting of an advisory board meeting comprised of HIV patient advocate and Key Opinion Leaders which has been the next major milestone in our resubmission process which we will further discuss in a minute. In addition, we have added impressive, well experienced advisors to work on this submission. This continues to be the top priority of the company, in order to restore credibility with the FDA and to continue advancing this molecule.
6:35: We have made significant advancements in the NASH program with the further development of a Phase 2B / 3 clinical trial protocol. In addition, we have begun to design a preclinical study, which we have been advised, significantly increases our probability of identifying a potential NASH strategic partner, which we will also be further discussing today.
7:01: Dr. Jonah Sacha and OHSU continue performing studies related to HIV for the company and we have begun the development process of a longer acting molecule through a partnership with a generative, artificial intelligence, drug discovery and development company which we are very excited about. This long acting molecule is vital for the long term strategy of the company as it will allow us to significantly increase our patent portfolio protection.
7:35: Before we dive further into these topics today, I would like to briefly touch base on the company's communication strategy. Over the last 18 months, the pendulum has swung completely to the opposite side of where it had been, with regards to our communication strategy. This was the result of some of the regulatory and legal issues the company has been subject to and is still currently working through. We are aware that the pendulum has probably swung too far, and is what tends to happen when adjustments are made. We are in the process of revisiting this strategy and expect to make some changes that we think investors will really appreciate. However, I also do want to take this time to remind everyone that as a publicly traded company, we must be careful with what we communicate and when. And also, that SEC regulations do require us to disclose material events so investors are made aware of them in due course. In particular, announcing the company impressions or conclusions about our communications with the FDA, could hurt our chances of resolving issues and undermine our relationship with the FDA which we are hard at work at repairing. I can also assure everyone, although we are not issuing press releases as frequently, that does not mean we are not diligently working on and advancing company initiatives on a daily basis. We continue to be working expeditiously and in good faith to resolve the outstanding issues with the FDA and to advance company objectives.
9:20: We do appreciate everyone's patience with this. We believe that investors will be pleased with some of the communication strategy changes that will be made as a result of the review of our strategy. I will now hand it off to Tanya Urbach, our board chair.
9:38: Tanya Urbach: Thank you Antonio. I very much appreciate the opportunity to be here to speak with everyone today. Recently, Dr. Arman returned to the company following his medial leave in his new capacity as Senior VP of Business Operations. On behalf of the board, I would like to thank Cyrus for his capable leadership during this past year and I know I speak for the whole company when I say, we are happy to have him back contributing towards the important work of demonstrating efficacy and commercial viability for the ultimate benefit of patients and shareholders alike. We are all tremendously grateful to Antonio Migliarese who was once again willing to step in and leverage his interim executive knowhow, to maintain stability, as the board searches for the next CEO of CytoDyn. The board has recently begun its efforts to recruit, interview and retain, a highly qualified CEO to guide the company. To that end, we are engaged with an executive search firm and have leveraged corporate partners and board members in our effort to identify exceptional CEO candidates. I have great confidence in our ability to successfully retain a seasoned executive with the right mix of ethical leadership scientific knowhow and financial backing to drive CytoDyn forward. In the interim, I am gratified to note that with recent additions, CytoDyn has, without a doubt, the strongest mix of just these attributes that it has had through my entire tenure on the board of directors. As such, the company is well positioned to effectively advance corporate objectives during the CEO search period. And, we expect to announce several positive developments in the coming months. Finally, as always, the board remains focused on its key objectives: Providing Strategic Direction, including related to the company clinical development objectives and pipeline development; Overseeing budgetary goals and insuring the company has sufficient financial resources and Advising Senior Management on the next basis. Thank you. Antonio:
12:12 Antonio Migliarese: Thank you Tanya. Next we are going to jump into the Amarex litigation which Tyler Block, our corporate counsel, will be providing some input on as well. We previously announced that we filed a statement claims against Amarex which we are quite pleased about. For those who don't remember, Amarex was our former CRO and we are seeking damages in excess of $100 million from them. Following of the statement of claim, the very important next step in the litigation, the company believes that it is in a good position to fully pursue this litigation, as in addition to the financing, the company has secured from the litigation, the company has also posted and secured $6.5 million to collateralize assurety bond related to this matter. We are very bullish on the outcome of this litigation. In particular, due to the results of independent audits, that have been performed on Amarex's work, as well as the results of Audits performed by the FDA, which resulted in regulatory action against Amarex, which we have become aware of. The company will do everything in its power, to pursue the maximum recovery possible from Amarex and its parent company NSF.
