The Peptide Promise With NervGen's Mike Kelly

The lead in its lineup is a peptide that's currently targeting spinal cord injury in a phase 1b-2a trial , but the company has stroke , alzheimer's , ms and ALS programs in its discovery and preclinical pipeline as well . Now peptides are a modality that color outside the lines a bit .

The FDA , which has been averaging a couple of peptide approvals per year , sometimes considers them a biologic , sometimes not a biologic , and they're generally considered neither a large molecule nor a small one by standard measures .

Neither a large molecule nor a small one by standard measures , but in some instances that gives them a leg up in terms of vascular permeability and bioavailability and , as we know , they're awfully buzzy in the obesity space right now . I'm Matt Pillar . This is the Business of Biotech and on today's episode we'll get to know Mike Kelly .

We'll learn his view on where peptides fit on the biopharmaceutical landscape . We'll learn about NervGen's peptide and the steps the company has taken and the ones it's taking now to pave the path for commercial prep , which , by the way , kelly has plenty of experience with . Mike , welcome to the show .

You got an undergrad , I think , in a business degree . You earned your MBA , that is , you have zero academic scientific training .

Yet since 1991 , not to age you , but since 1991 , you've been working in business development and senior leadership positions for life sciences companies , pretty much exclusively , and in fact you're currently on your third stint , I believe , as a biotech CEO . So it begs the question why life sciences ? How did you get into life sciences and why ?

There were some people in my life that were mentors of mine that I really respected and had many conversations with , and they love their jobs and I I got the , the itch to get into the field . I , I got the ish to get into the field and that's kind of .

I lived in Jersey so I went up and down route one , just like most college grads do , handing out resumes to all the HR departments that were , you know , j and J and the likes all the way . You know , every single pharmaceutical company under the sun was on route one . So you know you try to get in at any , at any level .

And then , through a friend , I was introduced to tap pharmaceuticals , which was my first role in the industry . So you know that's how I got in , why , why I stayed in and and why I pursued , you know , higher levels of my career is just the gratitude of being able to do something you like to do .

Grow personally , but also , you know , help people that , and people don't truly think of commercial and marketing when they think of pharmaceuticals . But you know the commercial side of business is just like any other business .

You know , even though there's novel things that are coming out every day being approved , you know , weekly from the FDA , you have to still connect those with patients and physicians and teach . You know , teach the world what it is and how it can help them .

Some are obviously a little bit more in your face than others , but you know they all have to be educated and brought awareness around , and so that was really the driver for me to continue going , cause I really liked doing that .

And then I had a couple of interviews and they said , listen , if you had really strong sales experience , you know we would consider you . So that's what I did .

I went and got a couple of years of strong sales experience at Selling Copters , which is a humbling job but it also teaches you a lot of skills , and went through Pitney Bowes , had a phenomenal training program and that's really kind of what that plus getting my MBA , I think , think gave me the leg up on others trying to get in .

Like maybe you're on a product line , you get to know that product line quite well , you get to understand relationships with physicians and and develop those relationships and you're and you're selling .

A thing as your career progressed I'm curious about , as your career progressed and you took on more responsibility for you know , not just a product , but perhaps you know a pipeline or the development of actual therapeutic products . What was the , I guess , motivating factor and what was the recipe for absorbing that and learning it ?

Uh , well , fortunate and unfortunate , I was supposed to be promoted into a hospital sales job and we went through restructuring and my house was on the market for sale and I was ready to move to North Jersey , be a hospital rep in New York and I got a call from the head of specialty sales and says hold on , take your house off the market , we're restructuring

. And so they downsized the hospital group . So I was kind of man without a nation for a period of time and they asked me if I wanted to join this group called Medical Research Associates , which in today's terms is an MSL or somebody in medical affairs .

So I took the job and that was really the immersion for me to show OK , you think you know how to sell you the commercial aspects of the business , but you really need to dig deep and understand science .

And I remember my boss , you know , taking me to the Robert Wood Johnson University Hospital Library , pulling out all of the medical journals and sitting down at a table and saying , ok , read these , I'll be back at lunch the table and saying , okay , read these , I'll be back at lunch and I , you know . So it was understanding , knowing .

