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| Statement |
|---|
| Overall, the team is very pleased with our recent progress |
| This drug is supported by robust positive clinical data and the regulatory and clinical trial strategy designed to potentially provide superiority data on a composite endpoint and potentially line up for registration under the advantageous LPAD pathway |
| We are very excited about the consistent positive clinical results for MAT2203 and our Compassionate/Expanded Use Access Program and the demonstration that MAT2203 can be a life-saving drug in patients with limited or no treatment options |
| Our LNC platform has afforded the opportunity to take amphotericin B, the most powerful and broad spectrum antifungal drug that has historically been settled with severe toxicity issues and inconvenient administration and create a safe and convenient product that has the potential to change the treatment paradigm for invasive fungal infections |
| In summary, this is a very exciting time for our company |
| These encouraging results confirm our belief that phosphatidylserine expression on the outer surface of tumor cells presents a targeting opportunity for potential future oncology applications with our LNC platform |
| We are intent on closing 2203 very strong and remain thankful for your ongoing support |
| And a stronger label brings with it a much more significant commercial market opportunity |
| So, it's important that you start with a strong foundation, and that's why we're so excited by what Dr |
| We are confident that FDA stands on this design puts us or a partner in a position of strength to launch our product with a much stronger label which can also be built upon during the subsequent life cycle of this product |
| Overall, the positive outcome of our meeting with the agency was driven by FDA's desire to put forth the best possible study design position for regulatory and commercial success with a goal of ultimately making MAT2203 widely available to patients |
| We believe that with this new composite superiority endpoint, MAT2203 could be optimally positioned for favorable regulatory and commercial outcome given the clinical data that has been generated to date in our Compassionate Use Program as well as the clinical experience from our completed EnACT trial |
| We're thrilled with our LNC-docetaxel data |
| We're excited and optimistic about our company's future and we can't wait to report additional progress over the next few months |
| We are energized by the continued clinical validation with MAT2203 and FDA dialogue and excited by the potential expansion of the LNC platform into areas such as inflammation and perhaps most interestingly, cancer |
| We're thrilled with our FDA update |
| We're grateful for our ongoing constructive dialogue with the FDA and look forward to finalizing the composite superiority endpoint as soon as possible |
| Clinical success in this target patient population continues to be supported by the clinically meaningful outcome seen in patients receiving MAT2203 in our Compassionate/Expanded Use Access Program in which patients with no other treatment options are receiving MAT2203 for treatment of multiple fungal infections in multiple different tissues highlighting the ability of MAT2203 to safely target and effectively eradicate a variety of severe and potentially deadly invasive fungal infections in the most challenging clinical circumstances |
| Earlier today, we announced that our recent FDA meeting was very successful in three key areas; first, FDA supported our intended target patient population with a step-down study design |
| Excellent |
| Overall, we continue to focus our efforts and resources on maximizing the potential for MAT2203 and on generating additional data with our LNC platform in areas where we believe our technology is differentiated and can create distinct advantages over currently available therapies |
| These in vivo results were a big step forward for our delivery platform, taking us beyond our clinical success in infectious diseases and providing proof of principle that orally administered LNCs can effectively target large tumors and successfully deliver small molecule therapeutics |
| Given that we plan on addressing the highest need patients, most of whom have limited or no treatment options, we believe that our case for BARDA to assist with the funding of further clinical development of MAT2203 is quite strong |
| Matkovits will go into more detail on all these areas in a moment, but it's important to emphasize that the potential to move away from a non-inferiority endpoint to a composite superiority endpoint is a significant win and something that could position MAT2203 for a much stronger label |
| Each patient successfully treated with MAT2203 increases our confidence for our proposed Phase 3 clinical trial |
| First, we've progressed from earlier in vitro studies that confirm the efficacy of an LNC formulation of docetaxel in inhibiting tumor cell growth in cell culture, to our recently announced positive in vivo results with oral LNC docetaxel in a syngeneic murine melanoma model |
| The combination of focusing treatment with MAT2203 on an orphan patient population, with a superiority composite primary endpoint is designed to maximize commercial potential while filling what is perhaps the biggest current unmet need in the treatment of deadly invasive fungal infections |
| Given the substantially better safety profile of our oral MAT2203 compared with IV-administered amphotericin B seen to-date, including the rate of toxicity seen with IV-administered amphotericin B in the published literature |
| Building on successful in vitro demonstrations that our LNCs get taken up by tumor cells |
| In the meantime, we wish all of our investors and anyone listening to the call, a very happy Thanksgiving holiday |
| Statement |
|---|
| The company's net loss for the first nine months of 2023 was $17.6 million or $0.08 per share |
| Our net loss for the third quarter of 2023 was $6.1 million or $0.03 per share |
| In October, we announced that a 61-year-old male with a challenging medical history, achieved complete clinical resolution of Candida krusei infection following only two weeks of treatment with MAT2203 |
| This compares with a net loss for the third quarter of 2022 of $6.5 million, also $0.03 per share |
| This patient is suffering from a CNS-based Fusarium infection and required transition from IV amphotericin due to significant electrolyte abnormalities |
| This compares with a net loss for the first nine months of 2022 of $17.4 million, also $0.08 per share |
| The LPS model is an acute inflammatory model in which healthy animals are injected with LPS, resulting in a severe acute inflammatory response |
| That's not how it works |
| These are forward-looking statements and involve risks and uncertainties |
| The challenge with BARDA and any nondilutive government funding can be the process and associated time lines for making a decision in funding an award |
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