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, today reported financial results and provided business updates for the first quarter ended March 31, 2021.
"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)
Inflammatory Bowel Disease ("IBD") and Primary Sclerosing Cholangitis ("PSC") (BX003)
Cystic Fibrosis ("CF") (BX004)
Atopic Dermatitis (BX005)
Colorectal Cancer
First Quarter 2021 Financial Results
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.
About BiomX
BiomX is a clinical-stage microbiome company developing both natural and engineered phage cocktails designed to target and destroy bacteria that affect the appearance of skin, as well as target bacteria in the treatment of chronic diseases, such as inflammatory bowel disease, primary sclerosing cholangitis, cystic fibrosis, atopic dermatitis and colorectal cancer. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.
Additional information is available at www.biomx.com, the content of which does not form a part of this press release.
Safe Harbor
This press release contains express or implied "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. For example, when BiomX discusses potential markets opportunities, the capabilities of the BOLT platform, the design, aim, expected timing, and interim and final results of its preclinical and clinical trials and studies, the sufficiency of its existing cash, cash equivalents and short-term deposits, its pipeline and the potential of its product candidates, BiomX is making forward-looking statements. 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. 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 BiomX control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption
"Risk Factors" in BiomX's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 31, 2021 and additional disclosures BiomX makes in its filings with the SEC, which are available on the SEC's website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.
BIOMX INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) USD in thousands, except share and per share data |
|||||||||
Three months ended
|
|||||||||
2021 |
2020 |
||||||||
Research and development expenses, net |
5,794 |
3,529 |
|||||||
Amortization of intangible assets |
379 |
379 |
|||||||
General and administrative expenses |
2,497 |
2,058 |
|||||||
Operating loss |
8,670 |
5,966 |
|||||||
Finance income, net |
(271) |
(65) |
|||||||
Loss before taxes |
8,399 |
5,901 |
|||||||
Tax expenses |
3 |
- |
|||||||
Net loss |
8,402 |
5,901 |
|||||||
Basic and diluted loss per share of Common Stock |
0.35 |
0.26 |
|||||||
Weighted average number of shares of Common Stock
|
23,944,573 |
22,897,723 |
BIOMX INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) USD in thousands |
|||||||||
As of
|
As of
|
||||||||
|
|||||||||
Current assets |
|||||||||
Cash and cash equivalents |
39,411 |
36,477 |
|||||||
Restricted cash |
976 |
763 |
|||||||
Short-term deposits |
13,205 |
19,851 |
|||||||
Other current assets |
2,943 |
3,576 |
|||||||
Total current assets |
56,535 |
60,667 |
|||||||
Property and equipment, net |
3,531 |
2,228 |
|||||||
Intangible assets, net |
2,658 |
3,038 |
|||||||
Operating lease right-of-use assets |
4,338 |
4,430 |
|||||||
Total non-current assets |
10,527 |
9,696 |
|||||||
67,062 |
70,363 |
||||||||
As of
|
As of
|
||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||||
Current liabilities |
|||||||||
Trade account payables |
2,685 |
2,320 |
|||||||
Other account payables |
4,350 |
3,978 |
|||||||
Current portion of operating lease liabilities |
763 |
863 |
|||||||
Total current liabilities |
7,798 |
7,161 |
|||||||
Non-current liabilities |
|||||||||
Operating lease liabilities, net of current portion |
4,738 |
5,032 |
|||||||
Contingent considerations |
572 |
701 |
|||||||
Total non-current liabilities |
5,310 |
5,733 |
|||||||
Stockholders' equity |
|||||||||
Preferred stock, $0.0001 par value; Authorized ? 1,000,000
|
- |
- |
|||||||
Common stock, $0.0001 par value; Authorized -60,000,000
|
2 |
2 |
|||||||
Additional paid in capital |
134,612 |
129,725 |
|||||||
Accumulated deficit |
(80,660) |
(72,258) |
|||||||
Total stockholders' equity |
53,954 |
57,469 |
|||||||
67,062 |
70,363 |
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