On May 11, 2022 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 a business update for the first quarter ended March 31, 2022 (Press release, BiomX, MAY 11, 2022, View Source [SID1234614242]).
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"We are continuing to make progress with our pipeline. In our cystic fibrosis ("CF") program, we are working actively to enroll patients in our Phase 1b/2a trial and continue to expect initial data from the first part of the trial in the third quarter of 2022," said Jonathan Solomon, Chief Executive Officer of BiomX. "We are also proud to have the support of the Cystic Fibrosis Foundation for the CF program through its recent equity investment in BiomX. The Cystic Fibrosis Foundation continues to play an instrumental role in bringing life-saving medicines to CF patients, and we appreciate their support for our program.
"I am also pleased to announce the clearance of an investigational new drug application ("IND") for BX005 for the treatment of atopic dermatitis ("AD"). Supported by Maruho Co. Ltd., we are developing the topical phage cocktail, BX005, to address disease pathology in the AD patient population by targeting Staphylococcus aureus, a bacteria thought to promote and exacerbate inflammation in AD skin. As we look forward to providing updates from our CF and AD programs later this year, we continue to have sufficient cash runway through multiple clinical readouts.
"We also looking forward to our upcoming KOL Webinar on May 12th, which will feature perspectives from leading CF experts on the current treatment landscape and the unmet medical need for patients with chronic Pseudomonas aeruginosa respiratory infections."
RECENT CORPORATE HIGHLIGHTS
In January 2022, BiomX announced that the Company received a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation. The first tranche of this Award closed on December 21, 2021, with the Cystic Fibrosis Foundation investing $3 million in shares of BiomX common stock. Upon completion of patient dosing in Part 1 of the Company’s Phase 1b/2a study of BX004, BiomX would have the right to receive the second tranche of $2 million, also as an equity investment.
Clinical Program Updates
Cystic Fibrosis (BX004)
BX004 is being developed for the treatment of chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF.
The Phase 1b/2a trial is composed of two parts and is planned to start imminently. Part 1 of the trial will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the third quarter of 2022. Part 2 of the 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 by the first quarter of 2023.
Atopic Dermatitis (BX005)
In April 2022, the United States Food and Drug Administration cleared the Company’s IND application for BX005, which is being developed for the treatment of mild-to-moderate AD.
BX005 is currently in the final stages of GMP production. The Company continues to expect the first data readout from its Phase 1/2 proof-of-concept trial evaluating the safety and efficacy of BX005 in the fourth quarter of 2022.
Inflammatory Bowel Disease ("IBD") and Colorectal Cancer Programs ("CRC")
Efforts to advance the Company’s IBD product candidate, BX003, and colorectal cancer product candidate are currently expected to resume during 2023.
First Quarter 2022 Financial Results
Cash balance, short-term deposits and restricted cash as of March 31, 2022, were $55.7 million, compared to $63.1 million as of December 31, 2021. The decrease was primarily due to net cash used in operating activities. Based upon the Company’s strategic focus on the CF and AD programs, the existing cash and cash equivalents are expected to be sufficient to fund the current operating plan through the end of 2023. Additional tranches that would become available to the Company under its venture debt facility upon satisfaction of certain specified milestones can further extend the Company’s cash runway to the first half of 2024.
Research and development ("R&D") expenses, net were $4.9 million for the three months ended March 31, 2022, compared to $5.7 million for the same period in 2021. The decrease was primarily due to pauses in the development of BX003, the product candidate for the treatment of IBD and primary sclerosing cholangitis, pauses in the development efforts in the CRC program, as well as the discontinuing of BX001, the product candidate for the treatment of acne. In addition, the decrease in R&D expenses is due to an increase in grants from the Israeli Innovation Authority, offset by an increase in expenses related to conducting pre-clinical and clinical trials of the Company’s CF and AD product candidates, BX004 and BX005, respectively.
There was no material change to general and administrative expenses that impacted earnings for the three months ended March 31, 2022, compared to the three months ended March 31, 2021.
Net loss for the first quarter of 2022 was $8.2 million, compared to $8.4 million for the same period in 2021.
Net cash used in operating activities for the three months ended March 31, 2022 was $7.4 million, compared to $6.4 million for the same period in 2021.
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 ended March 31, 2022. To participate in the conference, please dial 1-877-407-0724 (U.S.) 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.