PHAXIAM provides Business and Financial Update for the First Quarter of 2024
PHAXIAM Therapeutics, a biopharmaceutical firm specializing in phage therapy for bacterial infections, has released its Q1 2024 business and financial update. The company is advancing its Staphylococcus aureus programs, including a global Phase 2 study for Prosthetic Joint Infections (PJI) and a Phase 1 study for Endocarditis Infections (EI). Upcoming milestones include preliminary PK data (3Q 2024) and the launch of the global Phase 2 PJI study (1Q 2025). As of March 31, 2024, PHAXIAM held €5.8 million in cash, sufficient to fund operations until August 2024. Efforts are underway to secure additional financing.
- Successful refocus on high medical need indications like severe and resistant S. aureus infections.
- Accelerated development of global Phase 2 PJI and Phase 1 EI studies.
- Multiple upcoming milestones, including PK data (3Q 2024) and PJI regulatory approval (4Q 2024).
- Technological platform allows for additional evaluations in areas like Diabetic Foot Ulcer and Urinary Tract Infections.
- Cash and cash equivalents decreased from €10.5 million to €5.8 million in Q1 2024.
- Current cash reserves can only fund operations until August 2024, necessitating additional financing.
- Financial pressure from ongoing R&D and regulatory activities.
Insights
PHAXIAM's current financial position is a key point of interest for investors. The company holds
The company's ability to fund its operations only until August 2024 highlights the urgency for securing additional financing. Investors should closely monitor upcoming fundraising activities, as dilution risk could impact shareholder value. Additionally, the financial fragility might affect the company’s strategic flexibility and ability to meet its ambitious clinical milestones.
The upcoming regulatory and clinical events, particularly the Phase 2 study in Prosthetic Joint Infections (PJI) and the Phase 1 data for Endocarditis Infections (EI), could be pivotal. Positive outcomes may attract investment, but any setbacks could exacerbate financial strain.
PHAXIAM's focus on phage therapy, particularly for severe bacterial infections like S. aureus, positions the company uniquely in the biopharmaceutical landscape. The initiation of a Phase 1 study for Endocarditis Infections and the planned Phase 2 study for Prosthetic Joint Infections are significant milestones. These studies target high unmet medical needs, often associated with high mortality and healthcare costs.
The company's strategy to leverage its phage-therapy platform for diverse indications, including Diabetic Foot Ulcer and Urinary Tract Infections, demonstrates the versatility of its technology. However, the success of these programs will depend heavily on clinical trial outcomes, regulatory approvals and operational execution.
Investors should note that the competitive landscape in antimicrobial treatments is rapidly evolving. PHAXIAM's ability to demonstrate clear clinical benefits over existing therapies will be critical for market adoption and long-term success. The forthcoming clinical data will be important in validating the efficacy and safety of their phage therapies.
PHAXIAM's clinical advancements and strategic focus on phage therapies address significant market opportunities in combating antibiotic-resistant infections. The company's move into Phase 2 for PJI and Phase 1 for EI highlights a robust pipeline aimed at high-value medical needs. The growing global market for antimicrobial resistance solutions provides a favorable backdrop for PHAXIAM's growth ambitions.
However, the market dynamics in the biopharmaceutical sector can be highly volatile and investor sentiment is often shaped by clinical trial outcomes and regulatory milestones. The planned studies and forthcoming data releases will play a important role in shaping investor confidence and market positioning.
The company's strategic direction and clinical focus potentially position it as a leader in the niche but expanding field of phage therapy. However, operational challenges and financial constraints may pose risks to sustained growth. Investors should weigh the potential market impact of successful clinical outcomes against the financial and operational risks highlighted in the update.
PHAXIAM provides Business and Financial Update
for the First Quarter of 2024
Webinar (in French) today, May 15, 2024, at 6.00 pm CEST
- Accelerated clinical efforts to roll-out PHAXIAM’s strategy in order to create a global phage-therapy leader in high-value indications
- Cash and cash equivalents of
€5.8 million , as of March 31, 2024
Lyon (France) and Cambridge (MA, US), May 15, 2024, at 5.45 pm CEST – PHAXIAM Therapeutics (Euronext: PHXM; FR0011471135), a biopharmaceutical company developing innovative treatments for severe and resistant bacterial infections, today provides a business and financial update for the first quarter of 2024.
