| Page |
|---|
| PART I. FINANCIAL INFORMATION |
|---|
| | | |
|---|
| Item 1. | Financial Statements (unaudited) | 6 |
|---|
| | | |
|---|
| | Condensed Consolidated Balance Sheets | 6 |
|---|
| | |
|---|
| Condensed Consolidated Statements of Operations | 7 |
| |
|---|
| | Condensed Consolidated Statements of Stockholders’ (Deficit) Equity | 8 |
|---|
| | | |
|---|
| Condensed Consolidated Statements of Cash Flows | 9 |
| |
|---|
| Notes to Condensed Consolidated Financial Statements | 10 |
| | | |
|---|
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 21 |
|---|
| | | |
|---|
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 29 |
|---|
| | | |
|---|
| Item 4. | Controls and Procedures | 29 |
|---|
| | | |
|---|
| PART II. OTHER INFORMATION | 30 | |
|---|
| Item 1. | Legal Proceedings | 30 |
|---|
| Item 1A. | Risk Factors | 30 |
|---|
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 30 |
|---|
| Item 3. | Defaults upon Senior Securities | 30 |
|---|
| Item 4. | Mine Safety Disclosures | 30 |
|---|
| Item 5. | Other Information | 30 |
|---|
| Item 6. | Exhibits | 30 |
|---|
| SIGNATURES | 33 | |
|---|
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this “Quarterly Report”) and certain information incorporated herein by reference contain forward-looking statements, which are provided under the “safe harbor” protection of the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to our future financial performance and involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance, or events to be materially different from any future results, performance, or events expressed or implied by the forward-looking statements. Forward-looking statements in this Quarterly Report include, but are not limited to, statements regarding:
| ● | our estimates regarding anticipated operating losses, capital requirements and needs for additional funds; |
| ● | our ability to raise additional capital when needed and to continue as a going concern; |
| ● | our ability to manufacture, or otherwise secure the manufacture of, sufficient amounts of our product candidates for our preclinical studies and clinical trials; |
| ● | our research and development plans, including our clinical development plans and planned clinical trials; |
| ● | our ability to select combinations of phages to formulate our product candidates; |
| ● | our development of bacteriophage-based therapies; |
| ● | the potential use of bacteriophages to treat bacterial infections; |
| ● | the potential future of antibiotic resistance; |
| ● | our ability for bacteriophage therapies to disrupt and destroy biofilms and restore sensitivity to antibiotics; |
| ● | our planned development strategy, presenting data to regulatory agencies and defining planned clinical studies; |
| ● | the expected timing of additional clinical trials, including Phase 1b/Phase 2 or registrational clinical trials; |
| ● | our ability to manufacture and secure sufficient quantities of our product candidates for clinical trials; |
| ● | the drug product candidates to be supplied by us for clinical trials; |
| ● | the potential for bacteriophage technology being uniquely positioned to address the global threat of antibiotic resistance; |
| ● | the safety and efficacy of our product candidates; |
| ● | our anticipated regulatory pathways for our product candidates; |
| ● | the activities to be performed by specific parties in connection with clinical trials; |
| ● | our ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of our product candidates and commercialize any approved products on our expected timeframes or at all; |
| ● | our pursuit of additional indications; |
| ● | the content and timing of submissions to and decisions made by the U.S. Food and Drug Administration and other regulatory agencies; |
| ● | our ability to leverage the experience of our management team and to attract and retain management and other key personnel; |
| ● | the capacities and performance of our suppliers, manufacturers, contract research organizations and other third parties over whom we have limited control; |
| ● | our ability to staff and maintain our Marina del Rey production facility under fully compliant current Good Manufacturing Practices; |
| ● | the actions of our competitors and success of competing drugs or other therapies that are or may become available; |
| ● | our expectations with respect to future growth and investments in our infrastructure, and our ability to effectively manage any such growth; |
| ● | the size and potential growth of the markets for any of our product candidates, and our ability to capture share in or impact the size of those markets; |
| ● | the benefits of our product candidates; |
| ● | potential market growth and market and industry trends; |
| ● | maintaining collaborations with third parties including our partnerships with the Cystic Fibrosis Foundation (“CFF”), and the U.S. Department of Defense (the “DoD”); |
| ● | potential future collaborations with third parties and the potential markets and market opportunities for product candidates; |
| ● | our ability to achieve our vision, including improvements through engineering and success of clinical trials; |
| ● | our ability to meet anticipated milestones in the development and testing of the relevant product; |
| ● | our ability to be a leader in the development of phage-based therapeutics; |
| ● | the expected compliance with DoD grant requirements; |
| ● | the effects of government regulation and regulatory developments, and our ability and the ability of the third parties with whom we engage to comply with applicable regulatory requirements; |
| ● | the accuracy of our estimates regarding future expenses, revenues, capital requirements and need for additional financing; |
| ● | our expectations regarding future planned expenditures; |
| ● | our ability to achieve and maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act; |
| ● | our ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of any of our products and product candidates; |
| ● | our ability to protect our intellectual property, including pending and issued patents; |
| ● | our ability to operate our business without infringing the intellectual property rights of others; |
| ● | our ability to advance our clinical development programs; |
| ● | the effects of the ongoing conflict between Ukraine and Russia and the recent and potential future bank failures or other geopolitical events; and |
| ● | statements of belief and any statement of assumptions underlying any of the foregoing. |
In some cases, you can identify these statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of those terms, and similar expressions. These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Quarterly Report and are subject to risks and uncertainties. We discuss many of these risks in greater detail in the section hereof entitled “Risk Factors” and in our Annual Report on Form 10-K for the year ended December 31, 2023. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain. Given these uncertainties, you should not place undue reliance on any of the forward-looking statements included in this Quarterly Report. In addition, this Quarterly Report also contains estimates, projections, and other information concerning our industry, our business, and the markets for our product candidates, as well as data regarding market research, estimates, and forecasts prepared by our management. Information that is based on estimates, forecasts, projections, market research, or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information.
Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information, future events, or otherwise.
This Quarterly Report includes trademarks and registered trademarks of Armata Pharmaceuticals, Inc. Products or service names of other companies mentioned in this Quarterly Report may be trademarks or registered trademarks of their respective owners.
As used in this Quarterly Report, unless the context requires otherwise, the “Company,” “we,” “us,” and “our” refer to Armata Pharmaceuticals, Inc. and its wholly owned subsidiaries.
