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| Statement |
|---|
| We are confident that these enhancements will provide greater likelihood of clinical success and place DM199 on the fastest path to FDA approval and importantly, bringing DM199 to stroke patients who have no treatment options today |
| Masuoka has only been with us for a few short months, but is already making an enormous impact with clinical sites and building strong momentum with current and potential physician investigators |
| I'm excited to join management team at DiaMedica for several reasons: first, DM199 represents a potential breakthrough in the treatment of acute ischemic stroke, a serious and life-threatening condition for which no new approved medical therapy has emerged in over 25 years |
| On the basis of the subgroup analyses of the ReMEDy1 study, DM199 shows great promise in returning stroke patients back to baseline neurologic function and preventing recurrent stroke and death |
| They see DM199 as more like revascularization strategies such as tPA and mechanical thrombectomy and considerably more promising than the many failed neuroprotective agents |
| They were enthusiastic about DM199's mechanism of action to increase collateral circulation in the area of ischemic damage after a stroke without increased risk of hemorrhage |
| Finally, the ReMEDy2 trial is a thoughtfully conceived, well-designed study that is well managed, and I believe will provide definitive evidence of whether DM199 can become an important addition to the treatment options for patients who have suffered an ischemic stroke |
| We've also made some strategic additions to the clinical team that have enhanced activity and effectiveness |
| We also recently expanded our clinical operations with the addition of Rebekah de Vitry Fries as our Vice President of Clinical Operations in February to further expand and strengthen our clinical operations team leadership |
| So we made great progress in opening them shortly after the clinical hold was lifted and the final protocol was finalized in November |
| We're building momentum in our ReMEDy2 trial and look forward to the next update |
| Masuoka is board-certified neurologist with more than 25 years of experience building and expanding high-value pipelines in the biopharmaceutical industry |
| Our clinical team has been working diligently to identify, qualify and engage physician investigators and clinical sites and ensure that sites feel well supported to conduct this trial |
| We welcome, Lorianne, on the call today, and I'm thrilled to have her as a key member of our team |
| She has the history of building and leading high-performing teams in clinical development through all stages and the ultimate approval of new medicines |
| Great |
| We believe that our current cash and investments provide us a runway that will get us to 2026 |
| I would also remind everyone that as we discussed last quarter, the reason we submitted a protocol revision in October of 2023 was to increase our probability of clinical success |
| These new centers have substantial patient volumes and clinical research infrastructure and consistently rank among the top enrolling stroke centers in AIS studies |
| We would like to thank everyone for joining us this morning and for your continued support |
| Increased costs for patent prosecution and noncash share-based compensation also contributed to the increase |
| Our research and development expenses increased to $13.1 million for the year ended December 31, 2023, up from $7.8 million for the year ended December 31, 2022 |
| Thank you for joining, and have a pleasant day. |
| In our Phase II ReMEDy1 trial, they were the patients which demonstrated a greater level of full recovery as measured by the modified Rankin score of 0 to 1 on a 6-point scale where there was an 18% improvement of DM199 versus placebo |
| But beginning in mid-January and continuing through the ISC conference in February, we've had a surge of new site commitments |
| Also contributing to the increase were higher personnel costs, including noncash share-based compensation associated with expanding the clinical team |
| She was also an independent Board member of Opiant Pharmaceuticals, which was acquired last year for an upfront premium of over 100% and the potential for an approximately 200% premium if the contingent value rights are achieved |
| Thank you |
| Dietrich Pauls Great |
| Statement |
|---|
| New site commitment was slow over the holidays |
| It's an issue of numbers |
| Then it's an issue of numbers |
| The 3-judge panel recently informed us that they did not find sufficient causal link between PRA's breach of our study agreement and the damages we claimed |
| Importantly, we don't believe that this will dramatically reduce the number of eligible stroke patients |
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