Bob Katz Presents ForwardVue Pharma, Inc. at LSI USA '24

Bob Katz  0:04  
Thank you very much. I'm Bob Katz, the CEO of ForwardVue Pharma. It's a pleasure to be here this afternoon to introduce you to Ford view, and the compelling drug device combination product that we're developing for the treatment of chronic retinal disease. Our mission is to develop and deliver a simple, more potent and safe treatment solution for retinal disease. And we're developing a bio resorbable implant that will deliver a unique small molecule compound to accomplish those goals. New vascular retinal disease or macular degeneration, as it's commonly referred to, is the leading cause of blindness and vision loss on a worldwide basis. It is characterized by the pathologic growth of blood vessels in the retinal epithelium, which causes vessel damage, leakage, and ultimately the degeneration of the macular segment of the retina. The current standard of care is the injection into the back of your eye of a drug compound known as a growth factor antagonist or an anti VEGF. Now, the problem with these anti VEGF compounds is they don't really have the potency that we'd like to see. And therefore patients are subject to a treatment regimen that requires anywhere from six to eight to 12 injections per treated i per year. It's a significant treatment burden for patients and for clinicians who deliver them. And the outcomes associated with these, with this treatment program, basically, is certainly less than optimal. And patients struggle to maintain their vision much less see significant improvements. And So therein lies the unmet needs, right, way too many eye injections and far too few good outcomes at the end of the day. Now, we also know from more recent research that these anti VEGF not only lack potency, but they also lack durability, and neuroprotective properties, which means their treatment effect tends to trail off over time anywhere between the 12th and the 24th month after the treatment begins. Now for all those shortcomings of the current standard of care, the market for retinal disease treatment is expected to grow to over $25 billion dollars in the next four to five years. Currently, over 800,000 patients are being treated for macular degeneration, requiring over 4 million anti VEGF injections to be delivered by a small but hearty class of about 2500 retinal specialists who do these procedures. And you can do the math and realize that there's not enough bandwidth in the healthcare system to really support the kind of growth that people would like to see. So what's our solution? Well, our solution starts with a small molecule compound called carboxy, Amazo trizol, or CI, ci was actually developed by Merck in the 1980s. And subsequent research has shown that this particular compound not only has very potent anti angiogenic effects, but it also has anti inflammatory properties, and neuroprotective properties as well. And when you put those three elements together, you have the potential for a much more significant treatment option for chronic retinal disease. See, AI works very differently than the standard anti veg F compounds. It would be a lot to get into today. But basically see AI is a true multi target mechanism of action, meaning it affects a number of different aspects of the pathogenic pathway, as opposed to just the standard anti VEGF, which attacks only a single receptor site along the pathogenic process. So that gives us a multiplier effect in terms of potency. So how well does this work in retinal disease? So in our preclinical animal studies, in validated models of animals that produce retinopathy, we've been able to demonstrate both prevention and regression of established retinopathy in these animal models. In fact, we've been able to demonstrate over 90% inhibition in these models in terms of abnormal vessel growth. And that compares favorably to standard anti VEGF treatments, which in the same models only generally achieve about 50% inhibition. So we're seeing roughly a 2x improvement in potency with this particular compound. We've also in other studies demonstrated this compound does in fact, provide neuroprotective effects for the retina and this is important for down the line in terms of addressing the ongoing degenerative process in the retina itself. So how do we create a solution that's practical for the clinic for both patients and for clinicians? We're taking this compounds the AI and we've complex it with certain PLGA polymers to create a bio resorbable implant that can be delivered to the back of the eye, and delivers a constant bio effective dose of Caapi, over as long as four to six months. So a six month implant is basically two injections per year versus 12 injections per year. And it's a much more potent compound at the same time. Now, we've been able to create these bio resorbable implants in a form factor such that it fits through a standard intravitreal injection needle, it requires no special equipment, it requires no special training. And we're using materials in the PLGA Family Class of polymers that FDA has previously approved for use in the eye in other indications, so our risk is relatively reduced there as well from the materials point of view. We subsequently have taken our bio resorbable implants and we've done even more preclinical animal work this time in a validated model of retinopathy in a slightly larger eye. And we have in fact demonstrated that CCI compared head to head with the standard of care, anti VEGF treatments, again provides a significant improvement in terms of the ability to reduce vascular permeability in these induced eyes. And in fact, again, we've seen a roughly 2x improvement in the reduction in permeability by using the caaci implant, whereas it initially looks kind of similar between the orange which is the anti VEGF treatment, and the grey which is the CI implant at 30 days. By 60 days, the anti VEGF orange bar is starting to actually lose its effectiveness. But we are actually continuing to drive down the permeability issue using our particular implant. We went further and took a look what and what we call fundus imaging, which is a high resolution camera to the back of the eye. And what we can see is if you look on the far right, the F EPO two, which is the CDI implant is showing near normal vasculature as opposed to what you would otherwise see in an untreated eye, which is here on my left, and the anti veg F treated i which is the one in the middle, which shows a relatively mild reduction. So again, qualitative assessment showing that the quantitative measure of reducing permeability is real. And you can see it, and you can see it under microscopy when we go ahead and look at the overall retinal histology as well. And the retinal structure in the car implant looks exactly like the contralateral control eye, which has been neither induced nor treated to that point. So we're very happy with the results to this point. And we've demonstrated that we can in fact create this bio resorbable implant in a form factor that's simple to deliver to the back of the eye, we have improved potency, which we've demonstrated in multiple preclinical animal models at this point. And we've seen no safety signals across any of these studies. From an IP point of view, forward view has two patents issued. We have multiple applications pending. From a status perspective. We have the bioresorbable implant, we have our data from a preclinical testing. We recently had a pre ind meeting with FDA and got consensus with them on what we needed to provide in terms of the IND enabling program and the testing required so we could move to move to human studies, which is our next phase. We've gotten a lot accomplished on a million and a half and seed round. And we're currently seeking a $10 million series A equity round, which would support the completion of the IND enabling studies and then moving on to the first in human phase one phase two clinical trial in a significantly reduced program because of all the work we've previously done. And then for $10 million, yielding valuable human clinical data, a significant value inflection point, and multiple paths forward. Forward view was founded by Dr. Alan Franklin, who is an internationally recognized retinal surgeon backed by a board of directors with significant deep experience in the ophthalmology space and a elite clinical advisory board made up of KOLs from the retinol space from across the country. So in summary, forward view brings to the table a highly differentiated solution. We are developing a bio resorbable implant that delivers a highly unique and differentiated small molecule compound that's significantly more potent. We are directly addressing the significant unmet needs in this space, and for $10 million for our Series A round will get human clinical data and significant value You in flexion as a consequence of that thank you very much for your time