I mean in sales and in any kind of communications , if you don't know , if you're not a resource to the people you're calling on , you're just noise .

And so I actually became a resource after that job I realized , okay , this is , doctors are busy , they don't have much time , they really need you to focus on how you can help them , how your products can help them .

And if you don't understand the science not only the science behind the illness or disease that your product is treating , but how your product can impact that disease and what that could potentially translate into from a feature and a benefit perspective , that combination really kind of unlocked , you know , opened my eyes to OK , this is , this is how it's done .

You know , this is , this is the importance of science . And so , you know , I just read a ton and I , you know , was self-taught plus company , taught to learn the science and worked in many different therapeutic areas . You know , I worked in the cath lab when I was at Guilford .

I worked in neurosurgery , you know , watching glioblastomas be removed from patients' brains when they were putting gliliadel wafer in . So the span of things that you learn over time and the key is you've got to focus specifically .

And when a good hospital rep , sales rep , msl , is trained extremely well , they probably know as much about a specific area of a disease state and how drugs work in that disease state as the physicians that they're calling on and that's what a resource is . So that that's kind of what really kind of unlocked and it was the aha moment for me .

Um , you know , but you know , locking yourself in a room and reading fertility and sterility is not fun . You know , it wasn't fun for me as a 20 something year old kid , um , but then when it ? You know that my boss back then , lou Savant , is his name .

He's probably hopefully he'll listen to this someday but um , lou is the guy who really showed me okay , this is , this is how you translate your skillset and you make it much better . And that was that's when I started to really read , for you know interest rather than read , for you know a burden .

You know a lot of people go into training classes and now I got to read all this content . There was a transformational moment for me and you know I started to read .

You know I didn't read fertility and sterility for pleasure , but I read it for for business purposes and I , you know I was on the cutting edge of everything that was going on in the field , so that when I sat down with the head of the department at a major institution , um , I was a resource and they enjoyed the conversations rather than .

It was kind of a rather than rather than dropping lunch and brochures . It was kind of a rather than rather than dropping lunch and brochures .

And I'm assuming I want to get into this discussion , I'm assuming that was another point of momentum gain for you in terms of commercial sort of responsibility , because you know you joined the company in 2013 . It had been founded two years prior .

Today , you know , I mean , it's not , it wasn't that long ago and today the company's got more than a dozen branded products on the market . I'm assuming some of that activity took place under your watch .

So I'm curious how that experience with a , you know , a new pharmaceutical company that was nimble and fast I mean obviously you know , move quickly to get products to market how that sort of shaped your commercial perspective and how it's continued to sort of inform what you're doing today .

We were a spec pharma business , a group of five individuals , four of which were in Ireland and me in the US individuals four of which were in Ireland and me in the US and we bought products that were kind of either forgotten about or had much more value left , and we figured out how to reposition them , how to get more life out of them , how to help more

patients with them , and so that led to , you know , they got acquired by Jazz , and that built up my commercial experience for a larger organization running much divisions of companies . And then and then Covus .

What I learned at Covus the most was apologies , but I learned at Covus the most was what I started at Azure and Jazz is you have to build a really strong team . You know you can be , you can have all the knowledge in the world , but if you don't have a strong team , a core group of people who are generalists , you can't run a small company .

And you know we we had some moving parts . When I first joined the organization , it was a small startup . A lot of similarities between Covis and here I joined . Here it was a very small team .

But you have to really build a team with really strong players who have a core focus in a specific area and we call those the crown jewels and we manage that inside .

But one of the other big things that folks need to be able to do is manage out and outsource partners , and if they don't have those capabilities to treat partners like employees and to have them understand the importance of what they're doing on your behalf , then you're a small company trying to work in this big industry .

So Covus really helped me solidify all of the learnings that I've had in the two jobs prior to that . Number one . It was a good group that I started with . It was a better group that I helped bring into the organization . But then the next big step was prioritization , and I learned that earlier in my career too .

You have to prioritize the products that you're going to work on . You have to identify the opportunities where you can actually help more people , and that's . We had a large portfolio when I joined . Some of the products were old tail portfolio that people didn't want to let go of and I'm like you got to let go . This is genericized .

