Matinas BioPharma(US:MTNB)2022-11-03 00:43Financial Data and Key Metrics Changes - The company reported a net loss attributable to common shareholders of approximately $5.5 million or $0.03 per share for Q3 2022, compared to a net loss of $6.8 million or $0.03 per share for the same period in 2021, indicating a reduction in loss [19] - Cash, cash equivalents, and marketable securities at September 30, 2022, were approximately $33.1 million, down from $49.6 million at December 31, 2021, but the company believes this is sufficient to fund operations through 2023 [19] Business Line Data and Key Metrics Changes - The company achieved significant milestones in its MAT2203 program, particularly in the Phase 2 EnACT trial for cryptococcal meningitis, which demonstrated unprecedented survival rates exceeding 90% [9][10] - MAT2203 is positioned for global development and registration, with the European Medicines Agency granting orphan drug designation for the treatment of cryptococcosis [10] Market Data and Key Metrics Changes - The World Health Organization highlighted the rising threat of invasive fungal diseases, particularly among immunocompromised populations, which aligns with the company's focus on developing MAT2203 [10] - The WHO's fungal priority pathogens list includes cryptococcal meningitis and aspergillosis as critical threats, indicating a growing market need for effective treatments [10] Company Strategy and Development Direction - The company plans to initiate a Phase 3 trial for MAT2203 in cryptococcal meningitis in Q1 2023, expanding clinical sites and potentially adding patients to offset unforeseen deaths [15] - The strategy includes securing multiple orphan indications for MAT2203 and maximizing regulatory exclusivities while exploring broader applications for the treatment of invasive fungal infections [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the MAT2203 program's potential, citing strong clinical data and positive feedback from key opinion leaders [10][28] - The company is focused on maintaining a strong cash position and exploring non-dilutive financing options to support its development efforts [21] Other Important Information - The company is actively engaged in licensing discussions with BioNTech regarding the oral delivery of nucleic acids, which is seen as a significant opportunity [20] - The company has expanded its intellectual property portfolio surrounding the LNC platform with multiple new provisional patent filings [22] Q&A Session Summary Question: Can you expand on the feedback from doctors at ID Week regarding MAT2203? - Management noted that survival and safety were key elements that resonated with physicians, highlighting the unprecedented survival rates and safety profile of MAT2203 [26][28] Question: Will the Phase 3 study for invasive fungal infections enroll patients with different infections? - The company plans to enroll patients suffering from various invasive fungal infections, focusing on mucor and aspergillosis, and aims for a streamlined basket study design [30][31] Question: What is the standard treatment protocol with amphotericin for mucor and aspergillosis? - Typically, IV amphotericin is restricted to one to two weeks of treatment due to associated toxicities, followed by step-down therapy with azoles or echinocandins [36] Question: Can you provide details on the harmonization of the EU Phase 3? - Early feedback from the European Medicines Agency was incorporated into the protocol planning for the Phase 3 study, ensuring alignment with regulatory requirements [38] Question: What is the status of the BioNTech collaboration? - Discussions with BioNTech are ongoing, with both parties recognizing the potential value of the collaboration, although specific hurdles remain to be addressed [43]