
Life Sciences 360
Life Sciences 360 is an interview show that educates anyone on challenges, trends, and insights in the life-sciences industry. Hosted by Harsh Thakkar, a life-sciences industry veteran and CEO and co-founder of Qualtivate, the show features subject-matter experts, business leaders, and key life-science partners contributing to bringing new therapies to patients worldwide. Harsh is passionate about advancements in life sciences and tech and is always eager to learn from his guests— making the show both informative and useful.
Life Sciences 360
Breaking Down Barriers in Psychedelic Drug Development
Welcome to episode 052 of Life Sciences 360.
In this episode, of Life Sciences as we dive into the fascinating world of psychedelic therapeutics with Dr. Sam Clark, the Chief Executive Officer of Terran Biosciences. Dr. Clark shares his journey of founding Terran Biosciences, motivated by the need for better treatment options for psychiatric and neurological disorders. Discover how Terran Biosciences is leveraging a tech company structure to accelerate drug development, utilizing AI in imaging, and pioneering innovative prodrugs.
Learn about the company’s groundbreaking work in developing psychedelics without hallucinations and their mission to make these therapies affordable and accessible to patients.
Subscribe for more insightful conversations with leaders in the biotech and life sciences industries!
Chapters:
00:00 - Introduction
00:12 - Dr. Sam Clark's Motivation and Background
01:00 - Founding Terran Biosciences
01:35 - Challenges in Psychiatric and Neurological Treatment Development
02:55 - Innovating with a Tech Company Structure
03:18 - Use of AI and Drug Development Strategies
04:18 - Slow Translation of Research to Therapies
05:50 - Development of New Prodrugs
07:12 - Explanation of Prodrugs
08:49 - Terran's Lead Assets for Psychotic Disorders
10:16 - Creating Long-Acting Prodrugs
12:16 - Addressing Regulatory Hurdles in Psychedelic Research
14:20 - Pipeline Overview and Future Plans
16:13 - Importance of Collaboration in Psychedelic Research
17:58 - The Rise of Big Pharma Interest in Neuroscience
20:14 - Addressing Stigma Around Psychedelics
23:02 - Overcoming Regulatory Challenges
26:31 - Trends in Psychedelic Funding
31:48 - Making Medications More Accessible
37:00 - Impact of Psychedelic Approvals on the Industry
38:20 - Focus on Patient-Centric Approaches
41:11 - Final Thoughts and Future Announcements
Follow Terran Biosciences on LinkedIn and X, and visit their website for the latest updates and announcements.
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Links:
- [Terran Biosciences on LinkedIn](https://www.linkedin.com/company/terran/)
- [Terran Biosciences on X](https://x.com/terranbio)
- [Dr. Sam Clark on X](https://x.com/neonneurons)
- [Terran Biosciences Website](https://terranbio.com)
- [Tera XT Website](https://teraxt.com)
For transcripts, check out the podcast website - www.lifesciencespod.com
Harsh Thakkar (00:00.878)
All right, welcome to another episode of Life Sciences 360. My guest today is Dr. Sam Clark. He is the Chief Executive Officer of Terran Biosciences. It's a company that's really doing a lot of interesting things in the psychedelic therapeutic space. So let's dive in and have a chat with Sam. Welcome to the show, Sam.
Sam (00:20.644)
Thank you, thanks for having me on.
Harsh Thakkar (00:22.99)
Yeah, let's get right into it. You were in the dorm room at your university and you invested $10 ,000 in the seed round into this company. What was going on in your mind if you were to reflect back in that point of time?
Sam (00:43.108)
Well, when I founded Taren, it was because I was frustrated at the treatment options available for patients with severe psychiatric and neurological disorders. The issue was that, you know, growing up, I had a number of friends and family members with severe mental illness, specifically bipolar disorder. And also my grandmother died from Alzheimer's disease. And so that's why I went.
I wanted to find treatments. I went to Columbia to do the MD PhD program. But during my years of medical training is when I realized that the treatments we have, you know, there's just there's not that many new ones coming out. And I could see they weren't good growing up. But Columbia was like, Look, there's just no good ones coming out either. There's not much the pace of development is exceedingly slow.
And same thing for the other career option would have been to go into research. But I said, look, most of these research discoveries that are being found in the laboratory are not being translated into the clinic. And so I didn't have high hopes for a research being translated in the clinic that way, nor did I want to go just practice medicine with the existing therapies. So I said, look, I want to found a company that could address this. And I decided to found it a bit differently.