13:33: As mentioned, our corporate counsel, Tyler Block, has joined us here today, and he will provide some more color around the specifics of the Amarex litigation. Tyler.
13:45 Tyler Block (Attorney, Corporate Counsel): Thank you Antonio. As Antonio just explained, the company is well positioned to aggressively pursue our claim against Amarex and we have instructed Sidley Austin, the law firm representing the company, to take all steps necessary to maximize recovery. It is through this claim, that we will be pursuing all damages the company incurred as a result of Amarex's misconduct. Whether it be due to Amarex's failure to perform services to an acceptable professional standard, Amarex billing the company for services that it did not perform or whether it relates to the 10's of millions of dollars, the company was forced to incur to remedy the issues created by Amarex's numerous and blatant failures. In total, we will be seeking not less than $100 million in damages. We are confident in our case and have one of the preeminent litigation firms in the world representing the company in this preceding. On behalf of the company, Sidley Austin recently filed a detailed statement of claim and requested the final hearing date be set. Should we prevail at the final hearing, we will be entitled to recover our damages caused by Amarex, as well as our legal fees incurred in pursuing the matter. Finally, I wanted to acknowledge that we have indeed received a number of questions from investors in relation to the law suit against Amarex. As the litigation is still pending, it would not be prudent, to disclose additional details at this time, needless to say, that we do not want to put the company, or its claims against Amarex at risk, but management will look for opportunities to provide additional updates when appropriate. We understand the importance of this case to both the company and its investors and therefore will be working vigorously on pursuing this matter and will look to provide further update when possible. Thanks Antonio.
15:45 Antonio Migliarese: Alright, Thanks Tyler. Next we will provide a brief update on the company's finances. I quickly want to mention that due to securities laws and regulations, we are precluded from commenting on any current or future capital raise and activities on today's call and also that we have not filed our annual form 10K which is due by August 30, 2023, which limits the financial updates we can provide today. We do not report cash balances during interim months. What I can say is that we continue to be focused on reducing and aligning expenditures and resources with areas that are essential for the company and its current objectives. This judicious management of expenses and focused spending has been evident in our most recent 10Q filing and will be reflected in our upcoming annual form 10K filing.
As Tanya mentioned, from a financing perspective, we recently secured financing to secure sufficient capital to fund the Amarex litigation all the way to the finish line. The company does plan 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 until non dilutive alternatives are available.
Similar to all other prerevenue 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 time and terms available.
17:25: Next we will be providing update on the clinical hold submission. As mentioned earlier, this has been the #1, top priority of the organization. We have made substantial progress in our clinical hold resubmission and have been diligently hard at work, working through the consideration, received from the FDA, there in our most recent meetings with the agency. In particular, the agency, specifically asked us to obtain expert opinion and feedback from HIV patient advocates and Key Opinion Leaders regarding the HIV subpopulation they believe to benefit from LL when taking into consideration HIV drug approvals in recent years, in particular, the -MDR population. The agency has opted to consider the HIV population base, identified by these experts, to determine which would be of benefit, and to then update our response, taking into consideration, this population base, and updating our Risk / Benefit Analysis, General Investigational Plan and Preparing A Clinical Trial Protocol.
We are pleased to announce that we held an advisory board meeting just over a week ago to solicit this feedback requested by the FDA. We had a stellar turnout for this meeting although it did take some efforts to coordinate the various experts and the attendance of Key Opinion Leaders, there was great enthusiasm for LL, the potential they believe it has, and the various patients they believe it can still provide benefit to when taking into consideration the additional HIV drug approvals in recent years. The outcome of this meeting resulted in the identification of 5 potential HIV populations.
19:30: We are now diligently working on identifying and narrowing this down to the single most appropriate sub population. We expect to have the subpopulation narrowed down in the coming 2 weeks, and assuming everything goes according to the current time line, we would expect to resubmit our response during the month of September to the FDA. That being said, our submission will be made only when our experts believe, it is in a high quality, final complete state. This again, is to insure that we deliver a high quality filing, and continue rebuilding our credibility with the agency.
20:18: I do want to take a moment to thank everyone for their patience with the clinical hold submission as it has been a long and weary road. And it continues to take the company time to insure it submits a high quality submission that meets and exceeds the expectations of the FDA. We have brought on and continue to bring on, new advisors and consultants with the relevant clinical medical and regulatory acumen and expertise to assist us in insuring that we provide the FDA with what they are requesting of the company. At this point in time, I can say that our team, advisors and experts, are quite happy and often mystic about how things are shaping up with the current submission. We believe taking the time to bring in engaged additional professionals is allowing us to put our best foot forward and positioning us for a successful submission.