We're not making money , we're not helping more patients , but this product over here has a significant unmet medical need and a significant opportunity . Yeah , it's harder to figure out , but that's why you have to get great people in an organization . You know they have to figure .

Okay , figure it out , figure out how we're going to help more people with this product . And that's how you start to build product by product and a portfolio and a team and it starts to grow . So that was really what solidified for me at Covis .

And and you I think you just mentioned that you know , in some cases people are are tied to it , they're married to it , they may maybe they've got some emotional right .

And so it's just conversations like this . You have conversations to really explain what you're doing and why you're doing what you're doing and why you're making the decisions you're making .

Because if the team all doesn't agree and doesn't buy in , then you know when you only have 10 people on the team , if one of them doesn't buy in , you know you're at 90% effectiveness if all of the others are working at 100% .

So that's the other thing you learn in small startups is you got to get everyone to buy in and you got to get everyone focused and everyone's got to be at 110% or else you're not going to compete All right .

I mean everybody knows what that is . I'm assuming you played a role in its sale to Emergent for a princely sum , so tell me about that . Like you know , that's another I'm assuming that's another big inflection point in your career . That sort of inspired , informed provided some direction as to what came next . Tell me about that experience .

And when I was finishing up my term at Covus , I talked to the CEO founder CEO Seamus Mulligan , who has been a mentor of mine throughout my career , about joining the team , and I was trying to finish things at Covus but had an eye on helping Narcan .

So when I got there , they had the framework of a pretty solid team in the US marketplace and I think the biggest transition was number one , stepping into that role , getting to know the people who are currently on the team , but then number two , figuring out the product and how to navigate the waters .

And then number three , continuing to build out the team to execute . It was really all about operational execution . At that stage , the company had been trailing a competitor in the FDA review process and the competitor got a complete response letter .

So they went from bridesmaid to bride overnight , and now there's a very different strategy when you are planning to follow somebody versus planning on leading the way . So we had to pivot very quickly and figure it out . You know , we knew that we had a device and a drug that can save lives .

What we didn't know is well , how are we going to get it into the hands of people who could save those lives ? And the most logical first step for us was well , the first people on a scene of an overdose are police , and they're not trained . They're not trained medically to treat people , nor do they want to . That's not their job .

So we actually had to knock down a lot of barriers to allow police to carry the product without a prescription and deliver it to somebody who they thought might be having an overdose . So there was a lot of political things that we had to work on .

So it was a combination of knocking down political barriers but also then convincing groups who typically don't do things that they should be doing things . And then , once we got an anchor in the police departments across the country , the product just started to take off and they realized , ok , well , if police can save lives , anybody could save lives .

And that was the product just took off . We were finding different ways and different avenues just to get as much of this stuff out as we possibly could , because we knew that every 10 units we sold , we were likely going to save at least one life . So we were , you know , I tell folks the analogy we were building the car and driving it 100 miles an hour .

So we were building the company and we were trying to sell as much of this product as we could . We did a great job of it . But I think at the end of the day , when we had discussions with Emergent , they were a much bigger company , much more resources .

They were well connected in the public space , the public health space , with all of the work that they have done with the anthrax vaccination and anthrax . You know all of their government , you know public private partnerships , really took the product to the next level .

So when we , you know it was kind of bittersweet to sell the product because we were doing extremely well . But I think the management team at the time realized , okay , well , we're never going to get it to where they can get it . And you know , sure , we sold it for a decent product . But I think it . You know , everybody was happy that .

You know , when we left , when we left it in their hands and most of my team stayed there , uh , when we left it in their hands , uh , my team combined with their team and they took it . They actually almost doubled it from where we left it in their hands . My team combined with their team and they took it .

They actually almost doubled it from where we got it and it's saved many , many lives today . So it was a phenomenal turning point in my career .

Yet we've had plenty of conversations on this podcast around like , okay , we have a drug that made it through phase three , the FDA approved it , we're celebrating , the champagne bottles are popping , and then 18 months down the road , that product's no longer on the market because the execution of its commercial availability and use just completely falls flat on its face

. For myriad reasons , right , it fails . Myriad reasons , right , it fails . In this case , you had to develop a plan that was unlike any plan that probably had ever been executed in terms of that last mile to the patient .

