Spinogenix Founder and CEO Stella Sarraf sits with ForbesWomen Editor Maggie McGrath at the Nasdaq MarketSite to discuss her company's novel approach to treating neurodegenerative disease at the synaptic level.
00:00 – Intro: Meet Stella Rouseff, Founder of SpinoGenics
00:49 – Can Synapse Drugs Help Restore Memory?
02:01 – What Synaptic Regeneration Actually Looks Like
03:00 – Why SpinoGenics Took a Different Scientific Path
04:29 – Where the Trials Stand Today
06:43 – U.S. vs. Australia: Global Trial Strategy
08:31 – Could This Apply Beyond Alzheimer’s and ALS?
10:33 – The Power of a Once-a-Day Pill
11:57 – Why Government Funding Matters for Innovation
12:59 – The Personal Story Behind the Company
15:02 – From Venture Capitalist to Founder
17:22 – Why a Chemist Thinks Differently
18:28 – What Keeps Her Up at Night
19:24 – The Public’s Biggest Misconception About Alzheimer’s
21:05 – What She Hopes to Report in 2026
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00:00 – Intro: Meet Stella Rouseff, Founder of SpinoGenics
00:49 – Can Synapse Drugs Help Restore Memory?
02:01 – What Synaptic Regeneration Actually Looks Like
03:00 – Why SpinoGenics Took a Different Scientific Path
04:29 – Where the Trials Stand Today
06:43 – U.S. vs. Australia: Global Trial Strategy
08:31 – Could This Apply Beyond Alzheimer’s and ALS?
10:33 – The Power of a Once-a-Day Pill
11:57 – Why Government Funding Matters for Innovation
12:59 – The Personal Story Behind the Company
15:02 – From Venture Capitalist to Founder
17:22 – Why a Chemist Thinks Differently
18:28 – What Keeps Her Up at Night
19:24 – The Public’s Biggest Misconception About Alzheimer’s
21:05 – What She Hopes to Report in 2026
Subscribe to FORBES: https://www.youtube.com/user/Forbes?sub_confirmation=1
Fuel your success with Forbes. Gain unlimited access to premium journalism, including breaking news, groundbreaking in-depth reported stories, daily digests and more. Plus, members get a front-row seat at members-only events with leading thinkers and doers, access to premium video that can help you get ahead, an ad-light experience, early access to select products including NFT drops and more:
https://account.forbes.com/membership/?utm_source=youtube&utm_medium=display&utm_campaign=growth_non-sub_paid_subscribe_ytdescript
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More From Forbes: http://forbes.com
Forbes covers the intersection of entrepreneurship, wealth, technology, business and lifestyle with a focus on people and success.
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LifestyleTranscript
00:00Hi, everyone. I'm Maggie McGrath, editor of Forbes Women, reporting here from NASDAQ MarketSite.
00:08Today, 7 million Americans have Alzheimer's disease, and the Alzheimer's Association expects that number to nearly double within the next 25 years.
00:18Within this environment, women are more likely to experience neurocognitive decline than men are, and there is no one cure or treatment that has come to market.
00:30Our next guest is trying to change this reality.
00:34She is Stella Saraf, the founder and CEO of Spinogenics, a drug discovery and development company that is trying to not just prevent neurocognitive decline, but reverse it in some cases.
00:47Stella, thank you so much for being here.
00:49Thank you for having me, Maggie.
00:50So I don't want to say that your drugs can restore memory because that feels like overstating it a little bit, but can you talk about exactly what you are spearheading through your company?
00:59Yeah, I founded Spinogenics in 2016 with the goal to create synaptic regenerative treatments to combat a lot of brain diseases and Alzheimer's being one of the, I would say, one of our big indications that we're very excited for.
01:13By working at the synaptic levels, your synapses are the fundamental building blocks that allow your neurons to communicate and actually control the way you plan, think, movement, talking, even sight, and even breathing.
01:30So we are very excited because we have a small molecule drug in clinical development, working it, restoring those synapses, those connections that stop working.
