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| Statement |
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| And -- but we think we have a very good approach to not only execute that, but also keep track of it |
| Darolutamide is structurally unique to other androgen receptor inhibitors with an excellent efficacy and differentiated tolerability profile, coupled with minimal drug-drug interactions, making it an ideal combination partner for gedatolisib |
| We think that we would have an advantage relative to the challenges involved in administering that class of drugs |
| We then characterized the significant unmet needs in breast and prostate cancer and why gedatolisib is uniquely positioned to potentially improve the outcomes for the hundreds of thousands of patients with these tumors |
| So far, so good |
| That is why we believe development of an optimized PAM inhibitor, like gedatolisib, that targets all Class I PI3K isoforms and mTORC1 and mTORC2 represents one of the most important opportunities to improve the standard of care in these cancers |
| And so, we concluded that it was an opportunity for us to bolster the balance sheet and really -- can't say eliminate, but certainly reduce the potential balance sheet risk associated with our programs |
| And that is why we think the PAM pathway represents the largest drug development opportunity in solid tumors |
| If the data that we report is consistent with what's been reported in clinical studies that were done with an earlier-generation PAM inhibitor that is no longer under development, then we think geda would be on track to potentially offering a standard of care that was superior to PSMA-targeted therapies |
| There is also compelling clinical evidence with an earlier generation PAM inhibitor providing a proof of concept of our hypothesis that combining gedatolisib with an androgen receptor inhibitor may be efficacious |
| We believe this will extend our cash runway into mid-2026, and fund us through multiple critical milestones |
| We're excited about the opportunity to potentially offer breast and prostate cancer patients effective treatment for their PAM pathway-involved tumors, and we look forward to updating you on our progress over the coming quarters |
| For just as an example, a two-month improvement in PFS, which would translate to 100% improvement relative to what's been reported in fulvestrant recently two months medium fulvestrant, it would represent an HR of 0.5 |
| It was -- would be favorable for us to extend the runway |
| And so, we have multiple ways of gauging what the potential activity could be at the site, and also just multiple ways of ensuring that we're as top of mind as we can, and so far, so good |
| Our focus right now is demonstrating the proof of concept that combining pan-PI3K inhibitor like gedatolisib with an androgen receptor inhibitor like darolutamide, which is very potent, will induce a treatment effect in these patients that could be significant and advance the standard of care |
| We're excited that Bayer agreed to enter into a clinical trial collaboration and supply agreement to provide darolutamide, their approved androgen receptor inhibitor, for this trial at no cost |
| Good-bye |
| Appreciate the effort |
| Brian Sullivan Well, thanks again for participating in our call today and for your ongoing support |
| And then, the R&D expense pick-up this quarter, I mean, is that -- is it fair to say that's a direct indication that the enrollment for the trial is going, let's say, better than initially expected? Brian Sullivan I would say it's just in line with what we expected |
| Good morning, everyone |
| But geda is very stable, doesn't metabolize, or metabolizes at a very, very low rate |
| And so, for the most part, this incremental infusion of cash will primarily extend our cash run rate, which again, in this environment, having additional runway, we think, is just very prudent |
| Brian Sullivan You're welcome |
| Brian Sullivan You're welcome |
| Gil Blum Hey, good morning everyone |
| Thank you so much |
| Well, great to hear |
| Thank you |
| Statement |
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| We think that sentiment is misguided |
| But we don't think that the bar is raised to a level with those drugs that will create an impediment for us to be successful |
| Otherwise, uninhibited nodes may be activated and compensatory resistance may be induced, which in turn, compromises efficacy |
| Net loss for the third quarter of 2023 was $18.4 million or $0.83 loss per share compared to a net loss of $10.9 million or $0.75 loss per share for the third quarter of 2022 |
| This has led many drug developers and investors to question the relevance of the pathway as a cancer target |
| The primary reason why PAM inhibitors have not become standard of care drugs despite the importance of the PAM pathway, is because it is very difficult to safely and efficaciously inhibit this pathway |
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