Harsh Thakkar (01:50.382)
Mm -hmm.
Sam (02:04.868)
I said, you know, I've been looking at a lot of biotechs and based on the way they're organized with the more hierarchical structure, I feel like that contributes to why they move so slowly and it interferes with the pace of development. And so I founded Terran structured as a tech company based on seeing tech companies in Silicon Valley move very quickly, pivot fast and make big breakthroughs. So I said, you know, we're going to found a biotech that does this. And that's the structure of Terran.
Harsh Thakkar (02:17.87)
Hmm.
Sam (02:33.316)
fast small team of operators that where we bring on world experts to solve critical problems that other people have previously thought impossible.
Harsh Thakkar (02:42.222)
So it sounds like you and correct me if I'm wrong, but it sounds like you are like you said you are a biotech company, but you also have a proprietary AI driven platform that you use for drug development. Is that accurate?
Sam (02:56.292)
We use AI in imaging, in one of our imaging programs, but for drug development, it's actually a number of different things that we do to get drug development done.
Harsh Thakkar (02:58.83)
Okay.
Harsh Thakkar (03:07.694)
Okay, okay. And you said that when you were in school or university, you did this assessment and found that there was not much research going on. Now that you are in this position, you started a company, when you look back, do you know any reasons why there wasn't much research in this space?
Sam (03:30.66)
So to clarify, I think there was a lot of research going on into the mechanisms of disease. And it's the problem is the research is translated into actual therapies very slowly. So it's the slow pace that therapies are developed that hit the market. So for example, you know, when I was at MIT, I was reading about all these possible mechanisms for bipolar disorder, how it might work.
Harsh Thakkar (03:44.846)
Mm, okay.
Sam (03:57.988)
And, and a number of other conditions. And then when I went to Columbia, you know, I wanted to research, psychiatric conditions and I was doing some research into schizophrenia as well. But then, you know, apart from this rich body of different theories and ideas and research, those weren't really testing new drugs. It was more about how the disease might work and their ideas about new drugs. But then when I got into the clinic.
And I saw that, you know, in my psychiatric rotations, you know, we're using the same meds that we really been using with same mechanism for the last 40 years, new drugs that had just were just coming out around that time were really just kind of a redusting off the same mechanism, you know, with a little bit of an improvement here or there, you know, it's like, it's like, imagine a really old operating system and you get a little patch and they're patching it and like updating it a little bit, but there's no,
Harsh Thakkar (04:39.982)
Mm.
Sam (04:51.46)
transformational paradigm. And I said, we need to get in there and develop the ideas and theories into new transformational treatments that are completely different and really apply the most modern technology to this problem. And I was looking at a number of other biotechs working in this space, and I was just frustrated at the pace that it would move so slowly. So I said, you want to move, found a company, get in there, make that difference, help those people with neurological and psychiatric conditions. But
Harsh Thakkar (05:13.646)
Hmm.
Sam (05:21.188)
do it in a way that we can move much faster than is typically done in biotech.
Harsh Thakkar (05:25.486)
Got it, that's very interesting. Quick message for the audience, before we go into other questions and ask Sam about the pipeline and all of the projects that he's working on, if you enjoy these kinds of conversations with other executives from different biotech and life science companies, please, please subscribe to our YouTube channel and also our podcast on Apple and Spotify. It lets us know that you like this content and it also makes the guest more.
Interested in coming on to our show and sharing what they're doing. So back to the show We will talk about tell us about your pipeline in the company Like what are if what are the different types of products and what's like the one promising factor for each of them?
Sam (06:10.788)
So we have a couple of later stage assets for psychotic disorders and we'll go through them one at a time. Our lead asset right now is a combination of two prodrugs. These are prodrugs we've created and before I explain what it is, I better give a quick explanation of what a prodrug is. So prodrug is when you take a compound that is active and
highly effective, but you realize that compound has what's called pharmacokinetic problems or limitations. And what that means is you may have a highly active, very good compound for treating a disease, but it's not absorbed well into the body, or it's not in such a form that you can really turn it into a long acting form of the drug. So when you make a pro drug, you take that active ingredient, that active molecule, and you attach a little side chain to the side of it.
