Implementing A New CEO Strategy With NervGen's Adam Rogers, M.D. And Rich Macary

On this week's episode of the Business of Biotech, we talk with NervGen leaders Adam Rogers, M.D., and Rich Macary about NVG-291, a daily neuroreparative peptide designed to restore function in patients with spinal cord injuries. Adam talks about his strategy for the company after becoming CEO last July, including moving company trading from Canada's TSX Venture Exchange to the NASDAQ for better visibility, and making key hires for growth. Rich talks about his early work in RNA therapeutics as an advisor at Sarepta, cofounding Synaptica Therapeutics, and bringing Adam to NervGen. They also talk about engaging with the FDA on endpoints for NVG-291's Phase 3 trial, and the broader opportunity in neurotrauma. 

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.  

Subscribe to our monthly Business of Biotech newsletter.

Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com

Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

Transcript

Ben Comer 0:03

Welcome back to the business of biotech. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today I'm speaking with Adam Rogers, M.D., Chairman, President, and CEO, and Rich Macary, Board Advisor, Business Development and Strategy, both at NervGen, a company developing neuroreparative peptide therapies with a lead candidate targeting spinal cord injury. Adam joined the company as CEO last summer -- Rich was the matchmaker -- and NervGen is now on the verge of entering phase three trials with NVG-291, a peptide therapy built on the work of neuroscientist and Professor Jerry Silver. We'll talk about the company's transition and growth strategy under Adam's leadership, uh, early results in patients with spinal cord injury, the larger opportunity in neurotrauma, and what's next for the company. Uh, Rich and Adam, thanks, guys, for being here. I appreciate it.

Adam Rogers, M.D. 0:59

Thanks. Thank you, Ben. It's a pleasure.

Ben Comer 1:03

I uh as we do here on the Business of Biotech, I wanted to start off uh with uh a little background, and maybe I could uh start with the background uh between you two gentlemen. How did you meet? Uh, what were the circumstances uh that that led you, uh Adam and Rich to Nerve Gen?

Rich Macary 1:21

Yeah, well, that's uh that could be a long story, but the the short version of it is I was already an advisor to the company. Uh I got involved really because I saw a ton of parallels between work that I had done in RNA therapeutics with AVI BioPharma, which became Sarepta. I saw a lot of parallels and got involved as an advisor to the company. But uh in 2022, uh I actually had David Rogers, Adam's son, intern with me. And uh I had him focus on the company that I was putting a lot of attention into, which was NervGen. Uh he shared that research with Adam. Uh, and uh the rest is history. We ended up connecting actually through his son in that internship.

Ben Comer 2:01

Wow, that's so that's how you guys met for the first time. And Adam, that's how you became aware of uh of NervGen and what they were up to.

Adam Rogers, M.D. 2:10

Exactly. And it was really, I think, you know, if we have to put a date on this, it was probably January, February, March of 2022. And so my son was a senior in college, he was getting ready to work for Rich. I think Rich told him to go do some work on this company. He read the papers of Jerry Silver. He's like, he writes me up, he goes, he he he emails me, he goes, You got to take a look at some of these papers. This is some really, really interesting stuff. And I and I'm an ophthalmologist by training, I'm a retina specialist. Um, that's my area of expertise. I was in practice at Tufts Medical Center for almost 20 years. And so I kind of like, you know, begrudgingly took a look at it. I'm I'm not a neurologist at all and hadn't done any neurology, you know, since early in my ophthalmology training and really back in medical school. So I started reading Jerry's papers, and I just was amazed at the world of possibility that the drug that Jerry was developing, uh what it could open up for individuals that had spinal cord injury, and and even beyond that. I love the fact that his his science was based and his research was based on a physical model of an injury and not a genetic model. Um, and I also love the fact that so many other um academic labs were using his molecule and using it in their lab. And so it to me it validated the work. It just wasn't working in in Jerry's lab alone. And so I also then watched Jerry's, he had a number of um his lectures on YouTube, whether they were at meetings or sometimes he would give like an hour-long symposium to postdocs, and I would watch these and I'd read the papers over and watch his watch his presentations, and just really became fascinated with the with the potential for this drug and how many individuals that it could it could help.

Ben Comer 4:08

And Adam, you mentioned you're you're an ophthalmologist by training and a professor, but you previously founded Hemera Biosciences, uh, a gene therapy company that was targeting uh age-related macular degeneration. You sold that company. Uh you were CEO, I guess, for for from 2017 to 2020, sold it to J and J in 2020 uh in a deal, I think, worth over $400 million dollars. Um what made you want to become a biotech CEO uh initially, Adam? And you know, what was that experience like?

