UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE |
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For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE |
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For the transition period from _________________ to _______________________
Commission file number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of | (I.R.S. Employer Identification Number) |
incorporation or organization) | |
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(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (
4503 Glencoe Avenue, Marina Gel Ray, CA
(Former name, former address, and former fiscal year, if changed since last year)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company as defined in Rule 12b-2 of the Exchange Act. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ | Accelerated filer ☐ |
Smaller reporting company | |
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
The number of shares of the registrant’s Common Stock, par value $0.01 per share, outstanding as of August 4, 2023 was
TABLE OF CONTENTS
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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 clinical development plans, including planned clinical trials; |
● | our research and development plans, including our clinical development plans; |
● | 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 (the “FDA”) 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 (“CROs”) 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 (“cGMP”); |
● | 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 use of proceeds from the $16.3 million DoD grant; |
● | 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 the 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, 2022. 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.
PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
Armata Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
| June 30, 2023 |
| December 31, 2022 |
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(unaudited) | |||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | | $ | | |||
Prepaid expenses |
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Other receivables | | | |||||
Total current assets |
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Restricted cash | | | |||||
Property and equipment, net |
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Operating lease right-of-use asset |
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In-process research and development | | | |||||
Goodwill | | | |||||
Other assets |
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Total assets | $ | | $ | | |||
Liabilities and shareholders’ equity |
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Current liabilities |
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Accounts payable and accrued liabilities | $ | | $ | | |||
Accrued compensation | | | |||||
Current portion of operating lease liabilities | | | |||||
Convertible debt | | — | |||||
Total current liabilities |
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Operating lease liabilities, net of current portion | | | |||||
Deferred tax liability | | | |||||
Total liabilities |
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Shareholders’ equity |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total shareholders’ equity |
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Total liabilities and shareholders’ equity | $ | | $ | |
See accompanying notes to condensed consolidated financial statements.
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Armata Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 |
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Grant revenue | $ | | $ | | $ | | $ | | |||||
Operating expenses | |||||||||||||
Research and development |
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General and administrative |
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Total operating expenses | | | | | |||||||||
Loss from operations |
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Other income (expense) |
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Interest income |
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Change in fair value of convertible debt | | — | | — | |||||||||
Total other income (expense), net |
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Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Per share information: |
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Net loss per share, basic | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Weighted average shares outstanding, basic | | | | | |||||||||
Net loss per share, diluted | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Weighted average shares outstanding, diluted | | | | |
See accompanying notes to condensed consolidated financial statements.
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Armata Pharmaceuticals, Inc.
Condensed Consolidated Statements of Shareholders’ Equity
Three and Six Months Ended June 30, 2023 and 2022
(unaudited)
Shareholders’ Equity | ||||||||||||||
Common Stock | ||||||||||||||
Additional | Total | |||||||||||||
Paid-in | Accumulated | shareholders’ | ||||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
Balances, March 31, 2022 |
| | $ | | $ | | $ | ( | $ | | ||||
Issuance cost in connection with sale of common stock | — | — | ( | — | ( | |||||||||
Forfeiture of restricted stock awards |
| ( | — | — | — |
| — | |||||||
Exercise of stock options | | — | | — | | |||||||||
Return of restricted stock awards for tax withholdings | ( | — | ( | — | ( | |||||||||
Share-based compensation |
| — | — | | — |
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Net loss |
| — | — | — | ( |
| ( | |||||||
Balances, June 30, 2022 |
| | $ | | $ | | $ | ( | $ | | ||||
Shareholders’ Equity | ||||||||||||||
Common Stock | ||||||||||||||
Additional | Total | |||||||||||||
Paid-in | Accumulated | shareholders’ | ||||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
Balances, March 31, 2023 |
| | $ | | $ | | $ | ( | $ | | ||||
Forfeiture of restricted stock awards |
| ( | — | — | — |
| — | |||||||
Return of restricted stock awards for tax withholdings | ( | — | ( | — | ( | |||||||||
Share-based compensation |
| — | — | | — |
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Net loss |
| — | — | — | ( |
| ( | |||||||
Balances, June 30, 2023 |
| | $ | | $ | | $ | ( | $ | |
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Shareholders’ Equity | ||||||||||||||
Common Stock | ||||||||||||||
Additional | Total | |||||||||||||
Paid-in | Accumulated | Shareholders’ | ||||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
Balances, December 31, 2021 |
| | | $ | | $ | ( | $ | | |||||
Sale of common stock, net of issuance costs | | | | — | | |||||||||
Return of restricted stock awards for tax withholdings | ( | — | ( | — | ( | |||||||||
Forfeiture of restricted stock awards |
| ( | — | — | — |
| — | |||||||
Exercise of stock options | | — | | — | | |||||||||
Share-based compensation |
| — | — | | — |
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Net loss |
| — | — | — | ( |
| ( | |||||||
Balances, June 30, 2022 |
| | $ | | $ | | $ | ( | $ | | ||||
Shareholders’ Equity | ||||||||||||||
Common Stock | ||||||||||||||
Additional | Total | |||||||||||||
Paid-in | Accumulated | Shareholders’ | ||||||||||||
Shares |
| Amount |
| Capital |
| Deficit |
| Equity | ||||||
Balances, December 31, 2022 |
| | $ | | $ | | $ | ( | $ | | ||||
Return of restricted stock awards for tax withholdings | ( | — | — | — | — | |||||||||
Forfeiture of restricted stock awards | ( | — | ( | — | ( | |||||||||
Share-based compensation | — | — | | — | | |||||||||
Net loss |
| — | — | — | ( |
| ( | |||||||
Balances, June 30, 2023 |
| | $ | | $ | | $ | ( | $ | |
See accompanying notes to condensed consolidated financial statements.
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Armata Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
Six Months Ended June 30, | ||||||
| 2023 |
| 2022 | |||
Operating activities: | ||||||
Net loss | $ | ( | $ | ( | ||
Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||
Depreciation |
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Share-based compensation | | | ||||
Change in fair value of convertible debt | ( | — | ||||
Changes in operating assets and liabilities: |
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Accounts payable and accrued liabilities |
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Accrued compensation | ( | | ||||
Operating lease right-of-use asset and liability, net | ( | | ||||
Prepaid expenses and other current assets |
| ( |
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Net cash used in operating activities |
| ( |
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Investing activities: |
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Purchases of property and equipment | ( | ( | ||||
Net cash used in investing activities |
| ( |
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Financing activities: |
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Proceeds from issuance of convertible debt, net of issuance costs | | — | ||||
Proceeds from sale of common stock, net of offering costs | — | | ||||
Proceeds from exercise of warrants and stock options | — | | ||||
Net cash provided by financing activities |
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Net increase in cash, cash equivalents and restricted cash |
| ( |
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Cash, cash equivalents and restricted cash, beginning of period |
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Cash, cash equivalents and restricted cash, end of period | $ | | $ | | ||
Supplemental disclosure of cash flow information: |
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Unpaid offering costs | $ | — | $ | | ||
Property and equipment included in accounts payable | $ | | $ | |
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statement of cash flows:
Six Months Ended June 30, | ||||||
2023 |
| 2022 | ||||
Cash and cash equivalents | $ | | $ | | ||
Restricted cash | | | ||||
Cash, cash equivalents and restricted cash | $ | | $ | |
See accompanying notes to condensed consolidated financial statements.