And when it gets in the body, that side chain is removed, allowing the active compound that we already know is good to work. That is also good because not only have you improved the molecule to make longer acting forms that are easier for patients to take, but because it's a prodrug, it's often eligible for the FDA's 505b2 accelerated pathway, which...
Harsh Thakkar (07:36.206)
Hmm.
Sam (07:36.868)
allows reference of existing data five years after an approval, which means if this original molecule, which may not be optimized as approved, you can go to the FDA with your prodrug and they'll let you reference the original molecules, phase three data and safety to get yours approved very quickly five years after the first approval of the first molecule. So now with that summary of why prodrugs are good, one of our lead assets now is a prodrug.
Harsh Thakkar (07:57.646)
Interesting.
Sam (08:05.124)
of a compound called xenomaline and a prodrug of a compound called trospium. Now, xenomaline and trospium as a combination have been shown to be highly effective for the treatment of schizophrenia and they may be effective in other psychotic disorders as well. It's one of the first new mechanisms to treat the psychosis antipsychotic in over 50 years.
It's a really a true mechanism targeting the muscarinic receptors. There's a combination of old non -pro -drug forms of xenomaline introspium currently under FDA review. And it's expected to be approved this year. If that is approved, we are planning to put our pro -drug form called TeraXT forwards and hopefully get that via the 505b2 approved.
on the market. Now let me explain how that works. The old prodrug form of xenomaline, you know, xenomaline was invented in 1992 and trospium was invented in 1960. So there's a lot of room for modern pharmacological improvement. So what Taren did is we realized that the current version for FDA up under FDA review is an oral twice daily drug, you know, take it twice a day. So we said we will build prodrugs of this.
As we looked at many of the anti -psychotic, the big breakthrough anti -psychotics on the market, and many of them have already been turned into prodrugs, Abilify. One of the highest grossing anti -psychotics was turned into a long -acting prodrug. Invega, Sustana, Mate, Netrinza, and Hafiera, those are all turned into long -acting prodrugs. So we said, let's make longer -acting prodrugs of xenomyelidine and trospium. And then...
We'll formulate them into a once daily oral pill, and we'll make a long acting injectable form as well. That's our plan. And then plan to use the FDA's 505b2 path after the original twice daily oral non -pro drug form gets approved, hopefully later this year. So that's our lead asset, and we're very excited. It's called TeraXT, which stands for Teren -Xenomaline Trospium. And then...
Harsh Thakkar (10:28.206)
I see, okay.
Sam (10:28.324)
We also have, yeah, and then we also have another antipsychotic that we acquired in an exclusive licensing deal from Pierre Fabray in France. This was a compound that had been under development in the 90s as an add -on to antipsychotics. It was a new mechanism, a selective alpha -2 antagonist, and no drug to date has ever been approved with that selective mechanism.
So there's currently no FDA selective alpha -2 antagonists on the market. In the 90s, they showed that when added to a patient's baseline antipsychotic regimen, you could have an improvement on top of the baseline treatment that almost doubled the original treatment. Unfortunately, the drug had a very short half -life and had to be given three times a day. And so they couldn't figure out how to fix it, and development was discontinued.
We licensed it and successfully built a once daily form of the drug. And now we put it back in the clinic in over 100 healthy volunteers to show the FDA that we have the once daily form now of the drug. And then we plan to take that in the trials with schizophrenia where we hope it could be the first antipsychotic booster, adjunctive therapy to improve on baseline treatments. And then finally, our third main asset is
Harsh Thakkar (11:30.99)
Mm -hmm.
Harsh Thakkar (11:50.19)
Okay.
Sam (11:55.844)
a psychedelic where we've removed the hallucinations. And the idea there is that scientists have shown that psychedelics, as we've seen in clinical trials, can be highly effective for a variety of conditions. Antidepressant, they can be great for anxiety, PTSD. But one of the problems is that they have those long trips. And in many cases, it's about an eight hour, six to eight hour time commitment and a doctor has to be present the whole time.
This has been estimated to potentially cost tens of thousands per treatment session if this was rolled out in its current form later for, for example, psilocybin for depression or LSD for anxiety. But scientists also showed that psychedelics, while they hit a lot of receptors in the brain, only one is responsible for the trip, and that's the serotonin two -way receptor. So they said, what if we...
block selectively just the serotonin 2A receptor, but allow the psychedelic to hit all the other receptors. Animal models showed that that maintained efficacy. And then we did a human MRI analysis study that showed that when you do that, there's no trip, but you maintain what we believe to be the mechanism of action of the psychedelic. The functional network changes in the brain still happen even without the trip.