Thibaut du Fayet, Chief Executive Officer of PHAXIAM Therapeutics, stated: “Almost a year after the creation of PHAXIAM, the company is well on track to become a leading player in phage therapies targeting the most severe bacterial infections. Indeed, we have successfully refocused our clinical programs to indications of high medical needs to provide a therapeutic alternative mainly to patients with severe and resistant Staphylococcus aureus infections, often associated with high mortality and strong impact on healthcare budgets.
This is particularly the case for Prosthetic Joint Infections, where PHAXIAM plans to strengthen its leading competitive position through an upcoming first global Phase 2 study, but also for Endocarditis Infections, with the beginning, a couple of weeks ago, of a unique Phase 1 study in this indication with phage therapy.
Beyond these two strategic clinical studies, our technological platform and know-how enable us to evaluate our phages in additional indications, such as Diabetic Food Ulcer caused by S. aureus, and potentially later, Urinary Tract Severe Infections caused by E. coli, reinforcing our ambition to develop a unique portfolio of innovative therapies for patients who failed traditional antimicrobial treatments.”
BUSINESS HIGHLIGHTS
a) Important progress for the Staphylococcus aureus (S. aureus) program
- Prosthetic Joint Infections (PJI)
- PHAXIAM is accelerating its PJI clinical development efforts through active preparations of a global Phase 2 proof-of-concept (POC) study.
- The Phase 2 POC study is intended to be a multicentric, randomized, double-blind trial and is expected to include 100 patients in Europe and the US.
- PHAXIAM confirms its objective to file a Clinical Trial Application (CTA) with the EMA and the FDA in 3Q 2024 in view of starting patient enrollment in early 2025.
- The Company intends to capitalize on promising activity signals from real-life compassionate treatments and valuable insights from the PhagoDAIR pilot study, the data of which should be available by the end of 2024.
- Endocarditis Infections (EI)
- PHAXIAM has recently initiated the enrolment of a phase 1 study (pharmacokinetic (PK) data) in Endocarditis Infections caused by S. aureus, its second sponsored clinical trial, to evaluate the safety of intravenous administration (IV) of its anti-S. aureus phages.
- Preliminary clinical results are expected in 2H 2024.
b) Complementary clinical trials and programs to confirm the versatility and the value of PHAXIAM’s phage-platform
- Diabetic Foot Ulcer (DFU): Phase 2 (POC) Investigator-Sponsored Trial
- This clinical study is targeting DFU infections due to mono-bacterial S. aureus infection in 60 diabetic patients to be enrolled across 10 French hospitals.
- Escherichia coli (E. coli) program: Phase 1 PK Trial
- Targeting patients having failed traditional antimicrobial treatment in complex mono-bacterial E. coli infections in the urinary tract due to neurogenic bladder.
- PHAXIAM has received the validation from the ANSM (French Regulatory agency) to initiate this sponsored clinical trial in France, subject to available financing.
These complementary clinical studies are the opportunity to bring additional clinical POC data in other high-value indications.
1Q 2024 FINANCIAL INFORMATION
As of March 31, 2024, PHAXIAM had cash and cash equivalents totaling
The current cash position can fund PHAXIAM’s programs and planned operating expenses into August 2024. The Company is currently working on strengthening its financial position to support its clinical development efforts.
KEY NEWSFLOW AND MILESTONES EXPECTED OVER THE NEXT 12 MONTHS
- Preliminary PK data from the Phase 1 study in EI (3Q 2024)
- Global Phase 2 study in PJI Regulatory Approval (4Q 2024)
- PhagoDAIR pilot study in PJI clinical data (end 2024)
- Launch of the global Phase 2 study in PJI (1Q 2025)
1Q 2024 WEBINAR
PHAXIAM management will hold a webinar today, May 15, 2024, at 6.00 pm CEST to present 1Q 2024 financial information and provide an update on the Company’s activity and outlook. Thibaut du Fayet, CEO, and Eric Soyer, COO and CFO, will hold a brief presentation in French, followed by a Q&A session.
The webinar can be accessed via the following link: click here
A replay of the webinar will be available on the Company's website in the following days.
FINANCIAL CALENDAR
- Annual General Meeting on June 28, 2024
- Business and Financial Update for the Second Quarter of 2024 on September 25, 2024
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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 Eric Soyer COO & CFO +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.
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