Matinas BioPharma Updates — Q4 2021 Earnings And Conference Call Recap

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Matinas BioPharma Holdings Inc. MTNB, a clinical-stage biopharmaceutical company focused on redefining the intracellular delivery of nucleic acids and small molecules, recently reported financial results for the fourth quarter and full-year ended Dec. 31, 2021 and provided a corporate update.

In its press release, Matinas highlights the following key developments in 2021: 

• Fifteen patients enrolled to date in Cohort 4 of EnACT (all oral induction regimen) with topline interim data expected in the third quarter of 2022
• Potential pathway to new drug application (NDA) submission for MAT2203 with confirmatory data to come from Cohort 5 of EnACT trial
• Second in vivo study of the oral lipid nanocrystal (LNC) remdesivir to commence in March 2022
• Moving aggressively into nucleic acids with internal discovery programs initiated with mRNA, DNA and antisense oligonucleotides (ASOs)
• $49.6 million at year-end in 2021, enough to fund planned operations throughout 2023

“We are proud of the significant progress we made in 2021 to advance our LNC platform technology, including delivering compelling data for MAT2203 in the first three cohorts of the EnACT trial and meeting with the U.S. Food and Drug Administration (FDA) for an end of Phase 2 meeting,” Matinas CEO Jerome Jabbour said.

“In 2022, in addition to delivering data from Cohort 4 of the EnACT trial in the third quarter, we have moved aggressively into the formulation and delivery of nucleic acids and have initiated internal discovery programs based on the delivery of mRNA, DNA and antisense oligonucleotides. The unique properties of our LNC platform, including oral bioavailability, extrahepatic targeting, large payload capacity and improved stability and safety, are supported by key preclinical data that differentiates our technology from both lipid nanoparticles and viral vectors. We believe these unique properties represent the next generation in intracellular drug delivery.”

The report is available here. 

Matinas BioPharma Conference Call – Summary Highlights:

Highlights from Matinas’ March 8 conference call include:

• Reporting a strong trajectory for a highly successful year ahead 
• Matinas says it looks to continue delivering highly compelling clinical data with the EnACT trial and has partnered with a global contract manufacturing organization (CMO) to drive toward potential NDA readiness.
• Matinas has expanded its discovery team with the recruitment of world-class scientific and formulation experts.
• Matinas reports continuing to drive a comprehensive discovery program focused on the delivery of oligonucleotides, addressing major challenges in the delivery of these therapeutics and is on the brink of expanding its pharma and biotech partners for further collaboration. 
• Matinas highlights the following tangible progress: 
  • Continued validation of the LNC platform from the EnACT trial
  • Clear regulatory progression
  • Expanded scientific capabilities – both people and infrastructure

Addressing the FDA approval pipeline for the EnACT trial, the company said: “We believe that Cohort 5 will generate the confirmatory evidence FDA is seeking to facilitate an NDA submission in late 2023 or early 2024. We have completed protocol design for Cohort 5 in close collaboration with Dr. David Bower from the University of Minnesota and are scheduled to meet with the FDA early in the second quarter of 2022 to discuss specifics of the protocol.”

Speaking about the global commercialization of MATT2203, the company said: “First, we are preparing to submit a formal request for scientific advice to the European Medicines Agency (EMA) during the second quarter of 2022. This is a key step in gaining regulatory advice outside the U.S. and the key strategic input for partners seeking to develop and eventually commercialize MAT2203 outside the U.S. We expect to receive feedback from EMA later in 2022.”

With these developments on the horizon for Matinas, the company likely is looking to follow in the footsteps of corporate giants Vertex Pharmaceuticals Inc. VRTX and Regeneron Pharmaceuticals Inc. REGN in the years to come. Matinas may be an intriguing ticker for investors and traders to watch.

For the full picture, check out the call transcript here or the webcast here.

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