EX-99.1 2 ea161594ex99-1_biomxinc.htm INVESTOR PRESENTATION DATED JUNE 14, 2022

Exhibit 99.1

 

© 2020 BiomX LTD. All rights reserved Company Introduction

 

 

Safe Harbor Statement This presentation contains certain “forward - looking statements” within the meaning of the “safe harbor” provisions of the U . S . Private Securities Litigation Reform Act of 1995 . Forward - looking statements can be identified by words such as : “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters . Forward - looking statements are neither historical facts nor assurances of future performance . Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions . When we discuss our expectations regarding the sufficiency of cash, cash equivalents and short - term deposits to fund the our current operating plan until at least the middle of 2024 , the ability of our products to address unmet medical needs, the potential to receive up to $ 15 million in additional loan tranches if certain milestones are met, the design, aim, expected timing and results of our preclinical and clinical trials and studies, including resumption of certain development programs, including whether we will be able to obtain funding for such programs, as well as our pipeline and the potential of our product candidates, our ability to quickly generate clinical proof of concept in patients and the advantages of our BOLT platform as well as our leadership position in phage technology we are making forward - looking statements . Because forward - looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control . Actual results and outcomes may differ materially from those indicated in the forward - looking statements . Therefore, you should not rely on any of these forward - looking statements . You should review additional disclosures we make in our filings with the Securities and Exchange Commission (the “SEC”), which are available on the SEC’s website at www . sec . gov . Except as required by law, we are under no duty to (and expressly disclaim any such obligation to) update or revise any of the forward - looking statements, whether as a result of new information, future events or otherwise . 2

 

 

We develop disease modifying therapies based on natural or engineered phage cocktails as precision medicines to target and specifically destroy harmful bacteria What we do 3 Our R&D platform enables generation of clinical proof of concept in patients within 12 - 18 months from project initiation * * In certain indications the length of clinical validation may be longer depending on indication, identity of target bacteria, recruitment rate, cohort size and other factors.

 

 

Unique position as leader in phage technology 4 ၬ Technology • BOLT phage therapy platform – Rapid path from discovery to clinic • Scalable in - house manufacturing – can support annually over 50 different phage at a clinical grade • Therapeutics Development Award from the Cystic Fibrosis Foundation. • Maruho ROFO 2 for rights in Japan to atopic dermatitis product candidate • Biomarker discovery collaborations in IBD: Janssen (J&J) & Boehringer Ingelheim Partnerships Pipeline Financing and investors • Publicly traded ( NYSE:PHGE ) • Equity raised: $ 146 M • Grants received: $  M • Secured debt of up to $ 30 M • Expected cash runway until at least middle of 2024 1. Inflammatory Bowel Disease (IBD) , Primary Sclerosing Cholangitis (PSC) 2. Right Of First Offer Only clinical stage phage company focusing on chronic indications • Focusing on cystic expected to produce clinical data in 3Q22 • Additional programs in atopic dermatitis, IBD / PSC 1 & Cancer

 

 

Phage: Nature’s precision tool to target bacteria Each phage binds only to specific bacterial strains Phage have an amplifying lifecycle Locate Inject Infect Multiply Assemble Eradicate Seek 1 2 3 4 5 6 7 5 Source: Kortright et al. ( 2019 ), Cell Host & Microbe

 

 

Oncology • Colorectal Cancer – F. nucleatum • Gastric Cancer – H. pylori Other • Acne – C. acnes • Liver Disease - E. faecalis Multiple potential applications of phage therapy 6 Immune mediated • Inflammatory Bowel Disease (IBD) – K. pneumoniae • Primary Sclerosing Cholangitis (PSC) - K. pneumoniae • Atopic Dermatitis – S. aureus Infectious diseases • Cystic Fibrosis - P. aeruginosa • Carbapenem Resistance - K. pneumoniae

 

 

Phage discovery Preclinical Phase I Phase II Phase III Product Candidates Cystic fibrosis • BX004 Atopic dermatitis • BX005 IBD / PSC • BX 00  Colorectal cancer Pipeline 7

 

 