01:39And you can imagine by doing that, when you restore those connections, you can actually regain function.
01:44So our hope is that we can restore memory.
01:47Our hope is that someone who, let's just say, used to enjoy reading a book, can now pick up a book and actually finish it, that person with Alzheimer's.
01:56That is truly the hope, and we're in phase two right now.
01:59We're very excited.
02:01So just to paint a picture, you have a graph on your website that is before and after, and it kind of looks like a branch or a tree trunk with branches.
02:10And the before has a few branches, and the after has many, like, double the amount of branches.
02:16Is that effectively what synapse regeneration looks like?
02:20Yeah, actually, what you saw there, that's a picture we have of a Golgi staining in an animal where we treated before and after, and showing before, those were the synapses.
02:28And then after treatment, we increased the synapses.
02:31And those synapses, again, are the connections.
02:34So you can imagine, if you are able to get those connections functional again, you can actually restore cognition and help with improving memory.
02:41So our goal is that someone, while taking the synaptic drugs, will be able to function better, remember better.
02:48Some of the treatments that are out there are working to prevent the growth of plaques that can cause brain disease.
02:56Why did you go the synapse route versus the fighting the plaque route?
03:00Well, the plaques, actually, some drugs have been approved, and they do target the amyloid beta and the plaques.
03:09When I started spinogenics, it was really to think, it was different.
03:13You know, I looked at it as, what are we doing with brain diseases, and how can we tackle the problem in a completely different perspective?
03:21And when I look at a lot of brain conditions, neurodegenerative being one of them, Alzheimer's, neuropsychiatric schizophrenia, even if we start looking at ALS,
03:32you're, like, ground zero is your brain.
03:34And when you're born, you have synapses, and just like when you're born, you can learn so much.
03:39And then over time, just like you grow a certain amount, and then you stop, your synapse is just, there's an equilibrium.
03:45Then you have disease pathology that comes in, and then it starts affecting.
03:48So you can see, if you start, if there's a way to create a small molecule that actually gets and starts working at the synaptic level,
03:55so many possibilities of so many things you can help.
03:58And so, again, as a chemist, I just kind of, it was an out-of-a-box idea when we first started the company,
04:05and then step by step by step, we started building, no pun intended, building those connections,
04:09also with the community and other collaborators, professors to help us do those initial animal studies.
04:16And then, obviously, where we are now, which is in the clinic, really exciting.
04:19Let's talk more about where you are now.
04:21So you've done the animal studies, you're in, I think, clinical phase two.
04:24What does that mean for the general public, about where you are and how far you are away from commercial deployment?
04:29Well, drug development is a marathon.
04:32You first start off, let's just say, with the, you know, I first started my career in big pharma at the bench.
04:37So you're at the bench, you make your drug, and then you have to really understand the properties.
04:41And so we do stuff in cells, we do things then in animals, and then you have this translation from the animal studies.
04:48Again, people have cured a lot of diseases in animals.
04:50Going to humans, there's like that gap, that bridge, you need to really bridge that.
04:55So, you know, first thing you really want to understand in your animal studies, safety, right?
04:59First and foremost, this is what we call a new chemical entity that you're putting into the body.
05:03So it's a new drug.
05:04And then you want to understand the efficacy.
05:06Is it working or not?
05:07So after you do that in humans, then you, I mean, sorry, in the animals, then you want to go to humans.
05:12And that first kind of going from the animals to humans to do your phase one studies, which is required,
05:16phase one is human safety.
05:19And so when you bridge that and actually get your safety in humans, then at least one big, you know, checkbox is done.
05:24And then you get into your phase two studies that we're doing right now.
05:28And right now we're doing phase two studies in Alzheimer's, in ALS, in schizophrenia.
05:32And we have another program that works on a synaptic corrective mechanism, and that's in Fragile X,
05:38which is underneath the autism spectrum.
05:39Now, you have a clinical trial in Australia, but you also have some FDA fast-track grants,
05:46I think, for the Fragile X, if I haven't gotten them mixed up.
