Revolutionizing the Treatment
of Serious Infections Through
Phage Therapy
Corporate Presentation / April 2024
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 this presentation is current only as of the date on its cover. For any time after the cover date of this presentation, the information, including information concerning our business, financial condition, results of operations and prospects, may have changed. The delivery of this presentation shall not, under any circumstances, create any implication that there have been no changes in our affairs after the date of this presentation. We have not authorized any person to give any information or to make any representations about us in connection with this presentation that is not contained herein. If any information has been or is given or any representations have been or are made to you outside of this presentation, such information or representations should not be relied upon as having been authorized by us.
Forward-Looking Statements
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.
For example, when we discuss future potential clinical trials, including their design, objectives, costs, endpoints, potential benefits and timing, the potential outcomes of discussions that we may have with the U.S. Food and Drug Administration and foreign regulatory agencies, potential commercial opportunities, our expected cash runway, our financial needs to fund future clinical trials and our ability to protect our intellectual property assets in the future we are making forward-looking statements. In addition, past and current pre-clinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of BiomX clinical trials. 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.
No Offer or Solicitation
This presentation is for informational purposes only. Nothing in this presentation constitutes an offer to buy or sell or a solicitation of an offer to buy or sell investments, loans, securities, partnership interests, commodities or any other financial instruments.
This presentation and any oral statements made in connection with this presentation do not constitute, and may not be used for or in connection with, an offer or solicitation by anyone in any state or jurisdiction in which such an offer or solicitation is not authorized or permitted, or to any person to whom it is unlawful to make such offer or solicitation.
Trademarks and Service Marks
The trademarks and service marks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products.
FDA
This presentation concerns certain products that are under clinical investigation and which have not yet been cleared for marketing by the U.S. Food and Drug Administration. These products are currently limited by federal law to investigational use, and no representation is made as to the safety or effectiveness of these products for the purposes for which they are being investigated.
2
Acquisition of APT creates a leading phage company with an advanced clinical pipeline
On March 18, 2024, BiomX announced closing of the acquisition of Adaptive Phage Therapeutics (APT)
- Multiple clinical readouts: Two Phase 2 programs expected to read out in 2025
- Extensive clinical experience: ~80 compassionate use cases, multiple clinical studies & INDs
- Top tier investor base: Deerfield, AMR Fund, Orbimed and the CF Foundation
- Attracted significant non-dilutivegovernment funding: >$40M received from Defense Health Agency, NIH and other
- Large phage collection/bank:
- 185 phage cleared for investigational use by regulatory agencies or institutional review boards, targeting 8 bacterial species
- 100's of phage targeting multiple bacteria
• Advanced CMC capabilities: GMP certified facilities (upstream, downstream fill & finish), capacity of up to 40L, multiple formulation types (topical, inhalation,
IV, oral)
- APT selected for Fierce Biotech's 2023 Fierce 15 list for 15 most innovative and truly fierce biotechs
3
Combined pipeline provides two significant clinical inflection points in indications with high unmet need
Unmet need in cystic fibrosis ('CF')
BX004 - our lead program
- In CF patients, Pseudomonas aeruginosa (PsA) lung infections are a leading cause of morbidity and mortality
- Prolonged antibiotic treatments lead to significant resistance, creating a large unmet need - estimated 17,000 CF patients in the US and Western Europe with chronic PsA infections. Potential commercial opportunity of > $1.5 billion worldwide1
- In a Phase 1b/2a study, 3 out of 21 (14.3%) patients in the BX004 arm converted to sputum culture negative for PsA after 10 days of treatment compared to 0 out of 10 (0%) in the placebo arm2
- BX004 showed signals of improvement in pulmonary function vs. placebo, in relative FEV1 improvement (5.67% at Day 17, 1 week after EOT) and PRO in patients with reduced lung function3
- Phase 2b readout expected 3Q25
Unmet need in Diabetic Foot Osteomyelitis ('DFO')
BX211
(formally an APT program)
- DFO patients represent the majority of 160K lower limb amputations in diabetic patients annually in the US4
