| Page |
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| PART I |
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| Item 1 – Business | 4 |
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| Item 1A – Risk Factors | 18 |
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| Item 1B – Unresolved Staff Comments | 36 |
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| Item 1C – Cybersecurity | 36 |
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| Item 2 – Properties | 36 |
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| Item 3 – Legal Proceedings | 37 |
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| Item 4 – Mine Safety Disclosures | 37 |
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| PART II |
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| Item 5 – Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 38 |
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| Item 6 – [Reserved] | 38 |
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| Item 7 – Management’s Discussion and Analysis of Financial Condition and Results of Operations | 38 |
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| Item 7A – Quantitative and Qualitative Disclosures About Market Risk | 54 |
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| Item 8 – Financial Statements and Supplementary Data | 54 |
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| Item 9 – Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 54 |
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| Item 9A – Controls and Procedures | 54 |
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| Item 9B – Other Information | 55 |
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| Item 9C – Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 55 |
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| PART III |
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| Item 10 – Directors, Executive Officers, and Corporate Governance | 56 |
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| Item 11 – Executive Compensation | 60 |
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| Item 12 – Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 67 |
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| Item 13 – Certain Relationships and Related Transactions, and Director Independence | 68 |
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| Item 14 – Principal Accounting Fees and Services | 69 |
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| PART IV |
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| Item 15 – Exhibits, Financial Statement Schedules | 70 |
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| Signatures | 73 |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Report”) contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, which represent our expectations or beliefs statements concerning, without limitation, our operations, economic performance, financial condition, growth and acquisition strategies, investments, and future operational plans. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intent,” “could,” “estimate,” “might,” “plan,” “predict” or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. These statements, by their nature, involve substantial risks and uncertainties, certain of which are beyond our control, and actual results may differ materially depending on a variety of important factors, including uncertainty related to our partnerships, licenses, strategic transactions, governmental regulation, economic conditions, managing and maintaining growth, the operations of the Company, volatility of stock price, commercial viability of our product candidates and any other factors discussed in this and other registrant filings with the Securities and Exchange Commission (the “Commission”).
These risks and uncertainties and other factors include but are not limited to those set forth under “Risk Factors” of this Report. Given these risks and uncertainties, readers are cautioned not to place undue reliance on our forward-looking statements. All subsequent written and oral forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by these cautionary statements. Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statements or the risk factors described in this Report or in the documents and/or information that we incorporate by reference, whether as a result of new information, future events, changed circumstances or any other reason after the date of this Report.
This Report contains forward-looking statements, including statements regarding, among other things:
| ● | our ability to continue as a going concern; |
| ● | our anticipated needs for working capital, and our ability to secure additional financing on favorable terms, if at all; |
| ● | the availability of source materials, manufacturing components and other supplies necessary for our products and services as well as our ability to source them at favorable prices; |
| ● | the demand for our products and services; |
| ● | our sales, marketing, licensing and distribution prospects; |
| ● | our financial performance; |
| ● | the level of expenses related to our product development and operations and to our contract development and manufacturing operations; |
| ● | our efforts to expand our products and our business, including, specifically, related to the exclusive license rights to Toll-like Receptor 5 Agonists acquired from Statera Biopharma, Inc. and the acquired assets from Scorpius Holdings, Inc.; |
| ● | the implementation of our business model and strategic plans for our business and technology; |
| ● | regulatory or legal developments in the United States and other countries; |
| ● | developments or disputes concerning patent applications, issued patents or other proprietary rights; |
| ● | our expectations regarding the effects of a potential recession, market volatility and macroeconomic factors on our business, our suppliers and our customers; |
| ● | developments and projections relating to our competitors and our industries; |
| ● | the timing, likelihood and potential terms of government procurement of Entolimod for the Strategic National Stockpile (SNS) or other biodefense program; |
| ● | intellectual property licensed from third parties; |
| ● | our ability to successfully operate, grow and integrate Velocity Bioworks as a contract development and manufacturing organization (CDMO); and |
| ● | our ability to attract and retain CDMO customers and the success of our customers' product development programs. |
In addition, statements that “we believe,” "expect to," "anticipate" 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 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, and you are cautioned not to unduly rely upon these statements.
Actual events or results may differ materially from those discussed in forward-looking statements as a result of various factors, including, without limitation, the risks outlined under “Risk Factors” and matters described in this Report generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this Report will in fact occur. We caution you not to place undue reliance on these forward-looking statements. In addition to the information expressly required to be included in this Report, we will provide such further material information, if any, as may be necessary to make the required statements, in light of the circumstances under which they are made, not misleading.
You should read this Report and the documents that we reference in this Report and have filed as exhibits to this Report, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this Report by these cautionary statements.
