BiomX Stock

BiomX Inc. operates as a clinical stage microbiome product discovery company.

The company engages in developing products using both natural and engineered phage technologies designed to target and kill specific harmful bacteria associated with chronic diseases, such as cystic fibrosis (CF). By utilizing proprietary combinations of naturally occurring phage and by creating novel phage using synthetic biology, the company develops phage-based therapies intended to address both large-market and orphan diseases.

In the company's therapeutic programs, it focuses on using phage therapy to target specific strains of pathogenic bacteria that are associated with diseases. The company's phage-based product candidates are developed utilizing its proprietary research and development platform named BOLT (BacteriOphage Lead to Treatment).

Product Pipeline

Ongoing Programs

BX004 - Treatment of Cystic Fibrosis

BX004 is the company's therapeutic phage product candidate under development for chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa), a main contributor to morbidity and mortality in patients with CF. In preclinical in vitro studies, BX004 was shown to be active against antibiotic resistant strains of P. aeruginosa and demonstrated the ability to penetrate biofilm, an assemblage of surface-associated microbial cells enclosed in an extracellular polymeric substance and one of the leading causes for antibiotic resistance.

The Phase 1b/2a trial in CF patients with chronic respiratory infections caused by P. aeruginosa that consists of two parts. The study design is based on recommendations from the Cystic Fibrosis Therapeutic Development Network.

In February 2023, the company announced positive results from Part 1 of the Phase 1b/2a trial evaluating BX004. Part 1 evaluated the safety, tolerability, pharmacokinetics (PK), and microbiologic activity of BX004 over a 7-day treatment period in nine CF patients (7 on BX004, 2 on placebo) with chronic P. aeruginosa pulmonary infection in a single ascending dose and multiple dose design.

Part 2 of the Phase 1b/2a trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected in the third quarter (the year ended December 31, 2022) of 2023.

BX005 - Treatment of Atopic Dermatitis

BX005 is the company's topical phage product candidate targeting Staphylococcus aureus (S. aureus), a bacterium associated with the development and exacerbation of inflammation in atopic dermatitis. S. aureus is more abundant on the skin of atopic dermatitis patients than on the skin of healthy individuals and on lesional skin than non-lesional skin. By reducing the load of S. aureus, BX005 is designed to shift the skin microbiome composition to its 'pre-flare' state and potentially provide a clinical benefit. In preclinical in vitro studies, BX005 was shown to eradicate over 90% of strains, including antibiotic resistant strains, from a panel of S. aureus strains (120 strains isolated from skin of subjects from the U.S. and Europe).

The company is supporting a range of pre-clinical activities to move this program forward and working on evaluating timelines for a clinical trial.

On April 8, 2022, the U.S. Food and Drug Administration (FDA) approved the company's IND application for BX005.

The company has a stock purchase agreement with a subsidiary of Maruho Co. Ltd. (Maruho), a leading dermatology-focused pharmaceutical company in Japan. The company also granted Maruho a right of first offer to license BX005, in Japan. The right of first offer will commence following the availability of results from the Phase 1/2 study.

Programs On Hold

BX003 - Treatment of Inflammatory Bowel Disease (IBD) and Primary Sclerosing Cholangitis (PSC)

The company combined its IBD and PSC programs to create a single product candidate called BX003, which targets K. pneumoniae to treat both diseases in November 2020. Previously, the company had separate candidates named BX002 and BX003. In February 2021, a Phase 1a pharmacokinetic study of BX002 demonstrated that the company was safe and well-tolerated with no serious adverse events, and with high concentrations of viable phage delivered to the gastrointestinal tract.

In November 2021, the company announced that it had paused development efforts for BX003 due to prioritizing resources towards its CF and AD programs, and it cannot provide guidance on resuming its development.

CRC

The company is developing synthetically engineered phage to target bacteria found in colorectal tumors. The company observed in vitro and in vivo that phage can be used to target Fusobacterium nucleatum, which is commonly found in colorectal tumors. The company has successfully engineered an IL-15 gene into F. nucleatum phage.

In November 2021, the company announced that it had paused development efforts for this program due to prioritizing resources towards its CF and AD programs, and it cannot provide guidance on resuming its development.

Discontinued Programs

BX001 - Treatment of Acne

BX001 is a topical gel developed to modify skin appearance in a range of skin types, including acne-prone skin, using naturally occurring phage that target Cutibacterium acnes (C. acnes). A 4-week Phase 1 clinical study demonstrated that BX001 was safe, well-tolerated, and significantly reduced C. acnes levels for the high dose compared to the placebo. A 12-week Phase 2 clinical study on 140 women with mild-to-moderate acne vulgaris found that BX001 was well-tolerated, and a statistically significant improvement in the appearance of acne-prone skin was observed. As a result, the company decided to discontinue the program.