21:21: Next, with regards to NASH, NASH continues to be our predominant primary focus from our clinical, pre-development perspective. We have been diligently, hard at work, developing a Phase 2B / 3 NASH clinical trial protocol, that builds on the positive signals we saw in our previously conducted Phase 2 NASH study. We planned to complete and submit this protocol, sometime subsequent to the FDA hold submission.
21:53: Another exciting development we are beginning to advance in the NASH program is a preclinical study for NASH. With the anticipated near term approval in the NASH space, we have been advised, the likelihood of securing a partnership, could have significantly greater likelihood, with the addition of a preclinical study. We are currently in the early stages of developing and planning this preclinical study. This would allow us to couple our data from our Phase 2A study which we believe is combined with the data from this preclinical study. We are particularly excited about the NASH program, with what is going on in the NASH space currently. There are expectations that we will be seeing the first approval of a drug in this space soon which we think benefits CytoDyn and the other companies pursuing the NASH indication, as this will result in more patients becoming willing to seek treatment. Uncertainty exists without an approved drug, and how patients can be treated, that suffer from this disease. NASH is a very complicated disease that impacts multiple systems in the body which leads us to believe that in order to most effectively treat this disease, a combination therapy will be needed, where various treatments treat the different systems at play and that a monotherapy may not be sufficient.
23:35: We are very excited about NASH as we do believe it is one of the jewels of LL and this dual approach keeps our options open as to how we can continue advance and create value with our NASH program.
23:50: Next we will provide an Update on HIV and longer acting development. As mentioned earlier, Dr. Jonah Sacha continues to perform research at OHSU with regards to HIV-PREP, HIV-CURE with a longer acting therapeutic. Dr. Jonah Sacha had previously received an NIH grant which he continues to execute research on. Also as previously mentioned, the company has entered into a partnership with a 3rd party, generative, Artificial Intelligence drug discovery development company. This relationship is to work on the development of a longer acting molecule. We believe working with a company with AI capability will result in an expedited and robust development of this modified longer acting therapeutic for this company. We believe this new, longer acting modified therapeutic will lead to greater potential patient acceptance as it will result in less frequent injections such as monthly, quarterly or even longer instead of the current weekly regimen. Development of the longer acting therapeutic will also allow us to expand our IP portfolio protection, which is important for many reasons, including for partnership opportunities and preserving and increasing the value of our patent portfolio.
25:15: We currently can not publicly name who this partner is due to contractual obligations, however, we do plan to be able to in the future. We are very pleased to have secured this partnership and are excited about what will come out of it.
Before we conclude today's investment community webcast, I'd like to thank everybody for taking the time to attend today. I would like to reiterate that we continue to believe that LL is a very special molecule and we continue to have very compelling opportunities about it. Our view about what LL is capable of, has not changed. And although it has taken us longer than expected on the clinical hold, these delays are not due to new issues or problems but rather time well spent by the company and its advisors insuring our submission is of the upmost, highest quality, adequately addresses, all of the FDAs concerns and requests and puts the company in the best position of being successful. We feel very optimistic and positive about what is being done with the current submission. The efforts to get this company back into a place to proceed forward has taken some time. However, we do believe, that the current team, advisors and strategy that we have in place, we are in the best position to date to be successful.
Thank you everybody for your time today.
And with that, we conclude today's webcast.
3:12, Antonio Migliarese: Thank you Christina. Good Afternoon All and thank you for joining us today for CytoDyn's Quarterly Update Webcast. Before we get started, I do want to mention, that we had planned for Dr. Scott Hansen to join us today, however, unfortunately, he has been unable to join due to becoming ill. However on todays call, we will be providing you a company update covering both recent happenings and pitted developments in the coming months. We thank those of you who have submitted questions in advance of the call. We have received a number of question from investors and this webcast has been structured to cover as many of those questions as we are able to appropriately address at this time during the webcast.
3:55: As we get started today, I would like to spend a couple of minutes going over a couple of things. Over the last 18 months, CytoDyn has been going through a rebuilding and a transformation which starts with having the right people with the right values, the right processes, the right credibility and the right molecule. I will add that we believe we are lucky enough to be starting with a quite strong foundation as we believe and we continue to believe that LL is indeed a very, very special molecule. In addition, we have determined a short term, mid term and long term strategy which we have been executing against.