You did it and , as I said , recognizing that there probably isn't a very clean parallel to biologics or the products that you're working on now , I'm curious about how that , that win and that fortitude and that problem solving that you exercised during the the Narcan rollout , how does that translate to your commercial perspective now ?

Like you know , you're working obviously with different players . You know you're not working through municipalities and police departments and trying to get people to . You know , add this to your tool belt while you're on the beat . But but the lessons Right and the and the like I said for fortitude that it took .

Do you , do you find that it translates or is this like well , that happened and it's completely removed from from what I'm doing today .

Right , it's . It's that the commercial world is is turned on its head . The payer world has been , you know , very , very strong . So it really boils down to the team that you hire in order to execute and deliver , and that team isn't just your commercial team .

That team is your clinical team , your development team , your regulatory team , your CMC team , your tech ops team . So those learnings at I mean , the common thread throughout my career is just , I've been extremely fortunate to work with really smart people and bring smart people into organizations , and not just smart , intelligent smart , but smart , motivated smart .

I mean like give you an example , narcan , right , we had a guy who was head of marketing and I said to him listen , I know you want to be head of marketing , but PR is much more powerful than marketing here , and I had to kind of teach him that Probably more powerful and with a product like that , necessary . That's right , that's right .

And so rather his mindset was well , he wanted to run marketing . I'm like , well , why don't you focus on running PR Like ? That is like . And he , he changed his thinking and so he applied his skill set , but it was just a different approach . The same , the same goes for trade and distribution .

Our head of trade and distribution was a traditionalist trade and distribution . Our head of trade and distribution was a traditionalist right , he's sold traditional products for GSK and other companies through third-party logistics companies .

But if he didn't have the ability to think differently about how to distribute product directly to a department of health and set up a network that people could sign into a website and order it and we would ship it locally and bill centrally and have master prescriptions written , I mean , he developed that , he learned that .

You know , it wasn't a cookie cutter , we couldn't find that role . So those skills , I think , translate into any other job that we have and that's what I'm bringing , I believe , to NerveGen . You know this is we're going to treat spinal cord injury . No one's really ever succeeded here .

There's new paths that we have to pave and if we don't have smart people A but people who could think differently about how to create a path , were just going to be a traditional pharmaceutical company , and you can't be that if you're 12 people working virtually across the United States . And so that's what's translatable .

Translatable is pulling a group of people together that are extremely smart , that can actually be motivated enough , and generalists I call them generalists to be able to work without a net and to make decisions and to fail and to succeed and to fail again and succeed . It's that type of mindset in every department that we have Finance , you know .

Give you an example Our CFO . He's a great guy . He's worked in both Canada and the US Not a lot of CFOs have . We are a public company . In Canada we're 75% held by retail . You know that's not typical . You know typical biotech path is you have four institutional investors that are carrying you all the way . We're not there yet . We may get there .

We may never get there , but to be 70% retail , 80% retail at this stage of our life , you need a CFO who's going to think differently than a traditional . You know somebody who's going to go to the top 15 institutions in the US . You know we have to go into the high net worth groups . We have to go into retail .

We have to straddle the fence , but that's just one example of the types of people we are bringing into this organization and have at this organization are , you know , chief medical officers . The same way , he came from a large company and now he's working . It's him and one other person in our clinical department you know he's came from Amgen .

You know not many people could do that . You know could , could oversee . You know it's great to have the title chief medical officer , but now he's running clinical operations , he's overseeing data management . You know he's doing things that typical chief medical officers don't do . Yeah so that's what I mean .

It's really the people on the team that you put behind things that are consistently successful .

I , I was looking at you guys thinking like you know , does this fit ? Does this fit for the business of biotech podcast ?

And I , I recalled a conversation I had with uh , with uh , the VP of uh of content , effectively my boss here , um , I don't know , like a year ago , and he was like , so , for context , the business of biotech and bioprocess online is we focus on biologics , like we focus on large molecule therapeutics , development and manufacture of large molecule therapeutics .

And he came to me and he was like you know , hair on fire . He's like GLPs . Glps Because you know , like any publication , like any publishing industry , like we , we want to latch onto something that's , uh , you know , going to get clicks right , going to going to get eyeballs , and GLPs were it . And I was like , yeah , man , I don't know .

