Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
Please consider a small donation if you think this website provides you with relevant information
| Statement |
|---|
| So we believe this drug, 5 milligrams daily, is effective to achieve what we want in the retina with these very mild and well-tolerated AEs |
| We have some baseline demographic data from those subjects that shows actually very favorable balance in terms of the prognostic factors that would be predictive of disease |
| It's also important to note that in our treatment overall, this has been very well-tolerated |
| Financially, cash-wise, we're doing pretty well |
| When you have that and you're reducing the treatment burden so significantly with an oral once a day, I think patients will flock to this oral once a day treatment because it's going to be superior in terms of benefit to the patient, in terms of reducing treatment burden and reducing any potential risk to their ocular health and safety |
| We also just recently completed our Phase II study in Stargardt disease and presented very promising and positive results at AAO last week |
| That's exactly what we are going for because it gives us an opportunity to interrogate this whole early intervention differentiator, which is what we believe our drug will be able to do |
| This is phenomenal, in fact, it's never been reported before |
| We've also just recently presented positive 24-month treatment results from our Phase II, which Nathan will be presenting the results later on |
| So I think everything is turning out very well in terms of the baseline value, in terms of the baseline demographics for this Phase III Stargardt study |
| With an oral therapeutic that achieves the same level of efficacy that is a 20% slowing of lesion growth with a very clean systemic safety profile and no potential for adverse ocular ease that would be permanent, such as the occlusive retinobasculitis that's been documented in rare cases with the Apellis drug |
| And you can see here that there's a very nice correlation between the increase of Tinlarebant in blood and the decrease of retinal binding protein 4 in blood until we withdraw the drug at month 24, and you see a very rapid reversibility over about 28 days of drug cessation |
| So far, we have been granted fast-track designation, rare pediatric disease designation, and orphan drug designation |
| So we see there another potential market opportunity for us because they cannot use their drug effectively in our subjects |
| We believe that early intervention directed at emerging retinal pathology, which is not mediated by inflammation, will be the best approach to potentially slow disease progression in Stargardt’s disease and Geographic Atrophy |
| Yi Chen Thank you very much |
| Jennifer Kim Thanks |
| Nathan Mata Thank you |
| Nathan Mata Thank you |
| Basma Radwan Thank you so much |
| Thank you |
| Thank you |
| Thank you |
| Thank you |
| So it's very overwhelming and surprising that even the drugs approved for GA, most ophthalmologists still wouldn't prescribe it |
| That's why the Q2 expenses was much lower than what we expected because he didn't have the milestone |
| Statement |
|---|
| The second observation being once those incident lesions are formed, we have a slowing of the growth rate of those lesions compared to natural history |
| These kids will be losing vision over two years |
| That is, our lesion growth being about 50% lower than what was published in the ProgStar studies |
| I mean, so if we look at the approved drugs for GA right now, you're not getting anything better than about a 20% treatment effect on slowing lesion growth, and you're not getting much of a visual acuity benefit, and you have a significant safety risk |
| Under our treatment regimen, that chromophore will only be slowly supplied to the cone photoreceptors, so there will be a delay in their timing to attain maximum bright light sensitivity |
| So until you get outside of 10 letters, there really is nothing clinically significant to say about the data, but it's important to note that there is stabilization while we are, in fact, slowing lesion growth, as I've showed you in the previous slide |
| They will not, those drugs would not be effective in early-stage disease, which is one of our differentiators, because there's no inflammation in early-stage GA or early-stage Stargardt |
| That's why we had to delay the milestone for being fully enrolled from Q2 to Q3 |
| I mean, have $2 million lower given we don't have those milestone for the DRAGON to continue in the following quarters |
| So it's important to note that this phenomenon, what we're seeing, the slowing of lesion growth, is statistically significant at every time point that we've measured |
| So the finding that they're not converting from the early autofluorescent lesion type to the atrophic lesion type is actually very profound |
| This is significant because although this study was not powered for treatment efficacy against vision, it is important to see stabilization over 24 months because these subjects will, in fact, lose vision annually over time |
| On net loss, we had a net loss of $10.9 million compared to $2.4 million for the same period last year |
| But moving forward, it probably will go down to less than $2 million |
| That's necessary in order to meet the requirement for the endpoint, which is slowing the growth of atrophic lesions |
| So the fact that we're slowing lesion growth and also stabilizing vision is a very important finding |
| It's important to note that these subjects are reporting as mild, and of course it's transient |
| So it's not that significant |
| So we don't really expect this high expenses moving forward |
Please consider a small donation if you think this website provides you with relevant information