This article is based on TheStreet’s Stock & Markets Podcast. Hosted by Chris Versace, the veteran Wall Street investor and lead portfolio manager for TheStreet Pro, the weekly podcasts are available early to members of TheStreetPro investing club.
The key word here is “humane.”
Michael Breen, CEO of GT Biopharma (GTBP), a clinical-stage biotech company, stressed that point with TheStreet Pro’s Chris Versace during the Dec. 3 edition of the Stocks & Markets Podcast.
Versace explained that the biopharmaceutical drug cancer market is expected grow from roughly $225 million in 2024 to significantly higher figures over the next decade.
Some sources believe this market could exceed $360 billion by 2030–2034, driven by rising cancer rates, advanced therapies, and, Versace added, “a strategy that is near and dear to our heart of the Pro portfolio, the aging population.”
“We want to find a more humane cure for cancer,” Breen said, “because at the moment, if anyone is unfortunate enough to get cancer, the solutions that you’re given have been around since just after the Second World War.”
Breen analyzed the options currently facing cancer patients.
GT Biopharma will be applying for an investigational new drug application with the FDA.
Photo by Anadolu on Getty Images
CEO: Treatment much more humane
“The first one is obviously surgery,” he said, “where they take a scalpel to you to cut out the cancer. But of course, the cancer, because it’s moving around your blood system, could have spread.”The second one, Breen added, “is they’re going to poison your blood with chemotherapy.”
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“You’re going to feel incredibly sick, which also, ironically, I think a lot of people don’t actually realize this,” he said. “The chemotherapy kills your natural killer cells.”
“After you’re given chemotherapy, they tell you not to go out and not to mix with anyone who might be ill because your immune system has been wiped out.”
And the third option is radiotherapy, which, Breen said, “is burning your flesh.”
“Our molecule is a protein,” he explained. “It can be given by intravenous infusion or, in relation to the solid tumor trial, which we’re hoping to start next year, it’ll be from subcutaneous injection. So, it’s so much more humane.”
According to GT Biopharma’s Michael Breen, the company’s new cancer treatment drug is more humane than traditional interventions.
GT Biopharma
Breen said GT Biopharma will be filing an investigational new drug application with the U.S. Food & Drug Administration either by the end of the year or in the early part of January, “and we’re hoping that that trial will start in the first half of 2026.”
“And we are going to target all of the main, most prolific solid tumors,” he said. “I’m talking about bladder cancer, pancreatic cancer, ovarian cancer, lung cancer, head and neck cancer, and of course breast cancer and prostate cancer.”
Drug is cost effective, exec says
Breen said breast cancer affects one in 8 women, while one in 8 men is affected by prostate cancer.
“We’re targeting the biggest, most prolific cancers with a humane drug, which is a protein, which doesn’t involve cutting, doesn’t involve poisoning, doesn’t involve burning, and which we believe is the way forward that science and healthcare have been crying out for the last 80 years,” he said.
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“What sets GTE Biopharma apart from others that are trying to do this?” Versace asked.
“From what we’ve seen in our trials, our drug does not have any problems with toxicity,” Breen said. Our drug is significantly more cost-effective because it’s a protein and because it’s easier to manufacture. And itdoesn’t suffer from any toxicity issues.”
Since the treatment is cost-effective, he added, “it’ll be very much better received by health insurers.”
“Are there perhaps opportunities, maybe even greater opportunities, quicker opportunities for GT Biopharma outside the U.S.?” Versace asked.
“Unfortunately, cancer is a worldwide disease that affects everyone,” Breen said. “It doesn’t matter whether you’re from Australia or Singapore or America or wherever.”
“Therefore, it is very much appropriate that we are looking and exploring, having relationships with other clinical trials centers around the world.”
Amergers and acquisitions attorney, Breen said he approaches the business “very much from a perspective of commercialization of what we have.”
“The most important thing is the intellectual property,” he said. “And I am absolutely on top of it, ensuring that the intellectual property is completely and properly buttoned down and ensuring that we have patents applied for all around the world.”
Breen said GT Biopharma has “a whole bunch of candidates in our pipeline.”
“We have some very interesting tech,” he said. “Interesting and better technology. It’s worth bearing that in mind in terms of anyone doing due diligence on our company.”