Adam Rogers, M.D. 4:44

Well, you know, if you um the company Hemera was really started from scratch. It was um we started this in the lab at Tufts. It was ideas that a few of my partners in the retina department um had of how do we treat individuals with dry age-related macular degeneration, which at the time, and we started this mentally going over this company in 2005 to 2008. And at that point, there were absolutely no treatments for the advanced form, this advanced form of macular degeneration, which leads to atrophy in the retina and affects a lot of individuals. So it's really a debilitating disorder, and there were no treatments. It actually has a lot of parallels to nerve gen, and I and I will get into that in a second. But um, I just was involved with every aspect of the company from the founding of it, from the early science, and I just sort of naturally grew into the role of running the company. It wasn't like I want to become a CEO. It was almost I had to become the CEO and run this company because we, you know, we were raising money, we were manufacturing the drug. There were four of us in the in the company, and I was the only one that was really wanted to put forth the time and and and keep it going. And so I wouldn't say I wanted to be it, I would say I just sort of evolved into becoming the CEO of Hamira.

Ben Comer 6:09

So everyone in the lab's kind of looking around at each other, uh, you know, who who's gonna take this forward, who's gonna actually be the CEO, and you uh you rose rose to the top there.

Adam Rogers, M.D. 6:20

Exactly. It's that's really how it how it came about. Um and the company was one Ph.D. and then three M.D.s, and you know, we all had day jobs as well. And and you know, and so I just spent more and more and more time and really oversaw every aspect aspect of the company from the financing to the manufacturing to the clinical trials and writing the protocols. Um, and you know, and then it just continued to evolve and grow, and and my position just continued to evolve. So it was really a natural progression.

From RNA Drugs To Alzheimer’s

Ben Comer 6:52

Yeah, so you must have taken an interest in that kind of role. I'm sure you learned a lot about what it means to be a biotech CEO during that period, and I'm sure there were some learnings that you've now brought uh to NervGen, and we'll we'll get into that in a few minutes. Uh, Rich, I wanted to ask you about, you know, you you were at the the precursor to Sarepta, did early work in RNA therapeutic development, and you've advised uh company executives and investors at a number of different organizations. Your chairman and co-founder and president of Synaptica Therapeutics, a neurology company that's developing a unique approach to the treatment of Alzheimer's. What how did your uh interest in uh in neurology originate, Rich? And maybe tell me a little bit about Synaptica therapeutics.

Rich Macary 7:44

Sure, sure, yeah. I mean, my whole uh evolution really started by jumping into biotech through RNA therapeutics almost 20 years ago. That led me, uh, you know, the idea of programmable drugs uh was exciting. And a lot of people back then thought that was sort of uh Star Trek, uh, not something that was going to really translate. I believe differently. I love these kind of challenges where everybody thinks something uh might not be uh, you know, translatable or as big. Uh and I got involved early in that. And that was when, as you said, Sarepta was still AVI BioPharma, uh, Ionis was still Isis. And that progression led me into, I actually helped found the DMD program. I brought in uh ... Australia. Yeah, he was doing Exxon skipping, and I saw it, I thought this is super exciting. I brought it in that became the birth of the DMD program at Sarepta. And so that was uh really getting into neuromuscular. Um, eventually, I again I had that senior role uh vice president of business development at Sarepta. Around the time I was leaving, my mom developed Alzheimer's. And so my direction into neuroscience and neurology was driven by that situation. I first took a personal interest trying to find something to help her, and then that became a professional interest when I started to realize everybody was focused just on amyloid and tau. And I was looking at all these other things in my research, like neuroinflammation, uh, like microglial dysfunction. And then I started to look at synaptic dysfunction and plasticity mechanisms mechanisms. That's how I came to uh Synaptica. My my research found two gentlemen, both Italian, one at Harvard, the other one in Rome, uh, who were doing work with neuromodulation. They're using uh precision and personalized brain stimulation of the default mode network. Uh, I saw their research. I happened to be there when they turned over the cards on their first phase two, and the data was amazing. Still the best data I've seen in slowing the progression of Alzheimer's. I saw the ability to file IP, get breakthrough designation from the FDA. I helped create the company around them. Eventually got a former director of strategy for Boston Scientifics and Neuromod Area to become CEO. And that's marching toward hopefully a phase three in Alzheimer's later this year. But that same underlying technology about plasticity and my interest in Alzheimer's brought me to NervGen. Uh when I found out that this could be a neuroreparative technology, I got really excited. And that's how I jumped in.

Leadership Lessons From Reebok

Ben Comer 10:13

Well, that sounds like an uh an interesting program at Synaptica. We'll have to have you back on uh at some point later on, Rich, to talk about a little bit, tell us a little bit more about that company, maybe after you're in uh in phase three trials. Um I uh I want to get to NervGen, but I I was tipped off in an intro call with you guys that Adam, your father-in-law, is Paul Fireman of Reebok Fame. He brought the Reebok brand from America to England. Uh, he then bought Reebok outright, took it public, grew the company uh up until it sale to Adidas uh in 2005 for $3.8 billion. Um, I have to ask Adam, is there anything that you have learned from Paul? Uh any advice uh that he's given you that that you might share?