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Armata Pharmaceuticals, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Organization and Description of the Business
Armata Pharmaceuticals, Inc. (“Armata”), and together with its subsidiaries, is referred to herein as, the “Company”, is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata’s common stock is traded on the NYSE American exchange under the ticker symbol “ARMP”.
2. Liquidity
2023 Credit Agreement
On July 10, 2023, the Company entered into, as borrower, a credit and security agreement (the “Credit Agreement”) with Innoviva Strategic Opportunities LLC (“Innoviva”), a wholly owned subsidiary of Innoviva, Inc. (the “Parent”), a principal shareholder of the Company on July 10, 2023. The Credit Agreement provides for a secured term loan facility in an aggregate amount of $
The Credit Agreement contains customary affirmative and negative covenants and representations and warranties, including financial reporting obligations and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, investments, mergers or acquisitions and fundamental corporate changes. The Credit Agreement also includes customary events of default, including payment defaults, breaches of provisions under the loan documents, certain losses or impairment of collateral and related security interests, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the Credit Agreement, certain bankruptcy or insolvency events, and a material deviation from the Company’s operating budget.
2023 Convertible Credit Agreement
On January 10, 2023, the Company entered into, as borrower, a secured convertible credit and security agreement (the “Convertible Credit Agreement”) with Innoviva. The Convertible Credit Agreement provides for a secured term loan facility in an aggregate amount of $
Repayment of the Convertible Loan is guaranteed by the Company’s domestic subsidiaries and foreign material subsidiaries, and the Convertible Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.
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The Convertible Credit Agreement provides that if a Qualified Financing (as defined in the Credit Agreement) occurs, the outstanding principal amount of, and all accrued and unpaid interest on, the Convertible Loan shall be converted into shares of the Company’s common stock, par value $
2022 Equity Financing
On February 9, 2022, the Company entered into a securities purchase agreement (“February 2022 Securities Purchase Agreement”) to sell its Common Stock and warrants to Innoviva. Pursuant and subject to the terms and conditions of the February 2022 Securities Purchase Agreement and related agreements, Innoviva agreed to purchase
As of June 30, 2023, the Company had cash and cash equivalents of $
Management plans to raise additional capital through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses and other similar arrangements. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, these plans are not entirely within its control and cannot be assessed as being probable of occurring. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the United States and worldwide. The Company may not be able to secure additional financing in a timely manner or on favorable terms, if at all. Furthermore, if the Company issues equity securities to raise additional funds, its existing shareholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing shareholders. If the Company raises additional funds through collaboration, licensing or other similar arrangements, it may be necessary to relinquish valuable rights to its potential products on terms that are not favorable to the Company. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce or eliminate its research and development programs or other operations. If any of these events occur, the Company’s ability to achieve the development and commercialization goals would be adversely affected.
3. Significant Accounting Policies
Basis of Presentation
The condensed consolidated financial statements include the accounts of Armata and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated. The accompanying unaudited condensed
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consolidated financial statements of the Company should be read in conjunction with the audited financial statements and accompanying notes thereto as of and for the year ended December 31, 2022 included in the Company’s Form 10-K, filed with the SEC on March 16, 2023. The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial statements. Any reference in the Notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments that are of a normal and recurring nature and that are necessary for the fair presentation of the Company’s financial position and the results of its operations and cash flows for the periods presented. Interim results are not necessarily indicative of results for the full year or any future period.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in its condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates these estimates and judgments, which are based on historical and anticipated results and trends, and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates.
Fair Value of Financial Instruments
The carrying amounts of cash equivalents, other current assets, accounts payable, and accrued liabilities approximate fair value because of the short-term nature of these instruments.
In-Process Research and Development (“IPR&D”)
IPR&D assets are intangible assets with indefinite lives and are not subject to amortization. The Company’s IPR&D assets represent capitalized incomplete research projects acquired by the Company, which is related to the development of natural phage combinations for the treatment of Staphylococcus aureus infections (“S. aureus”), examples of which comprise AP-SA01 and AP-SA02. Such assets are initially measured at their acquisition-date fair values and are subject to impairment testing at least annually until completion or abandonment of research and development efforts associated with the projects. Upon successful completion of each project, the Company makes a determination as to the then remaining useful life of the intangible asset and begins amortization.
Goodwill
Goodwill, which has an indefinite useful life, represents the excess of purchase consideration over fair value of net assets acquired. Goodwill is not subject to amortization and is required to be tested for impairment at least on an annual basis. The Company tests goodwill for impairment as of December 31 of each year. The Company determines whether goodwill may be impaired by comparing the carrying value of the single reporting unit, including goodwill, to the fair value of the reporting unit. If the fair value is less than the carrying amount, a more detailed analysis is performed to determine whether goodwill is impaired. The impairment loss, if any, is measured as the excess of the carrying value of the goodwill over the implied fair value of the goodwill and is recorded in the Company’s consolidated statements of operations.
Basic and Diluted Net Loss per Share
Net earnings or loss per share (“EPS”) is calculated in accordance with the applicable accounting guidance provided in ASC 260, Earnings per Share. The Company uses the two-class method for the computation and presentation of net income (loss) per common share attributable to common shareholders. The two-class method is an earnings allocation
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formula that calculates basic and diluted net income (loss) per common share for each class of common stock separately based on dividends declared and participation rights in undistributed earnings as if all such earnings had been distributed during the period. Under the two-class method, warrants issued to Innoviva are assumed to participate in undistributed earnings on an as-exercised basis, in accordance with the warrant agreements. Undistributed net losses are allocated entirely to common shareholders since the participating security has no contractual obligation to share in the losses.
Accordingly, basic income or loss per share is calculated by dividing net income or loss by the weighted-average number of common shares outstanding, or using the two-class method, whichever is more dilutive. Diluted net income or loss per share is computed using the more dilutive of the treasury stock method which reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted to common stock, or the two-class method.