05:50But in general, can you talk about your approach to trials and whether that geographic diversity,
05:54the American FDA and an Aussie trial, is that intentional?
05:59Yeah, I wish I could take credit.
06:00I actually listen a lot to a lot of people who've done drug development.
06:03So we were doing things in the United States.
06:05We had a lot of support by the NIH and DOD to help us with some of the animal work.
06:09And then when it came time to do the phase one safety, I got a lot of guidance to, you know,
06:13things just in Australia with the phase one.
06:15They've just mastered doing things really quickly and the collaborations.
06:19So we went there to do the phase one safety, and we've already talked to the FDA.
06:23So there's a lot of collaborations happening globally with the institutions.
06:27So we got the phase one safety, which was key, and then started the phase twos there.
06:31But, again, our phase two studies initially are really just to understand,
06:36do we have that dose that we go from the animals to the humans, and can we see an effect?
06:40Because we're doing something extremely novel, innovative.
06:43No one's ever done that.
06:45And then we're still in the United States.
06:46So our other program, SPG 601 for Fragile X, that's only in the United States.
06:51We did get orphan disease designation and fast-track designation for the Fragile X,
06:56and we've actually completed that phase two study, and we're very excited about the results.
07:00And, again, working by the end of this year to go talk to the agency and start sharing kind of our other plans.
07:06And same thing with the others.
07:07So with our SPG 302 for ALS, we went back to the FDA, and we have IND clearance.
07:15So to start that trial here in the United States, we do have some people on compassionate use.
07:20Our goal as a company is to try to get as many patients access to the drug.
07:25Again, it's something that's very near and dear to my heart and able to just leave no patient behind, try as much as we can.
07:34We're very patient-centric and focused.
07:37You mentioned compassionate use, but that's just for the Fragile X, or is that for the ALS?
07:42That's for the ALS.
07:44And I imagine it has to clear clinical trial phase two before compassionate use.
07:49I guess what I'm getting at is how many phases are there?
07:51What's the road ahead?
07:52In drug development, just in general.
07:54Yeah, so drug development, you have your phase one safety, then you have your phase two studies, and then you have phase three, and then you can apply for an NDA to get onto the market.
08:03So it's a long road.
08:05When you deal with orphan diseases like ALS and Fragile X, there's really, like, with Fragile X, there's nothing approved.
08:12With ALS, we have limited therapies out there.
08:16So it's really, there's opportunities to talk to the FDA more to just try to understand, share what we have and understand kind of what we can do together to try to help those orphan indications.
08:31Now, you mentioned orphan disease, and one of my questions for you was going to be whether the synapse approach is only useful in the conditions that you're looking at, ALS, Alzheimer's, Fragile X, and schizophrenia.
08:43Or once you go through the process, recognizing that it is a process, could this synapse approach be applied to other neurocognitive issues?
08:52That's such a great question.
08:53So, yeah, synapses, as we were sharing on our website, we actually did put a nice little donut chart.
08:58How many diseases were synapses is just fundamental?
09:01And so, we have, we're going after these certain conditions, but there are many more indications where we see opportunities where we can help diseases.
09:11Obviously, right now, as I said, ALS, we're, you know, we have gotten orphan disease designation, and we're in the clinic for that.
09:18And that's a neurodevelopment, not sorry, a neuro, neurogeneral disease.
09:23But, again, more affects your motor, cognition, and respiration.
09:27Again, synapses, we've shown, have an effect on that.
09:30With Alzheimer's, we're really helping with the neurogeneral disease and helping with cognition and memory.
09:35And then with schizophrenia, we're really hoping, again, cognition and synapses are known to be fundamental to that.
09:41But are there other diseases?
09:42Yes.
09:42I mean, frontal temporal dementia is one that's very obvious.
09:45Parkinson's disease is another.
09:47There's only so many clinical trials we can do.
09:49We're a small company, but the applications of exploring synapses in all those other indications are very well understood.
