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Posted On: 03/31/2022 2:55:55 PM
Post# of 148903
From YMB
“This is my attempt to transcribe what was said on today's conference call after listening to the re-broadcast. I am making no judgments and am attempting to provide a reasonably accurate record. I apologize for my errors.
Standard legal language to start a call. Christina DeLeon is hosting the call. Joining is Migliarese, Urbach, Kelly, and Recknor. More standard legal language.
Migliarese started with a corporate and strategy update. Over 9 years CYDY has worked to turn Leronlimab into a platform drug. We have the ability to manufacture at commercial scale. “We are currently facing some challenges which will shape our plans for the immediate future and the next 6 months.” Focused on restoring credibility. Focused on leadership, management, and compliance issues. Working on HIV data from Amarex and BLA re-submission. Working on NASH, which we expect soon.
Urbach spoke. Board focused on strengthening and supporting management. Conducting a search for a new CEO. New member of the BoD is well qualified. Board is working to find a financial expert and other appropriate experts. We have worked with two executive search firms looking for a CEO and are excited about the quality of the candidate pool.
Scott Kelly spoke about Scientific Advisory Board. Trying to strengthen our position.
Migliarese spoke. Fully cooperating with SEC and DOJ investigations. Posted Amarex bond. Working with Samsung to resolve past due amounts related to inventory management.
Scott Kelly. Paused Brazil trials due to safety events. The patients were already incredibly sick, there were two cardiac events, and we do not know if they were test or control patients. These events did not seem out of line with normal physician experience for COVID. Pre-planned DSMC meeting in early April after which we plan to remove the pause. This was our decision and the right thing to do from an abundance of caution.
There were no ongoing COVID trials in the U.S. Not enrolling in HIV, and closing the long-term extension trials since we have 6-7 years. FDA wants safety data which Amarex was not aggregating. We believe this is a resolvable problem and are contracting with a new CRO.
Recknor on BLA and NASH. Delayed BLA timeline while we work with the new CRO. We have the data from the trials, and we will use it to move the BLA forward. Announced preliminary NASH results in January, and plan to update results in the new future. We are excited about this, as NASH is serious and there is no approved drug. We are exploring potential business opportunities here.
Scott Kelly. Have been contacted by academic institutions interested in Leronlimab. One institution in Boston is specifically interested in tumor micro-environment; hospital in NYC is interested in studying brain tumors. There may also be a study on checkpoint inhibitors, and an institution in London is interested in Alzheimer’s. Looking at Leronlimab as long-acting (3 month) HIV prevention agent. Looking at HIV and NASH applications where we don’t have to pay for the trial. Processing 3 articles for peer-reviewed publication.
Kelly, still. Turn attention to partnerships due to cost. HIV one possibility. Several HIV possibilities, etc. NASH Phase 2 clinical trial, hopefully. NASH combo and monotherapy. Turned it over for questions 17:53 in, which Urbach managed and gave to appropriate folks. Questions lasted 5:50, so less than 24 minutes for the total call. Question highlights included:
(Kelly?) Limited numbers of patients in Brazil, where many have been vaccinated. 2 digits between CD 16 and 17.
(Kelly?) Not enrolling for long haulers, but looking for partnership opportunities to pursue that indication.
NASH (Recknor)—continue to be optimistic, and should announce top line shortly.
Kelly—interested in pursuing basket trial partnerships.
Kelly—MTNBC very encouraged by preliminary results. Looking forward to pursuing.
Kelly—Would like to move from interim to full time CEO.
Migliarese re: Amarex litigation—Analyzing and arbitration starts mid-April.
Kelly—Lung cancer—looking for partnership opportunities.
Kelly—MTNBC do not believe we have enough data for BTD.
Kelly—General partnerships. “We are in discussions and have companies under NDA right now.” We cannot comment on that yet.
Migliarese—We expect to expect at least quarterly updates in the future, in addition to legal requirements. We have changed the pace of communication and have hired a professional firm.”
