Earnings Sentiment

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.

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Sentiment Distribution

   

Earnings Call Transcript Word Cloud

     

Bullish Statements during Earnings call

Statement
And so that's what is very encouraging at least from our perspective of supplying these patients
And the fact that VYJUVEK has already now gotten approved and patients are beginning to get identified is actually an excellent news for us because this is, like we mentioned earlier, is helping raise the awareness, identify these patients, and that's going to be a good cursor for us
The durability of both investigator-assessed [hemin] and patient-reported pain following a single administration of serving toughest RDEB wounds paints a very compelling and unique value proposition for EB-101 for patients
And as we all know, the EB-101 clinical profile is extremely compelling, given the onetime procedural nature and the long-term durability
And given that we have another several more months to go before EB-101 gets launched, I think it's a good setup and we are encouraged to hearing what this feedback are going to be from patients as they continue to get these therapies and better understand ensuring that they understand the value proposition of EB-101, which is a onetime therapy that can offer several years of durable benefit for their larger set wounds
about onboarding EB-101 as a treatment option, and we're encouraged by the level of interest
Physicians indicate there is a high unmet need in debt and particularly for a treatment like EB-101 that has a compelling value proposition
So I think this is all very encouraging for us
Furthermore, EB-101 demonstrated improvement in patient-reported and caregiver reported outcomes for itch and blistering severity
And we believe we're in a good position to establish that comparability based on the results that we've generated
And we're fairly confident we're making -- we're on the right track
We're excited by the broad potential for treating serious eye diseases with new AAV-based therapies using novel AAV capsids from our in-licensed AIM capsid library and internal research
So we feel fairly confident that things are coming together for a Q3 submission here
Debra and PeDRA in particular, have been fantastic partners
Having done that recently, we know really a strong network of people and the talent that are there and just eager to get them on board
We are happy to update you on our continued progress, in particular with our lead program, EB-101, our investigational autologous engineered cell therapy had to deliver years of sustained clinical benefit in patients with recessive dystrophic epidermolysis bullosa, or RDEB, in short
So based on the results that we have seen, we're fairly confident that the comparability of RVV from the two vector sources is adequately supportive
As you rightly mentioned, patient advocacy groups are really powerful in this setting, and they've been doing a lot of reports
Securing this NTAP is going to be extremely helpful because it provides additional payments to hospitals for Medicare-covered patients
But in terms of interest and demand, we are already seeing that happening, right? So we're excited by that
The positive feedback we hear from KOLs is consistent with what you've heard from payers, hospital administrators and patient advocacy groups
But besides providers, Maury, we're also engaging with the payer groups, as you may recall, the initial engagement we've had with Insurance companies was very helpful for us, and we want to continue this engagement as we go towards the launch so that we are fully equipped to ensure a broad market access and a rapid market access immediately post approval in the U.S
opportunity and address that unmet need first
We know that these patients travel, they travel distances to come to get their treatments done and our approach in the outer years or in outer months post launch will be to take advantage of the sales team in the non-sort of centers of excellence and raising awareness with the community-based physicians and making sure that patients understand where these treatments are available
And as we go closer to launch, we expect greater awareness, especially in these centers of excellence
Madhav Vasanthavada I think it's for sure, encouraging
The results presented at ISID and SPD showed that EB-101 improved wound healing and pain reduction at six, 12 and 24 weeks compared to control wounds following a onetime application of EB-101
We have made significant progress during the last quarter towards planned EB-101 BLA submission
So for sure, more to come, but it's a great starting point, tighten patient community and some amount of awareness that will already have been generated
So when we manufacture for a patient, we run a batch fly it to Florida or distant parts of the country and bring it back and after various standpoints, we look for stability of the drug product, and we're happy with what we're seeing that's all being written up as part of the BLA package in Module 3
       

Bearish Statements during earnings call

Statement
And many a times, these patients under ICD code 81.2 is what is used for RDEB, but several patients are also misdiagnosed or put in other classifications
Remember that all our clinical data pertain to treatment of large chronic booms, which are the hardest to treat and have remained open for years because they cannot sell to you and inflict the great [Indiscernible] burden to these patients
Net loss attributable to common shareholders was $16.7 million for the second quarter of 2023 or $0.92 loss per common share as compared to a net loss attributable to common shareholders of $7.9 million or $1.36 loss per common share in the second quarter of 2022
Various factors that could cause actual results to differ include, but are not limited to, those identified under the Risk Factors section in our Form 10-K and periodic reports filed with the SEC
   

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