Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Matinas BioPharma Holdings Inc (MTNB, Financial) has signed a nonbinding term sheet for the global licensing of MAT2203, indicating progress in their partnership efforts.
- The compassionate expanded use access program for MAT2203 has shown positive clinical outcomes in critically ill patients, bolstering confidence in the drug's efficacy and safety.
- Recent studies have demonstrated the potential of the LNC platform in delivering small oligonucleotides and small-molecule oncology drugs, showing promise in tumor growth inhibition.
- The company has reported a decrease in net loss and total expenses for the second quarter of 2024 compared to the same period in 2023, reflecting improved financial management.
- Cash, cash equivalents, and marketable securities increased to $14.3 million as of June 30, 2024, due to successful fundraising efforts, providing a stronger financial position.
Negative Points
- The partnership agreement for MAT2203 is still nonbinding, and there is no guarantee it will result in a definitive agreement, creating uncertainty.
- The company reported no revenue for the second quarter of 2024, similar to the same period in 2023, indicating a lack of income generation from operations.
- The anticipated start of the ORALTO Phase 3 trial for MAT2203 has been delayed, with the first patient visit now expected in early 2025, potentially impacting timelines.
- Weight loss observed in animal studies with the LNC platform, particularly with highly toxic agents like miriplatin, raises concerns about the safety and tolerability of these formulations.
- The company continues to face significant time and additional work ahead to identify additional potential product candidates from the LNC platform, indicating ongoing challenges in development.
Q & A Highlights
Q: Good news on the nonbinding term sheet. Should we expect an upfront payment and reimbursement for the ORALTO trials in this deal?
A: (Jerome Jabbour, CEO) Without commenting specifically, we expect a definitive agreement to include an upfront payment, development and commercial milestones, royalties, and clinical development costs. The nonbinding term sheet is a framework for a deal, and these elements have been discussed.
Q: Given the timeline for the partnership, do you still expect the ORALTO trial to start in Q4 2024 or early 2025?
A: (Jerome Jabbour, CEO) The delay is due to the complexity of the dialogues and thorough diligence. We are working with a global CRO to initiate the trial as soon as possible. While we aim to start in Q4 2024, the first patient visit might be safer to expect in 2025. Enrollment is projected to take about 24 months.
Q: How should we interpret the additional weight loss seen in the LNC platform's oncology indications?
A: (Jerome Jabbour, CEO) Weight loss could be due to high doses of oral therapy traditionally given IV, affecting animal feeding. For docetaxel, it might be dose-related. For miriplatin, it seems more related to the agent's toxicity. We are optimizing formulations to reduce toxicity and improve therapeutic index.
Q: Could you remind us of the key design elements and objectives of the upcoming non-inferiority study for ORALTO?
A: (Theresa Matkovits, Chief Development Officer) The ORALTO trial is a non-inferiority trial targeting patients with invasive aspergillosis who have no other treatment options. It compares MAT2203 after a two-day IV amphotericin step-down to MAT2203 with IV liposomal amphotericin. Primary endpoint is mortality at six weeks, with secondary endpoints including safety, global response, and pharmaco-economic impact.
Q: What are the recent milestones achieved for the ORALTO partnership?
A: (Jerome Jabbour, CEO) We have not yet secured a definitive agreement but have made significant progress. We are working with a single party to ensure all questions are answered and the program is set up for success. We will consider the milestone achieved when we have a definitive agreement.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