Adam Rogers, M.D. 11:00

Absolutely. Listen, I mean, when you when you get to work with someone like Paul who's had so much, has basically expansive business experience, you can't help but learn from him. And you know, I I learned a few things from Paul, and and he sat on, he was one of our investors at Hamira, and he sat on our board at Hamira. And the one thing I learned from Paul is he listens and he listens very intently, and he listens far more than he ever speaks. And so he he he he literally imbibes everything that's going on and really just kind of digests it and then synthesizes it. He really has four-dimensional views of of the world and has phenomenal business sense and making decisions. And you know, I just when I'm with him, I just sit, I listen to him, I watch how I watch how he operates. And that those are really the main takeaways that I've I've received from him. He's also a very decisive person and knows where it where he wants to go.

New CEO Strategy And NASDAQ Move

Ben Comer 11:59

Very decisive. Yeah, that's a uh you know, a valuable trait and a CEO, regardless of industry. Uh, thank you for thank you for that. Um sticking with you for a minute, Adam. You joined NervGen. Uh it's a clinical stage company last summer, I believe. Um, what what did you do first? Uh did you and Rich work together on a strategy for the first few months? I mean, what's your approach to kind of coming into a company like Nerv Gen? What you know, what was your game plan?

Adam Rogers, M.D. 12:30

Well, Ben, I I had been on the board of NervGen since July of 2022. So I had some pretty decent insight of the company. I was the acting president actually when I started with the company back in 2022 for about six months while we had an interim CEO who was one of the founders. Okay. And and so I I'd worked a little bit in the company, but really was a board member. And so most of my interactions uh at NervGen from you know quarter one of 23 until last summer of July was really sitting um as a board member and seeing what was going on. But obviously, when you're a board member and when you're running the company are two totally different things. Um and you know, getting back to my days at Hemera, where you, you know, you said, look, you must have learned a lot of things at Hemera, I did. And one of the things that I learned is you've got to, you know, when you're a small company, you've got to be nimble and you have to make decisions and you have to know where you want to go. And so obviously, when Rich and myself um and and others sat down at the company, when I sat down at the board, I knew exactly where we needed to go. You know, we needed, we needed to really digest all of the clinical data that that we had just finished in our Phase 1b/2a Connect SCI study. We needed to take that out there. We needed to be aggressive. Um, we made moves to um leave the Toronto Stock Exchange and get on to NASDAQ, where where, you know, we when you're up in Canada, and and this is not a bad thing, but not a lot of companies and our investors know who you are up when you're up on the Toronto Stock Exchange. And so we we needed to gain visibility. Um, and so that's so we really made we're gonna we're gonna get this into a phase three, we're gonna get onto the major uh stock exchanges in the U.S. for for visibility and for and you know um everything else that comes with that funds that can only invest in U.S. companies. And so we just made a lot of changes. I wanted the company to become very efficient and very nimble and make decisions and be very decisive.

Ben Comer 14:38

So moving over to the NASDAQ, gaining visibility, did that also improve uh the the fundraising situation? I mean, was there an immediate impact uh after that after that transition?

Hiring For Phase 3 Execution

Adam Rogers, M.D. 14:50

Well, what it what it does, what that does is it gets you onto the um it gets you into the world of the analysts. And the analysts then interact with you, you speak with them, you tell them what's going on. And then, you know, obviously when when they take up coverage of your company, they have readers and they have people that follow investors that follow them, and then obviously you you become more of a known commodity. We didn't have that up uh up on the Toronto Stock Exchange. And so we we were sort of toiling away in anonymity up there, and so we really needed to improve our visibility. And so, yes, that that and that would people know about you, then then they then you're on the radar. We needed to be on the radar, right?

Ben Comer 15:35

Right. Uh well NervGen now uh is in growth mode. You're heading into uh a phase three. Um, I wanted to ask a question, uh just uh in terms of thinking about growing the company, I wonder what you might say, Adam, about um hiring. I mean, are there are there specific things that you look for in a candidate aside from kind of like technical knowledge and skills? I mean, are there cultural aspects that you look for uh in in terms of growing out, you know, the team and personnel?

Adam Rogers, M.D. 16:09

Well, I'll take, for example, you will first of all, the the easy answer is yes. And then I'm gonna walk you through like one of the key hires I made this year, which is Shamim Ruff, and she is head of our regulatory affairs. And Shamim was at Sarepta, and she was also at Stoke Therapeutics. NVG-291, while while spinal cord injury in and of itself is too large of a group of individuals to be considered a rare disease or an orphan stage disease, the FDA looks at this as such an unmet need that it's almost rare. So I needed to find individuals that have experience in moving um drugs through the regulatory uh process um like Shamin. And she's done that at many different companies. And so I need to bring in people with that type of experience. Got it. Uh obviously, you're always looking for people that fit in as well. And then, you know, look, you need that. But I I'm looking, you know, we're a small company. I'm making very, very strategic hires for people that will dramatically help the company and keep moving this NVG-291 into not only just the clinic, but into the hands of individuals that desperately need this drug as as rapidly as possible.

