Biomx Inc. · AMEX:PHGE

Biomx — Investor Presentation (June 2025)

34 slides from Biomx's investor presentation, June 2025

  1. Slide 1: Corporate Presentation June 2025

    Clinical Stage Programs Addressing Urgent Need for Overcoming Antibiotic Resistance Corporate Presentation June 2025 NYSE American: PHGE

  2. Slide 2: Safe Harbor Statement

    SAFE HARBOR STATEMENT About this Presentation The information contained in this presentation has been prepared by BiomX Inc. and its subsidiaries (collectively, the “Company” or “BiomX”) and contains information pertaining to the business and operations of the Company. The information contained in t

  3. Slide 3: Opportunity: Clinical stage programs targeting antibiotic resistance

    Opportunity: Clinical stage programs targeting a critical threat to the global healthcare system – antibiotic resistance Phage Therapy Promise BX211 BX004 – S. aureus infections – P. aeruginosa infections Alarming rise in antimicrobial resistance signals urgent need Positive efficacy and safety Posi

  4. Slide 4: Antimicrobial Resistance: Rising concerns and limited treatment options

    Antimicrobial Resistance: Rising concerns and limited treatment options underscore the urgent need for novel therapies 42% Resistance Rate for Cephalosporin-resistant E. coli1 10M 35% Resistance Rate for Methicillin-resistant S. aureus1 Annual Deaths by 2050 WHO projected Antimicrobial Resistance Mo

  5. Slide 5: Phage Therapy: A century-old solution with renewed promise

    Phage Therapy: A century-old solution with renewed promise Key Advantages Safe Modality, Self-Amplifying No Disruption to Ability to Launch Active against Inert to Human Phages Increase Microbiome - Penetrates and Straight into Antibiotic Cells, and Efficacy of Each Targets Only Disrupts Biofilm Ear

  6. Slide 6: Phage Therapy Momentum: Growing clinical data signal a pivotal moment

    Phage Therapy Momentum: Growing clinical data signal a pivotal moment ahead1 March 2025: BiomX positive P2 data Nov. 2023: BiomX positive P1b/2a data 41 patients 43 patients Diabetic Foot Osteomyelitis Cystic Fibrosis Aug. 2024: Peer company reported May 2025: Peer company reported positive P2 Part

  7. Slide 7: BiomX—Built on a Strong Foundation

    BiomX—Built on a Strong Foundation: Backed by leaders in science, industry, and capital Strong Science & Scientific Founders Trusted by top biotech and healthcare investors Prof. Rotem Sorek Head of microbial genomics group at Weizmann Institute Phage genomics and CRISPR research ≥ $215 M Raised1 Pr

  8. Slide 8: Shared Targets, Expanded Potential

    Shared Targets, Expanded Potential: Clinical efficacy opens the door to potential additional Phase 2 studies across related infections Phase 2/3 Diabetic Foot BX211 Infection & Osteomyelitis BX211 Target: Diabetic Foot Osteomyelitis S. aureus March 2025, Positive Phase 2 Phase 2 Ready statistically

  9. Slide 9: BiomX's Groundbreaking Phase 2 Results

    BiomX's Groundbreaking Phase 2 Results Diabetic Foot Osteomyelitis (BX211): Cystic Fibrosis (BX004, on top of continuous SoC): -2.91 log10 CFU/g The 1st multi-center, double-blind, placebo- Demonstration of ability of phage to convert chronic lung controlled clinical study to demonstrate statistical

  10. Slide 10: BX211 Diabetic Foot Infections & Diabetic Foot Osteomyelitis

    BX211 Diabetic Foot Infections & Diabetic Foot Osteomyelitis (DFI & DFO)

  11. Slide 11: Disease Burden: DFI & DFO drive diabetic amputations

    Disease Burden: DFI & DFO drive diabetic amputations, burdening the healthcare system DFI to DFO Staphylococcus aureus is Bacterial infection the most common bacteria spreading from soft present in DFI / DFO tissue to bone Superficial ulcer DFI DFO Standard of Care Moderate-to-severe DFI & DFO SoC:

