Biomx Inc. · AMEX:PHGE
Biomx — Investor Presentation (February 2025)
33 slides from Biomx's investor presentation, February 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 February 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), Non-Cystic Fibrosis
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 100 cases of compassionate phage treatment BiomX positive (Belgian consortium)2 BiomX positive P1b/2a P1b/2a Part 2 data, • 35 hospitals, 29 cities 1 Part 1 data, Feb. 2023 3 Nov. 2023 5 • Clinical improvement reported
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 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: PsA 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 for 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 culture conversion 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 Osteomyelitis (DFO)
BX211 Diabetic Foot Osteomyelitis (DFO) 21
Slide 22: High unmet need in DFO
High unmet need in DFO DFO is a bacterial infection of the bone in patients with diabetes that is caused by bacteria spreading from adjacent infected soft tissue Infection reaches bone Staphylococcus aureus is 1. Superficial ulcer 2. Ulcer deepens 3. DFO – Ulcer and the most common extending through
Slide 23: 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 - S. aureus inhabiting biofilms are 10 to 1,000-fold more resistant to antibiotics, compared to planktonic cells • Poor blood s
Slide 24: Multiple compassionate treatments of DFO patients demonstrate potential for phage treatment
Multiple compassionate treatments of DFO patients demonstrate potential for phage treatment 12 DFO cases (S. aureus) 11 Osteomyelitis cases (not DFO, various bacteria) 9 patients No. of Bacteria Treatment cases • Single phage against S aureus • Topical application or injection to bone, A.baumanii an
Slide 25: BX211 phage treatment for DFO patients with S. aureus
BX211 phage treatment for DFO patients with S. aureus • Product – Phage treatment targeting S. aureus. Phage, originating • Treatment - On top of standard of care from a ‘phage-bank’, are personally matched for each patient • Key features – Is potentially effective on antibiotic resistant strains, •
Slide 26: Phase 2 Study Design (BX211)
PHASE 1B/2A STUDY – Study design Multicenter, double blind, placebo-controlled study to assess improvement of clinical outcomes Enrollment: BX211 Duration: 12 weeks of once weekly treatment1 Objective: Up to 45 Week 13 Week 52 patients (readout 1) (readout 2) with Diabetic Foot Osteomyelitis positiv
Slide 27: 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 28: Thank you
Thank you BiomX
Slide 29: 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 30: BX211 DFO addressable market of >$2B worldwide
BX211 DFO addressable market of >$2B worldwide BX211 References/Comments Patient population 160,000 Lower limb amputations (LLA), diabetic patients annually, US1 Deductions due to2: - 85% of amputation are due to DFO Assumed relevant population for BX211 - 50% positive for S. aureus 40,000 (25% of 1
Slide 31: 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 32: 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 33: 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