PHAXIAM Reports Third-Quarter 2024 Financial Information

Rhea-AI Summary

PHAXIAM Therapeutics reported its Q3 2024 financial results with cash and cash equivalents of €5.7 million as of September 30, 2024, up from €1.5 million in June 2024, following a €7.8 million capital increase. The company's cash runway extends until March 2025. Key upcoming milestones include clinical outcomes from compassionate treatments and PhagoDAIR pilot study by end-2024, first patient enrollment in Phase II Diabetic Foot Ulcer study in Q4 2024, initiation of GLORIA Phase II study for prosthetic joint infections in Q1 2025, and preliminary results from Phase I endocarditis study expected mid-2025.

Positive

• Successful capital raise of €7.8 million in July 2024
• FDA approval obtained for GLORIA Phase II study protocol
• Cash position increased to €5.7 million from €1.5 million in Q3 2024

Negative

• cash runway until March 2025
• Need for additional financing to extend operations beyond March 2025

Insights

Financial Analyst

The financial situation at PHAXIAM appears challenging, with a cash runway until March 2025. While the recent €7.8 million capital raise provided some breathing room, the current €5.7 million cash position suggests rapid cash burn. The company's market cap of approximately $20 million indicates significant investor skepticism.

The pursuit of multiple financing options, including cost reductions and non-dilutive funding, signals financial pressure. Without additional funding secured before Q1 2025, the company risks operational constraints that could impact its clinical development timeline, particularly the GLORIA study. The rapid depletion from €6.8 million net proceeds in July to €5.7 million by September suggests a monthly burn rate of roughly €0.5 million, raising concerns about long-term sustainability.

Medical Research Analyst

The advancement of PHAXIAM's bacteriophage therapy program shows promise, particularly with FDA approval for the GLORIA Phase II protocol targeting Staphylococcus aureus prosthetic joint infections. This represents a significant milestone as the first global bacteriophage study in this indication. The company's diversified pipeline, including studies in diabetic foot ulcers and endocarditis, demonstrates strategic positioning in high-value, antibiotic-resistant infection markets.

However, the success of these programs heavily depends on the company's ability to secure additional funding before March 2025. The upcoming clinical outcomes from compassionate use treatments will be important for validating the technology and potentially attracting investors.

• Cash and cash equivalents of €5.7 million as of September 30, 2024
• Execution of clinical strategy as planned, with the GLORIA global Phase II study initiation expected in the first quarter of 2025

Lyon (France), November 13, 2024, at 5:45 p.m. CET – PHAXIAM Therapeutics (Euronext: PHXM), a biopharmaceutical company developing innovative treatments for severe and resistant bacterial infections, today reports its financial results for the third quarter of 2024.

"The third quarter of 2024 was marked by the steady execution of our clinical roadmap. Our recent efforts have culminated in the U.S. FDA approval of the GLORIA Phase II study protocol, the first global bacteriophage study targeting prosthetic joint infections related to Staphylococcus aureus. We are actively working on the launch of patients recruitment for this strategic study in the first quarter of 2025, as planned. Financially, the funds raised in June 2024 have extended our cash runway until March 2025. We continue to assess new financing opportunities to further strengthen our financial structure and we remain confident in the execution of our strategy, which aims to establish PHAXIAM as a global leader in phage therapy for high value indications." stated Thibaut du Fayet, Chief Executive Officer of PHAXIAM.

THIRD-QUARTER 2024 FINANCIAL INFORMATION

On July 1, 2024, with the settlement-delivery of a €7.8 million capital increase, PHAXIAM's cash position increased by a net €6.8 million, after deduction of associated costs.

As of September 30, 2024, PHAXIAM reported cash and cash equivalents of €5.7 million, compared with €1.5 million as of June 30, 2024.

The Company estimates that this level of cash can fund its existing programs and expected operating expenses until March 2025. The Company is exploring all available options to extend its cash runway, including cost reduction measures, non-dilutive national and European funding, strategic and institutional investors commitments, etc.

KEY MILESTONES EXPECTED IN THE NEXT 12 MONTHS

• Clinical outcomes from updated compassionate real-life treatments and the PhagoDAIR pilot study, expected before the end of 2024
• Phase II (PHRC) study in Diabetic Foot Ulcer (DFU): first patient enrollment expected in the fourth quarter of 2024
• GLORIA Global Phase II study: clearance (CTA) from European and UK (MHRA) regulatory authorities to initiate patient enrollment in Europe
• Preliminary results from the Phase I pharmacokinetic study in endocarditis expected around mid-2025

About PHAXIAM Therapeutics

PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa.

PHAXIAM is listed on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.

For more information, please visit www.phaxiam.com

Contacts

PHAXIAM Thibaut du Fayet CEO +33 4 78 74 44 38 investors@phaxiam.com

NewCap Mathilde Bohin / Dušan Orešanský Investor Relations Arthur Rouillé Media Relations +33 1 44 71 94 94 phaxiam@newcap.eu

Forward-looking information

This press release contains forward-looking statements, forecasts and estimates with respect to the clinical programs, development plans, business and regulatory strategy and anticipated future performance of PHAXIAM and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond PHAXIAM's control. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Investor should carefully read the risk factors section of the Company which can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), including in the Company’s 2023 Universal Registration Document (Document d’Enregistrement Universel) filed with the AMF on April 5, 2024 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. PHAXIAM disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in PHAXIAM’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law.

Attachment

• PR_PHAXIAM_13112024_Q3 2024_ENG

FAQ

What is PHAXIAM's (PHXM) current cash position as of Q3 2024?

PHAXIAM reported cash and cash equivalents of €5.7 million as of September 30, 2024.

When will PHAXIAM (PHXM) initiate the GLORIA Phase II study?

PHAXIAM plans to initiate the GLORIA global Phase II study in the first quarter of 2025.

How much capital did PHAXIAM (PHXM) raise in July 2024?

PHAXIAM raised €7.8 million through a capital increase in July 2024, resulting in a net increase of €6.8 million after costs.

Until when does PHAXIAM's (PHXM) current cash runway extend?

PHAXIAM's current cash position is expected to fund operations until March 2025.