Phage therapy

BiomX Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, April 3, 2024
DFO, OrbiMed, NESS, Cystic Fibrosis Foundation, APT, FEV1, Part, Phage therapy, Patient, Orphan, KOL, Acquisition, Șaeș, Cystic fibrosis, Infection, Therapy, Pseudomonas aeruginosa, Pharmaceutical industry

CAMBRIDGE, Mass. and NESS ZIONA, Israel, April 03, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • and NESS ZIONA, Israel, April 03, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Initial top line results of the Phase 2 trial are expected in the first quarter of 2025.
  • However, our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
  • ET to discuss its fourth quarter and full year 2023 financial results and to provide a corporate update.

BiomX Announces Closing of the Acquisition of Adaptive Phage Therapeutics and Concurrent $50 Million Financing

Retrieved on: 
Monday, March 18, 2024
DFO, McDermott Will & Emery, NESS, Cystic Fibrosis Foundation, APT, Phage therapy, Patient, Cystic fibrosis, LLP, Acquisition, Cooley LLP, Infection, OrbiMed, RBC Capital Markets, Pharmaceutical industry

CAMBRIDGE, Mass. and NESS ZIONA, Israel, March 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (together with its subsidiaries and/or associates, “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the closing of its previously announced (March 6, 2024) acquisition (the “Acquisition”) of Adaptive Phage Therapeutics, Inc. (“APT”), a U.S.-based privately-held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections, and its previously announced $50 million private placement to certain institutional accredited investors, which was led by affiliates of Deerfield Management Company and the AMR Action Fund, and additional investors including the Cystic Fibrosis Foundation, OrbiMed and Nantahala Capital.

Key Points: 
  • “We are very pleased to announce the closing of the APT acquisition, which creates a leading phage company and an advanced pipeline that includes two Phase 2 assets each aimed at treating serious infections with unmet medical need,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • “We also appreciate the continued support of leading institutional healthcare investors.
  • Haynes and Boone, LLP served as legal counsel to BiomX.
  • Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel to the placement agents.

BiomX Announces Entry into Merger Agreement with Adaptive Phage Therapeutics and Concurrent $50 Million Financing

Retrieved on: 
Wednesday, March 6, 2024
Conference call, Pseudomonas aeruginosa, DFO, Staphylococcus, Infection, Biotechnology, Cystic fibrosis, EST, NESS, Sale, Conference, Staphylococcus aureus, Amputation, Cystic Fibrosis Foundation, Phage therapy, Patient, APT, OrbiMed, Pharmaceutical industry

CAMBRIDGE, Mass. and NESS ZIONA, Israel, March 06, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (together with its subsidiaries and/or associates, “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that it has entered into a definitive merger agreement with Adaptive Phage Therapeutics, Inc. (“APT”), a U.S.-based privately-held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections (the “Acquisition”). Immediately after the effective time of the Acquisition, and before giving effect to the concurrent private placement the former stockholders of BiomX will own approximately 55% and the former stockholders of APT will own approximately 45% of the consolidated entity of BiomX and APT. The Acquisition is expected to close within the next 30 days, subject to the satisfaction of the closing conditions described in the definitive merger agreement. Concurrently with entering into the definitive merger agreement, BiomX entered into a definitive purchase agreement for the sale of shares of newly created non-voting convertible preferred stock (“Series X Preferred Stock”) and warrants to purchase shares of BiomX common stock in a private placement to certain institutional accredited investors led by affiliates of Deerfield Management Company and the AMR Action Fund, and additional investors including the Cystic Fibrosis Foundation, OrbiMed and Nantahala Capital. The private placement is expected to result in gross proceeds to BiomX of $50 million before deducting placement agent and other offering expenses. The proceeds from the private placement are expected to provide funding through the results from a planned Phase 2b trial that will evaluate BiomX’s lead product candidate, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa) in CF patients expected in the third quarter of 2025 and Phase 2 results from APT’s clinical-stage product candidate, now named BX211, for the treatment of Staphylococcus aureus (S. aureus) infections in DFO patients expected in the first quarter of 2025. The private placement is expected to close substantially concurrently with, and subject to the closing of, the Acquisition.

