Robert Tessarolo has 25 years’ experience in the pharmaceutical industry, holding Chief Executive roles over two decades. Prior to his role at NeonMind Biosciences, Tessarolo held the position of President and CEO at MindMed, and was previously CEO at Cipher Pharmaceuticals – a specialist life sciences company listed on the Toronto Stock Exchange.
With Tessarolo’s formidable pharmaceutical expertise in key leadership roles, PSYCH was keen to learn about the management team he had assembled at NeonMind.
‘I wouldn’t call it a management team, because what we’ve tried to do at NeonMind is be very overhead-sparing, with a slim approach to building long-term engagements,’ said Tessarolo. ‘Instead, we have enlisted pharmaceutical experts who I have had personal experience working with and know that they can deliver.
‘Two such individuals are Ernie Ho, who is the VP of Corporate Development and evaluates transactions and programmes with a great understanding of the medical services side of the industry. The other is Philippe Martin, who is the Chair of our Research and Development advisory board. Philippe and I worked together at Celgene and he has twenty years of experience in biotechnology, leading moving compounds through the clinical trials required to gain regulatory approval.’
As NeonMind went public at the end of 2020, PSYCH was eager to learn if the company planned to uplist to senior stock exchanges in North America to access a greater number of investors across the Atlantic.
‘We only went public less than a year ago, and are listed on the Frankfurt Stock Exchange, the OTC Exchange and have DTC eligibility. Are we thinking about additional listings? For sure, as we will need additional capital and need to tap into additional liquidity opportunities. It’s in our windshield, but it’s not something I would say is coming at us full speed. At the moment we think we have adequate exposure to the capital markets and the investors who are interested in our business. Graduating to a senior exchange may be in our long-term plans, but at the moment we have no immediate plans to do so.’
With a number of tryptamines studied for their potential as psychedelic medicines, PSYCH was interested to know if NeonMind was investigating other compounds alongside psilocybin.
‘Our first two programmes are focused on psilocybin, as at NeonMind we try to be very frank and honest with our bandwidth. We are an early mover and at the forefront of looking at the obesity indication. We are close to an FDA consultation meeting, where we could get an IND to be the first company in the world to dose psilocybin to obese patients – beginning as early as 2022.
‘Are we interested in other compounds? Do we think other compounds have interesting profiles? For sure, but for now our proprietary preclinical data was done with psilocybin and had encouraging data. It demonstrated positive results in reducing weight gain and that is where we’re focused.
‘When we think about psilocybin, there are a number of reasons why we think it will be effective in the obesity realm. Moreover, we think there is a relatively rapid path to the clinic, utilising the therapeutic modality that combines a high dose of psychedelic with psychotherapy. In other indications, that is showing durable efficacy, a good safety profile and has been approved by a variety of regulators.
‘There is good underlying data with psilocybin, so it’s a good de-risked programme for us to get into the clinic. Then we have a very interesting research hypothesis in the obesity realm.’
Several drug developers are researching whether psychedelic compounds can be used to treat eating disorders; PSYCH asked Tessarolo why NeonMind is looking at obesity specifically.
‘Clearly, obesity is a grossly underserved indication, with fewer than five approved pharmacotherapies for chronic weight management,’ Tessarolo stated. ‘A number of patients proceed to bariatric surgery, which is a very invasive procedure, and, in many cases, a lot of patients regain weight and end up in the same unhealthy situation.
‘It’s a very underserved market, with a huge number of patients around the world suffering from obesity – at least 650 million globally. It’s a massive market. When looking at psychedelics, it is the indication with the largest potential and the data supports that.
‘When investors are evaluating the psychedelic sector and looking at different companies, it is critical to look at the indications sought and what organisations are doing for those specific indications. It is rather easy to paint mental health conditions with a broad brush as a be-all and end-all to solve all these problems. The reality is that to solve these problems, and utilise psychedelics as medicines, they will need to go through rigorous clinical trials to prove safety and efficacy.
‘We know that psilocybin acts on the 5-HT2A receptor and the 5-HT2C receptors. The 5-HT2A receptors are largely responsible for the hallucinogenic effects, and the 5-HT2C receptors are responsible for appetite control and have an anorectic effect. We know that psilocybin hits both these receptors, so with the programmes that we’re moving forward with, we fully expect to help obese patients keep this weight off.
‘It’s not that hard for patients with a high BMI to lose many pounds of weight, with lifestyle modifications, diet changes and caloric reductions. The challenge is adjusting to this new way of life. When something dramatic happens in your life, it is very hard to adapt, even if it’s a positive change, which is why we see so much weight regain and rebound.
‘The research hypothesis is that patients on psychedelic drugs, like psilocybin, report this renewed sense of self and wellbeing, and we think that is where there is an opportunity to transition to a new way of life. If we can help patients adapt to this new way of life, they will be in a better spot to maintain weight loss.’
With psilocybin hitting two receptors conducive to chronic weight loss, PSYCH was eager to learn if NeonMind had plans for both high and low doses of the psychedelic compound – referred to as acute and chronic dosing respectively.
‘We demonstrated that both high and low doses of psilocybin were able to reduce weight gain, by up to 30 per cent in some patients, so that points to two parallel development paths. One is the high-dose modality, or acute dosing, and the other is a low-dose modality that does not elicit a hallucinogenic experience. With the low-dose modality, we believe we will still hit the 5-HT2C receptors to promote appetite suppression and control appetite.
‘The challenge from a drug development perspective with chronic dosing is toxicity and cardiovascular safety. Those studies take a long time to conduct, and because the early data was done in an acute setting we know the data is out there and that it supports this compound’s safety when used that way.’
With a solid research hypothesis and the development of multiple proprietary psychedelic compounds in the pipeline, PSYCH pressed Tessarolo on why NeonMind is such an attractive proposition for investors.
‘NeonMind is a company that is very early out the gate on a very unique indication. We have an early-mover advantage and are as far as anyone in the world when looking at the potential of psilocybin in obese patients.
‘We have very critical value creating milestones in the coming months, with a consultative meeting with the FDA scheduled for later this year. Pending that feedback, we expect to have an IND approved to get into the clinic to conduct Phase I and II studies as early as the first half of 2022. We expect to read out the Phase I data in 2022 and have Phase II efficacy data in 2023. When you think about the biotech model, in the next 24 months we could be sharing very valuable data on the commercial viability of our proprietary asset in this massive indication.
‘The other side of the organisation that is very exciting is the medical services division. In the next five years there could be five to ten different psychedelics approved by the FDA, and all of those patients will need a specialised setting where these medicines can be delivered.
‘The medical services division also de-risks the nature of the biotech programme. In biotech programmes there are no guarantees; we will open the cards and see if it works. It also gives us exposure to the collective success of the psychedelic sector, as these centres need to be there for all indications.
‘There are already medicines approved today, like esketamine, that we can deliver in a NeonMind branded mental health clinic. The delivery of biologic medicines, which need to be injected or infused, is a US$100b-a-year business in the US. Biologic medicines have a striking level of efficacy and need to be administered in a specialised setting, like psychedelics. As a result, we see literally hundreds of thousands of patients needing a specialised setting to receive innovative medicines in the 2025/2026 timeframe.
‘We are hard at work trying to identify locations that make sense for our branded clinics. We are starting in Canada, as, again, we are trying to be honest with ourselves in respect to our bandwidth. Ideally, in the next two or three years, we will be at scale and profit positive on a location basis. We can then take that model into the United States when the time is right to coincide with the approval of psychedelics. We expect to announce our first clinic location by the end of the year, to open in the first quarter of 2022.’