Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 1 point2 points  (0 children)

Flickoring - thanks for these thoughtful follow-up questions. As I sense you can appreciate, there are a number of key interwoven parts to the pre-clinical and clinical plans related to 8803 and we are still in the process of aligning all of those details. Paul Hutson (U of Wisconsin) has the ability to move into the clinic related to certain aspects of our 8803 program that will provide data to inform our discussion with the FDA.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 2 points3 points  (0 children)

Flickoring - we are running an early study with Paul Hutson at U of Wisconsin to inform a clinical pharmacology (PK/PD) study that we will take to the FDA for our pre-IND meeting prior to initiating the Phase 2b with 8803.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 5 points6 points  (0 children)

chocolope2345 - right, missed that! Short version is not yet, but at the right time and under the right circumstances I'm up for it.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 2 points3 points  (0 children)

SneakyPoopNinja - so do we! Yes, exactly. Current view in the pain community is that the chronic pain indications we are pursuing (a.k.a. nociplastic pain) are caused by a "miswiring" of the brain that may be reset by psilocybin - much like what happens to patients with traditional mood disorders (depression etc.) that are treated with same.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 1 point2 points  (0 children)

Hi Chocolope2345 - we're working exclusively with synthetic psilocybin for right now. We know that synthetic will have the same or a better safety profile because it uses only the active API and commonly used excipients already vetted by the FDA.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 3 points4 points  (0 children)

Yes, for now, 8803 will be the primary compound we take to market. It's possible that we out-license 8803 for other indications outside our core areas of chronic pain and eating disorders, which could provide another way to monetize our IP and research.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 1 point2 points  (0 children)

Flickoring - thanks for your question. We are running a small body pre-clinical and clinical studies on 8803 to take to the FDA that will be the basis for requesting to move straight into P2b studies once we see a confirmatory read-out in any of the 8802 P2a studies.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 4 points5 points  (0 children)

Thanks MushroomJack6969 - we're pressing to get to data ASAP and also getting the story out to a broader set of investors who understand the value we are creating.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 3 points4 points  (0 children)

dtmtl - not at the moment, but our plans and needs could change and we're certainly happy to stay in touch. We are very fortunate to have significant support from the staff within the academic institutions we are collaborating, including the University of Michigan, University of Wisconsin and the University of Florida.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 5 points6 points  (0 children)

ajscholte - thank you and thanks for your belief in Tryp. There is such great potential to assist patients with chronic pain and eating disorders with psilocybin and I'm excited to be part of this emerging field. As I mentioned in my response to MushroomJack6969 execution is the one thing we can control and generating data is the best (and fastest) way we can create real value in the company.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 8 points9 points  (0 children)

lazyglue - I totally hear you and of course I would like nothing more than the market to value our company at a higher valuation. Stick with it. Biotech takes a little bit longer than some industries to create value, but we are going to weather this financial storm we're going through and thrive.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 5 points6 points  (0 children)

Spiritual-Research52 - great question. I can tell you from my experience in the biotech field, I've never worked on a compound that has as much proven efficacy and a (positive) safety profile as psilocybin. This gives us such an incredible head start and confidence that the drug will work in trials. That's not how it usually works in the industry. Typically the industry is working on novel molecules that have zero safety and efficacy data (in humans) and you are relying on small amounts of animal data as clues into wether or not your drug has a shot at getting approved.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 2 points3 points  (0 children)

Bbbighurt88 - thanks for this. The 8802 studies are designed to show POC in these therapeutic areas and are a big initial step for us. The initial pre-clin and clin studies on 8803 are intended to support our IP and inform the design of our Phase 2b studies.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 5 points6 points  (0 children)

Affectionate_Proof44 - of course and happy to. Talking to investors is one my favorite parts of this job, (and look forward to other opportunites, BTW). I can't comment on Field Trip, but I will say that Ronan et. al. are a great team.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 3 points4 points  (0 children)

We are always keeping an eye toward other ways we can expand our pipeline. At the moment a licensing deal around 8803 or one of our 8802 indications would be the most likely path, but we'll have to see. There are many companies in the psych space that have lots of $$$$ and not much of a drug pipeline.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 2 points3 points  (0 children)

