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| We have been very fortunate, and as part of today's announcement and what came out earlier this week was further validation that the collaborations that we already have in place, specifically the collaboration around the FA program with Neurocrine is advancing and moving forward |
| So we're comfortable and actually very enthusiastic about the siRNA approach we take |
| Turning to slide 9, you can see Voyager has started the year off strong, and we continue to execute on our milestones |
| All this has given us a strong balance sheet, which we expect to provide runway into 2027, removing our financial overhang and enabling us to potentially generate value creating clinical data in 2025 and 2026 |
| But it's important to note that the main outcome measure that was positive was the NfL with a lot of strong support from the other clinical outcome measures, but the one that was statistically significant was NfL |
| We have already demonstrated our strength as a leader in CNS capsid technology |
| So, the long answer to say that I think a positive result just underscores, I think, that the tau is a great target to go after |
| Moving to slide 6, when I look at the Alzheimer's space, I'm encouraged by the progress, particularly the approval of two anti-amyloid antibodies |
| All of these milestones are helping us build a robust pipeline, as you can see on slide 5 |
| So whether that's a competitive advantage or whether it's – we chose the program because we liked the fact that we can get proof of concept on the spread of tau very efficiently |
| Looking forward, Voyager is well capitalized to advance at least four wholly owned and partnered CNS programs into the clinic this year and next |
| The other distinguishing feature of aducanumab and lecanemab and donanemab is that you have a very robust effect on the amyloid PET imaging in one year |
| I view tau as the next exciting target in this field |
| And we really try to hit each of those components that Al mentioned to give us the best opportunity for success and to reduce any potential risks of tolerability issues |
| And so, we hope to see a robust, clear cut effect on tau PET imaging |
| I want to close by acknowledging all of the hard work of the Voyager team, which has allowed us to progress as much as we have |
| But again, even within the same region, some antibody blocks spread better than others |
| Additionally, we think an added benefit is that the effect is not limited to the spinal cord |
| So we're taking something forward that was quite robust and targets pathological tau specifically |
| But we have a lot of confidence in the toxicology package we chose |
| Finally, potential |
| And so, that continues to validate the science in the organization and also brings to the company additional cash flow revenues that we had not previously kind of projected as part of our overall cash runway |
| But because our IV approach leverages the vascular system to deliver across the blood brain barrier, we see not only strong knockdown along the spinal cord, but also lowering of the brainstem and motor cortex, which we believe will be important in addressing ALS |
| We are encouraged by the early data for both of these programs and look forward to continuing to share at scientific conferences |
| As we all know, tofersen did not meet the primary endpoint, which was a clinical outcome measure, the prespecified outcome measure of ALS functional rating scale, but it did have a strong effect, clear cut effect on neurofilament |
| And look, we're on track to achieve our goal of filing the IND in the first half of this year |
| So I think it's important to just be mindful that we don't provide guidance here, but we do believe that there could be further revenue generation as we move forward into 2024 |
| And good afternoon |
| One, could you highlight the features of your VY-TAU01 Phase 1b clinical plan that you would point to as competitive advantages relative to historical or ongoing tau clinical efforts? And our second question is, what lessons from lecanemab and other a-beta targeting therapies would you point to as most informative for the design of a tau targeting clinical program and specifically your VY-TAU01 program? Alfred Sandrock The VY-TAU, the Phase 2 program that we hope to get proof of concept based on tau PET imaging, our current plan – and we still have more work to do to actually get input from investigators and FDA, obviously |
| This brings our total of partnered programs to 13, with the potential to generate $8.2 billion in longer term milestone payments |
| Statement |
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| Alfred Sandrock So far, when you look at the N-terminal antibodies, it seems that the animal has negative predictive value |
| But a negative result, maybe because it was the wrong epitope |
| And I'll just reiterate that, in our assays, the internal antibodies that have failed in the clinic to date failed in that assay as well |
| And the problem is that those animals are sick because they carry human pathological tau |
| We have a question about the TAU01 program since there's some near term readouts for competing tau targeted therapies, including Phase 2 readouts from an anti-tau mid-domain antibody from Roche and UCB and OGA inhibitor from Lilly |
| These are diseases with such terrible consequences for patients |
| The C-terminal and mid terminal anti-amyloid antibodies were not as effective |
| And those have – I think, almost without fail, they have not succeeded in the clinic |
| I would say that we believe that epitope matters a lot |
| Two questions from us |
| And if we don't see that, we're not going to move forward |
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