And so we're developing that as well for depression and other conditions as a take -home medication. And then lastly, we have a whole bunch of classic psychedelics with the trip where we've invented new forms to enable the 505b2 pathway so that patients have access to affordable, cheap...
Harsh Thakkar (13:24.366)
Okay.
Harsh Thakkar (13:53.582)
Mm.
Sam (13:53.796)
medications as soon as somebody else gets those psychedelics approved. So I'll give you an example. Psilocybin is in clinical studies and when that gets approved, five years after the first approval, Taron has invented the world's first new form of psilocybin, a new salt in crystal form, and we're going to put that on the market in a 505b2. We're prepared to do the same for LSD, for MDMA, for...
R form of MDMA, an antimerically pure MDMA, for methadone, for several Ibogaine and DMT derivatives, and many others, including 5 -Methoxy DMT, where Taren has invented either new salts, polymorphs, deuterated forms. It's where you replace a hydrogen in the molecule with a heavy hydrogen and prodrugs. And so we've got this big program of 505b2s ready to go. And the goal of that is that
Harsh Thakkar (14:37.55)
Yep.
Sam (14:48.196)
we will be able to make sure patients have multiple options to break through any patent monopolies that may be set up so that patients do not have to be overcharged for any medication if that problem should arise.
Harsh Thakkar (15:05.622)
Yeah, so I have a few questions on the whole psychedelic therapeutic space because it's very interesting and there's, you know, we'll go into that but before we go there, I also wanted, so I think the one, the first product that you mentioned about when you were talking about prodrugs, that's a prodrug of a BMS drug that they acquired from Karuna Therapeutics, is that correct?
Sam (15:33.356)
That's correct.
Harsh Thakkar (15:34.542)
Okay, just for, yeah, okay. Okay, yeah, because I was reading that as you were, you know, you mentioned about it and I worked at BMS so I know a little bit about the companies they've acquired and the work they've done so I connected the dots there. In addition to, it sounds like you have an amazing pipeline of products that you're working on and you have a good strategy as to how you wanna get those therapies to market. But I also see that, you know, you are a part, you know,
You're also manufacturing GMP psychedelic compounds for other companies. So how, like, when did you decide that you also wanted to do this collaboration of manufacturing services for other companies? And how important is that, you know, for the revenue of your company to fund all the other projects you're doing?
Sam (16:24.1)
It's not that we're manufacturing for other companies, it's that we provide psychedelics to other researchers in clinics. So the issue is that, I mean, if other companies want psychedelics from us, they could also come to us, but so far, it's been clinics and researchers that have come to us. So let me kind of clarify how we got into that. So when we went into psychedelics, we wanted to do something completely different.
Harsh Thakkar (16:33.102)
Hmm.
Harsh Thakkar (16:43.63)
Okay.
Sam (16:52.548)
We're not trying to be the fifth company to get psilocybin approved or something like that. We're not competing to get one of these classic psychedelics approved that other groups are doing. We don't want to be redundant. So we said, look, it's this psychedelic without the trip that is Taron's lead focus. But in doing so, we had to set up massive manufacturing, GMP, which is fit for human consumption, of LSD, psilocybin, MDMA, and other psychedelics.
And we do all of that in Europe right now. And once we had that set up, researchers and clinics started coming to us in Europe and other places asking for access to the psychedelics. And so we do provide because if we're making it, we're happy to also provide it to push the field forward. But then that's when we realized that many of these in the course of researching for our main program, many of these would be perfect.
for 505b2 applications on existing psychedelics. See, what we saw was something very worrying, where a lot of companies were moving to lock down exclusivity on the psychedelic space in various niches from whether it be psilocybin, MDMA, or other aspects. So we say, well, Terran will create new forms to get around any of the IP that these other companies have set up so we can break through their IP.
barriers and get cheap affordable meds to patients so that we don't have a situation where patients only have access to one drug and that drug may be overpriced. And at Taren, we really just care about the patient. So in doing so, we've been able to break through the IP barriers of a number of companies. And that's what we also ended up doing when we developed Terra XT, our lead asset.