Key Points: 
  • Immediately after the effective time of the Acquisition, and before giving effect to the concurrent private placement the former stockholders of BiomX will own approximately 55% and the former stockholders of APT will own approximately 45% of the consolidated entity of BiomX and APT.
  • The Acquisition is expected to close within the next 30 days, subject to the satisfaction of the closing conditions described in the definitive merger agreement.
  • The private placement is expected to result in gross proceeds to BiomX of $50 million before deducting placement agent and other offering expenses.
  • The private placement is expected to close substantially concurrently with, and subject to the closing of, the Acquisition.

BiomX to Host Virtual Key Opinion Leader (KOL) Event to Review the Positive Results from Part 2 of Phase 1b/2a Trial of BX004 in Cystic Fibrosis Patients with Chronic Pseudomonas aeruginosa Infections on December 4, 2023

Retrieved on: 
Thursday, November 30, 2023
Urinary tract infection, University of California, Disease, Cystic fibrosis, Mortality, Pseudomonas aeruginosa, University, Phage therapy, Infection, Part, BOLT, Patient, NESS, KOL, Pharmaceutical industry

(University of California, San Diego), who will discuss phage therapy, the current treatment landscape, and the unmet medical need in cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (P. aeruginosa) respiratory infections.

Key Points: 
  • (University of California, San Diego), who will discuss phage therapy, the current treatment landscape, and the unmet medical need in cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (P. aeruginosa) respiratory infections.
  • Jonathan Solomon, Chief Executive Officer of BiomX, will review topline results from Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, as a potential treatment for chronic pulmonary infections caused by P. aeruginosa in CF patients.
  • BiomX is developing BX004, utilizing its proprietary BOLT platform, to address a significant unmet need facing thousands of CF patients who require new treatments to combat persistent and deadly lung infections.
  • P. aeruginosa is a main contributor to morbidity and mortality in patients with CF.

BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

Retrieved on: 
Wednesday, November 29, 2023
Patient, Colistin, Culture, Infection, Division, Șaeș, Tobramycin, Aztreonam, Lung, Cystic fibrosis, FEV1, Pediatrics, Therapy, Pseudomonas aeruginosa, University, Phage therapy, Part, Safety, NESS, KOL, Pharmaceutical industry

“These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, Chief Executive Officer of BiomX.

Key Points: 
  • “These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • Patients were on the same inhaled antibiotic (tobramycin, aztreonam, or colistin) from Day 1-10 (treatment period) and through Day 28 of the study.
  • BX004 vs. placebo showed a positive clinical effect in a predefined subgroup of patients with reduced baseline lung function (FEV1
  • BiomX management will host a conference call and webcast today at 9:00 am ET to review the results of Part 2 of the Phase 1b/2a trial results.

PHAXIAM Provides Business and Financial Update for the Third Quarter of 2023

Retrieved on: 
Tuesday, November 14, 2023
Webcast, Research, POC, European Medicines Agency, Lysin, Therapy, Infection, Conference call, Bank statement, S. aureus, Escherichia coli, S, Risk, Mortality, Phage therapy, EMA, ANSM, Patient, CET, AAC, FDA, Klebsiella pneumoniae, Fungal infection, Health, Pseudomonas aeruginosa, Partnership, CMC, IVD, EI, Cryptocurrency, Pharmaceutical industry, Dietary supplement, Medical device, Vaccine, Conference, Bloodstream infections

The enrollment is targeted to start by the end of 2023 and the first study results are expected in mid-2024.

Key Points: 
  • The enrollment is targeted to start by the end of 2023 and the first study results are expected in mid-2024.
  • Key financial figures for the first nine months of 2023 compared with the same period of the previous year are summarized below.
  • In the context of the Erytech-Pherecydes merger, PHAXIAM’s consolidated financial statements in IFRS standards include ex-Pherecydes financial results as from the date of the merger, i.e.
  • Consequently, PHAXIAM’s P&L information for the first 9 months of 2023 include 9 months of ex-Erytech activities and ex-Pherecydes activities since June 23, 2023.

PHAXIAM Therapeutics obtains authorizations to launch its phase 1 study in endocarditis infections caused by Staphylococcus aureus

Retrieved on: 
Tuesday, October 24, 2023
Fungal infection, Stroke, Phage therapy, Staphylococcus aureus, Incidence, National Agency for Food and Drug Administration and Control, Heart, Medication, Teaching hospital, Hope, Mortality, Endocarditis, Safety, ANSM, Infection, CEST, Pharmacokinetics, Endocardium, Clinical trial, S. aureus, Jean-Pierre du Teil, Bacteria, Blood, S, Therapy, Patient, Heart failure, CPP, Pharmaceutical industry

Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria.