09:58The biology is there.
10:00I always say, and I was saying this earlier, we are drugging known biology.
10:04So, what we're doing is super innovative because, at the end of the day, getting a small molecule to pass your blood-brain barrier and do its job is not easy.
10:13And, again, small molecule, you'll hear me say that all the time.
10:15Again, obviously, I'm a chemist, but why is that important?
10:17It's really important because it helps with patient compliance.
10:21It helps with caretakers to make sure the patients can get it.
10:24It's not an infusion.
10:27It's in many ways can help the health care system, and that's really the global picture of what we're doing.
10:33Just to emphasize something you just said, it's basically a pill versus an infusion, right?
10:39So, the standard of care, you can take it at home versus needing to go to a clinic.
10:43So, that makes it more approachable.
10:45Once a day pill.
10:46Once a day pill.
10:47And since we are the only company that's working on the synaptic regenerative and synaptic corrective mode of action,
10:56you can see that this can complement other approaches.
10:59So, this is just very, it's, we are, like I like to say, a new zip code that hasn't been explored.
11:04But, again, the biology has been known.
11:06We have just, have now created this pill, which I'm very happy to say is very well behaved.
11:11I mean, the safety is very, has turned out to be very well tolerated.
11:17And that's very important as you want to do the larger trials.
11:21It's really important because some of the existing memory drugs have significant gastrointestinal side effects
11:26that can then discourage patients from continuing the treatment plan, basically.
11:32Yes, and even as you talked about Alzheimer's, there are side effects even with the approved drugs out there.
11:37So, I mean, we're really hoping to just, again, with our, with our new potential therapies,
11:42be able to kind of push the envelope and, and do right by so many.
11:47And, again, it's just, patients are so critical in the everyday, the way I run our team.
11:52It's, it's no regrets.
11:53Let's do it.
11:54And, you know, let's leave no patient behind.
11:57When you talk about building a zip code, there's a lot that goes into building a new zip code
12:01to continue with the metaphor.
12:02And we are speaking in a moment where a lot of academic institutions have seen grant funding pulled.
12:07We've seen cuts at HHS, and that have, it's affected CDC, NIH, and so on.
12:13How does that macro environment affect your work?
12:16Well, I can tell you the grant mechanism has, was critical, especially when we were starting out.
12:20We have an innovative idea, raising money, and we haven't talked about my, again, I was on the, I had it, you know, other careers.
12:27You have a VC background, and I've been saving that.
12:29Yeah, so the grant mechanism is super critical for innovation, and we were fortunate to benefit from that.
12:36But we continue to, even with, as I mentioned earlier, getting those other grants,
12:40and even currently trying to do some other work with collaborations in hospitals.
12:44I'm hopeful that, again, we will continue to innovate and move forward,
12:48and people can benefit the same way we've been able to.
12:51So you have a really interesting background, and you mentioned you started your company in 2016.
12:56What was the impetus in starting SpinoGenics?
12:59It was personal.
13:00You know, it's one of those things, if you got me in grad school and told me you're going to be a certain entrepreneur,
13:05I would have laughed, you know, this wasn't something that I had planned to do.
13:08Life throws you curveballs.
13:10Both my parents ended up having very challenging battles with their health care.
13:14I mean, ended up losing their battles, more in oncology.
13:17But it really inspired me in actually, you know, trying to solve the problem, being frustrated.
13:24And my dad had Parkinson's.
13:25By the time you have the cardinal shake, you have so much irreversible brain damage.
13:28And I was like, to the neurologist, the neurologist said, if we can find out, instead of like 60%, 80% when they have the cardinal shake,
13:3340%, maybe with what's already out there, we can make an impact.
13:38And so I was like, huh, why aren't we doing this?
13:41You know, and so, again, I'm a problem solver.
13:43And so that really was the catalyst to my first company, which is focused on detecting diseases earlier,
13:48so that you can try to get treatments.
13:49And then after, when I got an NIH grant and we got some data out, fundraising, everyone was like, I don't want Alzheimer's.
