On November 12, 2020 BiomX Inc. (NYSE American: PHGE), a clinical stage company developing natural and engineered phage therapies targeting specific pathogenic bacteria, reported financial results and a business update for the third quarter ended September 30, 2020 (Press release, BiomX, NOV 12, 2020, View Source [SID1234570681]).

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"BiomX continues to lead in the field of phage therapy by implementing proprietary processes for accelerated development," commented Jonathan Solomon, Chief Executive Officer of BiomX. "Our novel BOLT platform, which is the result of an accumulated five years of technological development, significantly reduces the time required to reach clinical proof-of-concept. The improved efficiency of this platform allows us to expand our portfolio with two significant new programs without affecting our projected cash runway."

Continued Mr. Solomon, "This expansion includes near term opportunities with phage therapy candidates. We expect clinical proof of concept results in patients for cystic fibrosis and atopic dermatitis by the end of 2021 and mid-2022, respectively. Improvements in R&D also allow for the consolidation of our inflammatory bowel disease (IBD) and primary sclerosing cholangitis (PSC) programs. We now have one improved, broad host range product candidate, BX003, targeting Klebsiella pneumoniae, a potential pathogen implicated in both diseases to be developed for both indications. The consolidation of these programs results in an updated timeline for Phase 1b/2a results with BX003 expected in mid-2022. In addition, we expect data from a planned Phase 2 cosmetic clinical study in acne-prone skin in the second quarter of 2021."

About the BOLT Platform

The newly unveiled BOLT ("BacteriOphage Lead to Treatment") R&D platform enables BiomX to rapidly develop, manufacture and formulate a phage treatment targeting a given pathogenic bacteria. The platform allows BiomX to conduct an initial clinical proof of concept study in patients (Phase 2 results) within approximately 12-18 months of project initiation1. The ability to move quickly into clinical development is also driven by the strong safety profile of naturally-occurring phage, as corroborated by regulatory guidance provided to BiomX by the FDA as relating to its IBD program, allowing the Company to bypass safety studies and studies in healthy volunteers and to proceed directly to patient studies.

Recent Highlights and Key Upcoming Milestones

Acne-Prone Skin

The Company expects to initiate a Phase 2 cosmetic clinical study of phage therapy BX001 in the first quarter of 2021, with results expected in the second quarter of 2021.
Cystic Fibrosis

A new program for development of a phage therapy targeting chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with cystic fibrosis. Phase 2 results of a proof of concept clinical study evaluating safety and efficacy in patients are expected in the fourth quarter of 2021.
Atopic Dermatitis

A new program for development of a topically administered phage therapy targeting Staphylococcus aureus, a bacterium linked to the development and exacerbation of inflammation in atopic dermatitis. Phase 2 results of a proof of concept clinical study evaluating safety and efficacy in patients are expected in the first half of 2022.
IBD and PSC

Results of a Phase 1a study are expected in the first quarter of 2021. The study is designed to provide safety and pharmacokinetic data, including an assessment of delivery of viable phage to the gastrointestinal system as a key exploratory endpoint.
Results of the Phase 1b/2a study aimed at evaluating the efficacy of BX003, improved broad host range phage therapy, in reduction of the target bacteria Klebsiella pneumoniae are expected by mid-2022.
Tumor-Targeted Delivery in Cancer

BiomX is exploring phage mediated delivery of therapeutic payloads to Fusobacterium nucleatum bacteria residing in the tumors of patients with colorectal cancer. Preclinical results from animal studies evaluating use of phage therapy in combination with checkpoint inhibitors are expected in the second quarter of 2021.
Biomarker Discovery Collaboration with Boehringer Ingelheim

In September 2020, BiomX entered into a collaboration with Boehringer Ingelheim to utilize the BiomX XMarker microbiome-based biomarker discovery platform to potentially identify biomarkers associated with patient phenotypes in IBD.
Third Quarter 2020 Financial Results

Cash balance and short-term deposits as of September 30, 2020, were $64.5 million, compared to $82.4 million as of December 31, 2019. The decrease was primarily due to net cash used in operating activities.
Research and development expenses were $6.4 million in the third quarter of 2020, compared to $2.9 million in the same period of 2019. The increase was primarily due to growth in the number of employees which resulted in an increase of salaries and related expenses and due to an increase in depreciation and amortization expenses.
General and administrative expenses were $2.4 million in the third quarter of 2020, compared to $1.8 million in the same period in 2019. The increase was primarily due to expenses associated with operating as a public company, such as directors’ and officers’ insurance, filing and legal and accounting expenses.
Net loss was $8.8 million in the third quarter of 2020, compared to $4.3 million in the same period of 2019.
Net cash used in operating activities was $17.3 million for the nine months ended September 30, 2020, compared to $10.5 million in the same period of 2019.
Financial Expectations

Existing cash, cash equivalents and short-term deposits are expected to be sufficient to fund the Company’s current operating plan through mid-2022.
Conference Call Details

BiomX management will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the third quarter of 2020 and provide business updates. To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (international). A live and archived webcast of the call will be available in the Investors section of the company’s website at www.biomx.com.