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| PART I | | 7 |
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| Item 1. | Business | 7 |
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| Item 1A. | Risk Factors | 54 |
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| Item 1B. | Unresolved Staff Comments | 112 |
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| Item 1C. | Cybersecurity | 112 |
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| Item 2. | Properties | 113 |
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| Item 3. | Legal Proceedings | 113 |
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| Item 4. | Mine Safety Disclosures | 113 |
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| PART II | | 114 |
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| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 114 |
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| Item 6. | Reserved | 114 |
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| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 115 |
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| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 135 |
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| Item 8. | Consolidated Financial Statements and Supplementary Data | 136 |
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| Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 136 |
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| Item 9A. | Controls and Procedures | 137 |
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| Item 9B. | Other Information | 138 |
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| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspection | 138 |
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| PART III | | 139 |
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| Item 10. | Directors, Executive Officers and Corporate Governance | 139 |
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| Item 11. | Executive Compensation | 139 |
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| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 139 |
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| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 139 |
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| Item 14. | Principal Accounting Fees and Services | 139 |
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| PART IV | | 140 |
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| Item 15. | Exhibits, and Consolidated Financial Statement Schedules | 140 |
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| EXHIBIT INDEX | 140 | |
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| SIGNATURES | 145 | |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of the federal securities laws, Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are included in this statement for purposes of complying with those safe harbor provisions. All statements other than statements of historical facts contained in this Annual Report on Form 10-K are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
| Ø | our ability to obtain stockholder approvals allowing for (i) the issuance of common stock upon the conversion of our Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share, and Series B Non-Voting Convertible Preferred Stock, par value $0.0001 per share, in connection with our acquisition of ABCJ, LLC, the parent company of Polynoma, LLC ("Polynoma") pursuant to a Membership Interest Purchase Agreement, dated October 8, 2025, (ii) the issuance of common stock upon the conversion of our Series C Non-Voting Convertible Preferred Stock, par value $0.0001 per share issued pursuant to our licensing agreement with Unleash Immuno Oncolytics, Inc. ("Unleash"), dated March 2, 2026, and the respective timing thereof, and (iii) the potential issuance of shares of common stock pursuant to a Standby Equity Purchase Agreement (the “SEPA”) by and between us and YA II PN, LTD (“Yorkville”); |
| Ø | our cash position, our estimates and expectations regarding our capital requirements, cash and expense levels, liquidity sources, our need for additional financing and our ability to obtain, on satisfactory terms or at all, the financing required to support operations, research, development, clinical trials, and commercialization of products; |
| Ø | a potential delisting of our common stock from trading on the Nasdaq Capital Market; |
| Ø | our ability to continue as a going concern; |
| Ø | the results and timing of our preclinical and clinical trial activities, including but not limited to our ability to enroll a sufficient number of patients timely to advance our clinical trials; |
| Ø | our ability to expand our therapeutic candidate portfolio through internal research and development or the acquisition or in-licensing of intellectual property assets; |
| Ø | the therapeutic benefits, effectiveness and safety of our therapeutic candidates; |
| Ø | our ability to receive regulatory approval for our therapeutic candidates in the United States, Europe and other geographies; |
| Ø | the expected regulatory approval pathway for our therapeutic candidates; |
| Ø | potential changes in regulatory requirements, and delays or negative outcomes from the regulatory approval process; |
| Ø | our ability to maintain adequate quality processes and oversight of vendors |
| Ø | our ability to secure raw materials to support continued drug substance and drug product manufacturing |
| Ø | our reliance on third-parties for the planning, conduct, management and monitoring of clinical trials, for the manufacture of clinical drug supplies and drug product meeting our specifications, and for other requirements; |
| Ø | our estimates of the size and characteristics of the markets that may be addressed by our therapeutic candidates; |
| Ø | market acceptance of our therapeutic candidates that are approved for marketing in the United States or other countries; |
| Ø | our ability to successfully commercialize our therapeutic candidates, if approved for marketing; |
| Ø | the safety and efficacy of therapeutics marketed by our competitors that are targeted to indications which our therapeutic candidates have been developed to treat; |
| Ø | our ability to utilize our proprietary technological approach to develop and commercialize our therapeutic candidates; |
| Ø | our heavy dependence on licensed intellectual property, including our ability to source and maintain licenses from third-party owners; |
| Ø | our ability to protect our own or in-licensed intellectual property and operate our business without infringing the intellectual property rights of others; |
| Ø | our ability to attract, retain and motivate key personnel; |
| Ø | our ability to generate revenue and become profitable; |
| Ø | our reliance on third-party manufacturers to manufacture our drug substance and drug product that meets with our design specifications; |
| Ø | our dependence on contract research organizations and other parties to manage our clinical trials; |
| Ø | the outcome of our currently open Phase I/II clinical trial with TTX-MC138, which commenced in the third quarter of 2024, and our ability to complete this trial; |
| Ø | the impact of natural disasters, global pandemics, armed conflicts and wars, labor disputes, lack of raw materials or other supplies, issues with facilities and equipment, or other forms of disruption to business operations at our manufacturing or laboratory facilities or those of our vendors; |
| Ø | potential collaborations to license and commercialize any therapeutic candidates for which we receive regulatory approval in the future in or outside the United States; and |
| Ø | other risks and uncertainties, including those listed under the caption “Risk Factors” in this Annual Report on Form 10-K and in our other regulatory filings. |
The risks set forth above are not exhaustive. Other sections of this Annual Report on Form 10-K may include additional factors that could adversely affect our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for management to predict all risk factors, nor can we assess the impact of all risk 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. Forward-looking statements in this Annual Report on Form 10-K reflect our current views with respect to future events and with respect to our business and future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part II, Item 1A, “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. You are advised, however, to consult any further disclosure we make in our reports filed with the U.S. Securities and Exchange Commission (the “SEC”).
