Matinas BioPharma(US:MTNB)2020-05-12 02:45Financial Data and Key Metrics Changes - For Q1 2020, the company reported a net loss attributable to common shareholders of approximately $5.2 million or $0.03 per share, compared to a net loss of approximately $4.3 million or $0.04 per share in the same quarter last year [39] - Research and development expenses increased to approximately $4.1 million in Q1 2020 from approximately $2.3 million in the same quarter last year, primarily due to higher clinical development expenses [40] - General and administrative expenses rose to approximately $2.3 million in Q1 2020 from approximately $1.8 million in the previous year, mainly due to higher employee compensation costs [40] - The company ended Q1 2020 with approximately $71.2 million in cash, cash equivalents, and marketable securities, up from approximately $27.8 million at year-end 2019, bolstered by net proceeds of approximately $46.7 million from a public offering [41] Business Line Data and Key Metrics Changes - The company is focused on advancing its clinical stage candidates, particularly MAT9001 and MAT2203, with significant resources allocated to these drugs [70] - MAT9001 is positioned as a next-generation prescription-only omega-3 therapy, with enrollment for the ENHANCE-IT study expected to resume in June 2020 [15] - MAT2203, an oral formulation of amphotericin B, is being developed for the treatment of cryptococcal meningitis, with enrollment for the EnACT trial anticipated to resume in June [25] Market Data and Key Metrics Changes - The global invasive antifungal market is valued at several billion dollars, with MAT2203 expected to capture a significant share if approved [30] - The antifungal drug market is currently limited by the toxicity of existing treatments, creating an opportunity for MAT2203 to provide a safer oral alternative [72] Company Strategy and Development Direction - The company remains committed to its mission of developing therapies for critical needs, with a strong balance sheet allowing for continued progress despite the challenges posed by the COVID-19 pandemic [14] - The focus remains on advancing both MAT9001 and MAT2203, with the potential for increased attention and support for infectious disease treatments due to the pandemic [70] - The company is also exploring collaborations with big pharma to leverage their expertise and resources for further development [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the challenges posed by COVID-19, highlighting the importance of maintaining business continuity and prioritizing safety [10] - The company anticipates several meaningful inflection points in the coming quarters, with a cash runway extending into the first half of 2023 [41][42] - Management emphasized the importance of the ENHANCE-IT study for differentiating MAT9001 from competitors and the potential for MAT2203 to address significant unmet medical needs [62][75] Other Important Information - The company has implemented various mitigation strategies to ensure business continuity during the pandemic, including remote work measures and pausing clinical trial enrollments [11][12] - The company is preparing for an end-of-phase meeting with the FDA to discuss the phase 3 protocol for MAT9001, aiming for approval to enter phase 3 in the first half of 2021 [87] Q&A Session Summary Question: Update on MAT2501 - Management indicated that advancing MAT2501 will depend on support from the Cystic Fibrosis Foundation, with ongoing formulation work being conducted [46][48] Question: Expansion of ENHANCE-IT sites - The decision to expand sites was made to ensure timely data delivery and to mitigate risks associated with COVID-19 [50][52] Question: Impact of recent patent wins for Vascepa - Management stated that the patent situation for Vascepa does not impact MAT9001 directly, and the market for omega-3 therapies continues to expand [60][62] Question: Market opportunity for antifungal treatments - Management highlighted the significant unmet need in the antifungal market and the potential for MAT2203 to address this need effectively [68][72] Question: ENHANCE-IT's influence on Phase 3 protocol - ENHANCE-IT is primarily aimed at differentiation for commercialization and will provide additional safety data for submission [79][80]