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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| Statement |
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| We would prefer to have PFS since it would be quicker approval, obviously, but as Wally said, the data are becoming very impressive for OS |
| There's a lot to process here but in total, we believe this trial's data bodes well for an ultimate approval in advanced soft tissue sarcoma |
| We got better results |
| That's why we're so excited about the median OS that we're receiving |
| As a reminder, we have orphan drug designation and fast-track status in both indications, and we have a strong patent position for Annamycin and a range of potential indications |
| Again, this is what we were hoping to see in AML and if we continue to see this level of activity, we think we'll be in a very good position to establishing a marketing approval pathway |
| Annamycin does have orphan drug and fast track status in both indications and importantly, strong patent protection through 2040 |
| Annamycin is what we call a next generation anthracycline that's designed to be non-cardiotoxic and appears to be improving outcomes in both AML and STS |
| Look, we're clearly excited about this data, having it for the first time |
| Annamycin finally represents a real improvement in anthracyclines, and we're going to make this tool available to those patients who, until now, have been denied this opportunity |
| I mean, we can't speak to speculating on what the human PFSOS implications of this would be, but we've got very compelling data in a number of indications |
| Despite the fact that there have been more than a dozen new drug approvals in these indications over the last five or so years, the first line therapy for both indications and the best hope for a positive outcome remains with the use of anthracyclines |
| This VEN-AZA combination is capable of generating a complete response in 37% of patients, which is good for that 37% |
| We are very pleased to report that among patients who have completed their Annamycin dosing, we have three complete responses |
| We are really excited to welcome you to this Q3 earnings call |
| And we're expecting several clinical trials to benefit from outside funding this coming year |
| Add a dose that we zeroed in on, and we're getting substantially better data |
| As many of you know, we're doing this with a highly efficient capital structure by exploiting a global network of preeminent collaborators |
| We've been saying for some time now that this would be our year of data, and we are finally able to deliver on the Phase 2 data we've been hoping for |
| So, we realize that the data we're talking about today is not precisely the target that we're setting for a likely approval trial, but everything gets easier for us, we think, as we design this approval trial structure |
| In addition to demonstrating the synergy between Annamycin and Cytarabine that's now playing out in our Phase II AML trial, this ongoing research also eliminated the fact that Annamycin is 30 times better at accumulating in the lungs than doxorubicin, making it an ideal candidate for advanced STS, which is most commonly what is the point of metastasis is to the lungs |
| Considering that the median number of months from diagnosis for patients entering the Phase 2 portion of our trial was 20, the overall survival that we appear to be headed for could be an even stronger basis for a marketing approval |
| We had the pleasure of sharing these data with a group of soft tissue sarcoma key opinion leaders at the recent CTOS, that's Connected Tissue Oncology Society Conference in Dublin, and the enthusiasm was high |
| You should expect more positive updates in the next few quarters because this data is building |
| And it's able to avoid the multidrug resistance mechanisms that limit the efficacy of doxorubicin in many patients |
| We ended the quarter with roughly $25 million in cash on hand, and our balance sheet remained clean with no debt and little overhang with warrants |
| This runway allows us, we believe, to deliver these milestones into 2023, early 2024, and set the table for delivering the milestones later in 2024 |
| As it relates to expanding our pipeline, by the way, we are very effectively utilizing non-dilutive institutional funding for clinical development |
| But there's a strong consensus among clinicians that VEN-AZA is just too hard on patients |
| And our sponsored research has paid some big dividends thus far |
| Statement |
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| As a small example, 65% or more patients treated with doxorubicin will lose their hair |
| If you look at the soft tissue sarcoma, our number one by far adverse event is low blood counts, especially platelets |
| So it's just with an adverse event for one indication for the other, that's efficacy |
| Part of the challenge from a regulatory standpoint was needing to demonstrate the safety and the efficacy of Annamycin as a single agent before combining it with Cytarabine for AML patients |
| When you translate this reality to our lead indications, you see that more than half of all patients diagnosed with AML cannot receive currently prescribed anthracyclines because they're deemed unfit due to age or poor health |
| Unfortunately, today's anthracyclines have major limitations that prevent most patients from sharing in this benefit |
| Those anthracyclines haven't been improved in decades |
| But let's face it, that stuff is highly speculative and it's slow moving |
| And for those of you who are new to the story, frankly, your timing couldn't be better |
| We didn't have a DLT, but we had to delay therapy because of the low platelet counts, because it was hitting the bone marrow |
| Now, when it comes to cardiotoxicity, the data are quite surprising |
| The 330 we're doing for soft tissue sarcoma is actually lower than the 230 we're doing for AML because the 230 is for three straight days, which becomes 690 |
| We have seen liver enzymes fluctuate a little, but they never go up to a clinically significant degree |
| And worse ones |
| Given that we also had to demonstrate that patients could be safely dosed at well above the FDA's maximum allowable anthracycline dose, this also meant we had to work with patients who were receiving third, fourth, fifth line, or worse therapies, which are the most difficult patients to treat and expect any impact |
| It's very difficult for patients to tolerate and its clear there needs to be a better answer |
| That forces us at times to stop |
| So, because we accumulated in the lungs the way we do, we deliberately chose this worst possible selection criteria |
| We have not seen Billy Rubin go up |
| But the absence of cardiotoxicity is meaningless without efficacy |
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