Annual Letter to Shareholders of InMed
29 January, 2019
Dear Shareholders, Colleagues and Business Partners,
InMed achieved several key milestones in 2018 including many scientific advancements, strengthening of our executive and scientific team, and fortification of our financial position. I sincerely believe that the numerous achievements in 2018 have laid the foundation for a transformational 2019 for InMed. Accordingly, we have set high yet achievable goals for your Company in the coming year.
Eric A. Adams, CEO of InMed
Let me highlight a few key accomplishments that I believe are key to our corporate mission of unlocking the potential of cannabinoid medicines to treat serious diseases with high unmet medical needs.
Developing our proprietary biosynthesis platform technology
During the second half of 2018, InMed executed a handful of strategic contract manufacturing agreements designed to advance our biosynthesis program to the next level, which is to scale-up the existing process and to identify and address potential challenges associated with commercial manufacturing of cannabinoids via biosynthesis. These collaborations include (1) continuing our partnership with UBC to broaden our design of gene sequencing to enable and maximize cannabinoid production in a bacterial system; (2) launching a development program with the National Research Council of Canada to utilize their extensive biofermentation expertise to optimize conditions for fermentation process scale-up (‘up-stream biofermentation’); and, (3) engaging a GMP-ready pharmaceutical manufacturing contractor to identify and optimize the appropriate down-stream purification processes that lead to the final individual cannabinoid drug ingredients (‘down-stream purification’). Once these components have been individually optimized, we will combine them into one complete manufacturing process.
It’s important to note that completing this ‘trifecta’ of collaboration agreements was a primary goal for the biosynthesis program in 2018 and, thanks to the diligence of our dedicated and exceptionally talented staff, we executed on time and on budget.
Our proprietary biosynthesis platform technology will benefit InMed’s drug candidate pipeline, as well as other pharmaceutical companies seeking pharmaceutical-grade cannabinoids for their specific R&D purposes. Further commercial potential arises from non-pharmaceutical companies looking to source high-quality cannabinoids for their products, such as Over-The-Counter (i.e., non-prescription) medications and, potentially, recreational-oriented products. This biosynthesis technology has the potential to open up significant revenue opportunities ahead of our clinical development candidates.
Laying the foundation to transition to a clinical stage company with INM-750 for the treatment of Epidermolysis Bullosa
We had many key accomplishments during 2018 with our INM-750 program that set the stage for a clinical program commencing in the second half of 2019. Importantly, we demonstrated that the cannabinoid components of INM-750 each play important – albeit independent – roles for various target effects, including anti-inflammation and keratin up-regulation. We also conducted in vitro drug permeation studies on several formulation variations. In these studies, with our selected formulation, we demonstrated effective drug penetration, as well as suitable target drug concentrations in the epidermis, which is our target tissue for INM-750. We also completed two types of genotoxicity studies, which demonstrated no mutagenicity with the cannabinoid components. In addition, we completed four seven-day, dose-range finding and pharmacokinetic studies for assessment of dermal and systemic toxicity.
On the heels of these accomplishments, we remain on track to initiate discussions of our clinical development plans with regulatory authorities in the first half of 2019, which, we believe, will be followed with regulatory filing/initiation of clinical trials for INM-750 in the second half of 2019.
We plan to conduct our Phase I study(ies) in Canada under the authority of Health Canada; this process requires the submission of a Clinical Trial Application. In parallel, we will also seek guidance from the US FDA to support subsequent global clinical studies in EB patients. To support the INM-750 clinical trials, we will be selecting a contract manufacturer for our clinical drug product, as well as initiating process development and stability studies for our clinical trial materials. Finally, we have already selected a clinical Contract Research Organization to conduct the Phase I study(ies) and will begin to ramp up those activities in early 2019.
Building a championship team
We made a number of key executive-level hires in 2018. Most recently, we added Michael Woudenberg as Vice President, Chemistry, Manufacturing & Controls. Mike joins us with 20+ years of leadership in process engineering, GMP manufacturing and scale-up experience in the development, technology transfer and commercialization of active drug products. This is a critical function at InMed as we advance towards commercial-scale manufacturing of biosynthetic cannabinoids. In addition, Eric Hsu, Ph.D., joined us as Vice President, Pre-Clinical Research & Development. Dr. Hsu has gained a plethora of leadership experience in the areas of benchtop research, R&D expansion, formulation development and manufacturing process development, as well as patent prosecution. He serves a critical role in both our biosynthesis and R&D programs. Last, Josh Blacher came on board as Chief Business Officer, where he oversees our business development, strategic finance and investor relations functions within InMed. Collectively, these new hires add invaluable experience and skill sets to an already stellar team of professionals.
In January, 2019, we announced that our esteemed scientific founder, Sazzad Hossain, Ph.D., MSc, will assume a position as member of the Scientific Advisory Board and, contemporaneously, retire as our Chief Scientific Officer. Dr. Hossain has provided InMed with several drug development candidates and the fundamental know-how in selecting, validating and developing cannabinoid-based medicines. His contributions to InMed will continue to provide a strong scientific foundation for years to come. We are fortunate to continue to benefit from Dr. Hossain’s expertise as a member of our SAB. Our next generation of scientific talent, led by Dr. Hsu and in conjunction with our entire scientific team, will continue to execute on the Company’s many development programs.
Fortifying our capital war chest
During calendar 2018, we closed two significant financings, which raised InMed CAD $24.4 million in the aggregate (CAD $20.9 million on a net basis). As of September 30, 2018, our cash and other current assets stood at CAD $25.0 million, quite a remarkable increase from where we stood a year earlier (2017) with CAD $6.2 million. Additionally, in October we announced the signing of a contribution agreement with the National Research Council Canada Industrial Research Assistance Program to receive funding of up to CAD $500,000 to support InMed’s ongoing R&D efforts in cannabinoid biosynthesis. Our current capital position provides us ample means to accomplish our near-term objectives of advancing our biosynthesis manufacturing program to commercial scale, as well as bringing INM-750 into human trials. All told, our existing capital takes us into at least the second half of 2020.
Here’s the bottom line
InMed has never been in a better position – scientifically, financially, and with our outstanding leadership team – than we are today.
I would like to take this opportunity to express my gratitude to our incredibly dedicated and diligent in-house team at InMed, as well as our industry partners, for exceptional work on multiple fronts. Without their skills and daily commitment to execution on InMed’s programs, we would not be able to share these many achievements of 2018 with you here.
I would also like to express my gratitude to you, our valued shareholder, for your continued support in achieving all that we did in 2018, and I look forward to sharing our next round of successes on the scientific and business goals we have set for 2019. We are delighted to have you as a partner as we continue to establish InMed as a global leader in cannabinoid-based therapeutics. On behalf of the entire InMed team, thank you for your continued support.
Sincerely,
Eric A. Adams
President and Chief Executive Officer
InMed Pharmaceuticals Inc.