  12. Slide 12: Phase 2 Study Design

    Phase 2 Study Design: Multicenter, double blind, placebo- controlled study to assess improvement of clinical outcomes Primary Endpoint: Percent area reduction of study ulcer through Week 13 Duration: 12 weeks of once weekly treatment Enrollment: BX211 IV in week 1, topical for 12 weeks Week 13 Week

  13. Slide 13: Results Highlight: Phase 2 diabetic foot osteomyelitis

    Results Highlight: Phase 2 diabetic foot osteomyelitis Statistically significant Safe and well-tolerated improvements in ulcer depth in patients with ulcers at bone depth Sustained and statistically significant PAR ulcer size Favorable trends reduction1 compared to placebo  Separation from placebo

  14. Slide 14: Efficacy (1): BX211 reduction in ulcer surface area

    Efficacy (1): BX211 showed clinically relevant, statistically significant1, reduction in ulcer surface area Percent Area Reduction (PAR) from baseline of ulcer surface area (LS Mean ± SE)2 (See detailed data in next slide) From week 10 and on, P=0.046 BX211 showed an ulcer >40% surface area reductio

  15. Slide 15: Efficacy (2): BX211 reduction in ulcer surface area

    Efficacy (2): BX211 showed clinically relevant, statistically significant2, reduction in ulcer surface area Percent Area Reduction (PAR) from baseline of ulcer surface area (LS Mean ± SE)1 (Detailed data from previous slide) BX211 Placebo PAR at week: Difference (95% CI) P-value2 N (%) Mean (95% CI)

  16. Slide 16: Efficacy (3): Better recovery for ulcers at bone depth

    Efficacy (3): Patients with ulcers at bone depth1 displayed statistically significant2 better recovery in the BX211 group Change in tissue involvement of the ulcer for weeks 1 and 131 Depth Measurement Tissue3 Healed BX211 (N=13) Placebo (N=9) Dermis Below Dermis Week 1 Week 13 Week 1 Week 13 Bone 1

  17. Slide 17: Cystic Fibrosis and NCFB

    BX004 Cystic Fibrosis and NCFB

  18. Slide 18: Cystic Fibrosis: Chronic pulmonary infections primary causes of death

    Cystic Fibrosis: Chronic pulmonary infections and the inflammatory response are primary causes of death in CF Cystic Fibrosis Thickened Thick, sticky mucus traps bacteria and hinders Thick mucus promotes Mucus normal airway clearance, fostering chronic lung chronic bacteria infections, often driven

  19. Slide 19: Phase 1b/2a Study Design

    Phase 1b/2a Study Design: Multicentered, double blind, placebo- controlled study to assess safety, reduction of PsA burden and improvement in clinical outcomes Part 11 Part 2 Enrollment: BX004 7 days - Single 10 days of same ascending dose followed dose, twice daily 43 CF patients by multiple doses2

  20. Slide 20: Results Highlight: Phase 1b/2a cystic fibrosis

    Results Highlight: Phase 1b/2a cystic fibrosis (Part 1 and 2) Study drug was well-tolerated Reduction in bacterial load Culture conversion Clinical efficacy Part 1, at Day 15: -1.42 log10 CFU/g Part 2, in the BX004 arm, 3 of 21 BX004 showed signals of (BX004) compared to -0.28 log10 (14.3%) patients

  21. Slide 21: Efficacy (1): BX004 greater reduction in PsA levels

    Efficacy (1): BX004 demonstrated greater reduction in PsA levels compared to placebo PART 1 (after 7d of treatment): PART 2 (on top of continuous SoC): -2.91 log10 CFU/g CFU/g log change from Baseline: Mean (SE) BX004 Placebo BX004 (N=7)1 Placebo (N=5) Difference n 7 2 D4 -2.71 (1.21) 0.18 (0.64) -2

  22. Slide 22: Efficacy (2): BX004 greater culture conversion

    Efficacy (2): BX004 showed greater conversion (bacterial culture turned negative) in treatment over placebo In the BX004 arm 3 out of 21 (14.3%) patients converted to sputum culture negative for P. aeruginosa after 10 days of treatment (2 already after 4 days)2. In the placebo arm 0 out of 10 (0%)2