Our platform allows clinical POC within 12 - 18 months 8 Target Bacteria Target Validation Phage Synthetic Engineering (optional) Cocktail Optimization Discovery & Characterization Manufacturing & Formulation Phage Therapy 3 Clinical testing 1. Strong safety profile of naturally occurring phage supported by regulatory feedback allows proceeding to Phase 1/2 studies without preclinical safety studies or Phase 1 studies in healthy volunteers. 2. In certain indications the length of clinical validation may be longer depending on indication, identity of target bacteria, rec ruitment rate, cohort size and other factors. 3. Usually, we would develop an optimized phage therapy, which is comprised of several phage (a phage cocktail) optimized to add res s multiple characteristics such as bacterial host range, emergence of resistance and other factors. In some cases, we may alternatively develop personalized pha ge cocktails tailored to target specific strain/s of a given patient. We may complete a clinical POC by treating multiple patients with either an optimized phage cock tai l or personalized cocktails Clinical POC in patients enabled within 12 - 18 months 1,2 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Traditional pharma drug development Phage therapy Discovery CMC Tox Phase 1 Phase 1/2 Phase 2 Phage cocktail

 

 

Cystic Fibrosis Upcoming milestone: Phase 1 b/ 2 a part 1 data expected in ב Q 2022 Program is supported by Cystic Fibrosis Foundation

 

 

Recurring infections leading to antibiotic resistance are a main cause of death in CF 10 1. CF Foundation, Bomberg et al., 2008 2. Vertex 10K filing 2020, internal estimates Phases of P. aeruginosa infection in CF 1 Antibiotics Antibiotics Antibiotics Antibiotics Antibiotics Initial Intermittent Chronic Clonal selection Biofilm formation Genotype/phenotypic adaptation Infancy Childhood Adolescence / Adulthood Limit of detection P. aeruginosa density in sputum Repeated antibiotic courses lead to nonmucoid and mucoid multidrug - resistance (MDR) of P. aeruginosa strains • CF patients regularly use multiple therapies – CFTR modulators, anti - infectives, mucolytic agents, bronchodilators and other • Worldwide CF therapeutic market in 2020 was approximately $8.5B 2

 

 

Selected cases of compassionate use of phage therapy targeting P. aeruginosa 11 2 CF patients, Georgia 1,2 • 5 yr old & 7 yr old • Nebulized phage • Combined with antibiotics • 9 courses with 4 - 6 week intervals • Reduction in sputum bacterial burden (10 7 �� 10 4 CFU/g) 2 • Patient gained weight, clinical improvement observed 1 CF patient, San Diego, US 3 11 CF patients treated with phage targeting P. aeruginosa 1. Kutateladze et al., 2008 2. Kvachadze et al., 2011 3. Law et al., 2019 4. Stanley et al., 2020 8 CF patients, Yale University, US 4 • 26 yr old • Phage administered IV • Combined with antibiotics • No exacerbation within 100 days following the end of phage therapy • eIND path for 8 CF patients • Nebulized phage • 7 - 10 days, single or multiple rounds • Post phage therapy P. aeruginosa CFU titers decreased significantly ( 2.2 ± 0.76 log reduction) • Post phage therapy FEV 1 % changed in a range between 0 to 8.9 % Results demonstrate the potential of phage therapy to decrease bacterial burden and improve FEV1

 

 

12 BX004 is active on antibiotic resistant P. aeruginosa strains and penetrates biofilm in vitro BX004 displays enhanced biofilm penetration compared to antibiotics ** ** Bacterial count Colony forming units / well ** BX004 penetrates biofilm in vitro 1 BX004 Control Biofilm was grown from P. aeruginosa for 24 hours and then treated with BX004 for 6 hours (control - untreated wells). Treatment with antibiotics not shown Crystal violet – Used for biomass staining of biofilm. Staining substantially reduced following treatment with BX004 **p - value < 0.001 1. Internal data. A P. aeruginosa strain sensitive to antibiotics was grown to form biofilm 2. Imipenem 200 micrograms/ml (X100 MIC), (β - lactam antibiotic with activity against P. aeruginosa)

 

 

