To our Filament family and friends,
As we reach the end of another highly productive year I would like to take this opportunity to reflect on Filament’s accomplishments in 2023. As in years past, we believe that we can be very proud of our operational achievements.
Drug Development - Internal
This year we announced positive interim safety results from the ongoing phase 1 study at the University of California, San Francisco. This study is comparing the effects of our psilocybin and psilocin botanical drugs. This was also the very first study to be approved using Filament’s drugs and the first ever FDA study to administer natural psychedelic drug candidates.
In the fall, we announced Health Canada authorization for our pilot study in Opioid Use Disorder. In combination with our FDA-authorised study in Methamphetamine Use Disorder, this marks our pivot into substance use disorders which we believe are a very promising area for drug development. Vancouver, where Filament is based, is one of the global epicentres of the illicit drug crisis and we are working tirelessly to bring about potential solutions.
In January we announced that we partnered with Jaguar Health to form Magdalena Biosciences. Magadalena is focused on developing non-psychedelic botanical drugs for the treatment of mental health conditions including ADHD. The first announced drug candidate is derived from coca leaf extract, for which we imported coca leaves from Peru. The import itself was a significant achievement and not without its fair share of regulatory challenges!
An additional import of which we were proud this year was the first-ever Nagoya Protocol-compliant shipment of Iboga from Gabon. Iboga contains Ibogaine and other related compounds which have been traditionally used by the Gabonese Bwiti people for millennia. Ibogaine shows great promise for the treatment of substance use disorders and we have been working on an Ibogaine-based botanical drug. Stay tuned for more updates.
Drug Development - External
Filament is now firmly established as a leading - if not the leading - supplier of GMP psychedelic drug candidates globally. Through our partnership network our drugs are now in 30 approved clinical studies around the world. These studies provide us with excellent insight into how our drugs work in a broad range of indications and build our safety database which is essential for our own eventual approvals. In addition we get to work with the brightest minds in psychedelic research from leading institutions such as CAMH, UCSF, UCLA, University of Washington, Psychiatric Centre Copenhagen, and more.
In addition, we added to more revenue-generating licensing partnerships with Reset Pharma and Neolumina Biosciences joining the ranks of companies who have chosen PEX010 as the drug for their development.
We maintained our rapid progress on the IP front. Filament now has 25 issued and allowed patents covering many of the key aspects of our technology in areas such as extraction, purification, standardisation, and formulations. We believe that this gives us one of the best patent portfolios in the industry. But it’s good to keep in mind that much of our IP is protected as a trade secret which can outlast patented IP. These are things like genetic source material, harvesting methods, and even the precise final composition of our products. All of these things have been used by pharma companies to protect drugs from genericization long after patents expired. We are excited by applying the same logic to psychedelic botanical drugs.
Facilities and Licensing
We continued to update our facility, and increase its capacity to manufacture and store controlled substances, as well as to process new substances. In this regard we hosted Health Canada inspectors several times. We brought on a few new staff members to bolster our analytical and quality-related capacities. We also carried out several contract manufacturing batches of MDMA capsules for Pharmala.
Special Access Program
The Health Canada Special Access Programs allows physicians to request permission to prescribe experimental or unapproved therapies for patients suffering from serious or life threatening conditions. In January of 2022, Health Canada added psilocybin to the list of drugs available for request via the SAP. We are pleased to report that Filament fulfils over 90% of these approved requests, free of charge. Our team also provides countless hours of support to physicians as they navigate the sometimes complex nature of the program.
Media and Events
We continued to build our profile with significant media coverage this year. Filament was featured in The Globe & Mail, Bloomberg, The Associated Press, CTV, Global News and more.
I had the honour of speaking at SxSW in Austin earlier this year as well as at MAPS’s Psychedelic Science Conference in Denver, among other appearances. Our CSO Ryan Moss was invited to speak at Horizons Northwest in Portland earlier this month.
A summary of the year’s key media placements is listed below, along with a recap of important announcements.
Public Markets and Financing
Much of this year’s effort in this area was focused on completing the merger with Jupiter Acquisition, a Nasdaq-listed SPAC. In recent weeks, we announced that this deal ultimately would not be completed. Even though we had invested significant time and energy into its completion, our overriding responsibility is to preserve and increase shareholder value. We ultimately decided that the significant changes necessary in the late stages to complete the deal were such that it was not in the best interests of shareholders. This was a very difficult decision which was not taken lightly. We still believe in the pursuit of a Nasdaq listing but on terms that are more favourable to existing shareholders. We have retained Donohoe and Associates, a firm specialising in Nasdaq listings, to advise us on appropriate paths.
Looking into 2024 we see many exciting developments come to bear. Our internal drug development is slated to kick off in a big way, with two studies in substance use disorders that will hopefully provide groundbreaking results in important indications. We will likely see additional drug candidates besides our mushroom-derived products enter human trials. Our IP portfolio, revenue-generating and non-commercial licensing portfolio are all poised to continue to grow. Last but not least, market sentiment seems like it might change in 2024 to be much more favourable for development-stage biotech companies.
All in all 2023 was another impressive year for Filament even though we were dealt an unexpected setback in its closing weeks. Nonetheless we look to 2024 as excited as ever. As always, thank you for your support as we pursue our mission to see safe, natural psychedelics in the hands of everyone who needs them, as soon as possible.
FILAMENT’S 2023 MILESTONES SUMMARIZED:
- Jan 10 - Announced Formation of Magdalena Biosciences
- Jan 18 - Announced Clinical Trial Approval at Psychiatric Centre Copenhagen
- Feb 14 - Announced Second Psilocybin Supply Agreement with CAMH
- Mar 15 - Announced FDA Approval of Phase II Clinical Trial for MAUD at UCSF
- Apr 11 - Announced GMP Release of MDMA Capsules
- May 17 - Announced First Nagoya Protocol-Compliant Shipment of Iboga from Gabon
- May 30 - Announced Interim Results from Phase 1 FDA Clinical Trial at UCSF
- Jun 30 - Announced Exclusive Licensing Agreement with NeoLumina Bioscience
- Jul 6 - Announced Filament to Supply Psilocybin for Recipients of CIHR Research Grants
- Aug 8 - Announced FDA Approval of Two Clinical Trials Studying PEX010
- Aug 31 - Announced Licensing Agreement with Reset Pharma
- Sep 21 - Announced Import of Coca Leaf from Peru via Magdalena Biosciences
- Oct 10 - Announced Health Canada Approval for Phase II Clinical Trial for OUD at UBC
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