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. 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.

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Mission Statement

We develop precision medicines using both natural and engineered phage cocktails targeting harmful bacteria in chronic diseases and conditions such as acne, Inflammatory Bowel Disease, liver disease and cancer.

3

Unique Position as Leader in Phage Technology

Technology

Pipeline

Exclusive access to novel targets

Partnerships

Leading life science and strategic investors

  • Phage discovery platform
  • Proprietary synthetic biology capabilities
  • Cutting-edgedata science
  • In-housemanufacturing of customized phage cocktails
  • Initial 4 programs: acne, IBD, PSC (a liver disease), colorectal cancer
  • Phase I data in acne expected in Q1 2020
  • Phase I data in IBD expected in H2 2020
  • Phase I/II data in PSC expected in 2021
  • Proprietary targets in IBD and PSC
  • Target discovery and validation platform steered by cutting-edge research of scientific founders
  • Acne collaboration with leading global cosmetic company
  • Biomarker discovery in IBD for key Janssen (J&J) IBD drug
  • On Oct. 2019 publicly listed (NYSE:PHGE) through a merger with $60 million at closing

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Credentialed Leadership Team

Management Team

Jonathan Solomon I CEO and Board Member

Assaf Oron I CBO

ChondroSite

Sailaja Puttagunta, MD I CMO

Merav Bassan, PhD I CDO

Scientific Founders

Prof. Rotem Sorek

Prof. Eran Elinav

Prof. Timothy K. Lu

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Credentialed Leadership Team

Board of Directors

Russell Greig, PhD

Rob Woodman, PhD

Erez Chimovits

Jonas Grossman

Gbola Amusa, MD

Yaron Breski

Lynne Sullivan

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Growing Evidence of Role of Harmful Bacteria in Acne and Chronic Diseases

PSC

Klebsiella pneumoniae strains induce leaky gut and initiate liver inflammation and fibrosis

Nakamoto et al. (2019),

Nature Microbiology

Colorectal cancer

Reducing Fusobacterium load

results in reduced cancer cell proliferation and tumor growth

Bullman et al. (2017),

Cell

Acne

Propionibacterium acnes is associated with acne vulgaris

Fitz-Gibbon et al. (2013),

J Invest Dermatology

IBD

Klebsiella pneumoniae strains cause aberrant activation and stimulation of the immune system

Atarashi et al. (2017),

Science

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Phage: Nature's Precision Targeting Vector

Phage bind only to specific

Phage have an amplifying lifecycle

bacterial strains

1 Locate

2 Inject

3 Infect

4 Multiply

5 Assemble

6 Eradicate

7 Seek

Source: Kortright et al. (2019), Cell Host & Microbe

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Innovative Phage Technology Platform

Phage Hunting

  • Sample sourcing
  • Automated sample processing
  • SynBio prophage extraction

Customized

Phage Cocktail

Cocktail Optimization

Phage Engineering

(SynBio)

  • Applied selectively when required
  • Includes : Host range expansion,
    lysogenic to lytic conversion, payload incorporation
  • Multi-dimensionaloptimization in vitro and in vivo for characteristics such as: host range, resistance and biofilm degradation

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Proprietary Synthetic Biology Capabilities

Expanding phage host range

against multiple targets

Phage C

Phage A Phage B

Phage synthetic

engineering KP2

KP2 KP7

2 different

bacterial targets7

KP

Source: Internal experiments

Switching phage mode of action

from lysogenic to lytic

Lysogenic to lytic

Repressor deletion

LysogenicLytic

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Pipeline

Phage discovery

Preclinical

Phase I

Phase II

Product Candidates

Acne • BX0011

Phase I results expected 1Q20

Phase II results expected 2H20

IBD • BX002

Pre-IND meeting held 2H19

Phase I results expected 2H20

PSC • BX003

Pre-IND meeting expected 2H20

Phase I/II results expected 2H21

Colorectal cancer

Biomarker discovery

Validation

Development

Diagnostics

IBD (responder/ non-responder)

Partners

Global cosmetics company

(1) BX001 is intended to be developed and commercialized as a cosmetic

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Acne • BX001 Natural Phage Cocktail Attributes

  • Active against 96% of tested P. acnes clinical strains (in- vitro)
  • Active against antibiotic-resistant strains (in-vitro)
  • Self-amplifying:50-100 phage per bacteria killed
  • Penetrates biofilm (in contrast to antibiotic erythromycin)
  • Highly specific: Does not affect other skin microbiome bacteria
  • Proprietary gel formulation

