STARTUP BATTLEFIELD 2023: Narval

Okay next up From Guadalajara Mexico we have narval Presenting for narval is Dr Jose Luis Nuno and Alejandra Nano give him Round Of Applause and bring them on out Hi I'm Jose Luis Nuno CEO and founder of Narwal I am not a morning person but After my first coffee I am ready to Solve the seasons and change the world 600 million live with diabetes 37 Percent will develop diabetic Retinopathy an eye condition that causes Vision loss and blindness The available treatment is a two Thousand dollar Mountain injection of an Antibody drug in the eye This is complex risky for the patient And expensive but cannot be done Otherwise with a therapeutic Alternatives on the market No matter if you suffer from a Respiratory disease cancer or a Digestive disorder chances are that you Are going to be treated with an antibody Drug that costs thousands per dollars And can only be deliberate by injection Antibody drugs are a 200 billion dollar Market and fundamental to three diseases But these are not easy to use or Affordable Antibody drugs are made with monoclonal Antibodies which have significant Challenges like their incapability to Cross through most tissue barriers on

The body lack of stability out of cold Chain and high manufacturing costs these Limits their use into a very narrow set Of applications making impossible the Development of new antibody drugs for Hundreds of diseases that affect most of The global population We are solving this problem The sinusynthetic antibody mimetic Proteins to replace monoclonal Antibodies a novel first-in-class Therapeutics our goal is to create Antibody drugs that until now have been Impossible to develop Our synthetic antibody mimetic protein Platform or amp for short use a cdr3 Regions from single domain shark Antibodies fused to a synthetic Monoprotein scaffold from a sea snail or Amp platform uses molecular and Artificial intelligence processes Eliminating the use of molecular I'm Sorry of uh in Vivo Transgenic and cellular models our amps Are 40 times smaller than a monoclonal Antibody but with the same biological Functions where amps can cross through Tissue barriers generate limited immune Reactions even with no humanization can Target very small and heart reach Antigens and are heat resistant Disadvantages gives our amp platform the Ability to develop Antibody drugs that have been impossible

To develop like antibody drugs in Aerosol in eye drops viral delivery or Transthermal release our mission is to Make antibody drugs as affordable Accessible and easy to use as common Pharmaceutical drugs now let's move to The overhead camera please we are going To show you what our amps are capable of Alejandro will show the effect of an amp Over a respiratory virus on a long cell Culture this experiment takes several Hours so today we are going to see only The outcome now move to the demo please The microscope thank you Here we can see healthy lung cells which Are representative of someone with no Respiratory infection To these healthy lung cells we added a Sample of the respiratory virus the Virus infected the cells for replication Destroying the cell structure on their Way out after a few hours of incubation On a second sample we added the virus in Our amp the antiviral amp neutralizes The virus blocking its ability to infect The cells and to replicate protecting The cells and therefore the patient Lungs from the viral attack now back to The presentation please With a sign or amps from validated Targets focusing on correctivities on Development validation and preclinical Testing of our amps then we out license Our amps to pharmaceutical companies

Generating revenue from upfront payments Clinical phase and approval milestones And then royalties over sales of the Marketed products Our goal Our orbition is to create the largest Portfolio of antibody drugs for unsure Therapeutic needs our first amp Candidate amp1 for diabetic retinopathy Is going into clinical phase next year And we plan to license it on early 25. Or AMP one on in Vivo testing showing Proven capabilities for eye tissue Penetration and therapeutic activity on The back of the eye including Antibascularization and a decrease of Endothelial cell count of the macula This means that you will be able to take Your treatment in simple eye drops at Home no need for an eye injection also We are working on our first leaves for Respiratory diseases or amp4 shown full Neutralization capability of the Covid-19 virus on Long cell culture at Nanomolar level this is similar to FDA Approved coping 19 antibody drugs on the Market For me in Alejandro this is our third Step working together for almost 17 Years in biotech first we launch a Pharmaceutical product for Animal Health In 14 countries in partnership with a Global big Pharma then we'll launch a New diagnostic technology using Shark