Harsh Thakkar (18:29.582)
Hmm.
Harsh Thakkar (18:45.55)
Okay. Can you share names of any, any companies or academic researchers that you're partnering with?
Sam (18:55.012)
Well, there will be some announcements soon on groups. But I think, let's see, ones that were approved to mention, at least just the name, would be University of Leiden. We're providing something there. We've been providing an NRU, I believe, also some psychedelics as well. We can't comment on exactly what projects they're using it for, but just the name should be fine.
Harsh Thakkar (18:59.79)
Okay.
Harsh Thakkar (19:22.702)
Okay, okay. So how have...
Sam (19:25.828)
and also in the United States, I forgot to mention VCU as well. We've collaborated with there for psychedelic research.
Harsh Thakkar (19:29.038)
Yep.
Harsh Thakkar (19:33.742)
Okay.
Great, yeah. Yeah, I'll be following your company and you on LinkedIn after. That's what I do with all the guests, because once I talk to them, I learn so much more that it's like I wanna go down the rabbit hole and keep learning more about what you're doing. So I'll be sure to stay in touch there. How have you seen the treatment of neuropsychiatric disorders evolve since you started the company?
within your company and just in the industry as a general.
Sam (20:09.348)
Well, we've seen more focus on neuro from, you know, big pharma again, which is very encouraging because ultimately you want big pharma to invest some of the money they have back into neuroscience acquisitions and research programs. So I think there has been a focus to go back into neuro, whereas, you know, 20 years ago, there was a big exit from neuroscience. But now we're seeing kind of a resurgence of neuro research, which is really, really encouraging for us.
Harsh Thakkar (20:31.95)
Yep.
Harsh Thakkar (20:39.854)
And with the psychedelics, like some of the ones that you mentioned, right? So like LSD, MDMA, now there is some stigma with using these, right? So how have you approached that in your discussions with investors or whoever you're talking to or just the community?
Sam (21:03.524)
So there used to be a lot of stigma around psychedelics, but I will say that in recent years, due to the groundbreaking research that a number of these universities and other companies have done in publishing the results of clinical studies, I think the public has realized that these are very valuable medications. You can just look online, and anybody has access to Google, and they can look at all of the different studies.
clinical trials showing psychedelics having remarkable efficacy for neuropsychiatric diseases. So we haven't really dealt with any significant stigma in psychedelics. What we have dealt with is there are still a lot of regulatory hurdles that make researching psychedelics very difficult. That was set up when psychedelics were incorrectly put on schedule one back in on the 70s and 80s. And that
Harsh Thakkar (21:55.982)
Hmm.
Sam (22:01.572)
you know, as a side effect of the failed war on drugs when these safe and effective psychedelics were labeled as having no medical use and a high potential for abuse. And now we're seeing that largely disproven and that these psychedelics have shown not only medical use, but remarkable efficacy beyond what our current treatments have been capable of. And so we're very excited to push forward in the research, but those, but.
When a compound is placed in schedule one, there are a number of barriers set up that make it difficult to research in the United States. And that's why we have had to move manufacturing into Europe, as well as the creation of our new psychedelic libraries. Those were all done in the UK and in Europe. And so, there's just, with the regulations and restrictions, we've had to move that work out of the US.
Harsh Thakkar (22:58.798)
Okay. And you mentioned when you were talking about big pharma investing in Euro and you've seen that trend. So can you comment on the, you know, fundraising environment of psychedelic drug companies or bigger companies that are investing? Have you seen any trends or anything that's particularly interesting?
Sam (23:22.532)
Yeah, so around 2020, 2021, really 2021, as we saw it large, well, 2020, 2021, and right into 2022, there was a large influx of capital into psychedelics. And it was basically a bubble. And what happened was there were a lot of investors that had made money on cannabis stocks and cannabis companies and people who had founded cannabis companies. And so they rushed into
Harsh Thakkar (23:39.982)
Hmm.
Sam (23:52.132)
psychedelic companies say well, you know, marijuana and psychedelics, we feel like those go hand in hand and so they can't be that different, right? They didn't realize that the biotech industry is highly regulated compared to cannabis and getting drugs FDA approved is very, very difficult and requires very strict adherence to guidelines. So around that time, we were tracking two
Harsh Thakkar (24:00.718)
Yep.