BX001

A topical gel containing natural phage against P. acnes to modulate skin microbiome

Sources: Internal experiments;

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Acne • BX001 Preclinical Results

BX001 eradicates P. acnes (in-vitro)

Phage cocktails penetrate biofilm (in-vitro)

1.2

1

Untreated

Density

0.8

acne strain

0.6

Optical

0.4

BX001

0.2

0

0

30

60

90

120

150

Hours

Source: Internal experiments

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Acne • BX001 Preclinical Results

Release of active phage from BX001 gel

Release of active phage from BX001 gel on P. Acnes - artificially

on P. acnes bacterial lawn eradicated P. acnes

infected human skin

P. acnes lawn

Bacterial reduction on P. acnes-colonized human skin

after BX001 gel application

10000.00

*

*

2

1000.00

cfu/cm

100.00

10.00

1.00

Single application Repeat application

Single application Repeat application

Black:

Where gel with BX001 was applied

Placebo

Formulated

BX001

Red:

Area of phage activity (eradicated P. acnes)

*P<0.05

Source: Internal experiments

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Acne • BX001 Clinical Trial Design

Phase I - ongoing*

Phase II - planned

4-week study (placebo-controlled)

  • Objectives
    • Safety
  • Exploratory endpoints
    • Reduction of P. acnes (efficacy)
    • Skin microbiome evaluation
    • Lesion numbers (efficacy, trend)
  • 75 patients total over 3 cohorts
    • 2 doses + 1 placebo (vehicle)
    • 25 patients per cohort

12-week study (placebo-controlled)

  • Objectives
    • Safety and efficacy
  • Endpoints
    • Reduction of P. acnes (efficacy)
    • Skin microbiome evaluation
    • IGA and lesion numbers (efficacy)
  • 100 patients total over 2 cohorts
    • 1 dose + 1 placebo (vehicle)
    • 50 patients per cohort

Phase I

Phase II

2Q19

3Q19

4Q19

1Q20

2Q20

3Q20

4Q20

*An additional smaller single blinded, single application, placebo-controlled clinical trial to evaluate alternative methods of topical application is being conducted and expected to be completed in 1Q2020.

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IBD • Targeting Harmful Pro-inflammatory Klebsiella

Strains

Pro-inflammatoryKlebsiella strains

affect IBD pathology

Klebsiella

strains

Disease state

Inflammatory induction is seen in GF mice*

GF + 7 other mix

GF + target strain

TH1

IFN-g

IFN-g

GF - Germ Free

Higher abundance of Klebsiella strains in IBD patients

Induce

inflammation

Abundance of Klebsiella strains

% relative

CD - Crohn's disease

UC - Ulcerative colitis

Activity of bacterial target confirmed by BiomX

Source: Atarashi et al. (2017), Science

  • TH1 - A lineage of CD4+ effector T cell secreting IFNg and TNF. In IBD, TH1 cells accumulate in the intestinal tract of IBD patients and are directly associated with disease

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PSCKlebsiella Identified as Novel Pathobiont*

Th17** is induced in livers of GF mice

KP isolated from

mice's lymph nodes

inoculated with fecal samples from

colonized with

PSC patients

Discovery approach

patient samples

GF mice

Analysis of

Fecal

samples from

Humanized

PSC patients

microbiota mice

immune response

Healthy

PSC patients

Colitis patients

Klebsiella pneumoniae

plays a gating role

SPF - Specific-pathogen-free

HC - Healthy Controls

PSC/UC - PSC and ulcerative colitis

Klebsiella pneumoniae (KP) is a specific gut pathobiont of PSC that is an intestinal barrier disrupter and is pro-inflammatory ("leaky gut")

Source: Nakamoto et al. (2019), Nature Microbiology

  • Pathobiont - potentially pathological organism that under normal conditions lives as a non-harming symbiont **TH17 - A lineage of CD4+ effector T cell secreting IL17A+, promoting inflammation and fibrosis within the liver

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PSC • Bacterial Pathogens Contribute to Orphan

Liver Disease

PSC (primary sclerosing cholangitis)

Stricture of bile ducts impedes bile flow to intestines and gradually leads to cirrhosis of liver and liver failure

  • ~30,000 US patients
  • 10-15years until liver transplant is required
  • No existing therapy to avoid eventual liver transplant
  • Evidence that manipulation of microbiome impacts the disease
  • Abnormal high abundance of bacteria found in bile fluid of patients
  • Most PSC patients suffer from ulcerative colitis

