[Music] thank you welcome to CEO insights I'm Marilyn De Guzman with investing News Network Our Guest today is Philip young chairman and CEO of lobe Sciences who's providing some important insights from his company's recent acquisition of altemia Welcome Phil thank you I appreciate the opportunity to speak with you today yes we're glad to have you before we get to the meat of our discussion today why don't you tell our viewers who are may not be familiar with globe scientists


about your company sure I appreciate the opportunity lope Sciences is a commercial stage drug development company and specifically we have pivoted our focus and we're only looking at developing therapies for Orphan and rare diseases so our first two diseases that we've selected to identify treatments for and we have identifying things first treatments uh one of them is chronic cluster headaches which is a devastating headache that about 150 000 people in the United States get annually these headaches are


the most debilitating pain patients can ever say that they've experienced far far more painful than gun shop rooms and childbirth and these patients continually have headaches four to eight a day and these and these clusters can last for months or years and it's very very problematic and there's really no good therapeutic options in these patients today we believe l-130 is the ideal component the ideal drug to help these patients break the cycle of the cluster headaches and also eliminate the cluster headaches


and totality so we're excited about that we'll begin our first study up in New York City uh and about the next six to eight weeks uh where we'll be evaluating the safety of l-130 but in addition we'll start to generate some efficacy endpoints l131 our second silicon derived compounds and all of our compounds are proprietary to our company and patented and uh l131 is being developed for a confidential pediatric orphan drug indication uh We've kept it confidential for now because it it is


such an exciting space and we want to make sure that we get the orphan drug designation for the FDA before we announce what the indication is but once again 131 is a proprietary compound and very very exciting to get this going we'll be starting a pre-clinical model that we have to do for the FDA to demonstrate efficacy for the Pediatric indication and we should have that data ready to go for this summer and that's another exciting opportunity and then the big news yesterday was acquire altemia and


company that really sets us apart now makes us Revenue generating company and makes us so that we can go out generate significant Revenue use that to find our research and development it's a great opportunity for the shareholders uh the people who are receiving the shares aren't going to be selling with shares so the 76 million shares the company allocated to his acquisition are going to be placed with an Insider who has no desirous and that protects all shareholders right now but also helps prepare the ways and


future of developing altemia which I'm sure we'll talk about more right so we will talk about that acquisition a little bit later but I just want to ask you for those who may not be familiar with the terminology could you just provide sort of an overview of what an orphan disease is sure that's a that's a good point on Orphan drugs are a result of an act of Congress back in the 80s and and what was identified was that the small markets and to be qualified as an orphan drug there has to be fewer


than 225 000 patients in the United States and so these these indications or these these uh illnesses were being left behind by big Pharma there's no incentive to spend the money to develop a drug for so few patients big Pharma like big patient audiences millions and millions of patients and this isn't that so the the Congress developed the orphan drug designation the orphan Drug Act so that companies who develop drugs for these get special Market exclusivity extensions and they also went into


pediatric orphan drug indication have it opportunity to apply for a pediatric priority review voucher those vouchers are extremely valuable each voucher generally sells for a hundred million dollars give or take uh just recently blooper bio sold two priority review vouchers to another big Farmer for a couple hundred million so we now have the opportunity to get two priority review vouchers one for the Pediatric indication that was kept confidential so l-131 but also for San 100 which it is a very small capsule


formulation of altemia for Pediatric patients specifically so it's an exciting opportunity for us to go after patients that are also neglected by big Pharma and gives us the opportunity to take advantage of an opening where we think we can provide Superior Therapeutics so let's talk about the Ultima acquisition and what what it means for the company what was the value proposition for altemia that led to this acquisition sure um I'm happy too and I'm excited to um I'll back up a little bit the Genesis


of the altemia product line beginning with the altemia medical suit and San 100 started 20 years ago when Dr Fred sancillio started investigating sickle cell disease uh he he's an accomplished chemist and a drug developer as well as entrepreneur and and he spent time understanding the Dynamics of the circulatory blood system and sickle cell patients and specifically it's called Sickle Cell because patients red blood cells become misshapen in the shape of a sickle eventually they get very sticky


and they clog with arteries or small blood vessels really and it causes excruciating pain in the patients patients need to be on opioids and they need to be admitted to hospitals quite often Dr sancillio identified a specific uh compound that when given to animal models improve the animal's outcome tremendously so fast forward to a couple years ago he was developing altemia as a medical suit and a medical food is unique in the FDA regulatory process a medical food which was provided for and the orphan