The calculation of diluted loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of liability classified warrants, and the presumed exercise of such securities are dilutive to net loss per share for the period, an adjustment to net loss available to common shareholders used in the calculation is required to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method.
Grants and Awards
In applying the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), Armata has determined that grants and awards are out of the scope of ASC 606 because the funding entities do not meet the definition of a “customer”, as defined by ASC 606, as there is not considered to be a transfer of control of goods or services. With respect to each grant or award, the Company determines if it has a collaboration in accordance with ASC Topic 808, Collaborative Arrangements (“ASC 808”). To the extent the grant or award is within the scope of ASC 808, the Company recognizes the award upon achievement of certain milestones as credits to research and development expenses. For grant and awards outside the scope of ASC 808, the Company applies ASC 606 or International Accounting Standards No. 20, Accounting for Government Grants and Disclosure of Government Assistance, by analogy, and revenue is recognized when the Company incurs expenses related to the grants for the amount the Company is entitled to under the provisions of the contract.
Armata also considers the guidance in ASC Topic 730, Research and Development (“ASC 730”), which requires an assessment, at the inception of the grant or award, of whether the agreement is a liability. If Armata is obligated to repay funds received regardless of the outcome of the related research and development activities, then Armata is required to estimate and recognize that liability. Alternatively, if Armata is not required to repay the funds, then payments received are recorded as revenue or contra-expense as the expenses are incurred.
Deferred grant or award liability represents award funds received or receivable for which the allowable expenses have not yet been incurred as of the balance sheet date.
Leases
The Company determines if an arrangement contains a lease at inception. The Company currently only has operating leases. The Company recognizes a right-of-use operating lease asset and associated short and long-term operating lease liability on its condensed consolidated balance sheet for operating leases greater than one year. The right-of-use assets represent the Company’s right to use an underlying asset for the lease term and the lease liabilities represent the Company’s obligation to make lease payments arising from the lease arrangements. Right-of-use operating lease assets and lease liabilities are recognized based on the present value of the future minimum lease payments, including noncash lease payments, the Company will pay over the lease term. The Company determines the lease term at the inception of each lease, which includes renewal options only if the Company concludes that such options are reasonably certain to be exercised.
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As the Company’s leases do not provide an interest rate implicit in the lease, the Company uses its incremental borrowing rate, based on the information available on the date of adoption of Topic 842, Leases, as of the lease inception date or at the lease option extension date in determining the present value of future payments. The Company recognizes rent expense for the minimum lease payments on a straight-line basis over the expected term of the leases. The Company recognizes period expenses, such as common area maintenance expenses, in the period such expenses are incurred.
Research and Development Expenses
Research and development (“R&D”) costs consist primarily of direct and allocated salaries, incentive compensation, share-based compensation and other personnel-related costs, facility costs, and third-party services. Third-party services include studies and clinical trials conducted by clinical research organizations. R&D activities are expensed as incurred. The Company records accruals for estimated ongoing clinical trial expenses. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies, including the phase or completion of events, invoices received and contracted costs. Judgments and estimates are made in determining the accrued balances at the end of the reporting period.
Reclassifications
Certain prior year amounts, including tenant improvement receivable and awards receivable, have been reclassified to conform to the current year presentation. Refer to Note 6 Other Receivables table for details.
Recent Accounting Pronouncements Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance became effective for calendar-year smaller reporting public entities in the first quarter of 2023. The Company adopted this ASU as of January 1, 2023 which did not have an impact on its consolidated financial statements or related disclosures.
In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in ASU 2020-06 are effective for the Company as of January 1, 2024. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2020-06 on its financial statements and does not expect the adoption of this ASU to have a material impact on the Company’s consolidated financial statements.
4. Fair Value Measurements
The Company's Convertible Loan (Note 7) is measured at fair value, which is revalued at each measurement period.
The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following three levels:
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The Company estimates the fair value of its Convertible Loan (Note 7) using a weighted probability of various scenario of the Convertible Loan during its term, utilizing significant assumptions and estimates such as volatility and risk-free interest rates, which are level 3 fair value inputs unobservable from active markets.
The following table presents the Company’s fair value measurements using level 3 inputs during the three and six months ended June 30, 2023.
Fair Value | ||
Balance at December 31, 2022 | $ | |
Net issuance of the Convertible Loan | | |
Change in fair value |
| |
Balance at March 31, 2023 | $ | |
Change in fair value |
| ( |
Balance at June 30, 2023 | $ | |
5. Net Loss per Share
The following table sets forth the computation of basic and diluted net loss per common share for the periods indicated:
Three Months Ended | Six Months Ended | |||||||
| June 30, 2023 |
| June 30, 2022 |
| June 30, 2023 |
| June 30, 2022 | |
Basic and diluted net loss per common share calculation: |
| |||||||
Net loss attributable to common shareholders - basic | ($ | ($ | ($ | ($ | ||||
Change in fair value of convertible debt |
| | — | | — | |||
Net loss attributable to common shareholders - diluted | ($ | ($ | ($ | ($ | ||||
Weighted average common shares outstanding - basic | | | | | ||||
Net loss per share of common stock - basic | ($ | ($ | ($ | ($ | ||||
Weighted average common shares outstanding - diluted | | | | | ||||
Net loss per share of common stock - diluted | ($ | ($ | ($ | ($ |
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The following outstanding securities as of June 30, 2023 and 2022 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive:
| June 30, 2023 |
| June 30, 2022 |
| |
Options |
| |
| | |
Unvested restricted stock units | | | |||
Restricted stock awards |
| |
| |
|
Warrants | | | |||
Total |
| |
| |
|
6. Balance Sheet Details
Property and Equipment
Property and equipment as of June 30, 2023 and December 31, 2022 consisted of the following:
| June 30, 2023 |
| December 31, 2022 | |||
Laboratory and manufacturing equipment | $ | | $ | | ||
Furniture and fixtures | | | ||||
Office and computer equipment |
| |
| | ||
Leasehold improvements |
| |
| | ||
Total | | | ||||
Less: accumulated depreciation |
| ( |
| ( | ||
Property and equipment, net | $ | | $ | |
Depreciation expense totaled $
Other Receivables
Other receivables as of June 30, 2023 and December 31, 2022 consisted of the following:
June 30, 2023 |
| December 31, 2022 | ||||
Tenant improvement receivable | $ | | $ | | ||
Awards receivable | | | ||||
$ | | $ | |
7. Convertible Debt
As described in Note 2, on January 10, 2023, the Company received a Convertible Loan of $
The Convertible Credit Agreement provides that if a Qualified Financing occurs, which is defined in the Convertible Credit Agreement as a financing from new investors of at least $
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investors in such Qualified Financing. The Convertible Credit Agreement also required the Company to file the Registration Statement for the resale of all securities issued to the lender in connection with any conversion under the Convertible Credit Agreement, which the Company originally filed on February 13, 2023 and which was declared effective by the SEC on April 6, 2023. The Convertible Credit Agreement also confers upon the lender the option to convert any outstanding Convertible Loan amount, including all accrued and unpaid interest thereon, at the lender’s option, into shares of Common Stock at a price per share equal to the greater of book value or market value per share of Common Stock on the date immediately preceding the effective date of the Convertible Credit Agreement, which was $
The Company evaluated authoritative guidance for accounting for the Convertible Loan and concluded that the Convertible Loan should be accounted for at fair value under ASC 480, Distinguish Liabilities from Equity, due to the fact that the Convertible Loan will predominately be settled with the Company’s Common Stock. Consequently, the Company recorded the Convertible Loan in its entirety at fair value on its balance sheet, with changes in fair value recorded as other income (expenses) in the statement of operations during each reporting period.