4:37: We have a new board of directors, a leadership team and group of advisors in addition to our team, who all have been aggressively hard at work, executing on these objectives. Although, it may not be immediately apparent, we have made immense progress and implemented changes that we believe have reset the foundation of the organization for success while bearing in mind that success doesn't happen overnight, rather success is an accumulation of changes and actions over periods of time. The objectives that we have been working on consist of the following which we will dive deeper into during today's webcast. We have strengthened the leadership of the organization and will continue to do so including our search for CEO. We believe we have the strongest team in place to date at the organization.
5:31: We have taken a major step in the Amarex litigation by filing a statement of claim and securing the necessary financing to pursue this case to the finish line, which we do believe will result in significant benefit to the company. We have and continue to reduce in the line expenditure and resources with key value creating objectives to the organization. We have made substantial progress on the HIV partial clinical hold including the hosting of an advisory board meeting comprised of HIV patient advocate and Key Opinion Leaders which has been the next major milestone in our resubmission process which we will further discuss in a minute. In addition, we have added impressive, well experienced advisors to work on this submission. This continues to be the top priority of the company, in order to restore credibility with the FDA and to continue advancing this molecule.
6:35: We have made significant advancements in the NASH program with the further development of a Phase 2B / 3 clinical trial protocol. In addition, we have begun to design a preclinical study, which we have been advised, significantly increases our probability of identifying a potential NASH strategic partner, which we will also be further discussing today.
7:01: Dr. Jonah Sacha and OHSU continue performing studies related to HIV for the company and we have begun the development process of a longer acting molecule through a partnership with a generative, artificial intelligence, drug discovery and development company which we are very excited about. This long acting molecule is vital for the long term strategy of the company as it will allow us to significantly increase our patent portfolio protection.
7:35: Before we dive further into these topics today, I would like to briefly touch base on the company's communication strategy. Over the last 18 months, the pendulum has swung completely to the opposite side of where it had been, with regards to our communication strategy. This was the result of some of the regulatory and legal issues the company has been subject to and is still currently working through. We are aware that the pendulum has probably swung too far, and is what tends to happen when adjustments are made. We are in the process of revisiting this strategy and expect to make some changes that we think investors will really appreciate. However, I also do want to take this time to remind everyone that as a publicly traded company, we must be careful with what we communicate and when. And also, that SEC regulations do require us to disclose material events so investors are made aware of them in due course. In particular, announcing the company impressions or conclusions about our communications with the FDA, could hurt our chances of resolving issues and undermine our relationship with the FDA which we are hard at work at repairing. I can also assure everyone, although we are not issuing press releases as frequently, that does not mean we are not diligently working on and advancing company initiatives on a daily basis. We continue to be working expeditiously and in good faith to resolve the outstanding issues with the FDA and to advance company objectives.
9:20: We do appreciate everyone's patience with this. We believe that investors will be pleased with some of the communication strategy changes that will be made as a result of the review of our strategy. I will now hand it off to Tanya Urbach, our board chair.
9:38: Tanya Urbach: Thank you Antonio. I very much appreciate the opportunity to be here to speak with everyone today. Recently, Dr. Arman returned to the company following his medial leave in his new capacity as Senior VP of Business Operations. On behalf of the board, I would like to thank Cyrus for his capable leadership during this past year and I know I speak for the whole company when I say, we are happy to have him back contributing towards the important work of demonstrating efficacy and commercial viability for the ultimate benefit of patients and shareholders alike. We are all tremendously grateful to Antonio Migliarese who was once again willing to step in and leverage his interim executive knowhow, to maintain stability, as the board searches for the next CEO of CytoDyn. The board has recently begun its efforts to recruit, interview and retain, a highly qualified CEO to guide the company. To that end, we are engaged with an executive search firm and have leveraged corporate partners and board members in our effort to identify exceptional CEO candidates. I have great confidence in our ability to successfully retain a seasoned executive with the right mix of ethical leadership scientific knowhow and financial backing to drive CytoDyn forward. In the interim, I am gratified to note that with recent additions, CytoDyn has, without a doubt, the strongest mix of just these attributes that it has had through my entire tenure on the board of directors. As such, the company is well positioned to effectively advance corporate objectives during the CEO search period. And, we expect to announce several positive developments in the coming months. Finally, as always, the board remains focused on its key objectives: Providing Strategic Direction, including related to the company clinical development objectives and pipeline development; Overseeing budgetary goals and insuring the company has sufficient financial resources and Advising Senior Management on the next basis. Thank you. Antonio:
12:12 Antonio Migliarese: Thank you Tanya. Next we are going to jump into the Amarex litigation which Tyler Block, our corporate counsel, will be providing some input on as well. We previously announced that we filed a statement claims against Amarex which we are quite pleased about. For those who don't remember, Amarex was our former CRO and we are seeking damages in excess of $100 million from them. Following of the statement of claim, the very important next step in the litigation, the company believes that it is in a good position to fully pursue this litigation, as in addition to the financing, the company has secured from the litigation, the company has also posted and secured $6.5 million to collateralize assurety bond related to this matter. We are very bullish on the outcome of this litigation. In particular, due to the results of independent audits, that have been performed on Amarex's work, as well as the results of Audits performed by the FDA, which resulted in regulatory action against Amarex, which we have become aware of. The company will do everything in its power, to pursue the maximum recovery possible from Amarex and its parent company NSF.