Drug Act from the 1980s specifically for sickle cell uh it says that this is a this is a compound that must be used under the supervision of a physician a physician must prescribe it and the patients have to be monitored and managed by The Physician but it doesn't take the same path as a prescription drug because it's identified as a supple and our our base component of our compound is called DHA which is a a form of an omega-3 which everyone's familiar with the fish oils you can take fish oil


capsules and get small small levels of DHA but what Dr sancillio was able to do was to do a proprietary Emulsion formulation where we have very very high concentrations of DHA and very low concentrations of other uh fatty fishing wheels so it gives the patients the opportunity to take one package and it's it's based on a package of say ketchup from a fast food place you squeeze it into food or squeeze it into your mouth and that's it that package represents up to 10 capsules from the original


formulation that was developed without the emulsification so now we have this and we have the opportunity to bring it into patients immediately excuse me so through the acquisition we've acquired all the IP which is the formulation work and patent on using it for sickle cell which is important but we also brought into the company pretty sufficient amounts of inventory which we'll be able to uttize here in the next few months and that's very very good for us for the patients we'll be bringing in Physicians


prescribing for the patients we'll be bringing a new product opportunity that has demonstrated in the data shows very clearly that it can reduce vasocusive events which are the painful events that happens when their small vessels get blocked we also believe it will reduce opioid use we also believe it will reduce hospitalization that's what the doctors look for sickle cell is devastating even with the treatments that are available today patients generally have much shorter life expectancy by 20 to 30 years and we


believe that if we can help maintain their healthy Red Bullet cells maintain the circulatory Integrity of all of their vessels that we will reduce pain will will reduce hospitalizations excuse me and maybe one day in the future actually have the opportunity to extend the life of sickle cell patients and interestingly enough in the United States there's about a hundred thousand of them and that number is increasing a lot with the increased immigration yeah I understand there's no uh currently there's no cure for sickle


cell anemia and you know treatments can just relieve pain and help prevent complications I guess so um what's the next steps for you after this acquisition so is this um you know sort of the are you going into sort of the regulatory process to get um to get that process of getting this product into Market um we'll be doing two things one altemia the medical food we are putting the plans in place right now we've identified uh potential partners for distribution which is very important in


this Marketplace um and we have the right because we've done the uh production of the product and we've done the initial clinical research demonstrating that it's um better at reducing a biomarker of inflammation which is a core component or Sickle Cell so we have the data necessary and the product necessary to begin selling it into the marketplace that's for the altemia medical food and that that's important because we're able to concentrate are they very uh small Market it's it's


amazing to think that a hundred thousand patients uh the vast majority are managed in 55 centers across the United States very easy to Target very easy to message and very easy to partner with Physicians and their treatment staff to help the patients routine clinics have six to eight hundred patient visits a week it's a massively busy process and we really believe we can have a Major Impact so come this summer we'll be generating revenue from selling altibia a big step for a company that was just a


drug Discovery and development company when now commercially supporting ourselves that's a big deal and then we'll begin working on the follow-on product San 100 and San 100 as I mentioned earlier is a very tiny capsule that we will be developing for Pediatric or some drug patients the one thing we found when studies were done years ago is that kids taking a lot of capsules and they have to take a lot of medicine once they start to feel better and the adults they stop taking them it's just a


hassle and it's a pain and so Dr sancillio was able to identify and create a much better product presentation so that you can get the impact of 10 capsules in a ton capsule this is great for kids uh it's also an orphan indication we will apply for and also as I mentioned earlier it also qualifies us for the priority of review voucher so we've got a lot of work planned a phase three study would begin next year for that indication and that would take about a year to complete and uh at that point in 20 late 24 early 25


that would be filing to get approval in the United States for the follow-on product but all along the way we'll be selling altemia the medical food a very differentiated product in the marketplace right now right are there plans to um sell Altima so you mentioned the United States um are you bringing that potentially to Canada as well yes 100 I said I'm so Centric in the United States but certainly in North America is what I should be saying uh we definitely will be doing that we have a


partnership with a specialty Pharma company over in Italy they have licensed the rights to sell altemia the medical food in Europe and the Middle East uh very very large markets Europe is about the same size as the United States but it's once again that's increasing in size because of the massive immigration waves that are coming into Europe but the Middle East has millions of sickle cell patients and it's a very uh opportune market for us to attack through our partner he has well and well


he has deep um ties to the Middle East and actually we will be having discussions with some of the Middle Eastern governments in the next six weeks to get altimia the medical food into their medical systems to treat their patients and we get a nice double-digit royalty for many sales in Europe and the Middle East well that's wonderful and congratulations on that acquisition and we're certainly going to be watching for more news to come from your company thank you very much I appreciate the


chance to uh tell a story yeah well thank you for joining us and join us again next time for another engaging conversation on CEO insights [Music] foreign