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| Statement |
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| We think rhenium is an exciting new clinically relevant radioisotope and interest in that is very high |
| Our new radiotherapeutic, which is rhenium nanoliposome biodegradable alginate microsphere long term, but we call it RNL BAM and building on our organizational expertise and success in obtaining nondilutive grant funding |
| In addition, as Marc mentioned, the company continues to benefit from grant awards of $3 million from the NIH to support the GBM trial through Phase 2 |
| And it's a very unique opportunity in an unmet medical area that, we think it's well worth going for it, from a commercial perspective |
| Rhenium obisbemeda continues to demonstrate a very favorable safety profile despite delivering up to 20x the dose of radiation that is typically delivered by external beam radiation therapy for GBM, and that's typically around 35 gray and we've gone up to 740 gray and the mean dose we're giving now is about 300 to 350 gray |
| We have plenty of upside and ability, to increase specific activity with our current provider |
| So given the safety margins that we have seen thus far, with only a single administration of the radiotherapeutic drug and using the convection-delivery modality, we see tremendous opportunity and potential in both improving upon the standard-of-care in radiation delivery for GBM, which is EBRT in general but also improve upon current standard approaches for recurrent GBM such as surgery and chemotherapeutics and then expanding into other CNS tumor types of the brain parenchyma |
| So, I think we have a pretty good - we have a great - working relationship with CPRIT |
| I would add that FDA has embraced and are very pleased that with Plus and are pursuing the pediatric indications for high-grade glioma and ependymoma |
| Our ReSPECT-LM Phase 1/2 dose escalation trial of a single administration of rhenium obisbemeda for LM continues to show positive safety and efficacy signals and is making very good progress |
| But overall, we continue to think this potential exciting new upside opportunity is great for the company |
| We are incredibly grateful for the five-year support from the NCI University of Texas and the trial PI, up to this point, as we take the ball and move the trial from Phase 2 to a pivotal trial |
| And I know, Justin, you know this, but that's a very significant potential increase in our ability, to treat patients and create value for shareholders |
| We anticipate adding a total of five to eight new sites this year, which is currently ongoing, and we think that's going to provide a strong starting basis for a pivotal trial commencing in 2025 |
| We remain exceptionally encouraged by this test |
| Again, thank you to the investigators and patients and their employees who work so hard, and we're obviously very excited about where the company is right now |
| I think we're in an enviable position in the development of rhenium obisbemeda drug, in that with the recent progress we have made in LM |
| So, first, just from our trial, we see a step function improvement in diagnosis and also in disease management potential just in our patients, our small number of trials in our LM trial thus far |
| And we've had success |
| So comparing our Phase 2 data as it stands to - as of November of last year versus real-world data, that's the last time we reported data, a median overall survival, as a reminder, was 13 months, which is 63% better than current standard-of-care which is bevacizumab monotherapy, for example, that has - carries an overall survival of approximately eight months |
| So peds is on track, and it's been very well embraced by the agency |
| That continues to go very well |
| It was a very technical presentation and can be found on our website, but the bottom line is that using advanced imaging techniques beyond standard MRI and T1 T2-weighted images, using things such as relative cerebral blood volume, treatment response assessment maps and fit books, we can increasingly, if not reliably delineate pseudoprogression from progression as well as better understand patterns of recurrence, and we think this is going to help ensure that we are able to more rapidly develop and improve upon this novel new therapy for GBM, but also adapted for primary GBM and other brain cancers in children and adults |
| Those data will really drive what makes sense in terms of generating the best pivotal database |
| The update on this test is that we have successfully implemented the test back into our ReSPECT-LM trial, losing only a few patients in cohort 4 as of February 2024 |
| It's really about building up backup supply agreements, and then risk mitigation through increasing shelf life and improving inventory |
| So, we are in an advantage not only, because we have unmet medical needs, but also we're a Texas-based company |
| And so it really makes a lot of sense leveraging very experienced team in terms of getting grants, to continue to seek those for the foreseeable couple of years, or so as we hopefully bridge to improved product and revenue |
| Last November, we presented initial positive safety and feasibility data from the Phase 2 ReSPECT-GBM trial at the SNO meeting last November |
| And then, in terms of the other supply intermediates, we really have those pretty well in place |
| Statement |
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| But as you may recall, the prior company had very significant financial and operating issues |
| And overall critical organ radiation doses were low |
| As a result of these changes, the net loss decreased by $6.9 million from $20.3 million in the year ended December 31, 2022, to $13.3 million in the year ended December 31, 2023 |
| We missed, more or less, we missed cohort 4 when the test was unavailable |
| And that sort of further magnifies the commercial opportunity |
| CSF [technical difficulty] decreased by up to 91% following rhenium obisbemeda treatment, and the mean reduction was 53% |
| We would anticipate focusing on breast cancer with the leptomeningeal complications for several reasons |
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