Matinas BioPharma(US:MTNB)2021-08-10 15:22Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities at June 30, 2021, were approximately $59.8 million, compared to $58.7 million at December 31, 2020 [39] - Research and development expenses were approximately $2.5 million in Q2 2021, down from approximately $3.4 million in the same quarter of 2020, primarily due to the completion of the enhancement study of LYPDISO [40] - General and administrative expenses were approximately $2.3 million in Q2 2021, essentially unchanged from $2.4 million in the same period in 2020 [41] - The net loss attributable to common shareholders was approximately $5 million or $0.02 per share, compared to a net loss of $5.8 million or $0.03 per share in the same period of 2020 [41] - The company believes that cash on hand is sufficient to fund operations into 2024 [42] Business Line Data and Key Metrics Changes - The company is focusing on its Lipid Nanocrystal (LNC) Platform, which has shown potential for safe and effective intracellular drug delivery [10][12] - MAT2203, targeting HIV patients with cryptococcal meningitis, has completed enrollment for Cohort 2, with data expected to be discussed in September [16] - MAT2501, an oral formulation of amikacin, is set to enter a Phase 1 study in healthy volunteers in Q4 2021 [29] - The company has successfully formulated a potential oral version of Gilead's Remdesivir, with in vitro studies showing promising antiviral activity [31][34] Market Data and Key Metrics Changes - The company is addressing significant unmet medical needs in vulnerable patient populations, particularly with MAT2203 and MAT2501 [25][30] - The LNC Platform is positioned to transform the delivery of various therapeutic agents, including small molecules and complex biologics [14] Company Strategy and Development Direction - The company aims to validate its LNC Platform through ongoing clinical trials and collaborations with leading pharmaceutical companies [10][12] - There is a focus on obtaining regulatory approval for MAT2203 as a step-down therapy for cryptococcal meningitis, leveraging the unmet need in this area [25][63] - The company is exploring multiple regulatory pathways, including the Limited Population Pathway for anti-infective medicines [63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about upcoming data releases and the potential for significant milestones in the near term [43] - The company is confident in its ability to navigate regulatory discussions and expedite the development of its drug candidates [63][66] Other Important Information - The company has received positive feedback from the FDA regarding its development plans for MAT2501 [29] - The LNC Platform's ability to deliver drugs effectively across the blood-brain barrier is highlighted as a key advantage [18] Q&A Session Summary Question: Insights on MAT2501 and Remdesivir development timelines - Management indicated that MAT2501 will follow a streamlined regulatory process similar to MAT2203, with initial studies expected to begin by the end of next year [51][54] - For Remdesivir, in vivo studies are anticipated to start soon, with initial human data expected in the first half of 2022 [59] Question: Accelerated approval pathways for MAT2203 - Management discussed the potential for multiple regulatory pathways, including LPAD, and emphasized the importance of the data from Cohort 2 in discussions with the FDA [63][66] Question: Expectations for EnACT trial data - Management confirmed that survival data will be a key measure in both Cohort 1 and Cohort 2, with the design aimed at facilitating a step-down indication [71][73] Question: Number of patients in Cohort 2 and future milestones - Cohort 2 included 56 patients, with 40 on active treatment and 16 in the control group, and management expects to complete the EnACT trial in 2022 [82][85]