13:33: As mentioned, our corporate counsel, Tyler Block, has joined us here today, and he will provide some more color around the specifics of the Amarex litigation. Tyler.
13:45 Tyler Block (Attorney, Corporate Counsel): Thank you Antonio. As Antonio just explained, the company is well positioned to aggressively pursue our claim against Amarex and we have instructed Sidley Austin, the law firm representing the company, to take all steps necessary to maximize recovery. It is through this claim, that we will be pursuing all damages the company incurred as a result of Amarex's misconduct. Whether it be due to Amarex's failure to perform services to an acceptable professional standard, Amarex billing the company for services that it did not perform or whether it relates to the 10's of millions of dollars, the company was forced to incur to remedy the issues created by Amarex's numerous and blatant failures. In total, we will be seeking not less than $100 million in damages. We are confident in our case and have one of the preeminent litigation firms in the world representing the company in this preceding. On behalf of the company, Sidley Austin recently filed a detailed statement of claim and requested the final hearing date be set. Should we prevail at the final hearing, we will be entitled to recover our damages caused by Amarex, as well as our legal fees incurred in pursuing the matter. Finally, I wanted to acknowledge that we have indeed received a number of questions from investors in relation to the law suit against Amarex. As the litigation is still pending, it would not be prudent, to disclose additional details at this time, needless to say, that we do not want to put the company, or its claims against Amarex at risk, but management will look for opportunities to provide additional updates when appropriate. We understand the importance of this case to both the company and its investors and therefore will be working vigorously on pursuing this matter and will look to provide further update when possible. Thanks Antonio.
15:45 Antonio Migliarese: Alright, Thanks Tyler. Next we will provide a brief update on the company's finances. I quickly want to mention that due to securities laws and regulations, we are precluded from commenting on any current or future capital raise and activities on today's call and also that we have not filed our annual form 10K which is due by August 30, 2023, which limits the financial updates we can provide today. We do not report cash balances during interim months. What I can say is that we continue to be focused on reducing and aligning expenditures and resources with areas that are essential for the company and its current objectives. This judicious management of expenses and focused spending has been evident in our most recent 10Q filing and will be reflected in our upcoming annual form 10K filing.
As Tanya mentioned, from a financing perspective, we recently secured financing to secure sufficient capital to fund the Amarex litigation all the way to the finish line. The company does plan 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 until non dilutive alternatives are available.
Similar to all other prerevenue 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 time and terms available.
17:25: Next we will be providing update on the clinical hold submission. As mentioned earlier, this has been the #1, top priority of the organization. We have made substantial progress in our clinical hold resubmission and have been diligently hard at work, working through the consideration, received from the FDA, there in our most recent meetings with the agency. In particular, the agency, specifically asked us to obtain expert opinion and feedback from HIV patient advocates and Key Opinion Leaders regarding the HIV subpopulation they believe to benefit from LL when taking into consideration HIV drug approvals in recent years, in particular, the -MDR population. The agency has opted to consider the HIV population base, identified by these experts, to determine which would be of benefit, and to then update our response, taking into consideration, this population base, and updating our Risk / Benefit Analysis, General Investigational Plan and Preparing A Clinical Trial Protocol.
We are pleased to announce that we held an advisory board meeting just over a week ago to solicit this feedback requested by the FDA. We had a stellar turnout for this meeting although it did take some efforts to coordinate the various experts and the attendance of Key Opinion Leaders, there was great enthusiasm for LL, the potential they believe it has, and the various patients they believe it can still provide benefit to when taking into consideration the additional HIV drug approvals in recent years. The outcome of this meeting resulted in the identification of 5 potential HIV populations.
