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 |
|---|
| The new data show that the RYONCIL product, optimized and improved RYONCIL product made with the current manufacturing process that has undergone successful inspection by the FDA demonstrates greater potency than the earlier generation products |
| The new data show the RYONCIL product made with the current manufacturing process, which has undergone successful inspection by the FDA, demonstrates greater potency than the earlier generation products and provides, providing context to its greater impact that we've observed on survival |
| We think the long-term survival outcomes with remestemcel from a pivotal Phase 3 trial is unparalleled with other therapies that are available today |
| And it improved the ability of the surgeon to perform a definitive procedure that allows the heart to pump more effectively blood around the entire circulatory system |
| And we've had a very strong track record of managing our intellectual property in terms of out-licensing working with partners with collaborators and protecting out our territories when that's required |
| Revascor has also shown the potential to improve major outcomes in high-risk patients with the most severe end-stage disease, whether it's excessive inflammation and the presence of left ventricular assist devices |
| And we've got substantial innovations that are under our own patents to meet the future increasing capacity requirements, improvement in yields, reductions in cost of goods |
| We had a very encouraging meeting with the FDA regarding the regulatory path to approval |
| And I'm pleased to say that we've achieved all of the deliverables during the first quarter of this year and we have a number of planned activities for the rest of the next quarter and the rest of the year |
| And these mechanisms are now well-characterized and underpin the clinical data that we've published we've generated, and which I can tell you more about in coming slides |
| We are also pleased to report the 21% reduction in our loss after tax of $32.5 million |
| And the results were very encouraging and were published by the investigators in December in the Journal of Cardiothoracic Surgery |
| And under the RMAT we had a very encouraging meeting with the FDA during this month that I will update you on further in this presentation |
| With respect to the cardiovascular program, we achieved a very encouraging meeting with the FDA under our comments regarding the potential pathway to approval in adults based on our LVAD and DREAM heart failure trials and we further plan to meet with the FDA in next quarter regarding congenital heart disease program following the results of the randomized controlled trials that have been published |
| And as you can see in particular with respect to remestemcel for adults and pediatrics, GVHD we achieved the expected delivery of additional potency assay data, which was provided to the FDA |
| Silviu Itescu We hope that we've given a good update on our operational activities which have been substantial at least over the past quarter |
| I think last time I spoke with you what the pricing was but frankly better than I had anticipated |
| We met with the FDA very recently and had a very encouraging meeting under our existing RMAT designation to discuss the potential pathway to approval for patients with this devastating complication |
| This is another very large unmet opportunity, unmet need |
| And I think when you and some of the gene therapies that I'm providing that kind of curative outcomes charge some pretty remarkable prices |
| We discussed with FDA the mechanism of action by which Revascor is able to improve the major outcomes including mortality across the continuum of heart failure and inflammation |
| As noted in this publication, there appears to be an increase in the proportion of children following treatment with Revascor who have an enhancement in the growth of the left ventricle, at least by size, and are able to better tolerate so-called recruitment surgery |
| Long-term survival data shows durability of survival benefit for more than four years |
| Mesenchymal Stromal Cell, which is our second-generation monoclonal antibody based selected culture expanded stromal cell has generated substantial body of clinical data in two major indications associated with inflammation, heart failure with reduced ejection fraction and chronic inflammatory low back pain |
| The results showed that -- if we can go to slide 30, that a single injection into the left ventricle of these children at the time of surgical anatomy restructuring improved over 12 months the size of the left ventricle |
| And I think we're very comfortable that we're going to maintain that kind of quarterly burn perhaps even tighten our belts further beyond that |
| We have a substantial amount of promising initial data, including data from over 500 patients in the DREAM heart failure Phase 3 trial, which demonstrated early strengthening in the left ventricle by measurement of left ventricular ejection fraction |
| We have robust quality assurance processes in place to ensure the final product meets batch-to-batch consistency and reproducibility |
| And for that indication we've received a rare pediatric disease designation as well as an orphan drug designation by the FDA |
| We are the leaders in intellectual property for mesenchymal stromal cell sector |
| Statement |
|---|
| During the period, we also delivered on our planned cost containment strategies, which reduced our cash burn for operating activities |
| For these patients, mortality is dismal |
| In the three-month period ended December 2023, our cash burn for operating activities was $12.3 million, which is a 25% reduction on the comparative three-month period in FY 2023 |
| In the six-month period ended December 2023, the cash burn was reduced but 14% on the comparative six-month period in FY 2022 |
| Congested heart failure remains a major cause of mortality in the Western world with 50% patients dead at five years after diagnosis |
| Our revenue of $3.4 million is predominantly from royalties on sales of TEMCELL in Japan and our manufacturing expenditure reduced by $6 million or 47% for the six months ended December 2023 |
| With respect to the burn rate and I think runway, we've indicated that in the last quarter, our financial spend and our burn was reduced 25% relative to the comparative period |
| The FDA has inspected our manufacturing process and at the Lonza facility in Singapore and finally that process was acceptable |
| Steroid refractory acute graft versus host disease is a devastating complication of a bone marrow transplant |
Please consider a small donation if you think this website provides you with relevant information