Hepatology. (2013) Dec;58(6):2045-55,UpToDate, MedScape Hepatology. (2013) Dec;58(6):2045-55,UpToDate, MedScape

Source: NEJM 2016, PSC Review, LaRusso and Lazaridis

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IBD • BX002 Cocktail Designed to Address Resistance

by Using Phage Cocktails

How a phage cocktail overcomes resistance

Phage cocktail

Bacteria target

Phage cocktails are rationally optimized to prevent resistance by targeting multiple bacterial receptors and defense mechanisms

Infection dynamics of phage cocktails (in vitro)

Comparing various phage cocktail combinations

Density

Sub-optimal cocktails:

(no phage)

Resistant strains

Optical

Optimized cocktails:

No-resistant strains

Source: Internal experiments

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IBD • BX002 Cocktail Composition Drives Activity

1st-generation phage cocktail

(in-vivo)

Fecal bacterial load

Application of phage

1010

*

stool

108

106

Control

CFU/gr

104

1st-gen cocktail

LOD

102

100

0

2

4

6

8

10

Day from inoculation

*P < 0.01

2nd-generation phage cocktail (in-vivo) reduces bacterial load

Fecal bacterial load

Mucosa

Application of phage

Adding 2

phages with

** Control

*

new MOA

2nd-gen

cocktail

Control

Phage cocktail

*P<0.05 ; **P < 0.001

Source: Internal experiments

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IBD • Planned Clinical Development - Phase 1

Study

Phase 1a/b

Primary:

Safety and tolerability of orally-administered BX002

Secondary:

Study objectives

Reduction of target bacteria levels in stool

Evaluation of microbial composition in stool

Exploratory:

Local inflammatory

Population

Target bacteria carriers - patients or healthy individuals

30-45 patients across 3 cohorts

Cohorts

2 dose levels + placebo (vehicle)

10-15 patients per cohort

Treatment route,

Oral route

duration

4 weeks, daily administration

Patient A

Stool test

Specific qPCR

Target

bacteria

companion

diagnostic

Phage treatment BX002

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CRC • Most Colorectal Cancer (CRC) Patients

Do Not Respond to Immunotherapy

Immune

=

Immune

=

"Cold" tumor

+ checkpoint

Effect

"Hot" tumor

+ checkpoint

Effect on

inhibitors

on tumor

inhibitors

tumor

Sources: Vareki (2018), Journal for immunotherapy of Cancer; Galon et al. (2019), Nature Reviews/Drug Discovery

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CRC • Bacteria Residing Inside Tumors Offer a Novel

Targeted Intervention to "Uncloak" Tumors to "Hot"

Numerous observations of bacteria residing inside tumors

F. nucleatum

bacteria

Tumor

Bachrach et al. (2016), Cell Host & Microbe

Kostic et al. (2013), Cell Host & Microbe

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CRC • IV Delivery of Phage to Intra-tumor Bacteria has

been Demonstrated

Experimental outline

Results - Mice tumor qPCR analysis

+ / -

+ / -

F. nucleatum

Phage

CT26 SC

inoculation

Termination: 24h after IV administration of phage,

followed by qPCR analysis of the tumor for presence of

phage and F. nucleatum

Detection of lysogenized intra-tumorF. nucleatum demonstrates phage delivered IV reached bacteria within tumor microenvironment and integrated stably into host bacteria genome

Source: Internal experiments

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CRC • Engineered Phage Designed to Bring Immune- stimulating Payload to Bacteria in Tumors

Phage are designed to carry payload

targeting intra-tumor bacteria

Phage cocktail

Phage cocktail with a payload turns cold tumors into hot

Add payload using SynBio

Phage cocktail

Immune

=

"Cold" tumor

+ checkpoint

Effect on

inhibitors

tumor

"Cold" tumor

+ new gene

Phage cocktail

IV

Immune

=

"Hot" tumor

+ checkpoint

Effect on

inhibitors

tumor

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Key Catalysys

1H19

2H19

1H20

2H20

1H21

2H21

Acne

Mfg.

Phase I

Phase I

Phase II

Prep large-

Prep large-

started

Results

results

scale mfg.

scale mfg.

IBD

Phage

Pre-IND

Mfg.

Phase I

Phase II

Interim

cocktail

meeting

results

starts

results

PSC

Phage

Phage

Phage

Pre-IND

Phase I/II

Interim

discovered

cocktail

cocktail

meeting

starts

results

Cash and cash equivalents as of Nov. 29th 2019: $85 million

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Thank you

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BiomX Inc. published this content on 09 January 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 January 2020 20:47:00 UTC