You know , like I don't , I don't think they fit , I don't think these peptides are , uh , are a fit with , like , if we're going to stay true to our large molecule , you know , existence . I don't think they fit and it's ironic because I'm the first guy to break the rules , like I'll color outside the lines any chance I get .

And as time has kind of carried on here , like I said , I mean , sometimes the FDA treats them like a biologic . Sometimes , you know , depending on how big the chain of amino acids is , you know , whatever criteria they apply sometimes .

So I'm like , all right , you know , let's go ahead and spend more time learning about and covering peptide therapeutics potentially as biologics , right , sure , like they're biotechs that are building them , let's just do it .

So give me your take and I've got you know , we could probably go long on this your take on starting with your perspective on taking the job in NerveGen , right , like , was this something that you're like ? Well , you know , was it the indication opportunity ? Was it the therapeutic where you're like , yeah , you know , these peptides are kind of catching on .

It's a , it's a cool modality , like what led you into this , into this role , and , and since you've been in the role , give me your take on sort of the , the peptide I don't want to call it a revolution . I mean , like I said , you know , a few approvals a year , it's . It's still sort of nascent , but there's a lot of excitement around around peptides .

There's only a handful of manufacturers in the world who can do it well and I have no experience in peptide manufacturing . So that was to me one of the things I said OK , well , I look at companies of our size and I look at where they fail and where they fall down , and a lot of them fall down in manufacturing .

You know a lot of complete response letters over the last several years . They do everything perfect clinically , but they either can't make the stuff consistently or they can't , or if they do and they get approval , they just fail on the launch side .

So I got over that by talking to some colleagues that I've worked with in the past , by talking to some colleagues that I've worked with in the past who know peptides , know how to manufacture peptides , and it's not rocket science , but you have to have the right people and the right partners to be able to do it .

So I view NVG291 as a handful of amino acids behind becoming labeled a biologic , and biologics are just as challenging the formulation development , and so I'm actually learning a lot . And one of the gentlemen that came into our organization , chuck Olson .

He's teaching me , he's our head of tech ops and he's forgotten more about peptides and biologics and manufacturing than I'll ever know in my entire life and I have to trust that he knows what he's doing .

I mean , I'm a pretty good verifier if somebody is BSing me , um , but uh , you know , chuck is the one who's going to get this product manufacturing uh , manufactured uh , and quality controlled and and approved by the FDA that we can consistently make it over time . So is it an in vogue space ? Yeah , I mean , I think you know , you mentioned it earlier .

It's in vogue because of a lot of Lilly and Novo Nordisk are doing right now , but that's cyclical . I think it's in vogue because of everything that they're doing . But they have the know-how , they know how to work in this space . Not a lot of folks do .

If they are small molecule companies , they're going to have to bolt on the expertise of , of managing and working in the peptide space because , you know , manufacturing is not a simple process and there's a handful of people , like I said , there's a handful of people that can do it .

You can tweak a small manufacturing process and have a massive impact on your yields or your effectiveness or your toxicity . So your decision making then really has to be very , very fine tuned and you make decisions and stick with them .

You know , because once you're too far down the path , if you're sure , you could always improve upon something , but you may tweak something that send you all the way back to preclinical . So it's an art and a science mixed . When you're in the peptide space .

I was unaware of the fact that Narcan was a meat you know , a me too player , or a hat you know , and also ran before it became the crown jewel right Like that . That was news to me .

So I just wanted to make sure it wasn't . It wasn't that they were . You know , we were very different from them , we were very close to them , it's just that we jumped and leapt ahead of them .

You know we see antibodies , we see the cell and gene therapy space running after this . You know , we see , you know all sorts of you know , human tissue approaches . I mean there's a , you know there's any number of ways to skin that cat . I don't know if you can still say skin that cat , but I just said it .

So where do you see , where do you see , where do you see peptides kind of fitting into that landscape in terms of neuro ? And why like ? Why ? Why are peptides a compelling modality to chase down these indications ?

They discovered that there was this group of molecules , cspgs , that were inhibiting repair . You know they're ubiquitous throughout the body . They are kind of like the cement that holds things together in your spinal cord injury . But then when activated due to an injury , they work extremely well at holding things together but they prevent axonal regeneration .

