PHAXIAM Q1 2024 Business and Financial Update

PHAXIAM Therapeutics has provided a business and financial update for the first quarter of 2024. The company, which focuses on developing treatments for severe and resistant bacterial infections, is progressing well toward becoming a leader in phage therapies.

Thibaut du Fayet, CEO of PHAXIAM Therapeutics, highlighted the company's strategic focus on high medical need indications. The company is concentrating its clinical programs on severe Staphylococcus aureus infections, which are often associated with high mortality rates and significant healthcare costs. PHAXIAM is particularly focused on Prosthetic Joint Infections (PJI) and Endocarditis Infections (EI).

For PJI, PHAXIAM is preparing a global Phase 2 proof-of-concept (POC) study, which will be a multicentric, randomized, double-blind trial involving 100 patients in Europe and the US. The company aims to file a Clinical Trial Application (CTA) with both the EMA and FDA by the third quarter of 2024, and plans to begin patient enrollment in early 2025. This study is backed by promising results from compassionate treatments and the PhagoDAIR pilot study, with data expected by the end of 2024.

In the case of EI, PHAXIAM has recently started enrolling participants in a Phase 1 study to assess the safety of intravenous administration of anti-S. aureus phages. Preliminary clinical results are anticipated in the second half of 2024.

PHAXIAM's technological platform allows for the evaluation of phages in additional indications beyond PJI and EI. The company is conducting a Phase 2 POC investigator-sponsored trial targeting Diabetic Foot Ulcer (DFU) infections caused by mono-bacterial S. aureus in 60 diabetic patients across 10 French hospitals. Additionally, PHAXIAM has received validation from the French Regulatory Agency (ANSM) to initiate a Phase 1 pharmacokinetic trial for complex mono-bacterial E. coli infections in the urinary tract, subject to financing.

Financially, PHAXIAM reported cash and cash equivalents of €5.8 million as of March 31, 2024, down from €10.5 million as of December 31, 2023. The reduction in cash reflects the company's investment in R&D and regulatory activities, particularly in its S. aureus program. The current cash position is expected to fund operations until August 2024, and the company is actively working to strengthen its financial standing to support ongoing clinical development.

Key milestones expected over the next year include preliminary pharmacokinetic data from the Phase 1 EI study in the third quarter of 2024, regulatory approval for the global Phase 2 PJI study in the fourth quarter of 2024, clinical data from the PhagoDAIR pilot study by the end of 2024, and the launch of the global Phase 2 PJI study in the first quarter of 2025.

PHAXIAM held a webinar on May 15, 2024, to present the financial information for the first quarter of 2024 and provide an update on activities and future outlook. The webinar featured presentations by Thibaut du Fayet, CEO, and Eric Soyer, COO and CFO, followed by a Q&A session.

PHAXIAM Therapeutics is committed to developing innovative treatments for bacterial infections that are resistant to conventional antibiotics. The company's phage-based approach targets three of the most resistant and dangerous bacteria, which account for a significant portion of hospital-acquired infections: Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa. PHAXIAM is listed on the Euronext regulated market in Paris.