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PHAXIAM Therapeutics S.A. - PHXM STOCK NEWS

Welcome to our dedicated page for PHAXIAM Therapeutics S.A. news (Ticker: PHXM), a resource for investors and traders seeking the latest updates and insights on PHAXIAM Therapeutics S.A. stock.

PHAXIAM Therapeutics S.A. (PHXM), founded in 2004, is a pioneering biopharmaceutical company dedicated to developing innovative therapies that address unmet medical needs, with a significant focus on cancer and orphan diseases. The company leverages its proprietary technology, which is centered on the encapsulation of therapeutic molecules into red blood cells. This encapsulation method presents multiple benefits over free-form compounds, such as minimizing the risk of allergic reactions and allowing the therapeutic substance to remain active in the body for an extended period.

PHAXIAM's flagship product targets relapsed and refractory acute lymphoblastic leukemia by depriving tumors of necessary nutrients. Having completed Phase III development, this product promises a groundbreaking therapeutic solution for patients with this challenging condition. The company's state-of-the-art production facility, located in Lyon, holds “pharmaceutical establishment” status, underscoring its commitment to high-quality manufacturing standards.

PHAXIAM has strategically partnered with Orphan Europe-Recordati (for distribution in Europe) and Teva (for distribution in Israel), enhancing its global reach and ensuring that its innovative therapies are accessible to a broader patient population. Recent developments include various investigator-initiated studies funded by hospital clinical research programs, reflecting the collaborative efforts to advance medical research and patient care.

The company recently reported its FY 2023 financial results and announced the effectiveness of the voluntary delisting of its American Depositary Shares from the NASDAQ Stock Market. PHAXIAM continues to engage with its stakeholders, providing regular updates through webinars and financial disclosures. For more detailed information, stakeholders are encouraged to visit the PHAXIAM website.

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PHAXIAM Therapeutics has released its monthly report on voting rights and share capital composition for November 29, 2024. The company's total shares remained stable at 10,013,719 since October 2024. The gross voting rights slightly increased to 10,166,025, while net voting rights stood at 10,165,776.

Notable changes occurred in July 2024 when the total shares increased from 6,075,105 to 9,980,668, representing a significant expansion in the company's share capital. The report includes monthly data from December 2023 through November 2024, tracking both gross and net voting rights in accordance with French Autorité des Marchés Financiers regulations.

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PHAXIAM Therapeutics unveiled its strategic development plan focusing on phage therapy during a webinar titled 'Evolving strategic context for phages, Introducing new opportunities.' The company aims to leverage two complementary approaches: Phages Therapy Medical Product (PTMP) and Individualized Phages Therapy (IPT). Through IPT expansion in Europe, PHAXIAM targets revenues of €20M by 2027 and €100M by 2030. The PTMP model, including AAC and potential conditional market approval for Prosthetic Joint Infections, could generate €8M by 2027 and €100M by 2030. The company projects achieving operating profitability and positive free cash flow by 2027.

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PHAXIAM Therapeutics presented its IVD Phagogram test and phage susceptibility data at the first 'Phagogram Day' in Lyon on November 14, organized with Phage Canada. The event gathered international experts to discuss phagogram development and best practices. The company's phagogram test, the first CE-marked IVD test for phage activity, showed impressive results: 98.7% of Staphylococcus aureus strains were susceptible to at least one anti-S. aureus phage, while 71.3% of Pseudomonas aeruginosa strains were susceptible to at least one anti-P-aeruginosa phage through H1 2024. The data came from analyzing over 398 clinical strains.

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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.

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PHAXIAM reports its monthly voting rights and share capital composition as of October 31, 2024. The total number of shares stands at 10,013,719, with 10,165,846 gross voting rights and 10,165,597 net voting rights. The company saw a significant increase in shares from 6,075,105 in May 2024 to 9,980,668 in July 2024. The data, reported in compliance with Article 223-16 of French Autorité des Marchés Financiers regulations, shows minimal changes between October 8 and October 31, 2024.

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PHAXIAM Therapeutics has received FDA IND clearance for GLORIA, the world's first Phase II phage therapy study in Prosthetic Joint Infections (PJI) caused by Staphylococcus aureus. The multicenter, randomized, placebo-controlled study will include 100 patients across the US and Europe, with recruitment starting Q1 2025 and data readout expected Q3 2026. The study targets PJI, affecting 50-60,000 new cases yearly in Western countries, with current treatments showing 50% failure rates. The US market for anti-S. aureus phages in PJI is estimated at €600-700 million. Upon successful completion, PHAXIAM could seek Conditional Market Approval for European pre-commercialization by second half of 2027.

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PHAXIAM Therapeutics has released its monthly update on voting rights and share capital as of October 8, 2024. The company's total number of shares composing the share capital stands at 10,013,719. The total number of gross (theoretical) voting rights is 10,165,848, while the total number of net voting rights (excluding treasury shares) is 10,165,599.