8. Shareholders’ Equity
Private Investment
February 2022 Private Placement
On February 9, 2022, the Company entered into the February 2022 Securities Purchase Agreement to sell its Common Stock and warrants to Innoviva. Pursuant and subject to the terms and conditions of the February 2022 Securities Purchase Agreement and related agreements, Innoviva agreed to purchase
Warrants issued to Innoviva expire
Warrants
On June 30, 2023, outstanding warrants to purchase shares of Common Stock are as follows:
Shares Underlying Outstanding Warrants |
| Exercise Price |
| Expiration Date | |
| $ | | |||
| $ | | |||
| $ | | |||
| $ | | |||
| $ | | |||
| $ | | |||
| $ | | |||
| $ | | None | ||
|
|
|
|
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9. Equity Incentive Plans
Stock Award Plans
The Company maintains a 2016 Equity Incentive Plan (the “2016 Plan”), which provides for the issuance of incentive share awards in the form of non-qualified and incentive stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and performance-based stock awards. The awards may be granted by the Company’s Board of Directors to its employees, directors and officers and to consultants, agents, advisors and independent contractors who provide services to the Company or to a subsidiary of the Company. The exercise price for stock options must not be less than the fair market value of the underlying shares on the date of grant. Stock options expire no later than
The Company has issued restricted stock awards (“RSAs”) under certain legacy option plans that generally vest
Share-based Compensation
The Company estimates the fair value of stock options with performance and service conditions using the Black-Scholes valuation model (“Black-Scholes”). Compensation expense related to stock options granted is measured at the grant date based on the estimated fair value of the award and is recognized on the accelerated attribution method over the requisite service period.
The assumptions used in the Black-Scholes model during the six months ended June 30, 2023 and 2022 are presented below.
Six months ended | ||||
| June 30, 2023 | June 30, 2022 | ||
Risk-free interest rate | ||||
Expected volatility | ||||
Expected term (in years) | ||||
Expected dividend yield |
The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. Expected volatility is based on the historical volatility of Armata and peer companies’ common stock. The expected term represents the period that the Company expects its stock options to be outstanding. The expected term assumption is estimated using the simplified method set forth in the SEC Staff Accounting Bulletin 110, which is the mid-point between the option vesting date and the expiration date. For stock options granted to parties other than employees or directors, the Company elects, on a grant-by-grant basis, to use the expected term or the contractual term of the option award. The Company has never declared or paid dividends on its Common Stock and has no plans to do so in the foreseeable future. Forfeitures are recognized as a reduction of share-based compensation expense as they occur.
The tables below summarize the total share-based compensation expense included in the Company’s consolidated statements of operations for the periods presented:
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 |
| |||||
Research and development | $ | | $ | | $ | | $ | | |||||
General and administrative |
| |
| |
| |
| | |||||
Total share-based compensation | $ | | $ | | $ | | $ | |
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Stock option transactions during the six months ended June 30, 2023 are presented below:
Options Outstanding | ||||||||||
Weighted | ||||||||||
Average | ||||||||||
Weighted | Remaining | |||||||||
Average | Contractual | Aggregate | ||||||||
Exercise | Term | Intrinsic | ||||||||
| Shares |
| Price |
| (Years) |
| Value | |||
Outstanding at December 31, 2022 |
| | $ | |
| |||||
Granted |
| |
| |
|
| ||||
Exercised | — | — | $ | — | ||||||
Forfeited/Cancelled |
| ( |
| |
|
| ||||
Outstanding at June 30, 2023 |
| | $ | |
| $ | — | |||
Vested and expected to vest at June 30, 2023 |
| | $ | |
| $ | — | |||
Exercisable at June 30, 2023 |
| | $ | |
| $ | — |
Restricted stock award transactions under the Assumed 2016 Plan and restricted stock unit award transactions during the six months ended June 30, 2023 are presented below:
Weighted Avg | |||||
Grant Date | |||||
| Shares |
| Fair Value | ||
Outstanding at December 31, 2022 | | $ | | ||
Granted | — | — | |||
Forfeited/Cancelled | ( |
| | ||
Vested and Issued as Common Stock | ( | | |||
Outstanding at June 30, 2023 | | $ | |
The aggregate intrinsic value of options at June 30, 2023 is based on the Company’s closing stock price on that date of $
Shares Reserved for Future Issuance
As of June 30, 2023, the Company had reserved shares of its Common Stock for future issuance as follows:
| Shares Reserved | |
Stock options outstanding |
| |
Unvested restricted stock units | | |
Employee stock purchase plan |
| |
Available for future grants under the 2016 Plan |
| |
Warrants outstanding |
| |
Total shares reserved |
| |
10. Income Taxes
The Company did
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11. Commitments and Contingencies
Operating Leases
The Company leases office and research and development space under a non-cancelable operating lease in Marina del Rey, CA. The lease commenced January 1, 2012 and in April 2020, the Company amended the lease (“2020 Lease Amendment”) which, among other things, extended the lease term through December 31, 2031. Base annual rent for calendar year 2022, the first year under the Lease Amendment extended term, will be approximately $
Concurrent with the Company’s execution of the 2020 Lease Amendment, an irrevocable letter of credit in the amount of $
On October 28, 2021, the Company entered into a lease for office and research and development space under a non-cancellable lease in Los Angeles, CA (the “2021 Lease”). The 2021 Lease payment start date is May 1, 2022 and the total lease term is for
In connection with the 2021 Lease, the Company delivered an irrevocable standby letter of credit in the total amount of $
Legal Proceedings
From time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that there is adequate insurance to cover many different types of liabilities, the Company’s insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the Company’s consolidated results of operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our consolidated results of operations or financial position.
