An Irvine-based biotech firm is researching a cure for one of the most heart wrenching diseases to strike humans.
Reneo Pharmaceuticals Inc. (Nasdaq: RPHM) is testing a drug to treat rare genetic diseases, including primary mitochondrial myopathies (PMM). In more simple terms, the disease prevents people from metabolizing food in their bodies, meaning their muscles and other organs don’t fully develop.
“For the unfortunate people who are born with these rare diseases, a lot don’t make it out of childhood,” Chief Executive Greg Flesher told the Business Journal. “Those who make it to adulthood have horrible lives.”
Flesher said his company has the only drug that shown an effect to help these patients, which affects about 66,000 people in the U.S. and another 82,000 in Europe.
Reneo got its start as a compound originally investigated by a large European pharmaceutical company that decided not to pursue it.
“We felt it had great potential,” Flesher said.
A Phase 1b study showed patients could walk further and pain was reduced. It’s currently planning to have fully enrolled Phase 2b trial in the coming first quarter and the results may be known later this year. If it’s successful, the company can skip the usual Phase 3 trial since it’s considered treatment for a serious disease with no other options, Flesher said.
Public Co., OC Move
Since the company went public about 21 months ago, raising some $94 million, shares have fallen about 80% to around $2.35. It counted a $57 million market cap as of last week.
Flesher attributed the drop to the pharmaceutical industry falling out of favor with Wall Street.
Once the company proves its drug works, “investors will get excited,” he said.
While the company doesn’t have revenue, it does have $121 million in cash and other assets, enough to last until 2024 after the drug trial is completed, Flesher said.
The company, which was formed in 2017 in San Diego, moved to Irvine about 18 months ago because most of the executive team lives in Orange County, he said. The company is based in the Boardwalk office complex along Jamboree Road.
“I have established roots in Orange County,” Flesher said. “My preference is not to commute to San Diego.”
Flesher, who was hired in late 2020, has more than 25 years of executive experience in biopharmaceuticals, including serving as chief business officer role at Aliso Viejo’s Avanir Pharmaceuticals when it was acquired in 2015 for $3.5 billion.
Prior to Reneo, Flesher was CEO at Novus Therapeutics, a clinical-stage pharmaceutical company that changed its focus from ear infection medications to ALS, diabetes and autoimmune diseases. Last June, the Irvine-based company—now called Eledon Pharmaceuticals Inc. (Nasdaq: ELDN)—revealed positive topline results from a Phase 2a trial for people with ALS.
“I have good expertise in late-stage development and marketing,” he said. “I typically go to companies with good studies.”
OC Talent Pool
The company’s grown from 32 employees a year ago to 50 currently and could have as many as 150 employees in 2024 if its core drug, called REN001, is successful.
“I love small companies. My heart is small companies with less 100 employees.”
Reneo has several executives with dozens of years in biopharmaceutical research at major firms, including Chief Medical Officer Dr. Alejandro Dorenbaum, Chief Development Officer Dr. Ashley Hall and Senior Vice President of Clinical Operations Dr. Lynn Purkins.
Another big reason for moving the headquarters to Irvine was the available talent because of the downsizing of large companies like Allergan, Flesher said.
“There’s a very good talent pool of drug developers here,” he said. “I’d like to help Orange County build its bio tech industry.”