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| Statement |
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| With our more advanced programs, as well as on our regulatory front, we're also making significant strides |
| And there was great promise that by pushing the accelerator in addition to blocking the break of the T-cell more extraordinary things could happen |
| We're showing with a small denominator admittedly but we're showing about 50% response rates, which is really a very, very major improvement for depletion |
| Strong inspiration from value-based care, patient centric-care and integrated care systems, we focus on delivering efficient, personalized and top notch care for everyone who can benefit from it |
| As we recognize our first quarter achievements, we're grateful for the incredible support and momentum we've built with clinical experts and patients |
| And we're very encouraged that it will also translate to improve survival in many and all of the cancers that we've studied so far |
| This is truly an impressive accomplishment considering the patient population involved |
| Our bat/bal combination therapy has shown remarkable potential and improving response rates, which indicate deeper benefits for patients |
| In conclusion, we're very, very excited about the progress that we've made in our clinical programs as demonstrated by the updates that Steven and I shared with you earlier |
| We are enthusiastic about potential [indiscernible] progress and its potential to profoundly impact lives of patients with solid tumors |
| In conclusion, our unwavering commitment to advancing our clinical pipeline and delivering innovative treatment for cancer patients remains stronger than ever |
| The clinical data generated with botensilimab is truly inspiring |
| And we're thrilled with the progress we've made thus far |
| We're also proud to announce the fact that balstilimab combination has generated or has been granted Fast Track Designation by the FDA for treating non-MSI high colorectal patients without active liver metastasis |
| And clearly outside groups that we're working with who would be at least partially or entirely sponsoring the trial are also very encouraged with the data and that's why we're proceeding in this direction |
| So we're very encouraged with this outcome actually |
| Moreover, early clinical data indicates that important responses may be achievable in the neoadjuvant setting (ph), possibly introducing an entirely new treatment approach and enhancing patient outcomes |
| So we're very, very grateful to all of your support |
| Having said that, we think we have an excellent first generation CTLA-4 that's been in combination in cervical and now this will be the first real data in sarcoma |
| And, impressively, botensilimab has demonstrated clinical responses in both cold and hot tumors |
| At the ASCO-GI conference, we reported that this benefit has translated into improved survival in our metastatic colorectal patients |
| In a diverse patient population of nearly 400 individuals, across nine solid tumor types, all of them had exhausted prior treatment options botensilimab has made significant strides in eliciting responses, offering renewed hope for those who have failed all other available treatments |
| Our continued innovations and progress highlights our unwavering commitment to advancing cancer care |
| Across all nine solid tumors, we've observed remarkable response rates of up to 50% in highly refractory cancers |
| Of course, the data that we showed at ASCO-GI with survival curves indicates, and of course, mind you, this is not a randomized trial but the differentiation in this patient population in terms of overall survival is such that we are confident that the responses are going to translate to longer term benefit including survival |
| So the 50% response rates, if continued in a larger denominator will demonstrate a very significant benefit for patients who have failed chemo plus PD-1 and who are otherwise going to be treated with [indiscernible], which as I said shows a variable bar of 9% response so far |
| But what's very encouraging also to us that remember, as we said during our call today, since late June of last year, we have presented data at oral plenary opening sessions at so many major conferences, which is really unprecedented for a single product if you look at it |
| So very encouraged, but stay tuned for the rest of it |
| So our CD137 were incredibly excited about and as you said, we will be updating the Phase I monotherapy trial at ASCO and a poster discussion session in the coming weeks |
| For example, with potential amount, we're activating T-cells, wireless will also generating memory and depleting regulatory T-cells, but activating T-cells better than the first generation CTLA-4 |
| Statement |
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| The agonists have struggled mightily with toxicity issues, particularly around liver toxicity with first generation |
| Those are two very important indicators as to the status of the patients being a very poor prognosis patient |
| For the first quarter ended March 31, 2023, we recognized revenue of $22.9 million and incurred a net loss of $70.9 million which includes non-cash expenses of $24.9 million |
| Immunotherapy treatments of combinations PD-1and CTLA-4 have similarly reported poor response rates of only 1% to 5% in comparable populations |
| But with CTLA-4 targeting agents, generally and that we're going to collaborate on this, that it would be impossible to think about a trial where response rates will now translate to survival |
| The biotech market has been challenging in the last year or so, but we're proceeding in a way that really supersedes any of these challenges because what we've got in our portfolio is something very important for the benefit of these patients and certainly patients that have exhausted all options but even patients that are in the earlier stages of disease and can benefit from our compounds in ways that we'll provide them with an option, which is typically not being addressed properly or effectively with current treatments |
| These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks |
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