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12. Grants and Awards
MTEC Grant
On June 15, 2020, the Company entered into a Research Project Award agreement (the “MTEC Agreement”) with the Medical Technology Enterprise Consortium (“MTEC”), pursuant to which the Company received a $
Upon license or commercialization of intellectual property developed with the funding from the MTEC Agreement, additional fees will be due to MTEC. The Company will elect whether to (a) pay a fixed royalty amount, which is subject to a cap based upon total funding received, or (b) pay an additional assessment fee, which would also be subject to a cap based upon a percentage of total funding received.
The MTEC Agreement is effective through October 30, 2024. The MTEC Agreement may be terminated in whole or in part, 30 calendar days following written notice from the Company to MTEC. In addition, MTEC has the right to terminate the MTEC Agreement upon material breach by the Company.
The Company determined that the MTEC Agreement is not in the scope of ASC 808 or ASC 606. Applying ASC 606 by analogy the Company recognizes proceeds received under the MTEC Agreement as grant revenue on the statement of operations when related costs are incurred. The Company recognized $
CFF Therapeutics Development Award
On March 13, 2020, the Company entered into an award agreement (the “Award Agreement”) with CFF, pursuant to which the Company received a Therapeutics Development Award of up to $
The first payment under the Award Agreement, in the amount of $
If the Company ceases to use commercially reasonable efforts directed to the development of AP-PA02, or any other Product (as defined in the Award Agreement), for a period of
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Upon commercialization by the Company of any Product, the Company will owe a fixed royalty amount to CFF, which is to be paid in installments determined, in part, based on commercial sales volumes of the Product. The Company will be obligated to make an additional fixed royalty payment upon achieving specified sales milestones. The Company may also be obligated to make a payment to CFF if the Company transfers, sells or licenses the Product in the CF Field, or if the Company enters into a change of control transaction.
The term of the Award Agreement commenced on March 10, 2020 and expires on the earlier of the date on which the Company has paid CFF all of the fixed royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier termination of the Award Agreement. Either CFF or the Company may terminate the Award Agreement for cause, which includes the Company’s material failure to achieve certain development milestones. The Company’s payment obligations survive the termination of the Award Agreement.
The Company concluded that the CFF Award is in the scope of ASC 808. Accordingly, as discussed in Note 3, the Company recognizes the award upon achievement of certain milestones as credits to research and development expenses. No credits were recognized during the three and six months ended June 30, 2023 or 2022. In addition, the Company concluded under the guidance in ASC 730 that it does not have an obligation to repay funds received once related research and development expenses are incurred.
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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report, and our audited financial statements and notes thereto as of and for the year ended December 31, 2022 included in our Annual Report on Form 10-K filed on March 16, 2023 with the U.S. Securities and Exchange Commission (the “SEC”).
Our common stock is traded on the NYSE American exchange under the symbol “ARMP.” We are currently headquartered in Los Angeles, CA, and we have a research and development facility for product development to support advancing phage products from the bench to the clinic. In addition to microbiology, synthetic biology, formulation, chemistry and analytical laboratories, the facility is equipped with two licensed current good manufacturing practice (“cGMP”) drug manufacturing suites enabling the production, testing and release of clinical trial material.
Statements contained in this Quarterly Report that are not statements of historical fact are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements concerning product development plans, commercialization of our products, the expected market opportunity for our products, the use of bacteriophages and synthetic phages to kill bacterial pathogens, having resources sufficient to fund our operations into the third quarter of 2023, future funding sources, general and administrative expenses, clinical trial and other research and development expenses, costs of manufacturing, costs relating to our intellectual property, capital expenditures, the expected benefits of our targeted phage therapies strategy, the potential market for our products, tax credits and carry-forwards, and litigation-related matters. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These statements are subject to risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 16, 2023 with the SEC, and under Item 1A, “Risk Factors” and elsewhere in this Quarterly Report. These forward-looking statements speak only as of the date on which they were made, and we undertake no obligation to update any forward-looking statements.
Overview
We are a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat acute and chronic bacterial infections using our proprietary bacteriophage-based technology. Bacteriophages or “phages” have a powerful and highly differentiated mechanism of action that enables binding to and killing specific bacteria, including those forming biofilms, in contrast to traditional broad-spectrum antibiotics. We believe that phages represent a promising means to treat bacterial infections, especially those that have developed resistance to current standard of care therapies, including the so-called multidrug-resistant or “superbug” strains of bacteria. We are a leading developer of phage therapeutics administered intravenously as well as locally, and are uniquely positioned to address the growing worldwide threat of antibiotic-resistant bacterial infections.
We are combining our proprietary approach and unique purification procedures and expertise in identifying, characterizing and developing both naturally-occurring and engineered (synthetic) bacteriophages with our proprietary phage-specific cGMP capabilities to advance a broad pipeline of high-quality multi-bacteriophage product candidates that can be tolerated no matter the route of deliverer from intravenously, topically and inhaled.
We are developing and advancing the clinical phage candidate, AP-PA02, for Pseudomonas aeruginosa (“P. aeruginosa”). On October 14, 2020, we received the approval to proceed from the FDA for our IND application for AP-
24
PA02-101, which was a Phase 1b/2a, multicenter, double-blind, randomized, placebo-controlled, single ascending dose (“SAD”) and multiple ascending dose (“MAD”) clinical trial to evaluate the safety and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis (“CF”) and chronic pulmonary P. aeruginosa infection. In the first quarter of 2023, Armata announced positive topline results from the completed “SWARM-P.a.” study. Data indicated that multiple days of inhaled AP-PA02 was well-tolerated with a treatment emergent adverse event (TEAE) profile similar to placebo. Only mild, self-limited adverse events possibly related to study drug were reported in a few CF subjects. Pharmacokinetic findings confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure. SAD and MAD resulted in a proportional increase in exposure as measured in induced sputum. Additionally, achieved exposures were relatively consistent from subject to subject. Bacterial levels of P. aeruginosa in the sputum were measured at several time points and compared to baseline levels prior to study drug administration. Trends suggest improvement in bacterial load reduction for subjects treated with AP-PA02 at end of treatment as compared to placebo after ten days of dosing. Pharmacokinetic/Pharmacodynamic analysis indicates significant microbiological impacts in the subjects with highest exposures. Importantly, for subjects with the highest average exposure of susceptible phage, there was durability of approximately two-log reduction from end of treatment to end of study (day 28 post dose). This study is supported by the Cystic Fibrosis Foundation (“CFF”), which granted Armata a Therapeutics Development Award of up to $5.0 million.
