On May 24, 2021 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported financial results and provided business updates for the first quarter ended March 31, 2021 (Press release, BiomX, MAY 24, 2021, View Source [SID1234580493]).

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"We are off to a strong start in 2021 and are well-positioned to continue making solid progress throughout our entire pipeline of novel phage therapies with the potential to make a significant impact in the microbiome space. Within the next 14 months, we will have clinical readouts in four distinct indications and remain committed to advancing our phage therapies that have the potential to restore health to the microbiome and in turn, provide safe and effective treatments to patients in need," said Jonathon Solomon, Chief Executive Officer of BiomX. "In March, we initiated a Phase 2 cosmetic clinical study of BX001 for acne-prone skin and today we are announcing completion of enrollment for 140 patients with results at the 8- and 12-week treatment periods expected in the third and fourth quarters of 2021, respectively. Importantly, in the first quarter we also announced positive safety and tolerability results from the Phase 1a study of BX002 for Inflammatory Bowel Disease, which met its objective of delivering high concentrations of viable phage to the gastrointestinal tract. With these promising results in hand, we are advancing to a Phase 1b/2a study of BX003 for Inflammatory Bowel Disease and Primary Sclerosing Cholangitis to evaluate the reduction of target bacteria, Klebsiella pneumoniae, with data expected in the second quarter of 2022."

Mr. Solomon added, "Based on ongoing conversations and recommendations from the cystic fibrosis Therapeutic Development Network, we are modifying our Phase 2 trial design in cystic fibrosis to a Phase 1b/2a trial design comprised of two parts. Results from Part 1 and Part 2 are expected in the first and second quarters of 2022, respectively. We are pleased that Dr. David Nichols, M.D., an experienced cystic fibrosis clinical investigator and clinician, will be assisting us with this trial as the academic principal investigator through the Therapeutic Development Network."

RECENT HIGHLIGHTS AND KEY UPCOMING MILESTONES

Acne-Prone Skin (BX001)

In March 2021, BiomX dosed the first subject in a Phase 2 cosmetic clinical study of BX001 and reported completion of enrollment for this study. BX001 is a topical gel that includes a combination of naturally occurring phage that specifically target Cutibacterium acnes. The study will evaluate reduction in Cutibacterium acnes burden as well as improvement in the appearance of acne-prone skin in 140 subjects with mild-to-moderate acne vulgaris. The trial is a 12-week randomized, single center, double-blind, placebo-controlled study, and is on track for results to be reported following the 8- and 12-week treatment periods in the third and fourth quarters of 2021, respectively.
Inflammatory Bowel Disease ("IBD") and Primary Sclerosing Cholangitis ("PSC") (BX003)

In February 2021, BiomX announced positive Phase 1a pharmacokinetic data of BX002 designed to target Klebsiella pneumoniae, a bacteria linked to the pathogenesis of IBD and PSC. The results showed that orally administered BX002 was safe, well-tolerated and met its key objective of delivering viable phage at high concentrations of approximately 1010 plaque forming units to the gastrointestinal tract as measured in all stool samples of treated subjects.
Based on the promising results from the Phase 1a trial of BX002, BiomX plans to initiate a Phase 1b/2a study to evaluate the safety, tolerability, and efficacy of BX003 amongst 60 subjects. Results are expected in the second quarter of 2022. The goal of this study is to demonstrate reduction of target bacteria Klebsiella pneumoniae, as measured in stool of target bacteria carriers. BiomX previously consolidated its IBD and PSC programs to develop one product candidate, BX003, with a broad host range for both indications.
BiomX is hosting a Key Opinion Leader ("KOL") webinar on May 26th at 8:00 am ET with a focus on BX003, the Company’s microbiome-based therapeutic, for IBD. The event will feature KOL, Ryan Balfour Sartor, M.D., who will discuss the IBD treatment landscape as well as the unmet medical need for these patients. Dr. Sartor will be joined by BiomX management, who will provide updates on the BX003 program for IBD and PSC.
Cystic Fibrosis ("CF") (BX004)

In March 2021, BiomX announced the selection of phage cocktail candidate, BX004, for chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF.
BiomX is updating its Phase 2 proof-of-concept study design and timelines to a Phase 1b/2a trial comprised of two parts in CF patients with chronic respiratory infections caused by Pseudomonas aeruginosa. Part 1 results are expected in the first quarter of 2022 and will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple ascending dose design. Part 2 of the Phase 1b/2a trial will evaluate the safety and efficacy of BX004 in 21 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected by the second quarter of 2022.
Atopic Dermatitis (BX005)

In March 2021, BiomX announced the selection of a phage cocktail candidate, BX005, aimed to target Staphylococcus aureus, a bacterium associated with the development and exacerbation of inflammation in patients with atopic dermatitis. When patients experience flares, this bacterium increases in abundance and becomes the dominant bacteria. By reducing Staphylococcus aureus burden, BX005 is designed to shift the skin microbiome composition to its "pre-flare" state to potentially result in clinical improvement.
Results from a Phase 2 proof-of-concept trial evaluating the safety and efficacy of BX005 in atopic dermatitis patients are expected in the first half of 2022.
Colorectal Cancer

BiomX is exploring phage-mediated delivery of therapeutic payloads for the treatment of colorectal cancer, such as immune-stimulating proteins, GM-CSF and IL-15, to target Fusobacterium nucleatum bacteria, which are present within a majority of colorectal tumors.
BiomX is on track to report results from preclinical in vivo studies evaluating the use of phage therapy for colorectal cancer in combination with checkpoint inhibitors in the second and third quarters of 2021.
First Quarter 2021 Financial Results

Cash balance and short-term deposits as of March 31, 2021, were $53.6 million, compared to $57.1 million as of December 31, 2020. The decrease was primarily due to net cash used in operating activities. Existing cash, cash equivalents and short-term deposits are expected to be sufficient to fund the Company’s current operating plan and capital expenditure requirements until at least mid-2022.
Research and development (R&D) expenses, net were $5.8 million for the three months ended March 31, 2021, compared to $3.5 million for the same period in 2020. The increase was primarily due to the growth in the number of employees, resulting in additional stock-based compensation, salaries and related expenses, and due to clinical activities and expenses related to conducting pre-clinical and clinical trials of our product candidates.
General and administrative expenses were $2.5 million for the three months ended March 31, 2021, compared to $2.1 million for the same period in 2020. The increase was primarily due to an increase in stock-based compensation, salaries and related expenses and an increase in expenses associated with operating as a public company, such as directors’ and officers’ insurance.
Net loss for the first quarter of 2021 was $8.4 million, compared to $5.9 million for the same period in 2020.
Net cash used in operating activities for the first quarter of 2021 was $6.4 million, compared to $6.9 million for the same period in 2020.
Conference Call and Webcast Information

BiomX management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the first quarter 2021 ended March 31, 2021. To participate in the conference, 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 on the Investors section of the Company’s website at www.biomx.com.

About Phage Therapy

Bacteriophage, or phage, are viruses that target bacteria and are considered inert to mammalian cells. Phage are designed to target and kill specific bacterial species or strains without disrupting other bacteria or the healthy microbiota. BiomX’s phage-based product candidates derive from its proprietary BOLT ("BacteriOphage Lead to Treatment") R&D platform that enables the company to rapidly develop, manufacture and formulate rationally-designed phage combinations ("cocktails") of naturally-occurring or synthetic phage to target pathogenic bacteria. The phage cocktails contain multiple phage with complementary functions optimized through in vitro and in vivo testing.