“This is my attempt to transcribe what was said on today's conference call after listening to the re-broadcast. I am making no judgments and am attempting to provide a reasonably accurate record. I apologize for my errors.
Standard legal language to start a call. Christina DeLeon is hosting the call. Joining is Migliarese, Urbach, Kelly, and Recknor. More standard legal language.
Migliarese started with a corporate and strategy update. Over 9 years CYDY has worked to turn Leronlimab into a platform drug. We have the ability to manufacture at commercial scale. “We are currently facing some challenges which will shape our plans for the immediate future and the next 6 months.” Focused on restoring credibility. Focused on leadership, management, and compliance issues. Working on HIV data from Amarex and BLA re-submission. Working on NASH, which we expect soon.
Urbach spoke. Board focused on strengthening and supporting management. Conducting a search for a new CEO. New member of the BoD is well qualified. Board is working to find a financial expert and other appropriate experts. We have worked with two executive search firms looking for a CEO and are excited about the quality of the candidate pool.
Scott Kelly spoke about Scientific Advisory Board. Trying to strengthen our position.
Migliarese spoke. Fully cooperating with SEC and DOJ investigations. Posted Amarex bond. Working with Samsung to resolve past due amounts related to inventory management.
Scott Kelly. Paused Brazil trials due to safety events. The patients were already incredibly sick, there were two cardiac events, and we do not know if they were test or control patients. These events did not seem out of line with normal physician experience for COVID. Pre-planned DSMC meeting in early April after which we plan to remove the pause. This was our decision and the right thing to do from an abundance of caution.
There were no ongoing COVID trials in the U.S. Not enrolling in HIV, and closing the long-term extension trials since we have 6-7 years. FDA wants safety data which Amarex was not aggregating. We believe this is a resolvable problem and are contracting with a new CRO.
Recknor on BLA and NASH. Delayed BLA timeline while we work with the new CRO. We have the data from the trials, and we will use it to move the BLA forward. Announced preliminary NASH results in January, and plan to update results in the new future. We are excited about this, as NASH is serious and there is no approved drug. We are exploring potential business opportunities here.
Scott Kelly. Have been contacted by academic institutions interested in Leronlimab. One institution in Boston is specifically interested in tumor micro-environment; hospital in NYC is interested in studying brain tumors. There may also be a study on checkpoint inhibitors, and an institution in London is interested in Alzheimer’s. Looking at Leronlimab as long-acting (3 month) HIV prevention agent. Looking at HIV and NASH applications where we don’t have to pay for the trial. Processing 3 articles for peer-reviewed publication.
Kelly, still. Turn attention to partnerships due to cost. HIV one possibility. Several HIV possibilities, etc. NASH Phase 2 clinical trial, hopefully. NASH combo and monotherapy. Turned it over for questions 17:53 in, which Urbach managed and gave to appropriate folks. Questions lasted 5:50, so less than 24 minutes for the total call. Question highlights included:
(Kelly?) Limited numbers of patients in Brazil, where many have been vaccinated. 2 digits between CD 16 and 17.
(Kelly?) Not enrolling for long haulers, but looking for partnership opportunities to pursue that indication.
NASH (Recknor)—continue to be optimistic, and should announce top line shortly.
Kelly—interested in pursuing basket trial partnerships.
Kelly—MTNBC very encouraged by preliminary results. Looking forward to pursuing.
Kelly—Would like to move from interim to full time CEO.
Migliarese re: Amarex litigation—Analyzing and arbitration starts mid-April.
Kelly—Lung cancer—looking for partnership opportunities.
Kelly—MTNBC do not believe we have enough data for BTD.
Kelly—General partnerships. “We are in discussions and have companies under NDA right now.” We cannot comment on that yet.
Migliarese—We expect to expect at least quarterly updates in the future, in addition to legal requirements. We have changed the pace of communication and have hired a professional firm.”
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