Ben Comer 17:26

So people that have demonstrated that they can accomplish a give a specific task associated with growing the business.

Adam Rogers, M.D. 17:34

Absolutely. And, you know, look, this is an easy story to tell. It's a phenomenal story to tell. You're you're taking a drug, you're repairing neurons. This is a very neuroplastic drug that's never been on the market before. There's really nothing out there like this drug. And so, you know, look, you people understand the big world out there that you're trying to make an impression on. And so it's it's easy to, you know, you can find these people and they they understand the mission that this company's on, uh, that I'm on, that we're all on, to really improve individuals that have undergone neurotrauma.

Peptide Manufacturing And Scale-Up

Ben Comer 18:12

Right. Right. Uh we're talking about NVG-291, that's NervGen's lead candidate, which is a peptide. Um, is it similar to peptide therapies like like GLPs?

Adam Rogers, M.D. 18:24

It's very similar. It's a 35 amino acid peptide uh we manufacture here in the United States. Um it's very, very similar.

Ben Comer 18:35

Is there any capacity issues given the you know the absolute explosion of of interest and of uh of development of various GLP-1 therapies, uh primarily for diabetes and obesity? Um, but I'm curious about the the capacity uh with you know with partners with C DMOs. Uh has that been an issue at all, finding uh partners that that can manufacture, particularly now that you're you know gearing up for a phase three trial?

Adam Rogers, M.D. 19:05

No, it's it's not been an issue for us. We've we've actually um invested heavily in the manufacturing side of things. That's the one thing that I also learned from from my days in Hemera is you know, you've got to have a strong source of drug and a really you know strong partnership with uh with the manufacturers. And and we've done that. And I've uh Charles Olson, Chuck Olson works for us out in California. He's he heads up our CMC, he's phenomenal, highly experienced, um, and he runs everything. So we are we have a very scalable model um that uh is able to supply drug. And so we've had no issues with that given our really our our large investment in that area.

Ben Comer 19:50

And you guys are planning to initiate the phase three uh in the second half of this year. Is that is that correct?

Adam Rogers, M.D. 19:57

We we you we're calling it mid-2026.

FDA Meetings And Phase 3 Setup

Ben Comer 20:00

Mid-2026. I saw on your website that you had a um an end of phase two meeting with the FDA. Uh this is the um, I guess technically the tetraplegia. Tell me how to tetraplegia indicate is it's spinal.

Adam Rogers, M.D. 20:16

It's tetraplegia, which is what we used to call quadriplegia, but now the now it's termed tetraplegia. And so we we we've had two meetings with the FDA. One, a type C meeting, which was on Zoom, not an in-person meeting, back in the fall of 25. And the end of Q1 um 26, we had a type C in-person, what you would call an end of phase two meeting with FDA. I would call this a very, very collaborative meeting with the FDA. Um, we um have really, from a collaborative stack collaborative standpoint, have an understanding of both our primary and secondary endpoints and are moving rapidly into starting a single uh registrational study this summer in individuals that you would call chronic tetraplegia or you may call motor incomplete cervical spinal cord injury.

Mechanism And Patient Improvements

Ben Comer 21:11

You guys are both uh excited about the potential of this development candidate. I wonder um if you could tell me a little bit about uh why, maybe some of the early results that that you've seen in patients receiving this therapy. Uh, you know, what what makes you so bullish about this this development candidate?

Adam Rogers, M.D. 21:30

So let me group our results in really like two buckets. The first one, we did electrical testing in these individuals because what this drug does, the drug is a 35 amino acid peptide. It's injected into the abdomen, so it's a very easily administered drug.

Ben Comer 21:47

And that's a day a daily and every day, right?