Key Points: 
  • Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria.
  • The main cause of endocarditis infections, S. aureus, is responsible for around 30%1 of cases.
  • Pascal Birman, Chief Medical Officer of PHAXIAM Therapeutics, stated: "This phase 1 study was designed primarily to assess the safety and pharmacokinetics of our anti-S. aureus phages in the treatment of endocarditis infections.
  • The treatment of endocarditis infections caused by S. aureus using phage therapy could thus offer a major alternative and hope to many patients who have reached a therapeutic impasse.”

PHAXIAM Therapeutics announces high coverage performance of its two anti-Staphylococcus aureus phages over clinical strains

Retrieved on: 
Monday, October 9, 2023
IVD, Salvage therapy, PST, CEST, Therapy, Phage therapy, AAC, Staphylococcus aureus, Medical device, Pharmaceutical industry

A retrospective analysis was carried out with 105 clinical Staphylococcus aureus strains which were tested using PHAXIAM’s phagogram in the context of clinical trials, salvage therapy and early access program (AAC).

Key Points: 
  • A retrospective analysis was carried out with 105 clinical Staphylococcus aureus strains which were tested using PHAXIAM’s phagogram in the context of clinical trials, salvage therapy and early access program (AAC).
  • The results demonstrated that 98% of these pathogenic S. aureus strains were susceptible to at least one of the two PHAXIAM’s anti-S. aureus phages (PP1493 and PP1815).
  • Phagogram is an in vitro diagnostic (IVD) test designed to determine the in-vitro activity of PHAXIAM’s phages to patients’ bacterial strains.
  • The 98% spectrum of activity of our anti-S. aureus phages is exceptionally high when compared with other competing solutions.

BiomX Announces Completion of Patient Dosing in Part 2 of the Phase 1b/2a Study Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

Retrieved on: 
Wednesday, October 4, 2023
Part 1, Trial of the century, Phage therapy, Cystic fibrosis, Part, ECFS, Fright Night Part 2, ERS, Pseudomonas aeruginosa, Congress, Patient, Randomness, Nebulizer, European Respiratory Society, NESS, CF, NYSE, Pharmaceutical industry

CAMBRIDGE, Mass. and NESS ZIONA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the completion of patient dosing in Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”). The Company remains on track to report results from Part 2 of the study in November 2023.

Key Points: 
  • and NESS ZIONA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the completion of patient dosing in Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”).
  • The Company remains on track to report results from Part 2 of the study in November 2023.
  • “BX004 has been designed to address a significant unmet need facing thousands of CF patients who require new treatments to combat persistent and deadly lung infections,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • “With patient dosing now complete in Part 2 of our Phase 1b/2a study, we remain on track to announce results next month.

PHAXIAM Therapeutics and Vetophage Announce Strategic Research Collaboration

Retrieved on: 
Tuesday, October 3, 2023
Heart, Human, Partnership, Infection, Research, Animal, CEST, Phage therapy, Knowledge, Health, Therapy, Pharmaceutical industry, Antibiotics

Strategic research partnership between PHAXIAM Therapeutics and Vetophage, a biotechnology company specialized in veterinary phage therapy

Key Points: 
  • Strategic research partnership between PHAXIAM Therapeutics and Vetophage, a biotechnology company specialized in veterinary phage therapy
    Lyon (France) and Cambridge (MA, US), October 03, 2023 – 10:05 pm CEST – PHAXIAM Therapeutics (Nasdaq & Euronext: PHXM) and Vetophage, a company specialized in phage therapy applied to animal health, announce the signature of a long-term strategic research partnership to combine their expertise in the research of new phages and phage-derived proteins (endolysins) in the fight against antimicrobial resistance.
  • The company enables PHAXIAM Therapeutics to screen its broad phage and endolysin bank targeting highly antimicrobial-resistant infections.
  • This agreement gives PHAXIAM Therapeutics exclusive licensing options on specified phages and endolysins in human health from the Vetophage platform, to further strengthen its product portfolio.
  • « The agreement with Vetophage is a significant milestone for PHAXIAM Therapeutics' development in the fight against severe resistant infections.