A key advantage of Armata’s phage manufacturing expertise is the purity profiles of our phage products, including AP-SA02, our phage product candidate for Staphylococcus aureus (“S. aureus”); this has enabled Armata to pursue treatment of complicated S. aureus bacteremia, where repetitive intravenous dosing is required. On June 15, 2020, the Company entered into a Research Project Award agreement (the “MTEC Agreement”) with the Medical Technology Enterprise Consortium (“MTEC”), pursuant to which the Company received a $15.0 million grant and entered into a three-year program administered by the U.S. Department of Defense (the “DoD”) through MTEC with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. On September 29, 2022, the MTEC Agreement was modified to increase the total award by $1.3 million to $16.3 million and extend the term into the third quarter of 2024. The MTEC funds are to partially fund a Phase 1b/2a, multi-center, randomized, double-blind, placebo- controlled dose escalation study that will assess the safety, tolerability, and efficacy of our phage-based candidate, AP-SA02, for the treatment of adults with complicated S. aureus bacteremia. On November 17, 2021, Armata announced that it had received from the FDA the approval to proceed for our Investigational New Drug application for AP-SA02, and in May 2022, the Company dosed the first patient in the Phase 1b/2a trial (“diSArm” study). The Phase 1b part of the study has been fully enrolled as planned, and the Company anticipates initiation of the Phase 2a part of the study in the third quarter of 2023.
On February 22, 2022, Armata announced that it had received from the FDA the approval to proceed for our IND application for AP-PA02, in a second indication, NCFB (non-cystic fibrosis bronchiectasis). We initiated a Phase 2 trial (“Tailwind”) in NCFB in 2022 and reported first patient dosing in the first quarter of 2023. The “Tailwind” study is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 phage therapeutic in subjects with NCFB and chronic pulmonary Pseudomonas aeruginosa infection.
On August 1, 2022, Armata announced that it had received from the FDA the approval to proceed for our IND application for AP-SA02, in a second indication, PJI (periprosthetic joint infection). With progress made in the Phase 1b bacteremia study we are proceeding with the second application. We are advancing start-up activities for a Phase 1b/2a trial that will assess the safety and tolerability of intravenous and intra-articular AP-SA02 as an adjunct to standard of care antibiotics in adults undergoing debridement, antibiotics, and implant retention for the treatment of periprosthetic joint infections caused by S. aureus.
We are committed to conducting randomized controlled clinical trials required for FDA approval in order to move toward the commercialization of alternatives to traditional antibiotics and provide a potential method of treating patients suffering from drug-resistant and difficult-to-treat bacterial infections.
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The following chart summarizes the status of our phage product candidate development programs and partners.
We have incurred net losses since our inception and our operations to date have been primarily limited to research and development and raising capital. As of June 30, 2023, we had an accumulated deficit of $257.5 million. We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on completing the development and seeking to obtain regulatory approval of our product candidates.
We currently expect to use our existing cash and cash equivalents for the continued research and development of our product candidates and for working capital and other general corporate purposes. We expect to continue to incur significant and increasing operating losses at least for the next several years. We do not expect to generate product revenue unless and until we successfully complete development and obtain marketing approval for at least one of our product candidates.
We may also use a portion of our existing cash and cash equivalents for the potential acquisition of, or investment in, product candidates, technologies, formulations or companies that complement our business, although we have no current understandings, commitments or agreements to do so. Our existing cash and cash equivalents will not be sufficient to enable us to complete all necessary development of any potential product candidates. Accordingly, we will be required to obtain further funding through one or more other public or private equity offerings, debt financings, collaboration, strategic financing, grants or government contract awards, licensing arrangements or other sources. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and potential disruptions to, and volatility in, financial markets in the United States and worldwide. Adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed or on acceptable terms, we may be required to defer, reduce or eliminate significant planned expenditures, restructure, curtail or eliminate some or all of our development programs or other operations, dispose of assets, enter into arrangements that may require us to relinquish rights to certain of our product candidates, technologies or potential markets, file for bankruptcy or cease operations altogether. Any of these events could have a material adverse effect on our business, financial condition and results of operations and result in a loss of investment by our shareholders.
Recent Events
2023 Credit Agreement
On July 11, 2023, we announced that we had entered into, as borrower, a credit and security agreement (the “Credit Agreement”) with Innoviva Strategic Opportunities LLC (“Innoviva”), a wholly owned subsidiary of Innoviva, Inc. (the “Parent”), a principal shareholder, on July 10, 2023. The Credit Agreement provides for a secured term loan facility in an aggregate amount of $25 million (the “Loan”) at an interest rate of 14.0% per annum, and has a maturity date of January 10, 2025. Repayment of the Loan is guaranteed by our domestic subsidiaries, and the Loan is secured by substantially all of our assets and our subsidiary guarantors.
The Credit Agreement contains customary affirmative and negative covenants and representations and warranties, including financial reporting obligations and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, investments, mergers or acquisitions and fundamental corporate changes. The Credit Agreement also includes customary events of default, including payment defaults, breaches of provisions under the loan
26
documents, certain losses or impairment of collateral and related security interests, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the Credit Agreement, certain bankruptcy or insolvency events, and a material deviation from our operating budget.
2023 Convertible Credit Agreement
On January 10, 2023, we entered into, as borrower, a secured convertible credit and security agreement (the “Convertible Credit Agreement”) with Innoviva. The Convertible Credit Agreement provides for a secured term loan facility in an aggregate amount of $30 million (the “Convertible Loan”) at an interest rate of 8.0% per annum, and has a maturity date of January 10, 2024. Concurrently with the execution of the Credit Agreement, we entered into an amendment to that certain secured convertible credit and security agreement (the “First Amendment to Convertible Credit Agreement”). Pursuant to the First Amendment to Convertible Credit Agreement, the parties agreed to, among other things, extend the maturity date from January 10, 2024 to January 10, 2025.
Repayment of the Convertible Loan is guaranteed by our domestic subsidiaries and foreign material subsidiaries, and the Convertible Loan is secured by substantially all of our assets and the subsidiary guarantors.
The Convertible Credit Agreement provides that if a Qualified Financing, as defined in the Convertible Credit Agreement, occurs, the outstanding principal amount of, and all accrued and unpaid interest on, the Convertible Loan shall be converted into shares of our common stock, par value $0.01 per share (“Common Stock”) at a price per share equal to a 15.0% discount to the lowest price per share for Common Stock paid by investors in a Qualified Financing (which price paid by investors in a Qualified Financing may not be less than a 15.0% discount to the closing price of Common Stock immediately prior to the consummation of a Qualified Financing event). The Convertible Credit Agreement also required us to file a registration statement (the “Registration Statement”) for the resale of all securities issued to the lender in connection with any conversion under the Convertible Credit Agreement, which the Company originally filed on February 13, 2023 and which was declared effective by the SEC on April 6, 2023. The Convertible Credit Agreement also confers upon the lender the option to convert any outstanding Convertible Loan amount, including all accrued and unpaid interest thereon, at the lender’s option, into shares of Common Stock at a price per share equal to the greater of book value or market value per share of Common Stock on the date immediately preceding the effective date of the Convertible Credit Agreement, which was $1.52 (as may be appropriately adjusted for any stock split, combination or similar act).