Adam Rogers, M.D. 21:50

A daily administration of the drug, correct. We give it for up to 12 weeks at this point in time. And so in the individuals in the study, they they received it just that way daily. Uh for 12 weeks. It can be self-administered at home as well. So it's not like you've got to be in you've got to be in the hospital to have it administered. It's no different, like you were, you brought up GLP-1s. It's very much the same. So our our what we looked at was, you know, well, let me get into how this drug works. There are inhibitory uh molecules called CSPGs or chondroitin sulfate proteoglycans that really in an injury state get upregulated. They're found in the normal nervous system, um, they're found uh around neurons and they create a net to keep the keep neurons going to the direction or the or the area where they're supposed to go. But when there's an injury, these CSPGs or chondroitin sulfate proteoglycans get upregulated. So your body, and you know, your body will say, look, the neurons that are damaged are like I'm, you know, will try to regenerate, but these CSPGs, which inhibit the neurons, they block these small neurons that are sprouting after the injury from reconnecting. So the first thing that we wanted to see was, okay, how does this drug, which interferes with the CSPG cascade, do we improve uh neuronal conductivity? Are we able to measure the electrical impulse from around the area of the injury out to the out to an extremity? And we showed we we had a positive result there. And then we looked at functional outcomes. And so the the first and main functional outcome that we looked at was hand function. And we measure it through something called GRASSP, which is an acronym G R A S S P. It's called GRASSP Quantitative Prehension, and it's four small tests that a person does, and they're and they're graded on time and and um how correct they do it. And it's putting a key in a lock and turning it, putting a nut on a bolt and turning that, um, taking a glass of um, taking a uh some water and pouring it into a cup, so cylindrical grip, and and then the final one is taking pegs and putting them in a peg hole. So it it tests very fine um hand motor function. Very, very fine. And so we had an 825% improvement from day zero to week 12 in individuals with hand function, and and that exceeded a point which physicians or key key people in the field would say beyond that point, an individual can hold a fork and feed themselves, comb their hair, brush their teeth, button, you know, button their shirt or their sweater, uh, zipper up their pants, do certain functions that on a day-to-day basis improves their ability to live an independent life. And that's what we found with the hand function. And hand function in individuals with spinal cord injury, especially cervical spinal cord injury, is probably the most important function that they can gain back. Because if you think about it, then everything that we do in the world is either looking at it, vision, or hand function, just picking up your phone and texting people, or you know, how do you eat and make a meal? It's those are vital, vital uh aspects. Um, and then we we did blinded exit interviews. So actually before that, we discontinued the drug at week 12, and then we measured the hand function again at week 16. And what we saw was that there was even continued improvement in the hand function test after they had been off the drug for four weeks, which which demonstrates to us that the new neuronal connections that are being made are permanent, and we're seeing this permanence in the functional outcome that they're having. We also did blinded exit interviews with these individuals, and they did not know whether they received the drug. And those were on average up to 250 to 260 days after they left the clinical trial. And we had about a two-thirds improvement in bladder function and a 56 to 60 percent improvement in um reduction in spasticity. So spastic muscles are a big problem as well. And so we saw really dramatic whole body improvements in these individuals. Two individuals that were received the drug could not complete a 10-meter walk test at the beginning of the trial, and they were able to do so um at the end. So we really are seeing some whole body global um therapeutic impact of the drug based on their functional um improvements that we're seeing.

Ben Comer 26:39

Wow. Well, that is exciting. I mean, regaining function after spinal cord injury, I could probably leave it there. I mean, that's a that's a huge uh uh accomplishment. Um the the grasp outcome or the the kind of uh hand related outcome is that uh is that what you talked about with FDA? Is that what the the you know the kind of primary endpoint in phase three? Yes.

Adam Rogers, M.D. 27:01

We took we talked with them about that back in September, and then we spoke with them about that um in the first quarter this year. And so we we had to become aligned, they had to understand the grasp study, um, you know, and and understand, you know, it's just an understanding of that it's a validated study and how how important it is for an individual to regain hand function for someone that has spinal cord injury. And I may have overlooked this too. The individuals that we enrolled in this clinical trial were one to 10 years out from their injury. And so, so these are individuals that by all means, you know, they there's no standard of care for anyone for for these, for these, uh, for people that have suffered a spinal cord injury. So, for all intents and purposes, this is the you know, the only therapeutic option that they have that's in testing right now to uh to improve their functional outcome.

Ben Comer 28:00

Right. And this mechanism that you just described, Adam, uh that uh comes from from Jerry Silver. Rich, is that, you know, is that also you know what excited you uh about the company and and brought you of, you know, to to NervGen initially?

Rich Macary 28:16

Completely. I mean, when I first started getting involved in RNA therapeutics, uh and I saw the original uh MDX rodent models for Duchenne muscular dystrophy that showed proof of concept. Again, that's a genetic model. I got excited because this is, as Adam said, a physical, mechanical model. You're not emulating the disease, you're literally Yeah, it's not a biomarker, right? Exactly. And so, you know, even when that was graduated to uh canines in DMD and we saw that improvement, you're hoping it was going to translate. Uh in seeing this model, I I made the bet early on, and that's why I got excited that this was going to translate into humans. And that's exactly I've never seen anything translate like this. If you look at the rodents, even the videos of it, and then ultimately see we did capture videos uh in this trial, it is it is unbelievable. Um, and we're seeing all the same things in that model, like they continue to improve. We saw the people between 12 and 16 weeks improve, and it brings it to life. Some of these folks have actually gone and talked to the media about their stories, and we get to see that. You you look at the numbers, but actually seeing what happened in their lives. And and I know this from Sarepta when you know we first moved forward and got that controversial uh approval for DMD. That was one of the first in rare disease. FDA became a lot more conscious about these endpoints actually translating to functional uh improvements in these people's daily lives. They want to know that this wasn't just a test that you passed, that this was something that is actually going to make a difference in your lives, in the in in the lives of these individuals. And that came out of this interaction with FDA. It was highly collaborative. Uh, and they almost feel you know like a motivated partner and wanting to help us get this across the line. That's the way it felt. I don't know if you feel that way, Adam, as well from the interactions.

