revolutionary medicine You may be on the verge of a breakthrough.
The company is expected to soon release results from a Phase 3 trial of an experimental drug that could be the first targeted therapy for pancreatic cancer, the deadliest of all major cancers. The five-year survival rate for pancreatic cancer patients after diagnosis is just 13%, and that number hasn’t changed much, despite the promise that new drugs such as immunotherapy will improve other cancers. The potential for new treatments has pushed RevMed’s stock price up nearly 185% over the last year, making it a prime acquisition target.
“This is very important,” said RBC Capital Markets analyst Leonid Timashev. “Doctors said this could be the biggest advance in pancreatic cancer history.”
RevMed was in the spotlight this week after former Sen. Ben Sasse told The New York Times that he was taking the company’s drug dalaxone lasib. Late last year, Sasse announced that he had been diagnosed with stage 4 pancreatic cancer and was given three to four months to live.
Sen. Ben Sasse (R-Nebraska) speaks during the confirmation hearing for attorney general nominee Merrick Garland before the Senate Judiciary Committee on February 22, 2021 in Washington, DC.
Al Drago | Pool | Reuters
Mr Sasse told the Times that his tumor had shrunk by 76% since he started treatment, but that it was a “nasty drug” that caused “crazy” side effects, including a rash. Seeing Sass’ bloody and raw face, the interviewer said Sass looked “horrible.”
RevMed’s daily pills broadly target RAS mutations that promote tumor growth and are found in approximately 90% of pancreatic cancer cases. Timashev explains that RevMed’s drugs strike at the heart of what drives cancer.
It’s both an advantage and a liability. RAS proteins are present throughout the body, especially in the skin. RevMed’s drug does not differentiate between mutant and conventional forms, leading to unpleasant side effects like those experienced by Sasse.
RevMed said in a statement that the majority of cases of rash were mild and no patients had stopped treatment because of it. The company added that reports of a rash with bleeding have been reported anecdotally by clinical trial investigators and are considered rare.
CEO Mark Goldsmith said Daraxone Rajiv is so broadly effective against all types of RAS that RevMed initially wasn’t sure if people could even tolerate it. The company started with a “very low dose” and escalated the dosage in stages.
“We were worried every time things escalated,” he said. “Every time the team said we were going to increase doses, our senior group sitting in the conference room was scratching their heads and thinking, ‘Is this the end? Can we increase more?'”
Goldsmith said the company’s scientists predicted that at 80 milligrams, tumors would begin to shrink.
“They predicted it scientifically and that’s exactly what happened,” he said. “We saw the first patient’s tumor shrink and said, ‘Wow, our team is pretty good. They know how to predict this thing.'”
But simply showing that the drug can shrink tumors likely won’t be enough to win approval from the U.S. Food and Drug Administration. Goldsmith said regulators have made it clear internally and externally that RevMed needs to demonstrate the life-prolonging effects of dalaxone lasib, which is known in the medical community as having a proven overall survival benefit.
The size of that benefit could have a significant impact on how widely the drug is used and how the company’s stock price reacts to late-stage data. RevMed plans to share data this quarter from a Phase 3 trial comparing its pills to chemotherapy in patients whose cancer has spread and who have already tried other treatments.
Analysts at RBC Capital Markets laid out their base case in a note to clients on Friday, predicting that RevMed’s stock could rise 25% to 40% if the drug shows an improvement in overall survival of more than 13 months and reduces the risk of death by half compared to chemotherapy. Timashev said it would be an “incredible disappointment” if the drug failed the Phase 3 trial, adding that he considered that outcome unlikely. The more likely risk, he says, is that the drug won’t deliver the returns investors expect.
Part of the recent surge in RevMed’s stock price has come from speculation that the company could be acquired, with Merck reportedly considering an acquisition earlier this year.
Goldsmith said RevMed doesn’t pay much attention to “external noise” and is focused on building the company.
“We know that pharmaceutical companies have a strong interest in our business,” he said. “Either they’re trying to copy it or they’re trying to get it. And things like that happen all around us. There will be rumors from time to time. What can we say? Are we less focused on how to get the company into other people’s hands? We’re more focused on how to make the biggest difference.”
