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the context otherwise requires, references in this Exhibit 99.1 to "we," "us," and "our" refer
to BiomX Inc. and its wholly-owned Israeli subsidiary, BiomX Ltd. and RondinX Ltd., an Israeli company and wholly-owned subsidiary
investment in our securities carries a significant degree of risk. You should carefully consider the following risks, as well
as the other information contained in our Annual Report on Form 10-K for the year ended December 31, 2019, or our Annual Report,
our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, or our Quarterly Report, and our other filings with
the Securities and Exchange Commission, or the SEC, including our historical financial statements and related notes included therein,
before you decide to purchase our securities. Any one of these risks and uncertainties has the potential to cause material adverse
effects on our business, prospects, financial condition and operating results which could cause actual results to differ materially
from any forward-looking statements expressed by us and a significant decrease in the value of our Common Stock, warrants. Refer
to "Cautionary Statement Regarding Forward-Looking Statements" in our Annual Report, our Quarterly Report or our other
filings with the SEC.
may not be successful in preventing the material adverse effects that any of the following risks and uncertainties may cause.
These potential risks and uncertainties may not be a complete list of the risks and uncertainties facing us. There may be additional
risks and uncertainties that we are presently unaware of, or presently consider immaterial, that may become material in the future
and have a material adverse effect on us. You could lose all or a significant portion of your investment due to any of these risks
Related to Our Business, Technology and Industry
are a development clinical-stage company with limited operating history and have incurred losses since our inception. We anticipate
that our expenses will increase significantly and we will continue to incur increasing and significant losses for the foreseeable
are a development clinical-stage biopharmaceutical company with limited operating history. We have incurred losses in each year
since BiomX Ltd.'s inception in 2015. As of September 30, 2020, our accumulated deficit was $63.1 million, and we expect
to incur increasingly significant losses for the foreseeable future. Preclinical development and clinical trials and activities
are costly. We have devoted, and will continue to devote for the foreseeable future, substantially all of our resources to research
and development and clinical trials for our product candidates. We do not expect to generate any revenue from the commercial sales
of our product candidates in the near term. For the nine months ended September 30, 2020 and the years ended December 31, 2019
and 2018, we had losses from operations of $21.2 million, $22.2 million and $12.5 million, respectively. We anticipate that our
expenses will increase substantially if and as we:
will need to raise additional capital in the future to support our operations.
September 30, 2020, we had cash, cash equivalents and short-term deposits of $64.5 million, and we have had recurring losses from
operations and negative operating cash flows since inception. We will need to raise additional capital in the future to support
our operations and product development activities. In the near term, we expect to continue to fund our operations and other development
activities relating to additional product candidates from the cash held by us, governmental and other grants and through future
equity financings. We may also seek funds through arrangements with collaborators or others that may require us to relinquish
rights to the product candidates that we might otherwise seek to develop or commercialize independently. If we enter into a collaboration
for one or more of our current or future product candidates at an earlier development stage, the terms of such a collaboration
will likely be less favorable than if we were to enter the collaboration in later stages or if we commercialized the product independently.
If we raise additional funds through equity offerings, the terms of these securities may include liquidation or other preferences
that adversely affect our stockholders' rights or cause significant dilution to our stockholders. If we raise additional
capital through debt financing, it would be subject to fixed payment obligations and may be subject to covenants limiting or restricting
our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring
or licensing intellectual property rights.
additional capital is not available to us when needed or on acceptable terms, we may not be able to continue to operate our business
pursuant to our business plan and may be required to delay our clinical development. While we believe that our existing cash and
cash equivalents, together with our existing resources, will be sufficient to fund our planned operations for at least the next
24 months, we cannot provide assurances that our estimates are accurate, that our plans will not change or that changed circumstances
will not result in the depletion of our capital resources more rapidly than we currently anticipate.
drugs and conducting clinical trials is expensive. Our future funding requirements will depend on many factors, including:
and international equity and debt markets have experienced and may continue to experience heightened volatility and turmoil based
on domestic and international economic conditions and concerns. In the event these economic conditions and concerns continue or
worsen and the markets continue to remain volatile, or a bear market, or recession, ensues in the U.S. stock market, and the impact
recently seen associated with the coronavirus outbreak, our operating results and liquidity could be affected adversely by those
factors in many ways, including making it more difficult for us to raise funds if necessary and our stock price may decline.
can be no assurance that sufficient funds will be available to us when required or on acceptable terms, if at all. Our inability
to obtain additional funds could have a material adverse effect on our business, financial condition and results of operations.