Adam Rogers, M.D. 30:04

No, that's that's a it's a that's a great summary, Rich. You know, look, Ben, like Rich said, they see an endpoint, you know, uh quantitative prehension of hand function. But really, what the FDA and our discussions, the two discussions we had with them, FDA really wants to understand how the drug impacts an individual's life, an individual spinal cord injury that took this drug. What are the improvements that they got on a day-to-day basis? How does it, how does it from their activity of daily living, you know, what is the major impact that this drug is having? They they want really a holistic view of everything.

Phase Three Design And NDA Path

Ben Comer 30:42

Right, right. Uh well, that's uh that's fantastic. Um, give me a sense of the size of the phase three trial, uh, if you can, and kind of, I guess, how long it might last or you know, what the testing period is.

Adam Rogers, M.D. 30:56

It's it's going to be almost identical to the 1v2A Connect SCI study. We call this the Restore study. There'll be 150 individuals, all with um uh chronic tetraplegia or motor incomplete cervical spinal cord injuries C7 or higher, one to 10 years after the injury, 150 individuals. 75 will receive uh drug NVG-291 on a daily basis for 12 weeks. 75% of 75 will receive placebo. And then we'll we'll measure their will the primary endpoint will be the GRASSP quantitative prehension, those four tests. And then we have secondary endpoints that we've aligned with on FDA that will evaluate just how the impact of this drug is from a patient standpoint or the patient global impression of change and how the clinician feels that they've improved, or something called Clinician Global Impression of Change. And those are the main ones. We're also gonna evaluate um uh a 10-meter walk test, but not just from how how rapidly they walk, but we want to evaluate um from video analysis, we're gonna look at their walking as well, but that'll be more of an exploratory endpoint.

Ben Comer 32:09

Do you anticipate being able to now let's assume that the phase three trial performs the same way that the phase two trial does? Um, you know, you get great results at the end. Do you anticipate being able to file uh at that point? Uh or would you have to do like a second phase three confirmatory trial?

Adam Rogers, M.D. 32:30

Right now, right now our plan is to file with a single confirm with a single phase three study. Um it'll start, it'll start mid-2026 this summer. Uh, we anticipate that we will be fully enrolled by, you know, with with um close out the study by second half of 27 results first half of 28, and then file the NDA at some point, second half of 28 are our plans at this point.

Ben Comer 32:55

And do you guys have a runway, a financial runway right now to get through that? Are you in fundraising mode currently uh to support those plans? Uh, where do you sit there?

Adam Rogers, M.D. 33:07

We raised additional capital in November, and we will we will we're exploring all options, um, both non-dilutive and traditional um fundraising pathways uh as we move forward to to fund the remainder of the study.

Funding Runway And Fundraising Options

Ben Comer 33:23

We've been uh we've been talking about uh spinal cord injury, but NVG- 291 is being developed for other indications uh as well, including traumatic brain injury, uh hearing loss, stroke. Um can you talk a little bit about the clinical strategy overall for this candidate?

Beyond SCI Into Neurotrauma

Adam Rogers, M.D. 33:43

Uh, I guess in terms of indication selection and you know how you sequence the development The way the way I look at it, and and I look at this as sort of conservation of biology, Ben. Um, I don't think of ourselves being Nerve Gen. I do not look at NervGen as just a spinal cord injury company. I look at it as a us as a as a um company that is targeting chondroitin sulfate proteoglycans or CSPGs. And whenever there is an elevation, an abnormal elevation of CSPGs in the central nervous system, um be it through neurotrauma or neurodegenerative disorders, we we I feel very strongly that we will be able to target that. We are internally um discussing, and we'll likely come out this summer with our our second and potentially third indication of where we will go next. But it's going to be something that targets uh CSPGs um uh at this point in time.

Ben Comer 34:48

Yeah, the the CSPGs are are really interesting because um they're they're the that's the the mechanism that's preventing the regeneration from happening that you're essentially trying to remove or or halt. Is that is that correct?

Adam Rogers, M.D. 35:02

I just want to make sure I'm getting so so CSPGs are an inhibitory uh molecule in the extracellular matrix. And so they really prevent neurons from going into aberrant areas. And like I said earlier, in in neurotrauma, um, especially in the area around trauma, these CSPGs are upregulated. And then what they do is sprouting neurons will just interact with the CSPG and they'll think they're they're perfectly happy and they're doing something, but they're just interacting with the CSPG. We don't get rid of the CSPG. What we do is we the inhibitory um signals that that are being sent out by the CSPG, we downregulate those. So we're not we're not ridding the body of the CSPG. We're diminishing the the inhibitory effect that the CSPG has on a neuron from re-sprouting and reconnecting to its normal location.

