CEO.CA sat down with Filament Health’s CEO Ben Lightburn to discuss questions submitted by the CEO community. The following is a transcript from the discussion at on 11th April 2024.

What is the game plan for the rest of 2024? What are you looking forward to?

Obviously, we had a major effort in the SPAC merger take up most of 2023. Our team was working literally around the clock for most of the year. After it was terminated, we spent some time regrouping and coming up with some new ideas to move forward. Some of these ideas will be ready to present to the market in the near term so stay tuned. Fortunately, we have great partners in Negev who invested in us through the SPAC process and are working closely with us right now. What's exciting to me is all the progress we have been making in drug development. We have an open IND in the US for substance use disorders and some real exciting studies in the works. This seems to be aligning perfectly with renewed interest in the sector.

What drug candidate trials are currently ongoing? Are any in phase 3?

Our main candidate PEX010: 31 total authorized clinical trials; 28 partner trials. At least 13 different indications being studied: palliative care, depression, coma, OUD, AUD, MAUD, pain, etc. Everything is currently in phase 2. Our internal development is focused on substance use disorders, in particular Opioid and Stimulant Use Disorder which includes Methamphetamine and cocaine. We decided to focus on SUD because of the very large unmet need, the large amount of anecdotal and clinical evidence in this area, and the fact that treatment infrastructure is largely in place (think residential addiction centers).

Can you tell us more about the SPAC and are there any plans to list elsewhere?

As we got further and further down the road the SPAC deal got worse and worse for FH shareholders. At the very last minute, a major change was required to get it across the line which would have made the economics very bad. Instead of going forward with a terrible deal, we made the decision to terminate. We are still intent on an uplisting to a senior US exchange. As we announced previously, we engaged Donohoe which is a leading advisory form for NASDAQ listings. We have come up with a few ideas, more to come on that topic. I think it's clear that the majority of the market for psychedelic drug development is focused on senior US exchanges.

Are you in any acquisition talks with larger drug companies?

Like any startup, we are in constant discussion with potential acquirers. I can't comment on the state of any of these discussions but perhaps it's worth noting that I sold my last company to a large US based acquirer, so we know the process.

Are research findings transferrable internationally?

Great question, and the answer is yes provided the research is done according to ICH guidelines. This is one of the main reasons we are providing drugs to so many international researchers. We get clues about how our drugs work in new populations and new indications. For a marketing authorization, it's required to present all of your patient exposure data, and a minimum number of exposures is required. In our case we plan to have these minimums well in hand between all of out CTs and SAPs. Some jurisdictions require that a certain portion of the development happens domestically.

Our OUD trial, even though it's running in Canada, and was approved by HC, we went ahead and also got a US IND open for it, meaning we got the FDA to review and authorize it as well. This is so that in the future the FDA can accept the study as part of an eventual US marketing application.

What is the market size for psychedelics? Is the market only for medication or recreational?

Its another great question and the answer has many parts: looking by indications (in prescription model): Depression; 264M people suffering globally, $4B global spend on depression annually (2020). For FH focus, SUD – for Americans aged 12 or older in 2021, 8.6%, or 24M people had at least 1 drug use disorder that year. OUD – global pharmaceutical market is projected to grow from $3.35 billion in 2023 to $6.14 billion by 2030. For SUD there are no currently approved dugs but about 4M self reported sufferers in the US alone.

We forecast an addressable OUD patient population of 295,000 with peak annual revenues of ~$387 million and for SUD 835,000 with peak annual revenues of $1.2 billion. For recreational, yes, I do think there will be a big market although it's very tough to size at the moment. Currently all the attention is on a medical market but it's pretty clear there’s a large amount of people using psychedelics (especially natural ones!) recreationally.

Which governments are looking to decriminalize?

There is a big difference between decriminalization and legalization. Many jurisdictions have already decriminalized. In terms of legalization, we have seen OR already and soon CO. There are some international jurisdictions like NL for truffles and Jamaica. I think we will continue to see US states fall like dominoes and hopefully soon after some bigger countries.

You do already have some federally approved medical emergency access in Canada via the SAP and the AP scheme in AUS.

What are the timelines for new drug development at FH, is there any short-term catalysts your team is looking forward to?

Yes- for OUD we anticipate enrolment later this year and completion 6-12 months after that as it's a relatively small study. For Methamphetamine use disorder we are on a similar timeline to start but the study will be larger and therefore take longer.

What are some relevant research studies to support Filament's vision and any recommendations on videos or books to read?

Obviously there is lots of historical anecdotal data of the effectiveness of psychedelics (especially natural ones). Way back in the 50s and 60s fold were getting treated for substance use disorders.

More recently, modern research has started coming out:

  • In 1973 – Savage et al did an RCT with LSD, abstinence from opioids was 25% vs 5% (control)
  • 2002 – Krupitsky et al. 2002: high-dose ketamine therapy demonstrated significantly higher abstinence in patients with heroin addiction vs. control
  • 2016 – Johnson (Hopkins): 67% 1yr smoking abstinence n=15
  • And perhaps the most impressive modern research:
  • 2022 – Bogenschutz (NYU): 83% reduction in heavy drinking n=93

In addition, UAB has been running a study in cocaine use disorder. In 2018 some pilot data was presented showing very good effectiveness of psilocybin at reducing the amount of cocaine used. All of the above support our vision to brig new effective natural SUD treatments to market. As I mentioned, this is an area of huge unmet need desperately crying out for new therapies.

Peter Hendricks presenting his pilot data: