Biomx Inc. · AMEX:PHGE
Biomx — Investor Presentation (March 2025)
40 slides from Biomx's investor presentation, March 2025
Slide 1: Revolutionizing the Treatment of Infections Associated with Chronic Disease Through Phage Therapy
Revolutionizing the Treatment of Infections Associated with Chronic Disease Through Phage Therapy INVESTOR PRESENTATION March 2025 NYSE American: PHGE 1
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
Slide 3: At-a-Glance
AT-A-GLANCE Company Clinical stage biotech harnessing the therapeutic potential of phage therapy Treatment of underlying persistent infections in chronic diseases that become harder to treat as antibiotic-resistant pathogens emerge • Pulmonary infections in Cystic Fibrosis (CF) and Non-Cystic Fibros
Slide 4: Our Science: Phage Therapies
OUR SCIENCE PHAGE THERAPIES 4
Slide 5: Phage: Nature's tool to target bacteria
Phage: Nature’s tool to target bacteria KILLING MECHANISM ORTHOGONAL 2 TO ANTIBIOTICS 1 SPECIFIC Phage proteins burst bacterial Each phage binds only to specific bacterial cell wall from within strains 3 BREAKDOWN BIOFILM 5 SAFETY PROFILE Phage can breakdown biofilm (a polysaccharide mesh 100s of co
Slide 6: Phage therapy picking up momentum
Phage therapy picking up momentum >50 compassionate cases utilizing BiomX phage 100 cases of compassionate phage treatment (Belgian By Indication consortium)2 • 35 hospitals, 29 cities • Clinical improvement reported Other in 77% of cases Feb. 2019 Lung Wound infection infection Phage LVAD infection
Slide 7: Accumulating clinical efficacy and safety data for phage therapy in the industry
Accumulating clinical efficacy and safety data for phage therapy in the industry1 BiomX positive P2 data, March. 2025 5 • 41 patients BiomX positive • Diabetic Foot Osteomyelitis P1b/2a Part 2 data, BiomX positive P1b/2a Nov. 2023 Part 1 data, Feb. 2023 • 34 patients 100 cases of compassionate phage
Slide 8: Pipeline: Addressing Chronic Disease with Hard-to-treat Bacterial infections
Pipeline: Addressing Chronic Disease with Hard-to-treat Bacterial infections BiomX harnesses its proprietary platform to develop novel phage therapies to treat underlying persistent infections in chronic diseases that become harder to treat as antibiotic-resistant pathogens emerge Preclinical Clinic
Slide 9: BX004 Cystic Fibrosis and NCFB
BX004 CYSTIC FIBROSIS and NCFB 9
Slide 10: Chronic pulmonary infections and the inflammatory response are a primary cause of death in CF patients
Chronic pulmonary infections and the inflammatory response are a primary cause of death in CF patients CF causes severe damage to the lungs, digestive system and other organs with > 80% of deaths from respiratory failure. 105K individuals are estimated to live with CF worldwide, with 33k in the US a
Slide 11: Pseudomonas aeruginosa bacteria are associated with decreased lung function (FEV1) in CF patients
Pseudomonas aeruginosa (PsA) bacteria are associated with decreased lung function (FEV1) in CF patients PsA colonization associated with lower FEV11 PsA colonization associated with lower FEV12 Eradicated – Cleared early/first Arrows show aggregates time PsA when treated with the of PsA (red) within
Slide 12: BX004 – proprietary phage cocktail to treat CF patients with chronic PsA lung infections
BX004 – BiomX’s proprietary phage cocktail has the potential to treat CF patients with chronic PsA lung infections BX004 Product – Proprietary phage cocktail targeting PsA Patient population – CF patients with chronic PsA lung infections Delivery – Nebulized Key features – Potentially effective on a
Slide 13: Phase 1b/2a Study Design
PHASE 1B/2A STUDY – Study design1 Multicentered, double blind, placebo controlled study to asses safety, reduction of PsA burden and improvement in clinical outcomes BX004 Part 1 Part 2 Total enrollment: 7 days - Single 10 days of same ascending dose dose, twice daily 43 CF patients with chronic PsA
Slide 14: Phase 1b/2a – Result highlights (Parts 1 and 2)
Phase 1b/2a – Result highlights (Parts 1 and 2) • Study drug was well-tolerated • In Part 1, Mean PsA CFU/g1 reduction at Day 15: -1.42 log10 CFU/g (BX004) compared to -0.28 log10 CFU/g (placebo) • Culture conversion: Part 2, in the BX004 arm, 3 of 21 (14.3%) patients converted to sputum culture neg
Slide 15: Part 1: BX004 demonstrated greater reduction in PsA levels compared to placebo
PART 1 BX004 demonstrated greater reduction in PsA levels compared to placebo BX004 Placebo n 7 2 Mean reduction (SD) -1.42 (1.03) -0.28 (0.13) Log10 CFU/g Max, Min -3.27, -0.37 -0.37, -0.18 1. CFU– Colony forming units 15
Slide 16: Part 2: BX004 showed greater conversion in treatment over placebo
PART 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 Patient
Slide 17: Part 2: BX004 shows meaningful clinical improvement after 10 days of treatment
PART 2 BX004 shows meaningful clinical improvement after 10 days of treatment in multiple clinical readouts 1 ppFEV1 CFQR (respiratory) Treatment Follow up Treatment Follow up Clinical improvements were observed BX004 BX004 Placebo Placebo on both objective & patient reported # outcomes 5.67% 8.87 C
Slide 18: Phase 2b 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 BX004 Part 2b Total enrollment: 2 months of same dose, twice daily Objective: ~60 CF patients with chronic PsA infections 2 months 6
Slide 19: Bacterial Reduction Potential Regulatory Endpoint
Bacterial Reduction Potential Regulatory Endpoint Evaluating Real-World Evidence Peer-reviewed publications demonstrated that P. aeruginosa reduction improves patient outcomes, and ongoing real-world evidence (RWE) analysis may support regulatory filings Journal of Cystic Fibrosis 22 (2023) 98–102 P
Slide 20: BX004 is a promising candidate for treating NCFB
BX004 is a promising candidate for treating NCFB Non-Cystic Fibrosis Characterized by permanent No FDA approved treatments. NCFB patients infected with Bronchiectasis (NCFB) is a dilatation of the bronchi Insmed recently announced PsA present worse clinical chronic progressive inflammatory caused by
Slide 21: BX211 Diabetic Foot Infections & Diabetic Foot Osteomyelitis (DFI & DFO)
BX211 Diabetic Foot Infections & Diabetic Foot Osteomyelitis (DFI & DFO) 21
Slide 22: High unmet need in DFI & DFO
High unmet need in DFI & DFO • DFI is a bacterial infection of the soft tissue of the foot in patients with diabetes • In DFO the infection spreads from the adjacent infected soft tissue to the bone Staphylococcus aureus is 1. Superficial ulcer 2. DFI - Ulcer deepens 3. DFO – Ulcer and the most comm
Slide 23: Amputations in diabetic patients are an enormous burden to the health system
Amputations in diabetic patients are an enormous burden to the health system >38M Individuals diagnosed with ~$50K Amputation costs Patients diabetes, US 2024 Cost (direct), per patient, US Staggering economic burden ~400K ER hospital visits due to ~$8bn Diabetic amputations cost the US healthcare I
Slide 24: No new anti-infectives approved in the US for DFI and DFO in the last 20 years
No new anti-infectives approved in the US for DFI and DFO in the last 20 years Most recent anti-infectives approved for the treatment of DFI: Year of approval Drug Study type Endpoint (for DFI) Primary: Clinical success : cure or improvement Zosyn (Pfizer), 1 non-inferiority Secondary: Bacteriologic
Slide 25: Biofilm and antibiotic resistance among key drivers of treatment failure
Biofilm and antibiotic resistance among key drivers of treatment failure S. aureus forms biofilm patches in diabetic foot ulcers Key drivers of treatment failure: • Biofilm – lead to greater remittance to antibiotics • Poor blood supply limits effectiveness of IV/oral S. aureus bacteria (green) anti
Slide 26: BX211 phage treatment for moderate to severe DFI & DFO patients with S. aureus
BX211 phage treatment for moderate to severe DFI & DFO patients with S. aureus Product – Proprietary phage treatment targeting S. aureus Patient population – Moderate to severe DFI & DFO patients with S. aureus infection BX211 (note: moderate-severe DFI and DFO patient populations overlap) Delivery
Slide 27: Phase 2 Study Design