Ben Comer 35:59

So in a healthy body, uh you would want, I guess, you know, that the CSPG, I guess what, what, what are what kind of role are they performing?

What CSPGs Do In The Body

Adam Rogers, M.D. 36:08

In a healthy, in a healthy body, they form uh CSPGs form what's called a perineuronal net. Think of it almost like um around a wire, how there's like um there's some insulation around a wire. They're almost like an insulation around the wire. They form this perineuronal net and they keep the neurons going in a certain location. Um this drug has no effect on individuals that have a normal amount of CSPGs. Unless there is an aberrant upregulation of the CSPGs, will will this drug have an effect on someone? So in in healthy individuals, we we don't see any, there's no benefit whatsoever that we that we identify.

Ben Comer 36:51

Okay, interesting. Um, I saw in your pipeline slide you've received some funding uh from the Department of Defense. Uh, I think a couple of different groups within the Department of Defense. And I I'm assuming that that's due to the the injury aspect and that you know that this could perhaps be used uh in the military, but I I'm making assumptions here. Can you tell me it maybe about how, you know, and I think it was before your time, Adam, you know, when this when this funding came in. Maybe Rich, you could speak to it, but um what I I guess how did that funding come in the door and and what um what is that collaboration, if if there is one, look like?

Department Of Defense Backing

Rich Macary 37:33

Yeah, sure. Again, even going back to when I was at Sarepta, people forget that in the early days, we had a lot of funding that came from uh the DOD. It came from work that we were doing with USAMR, Ebola, Marburg. That was an infectious disease. Here, given that this mechanism and spinal cord injury is of interest to the Department of Defense. But beyond that, the field of neurotrauma, I believe they've spent billions in research in this area. This is one of the things that they're trying to improve on for the warfighter and for veterans. And so um, we actually, predating me, uh, we uh had uh the uh departing head of the uh U.S. Combat Casualty Care Research Center at the DOD, now the DOW. Um, he ended up becoming a consultant to the company. Uh his name is Dr. Mike Davis. Um he really was excited, believed in the science the way all of us do, uh, as somebody who looked at all of these things on behalf of the DOD for many years. And he got involved in helping us navigate where to go and telling the DoD this is something different and unique than you've seen before. We're not trying to just go after inflammation. Uh, this is a completely new mechanism, and so helped us get money. Some of it's congressionally directed funding, uh, some of it's coming from directly from agencies of the government within the military. There are so many different funding pockets, but that allowed us to do the blast-induced hearing loss study with the Air Force. It allowed us to do a peripheral nerve injury study that's involving uh the the DoD, but also uh that came with through Washington University and ongoing. We don't have the results yet, but uh we're doing a study in traumatic brain injury with Walter Reed. All that non-dilutive funding coming from various sources. So the the partnership uh and involvement of the DOD, I think, is really, really important. Uh they have obviously uh you know their own path in terms of how they work with the FDA. Um and everything that we're doing crosses over, right? It's important to the warfighter, but uh traumatic brain injury and spinal cord injury and hearing loss affect millions of people. Uh so it it is um it's a benefit. And we think we may see more funding come uh and be a non-dilutive way that we could move forward at least one of those neurotrauma programs in the future.

Ben Comer 39:51

Yeah, and I imagine there are people listening to this show, uh, company leaders who who would love to get some money uh from the US government, from the Department of Defense, Department of War. Um can you and Rich, may can you speak to like how you just even get their eyes on it initially? Is there, you know, is there is there a trick to because I, you know, there I have no doubt that there are a lot of people reaching out, you know, with with great ideas, uh things that that could cross over, things that could be useful uh in all sorts of ways. Um, but how do you, you know, how do you kind of break through and and actually, you know, get some engagement with with those groups?

Getting DoD Attention For A Program

Rich Macary 40:29

Yeah, a lot of that is really just putting together work and then you know, filing for grants, knowing where they're looking for something and pursuing it. I I think the reason we got advisors and it, you know, it really is also sort of a process of familiarity. The DOD and and the apparatus, you know, they need to know who you are, you have to establish credibility. It doesn't just happen immediately. I mean, as you can see for us, it's happened over years to develop this relationship and get the work that's built upon itself. It's creating a body of research that we can use moving forward, but it's also then opening the door to more funding. So it is a multi-year process. The only thing I could say is if you happen to be in an area where the immediacy of what the DOD needs, um, you know, like in a I'm gonna say like in the countermeasure way, um, that whole thing could be short-circuited and happen really, really quickly. And, you know, I'm gonna say what we're seeing right now is a big, big uptick in modern warfare in neurotrauma. More and more traumatic brain injuries, more and more traumatic hearing loss and SCI. So this is an important area for them. And we think, again, that's gonna help us continue to have collaboration with the DOD and continue to have that, you know, other collaboration that moves us forward, um, you know, with researchers and with the FDA to get this over the line and eventually get this to both, right? The warfighter and to uh and to individuals who experience any kind of trauma, in this case, spinal heart injury.