Sam (24:19.588)
120 companies developing psychedelics and and raising money around psychedelics of which over a hundred were doing either some form of psilocybin or LSD or MDMA and or DMT and Now most of those companies have gone out of business and for a while funding for psychedelics You know after they hit that bubble and people realize that these companies that just raised small rounds were not going to be sustainable and
Harsh Thakkar (24:23.982)
Wow.
Harsh Thakkar (24:36.398)
Mm.
Sam (24:48.996)
there was a big drop in psychedelics funding that didn't affect Taron because Taron is or it didn't affect Taron in a in a manner in a way that affected as much the other companies because we also have non psychedelic assets like Terra XT, Ida's ox and XR things like that. But now we've seen after that kind of lull the bubble popped psychedelic there's more funding returning to psychedelics again, but they're doing it in a more cautious.
manner, where they're really investors are getting smarter about looking at whether a company really has the regulatory and manufacturing expertise. And this is very good for Taron, as we're a leader in this space of manufacturing. We understand what to do on the regulatory side and the development of new drugs. So that actually we see as a very beneficial and positive thing for the industry.
Harsh Thakkar (25:43.822)
Yeah, and also, you know, as you were mentioning earlier, you know, it's interesting that you said 220 companies. So was that just in US or worldwide?
Sam (25:57.924)
that would be worldwide, including Canadian companies. I mean, there's not many in Europe. It was mostly you. Most of them were us and Canada.
Harsh Thakkar (25:59.022)
Worldwide, okay, okay. Yeah.
Harsh Thakkar (26:05.774)
Okay, okay. Yeah, I've actually talked to a few friends, because I work in quality and regulatory consulting space and technology consulting space. So oftentimes, you know, I've heard from some clients in the cannabis industry, or food and beverage industry and consultants who work in there. And they don't really understand the, like, yes, the regulations are somewhat similar in terms of expectation.
but the scrutiny is much higher when you enter biotech and pharma. And they see it when they work with me or with my team on projects like, we never did this when I was in the other role at the cannabis or food and beverage. And why are we doing all this extra work? And it's like, yeah, welcome to our life. So yeah, I've seen the same thing with consultants that I work with. You mentioned also another point that,
Sam (26:45.956)
Thank you.
Harsh Thakkar (27:03.758)
what Taren's doing is trying to break the IP barriers or trying to develop a different strategy to get the medicines to the patients, make it more sort of democratizing the access, yes. So what are some other things that you're doing internally to also make the medicines more accessible?
Sam (27:31.396)
by internally, do you mean in research or do.
Harsh Thakkar (27:33.454)
Like within, yeah, research and within your company, are there any particular strategies that your team has to, you know, make the psychedelic therapies more accessible?
Sam (27:42.468)
Yes.
Sam (27:46.186)
absolutely. So one example has been through the creation of new salts and polymorphs. Those are crystal structures. And the second strategy has been through the creation of prodrugs. Let me give you two case studies on how we've really broken through some barriers there. Psilocybin was thought for, you know, up until now, to only exist in one
Harsh Thakkar (27:46.83)
Yeah.
Sam (28:12.1)
crystal main, you know, form one salt form, essentially, essentially, it says water ion, which is the idea that it can't really make salts. And as such, there only existed three crystal forms. And since all three had been patented, the idea was that it was possible potentially, for a company to control the entire psychedelic market, since they own the patent.
Harsh Thakkar (28:20.27)
Hmm.
Sam (28:37.796)
on all of the current crystal forms. And since the crystal forms are regulated by FDA, you'd ultimately have a product that would have to be one of those forms. But we see monopolies being set up like that as very bad for the patient. And so we said at Terran, we're going to create the world's first new salt of psilocybin. And people said that's not possible. So we applied Terran's model, which is build a team of world experts around the problem.
And at the end of the day, we did, we created psilocybin hydrochloride and psilocybin adesylate and psilocybin mesylate. These are the world's first new salts, new crystal forms. That means all the patents on original psilocybin do not block, tarin that are dependent on those original salts do not block tarin from getting around all of that IP, shortcutting all of it for a 505 B2 application with our new form.