Moreover, if we are unable to obtain additional funds on a timely basis, there will be substantial doubt about our ability to
continue as a going concern and increased risk of insolvency and up to a total loss of investment by our shareholders.
are seeking to develop product candidates using phage technology, an approach for which is difficult to predict the time and cost
of development. To our knowledge, no bacteriophage has thus far been as a drug in the United States or in the European Union.
are developing our product candidates with phage technology. We have not, nor to our knowledge has any other company, received
regulatory approval from the U.S. Food and Drug Administration, or FDA, or equivalent foreign regulatory agencies for a product
based on this approach. While in vitro and in vivo studies have characterized the behavior of phage in cell cultures
and animal models and there exists a body of literature regarding the use of phage therapy in humans, the safety and efficacy
of phage therapy in humans has not been extensively studied in well-controlled modern clinical trials. Most of the prior research
on phage-based therapy was conducted in the former Soviet Union prior to and immediately after World War II and lacked appropriate
control group design or lacked control groups at all. Furthermore, the standard of care has changed substantially during the ensuing
decades since those studies were performed, diminishing the relevance of prior claims of improved cure rates. Any product candidates
that we develop may not demonstrate in patients the therapeutic properties ascribed to them in laboratory and other preclinical
studies, and they may interact with human biological systems in unforeseen, ineffective or even harmful ways. We cannot be certain
that our approach will lead to the development of approvable or marketable products. Furthermore, the bacterial targets of phage
may develop resistance to our product candidates over time, which we may or may not be able to overcome with the development of
new phage cocktails or we may not be able to construct a cocktail with sufficient coverage of our target pathogen universe.
our product candidates receive regulatory approval but do not achieve an adequate level of acceptance by physicians, healthcare
payors and patients, we may not generate product revenue sufficient to attain profitability. Our success will depend upon physicians
who specialize in the treatment of diseases targeted by our product candidates that we pursue as drugs, prescribing potential
treatments that involve the use of our product candidates in lieu of, or in addition to, existing treatments with which they are
more familiar and for which greater clinical data may be available. Our success will also depend on consumer acceptance and adoption
of our products that we commercialize. Adverse events in preclinical studies and clinical trials of our product candidates or
in clinical trials of others developing similar products and the resulting publicity, as well as any other adverse events in the
field of phage therapeutics, could result in a decrease in demand for any product that we may develop. The degree of market acceptance
of any approved products will depend on a number of factors, including:
our product candidates on a commercial scale will require substantial technical, financial and human resources. We and our third-party
collaborators may experience delays in developing manufacturing capabilities for our product candidates, and may not be able to
do so at the scale required to efficiently conduct the clinical trials required to obtain regulatory approval of those of our
product candidates that require it, or to manufacture commercial quantities of our products, if approved or otherwise permitted
are considering marketing our lead candidate product - BX001 - as a cosmetic, although this positioning also presents
some challenges, as explained in the risk factors below.
product candidates must undergo clinical testing which may fail to demonstrate the requisite safety and tolerability for cosmetics,
safety and efficacy for drug products, or safety, purity, and potency for biologics, and any of our product candidates could cause
adverse effects, which would substantially delay or prevent regulatory approval and/or commercialization.
we can obtain regulatory approval for a product candidate or otherwise obtain evidence allowing us to market the product, we must
undertake extensive preclinical and clinical testing in humans to demonstrate safety and efficacy to the satisfaction of the FDA
or other regulatory agencies. Clinical trials of product candidates sufficient to obtain regulatory marketing approval or otherwise
demonstrate safety prior to marketing, are expensive and take years to complete, especially for our product candidate designed
to treat colorectal cancer, or CRC, as the phage will be genetically modified, which could make the conduct of clinical trials
more complex. Furthermore, results from these clinical trials may not show safety or efficacy of our product candidates sufficient
to lead to approval, or to warrant further development. For example, our approach is intended to design phage combinations, or
cocktails, to target specific strains of pathogenic bacteria in order to alter microbiome composition and confer potential therapeutic
or cosmetic benefit to patients. However, there can be no assurance that the eradication of the selected targets will result in
a clinically meaningful effect on the underlying disease, such as in cases where the pathology of the disease is not well-defined.
In addition, the bacteria that we target may be associated with the disease, but may not be causative or contributive to the pathology
of the disease, or there may be other bacteria that our product candidates do not target that are more meaningful drivers of the