Health Care of the Future Innovation Award co-winner 2019: CytoDyn, Nader Pourhassan
https://www.bizjournals.com/portland/news/201...rd-co.html
CytoDyn Inc. is, after several ups and downs, on a really good run. Should that hot streak continue, it could mean great things for millions.
Founded in Vancouver, Wash., where President and CEO Nader Pourhassan lives, CytoDyn is now based in Fort Lauderdale. It has completed all clinical trials for its HIV therapy, leronlimab, and in March submitted the first third of a three-part Biologics License Application to the U.S. Food and Drug Administration. The plan is to complete the application this year with a goal of earning FDA approval early next year.
"We hope to have revenue in the second quarter of next year," Pourhassan said.
CytoDyn's leronlimab is a combination therapy with HAART, or highly active antiretroviral therapy, for HIV-infected patients. The drug is a viral-entry inhibitor that masks a cellular receptor and blocks HIV from entering healthy T cells.
The company has successfully completed nine clinical trials involving more than 700 people. What's more, CytoDyn is also evaluating potential licensing deals with companies that could commercialize leronlimab. Those deals could bring "significant upfront and milestone payments" for the company's products, Pourhassan said earlier this year.
The impending arrival of leronlimab marks another stop in a long odyssey for CytoDyn.
The company went public in 2005, two years after it launched. It hit a peak of close to $4 a share in 2011. CytoDyn, which trades on the Over-the-Counter exchange (OTC: CYDY), trades at around the 40-cent a share mark today. Its market cap is $151 million.
Some six years ago, the company teetered on the edge of bankruptcy, rescued by Pourhassan, who believed he could get its lead product to market and transform the lives of HIV patients.
After taking over as CEO, Pourhassan initiated the acquisition of PRO 140 from Progenics Pharmaceuticals Inc. and named it leronlimab. The treatment belongs to a new class of drugs called “viral-entry inhibitors.” And while it’s not a cure for HIV, clinical trials have proven it can significantly reduce patients' viral burden.
Investors have taken notice. The company raised $33 million in January 2016 and landed in the national health conversation when actor Charlie Sheen, who'd been recently diagnosed with HIV, expressed interest in CytoDyn's efforts.
Big things continued to happen. In April, the company revealed it signed a manufacturing agreement with Samsung BioLogics, potentially worth $1 billion. The revenue is based on the possibility the treatment could generate $120,000 per patient per year.
Samsung Biologics has secured eight biologics drug approvals from the FDA and 22 worldwide over the past four years.
"The Samsung deal was huge because in order for a little company like ours that wants to manufacture products, we need help from a big contract manufacturing organization," Pourhassan said.
As it awaits leronlimab's rollout and subsequent revenue, Cytodyn operates leanly, with between six and nine full-time employees. Next year, when the approvals are expected to be completed, can't come soon enough for Pourhassan.
"We're ready to go," he said.
Innovation Award
The Health Care Innovation Award is presented to an Oregon or S.W. Washington-based organization for developing an innovative product or service with disruptive and scalable potential. The innovation should be expansive in scope with the potential to dramatically improve current practices in health care.
About the winner
CytoDyn
Senior executive
Nader Pourhassan, president and CEO
Why the company won: CytoDyn in April signed a $1 billion manufacturing agreement for its HIV therapy, which the company hopes to begin manufacturing next year, pending FDA approval. CytoDyn has successfully completed nine clinical trials in more than 700 people. The drug is a viral-entry inhibitor that masks a cellular receptor and blocks HIV from entering healthy T cells.
Nader Pourhassan
Pourhassan took over as CytoDyn's CEO in 2012 and initiated the acquisition of PRO 140, as leronlimab was originally called, from Progenics Pharmaceuticals Inc., for $3.5 million down and an agreement on cash royalties and a percentage of sales.
The company completed a $33 million equity raise and a $4.3 million capital raise in 2016.
