Mindset Pharma CEO, James Lanthier, Issues Letter to Shareholders

Mindset Pharma Inc. (CSE: MSET | FSE: 9DF | OTCQB: MSSTF), a drug discovery and development company focused on creating novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today issued a letter to shareholders from James Lanthier, Chief Executive Officer of Mindset.

Dear Fellow Shareholders:

Mindset’s overarching strategy since inception has been to methodically apply state-of-art drug discovery approaches in medicinal chemistry and pharmacology to known psychedelic compounds to create the next-generation of psychedelic drug candidates to better serve patients in need. In the last 6 months, our focused efforts have begun to deliver an impressive and growing series of world class innovations, partnerships, and feedback reinforcing our patent portfolio position, which collectively differentiates and establishes Mindset as the premiere biotech company working in the psychedelic space today.

I would like to take a moment to review these accomplishments:

While Mindset’s focus has been on discovering novel drugs, we have further leveraged insights that we have learned around drug design techniques into complementary inventions in synthesis and, most recently, in drug delivery technology. In June of 2022, we announced our proprietary novel, patent-pending, intranasal formulation technology, which we believe has the potential for improving the administration of a wide range of central nervous system (“CNS”) medications, including first and subsequent generations of psychedelic medicines. The intranasal formulation leverages Mindset’s unique patent-pending platform technology and has been demonstrated to alter the pharmacokinetics profile of the active pharmaceutical ingredient (“API”) of first-generation psychedelic drug candidates.

The initial Proof-of-Concept (“PoC”) of our intranasal technology using 5-MeO-DMT showed promising results. In a side-by-side comparison to a standard formulation, plasma exposure (Cmax, AUC and oral bioavailability (F(%)) was higher for our proprietary formulation. As such, this newly developed technology has the potential for reducing dose level, speeding uptake and out-take from the brain, and reducing peripheral side-effects, thereby enabling a more efficient, safer, and more cost-effective treatment delivery system. We look forward to broadening our validation data as we anticipate this technological advancement to be interchangeable with other known and novel psychedelic and CNS therapeutics.

The development of this proprietary formulation technology is yet another excellent example of the dedication and scientific innovation engine from the Mindset team.

At Mindset, we also understand the immense value of strategic scientific and business partnerships with industry leading experts.

In May of 2022, Mindset engaged a UK-based Contract Research Organization (“CRO”), Clerkenwell Health, to prepare for an initial scientific meeting with regulators from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) to discuss our initial plans for clinical development of our first psychedelic drug candidate, MSP-1014, a novel and patented second-generation psilocybin-like drug candidate. It was key for us to engage Clerkenwell Health as we make headway in progressing MSP-1014, our Family 1 lead clinical candidate, towards First-in-Human clinical trials.

Another exciting partnership for Mindset is our innovative research collaboration with the Centre for Addiction and Mental Health (“CAMH”), a top psychiatric research hospital based in Toronto, Canada. We are sponsoring a preclinical study at CAMH on MSP-1014 alongside psilocybin. The study is interrogating how macro and micro doses of psychedelic compounds modulate expression levels of molecular biomarkers of brain plasticity in rats. The team expects to uncover short- and long-term changes in cFOS and BDNF expression that could underlie the long-term behavioral changes associated with a single psychedelic experience and develop molecular insights into the magnitude of effects of MSP-1014 compared to psilocybin. This collaboration will profile and build our understanding of the observed superiority of MSP-1014 to psilocybin at the molecular level.

Mindset’s strategic relationships have been thoughtfully selected to drive our continued development and growth. This includes, most notably, our partnership with the McQuade Center for Strategic Research and Development (“MSRD”), a member of the global Otsuka family of pharmaceutical companies, to provide ongoing funding of development expenses and top-tier CNS expertise needed to bring clinical candidates from both Mindset’s Families 2 and 4 of next-generation psilocybin and 5-MeO-DMT compounds, respectively, through Phase 1a and Phase 1b human clinical trials. This partnership with Otsuka, a global leader in bringing CNS medications to market, is an yet another incredible opportunity for Mindset, differentiating us from our peers in the psychedelic space, as the first and only company, to date, to partner with big pharma and focus on new drug development.

As we develop our pipeline of innovative next-generation psychedelic drug candidates, ensuring a strong IP position is an essential goal for Mindset’s team. Our recent announcements validate the strength of our IP position and validate our strategy of focusing on IP from the beginning.

Most recently, the United States Patent and Trademark Office (“USPTO”) has granted allowance for Mindset’s patent application number 17/387,864, titled “3-Pyrrolidine-Indole Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders.” Included within this application are drug candidates from Family 2, which are novel analogues of psilocybin that exhibit a range of pharmacokinetic and pharmacodynamic improvements in pre-clinical studies. Family 2 has a potentially superior in-clinic macrodose profile to psilocybin. This issued patent and other Family 2 patent-pending applications are included within our collaboration with MSRD.

In addition, the USPTO has recently issued a Notice of Allowance for another Mindset patent application, number 17/387,845, titled, “Psilocin Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders.” Included within this application are several drug candidates that are classified as belonging to Family 1 which are second-generation compounds with potential improvements compared to psilocybin in overall pharmacokinetic profile, effect size, safety, and manufacturing.

Mindset also filed additional provisional patent applications covering 2 classes of new chemical entities (“NCEs”) that expand our next-generation DMT and 5-MeO-DMT drug candidate platforms, or Family 4, currently under development in collaboration with MSRD.

I am extremely encouraged with the progress we’ve made so far in bringing novel mental health therapies one step closer to patients in need. Mindset has successfully developed a leading portfolio of next generation NCEs, patent pending processes to synthesize first generation psychedelic drug candidates efficiently and cost-effectively, and a novel intranasal delivery system to improve the overall pharmacokinetic properties of first- and second-generation psychedelic drug candidates.

Over the next twelve months, we expect to launch one or more of our novel drug candidates to in-human clinical trials. Additionally, we will look to find more synergistic strategic partners that share our vision to continue to advance our growing pipeline of new drugs.

With a strong team and alliances in place to expedite our time-to-market and de-risk our drug development programs, we will continue to work hard on the research and development required to unlock new discoveries so that we can provide better insight into the pharmacological potential of psychedelic medicines, both for the industry at large and, one day, to help patients overcome a range of psychiatric and neurological disorders.

On behalf of the Mindset management team and Board of Directors, I sincerely thank you for your continued support of the company and I look forward to providing you with further updates as our progress continues.

Sincerely,

James Lanthier
CEO of Mindset Pharma

Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybins in addition to its own proprietary compounds. The company has a co-development agreement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for its short-duration compounds, Mindset Families 2 & 4.