13:57I don't want to know there's nothing you can do about it.
13:58So I was like, huh, so challenge accepted.
14:01And that's what led to spinogenics.
14:02It was really just, you know, I was really frustrated because I was like, neurology is where oncology was decades ago.
14:09Because here my mom felt a lot, went to an OB-GYN, and we got 13 extra years.
14:13And then, you know, having to challenge it to answer.
14:16And then I saw neurology, wow, we just need to do more.
14:18And so, really, it was a personal push that got me going.
14:22And then once I had an idea and I saw no one else was doing it, I was compelled to actually kind of pull in on my other previous careers,
14:30having been in big pharma and then having been in the VC world.
14:33And my job was to analyze companies and try to poke as many holes in it.
14:37So when I started my own company, I shifted hats.
14:41And trust me, I've poked, you know, and that's how I built the company.
14:43I built the company because I kind of know what's going to happen on the other side.
14:47So how can I de-risk it?
14:48How do I build it step by step by step?
14:51I have, like, five follow-up questions.
14:52But I want to go back to something you just said.
14:53When you were fundraising for your first company, investors told you,
14:58I don't want to know if something's there unless there's a treatment?
15:01Yeah, again, that was a long time ago.
15:03So I started that company in 2013.
15:05And that was kind of like, yeah, I don't want to know because they don't, you know,
15:10and I have gotten that on quite a few.
15:11Like some people don't want to know if they have a deadly disease.
15:14It's different now or a neurogenic disease.
15:18Nowadays, we're the generation where we track steps.
15:20And you want to know how many, did I have good REM sleep?
15:23And, you know, it's completely changed since then.
15:26But, yeah, that was the reality of the field back then.
15:29So it's a personal mission, but also it helped you tweak your approach from company one to company two.
15:35Yeah, it was why I started company two.
15:38Because, no, it wasn't like I wanted to.
15:40Again, the idea and looking, again, the way I approached something, it was different.
15:44I was looking at a holistic kind of all of these conditions.
15:47And for me, the underlying was synapses and, again, the biology there.
15:50And I'm the chemist, so that's kind of how it all started.
15:53Now let's talk about your VC background.
15:55So you worked on the bench as a researcher for a while, and then you entered the world of venture capital.
16:00How long did you do that, and has that helped you fundraise for your companies as an entrepreneur?
16:04Yeah, I was in VC for over 10 years.
16:07It was invaluable because I just, you learn a lot of, you know, what it takes
16:13and how to also finance.
16:14So I always just was very creative in how I built my companies.
16:17It was always designed to how do I get to the next step?
16:20What do I need to get to the next step?
16:21How do we de-risk it?
16:22How do we get to the patients as fast as possible?
16:25And so really just being creative in taking advantage of all resources.
16:29And, of course, yes, my previous connections helped because I got to have conversations.
16:33And I can tell you throughout over 10 years, you know, there's been good times and bad times for fundraising.
16:40But it's when you're, it's a marathon.
16:42So you really just have to plan.
16:44I mean, I have a plan A, B, C, D.
16:46Like, it's always just like multi-pronged.
16:48Let's just try to do all we can because everything's, you know, not only is disease so heterogeneous
16:54and hard to tackle, but just on financing is hard to tackle.
16:59You know, regulatory, everything is hard.
17:01So you just have to try your best to de-risk all steps as you kind of navigate this, you know.
17:07Having a plan A, B, C, D feels very scientific.
17:10It feels like it goes back to your time on the bench.
17:13How do you think being a chemist has helped you build this company?
17:16Do you think you see connections and breakthroughs in a way that a biologist or a medical doctor might not?
17:22Well, I think being a chemist is, well, I guess having a Ph.D.
17:26I always say a Ph.D. is learning how to think.
17:28So you're a problem solver.
17:29So I just problem solve, again, more concretely, I would say, as a chemist.
17:33And, again, I love being a chemist.