Intellectual Property

Patent Portfolio

The company's patent portfolio consists of owned patent applications, as well as both licensed and co-owned patent applications (that are also licensed). For some of these applications, prosecution has not started, and others are in the early stages of prosecution in the United States and in selected jurisdictions outside of the United States. The company solely owns four patent families. The company co-owns one U.S. patent family with Keio University in Tokyo, Japan, or Keio, one international patent family (the United States, Australia, Brazil, Canada, European Patent Office national filings) with Yeda Research and Development Company Limited (Yeda), and one international patent family (the United States, Europe) with both Keio and Yeda. The company has an exclusive license from Yeda and Keio for these co-owned patent applications. The company has exclusive licenses from Yeda or Keio for the rest of the patents and patent applications in its portfolio.

A significant portion of the company's portfolio is directed to its product candidates, specifically CF, AD, IBD, PSC, and CRC, as well as to its bacterial target discovery and bacteriophage discovery technology platforms.

CF

The company solely owns one patent family (PCT stage) containing claims directed to pharmaceutical compositions comprising combinations of bacteriophage to treat chronic Pseudomonas lung infections, especially common in CF patients, methods of use for these bacteriophage combinations, and methods of identifying patients who will respond to these bacteriophage combinations. Any United States patents issuing from the pending application covering the company's lead bacteriophage combination in this program, if issued, are expected to expire in 2042. Patent term adjustments or patent term extensions could result in later expiration dates.

AD

The company solely owns one patent family (PCT stage) containing claims directed to pharmaceutical compositions comprising combinations of bacteriophage to treat skin infections, especially common in AD patients, methods of use for these bacteriophage combinations, and methods of identifying patients who will respond to these bacteriophage combinations. Any United States patents issuing from the pending application covering the company's lead bacteriophage combination in this program, if issued, are expected to expire in 2042. Patent term adjustments or patent term extensions could result in later expiration dates.

IBD

The company solely owns one patent family (PCT stage), co-owns with Keio one U.S. patent family and co-owns with Keio and Yeda one international patent family (the United States, Europe), containing claims directed to pharmaceutical compositions comprising combinations of bacteriophage useful to treat IBD and other diseases of the gastrointestinal tract, methods of use for these bacteriophage combinations, methods of identifying patients who will respond to these bacteriophage combinations, and methods of treating IBD by targeting bacterial strains discovered to cause or contribute to that disease.

The company also has an exclusive license from Keio for an international patent family, including patent applications in the United States, Australia, Canada, China, Europe, and Japan. These applications are directed to methods of use for these bacteriophage combinations, methods of identifying patients who will respond to these bacteriophage combinations, and methods of treating IBD by targeting a bacterial strain discovered to cause or contribute to that disease. Any United States patents issuing from the pending applications covering the company's lead bacteriophage combination in this program, if issued, are expected to expire in 2037, 2038, or 2042. Patent term adjustments or patent term extensions could result in later expiration dates.

PSC

The company has an exclusive license to one United States national patent application and two Japanese patent applications with claims directed to pharmaceutical compositions comprising bacterial strains discovered to be beneficial in the treatment of PSC and methods of using the same, and to methods of treating PSC by reducing the level of certain bacterial strains discovered to contribute to PSC. Any United States patents issuing from the pending applications in this program, if issued, are expected to expire in 2038 or 2039. Patent term adjustments or patent term extensions could result in later expiration dates.

CRC

The company solely owns one patent family (PCT stage), containing claims directed to pharmaceutical compositions and formulations comprising combinations of bacteriophage (both synthetic and naturally occurring) useful to treat cancer. Any U.S. patent issuing from the pending application covering the company's lead bacteriophage combination in this program, if issued, are expected to expire in 2041. Patent term adjustments or patent term extensions could result in later expiration dates.

Research and Development (R&D)

For the year ended December 31, 2022, the company's R&D expenses were $16.2 million.

Government Regulation

Certain of the company's product candidates must be approved by the FDA through a Biologics License Application, or BLA, process before they may be legally marketed in the United States.

In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservancy and Recovery Act, and the Toxic Substances Control Act, affect the company's business.

The U.S. Foreign Corrupt Practices Act, to which the company is subject, prohibits corporations and individuals from engaging in certain activities to obtain or retain business or to influence a person working in an official capacity.

History

BiomX Inc. was founded in 2015. The company was incorporated under the laws of the state of Delaware in 2017.