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 a business update for the second quarter ended June 30, 2022.
"It has been an eventful quarter for the Company. We enrolled our first patients in our BX004 cystic fibrosis program, expanded our partnering activities, published important research, and successfully restructured our operations to further extend our cash runway," said Jonathan Solomon, Chief Executive Officer of BiomX. "With the ongoing enrollment of patients in our CF study, we are one step closer towards reaching an important milestone in the BX004 program. Sites have been opening according to plan and, provided that the pace of enrollment for the study will continue as expected, we continue to anticipate a data readout from the first part of the study by the end of the third quarter of 2022. Our recent KOL event also highlighted the unmet medical need that exists today for so many CF patients who require innovative new therapeutic approaches to help combat these persistent and difficult-to-treat lung infections.
"As we enter the second half of 2022, BiomX also remains well positioned financially, with our cash runway now expected to take us through at least mid-2024. Over this period, we expect to reach potential milestones intended to help drive significant shareholder value, and I look forward to sharing additional updates later this year."
RECENT CORPORATE HIGHLIGHTS
Clinical Program Updates
Cystic Fibrosis (BX004)
Atopic Dermatitis (BX005)
Second Quarter 2022 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 second quarter 2022. 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 BiomX
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. 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 future updates on its CF, AD and other programs, its expectations regarding the opening of sites, pace of enrollment and timing of the results of the CF trial, the potential safety, tolerability and potential treatment effect of its product candidates, the potential to achieve the applicable clinical milestones required to receive an additional $2 million investment from CFF, and its cash runway, capitalization and financial condition, 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's 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 30, 2022 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.
BIOMX INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(USD in thousands, except share and per share data) |
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(unaudited) |
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|
Three Months Ended
|
Six Months Ended
|
|
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|
2022 |
|
2021 |
2022 |
|
2021 |
|
||||
|
|
|
|
|
|
|
|
||||
Research and development ("R&D") expenses, net |
4,584 |
|
3,824 |
9,513 |
|
9,494 |
|
||||
Amortization of intangible assets |
379 |
|
380 |
759 |
|
759 |
|
||||
General and administrative expenses |
2,361 |
|
3,098 |
4,838 |
|
5,591 |
|
||||
Operating loss |
7,324 |
|
7,302 |
15,110 |
|
15,844 |
|
||||
|
|
|
|
|
|
|
|
||||
Interest expenses |
488 |
|
- |
949 |
|
- |
|
||||
Financial expenses (income), net |
(339 |
) |
31 |
(426 |
) |
(112 |
) |
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|
|
|
|
|
|
|
|
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Loss before tax |
7,473 |
|
7,333 |
15,633 |
|
15,732 |
|
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|
|
|
|
|
|
|
|
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Tax expenses |
9 |
|
3 |
18 |
|
6 |
|
||||
|
|
|
|
|
|
|
|
||||
Net loss |
7,482 |
|
7,336 |
15,651 |
|
15,738 |
|
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|
|
|
|
|
|
|
|
||||
Basic and diluted loss per share of Common Stock |
0.25 |
|
0.30 |
0.53 |
|
0.65 |
|
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|
|
|
|
|
|
|
|
||||
Weighted average number of shares of Common Stock outstanding, basic and diluted |
29,774,709 |
|
24,320,259 |
29,764,588 |
|
24,134,065 |
|
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BIOMX INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(USD in thousands, except share and per share data) |
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(unaudited) |
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As of |
|
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|
June 30,
|
|
December 31,
|
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ASSETS |
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|
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|
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|
|
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Current assets |
|
|
|
|
||
|
|
|
|
|
||
Cash and cash equivalents |
37,745 |
|
62,099 |
|
||
Restricted cash |
963 |
|
996 |
|
||
Short-term deposits |
8,000 |
|
- |
|
||
Other current assets |
1,605 |
|
3,543 |
|
||
Total current assets |
48,313 |
|
66,638 |
|
||
|
|
|
|
|
||
Property and equipment, net |
5,252 |
|
5,694 |
|
||
Intangible assets, net |
760 |
|
1,519 |
|
||
Operating lease right-of-use assets |
4,057 |
|
4,139 |
|
||
Total non-current assets |
10,069 |
|
11,352 |
|
||
|
|
|
|
|
||
|
58,382 |
|
77,990 |
|
||
|
|
|
|
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LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
||
|
|
|
|
|
||
Current liabilities |
|
|
|
|
||
Trade accounts payable |
1,656 |
|
2,795 |
|
||
Other accounts payable |
2,394 |
|
5,453 |
|
||
Contract liability |
- |
|
1,976 |
|
||
Current portion of operating lease liabilities |
708 |
|
819 |
|
||
Current portion of long-term debt |
1,732 |
|
- |
|
||
Total current liabilities |
6,490 |
|
11,043 |
|
||
|
|
|
|
|
||
Non-current liabilities |
|
|
|
|
||
Contract liability |
1,976 |
|
- |
|
||
Long-term debt, net of current portion |
12,929 |
|
14,410 |
|
||
Operating lease liabilities, net of current portion |
4,039 |
|
4,787 |
|
||
Other liabilities |
209 |
|
215 |
|
||
Total non-current liabilities |
19,153 |
|
19,412 |
|
||
|
|
|
|
|
||
Stockholders' equity |
|
|
|
|
||
|
|
|
|
|
||
Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of June 30, 2022 and December 31, 2021. No shares issued and outstanding as of June 30, 2022 and December 31, 2021. |
- |
|
- |
|
||
Common Stock, $0.0001 par value; Authorized - 60,000,000 shares as of June 30, 2022 and December 31, 2021. Issued ? 29,780,409 shares as of June 30, 2022 and 29,753,238 shares as of December 31, 2021. Outstanding ? 29,774,709 shares as of June 30, 2022 and 29,747,538 shares as of December 31, 2021. |
2 |
|
2 |
|
||
|
|
|
|
|
||
Additional paid in capital |
156,872 |
|
156,017 |
|
||
Accumulated deficit |
(124,135 |
) |
(108,484 |
) |
||
Total stockholders' equity |
32,739 |
|
47,535 |
|
||
|
58,382 |
|
77,990 |
|
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