PHASE 2 – Study design Multicenter, double blind, placebo controlled study to assess improvement of clinical outcomes BX211 Duration: 12 weeks of once weekly treatment Enrollment: IV in week 1, topical for 12 weeks Week 52 41 patients with Diabetic Week 13 (readout 1) (Follow Up) Foot Osteomyelitis
Slide 28: Results highlight – Phase 2 Diabetic Foot Osteomyelitis
Results highlight – Phase 2 Diabetic Foot Osteomyelitis • BX211 was safe and well-tolerated • BX211 demonstrated sustained and statistically significant¹ PAR ulcer size² (p = 0.046 at week 12; p = 0.052 at week 13), with a separation from placebo starting at week 7 with a difference greater than 40%
Slide 29: BX211 showed statistically significant reduction in ulcer surface area
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 (See detailed data in next slide) P=0.046 P=0.052 >40% Group Placebo BX211 From week 10 and on, BX211 showed an ulcer surface
Slide 30: BX211 showed statistically significant reduction in ulcer surface area (detailed data)
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) PAR at BX211 Placebo Difference P-value2 week: N (%) Mean (95% CI) N (%) Mean (95% CI) (9
Slide 31: Patients with ulcers at bone depth displayed better recovery in the BX211 group
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 BX211 (N=13) Placebo (N=9) Depth Measurement Tissue3 Healed Week 1 Week 13 Week 1 Week 13 Dermis Below Dermis Bone Unknown 12/13 (
Slide 32: BX211 performs better than placebo across a range of clinical outcomes
BX211 performs better than placebo across a range of clinical outcomes Favors Placebo Favors BX211 • Evidence of DFO resolution by MRI/X-ray at week 121,4 (BX211 N=13, Placebo N=6) P-val6 = 0.048 • Improvement in tissue involvement at week 131,2,5 (BX211 N=13, Placebo N=9) • 50% Reduction From Basel
Slide 33: BX211: Potential Breakthrough in DFO/DFI
BX211: Potential Breakthrough in DFO/DFI • Results of the Phase 2 study mark, to the Company’s knowledge, the first well-controlled, double-blind, placebo-controlled clinical study to demonstrate statistically significant efficacy of a phage therapy in a clinical endpoint for a chronic bacterial inf
Slide 34: Executive Summary
Executive Summary • In several chronic diseases, such as CF, NCFB, and diabetes, underlying related infections become UNMET NEED harder to treat as resistant pathogens emerge • Accordingly, the need for new antimicrobial therapies becomes more urgent every year PHAGE THERAPY - • BiomX and peer compa
Slide 35: Thank you
Thank you BiomX
Slide 36: BX004 CF addressable market of > $1.5 billion worldwide
BX004 CF addressable market of > $1.5 billion worldwide BX004 References/Comments Patient population (US) ~8,000 Number of CF patients with chronic PsA infections1 Suppression/eradication of PsA (CFU in Magnitude observed under tobramycin Phase 3 study was Potential effect on PsA CFU in lungs sputum
Slide 37: BX211 moderate-severe DFI & DFO addressable market of >$2.5B worldwide
BX211 moderate-severe DFI & DFO addressable market of >$2.5B worldwide BX211 References/Comments Incidence of moderate-severe DFI + DFO Moderate-Severe DFI overlaps with DFO population 400,000 (annually, US) Incidence assumed based on 400K ER hospital visits due to DFI1 Relevant incidence for BX211
Slide 38: Management Team
Management Team JONATHAN SOLOMON | CEO & BOARD MEMBER Prior to his role in BiomX, Mr. Solomon was a co-founder, president, and CEO of ProClara (formerly NeuroPhage), which is pioneering an approach to treating neurodegenerative diseases. Under his leadership, the company raised more than $100 millio
Slide 39: Management Team (cont'd)
Management Team (cont’d) MARINA WOLFSON | CFO Marina Wolfson, Chief Financial Officer, joined BiomX in December 2019, bringing extensive experience from large pharmaceutical and high-tech companies, as well as venture capital funds. Prior to joining the company, Ms. Wolfson served as Vice President
Slide 40: Board of Directors
Board of Directors RUSSELL GREIG, PH.D. JONATHAN LEFF CHAIRMAN OF THE BOARD OF DIRECTORS DIRECTOR Russell G. Greig, Ph.D. worked at GlaxoSmithKline for three decades, most recently Jonathan Leff is a Partner on the Therapeutics team at Deerfield and Chairman of as President of SR One, GlaxoSmithKlin