CytoDyn Inc (OTCMKTS:CYDY) CEO Nader Pourhassan sat down for an interview with Dave Gentry of The RedChip Money Report, where he delved into the company’s lead drug leronlimab’s multiple cancer indications and teased upcoming milestones.
The Vancouver-based company has completed a Phase 3 trial for leronlimab as a combination HIV therapy, and Pourhassan believes commercialization is on the horizon.
“That was a very exciting result,” Pourhassan said in the interview. “We [met] our primary endpoints with the FDA, and they granted us rolling review submission. We submitted one third of the Biologic License Application, and two thirds will be submitted this month... Six months later, we should have approval.”
The interview will air at 3 pm on the RedChip Money Report television program on Bloomberg international, which is available in more than 100 million homes across Europe.
If things go according to plan, commercialization for leronlimab as a monotherapy for HIV will follow. The company has already sent that protocol to the FDA, Pourhassan said, and the agency wants to meet to finalize the details.
“[The] combination therapy [market] for us is about $2 billion ... And monotherapy, as Gilead reported two years ago, is quite a bit larger than that — maybe $7 billion to $8 billion," he said.
Leronlimab has also shown promise as a treatment for triple metastatic breast cancer, colon cancer as well as diseases like Graft Versus Host and NASH. The company is moving forward with a basket trial, which would allow it to test multiple cancer indications at once.
“One out of 5,000 products makes it to commercialization,” he said. “We are one of the 5,000 we believe. ... The future of cancer could be in our hands. Our very impressive results in cancer will be tremendous news every month going forward.
“[We’ve seen the] stunning results of three patients having zero metastasis, tumors shrunk, and all those good things that could happen.”
The company has sent an application for a Breakthrough Designation to the US Food and Drug Administration.
Pourhassan also plugged the company’s agreements with Samsung BioLogics Co Ltd and Vyera Pharmaceuticals LLC.
"The Samsung folks looked at our company a year ago and they thought it was very impressive,” he said. “They agreed to defer $16 million worth of payments to a later time where we get approved. Now we will have about $500 million worth of product [in the] second quarter of this year.
“Vyera gave us $87.5 million worth of milestone payments [in December], and $4.5 million up front, which was some equity purchase. Fifty percent of the net sales goes to us, and cost of goods plus 10% also goes to us.”
Gentry noted that the company has received roughly $228 million in investments since its founding.
Pourhassan closed with a personal story about the impact leronlimab has had on someone in is his own life.
“My own mother-in-law has stage four metastases to her liver, lung, brain, [and she was] given three months to live,” he said. “Now the doctor says if the progress is the same as it is, she could live at least three years, if not more.
“Our animal study indicated a 19-year extension to cancer patients. This is unheard of. [Typically,] with three months extension, a product gets approved. So having this tremendous opportunity is just mind blowing for us.”
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