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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| I believe Victor's extensive track record as a clinical researcher in drug development in oncology and me and his unique medical affairs expertise in rare diseases and oncology will be instrumental to the company's success as we prepare the clinical plan and regulatory strategy for narazaciclib and rigosertib |
| I'll open by saying that Onconova has made excellent progress in the third quarter of 2023 |
| Sun damaged squamous cell has a very good prognosis |
| In addition to its multi-kinase activity, we believe that as a cycle it may be differentiated from the other approved CDK4/6 inhibitors because of the potential for an improved tolerability profile and based on our preclinical studies, improved efficacy as well |
| These milestones will provide a strong foundation for the next steps for narazaciclib and LGEEC with added potential indications including breast cancer, ovarian cancer, and mantle cell lymphoma |
| In closing, we are enthusiastic about the excellent progress that has been made for both narazaciclib and rigosertib in the third quarter |
| There is consistent positive clinical data on the class in endometrial cancer |
| In closing, I am optimistic about our programs, our progress and the outlook for rigosertib and narazaciclib in 2024 |
| I would like to echo Steve's comment that our decision to add at least one more dosing cohort to the dose escalation study is very good news for the program because it underscores the potential for narazaciclib to have a differentiated safety profile and wide therapeutic index |
| The second reason is the initial data from our dose ranging studies suggest that narazaciclib has the potential to be safer than the other indicated CDK4/6 approved inhibitors with a wide dosing window that supports an excellent therapeutic index |
| We believe this is very good news for total program, because it underscores the potential for narazaciclib to have a differentiated safety profile and a wide therapeutic index |
| We selected this to be the lead registrational indication based on the very impressive clinical responses we have seen to-date in previously refractory patients and with the significant unmet medical need for this desperate patient population |
| Publication of positive studies with other CDK4/6 inhibitors and letrozole combinations and compendia data indicating off-label use support the potential for a high probability of technical success |
| We believe that these two distinctive characteristics may enable a wide dosing window that supports an excellent therapeutic index for narazaciclib |
| Achievement of these milestones will also enable us to establish a solid foundation to expand the program to include other indications, such as breast cancer and ovarian cancer |
| Number 1, narazaciclib is safe and well tolerated to-date |
| In addition to target engagement, our program is showing acceptable initial safety which could give narazaciclib a unique profile |
| These features are a cornerstone of my enthusiasm and optimism for narazaciclib |
| This data plus its unique activity on Plk1 and KRAS pathways make rigosertib a very interesting anti-cancer agent |
| We think that's much more valuable |
| Secondly, initial data from our dosing study suggests that narazaciclib may be able to avoid the difficult adverse event of diarrhea |
| Based on our expansive large preclinical studies, we have defined a multi-kinase profile that could result in differentiated activity and the potential for broader clinical utility |
| For rigosertib, the promising activity that we have observed in RDEB-associated squamous cell cancer is distinct and could address a critical medical need for this ultra-rare condition |
| As indicated by Steve, based on the good target engagement and overall safety that we are observing, we believe that it would be reasonable to dose escalate to at least one more dosing cohort in order to fully explore the safety profile of narazaciclib and to enable us to achieve the optimal recommended Phase 2 dose |
| Number one, the proposed registrational trial has a high technical and regulatory success - probability of success |
| Victor and I previously worked together at J&J, where he was instrumental in getting approval for some of the most revolutionary and impactful drugs in both supportive care and hematology oncology |
| Mark Guerin Thanks very much Victor and good afternoon everyone |
| They prevent tumor proliferation, thus improvement hopefully in PFS and overall survival, which we anticipate seeing in our registration track |
| Our expansive preclinical studies have helped to define narazaciclib ability to impact on additional vital targets involved in cell signaling and cancer survival, including the proteins ARK5, also known as [NUAC1], CSF1R, and BUB1 |
| As you know, our mission remains to develop novel proprietary products for patients with hard-to-treat cancer and with an unmet medical need |
| Statement |
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| I know that we discussed before some of the challenges on that |
| Net loss for the third quarter of 2023 was $4.7 million or $0.23 per share on 21 million weighted average shares outstanding |
| This compares with a net loss for the third quarter of 2022 of $5.4 million or $0.26 per share on 20.9 million weighted average shares outstanding |
| Perhaps she was - the connection was lost |
| We see some mild neutropenia |
| For instance, sun damaged squamous cell |
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