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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| Again, these data appear to demonstrate the role of PDS01ADC in promoting strong and compelling objective response rates even in late stage ICI resistant cancer patients |
| We are excited about the strides we are making, fueled by our commitment to developing groundbreaking therapies that revolutionized cancer treatments based on our proprietary reverse immune platform |
| Now, from PDS perspective, for us, this is not surprising because again, even in our oncology products, we've shown very good translation from preclinical models to human right |
| You are sitting on what we consider to be a very strong asset profile and the data that you've accumulated to date |
| We've seen very good safety profile today with PDS0101 |
| The delta today is quite significant when you look at the delta of what we've see at the two-year results versus what we see in the published data, we know that by far exceeds what we'll have to achieve for approval, but as a risk mitigation strategy in terms of our statistical design, what we are also looking at is we are also saying, well, let's assume PDS0101, the patients in our control arm taking KEYTRUDA, we'll do much better than KEYNOTE-048 |
| So, we have shown very good translation |
| We are pleased with our current progress driven by our mission to develop groundbreaking therapies that transform cancer treatment |
| And how do you know that your technology or product is actually achieving that? What we have seen now with our circulating tumor, DNA in that study is the strong potential for PDS0101 to actually dramatically eliminate and reduce and eliminate the circulating tumor DNA, right at five weeks, 92% reduction versus 52% reduction with the standard of care |
| However, after talking to key opinion leaders in the field, as well as the regulatory experts, it's evident that the survival and safety data generated with a doublet, presents the most straightforward regulatory pathway, as well as the robust uptake if and when it becomes standard of care, right? With the doublet will also enable a more rapid potential approval path for early, even early use |
| The progress made this quarter has been truly exciting |
| We remain enthusiastic about what lies ahead for the rest of this quarter and into 2024 |
| We've had and continue to provide what we believe to be favorable development milestones to the market and have upcoming development milestones we believe may provide additional Catalysts to investors |
| We are confident that our efforts will positively impact these patients with critical unmet medical needs leading to longer lives and improved quality of life |
| With this data, we believe that we are on track to revolutionize the treatment of head and neck cancer with improved clinical outcomes and better tolerability |
| TDS Biotech has had a fruitful quarter and we are preparing to finish out the year strong as we move into 2024 |
| At PDS Biotech, we are highly optimistic about the potential of these novel PDS01ADC assets in cancer therapy |
| As anticipated, the FDA reviewed Phase III clinical trial design has been pivotal to our business development discussions, which has yielded positive insights from prospective partners |
| MD Anderson is extremely excited about that because they believe it has direct implications for patient survival and very importantly, recurrence of the cancer, right? So that is -- data that we will hopefully be expecting to see coming up in 2024, how that elimination of circulating tumor DNA correlates with recurrence of the cancer and survival of the patients |
| We are encouraged by the potential of this combination |
| The triple combination also shows a compelling three-year survival of 75% |
| We also showed successful prevention of viral replication in the lungs when the animals were given lethal doses of the H1 N1 virus, as well as protection against infection in the ferrets also |
| Overall, the experts were enthusiastic about the updated VERSATILE-002 data and the planned initiation of the Phase III VERSATILE-003 trial |
| Data from the PDS01ADC and docetaxel trial presented at Cytokines, demonstrated tolerability of the combination and encouraging PSA biomarker results and immune responses |
| And with IMMUNOCERV, the investigators are extremely encouraged with the data that they've seen today |
| To summarize, we hosted AK successful KOL event where we announced positive updated overall survival and safety data from the VERSATILE-002 trial and gained important insights from head and neck oncology leaders about the potential of PDS0101 in the treatment of HPV Positive head and neck cancer |
| We have seen highly encouraging survival data with PDS0101, as well as PDS01ADC, as well as extremely encouraging ORR with the PDS01ADC |
| With PDS0202, as you mentioned, this is a program that we are quite excited about |
| The NIAID is extremely encouraged by the data that they've seen today |
| This study provides compelling evidence that supports the potential synergy between our adverse immune-based targeted T-cell immunotherapies and our IL 12 fused antibody drug conjugate that provides the sustained presence of IL 12 in the tumor, thus providing further expansion and activation of the Versamune-induced multifunctional killer T-cells within the patient's tumor |
| Statement |
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| The combination also led to subsequent decreases in the population of CD8 killer T-cells in the circulating blood |
| The higher net loss this quarter was primarily due to cost incurred in connection with our research and development and clinical programs |
| So, one of the key things that I mentioned over the last couple of earnings calls has been the fact that we are waiting to see the data from the VERSATILE-002 refractory arm |
| No problem |
| It is reported that the combination of KEYTRUDA and chemotherapy resulted in 72% of patients having Grade 3 through Grade 5 treatment-related adverse events |
| Net loss for the period was approximately $10.8 million or $0.35 per basic and deleted share compared to a net loss of approximately $7.4 million or $0.26 per basic and diluted share for the three months ended September 30th, 2022 |
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