Then we made new forms of MDMA and we made new forms of LSD and many other psychedelics We made pro drugs of 5 methoxy DMT that would be orally active so to get ready for 505 b2s and what that means just in the most direct Language is that when any of these companies get a psychedelic approved? Five years after that approval Taron will be right there ready to go
with another form of the drug that can reference their data. And we'll get that on the market and we're going to price it low. And we're going to make sure that patients have access to affordable medications quickly so that treatment is not delayed and that nobody has to be overcharged for psychedelics. And then that pro drug approach has also led us to some of our biggest breakthroughs to make medications accessible.
Harsh Thakkar (30:12.43)
Mm -hmm.
Sam (30:36.932)
For example, with Terax -T, where we feel we are short -cutting a typical life cycle management strategy to roll out improvements every 10 to 20 years, with Terax -T, we want the best forms of xenomaline introspium that we can make to be available to patients quickly. And we plan, five years after the first xenomaline introspium drug to be approved, hopefully this year, that we will have forms that are
Harsh Thakkar (30:57.87)
Hmm.
Sam (31:06.468)
Long acting on the market is Terra XT.
Harsh Thakkar (31:10.862)
I see. Yeah, it's very interesting, like I said, you know, so the five year, that's like the patent exclusivity period, like once that ends, then other companies can, like you are doing the 505B2. So that's what that five year, okay. Okay, okay.
Sam (31:26.468)
That's, it's a data exclusivity, marketing and data exclusivity period, by which then after that period, the FDA lets you use the data from the original company that got the first drug approved. Now, often those companies will have patents that block anyone from accessing the molecule even if after the exclusivity period expires. But that's where Taren comes in and we specialize on getting around those patents, breaking through those patents.
Harsh Thakkar (31:36.59)
Hmm.
Harsh Thakkar (31:48.366)
I see.
Harsh Thakkar (31:53.038)
Hmm.
Sam (31:55.492)
and making sure that treatment is neither delayed nor denied to patients. That patients don't have to wait for the best forms of the drugs. That patients won't be overcharged for their medications. That there will be competition on the market brought by TARIN in the form of our new innovative breakthroughs.
Harsh Thakkar (32:00.59)
Okay.
Harsh Thakkar (32:15.054)
Yeah, thank you for clarifying that. So I want to talk to you about your entrepreneurial journey, right? What are some of the lessons you have learned building the company and, or even building yourself as a leader, working with teams? What are some lessons that you've learned in your journey?
Sam (32:37.892)
You have to be able to pivot very quickly as the science evolves, as the market conditions evolve. Basically, biotech is a game of moving very fast. And in moving quickly and adapting, that's why we've been able to break through these IP barriers. This is something where you have to be very alert. You have to be very focused.
But you have to be ready to pivot at a moment's notice. You can't just be focused on one trajectory. You have to be constantly evolving. It's a game where when things move and change, the pieces change very quickly. I love the quote that no man ever steps in the same river twice because it is not the same river.
Harsh Thakkar (33:32.11)
Hmm.
Sam (33:35.012)
and he is not the same man. And it just illustrates how quickly things are changing even when we don't see them change.
Harsh Thakkar (33:37.518)
Interesting.
Harsh Thakkar (33:44.302)
That's a very interesting quote. Looking at the future in the biotech industry or in the neuropsychiatric space, is there anything that you're really excited about that you have your eyes on?
Sam (34:01.38)
Well, I'm, you know, hate to come back to it, but Tera XT we are very excited about because the muscarinic system is the first new antipsychotic mechanism in 50 years. If you think about it, and this was part of why I was so frustrated back in the medical years, every single antipsychotic approved was either primarily blocking just the dopamine type two receptor, or it was blocking the dopamine type two receptor and the serotonin two -way receptor.
Harsh Thakkar (34:06.798)
Yep, yep.
Sam (34:31.556)
And every variant of that was just a little change on that mechanism. It was, okay, well, we blocked dopamine 2 a little less than other antipsychotic or were a partial agonist at D2 ,3. But there's nothing really new. The muscarinic system represents enormous wealth of new potential. This is an entire new neurotransmitter system. And it's also with idaxoxan, the second drug we have up that's in the clinic right now. It's an alpha -2 antagonist.
Harsh Thakkar (34:44.494)
Hmm.
Sam (35:01.348)
There hasn't been a single selective alpha -2 antagonist drug approved ever in history. And so again, we're very excited about that potential as well. And so that combined with the enthusiasm for neuroscience that we're seeing now from big pharma and investors really combines to be an optimal set of conditions that we're very excited about.