17:36You can have an idea in the morning and by night you can have your answer, right?
17:39So it's kind of like just a building towards that.
17:42But having said that, what has made us successful at SpinoGenics is we have an integrated team.
17:48Every day I talk to, you know, my chief science officer is a biologist.
17:52We complement each other.
17:53We can look at the same problem and just all come in and just we speak in unison.
17:57And I think that's what's really led us, and it's one of our competitive advantages, which is everyone has a seat at the table.
18:03We're all talking, and we look at the problem in different ways.
18:06And so I would say that's another reason why we've been so strong.
18:10We have regulatory.
18:11There's so many things involved in getting a drug onto the market.
18:15It's not just actually the drug itself.
18:18What is your biggest challenge at this moment, spring 2025?
18:23As you look at growing your company and getting your drugs to market, what would you say is the thing that keeps you up at night?
18:28What keeps me up at night is honestly the responsibility I feel I hold with all the patients that are kind of on our wait list.
18:35You know, I have, I receive so many emails from people who, the stories break your heart.
18:42Like, I wish I could do more.
18:44But again, we have to follow a process with the FDA and just, again, it's a process for everybody.
18:50Like, that's just what we have to do.
18:51So what keeps me up at night is just asking, is there anything else I could do?
18:55What else can I be doing?
18:56You know, with all of our diseases, but especially the ones where it's like every single day counts.
19:03What do you think is the biggest misconception out in the general public about either Alzheimer's, ALS, or neurodegenerative disease as a whole?
19:13And I ask because you're an expert in the space, so I'm sure you kind of encounter public myths or just misconceptions.
19:20Then I'd love to give you a chance to clear something up for our audience.
19:23Well, that's a great question.
19:25If I were to reflect this, I would say, this past couple of years, I would say the biggest misconception, especially in neurodegenerative diseases and neurology, I would say, is there isn't a single cure.
19:38We always hear like, oh, is this going to be a cure?
19:40I like to think, again, neurology is what oncology was decades ago.
19:43It's going to be a combination.
19:45You really need to provide, we need to provide doctors with as many different solutions because this is the catch.
19:52All of these disease populations is heterogeneous, meaning one Alzheimer's patient is not like the other.
19:58One Parkinson's is not like the other.
20:00These are just like a big, you hear dementia, right?
20:02Dementia, there's so many different subtypes.
20:06And it's kind of like what we understand a lot more in oncology and cancers and the various subtypes.
20:11We're at our infancy in neurology.
20:13And so that's my thing.
20:14Why am I so excited about our approaches right now with what spinogenics is doing?
20:18It's because it's the first in the synaptic regenerative area.
20:23And so we're hoping, first of all, we catalyze more people to try to not only, like this is one thing, most drugs right now are just slow progression.
20:30We're pushing the envelope.
20:32We're trying to actually stabilize and improve.
20:35You know, my goal is for some people with ALS to make it a chronic disease.
20:39I mean, I know it sounds crazy out there, but, you know, I have no regrets.
20:43Let's just try it.
20:44Let's do what we can to understand it.
20:46And why is that?
20:47ALS is extremely heterogeneous as well.
20:49You have so many different subtypes, right?
20:52And so I would say the biggest misconception is that, you know, using the word cure as freely because, again, it's going to take, you know, I would say cocktail therapy.
21:01And we need to be able to use these things in combination.
21:05So spring 2025, we establish you have a few clinical trials, a few FDA orphan fast track designations.
21:12If we were to speak one year from now, spring 2026, what would you hope to be able to report to the Forbes audience?
21:20Oh, well, I hope that, oh, God.
21:23Well, first of all, the dream is right now that we are actually treating patients.
21:26And by then, hopefully, we'll have advanced and into speaking to the regulatory authorities and being able to actually treat more people in the clinical trials and just moving one step forward.
21:39Stella Saraf, SpinoGenX founder, thank you so much for joining us at NASDAQ Market Sight.
21:44We really appreciate your time and your insight.
21:46Thank you so much for having me.