- Treating DFO patients infected with S. aureus, the most common pathogen, represents a potential commercial opportunity of > $2 billion worldwide4
- Numerous compassionate cases provide justification for approach
- Targeting S. aureus in a personalized approach
- Phase 2 ongoing, readout expected in 1Q25
Financing and investors
- Publicly traded (NYSE American: PHGE)
- $15.9 million cash and cash equivalents as of December 31, 2023
- On March 18, 2024, announced closing od the acquisition of APT and concurrent financing of $50 million led by Deerfield and AMR Action Fund and including Orbimed, CF Foundation and Nantahala Capital, among other investors
1. | See slide 35 | |
4 | 2. | In patients that had quantitative CFU levels at study baseline |
3. | FEV1 or ppFEV1 - percent predicted forced expiratory volume, EOT - End of treatment, PRO - Patient reported outcome, reduced lung function - Predefined group with Baseline FEV1<70% | |
4. | See slides 30 and 36 |
Strong leadership and scientific team
Management
Jonathan Solomon - Chief Executive Officer, Director Former co-Founderand CEO Proclara
Merav Bassan, PhD - Chief Development Officer
20 years drug and clinical development; former at Teva
Assaf Oron - Chief Business Officer
Former EVP business development at Evogene
Avi Gabay, CPA - Chief Financial Officer (interim)
Former Oramed Pharmaceuticals, KPMG
Inbal Benjamini-Elran - Chief HR Officer
Former HR roles at Teva and Herzog Law
Michael Billard - General Manager US
Former roles APT and MedImmune
Board of Directors
Russell Greig, PhD Chairman of the Board
Former president of GSK Pharma International
Jesse Goodman, MD,MPH - Director
Former Chief Scientist of the FDA
Jonathan Leff - Director
Partner on the Biotherapeutics team, Deerfield
Greg Merril - Director
Former founding CEO of Immersion Medical
Alan Moses, MD - Director
Former Global Chief Medical Officer of Novo Nordisk
Jonathan Solomon - Chief Executive Officer, Director Former co-Founderand CEO Proclara
Eddie Williams - Director
Former special advisor to the CEO of Ascendis Pharma, Inc.
Scientific Team
Prof. Rotem Sorek | Carl R. Merril, MD, Capt Usphs (Ret) |
Head of microbial genomics group at Weizmann Institute | NIH Emeritus Scientist |
Phage genomics and CRISPR research | Internationally recognized expert in bacteriophage science |
Prof. Eran Elinav | Prof. Eitan Kerem |
Principal investigator at Weizmann Institute | Former Chairman of Pediatric Pulmonology Unit, Hadassah Medical Center |
Immune system and intestinal microbiome interactions | World leader in CF care and research |
5
Pipeline
Phage Discovery | Preclinical | Phase I | Phase II | Phase III |
Program Indication
BX004(1) | Cystic Fibrosis | Ph2b Topline Expected |
Q3 2025 | ||
BX211 | Diabetic Foot | Ph2 Topline Expected |
Osteomyelitis | Q1 2025 and Q1 2026 | |
Potential additional indications:
- Prosthetic Joint Infections (PJI)
- Non-CysticFibrosis Bronchiectasis (NCFB)
- Nontuberculous mycobacteria (NTM)
1. Granted Orphan Drug Designation and Fast Track by the FDA
6
Introduction To
PHAGE
Phage: Nature's precision tool to target bacteria
1. SPECIFIC
Each phage binds only to specific
bacterial strains
Kortright et al. (2019), Cell Host & Microbe
2. KILLING MECHANISM ORTHOGONAL TO ANTIBIOTICS
Lysin proteins burst bacterial cell wall from within
4. AMPLIFY
Phage components multiply and assemble within bacterial cell
3. BREAKDOWN BIOFILM
Phage can breakdown biofilm
(a polysaccharide mesh secreted by bacteria)
5. SAFETY PROFILE
100s of compassionate use cases with no significant side effects to date
8
Key challenges in developing phage therapies
- Host range - Narrow specificity to a subset of bacterial strains
- Resistance - Bacterial defense systems (e.g. CRISPR)
• CMC - Manufacturing (e.g. purity, stability)
And many other considerations
• Phage titer
- Biofilm breakdown
- Absence of toxic genes
- Other
Phagoburn study The Lancet, inf..Dis.2019 Jan;19(1):35-45.doi:10.1016/S1473-3099(18)30482-1.
Nestle study: E.BioMedicine 2016 Jan 5;4:124-37. doi: 10.1016/j.ebiom.2015.12.023.
Patterson case: Antimicrob Agents Chemother 2017 Sep 22;61(10):e00954-17. doi: 10.1128/AAC.00954-17.
9
Complementary approaches taken by BiomX for phage treatment
Fixed phage cocktail
Applicable where a 3-5 phage cocktail can:
- Target a broad host range of various bacterial strains across patients
- Address multiple resistance mechanisms that may develop
1 | 2 | 3 | ||
Cocktail | GMP | Treatment |
design | manufacturing |
Personalized phage treatment
- Enables rapid entry into clinical proof of concept, prior to fixed cocktail design
- Could be applied to polymicrobial infections
- Applicable in cases where bacterial diversity hinders fixed cocktail development
1 | 2 | 3 | 4 |
Sampling | Susceptibility | Pharmacy- | Treatment |
testing | based inventory |
10
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
BiomX Inc. published this content on 03 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 April 2024 16:02:06 UTC.