The report provides a historical breakdown of these figures from December 31, 2023, to October 8, 2024. Notably, there was a significant increase in the number of shares and voting rights between May 31, 2024, and July 1, 2024. The company's shares are listed on Euronext Paris (Market segment C) under the symbol PHXM with ISIN Code FR001400K4B1.

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PHAXIAM Therapeutics announces the validation of a new investigator-initiated phase 2 study called PHAGOSCARPA. The study, sponsored by Assistance Publique – Hôpitaux de Paris (AP-HP), will evaluate the efficacy of PHAXIAM's anti-S. aureus phages for treating extra-cavitary vascular graft implant infections caused by Staphylococcus aureus. The study plans to enroll 80 patients across 27 French clinical centers.

The primary endpoint is the therapeutic success rate at 3 months, including absence of clinical infection signs, normal graft function, and absence of radiological infection evidence. The study's launch is subject to validation by the French health authority (ANSM), expected in H1 2025. PHAXIAM will supply the clinical doses and negotiate access to the generated clinical data.

Two other investigator-sponsored trials are also planned: a phase 2 study in Diabetic Foot Ulcer (60 patients) and a phase 2 study in nosocomial pulmonary infections (180 patients).

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PHAXIAM Therapeutics (Euronext: PHXM) provided a business and financial update for the first half of 2024. The company is focused on developing phage therapies for severe and resistant bacterial infections, with a strategic emphasis on Prosthetic Joint Infections (PJI). Key highlights include:

1. Imminent filing of IND and CTA for the GLORIA Phase II study in PJI, with expected regulatory approval in Q4 2024 and study launch in Q1 2025.

2. Ongoing patient enrollment for Endocarditis Infections study with results expected mid-2025.

3. Compassionate treatment data showing promising results with infection control at 3 months reaching approximately 80%.

4. Financial results: €11.7 million in operating expenses, €10.6 million net loss, and €1.5 million in cash and cash equivalents as of June 30, 2024.

5. Management changes with Frédéric Mathat succeeding Eric Soyer as CFO.

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Phaxiam has released its monthly update on the total number of voting rights and shares composing its share capital as of July 1, 2024. The company, listed on Euronext Paris under the symbol PHXM, reported a significant increase in both the total number of shares and voting rights from previous months. The share capital expanded from 6,075,105 shares on May 31, 2024, to 9,980,668 shares by July 1, 2024. Correspondingly, gross voting rights increased from 6,226,989 to 10,132,597 and net voting rights saw a similar rise from 6,226,740 to 10,132,348. These figures are important for stakeholders evaluating the company's market position and shareholder influence.

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FAQ

What is the market cap of PHAXIAM Therapeutics S.A. (PHXM)?

The market cap of PHAXIAM Therapeutics S.A. (PHXM) is approximately 19.9M.

What does PHAXIAM Therapeutics specialize in?

PHAXIAM Therapeutics specializes in developing innovative therapies for cancer and orphan diseases, utilizing its proprietary red blood cell encapsulation technology.

What is the core technology of PHAXIAM Therapeutics?

PHAXIAM's core technology involves encapsulating therapeutic molecules into red blood cells, which helps reduce allergic reactions and prolongs the active life of the substance in the body.

What is PHAXIAM's lead product?

PHAXIAM's lead product targets relapsed and refractory acute lymphoblastic leukemia by starving tumors of essential nutrients. It has completed Phase III development.

Where is PHAXIAM's production facility located?

PHAXIAM's production facility is located in Lyon, France, and holds the status of a “pharmaceutical establishment.”

Who are PHAXIAM's distribution partners?

PHAXIAM has partnered with Orphan Europe-Recordati for distribution in Europe and Teva for distribution in Israel.

What recent financial updates has PHAXIAM provided?

PHAXIAM has reported its FY 2023 financial results and announced the effectiveness of the voluntary delisting of its American Depositary Shares from the NASDAQ Stock Market.

How can I stay informed about PHAXIAM's latest developments?

You can stay informed about PHAXIAM's latest developments by visiting their official website and participating in their webinars and financial update sessions.

What recent studies has PHAXIAM been involved in?

PHAXIAM has been involved in several investigator-initiated studies funded by hospital clinical research programs.

What are the benefits of PHAXIAM’s encapsulation technology?

PHAXIAM’s encapsulation technology reduces potential allergic reactions and enables therapeutic substances to remain in the body longer, enhancing their effectiveness.

Where can I find more information about PHAXIAM Therapeutics?

More information about PHAXIAM Therapeutics can be found on their official website at www.phaxiam.com.
PHAXIAM Therapeutics S.A.

Nasdaq:PHXM

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19.86M
6.07M
2.69%
0.02%
Biotechnology
Healthcare
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France
Lyon