BX003 / BiomX - LARVOL DELTA

BiomX Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update (BioSpace) - "Research and development ('R&D') expenses, net were $16.2 million for the year ended December 31, 2022, compared to $22.7 million for the prior year. The decrease was primarily due to a decrease in salaries and related expenses and stock-based compensation expenses due to a reduction in workforce, as a result of a corporate restructuring; as well as discontinuing pausing the development of BX003, our product candidate for inflammatory bowel disease and delaying the development of BX005, our product candidate for atopic dermatitis."

Commercial • Atopic Dermatitis • Immunology • Inflammatory Bowel Disease

BiomX Reports Third Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Research and development expenses, net were $3.5 million for the three months ended September 30, 2022, compared to $6.6 million for the same period in 2021. The decrease is primarily due to a decrease in salaries and related expenses and stock-based compensation expenses driven by a reduction in personnel, as part of the corporate restructuring the Company announced in May of this year, as well as pausing the development of BX003, the product candidate for the treatment of Inflammatory Bowel Disease and Primary Sclerosing Cholangitis..."

Commercial • Immunology • Inflammatory Bowel Disease

BiomX Reports Second Quarter 2022 Financial Results and Provides Business Update (Businesswire) - "Research and development ('R&D') expenses, net were $4.6 million for the three months ended June 30, 2022, compared to $3.8 million for the same period in 2021. R&D expenses, net were $9.5 million for six months ended June 30, 2022, as well as for the six months ended June 30, 2021....An additional offset is due to pauses in the development of BX003, the product candidate for the treatment of IBD..."

Commercial • Immunology • Inflammatory Bowel Disease

BiomX Announces Publication in Cell of Research Demonstrating Proof-of-Concept Assessment of Orally Administered Phage Treatment in Preclinical Model of Inflammatory Bowel Disease (Businesswire) - "Provides Further Rationale for BiomX’s BX003 Phage Candidate Targeting Klebsiella Pneumoniae for Treatment of IBD; Positive Results Also Demonstrated in a First-in-Human Randomized, Single-Blinded, Placebo-Controlled Clinical Trial...BiomX Inc...announced the publication of a scientific paper...in the journal, Cell. The research was conducted across several organizations, including scientists from BiomX and the Weizmann Institute of Science (Rehovot, Israel)."

P1 data • Preclinical • Immunology • Inflammatory Bowel Disease

Efforts to advance the Company’s IBD product candidate, BX003, and colorectal cancer product candidate are currently expected to resume during 2023. (BioSpace) - "Research and development ('R&D') expenses, net were $4.9 million for the three months ended March 31, 2022, compared to $5.7 million for the same period in 2021. The decrease was primarily due to pauses in the development of BX003, the product candidate for the treatment of IBD..."

Commercial • Immunology • Inflammatory Bowel Disease

BiomX Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update (BioSpace) - "Inflammatory Bowel Disease ('IBD') and Colorectal Cancer Programs: BiomX’s IBD product candidate, BX003, is planned to enter its clinical trial in 2023..."

New trial • Immunology • Inflammatory Bowel Disease

BiomX Reports Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Consistent with the new strategic focus on CF and AD programs and the efficient deployment of BiomX capital, the Company plans to temporarily pause its development efforts in IBD and colorectal cancer until early 2023, as neither program would otherwise be expected to yield proof-of-concept data in patients through the end of 2022."

Clinical data • Trial suspension • Immunology • Inflammatory Bowel Disease

BiomX To Host Key Opinion Leader Event on BX003 for the Treatment of Inflammatory Bowel Disease (GlobeNewswire) - "BiomX Inc...announced that that the Company will host a virtual key opinion leader ('KOL') webinar on BX003 for the treatment of inflammatory bowel disease ('IBD') on Wednesday, May 26, 2021 at 8:00 AM EDT...BiomX plans to advance into a Phase 1b/2a study aimed at evaluating safety, tolerability, and efficacy of BX003 in reduction of the bacterial target with results expected by the second quarter of 2022."

P1/2 data • Immunology • Inflammatory Bowel Disease

BiomX Announces Positive Results of a Phase 1a Pharmacokinetic Study for Inflammatory Bowel Disease/Primary Sclerosing Cholangitis (IBD/PSC) Evaluating Delivery of Oral BX002 Phage Therapy (Businesswire) - P1a, N=18; "BiomX Inc...announced positive results of a first-in-human Phase 1a pharmacokinetic study of BX002...BX002 was demonstrated to be safe and well-tolerated...the study met its objective of delivering high concentrations of viable phage to the gastrointestinal tract of approximately 1010 PFU (plaque forming units)...BiomX plans to advance to a Phase 1b/2a study evaluating the efficacy of BX003...Results from the Phase 1b/2a study are expected by mid-2022."

New P1/2 trial • P1 data • P1/2 data • Immunology • Inflammatory Bowel Disease

BiomX Presents Preclinical Results of Phage Targeting Klebsiella pneumoniae for Primary Sclerosing Cholangitis and Inflammatory Bowel Disease (Businesswire) - "BiomX Inc...today announced that phages identified by BiomX with a broad host range were able to target and eradicate 89 percent of distinct gut-harbored Klebsiella pneumoniae strains isolated from samples obtained from patients with inflammatory bowel disease (IBD) and primary sclerosing cholangitis (PSC)....In addition, oral administration of selected phage demonstrated efficacy in reducing target bacterial load in an in vivo model."

Preclinical • Immunology • Inflammatory Bowel Disease

BiomX Reports Third Quarter 2020 Financial Results and Announces Expanded Portfolio of Phage Therapy Candidates (Businesswire) - "Improvements in R&D also allow for the consolidation of our inflammatory bowel disease (IBD) and primary sclerosing cholangitis (PSC) programs. We now have one improved, broad host range product candidate, BX003...developed for both indications. The consolidation of these programs results in an updated timeline for Phase 1b/2a results with BX003 expected in mid-2022...Results of a Phase 1a study are expected in the first quarter of 2021."

P1 data • P1/2 data • Inflammatory Bowel Disease