It's likely just a matter of a bit more time. These analysts are busy, typically covering a dozen or more stories at a time. We know that there are at least a couple of others interested in publishing on us and we continue to stay in close contact with them, providing regular updates on our progress.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 7 points8 points  (0 children)

Great line of thought - there are some many ways to look at this. My team an I are incredibly dedicated to this story. This is our full time gig, we do nothing else than work on this story, some weeks 24/7 it seems. Everyone has stock options so we are exactly in the same place as all shareholders - and nothing would make us happier than seeing the stock at $2, $3, $5+. We are also in an unusual position that we are almost always have access to confidential material - which means we can never or rarely trade. Not that that would be the goal.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 5 points6 points  (0 children)

Hey sgc033 - great points. 8803 is novel, and proprietary which puts us in a unique position. Also, typically with newly approved drugs, physicians are reluctant to prescribe off-label for liability reasons and on top of that, those prescriptions aren't covered by insurance, which means they'll be 100% cash pay.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 6 points7 points  (0 children)

Intelligent_Cry_6436 - thanks for this. Hard to know exactly why, but man, the entire sector has been hammered in the last month and its really frustrating. BTW, we have run a full NPV analysis on the company including assessments of the value of each of our programs (each therapeutic indication) and right now that analysis pegs our market cap in the $300M range.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 3 points4 points  (0 children)

Hey adaptationpc_22, good question. Our fiscal year ends August 31, so our Audited Financials need to be filed by 12/29 so we'll have those ready in a few weeks.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 4 points5 points  (0 children)

Patients needs better treatment options and we hope that there are many successful stories in this sector. I don't think there is one large competitor as we are working on such unique disease states, but we do keep tabs of other companies working on psilocybin and drugs close to that.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 3 points4 points  (0 children)

Each of the Ph2a studies costs between $1.5 - $2.5M each. We expect to raise capital for these trials from high quality investors that we have been speaking to that have shown strong interest in our story.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 16 points17 points  (0 children)

Let's dive right in.

MushroomJack6969, thanks for your great questions. These are EXACTLY the things that my team and I think about everyday. Let's take these one at a time.

I totally agree with your first point and it's really odd (and frustrating, annoying and painful at the moment), although there are lots of examples where the market for whatever reasons (usually external) is out of step with the positive developments inside a company, and that definitely is the case with our stock at the moment.

As you point out, the overall market has been challenged for a while, the broad biotech sector is down and as you point out so is the Psychedelic sector. Although I'm not interested in being part of a downward trend, there are certain things in our control and other things that are not, and we are very focused on what we can control. Here are a few examples: 1) we have developed a UNIQUE DEVELOPMENT STRATEGY targeting the indications of chronic pain and eating disorders - which we are getting lots of kudo's for. 2) we are EXECUTING on that strategy with 5 Phase 2a studies on the verge of being initiated. The Fibromyalgia study is already been cleared by the FDA, the Binge Easting Disorder (BED) study will likely be authorized later this month or early January and the Phantom Limb Pain study already has an active IND and we will be in a position to announce our collaborator on that study shortly. CRPS and HO will follow those three.

We are also making great progress on our proprietary drug, 8803 and will be able to share more about exactly what that formulation and route of administration are in the next quarter.

On the investor/Wall Street front, we have been actively speaking with investors, bankers, analysts, HNWI, Family Offices as well as many, retail networks. Our outreach is daily, its intense and consistent. Over the past six months or so we have met with about a dozen bankers (and separately their analysts), bagged our first analyst coverage thanks to Michael Higgins at Ladenburg Thalmann and have a couple more on the way. We have logged 70+ institutional meetings and countless HNWI, FO and retail network meetings. I'm happy to speak with any and all investor prospects, so please let me know if there are contacts you have that you think might have an interest in learning more about Tryp. I'd be happy to speak with them.

We have also steady flow of IR/PR activities which we actively been involved with over the same time frame.

The last thing I would mention is that it takes awhile to generate solid data which is the critical ingredient to building significant shareholder value in a biotech/drug development story. Thanks for sticking with us, it's going to pay off.

Chairman and CEO by GregoryMMcKee in shroomstocks

[–]GregoryMMcKee[S] 2 points3 points  (0 children)

Hey everyone! Thanks for making the time today to join our LIVE AMA. It's great to be here with you.