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| CAP-1002 has a strong safety profile and as a once-a-quarter infusion that has shown to be well tolerated |
| This potential revenue stream will be very supportive of a strong launch and will provide an initial commercial market for this product |
| This positive data, combined with the strong safety profile has led to nearly full participant in Open Label Extension studies |
| All of this taken together puts Capricor in a good position as we prepare for our potential initial commercial product in DMD |
| This important positive outcome triggered our first milestone payment of $10 million from Nippon Shinyaku further strengthening our balance sheet and extending our cash runway |
| Obviously, there's tremendous opportunities for expansion |
| And we -- this -- the most natural expansion, I think we talked about it, it was the Becker dystrophy that we see tremendous increase in value in other bigger companies |
| We also are able to control COGS effectively to drive margins as high as possible on revenue and/or revenue shares |
| This has also allowed us to strengthen our IP portfolio with additional process and method-based patent filings and know-how |
| So we are very confident that payers would find it beneficial to cover both the dystrophinopathy management strategy as well as CAP-1002 for the management of the inflammation and the fibrosis |
| In addition, there were significant improvements in left ventricular end-systolic and left ventricular end-diastolic volume further suggesting structural improvements in the heart |
| They recognize the positive safety and efficacy data |
| The two-year results underscore the potential long-term benefits of CAP-1002 treatment in DMD |
| Would it be your expectation that CAP-1002 would be the first therapy essentially given in this cascade? And would that be in an advantage in case there is some payer pushback? Linda Marban So we've had really positive feedback from payers, not just at Capricor, but also NS Pharma has done significant work in preparing for market launch |
| As we envisioned CAP-1002 as a multiyear treatment, this data set will strengthen both our potential revenue modeling and payer discussions for long-term reimbursement |
| And where we are right now is just so staggeringly exciting to me |
| This strategic financing was anchored by Nippon Shinyaku further cementing our strong relationship and their commitment to Capricor |
| I'm encouraged with the progress we have made at Capricor in 2023 and into 2024 |
| So we can make doses here and ship them to Europe, which is an added benefit |
| And we certainly are poised to expand our efforts |
| This opportunity is very important for Capricor because it supports our exosome-based vaccine and while we don't have intention to become a vaccine focused company, it sets up the program nicely for partnering and other business development opportunities |
| So in terms of the timing of how that's done, that remains to be seen, but we're very confident that it will be part of the overall treatment paradigm of Duchenne |
| Importantly, CAP-1002 treated patients saw improvements in left ventricular ejection fraction, which is the gold standard measure of cardiac function |
| To remind you, and I stated this, we saw a 4% improvement in ejection fraction, the gold standard of cardiac function and HOPE-2 |
| This will be the only multivalent candidate tested as far as we know, and we have high hopes for success in terms of potential safety and efficacy |
| As many of you know, FDA leadership has taken a great interest in helping move the field of treating DMD forward, and we continue to believe that we can work with them on a strategy to move CAP-1002 towards approval |
| Additionally, we are in the early stages of establishing a strong commercial team to support our partners at NS Pharma |
| Should it work in humans as well as in preclinical animal studies, it could be a very important improvement in vaccinology |
| But we're pretty convinced that it's going to be one of the major parts of what we're going to look for on our label, and it's the primary secondary endpoints that has been built in to HOPE-3 both Cohort A and Cohort B |
| CAP-1002 is perfectly positioned to be a partner therapy for DMD as the stated mechanism of action is immunomodulation and reduction in fibrosis |
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