So I think early Jerry Silver's work early on is really what started this company . Harold Poonit , who's the founder , his daughter-in-law had a tragedy . She fell , she got paralyzed and he started to scour the earth for anything that would help his daughter-in-law . And he came across Jerry's nature paper and said , wow , this is .

I don't think he was thinking , oh , this is a peptide . At the time he was thinking this is showing some phenomenal results in animal models . And he had discussions with Jerry and he ultimately found a group of investors in Vancouver to in-license technology and NerveGen was formed . So I think sometimes you know I'm trying to give an analogy .

I'm coming blank , but sometimes the therapeutic will define the space rather than the space defining the therapeutic . And then , through our work with NVG291 , matt Fehlukachev , who's our head of preclinical development and has identified other different ways which are similar . You know similar ways has discovered MVG 300 .

And now we're testing that and that is actually you know could potentially qualify as a biologic . So even though we're a peptide with MVG 291 , our next product could potentially be a biologic . So we're not necessarily wedded to being the peptide company .

What we're doing is we're trying to take what NVG291 has demonstrated preclinically and we're trying to see if it can be translated into humans , because it basically and we're learning a lot , we're learning a ton and we're doing a lot more work on MBG291 . We're trying to get down to well , what is the exact molecular mechanism ?

We know what happens when you put it into the situation . Right , we know that it turns CSPGs off , you get axonal regeneration , you get remyelination of damaged axons and you enhance plasticity near and far from the injury . So what we don't know is well , molecularly , how is it doing that ? And that's what we're doing now .

We're doing a lot of work to understand it . Now we hope to have all of that work in a nice package with a bow on it to sit down with the FDA . But look at all the package inserts of all the products that are out there that are approved at the first line in the mechanism of action state .

The actual mechanism is not known , however , and then all of the data goes . So that's right now . If the package insert were printed , we'd be a peptide . We would say we don't know the specific molecular mechanism , however , and then it would be all the data that we do see .

So I know I'm kind of skirting your question around on peptides , but I think you know we're wedded to peptides because we're wedded to NVG 291 . Nvg 300 works and translates we'll be wedded to biologics . So we're opportunistic in that you know finding products that will solve problems for diseases that are . You know the uniqueness .

The way MG291 works is different than how other people are targeting the disease . You know they're targeting . They're trying to get nerves to grow . They're trying to get things to fight through the glial scar , things to fight through the glial scar .

What we're doing is we're just shutting off something that is in the body that is stopping things from repairing itself . So we'll see if it works and we'll you know , I think we're going to be synergistic with , especially in spinal cord injury , I think it's going to be two or three different products mechanistically that will give folks gains .

And it's really as you dig into spinal cord injury you realize that it's going to be as much pressure is going to be put on the drug to produce as the patient to produce . Because we can actually , if we can regenerate right , if we can remake connections and remyelinate . That's one step one .

The patient is actually going to have to turn those muscles that those nerves are talking to into motion and action and function . So that's why , you know , we're doing this study at Shirley Ryan and we're doing it in a rehab facility and we're combining all of those modalities together .

He's well-experienced at putting products on the market and seeing them through . And then he joins NerveGen and it's like , well , you know , at the surface level he just took a giant step backward because you know , 1b2a is cool and everything , but it's still quite a ways from the commercial side of things .

So on one hand you're like , wow , that's a giant step backward , like if Mike sticks around there for a few years , he's , you know , he's unlikely , at least in the short term , to feel that again right .

But on the other hand , I'm like I don't know why I'm thinking , I don't know why you wouldn't want someone in the CEO's chair who has taken things through development all the way to commercialization at this early stage , because the work that Chuck Olson is doing in tech , ops and CMC , he's making decisions .

You know he and others I'm sure are making decisions that are either going to seal you know they're going to seal the fate one way or the other . Right , they have major implications on how quickly you move through the clinic and how to your point manufacturable these difficult-to-work-with peptides are , to your point , manufacturable .

These difficult to work with peptides are all sorts of regulatory implications . So I'm using a lot of words here . To get back to Chuck Olson and the work he's doing and I'd like you to share with us about .