Results of Operations
Comparison of three and six months ended June 30, 2023 and 2022
Three Months Ended | Change | |||||||||||
| June 30, 2023 |
| June 30, 2022 |
| Amount |
| % | |||||
Grant revenue | $ | 980,000 | $ | 1,883,000 | $ | (903,000) | (48.0)% | |||||
Operating expenses | ||||||||||||
Research and development |
| 8,259,000 | 9,020,000 |
| (761,000) | (8.4)% | ||||||
General and administrative |
| 2,350,000 | 2,083,000 |
| 267,000 | 12.8% | ||||||
Total operating expenses | 10,609,000 | 11,103,000 | (494,000) | (4.4)% | ||||||||
Loss from operations |
| (9,629,000) |
| (9,220,000) |
| (409,000) |
| 4.4% | ||||
Other income (expense) |
|
|
|
|
|
|
|
| ||||
Interest income | 46,000 | 5,000 |
| 41,000 |
| 820.0% | ||||||
Change in fair value of convertible debt | 6,036,000 | — | 6,036,000 | 100.0% | ||||||||
Total other income (expense), net |
| 6,082,000 |
| 5,000 |
| 6,077,000 |
| 121540% | ||||
Net loss | $ | (3,547,000) | $ | (9,215,000) | $ | 5,668,000 |
| (61.5)% |
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Six Months Ended | Change | |||||||||||
| June 30, 2023 |
| June 30, 2022 |
| Amount |
| % | |||||
Grant revenue | $ | 1,776,000 | $ | 3,119,000 | $ | (1,343,000) | (43.1)% | |||||
Operating expenses | ||||||||||||
Research and development |
| 17,863,000 | 17,048,000 |
| 815,000 | 4.8% | ||||||
General and administrative |
| 4,888,000 | 4,066,000 |
| 822,000 | 20.2% | ||||||
Total operating expenses | 22,751,000 | 21,114,000 | 1,637,000 | 7.8% | ||||||||
Loss from operations |
| (20,975,000) |
| (17,995,000) |
| (2,980,000) |
| 16.6% | ||||
Other income (expense) |
|
|
|
|
|
|
|
| ||||
Interest income | 64,000 | 6,000 |
| 58,000 |
| 966.7% | ||||||
Change in fair value of convertible debt | 2,874,000 | — | 2,874,000 | 100.0% | ||||||||
Total other income (expense), net |
| 2,938,000 |
| 6,000 |
| 2,932,000 |
| 48867% | ||||
Net loss | $ | (18,037,000) | $ | (17,989,000) | $ | (48,000) |
| 0.3% |
Grant Revenue
The Company recognized $1.0 million and $1.9 million of grant revenue during the three months ended June 30, 2023 and 2022, and $1.8 million and $3.1 million of grant revenue during the six months ended June 30, 2023 and 2022, respectively, which represents MTEC’s share of the costs incurred for the Company’s AP-SA02 program for the treatment of Staphylococcus aureus bacteremia.
Research and Development
Research and development expenses for the three months ended June 30, 2023 and 2022 were $8.3 million and $9.0 million, respectively. The decrease of $0.7 million was primarily related to a decrease of $0.7 million related to decreased clinical trial activities and laboratory supplies expenses, a decrease of $0.3 million in personnel costs, offset by an increase of $0.3 million in lease and professional services expenses.
Research and development expenses for the six months ended June 30, 2023 and 2022 were $17.9 million and $17.0 million, respectively. The increase of $0.9 million was primarily related to an increase of $0.5 million in personnel costs, a $0.7 million increase in professional services, $0.4 million increase in lease expenses, and offset by a $0.7 million decrease in clinical trial activities and laboratory supplies expenses.
General and Administrative
General and administrative expenses were $2.4 million and $2.1 million for the three ended June 30, 2023 and 2022, respectively. The increase of $0.3 million is primarily related to a $0.6 million increase in legal and professional expenses, and $0.1 million of increase in lease expenses, offset by a decrease of $0.4 million in personnel costs.
General and administrative expenses were $4.9 million and $4.1 million for the six months ended June 30, 2023 and 2022, respectively. The increase of $0.8 million is primarily related to a $1.0 million increase in legal and professional expenses, offset by a $0.2 million decrease in personnel expenses.
Other Income (Expense)
For the three and six months ended June 30, 2023, we recorded other income due to change in our Convertible Loan from Innoviva, which is recorded at fair value in its entirety, of $6.0 million and $2.9 million, respectively.
Income Taxes
There was no income tax expense or benefit for the three and six months ended June 30, 2023 and 2022.
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Operating Activities
Net cash used in operating activities for the six months ended June 30, 2023 was $29.6 million, as compared to $11.7 million for the six months ended June 30, 2022. The increase of $17.9 million in cash used for operating activities was primarily due to an increase of $14.8 million in cash used for operating assets and liabilities including payments made under our operating lease arrangements and prepayments for clinical activities, and offset by decreases of $3.1 million related to non-cash reconciling items from net loss to cash used in operating activities.
Investing Activities
Net cash used in investing activities was $2.2 million and $1.4 million for the three and six months ended June 30, 2023 and 2022, respectively, and primarily related to purchases of laboratory equipment.
Financing Activities
Net cash provided by financing activities was $29.2 million for the six months ended June 30, 2023, which was primarily comprised of $29.2 million of proceeds raised from the convertible debt issued to Innoviva, net of issuance costs.
Net cash provided by financing activities was $44.5 million for the six months ended June 30, 2022, which was comprised of $44.4 million of net proceeds raised from the February 2022 private placement transactions with Innoviva, and $0.1 million of proceeds for exercise of stock options.
Liquidity, Capital Resources and Financial Condition
We have prepared our condensed consolidated financial statements on a going concern basis, which assumes that we will realize our assets and satisfy our liabilities in the normal course of business. However, we have incurred net losses since our inception and have negative operating cash flows. These circumstances raise substantial doubt about our ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning our ability to continue as a going concern. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are not entirely within its control and cannot be assessed as being probable of occurring. We may not be able to secure additional financing in a timely manner or on favorable terms, if at all.