Harsh Thakkar (35:28.334)
Yeah, and you know, as, so when you mentioned earlier that there were 220 companies in this space between 2021 and 2022, so as some of those companies are observing your journey and Taron's journey, and also just the general like approval strategies from the agency on, you know, psychedelic drugs and this sector, how do you think like,
your success is going to, is it going to help those companies develop a similar strategy? Is it gonna open more doors for other companies? What do you think is gonna happen with all the success that you're having to the overall sector?
Sam (36:12.868)
Well, I think for in terms of breaking down regulatory barriers, a rising tide lifts all boats. And so I think that anytime a company gets a psychedelic approved, and then that results in a rescheduling of the drug, we move the field forward. Anytime a new neuroscience mechanism is approved, the field moves forward. And so I think that provides, it provides a playbook for other companies to follow.
Harsh Thakkar (36:21.23)
Mm -hmm.
Sam (36:43.172)
It provides proof that these are fundable assets, they're effective, they can be used to treat diseases. And so I think all of that can be helpful to other companies following in this space.
Harsh Thakkar (36:58.638)
Yeah, and you've shared a couple of great quotes. So I'm gonna ask you one more question, because I think maybe you might have one more quote in your bag. But before we wrap up, what's one key piece of advice or mantra or something that guides all the work you do?
Sam (37:20.928)
Well, this is not so much a quote, but it's a focus on the patients. And, you know, a number of you know, sometimes you talk to other companies, and it's really, you know, about, you know, the key stakeholder being the investor, or the key stakeholder, you know, being another like a venture capital group. But in this case, our number one key stakeholder focus is the patient.
And that is what enables us to stay focused and motivated on breaking through these other IP barriers set up by other companies, as well as our other lead assets. And so in that sense, we believe that we need to move very quickly to bring these new medications to patients, these pro drugs with potentially improved pharmacokinetics. Because the issue we see at hand is that if we don't,
patients will be waiting many, many years for old patents to expire before they're able to access potentially better forms. We've seen in big pharma, the delay of bringing better forms to the market until an old patent expires. And in this sense, we feel that treatment delayed is treatment denied. And so we focus on moving quickly to get
these treatments to the patients because lives are at stake and people are dying every day. And so that's what keeps us motivated at Tarrant.
Harsh Thakkar (38:58.094)
Yeah, that's really exciting. And like you said, the drug development process, the regulatory hurdles, it's really tiring for any biopharma company. So having a team, like you mentioned, that you've intentionally built a team that's agile, that can pivot, that can do things at a really fast pace. So that's really a...
really big advantage, I think, for any company, not just a biotech, but even tech or, you know, the world is changing really fast. And if you have a group of people that can keep up with that pace and then also stay on track with the mission, I think that's, that's like the best thing you can ask for, you know, from your team.
Sam (39:44.356)
That's right.
Harsh Thakkar (39:46.114)
So you've mentioned that there's gonna be some announcements. You mentioned that there's a lot of interesting stuff going on with the pipeline at Terran. So where can listeners learn more about you or more about Terran to keep up with all these upcoming developments?
Sam (40:02.212)
So you can follow us on LinkedIn, TeraBioSciences. I'm also on LinkedIn. We also put our announcements out on X, TeraBio, and my X is at Neon Neurons. So those are all great places and our website. We also have our press releases and announcements on the website. And we have a dedicated website for TeraXT, which is setterext .com.
Harsh Thakkar (40:26.446)
Mm.
Harsh Thakkar (40:30.638)
Interesting any any final words before we wrap this up. I really enjoyed learning more about you and everything you're doing in this psychedelic therapeutic space
Sam (40:41.572)
Well, I'm just very happy to be on here and tell you about the work we're doing in the breakthroughs and that, you know, we are excited to validate the model that we set out to do to move very quickly to bring treatments for patients and wherever IP barriers are set up that could inhibit or delay the pace of research, we will be there ready to go with our new forms of the drug and to break through those barriers. We move very quickly and
We're excited not just to break through barriers in psychedelics and in the zoonomaline space, but we're working on several others right now.
Harsh Thakkar (41:19.246)
Great, great. Thank you so much for your time, Sam. Appreciate everything you've shared and wish you all the best with everything going on with your team and all the developments and everything you're doing to bring these medicines for the patients. So thank you.
Sam (41:38.308)
Thank you.