Filament Health Corp (NEO:FH, OTCQB:FLHLF) CEO Benjamin Lightburn sees another exciting year ahead for the Vancouver-based drug developer after in 2023 it sharpened its focus to advancing its botanical psilocybin asset PEX010 for substance use disorders, including opioid use disorder.
During a fireside chat hosted by Water Tower Research senior research analyst Robert Sassoon on Thursday, Lightburn told investors that the desperate need for new and better treatments for substance use disorders was a key consideration behind the company’s decision to focus on this area.
“There are few other unmet needs as great and as serious as there is for better treatments for substance use disorders,” Lightburn said.
“Here in British Columbia where we are based, illicit drug deaths now account for the largest cause of death for all citizens between the ages of 13 and 59. Every year, 100,000 Americans will die of illicit opioid overdoses.”
He added that psychedelics have long shown promise as an effective treatment for these disorders.
“When you look at the great unmet need and the high degree of demonstrated efficacy from historical practice as well as modern research that is both published and soon to be published, you see a humongous opportunity,” Lightburn said.
Additionally, he noted that for substance use disorders there is an existing treatment infrastructure. He said that there are about 1,600 drug treatment facilities in the United States, 1,000 of which are already prescribing drugs for substance use disorders, that could easily be fitted out the administer psychedelic therapy.
The company has made significant progress on its narrowed focus area. Filament’s trial of PEX010 for opioid use disorder trial being carried out at the University of British Columbia plans to enroll patients and get results within the year, Lightburn noted.
“One of the unique things about this study is that the administration of our drug PEX010 will be as a first-line therapy rather than as an adjunct therapy to commonly prescribed substitution therapies because we believe that patients are really crying out for a way to get off all opioids,” he said.
This trial will be followed up by a larger controlled study in methamphetamine use disorder and other stimulant subtypes which should begin enrolling patients this year, the CEO said.
Licensing and export milestones
Filament Health generates revenue from licensing its drug candidates to commercial and academic parties in areas where it complements its own drug development program.
In 2023, it saw revenue from its licensing and manufacturing activities approximately double, growing to almost $800,000 from about $400,000 in 2022.
The company has successfully exported its drugs to multiple international jurisdictions, which Lightburn said demonstrated that the regulatory expertise of Filament’s team was “unmatched.”
“It is no insignificant feat to get a drug exported and approved to enter into a clinical study in Israel, especially when that drug is a unique botanical extract of a psychedelic mushroom,” he told investors.
The company has also successfully shipped into Australia, which has recently allowed patients to be prescribed psilocybin and MDMA for specific mental health conditions. Its drugs are also being used in clinical trials all over the world, including in the US, Canada, Belgium and France.
Advancing US uplisting
Filament in 2023 chose to walk away from a merger with special purpose acquisition company (SPAC) Jupiter Acquisition Corporation but continues to work toward uplisting to a senior US exchange.
“While it might seem from the outside like a disappointment that the SPAC merger did not get across the line, we’re the ones who terminated it because as the deal progressed… the terms were significantly worse than what we were offered at the beginning,” Lightburn told investors.
“We want to list on a senior US exchange from a position of strength rather than a position of weakness, in a good deal.”
Lightburn added that he was confident the decision to not go ahead with the merger was made in the best interest of shareholders and that the company was fully committed to exploring alternative ways to list on a senior US exchange.
Filament has engaged consultancy firm Donohoe Advisory to provide advice on the uplisting and, following discussions, is actively pursuing several options that Lightburn said he could not comment on at this time.
Water Tower Research’s Sassoon questioned Lightburn over why Filament’s considerable intellectual property (IP) portfolio was not currently reflected in its share price.
Lightburn said, while he couldn’t speak for all shareholders, that he sensed there is not a sophisticated biotech audience looking at companies trading on the CBOE Canada.
“Our junior markets are more focused on mining and resource exploration, so you just don’t have the same body of investors, appetite and activity as you do in the US for junior biotech companies,” Lightburn said.
“All this gets back to our plans in the past and future to list on senior exchanges in the US.”
All in all, Lightburn is excited about what’s to come for Filament.
“We have laid all the necessary groundwork to begin clinical development in substance use disorders,” he said.
“When you combine that with the licensing revenue we’ve been able to bring in, the partnerships we’ve had, the different academic studies that are providing us data on how our drug performs in different indications, and the actual real patients in Canada that we’re able to treat via the Special Access Program, there is so much value here in Filament.
“The future is as bright and promising as always, probably even more so.”