CytoDyn signed a manufacturing agreement with Samsung BioLogics worth $1 billion. Samsung Biologics will manufacture CytoDyn’s drug leronlimab, with estimated revenue potential of $120,000 per patient per year.
https://www.bizjournals.com/portland/news/201...rd-co.html
CytoDyn Inc. is, after several ups and downs, on a really good run. Should that hot streak continue, it could mean great things for millions.
Founded in Vancouver, Wash., where President and CEO Nader Pourhassan lives, CytoDyn is now based in Fort Lauderdale. It has completed all clinical trials for its HIV therapy, leronlimab, and in March submitted the first third of a three-part Biologics License Application to the U.S. Food and Drug Administration. The plan is to complete the application this year with a goal of earning FDA approval early next year.
"We hope to have revenue in the second quarter of next year," Pourhassan said.
CytoDyn's leronlimab is a combination therapy with HAART, or highly active antiretroviral therapy, for HIV-infected patients. The drug is a viral-entry inhibitor that masks a cellular receptor and blocks HIV from entering healthy T cells.
The company has successfully completed nine clinical trials involving more than 700 people. What's more, CytoDyn is also evaluating potential licensing deals with companies that could commercialize leronlimab. Those deals could bring "significant upfront and milestone payments" for the company's products, Pourhassan said earlier this year.
The impending arrival of leronlimab marks another stop in a long odyssey for CytoDyn.
The company went public in 2005, two years after it launched. It hit a peak of close to $4 a share in 2011. CytoDyn, which trades on the Over-the-Counter exchange (OTC: CYDY), trades at around the 40-cent a share mark today. Its market cap is $151 million.
Some six years ago, the company teetered on the edge of bankruptcy, rescued by Pourhassan, who believed he could get its lead product to market and transform the lives of HIV patients.
After taking over as CEO, Pourhassan initiated the acquisition of PRO 140 from Progenics Pharmaceuticals Inc. and named it leronlimab. The treatment belongs to a new class of drugs called “viral-entry inhibitors.” And while it’s not a cure for HIV, clinical trials have proven it can significantly reduce patients' viral burden.
Investors have taken notice. The company raised $33 million in January 2016 and landed in the national health conversation when actor Charlie Sheen, who'd been recently diagnosed with HIV, expressed interest in CytoDyn's efforts.
Big things continued to happen. In April, the company revealed it signed a manufacturing agreement with Samsung BioLogics, potentially worth $1 billion. The revenue is based on the possibility the treatment could generate $120,000 per patient per year.
Samsung Biologics has secured eight biologics drug approvals from the FDA and 22 worldwide over the past four years.
"The Samsung deal was huge because in order for a little company like ours that wants to manufacture products, we need help from a big contract manufacturing organization," Pourhassan said.
As it awaits leronlimab's rollout and subsequent revenue, Cytodyn operates leanly, with between six and nine full-time employees. Next year, when the approvals are expected to be completed, can't come soon enough for Pourhassan.
"We're ready to go," he said.
Innovation Award
The Health Care Innovation Award is presented to an Oregon or S.W. Washington-based organization for developing an innovative product or service with disruptive and scalable potential. The innovation should be expansive in scope with the potential to dramatically improve current practices in health care.
About the winner
CytoDyn
Senior executive
Nader Pourhassan, president and CEO
Why the company won: CytoDyn in April signed a $1 billion manufacturing agreement for its HIV therapy, which the company hopes to begin manufacturing next year, pending FDA approval. CytoDyn has successfully completed nine clinical trials in more than 700 people. The drug is a viral-entry inhibitor that masks a cellular receptor and blocks HIV from entering healthy T cells.
Nader Pourhassan
Pourhassan took over as CytoDyn's CEO in 2012 and initiated the acquisition of PRO 140, as leronlimab was originally called, from Progenics Pharmaceuticals Inc., for $3.5 million down and an agreement on cash royalties and a percentage of sales.
The company completed a $33 million equity raise and a $4.3 million capital raise in 2016.
CytoDyn signed a manufacturing agreement with Samsung BioLogics worth $1 billion. Samsung Biologics will manufacture CytoDyn’s drug leronlimab, with estimated revenue potential of $120,000 per patient per year.
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