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Posted On: 07/26/2023 1:49:56 PM
Post# of 148870
The article just pieces together excerpts from the conference call...
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"CytoDyn leader on taking HIV treatment back to FDA, is upbeat about Amarex litigation"
By Elizabeth Hayes – Staff Reporter, Portland Business Journal
Jul 24, 2023
Updated Jul 24, 2023 2:51pm PDT
CytoDyn Inc. (OTCQB: CYDY), which has been stalled for more than a year in moving its potential HIV therapy forward, expects to resubmit documents to the Food and Drug Administration in September.
So said CFO and interim President Antonio Migliarese on a Monday webcast for investors.
The Vancouver, Washington-based company has been in a holding pattern with its drug candidate leronlimab since March 30, 2022, when the FDA put a partial clinical hold on its HIV program. It withdrew its pending Biologics License Application last October, citing citing issues with its former contract research organization, which was managing its clinical trials.
CytoDyn has endured a tumultuous three years of turnover, litigation, a potential hostile takeover by investors and the indictment of its former CEO, Nader Pourhassan.
But Migliarese assured investors that things are getting back on track.
“Over the last 18 months, CytoDyn has been going through a rebuilding and transformation, which starts with having the right people, the right values, the right processes and the right molecule,” Migliarese said. “We’ve made immense progress that will set up the company for success, bearing in mind that success doesn’t happen overnight.”
CytoDyn is currently searching for a CEO. Dr. Cyrus Arman, who had served as president, recently returned after a medical leave to take on a new role as senior vice president of business operations.
Migliarese said the company recently hosted a meeting with HIV advocates and opinion leaders to help determine the best target populations for leronlimab.
“The top priority of the company is to restore credibility with the FDA,” Migliarese said. “We’ve made substantial progress and we’re hard at work working through the considerations from the FDA…It’s been a long and weary road and it continues to take the company time to submit a high-quality submission that meets and exceeds the expectations of the FDA.”
Leronlimab belongs to a class of drugs called “viral-entry inhibitors.” CytoDyn, which has been trying for several years to gain FDA approval, had positioned the monoclonal antibody as a treatment option for people with multi-drug-resistant HIV and one that could be injected weekly.
Migliarese also touched on CytoDyn’s litigation against its former business partner, Amarex, a contract research organization in Maryland. CytoDyn is seeking $100 million in damages on grounds that Amarex failed to perform work to a professional standard and billed for services it didn’t carry out. Migliarese said CytoDyn has secured financing “to see the case to the finish line,” though it may seek approval to issue more shares until “nondilutive options are available.” The law firm Sidley Austin LLP is representing Cytodyn in the lawsuit.
“We’re in a good position to fully pursue the litigation,” Migliarese said. “We will do everything in our power to pursue the maximum recovery from Amarex.”
https://www.bizjournals.com/portland/news/202...limab.html
__________________________________________
"CytoDyn leader on taking HIV treatment back to FDA, is upbeat about Amarex litigation"
By Elizabeth Hayes – Staff Reporter, Portland Business Journal
Jul 24, 2023
Updated Jul 24, 2023 2:51pm PDT
CytoDyn Inc. (OTCQB: CYDY), which has been stalled for more than a year in moving its potential HIV therapy forward, expects to resubmit documents to the Food and Drug Administration in September.
So said CFO and interim President Antonio Migliarese on a Monday webcast for investors.
The Vancouver, Washington-based company has been in a holding pattern with its drug candidate leronlimab since March 30, 2022, when the FDA put a partial clinical hold on its HIV program. It withdrew its pending Biologics License Application last October, citing citing issues with its former contract research organization, which was managing its clinical trials.
CytoDyn has endured a tumultuous three years of turnover, litigation, a potential hostile takeover by investors and the indictment of its former CEO, Nader Pourhassan.
But Migliarese assured investors that things are getting back on track.
“Over the last 18 months, CytoDyn has been going through a rebuilding and transformation, which starts with having the right people, the right values, the right processes and the right molecule,” Migliarese said. “We’ve made immense progress that will set up the company for success, bearing in mind that success doesn’t happen overnight.”
CytoDyn is currently searching for a CEO. Dr. Cyrus Arman, who had served as president, recently returned after a medical leave to take on a new role as senior vice president of business operations.
Migliarese said the company recently hosted a meeting with HIV advocates and opinion leaders to help determine the best target populations for leronlimab.
“The top priority of the company is to restore credibility with the FDA,” Migliarese said. “We’ve made substantial progress and we’re hard at work working through the considerations from the FDA…It’s been a long and weary road and it continues to take the company time to submit a high-quality submission that meets and exceeds the expectations of the FDA.”
Leronlimab belongs to a class of drugs called “viral-entry inhibitors.” CytoDyn, which has been trying for several years to gain FDA approval, had positioned the monoclonal antibody as a treatment option for people with multi-drug-resistant HIV and one that could be injected weekly.
Migliarese also touched on CytoDyn’s litigation against its former business partner, Amarex, a contract research organization in Maryland. CytoDyn is seeking $100 million in damages on grounds that Amarex failed to perform work to a professional standard and billed for services it didn’t carry out. Migliarese said CytoDyn has secured financing “to see the case to the finish line,” though it may seek approval to issue more shares until “nondilutive options are available.” The law firm Sidley Austin LLP is representing Cytodyn in the lawsuit.
“We’re in a good position to fully pursue the litigation,” Migliarese said. “We will do everything in our power to pursue the maximum recovery from Amarex.”
https://www.bizjournals.com/portland/news/202...limab.html
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