As of June 30, 2023, we had cash and cash equivalents of $12.5 million. Management believes that our current cash resources, along with the funds received in the $25.0 million Loan financing that closed in July 2023, will be sufficient to fund the Company’s planned operations into the first quarter of 2024. For the foreseeable future, our ability to continue our operations is dependent upon our ability to obtain additional capital.
Future Capital Requirements
We will need to raise additional capital in the future to continue to fund our operations. Our future funding requirements will depend on many factors, including:
● | the costs and timing of our research and development activities; |
● | the progress and cost of our clinical trials and other research and development activities; |
● | manufacturing costs associated with our targeted phage therapies strategy and other research and development activities; |
● | the costs of completing the construction and improvements of our leased premises to be used as our new headquarters. As of June 30, 2023, the total projected construction costs of our new leased headquarter in Los |
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Angeles was estimated to be approximately $26.5 million, inclusive of $7.3 million reimbursable from the landlord, and of which $15.7 million have been incurred to date. The estimated total construction costs may change as the project progresses; |
● | the terms and timing of any collaborative, licensing, acquisition or other arrangements that we may establish; |
● | whether and when we receive future Australian tax rebates, if any; |
● | the costs and timing of seeking regulatory approvals; |
● | the costs of filing, prosecuting and enforcing any patent applications, claims, patents and other intellectual property rights; and |
● | the costs of potential lawsuits involving us or our product candidates. |
We may seek to raise capital through a variety of sources, including:
● | the public equity market; |
● | private equity financings; |
● | collaborative arrangements, government grants or strategic financings; |
● | licensing arrangements; and |
● | public or private debt. |
Any additional fundraising efforts may divert our management team from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Our ability to raise additional funds will depend, in part, on the success of our product development activities, including our targeted phage therapies strategy and any clinical trials we initiate, regulatory events, our ability to identify and enter into in-licensing or other strategic arrangements, and other events or conditions that may affect our value or prospects, as well as factors related to financial, economic and market conditions, many of which are beyond our control. We cannot be certain that sufficient funds will be available to us when required or on acceptable terms. If we are unable to secure additional funds on a timely basis or on acceptable terms, we may be required to defer, reduce or eliminate significant planned expenditures, restructure, curtail or eliminate some or all of our development programs or other operations, dispose of technology or assets, pursue an acquisition of our company by a third party at a price that may result in a loss on investment for our shareholders, enter into arrangements that may require us to relinquish rights to certain of our product candidates, technologies or potential markets, file for bankruptcy or cease operations altogether. Any of these events 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 loss of investment by our shareholders. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities could result in dilution to our existing shareholders. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the United States and worldwide.
Off-Balance Sheet Arrangements
As of June 30, 2023, we did not have off-balance sheet arrangements.
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Critical Accounting Policies and Estimates
Management’s discussion and analysis of financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, including those related to fair value of our convertible debt, the allowance for doubtful accounts, useful lives of intangible assets, recoverability of the carrying amounts of goodwill and intangible assets, share-based compensation and income tax provision. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Refer to Note 3 to the condensed consolidated financial statements contained elsewhere in this report. During the three and six months ended June 30, 2023, there were no material changes to our critical accounting policies from those described in our Annual Report on Form 10-K filed with the SEC on March 16, 2023.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and are not required to provide the information required under this item.
Item 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (our Principal Executive Officer) and Chief Financial Officer (our Principal Financial and Accounting Officer), of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the period covered by this quarterly report on Form 10-Q. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2023.
Changes in Internal Control over Financial Reporting
An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of any change in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. That evaluation did not identify any change in our internal control over financial reporting that occurred during our latest fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting; however, that evaluation is ongoing and because of its ongoing nature, there can be no assurance that we will not identify any change that would materially affect, or be reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and our Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints,
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and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.
PART II. OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
From time to time, we are a party to certain litigation that is either judged to be not material or that arises in the ordinary course of business. We intend to vigorously defend our interests in these matters. We expect that the resolution of these matters will not have a material adverse effect on our business, financial condition or results of operations. However, due to the uncertainties inherent in litigation, no assurance can be given as to the outcome of these proceedings.
Item 1A. RISK FACTORS
Our business is subject to a number of risks, including those identified in Item 1A of Part I of our 2022 Form 10-K. There have been no material changes to the risk factors described in our 2022 Form 10-K.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On July 10, 2023, we entered into an amendment with Innoviva (the “First Amendment to Second A&R Voting Agreement”) to the Second Amended and Restated Voting Agreement (“Voting Agreement”), dated as of February 9, 2022, by and among us and Innoviva to extend the expiration date of the Voting Agreement to the earlier of the fifth anniversary of the effective date, or February 9, 2027, and the date of receipt of approval by the U.S. Food and Drug Administration of any of our product candidates for marketing and commercial distribution.
Item 3. DEFAULTS UPON SENIOR SECURITIES
None.
Item 4. MINE SAFETY DISCLOSURES
Not applicable.
Item 5. OTHER INFORMATION
None.
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Item 6. EXHIBITS
Number |
| Description | |||
3.1 | |||||
3.2 | |||||
3.3 | |||||
3.4 | |||||
3.5 | |||||
3.6 | |||||
3.7 | |||||
3.8 | |||||
3.9 | |||||
3.10 | |||||
4.1 | Reference is made to Exhibits 3.1 through 3.4. | ||||
10.1 | |||||
10.2 | |||||
10.3 | |||||
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10.4 | |||||
10.5 | |||||
10.6 | |||||
31.1 | Certification of Principal Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a). | ||||
31.2 |
| Certification of Principal Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a). | |||
32.1† |
| ||||
32.2† |
| ||||
101.INS |
| Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |||
101.SCH |
| Inline XBRL Taxonomy Extension Schema Document. | |||
101.CAL |
| Inline XBRL Taxonomy Extension Calculation Linkbase Document. | |||
101.DEF |
| Inline XBRL Taxonomy Extension Definition Linkbase Document. | |||
101.PRE |
| Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |||
101.LAB |
| Inline XBRL Taxonomy Extension Label Linkbase Document. | |||
104 | Cover Page Interactive Data File Cover Page Interactive Data File (embedded within the Inline XBRL document) |
† | The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ARMATA PHARMACEUTICALS, INC. | |||
Date: August 14, 2023 | By | /s/ Deborah L. Birx | |
Name: Deborah L. Birx, M.D. | |||
Title: Chief Executive Officer | |||
(Principal Executive Officer) | |||
By | /s/ Julianne Averill | ||
Name: Julianne Averill | |||
Title: Chief Financial Officer | |||
(Principal Financial and Accounting Officer) |
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