Full Press Release Details
Reports Third Quarter 2021 Financial Results and Provides Business Update
Announces Strategic Focus on Cystic Fibrosis
and Atopic Dermatitis Programs Based on
Potential Proof-of-Concept Clinical Data Readouts in 2022
Cash Runway Now Extended to End of 2023, Well
Beyond Key 2022 Data Readouts
FDA Clears BiomX to Begin Phase 1b/2a Trial
in Cystic Fibrosis; Trial to Start Imminently
Company Will Host a Conference Call and Webcast
BRANFORD, Conn. and NESS ZIONA, Israel - November 15, 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 today financial
results and provided a business update for the third quarter ended September 30, 2021.
"In planning for the years
ahead, BiomX has made the decision to prioritize the development of our cystic fibrosis and atopic dermatitis product candidates, as each
has the potential to generate proof-of-concept clinical data readouts in 2022. BiomX will also discontinue development of its acne program,"
said Jonathan Solomon, Chief Executive Officer of BiomX. "We believe that by focusing on the efficient use of BiomX's capital
on selected programs that can generate clinically meaningful, proof-of-concept data, will best position our company to drive value creation
for shareholders. With this decision, we intend to also postpone our development efforts temporarily in inflammatory bowel disease and
colorectal cancer until 2023.
new strategic focus will have a positive impact on our balance sheet. This new focus may allow us to extend our cash runway by up to 6
months, until at least the end of 2023, and additional tranches that may become available to us under our venture debt facility upon satisfaction
of certain specified milestones may further extend our cash runway to the first half of 2024." We therefore believe that we remain
well-positioned financially through our expected clinical data readouts in cystic fibrosis and atopic
RECENT CORPORATE HIGHLIGHTS
Clinical Program Updates
Cystic Fibrosis ("CF")
Atopic Dermatitis ("AD")
Inflammatory Bowel Disease
("IBD") and Colorectal Cancer Programs
Acne-Prone Skin (BX001)
Third Quarter 2021 Financial Results
Conference Call and Webcast Information
will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the third quarter 2021
ended September 30, 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.
BiomX is a clinical-stage microbiome company
developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases, such
as cystic fibrosis, atopic dermatitis, inflammatory bowel disease, primary sclerosing cholangitis, 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.
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 its expectations regarding the sufficiency of cash, cash equivalents and short-term deposits
to fund the Company's current operating plan until at least the end of 2023, or even later, the ability of its products to address
unmet medical needs, the potential to receive up to $15 million in additional loan tranches if certain milestones are met, the design,
aim, expected timing and results of its preclinical and clinical trials and studies, including resumption of certain development programs,
as well as 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 other 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
USD in thousands, except share and per share
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
| Note | 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Research and development ("R&D") expenses, net | 6,608 | 6,056 | 16,102 | 13,302 | ||||||||||||||
| Amortization of intangible assets | 380 | 380 | 1,139 | 1,139 | ||||||||||||||
| General and administrative expenses | 2,845 | 2,394 | 8,436 | 6,749 | ||||||||||||||
| Operating loss | 9,833 | 8,830 | 25,677 | 21,190 | ||||||||||||||
| Financial expenses (income), net | 188 | 5 | 76 | (248 | ) | |||||||||||||
| Loss before tax | 10,021 | 8,835 | 25,753 | 20,942 | ||||||||||||||
| Tax expenses | 10 | - | 16 | - | ||||||||||||||
| Net Loss | 10,031 | 8,835 | 25,769 | 20,942 | ||||||||||||||
| Basic and diluted loss per share of Common Stock | 6 | 0.37 | 0.38 | 1.03 | 0.91 | |||||||||||||
| Weighted average number of shares of Common Stock outstanding, basic and diluted | 27,077,903 | 23,150,253 | 25,120,037 | 23,013,790 |
CONDENSED CONSOLIDATED BALANCE SHEETS
| As of | ||||||||||
| Note | September 30, 2021 | December 31, 2020 | ||||||||
| ASSETS | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 67,346 | 36,477 | ||||||||
| Restricted cash | 985 | 763 | ||||||||
| Short-term deposits | - | 19,851 | ||||||||
| Other current assets | 1,467 | 3,576 | ||||||||
| Total current assets | 69,798 | 60,667 | ||||||||
| Property and equipment, net | 5,863 | 2,228 | ||||||||
| Intangible assets, net | 1,899 | 3,038 | ||||||||
| Operating lease right-of-use assets | 4,239 | 4,430 | ||||||||
| Total non-current assets | 12,001 | 9,696 | ||||||||
| 81,799 | 70,363 |
| As of | ||||||||||
| Note | September 30, 2021 | December 31, 2020 | ||||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current liabilities | ||||||||||
| Trade account payables | 1,879 | 2,320 | ||||||||
| Other account payables | 6,321 | 3,978 | ||||||||
| Current portion of operating lease liabilities | 799 | 863 | ||||||||
| Total current liabilities | 8,999 | 7,161 | ||||||||
| Non-current liabilities | ||||||||||
| Long-term debt | 4 | 14,225 | - | |||||||
| Operating lease liabilities, net of current portion | 4,728 | 5,032 | ||||||||
| Other liabilities | 420 | 701 | ||||||||
| Total non-current liabilities | 19,373 | 5,733 | ||||||||
| Commitments and Collaborations | 3 | |||||||||
| Stockholders' equity | 5 | |||||||||
| Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of September 30, 2021 and December 31, 2020. No shares issued and outstanding as of September 30, 2021 and December 31, 2020. | - | - | ||||||||
| Common Stock, $0.0001 par value; Authorized - 60,000,000 shares as of September 30, 2021 and December 31, 2020. Issued - 28,206,229 shares as of September 30, 2021 and 23,270,337 shares as of December 31, 2020. Outstanding - 28,200,529 shares as of September 30, 2021 and 23,264,637 shares as of December 31, 2020. | 3 | 2 | ||||||||
| Additional paid in capital | 151,451 | 129,725 | ||||||||
| Accumulated deficit | (98,027 | ) | (72,258 | ) | ||||||
| Total stockholders' equity | 53,427 | 57,469 | ||||||||
| 81,799 | 70,363 |
Corporate Project Manager