Matinas BioPharma Holdings, Inc. is a clinical-stage biopharmaceutical company developing novel antifungal therapies using lipid nanocrystal platform technology, with its lead product candidate MAT2203 intended for invasive fungal infections.

# Company Overview - Matinas BioPharma Holdings, Inc.

## Business Focus
- **Type:** Clinical-stage biopharmaceutical company
- **Core Technology:** Lipid nanocrystal (“LNC”) platform delivery technology (LNC Platform)
- **Main Product Candidate:** MAT2203 (oral amphotericin B)
  - **Use:** Highly potent antifungal drug reformulated for oral administration
  - **Benefits:** Safe, well-tolerated, oral, eliminates nephrotoxicity associated with IV forms
  - **Development Status:** 
    - EnACT Phase 2 trial in cryptococcal meningitis showed promising efficacy
    - Positioned for Phase 3 trial (ORALTO) for invasive aspergillosis
    - Need for partnership or capital raise to proceed with Phase 3

## Pipeline and Strategic Activities
- **Lead Candidate:** MAT2203 for invasive fungal infections
  - **Designations:** QIDP, Fast Track, Orphan Drug designations
  - **Initial Indication:** Step-down therapy from IV amphotericin B for invasive aspergillosis
  - **Regulatory Milestones:** Agreement with FDA on Phase 3 trial design; trial planned at ~216 patients
  - **Current Status:** Paused clinical development pending licensing or partnership; supporting a compassionate use program with 37 enrolled patients

- **Other Pipeline Programs:** 
  - Focused on small molecules, oligonucleotides, oncology, and inflammatory diseases
  - Development paused for internal pipeline after workforce reduction in October 2024

## Financial and Operational Details
- **Employees:** 3 full-time employees as of March 31, 2025; approximately 4 contractors/consultants
- **Revenue:** None reported (no product sales yet)
- **Net Income and Losses:**
  - **2024:** Loss of $24.3 million
  - **2023:** Loss of $22.9 million
- **Total Assets (as of Dec 31, 2024):** Data not specified; cash and cash equivalents of $7.284 million
- **Market Capitalization (as of June 30, 2024):** Approximately $38.7 million

## Strategic Events
- **Funding:**
  - Raised ~$10 million in April 2024 from institutional investors
  - Raised ~$3.3 million in February 2025 through preferred stock and warrants
- **Corporate Actions:**
  - Workforce reduction of 80% in October 2024
  - Reverse stock split at 1-for-50 ratio effective September 2024
  - NYSE American compliance issues; ongoing efforts to regain compliance
  - Anticipated need for additional capital or licensing deals to continue development
  - No current sales, marketing, or commercialization infrastructure

## Proprietary Assets
- **Patents and IP:** 
  - License from Rutgers University for core platform technology
  - Extensive portfolio with patents expiring around 2033-2043
  - Proprietary LNC platform protects small molecules and oligonucleotides
- **Trade Secrets and Know-How:** Critical to maintaining competitive advantage

## Market Opportunity
- **Global antifungal market:** Valued at ~$15.8 billion in 2023, projected to reach ~$20.5 billion by 2030
- **Infections Treated:** Over 1.5 million invasive fungal infections annually worldwide, including Candida, Aspergillus, and Cryptococcus
- **Cost Implications:** High treatment costs, with hospitalizations exceeding $40,000 to $150,000 per patient

## Summary
Matinas BioPharma is focused on developing innovative antifungal therapies using its lipid nanocrystal platform, with MAT2203 as its lead candidate targeting invasive fungal infections. The company relies on partnerships, licensing, and capital raises, and is currently paused in clinical development to explore strategic alternatives due to financial and operational challenges. It holds patents and proprietary IP licensed from Rutgers University and has no current revenue or employees beyond a small core team.

Matinas BioPharma Holdings, Inc. is a clinical-stage biopharmaceutical company developing innovative therapies using its proprietary lipid nanocrystal platform for targeted delivery.

# Company Overview

Matinas BioPharma Holdings, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies using its proprietary **lipid nanocrystal (LNC) platform delivery technology**. The company aims to encapsulate small molecules and small oligonucleotides to facilitate targeted and extrahepatic delivery to desired cells and tissues with minimal toxicity.

## Key Areas of Focus

1. **Lead Product Candidate**: 
   - **MAT2203 (oral amphotericin B)**: An oral formulation of an antifungal drug that is known for being highly potent. MAT2203 is designed to be safe and well-tolerated for prolonged administration in patients with life-threatening invasive fungal infections.
   - The company is gearing up for a **Phase 3 registration trial** (ORALTO trial) for MAT2203, which targets patients with invasive aspergillosis who have limited treatment options.

2. **Other Developments**:
   - Research programs targeting the safe and effective delivery of **chemotherapeutic agents for oncology** applications.
   - Development of formulations for **small oligonucleotides**, including antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), focusing on applications in inflammation.

## Company Structure and Financial Overview

- **Headquarters**: Bedminster, New Jersey.
- **Number of Employees**: 32 full-time employees (as of March 18, 2024).
  
### Financial Performance

- **Annual Research and Development Expenses**:
  - 2023: $14,489,000
  - 2022: $16,678,000

- **Net Loss**:
  - 2023: $22,942,000
  - 2022: $20,997,000

- **Accumulated Deficit**: As of December 31, 2023, the accumulated deficit stood at **$175,573,000**.

- **Revenue**: The company has not generated any revenue from product sales. Revenue generation is not expected until MAT2203 or other product candidates receive regulatory approval and are commercialized.

## Customer Base and Market Focus

While specific customer numbers are not provided, Matinas is focusing on a critical area of healthcare—**infectious diseases, particularly invasive fungal infections**. The company's efforts target clinicians, pharmaceutical partners, and healthcare systems managing seriously ill patients, especially those with limited therapeutic options.

## Strategic Goals

- The company plans to advance MAT2203 through clinical trials and regulatory approval processes, aiming to address a significant medical need for effective oral antifungals and meet the growing demand for innovative therapies in the biopharmaceutical market.

Matinas BioPharma Holdings, Inc. operates in a challenging financial landscape, with substantial investments geared toward drug development and regulatory processes, yet its innovative delivery platform positions it to potentially address unmet clinical needs in critical therapeutic areas.

Matinas BioPharma Holdings, Inc.

10-K / April 15, 2025

10-K / March 27, 2024

10-K / April 15, 2025

Company Overview - Matinas BioPharma Holdings, Inc.

Business Focus

Pipeline and Strategic Activities

Financial and Operational Details

Strategic Events

Proprietary Assets

Market Opportunity

Summary