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Matinas BioPharma(MTNB) - 2022 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a net loss attributable to common shareholders of approximately $6 million or $0.03 per share for Q1 2022, compared to a net loss of $5.2 million or $0.03 per share for the same period in 2021 [40]. - Research and development expenses increased to approximately $5 million in Q1 2022 from approximately $3.2 million in Q1 2021, primarily due to higher development expenses and increased personnel costs [41]. - Cash, cash equivalents, and marketable securities were approximately $43.9 million as of March 31, 2022, down from $49.6 million at December 31, 2021, with sufficient cash projected to fund operations through 2023 [42]. Business Line Data and Key Metrics Changes - The MAT2203 program, an oral LNC formulation of amphotericin B, is currently in a Phase II trial for HIV patients with cryptococcal meningitis, with 50% of patients enrolled in Cohort 4 [16][17]. - MAT2501, an oral LNC delivered amikacin product, has completed a clinical single ascending dose trial with no serious adverse events reported, and the company anticipates starting a Phase II trial in 2023 [30][31][76]. Market Data and Key Metrics Changes - The partnership with BioNTech is expected to enhance the company's visibility in the messenger RNA space and potentially lead to a formal license agreement [11][55]. - The company is also expanding its collaboration with Genentech to include a third compound, indicating a growing interest in optimizing oral formulations of biologics [34][85]. Company Strategy and Development Direction - The company aims to validate its LNC platform delivery technology through consistent clinical data and external collaborations, focusing on expanding its drug delivery capabilities [10][12]. - The regulatory strategy for MAT2203 includes a streamlined development pathway that may allow for a single Phase III trial for NDA submission, which is a significant improvement over traditional requirements [22][68]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of MAT2203 to save patients' lives and the importance of aligning with pharmaceutical giants to leverage the LNC platform [46][47]. - The company is focused on optimizing the design of its Phase III trial to meet both FDA and EMA regulatory requirements, which is crucial for global registration [68][70]. Other Important Information - The company has initiated pre-clinical studies for MAT2203 to support potential label expansion into other invasive fungal infections [24][25]. - The collaboration with BioNTech is seen as a significant opportunity to advance the delivery of messenger RNA vaccines and therapeutics [11][36]. Q&A Session Summary Question: General terms for the BioNTech collaboration - Management discussed the importance of collaboration with BioNTech and the potential for a license agreement, focusing on exclusivity and the breadth of the relationship [55]. Question: Safety and efficacy readouts for MAT2203 - Management highlighted the significance of Cohort 4 in demonstrating the impact of an all-oral regimen and anticipated data readouts in Q3 2022 [62][63]. Question: Next steps for MAT2501 - The company plans to initiate a Phase II trial for MAT2501 in Q2 or Q3 of 2023, pending the completion of long-term toxicity studies [76]. Question: Urgency of advancing LNC remdesivir - Management acknowledged the importance of the oral remdesivir program and the need for data from ongoing studies before further engagement with Gilead [84]. Question: Evolution of the Genentech collaboration - Management expressed the goal of formalizing the relationship with Genentech as data becomes available, indicating a positive outlook for future collaboration [88][89].