You know some of the details around the work he's doing that you look at and you go , yeah , you know like we're still developing , we're still figuring out manufacturability , but the decisions he's making are going to pay dividends when we're in phase three and beyond .

Um , and we just actually it's funny cause I was on with a group yesterday and we were talking about , you know , bringing another person of talent into the organization and everybody has their opinion on what that person should be doing and saying and their experience and how long they should be around is one thing .

But working in this environment in a startup , I've seen people who are phenomenally experienced at Merck I've hired them and I put them in this environment and they vapor lock . And what I mean by vapor lock is like the . They don't have a , an assistant , they don't have uh , they have to call . They have to actually figure out how to work their computer .

You know they may not get a computer for the first couple of days . You know , when they do get a computer , they have to learn how to do our filing system online . You know they have to make their own travel arrangements , they have to run their own schedule , they have to call their own meetings . So we have outsourced HR .

So if they have an issue , it's just not the right environment for everybody . A lot of folks like all of that stuff taken care of and then they can operate In this environment .

You have to go with the flow and operate and take care of it , but with that you get to make bigger decisions than you've ever made before in your career , and that's what fuels people . And so I look for people who could live in this environment and thrive in this environment . And I'm a very big fan of test driving , you know .

You know , because they're testing us , we're testing them . So Chuck is perfect example . Chuck joined us as a consultant . You know he had his own consulting company . He started working five hours a week and 10 . And then Chuck started working like 30 to 40 hours a week and not billing us .

And I'm like , hey , chuck , do you want to 40 hours a week and not billing us ? And I'm like , hey , chuck , do you want to join the company ? And I know you're going to be putting your company on hold . Um , but we really could use you on the leadership team of this company . And and he joined the company .

So that to me is you know he he's doing more than just CMC and tech ops . Uh , he's a generalist . He's running a big portion of this business . He's empowered by that .

He's making big decisions when he's challenged with , you know , if it's a huge decision , he brings it to the management team and we meet once a week and he says , ok , here's what I'm thinking , here's a decision I'm making , here are the alternatives . Anybody agree , disagree , and people challenge him .

People say , well , did you think about this , do you think about this ? Well , what about this ? Yeah , I guess . So Just to kind of summarize the discussion around Chuck , which is the same discussion around everyone who's running a function in my group , on my team , is they have to be a generalist .

They in my group , on my team , is they have to be a generalist , they have to be a strategic thinker , they have to have good judgment , because they're making judgment calls every day and you know we can't have this hierarchical approval of things . You know we wouldn't get anything done . So and they have to be .

They can't be afraid of making a decision and moving on . And you know , if it's a major decision , they also have to have the sound judgment to know that this is a major decision that's going to have knock on effects to the business . So I'm going to bring it to the team and just vet my decision here .

So that's , that's the process , it's , and then you know , you go away and execute , so it's not like we're spending weeks on trying to figure something out . You bring it to the team , you make a decision , you move on .

So those two manage everything having to do with manufacturing . Cmc Chuck also oversees regulatory . So we don't have a regulatory person in-house . We will ultimately be bringing somebody in-house but at this stage of the company we don't .

You know we need experts and to hire the experts who would cost way too much money so and they would be bored because we have one program . So we hire experts and they report into . You know , chuck and me and Dan when we're when we need advice on what to do and what to say and how to approach the FDA .

I've found in my discussions with biotech leaders that there doesn't necessarily appear to be like a super formulaic approach to .

You know , when you bring in a CMO or a chief regulatory officer or a chief commercial officer , you know the general response I get is like , well , you know , the sooner the better , but they don't all , you know , not everyone follows the same playbook .

So I I guess two part question on that what is your sort of general approach to like spacing out , sort of gating , the hiring of these positions , and and and and and like why ? What's sort of the , the strategy behind when you bring these people on board ?

Cause if you do it at the wrong time , I mean you're you're either wasting money early to your point , like you'd be wasting money on a chief regulatory officer right now . You bring them in too late . You know you could create some problems there too .

But you know , I think the way I'm , the way I make decisions and I think the way my most of my team makes decisions on bringing people in is I'll give you an example Our head of preclinical right now is working on MBG 300 and advancing that , but also working on all the preclinical package for MBG 291 .