13 Phase 1b/2a study targeting P. aeruginosa with first readout expected in 3Q 2022 Phase 1b/2a – Part 1 Objectives • Safety, PK and microbiologic/clinical activity • Endpoints • Safety and tolerability • Decrease in P. aeruginosa burden • Sputum pharmacokinetics • FEV1 (forced expiratory volume) • CFQ - R (CF Questionnaire - Revised) and CRISS Study Population • CF patients with chronic P. aeruginosa infection 8 Subjects • 6 receive nebulized BX004 • 2 receive nebulized placebo • 6 days duration of treatment Key Design Features • Single ascending dose followed by multiple doses Phase 1b/2a – Part 2 Objectives • Safety and efficacy Endpoints • Safety and tolerability • Decrease in P. aeruginosa burden • FEV1 (forced expiratory volume) • CFQ - R (CF Questionnaire - Revised) and CRISS Study Population • CF patients with chronic P. aeruginosa infection 24 subjects • Nebulized BX004 phage therapy or placebo • 2:1 randomization • 10 days duration of treatment Data expected  Q 2022 Data expected  Q 

 

 

Atopic Dermatitis Upcoming milestone: TBD

 

 

Atopic Dermatitis (AD) flares are associated with presence of S. aureus Relative abundance of staphylococcal species on skin during AD disease stages (metagenomics analysis) Control = healthy skin Baseline = routine AD disease state Flare = worsening in the clinical severity of the typical AD, without usage of skin - directed antimicrobial and anti - inflammatory treatments for seven days Post flare = 10 – 14 days after initiation of skin - directed therapies Individuals Mean relative abundance Control Baseline Flare Post - flare Byrd and Kong (2017) Sci Transl Med. 05 9(397) S. aureus becomes the dominant bacterial species during AD flares and is correlated with SCORAD 15

 

 

16 BX005 eradicates S. aureus ( in vitro assay with 3 strains) Time (hours) Bacterial growth (measured by optical density) BX005 phage cocktail shows broad host range targeting of S. aureus in vitro In vitro, BX005 eradicated over 90% of S. aureus strains 1 0 0.2 0.4 0.6 0.8 0 5 10 15 20 3 untreated S. aureus strains The same 3 strains treated with BX 005 Source: Internal data 1 . Panel of 120 strains isolated from skin of subjects from the US and Europe

 

 

17 BX005 has the potential to be an efficacious and safe topical treatment for long - term use • Atopic dermatitis, a rapidly growing market 1 : • > $5 billion in 2020 • Expected to surpass $15 billion in 2027 • Over 35% of atopic dermatitis patients are children • Parents are seeking efficacious topical treatments with a better safety profile • Calcineurin inhibitors and recently approved topical JAK inhibitor carry a black box warning for cancer risks in the US • Corticosteroids – limited for short term use. Long - term use has been associated with skin atrophy, starch marks, and corticosteroid addiction • Based on clinical experience of using natural phage topically 3 , BX005 is expected to have fewer side effects and a safer profile compared to existing treatments 1. Atopic dermatitis Market forecast, trend analysis & competition tracking, Fact Mr. report 2. Atopic dermatitis: Global drug forecast and market analysis to 2027, GlobalData report 3. Based on safety data from BiomX’s clinical studies using a topical phage cocktail for acne - prone skin Children are the largest atopic dermatitis patient group Atopic dermatitis patients by age group (US) 2 Age 0 - 19 37 % Age 20 - 39 32 % Age 40 - 59 20% Age >60 11 % Age 0 - 19 37% Age 20 - 39 32% Age 40 - 59 20% Age >60 11 %

 

 

18 Phase 1 b/ 2 a atopic dermatitis study targeting S. aureus Study design - A double - blind, randomized, multicenter, vehicle - controlled study • Objectives • Safety, efficacy and pharmacodynamics • Endpoints • Safety and tolerability • Decrease in target bacteria • Clinical improvement (e.g. change in EASI / IGA / SCORAD scores) • Study Population • Adults with moderate - to - severe atopic dermatitis • S. aureus colonized • Approximately 48 subjects • BX005 or placebo (vehicle) administered topically twice daily • 8 - week duration of treatment wk: week; F/U: Follow - Up BX005/Placebo Applications Sampling First application Last application Topical administration Baseline 8 wks 4 weeks 8 weeks Screening 12 wks Post - dosing safety F/U

 

 

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