Antibodies microfluidics and artificial Intelligence now at narbal we are Joining with our academic co-founder Dr Alex elisea a world-renowned scientist With deep experience on Marine protein Engineering and also a former founder Today we are launching narbal come and Join us bringing down the limits on Healthcare we are nurbal and we are the Future of antibody drugs today Wow give him a round of applause I think that's the first time we've ever Looked at cells on this stage before Live so thank you for that okay who Wants to go first all right I I know the Anti-vegef market I know that the Antibodies work a lot of them are coming Off patent and you all have to inject Them uh the data on how it passes to the Back of the eye to the retina uh it went By pretty fast on the slides so I want To understand that more but my key Question is can you tell us about Who can manufacture shark antibodies Today and what do you need to do in a System to be able to manufacture your Drug so how do you making your drug even For the clinical procedures are going to Start next year can you guys take one Step closer to me yeah get in the light There thank you thank you so uh Something really important is this is Not the full shark antibody so what we Do is we select the shark antibody from

My library and then we just isolate the Cdr3 and fuse it to the scaffold so it's Just part of a shark antibody so this Amps are completely synthetic so they Are manufactured by synthesis like a Peptide ah so we are not using bacterial Cells you know or not show cells or Anything like that okay yeah can you Speak a little more to the ability to Get to the back of the eye there By just an eye dropper treatment You want to do it no okay so Um can you repeat the question please Yeah so the idea is we don't inject to The back of the eye right we put it in The eye and it travels to the back of The eye can you and then you wants to Have a therapeutic window once there can You talk a little bit more there about What that looks like okay so what we Have shown already on uh testing on Animals around the third hour after uh The application of the eye drop with the Anti-bgf amp which see already the amp Inside the eye so we measure that so for Example 10 milligrams of the solution on The eye we can measure this up to like 24 hours after the application so what Happens is travel through the tissues And then it gets to the back of the eye And then it decreases the Vascularization for example in this case On the area and also the decrease on Endothelial cell count so this helps to

Maintain uh well the same is doing the Same thing that the monocular antibody But the application way is different Mark can you can you talk a little bit How insurers and carriers will play into Your commercialization model going Forward Oh sorry Can you speak a little bit to from a Commercialization perspective how do you How do you need kind of insurers and Carriers to to play into this going Forward versus you know how much is out Of pocket from the consumer versus Covered by insurance and how do you Imagine that mix to kind of grow or stay Stagnant going forward okay in this case Well our business model is to work with The former company the Pharma company is The one commercial doing the Commercialization of the molecule so but It will work the same way as any other Monoclonal so it's the same process it's The same commercialization strategy Etc The thing that we are substituting the Use of a monogram which is injected with An amp that goes into eye drops but the Model is the same one Yep I I think I might have missed it but Can you speak to some of the efficacy Data that you have I'm sure you've done Some uh testing on this as well Um if you could share some of that and Then what the response has been from

Pharmaceutical companies uh to that data And into your designs especially on the AI aspect of uh you know what you're Doing to to calculate all of these Outcomes Okay so let's start with the clinical Data the most important part of the Clinical testing that we did was on Animals so we already have testing on The migration of the amp inside the eye And the vascular antivascularization Processes in the therapeutic processes So what happened is we see the amp three Hours of the application already inside Of the eye and we see a decrease of Um it was like 40 percent of the Notarial silicone inside of the eye like Around the third day after application 40 after the third day after application But the the uh the action started within A zero to three hours and you saw that Immediately no we didn't measure any Also we didn't measure after the three Hours had happened so no we we were Mentioning like every single day so Every 40 24 hours so we don't have data For the first like three hours or Minutes or so and in terms of what the Interest from a pharmaceutical company We have been already meeting with Pharmaceutical companies we're already Closing our first contract with the Pharmaceutical company for a disease That we cannot disclose right now but

There's already a Consulting process What is that contract for is it for your Technology or is it for your for your Actual no no what what we sell or what We license is the molecule okay already Tested the ballot Etc so we transfer the Molecule a really pre-i pre-ind so ready To go into phase one first in humans Yep so we're already closing the first Contract and there's already a like Other four pharmaceutical companies Ready to sign Sarah Libby I was going to go in a different Direction and just ask uh you guys have Founded something together before Curious kind of lessons learned about Yourselves Um as complementary co-founders or about Go to market or whatever Lessons Learned From that experience that you're Bringing into this Venture yeah yeah 30 Seconds okay All the the adversity that we have found Has taught us more than we have learned From other from school or for so that's Something I have learned it's something Important for us is the importance about The network that you're building right Now we have a very big Network in the Pharma industry Center because it's a Regular sort of startup so we find That's very important the team that you Are building with you in or the

Relationship that we have already with Former companies and research centers Etc Thank you very much give a round of Applause Okay