  23. Slide 23: Efficacy (3): BX004 clinical improvement after 10 days

    Efficacy (3): BX004 shows meaningful clinical improvement after 10 days of treatment in multiple clinical readouts 1 ppFEV1 CFQR (respiratory) Treatment Follow up Treatment Follow up BX004 BX004 Clinical improvements Placebo Placebo were observed on both # objective & patient reported outcomes 5.67%

  24. Slide 24: Phase 2b Study: Study design

    Phase 2b Study: Study design International, multicenter, double blind, placebo-controlled study to assess reduction of PsA burden and improvement in clinical outcome Part 2b BX004 2 months of same dose, Enrollment: twice daily Objective: ~60 CF patients1 with chronic PsA infections 2 months 6 months

  25. Slide 25: Real-world Evidence: Potential for accelerated approval

    Real-world Evidence: Potential for accelerated approval1 Peer-reviewed publications demonstrated that P. aeruginosa (PsA) reduction improves patient outcomes, and ongoing real-world evidence (RWE) analysis may support regulatory filings Journal of Cystic Fibrosis 22 (2023) 98–102 Pediatric Pulmonolo

  26. Slide 26: NCFB: A promising next candidate

    NCFB: A promising next candidate given its medical similarity to cystic fibrosis Non-Cystic Fibrosis Worse Clinical Symptoms and More Inpatient / Outpatient Encounters Associated with PsA Infections2 Bronchiectasis (NCFB) Inpatient Admissions Outpatient Admissions per Pt (1 yr) per Pt (1 yr) 2.6 PsA

  27. Slide 27: CMC & IP

    CMC & IP

  28. Slide 28: GMP Production Experience

    GMP Production Experience Internal GMP Facility (BiomX):  10 drug substance (DS) batches at 4–20L scale  Clinical-scale master phage seed (MPS) manufacturing (~300 vials)  DP cream/gel manufacturing (up to 11kg batches in 50g containers) Integrated model  Sterile drug product (DP) manufacturing

  29. Slide 29: BiomX Manufacturing Capabilities

    BiomX Manufacturing Capabilities Area 400 m2 Grade D - DP Grade D - DP Class B,C and D Room's Grade D Fully controlled clean rooms classifications Dry product Warehouse (temp., pressure, RH) Phage production - 2,000L Grade C Grade Grade per year USP+DSP C– D- USP DSP No. of production 2 Phage produc

  30. Slide 30: Robust IP Portfolio Protecting Core Phage Assets Through 2045

    Robust IP Portfolio Protecting Core Phage Assets Through 2045 • 3 patent families with expirations through 2045, covering key aspects of phage discovery, formulation, and application • 2 families in national phase (USA, Europe, Japan, Australia, Canada, China) and 1 in pre-PCT stage, ensuring global

  31. Slide 31: Summary

    Summary

  32. Slide 32: Driving Next Phase of Growth

    Driving Next Phase of Growth ANTIBIOTIC PHAGE THERAPY - FINANCING AND RESISTANCE MOMENT HAS ARRIVED BX211 BX004 INVESTORS Rapidly growing global Rapidly growing global The incidence of moderate- Pseudomonas aeruginosa Publicly traded (NYSE concern, driving the need concern, driving the need severe D

  33. Slide 33: Strong Leadership

    Strong Leadership Management Board of Directors Russell Greig, PhD Jonathan Solomon Greg Merril Chairman of the Board Chief Executive Officer, Director Director Former president of GSK Pharma International Former co-Founder and CEO Proclara Former CEO APT, founding CEO of & SR one, GSK corporate ven

  34. Slide 34: Reputable Investors & Partners

    Reputable Investors & ≥ $215 M Partners 3 Patent Raised Families ~$40M Non-Dilutive Robust Scientific Expertise 2 Phage Therapy ≥ 50% PhDs in Leadership Programs Strong 2 Phase 2 ≥ $4 B Addressable Manufacturing Studies Market World-wide Capabilities 34

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