And we raised we weren't doing a ton of work on MBG 300 . We raised some capital , we had some cash , we gave it to him . So , doing a ton of work on MBG 300 . We raised some capital , we had some cash , we gave it to him . So now he's got 15 to 20 projects going . He's working 50 hours a week . He's not taking a vacation a year .

It's like , hey , it's time that you bring some help on here Because he is prioritizing . Mbg 291 is the lead priority . But now that we told the world we have 300 and we set some expectations externally , now we've got to hit these deadlines . So I think it's two things to answer your question directly .

Number one when you see the talent , you have to hire them . When you find somebody like a Chuck who's working extremely well with the organization . He works seamlessly with the executive team . He led the group in CMC .

So when you find him , you hire him or you try to get him here as quickly as you can , Even if even if it's only 50 percent job and for him it was much more than 50 percent .

So my , my rule of thumb is if there's 75 percent of a job here and you find somebody , hire them , and if you don't find that person , keep looking until it gets closer , and if you're over 100% , you're in trouble . So you should have already been looking . So we're constantly looking . That's one of the things about executives and startups .

They are constantly looking for talent who will live well in this environment and execute , and it's hard to find . So when you find them , either hire them as a consultant to do some work for you , to keep them close to you , or stay in touch with them , and I right now have .

Well , we just hired a head of program management the same time we hired Chuck and she was a consultant as well and she joined us . We currently have a consultant working on corporate and business development and I've worked with him for 15 years and as soon as I get enough cash in the coffers , I'm going to hire him full time .

So that's kind of how we we operate and I think it's a you got to identify the talent and then be . You know , you have to time it right so that they're not sitting on their hands and doing nothing Right . But if you hire the right startup type person , they'll do anything . They'll do like I'm giving a perfect example .

Liz Eberhardt , who's our head of program management . She's dug in and she's the key point person on enrollment in our current clinical trial . That's not her job on enrollment in our current clinical trial .

That's not her job , but she has the experience and she's mature enough and she's well-versed enough in PR which is essentially what you're doing when you're trying to bring awareness to your trial to oversee an outside sourced PR firm . So she stepped in , she stepped up and she's running it . So that's kind of the model .

But you bring up a , you know , you bring up the point around like , oh , I'm going to hire this guy as soon as I can afford to , right , and companies find themselves , companies like NerveGen , as a matter of fact .

I think you do probably find yourself in one of those positions right now where you know , maybe the cash runway management needs to be a little bit more scrupulous , because you're running up to a point where soon , you know , perhaps I don't know , I don't want to make any forward-looking statements but perhaps soon , in the next few quarters , you'll have some you're

pre-human data . Right now , We'll put it that way You're pre-human data .

We're targeting to complete enrollment in the chronic cohort this quarter , which would give us data in Q1 of next year for that cohort and that's really going to be the coming out party for this company .

Once we have that data , we're working financially to make sure that we're in a position where we can uplist onto NASDAQ , we can get some institutional investors in , we can fund our phase three . We're actually interviewing people today to help us tee up that phase three . So all of this work is being done .

So , to answer your question , yeah , we're targeting Q2 for chronic enrollment and targeting Q1 for data .

So I was curious about what the funding strategy might look like Should you get to that point and the and the and the data looks , looks real good . You mentioned that you're , you know , largely retail right now . Where would you like to see the company ?

You know , maybe at this point next year , right Like August 2025 , in terms of like where the stuff that's feeding the coffers is coming from ?

Now , obviously , it really is dictated upon how big that next study is and how much that next study is going to cost , but I really want to be in a position where funding is not an issue for this company anymore and talent acquisition is that's really the key is so for here this time next year teeing up a phase three program for chronic spinal cord injury ,

and then hopefully , mvg 300 is entering into iron or entering into or in the middle of IND , enabling studies , depending on funding . I think that's a real company .

That's like you know , not that we're not a real company today , but I mean that's a real NASDAQ listable company and I think that has some vision on where we're going and what we're doing and timelines and how to get there .

Uh , that'd be fun , but I wish you all the luck in the world . It's a fascinating story and you've been very transparent , and , and , and , and , and I . I think , I think there's a lot of value , sort of , in the stories that you've shared with us . So so , thanks for coming on .

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