19:30: We are now diligently working on identifying and narrowing this down to the single most appropriate sub population. We expect to have the subpopulation narrowed down in the coming 2 weeks, and assuming everything goes according to the current time line, we would expect to resubmit our response during the month of September to the FDA. That being said, our submission will be made only when our experts believe, it is in a high quality, final complete state. This again, is to insure that we deliver a high quality filing, and continue rebuilding our credibility with the agency.
20:18: I do want to take a moment to thank everyone for their patience with the clinical hold submission as it has been a long and weary road. And it continues to take the company time to insure it submits a high quality submission that meets and exceeds the expectations of the FDA. We have brought on and continue to bring on, new advisors and consultants with the relevant clinical medical and regulatory acumen and expertise to assist us in insuring that we provide the FDA with what they are requesting of the company. At this point in time, I can say that our team, advisors and experts, are quite happy and often mystic about how things are shaping up with the current submission. We believe taking the time to bring in engaged additional professionals is allowing us to put our best foot forward and positioning us for a successful submission.
21:21: Next, with regards to NASH, NASH continues to be our predominant primary focus from our clinical, pre-development perspective. We have been diligently, hard at work, developing a Phase 2B / 3 NASH clinical trial protocol, that builds on the positive signals we saw in our previously conducted Phase 2 NASH study. We planned to complete and submit this protocol, sometime subsequent to the FDA hold submission.
21:53: Another exciting development we are beginning to advance in the NASH program is a preclinical study for NASH. With the anticipated near term approval in the NASH space, we have been advised, the likelihood of securing a partnership, could have significantly greater likelihood, with the addition of a preclinical study. We are currently in the early stages of developing and planning this preclinical study. This would allow us to couple our data from our Phase 2A study which we believe is combined with the data from this preclinical study. We are particularly excited about the NASH program, with what is going on in the NASH space currently. There are expectations that we will be seeing the first approval of a drug in this space soon which we think benefits CytoDyn and the other companies pursuing the NASH indication, as this will result in more patients becoming willing to seek treatment. Uncertainty exists without an approved drug, and how patients can be treated, that suffer from this disease. NASH is a very complicated disease that impacts multiple systems in the body which leads us to believe that in order to most effectively treat this disease, a combination therapy will be needed, where various treatments treat the different systems at play and that a monotherapy may not be sufficient.
23:35: We are very excited about NASH as we do believe it is one of the jewels of LL and this dual approach keeps our options open as to how we can continue advance and create value with our NASH program.
23:50: Next we will provide an Update on HIV and longer acting development. As mentioned earlier, Dr. Jonah Sacha continues to perform research at OHSU with regards to HIV-PREP, HIV-CURE with a longer acting therapeutic. Dr. Jonah Sacha had previously received an NIH grant which he continues to execute research on. Also as previously mentioned, the company has entered into a partnership with a 3rd party, generative, Artificial Intelligence drug discovery development company. This relationship is to work on the development of a longer acting molecule. We believe working with a company with AI capability will result in an expedited and robust development of this modified longer acting therapeutic for this company. We believe this new, longer acting modified therapeutic will lead to greater potential patient acceptance as it will result in less frequent injections such as monthly, quarterly or even longer instead of the current weekly regimen. Development of the longer acting therapeutic will also allow us to expand our IP portfolio protection, which is important for many reasons, including for partnership opportunities and preserving and increasing the value of our patent portfolio.
25:15: We currently can not publicly name who this partner is due to contractual obligations, however, we do plan to be able to in the future. We are very pleased to have secured this partnership and are excited about what will come out of it.
Before we conclude today's investment community webcast, I'd like to thank everybody for taking the time to attend today. I would like to reiterate that we continue to believe that LL is a very special molecule and we continue to have very compelling opportunities about it. Our view about what LL is capable of, has not changed. And although it has taken us longer than expected on the clinical hold, these delays are not due to new issues or problems but rather time well spent by the company and its advisors insuring our submission is of the upmost, highest quality, adequately addresses, all of the FDAs concerns and requests and puts the company in the best position of being successful. We feel very optimistic and positive about what is being done with the current submission. The efforts to get this company back into a place to proceed forward has taken some time. However, we do believe, that the current team, advisors and strategy that we have in place, we are in the best position to date to be successful.
Thank you everybody for your time today.
And with that, we conclude today's webcast.
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