Ben Comer 41:57

Right, right. Um uh I would be uh remiss if I didn't mention the the other candidate that NervGen has. It's in preclinical stages, NVG- 300. Uh, is there anything that at this stage that you can tell me about that candidate? Is it also a peptide?

Adam Rogers, M.D. 42:17

Yeah, Ben, it is also a peptide and would be administered very similar to NVG-291. Obviously, look, I mean, part of what we want to do is ease of administration. But that that is still in, you know, from from our standpoint, we are internally still uh discussing and deciding how to uh deploy it and and which indications we'll be using it for. So as we, you know, we will come out publicly with that in the future on NVG-300.

Ben Comer 42:48

Got it, got it. All right. Well, uh, we are getting to the end of our time here. Um maybe we could just end with your top priorities for the company for the rest of the year, and and also, you know, what you see as the biggest challenges that that NervGen faces uh for the rest of let's call it a year for the next year.

NVG-300 And What Comes Next

Adam Rogers, M.D. 43:07

So listen, in the immediate future, and and I and I would group this into the challenges too, is our look, I'm a very focused person as far as getting, you know, I know where we need to go, and and I have a group around me that helps helps this company move forward to get there. And so our goal, we are uh steaming ahead with getting our phase three study up this summer on NDG-291 for individuals with chronic uh cervical SCI. Um we are, you know, that's our main number one focus uh right now. And then obviously over the summer, we will also uh discuss publicly what our next indications will be. But our our number one goal get the study up and running, get it, get enrollment going as efficiently and quickly as possible, and enroll those individuals within a nine to twelve month period. Period. That that's our that's our probably one through ten most important list of things to do this year.

Commercialization Plans And Building The Market

Ben Comer 44:06

Got it. Got it. Um well I really uh really enjoyed speaking. Oh, let me ask one final thing. Um uh do you guys plan? I mean, do you have a strategy to potentially uh if if it sales through phase three, uh you file, you get approval, are you prepared to commercialize this drug as NervGen yourself? Or or is it more of a kind of must partner or or must sell type of strategy that that you're working on? How do you think about that aspect?

Adam Rogers, M.D. 44:38

The way I look at it, and I had this exact same uh same approach uh of Hemera, our goal is to take this drug all the way and commercialize it. And I don't think you can think any other way. I I I did not join this company, and we're not building this company to be sold, we're building it to get a drug to market and to improve the lives of individuals with spinal cord injury. And that's that's just my focus and the way I view the world. You know, it it I can't tell you what's gonna happen down the road. I don't know. I don't have a crystal ball, but all I know is we're gonna start a phase three study, we're gonna take our results to the FDA, and we intend to take that drug to market and to improve the lives of all those individuals that that you know have this enormous unmet need of spinal cord injury. And then right after that, what we want to do is we want to expand it to everyone with the spinal cord injury. You know, we're we're not including individuals with lumbar or thoracic injury, and there's no reason that just because they've got a, you know, this works in cervical spinal cord injury, that it's not going to work in thoracic or lumbar injuries at all. So my goal is to get everyone with a spinal cord injury, um, give them, get them access to this drug as as efficiently as possible.

Rich Macary 45:53

And Ben, if I could add to that, uh the experience that I had at Sarepta, you know, when we started talking about DMD, outside of like the Jerry Lewis telethon, a lot of investors didn't know about this area, but more so there wasn't a built therapeutic model to go out there and uh bring that forward. So, you know, Sarepta created that model, and that's exactly the opportunity we have here. We have no therapeutic for SEI. So not only do we expect to be the first one to go over the line and get an approved drug, but to build that call point and that infrastructure to deliver this to these patients is an opportunity. Uh, and and you know, we we think that that is very, very doable for a company like this. There isn't a bigger company that already has a footprint to do this. So we'll build it, and that will probably make us more valuable as a company and do a service to the community by putting together really that delivery infrastructure.

Ben Comer 46:50

Got it. All right. Well, um, Adam and Rich, it's it's been a pleasure speaking with you. I really appreciate you taking the time. Same, Ben.

Adam Rogers, M.D. 46:59

And thank you very much for your time. It's been a pleasure.

Closing And Where To Subscribe

Ben Comer 47:02

We've been speaking with Adam Rogers, M.D., and Rich Macary at NervGen. I'm Ben Comer, and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts, and be sure to check out our weekly video cast of these conversations every Monday under the Business of Biotech tab at life scienceleader.com. We'll see you next week, and thanks as always for listening.