This Annual Report on Form 10-K may include data that we obtained from industry publications and third-party research, surveys and studies. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. This Annual Report on Form 10-K also may include data based on our own internal estimates and research, including estimates regarding our consolidated financial statements and business operations. Our internal estimates have not been verified by any independent source and, while we believe any data obtained from industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data. Such third-party data, as well as our internal estimates and research, are subject to a high degree of uncertainty and risk due to a variety of factors, including those described in Part II, Item 1A, “Risk Factors” and elsewhere in this Annual Report on Form 10-K. These and other factors could cause our results to differ materially from those expressed in this Annual Report on Form 10-K.
This Annual Report on Form 10-K may contain trademarks, service marks and trade names of third parties which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks, trade names or products in this Annual Report on Form 10-K is not intended to, and does not imply a relationship with, or endorsement or sponsorship by us. Solely for convenience, the trademarks, service marks and trade names referred to in this Annual Report on Form 10-K may appear without the ®, TM or SM symbols, but the omission of such references is not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable owner of these trademarks, service marks and trade names.
Summary of Material Risks
Our business is subject to numerous material and other risks and uncertainties that you should be aware of in evaluating our business. These risks are described more fully elsewhere in this Annual Report on Form 10-K and include, but are not limited to, the following:
| Ø | risks related to our acquisition of Polynoma and its potential effects on our business and the price of our common stock and other securities, including our issuance to DEFJ of our Series A Preferred Stock and Series B Preferred Stock, which are not convertible until our stockholders approve the conversions thereof; |
| Ø | risks related to our licensing agreement with Unleash including our issuance to Unleash of our Series C Preferred Stock, which is not convertible until our stockholders approve the conversion thereof; |
| Ø | risks related to the potential issuance of our common stock pursuant to the SEPA with Yorkville and its potential effects on the price of our common stock and other securities; |
| Ø | our low cash position and our estimates and expectations regarding our capital requirements, cash and expense levels, liquidity sources and our ability to obtain, on satisfactory terms or at all, the financing required to support operations, research, development, clinical trials, and commercialization of products; |
| Ø | our business is highly dependent on the success of TTX-MC138, our lead therapeutic candidate which is at the early stages of development. Our therapeutic and diagnostic candidates require significant additional preclinical, clinical development and manufacturing validation before we may be able to seek regulatory approval for and launch approved products commercially; |
| Ø | a potential delisting of our common stock from trading on the Nasdaq Capital Market if we do not comply with Nasdaq listing requirements; |
| Ø | our ability to continue as a going concern; |
| Ø | the results and timing of our preclinical and clinical trial activities, including but not limited to our ability to enroll a sufficient number of patients timely to advance our clinical trials; |
| Ø | our ability to expand our therapeutic candidate portfolio through internal research and development or the acquisition or in-licensing of intellectual property assets; |
| Ø | the therapeutic benefits, effectiveness and safety of our therapeutic candidates; |
| Ø | our ability to receive regulatory approval for our therapeutic candidates in the United States, Europe and other geographies; |
| Ø | potential changes in regulatory requirements, and delays or negative outcomes from the regulatory approval process; |
| Ø | our reliance on third-parties for the planning, conduct, management and monitoring of clinical trials, for the manufacture of clinical drug substance and drug product that meets our specifications and for other requirements; |
| Ø | market acceptance of our therapeutic candidates that are approved for marketing in the United States or other countries; |
| Ø | our ability to successfully manufacture and commercialize our therapeutic candidates; |
| Ø | the safety and efficacy of therapeutics marketed by our competitors that are targeted to indications which our therapeutic candidates have been developed to treat; |
| Ø | our ability to utilize our proprietary technological approach to develop and commercialize our therapeutic candidates; |
| Ø | our heavy dependence on licensed intellectual property, including our ability to source and maintain licenses from third-party owners; |
| Ø | our ability to protect our intellectual property and operate our business without infringing the intellectual property rights of others; |
| Ø | our ability to attract, retain and motivate key personnel; |
| Ø | our ability to generate revenue and become profitable; |
| Ø | our ability to initiate and complete our clinical trials; |
| Ø | our ability to arrange potential collaborations to license and commercialize any therapeutic candidates for which we receive regulatory approval in the future in or outside the United States; |
| Ø | clinical development involves a lengthy, complex and expensive process, with an uncertain outcome, and the results of preclinical studies, manufacturing, and early-stage clinical trials of our therapeutic candidates may not be predictive of the results of later-stage clinical trials; |
| Ø | we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development, manufacturing and commercialization of TTX-MC138 or any of our other therapeutic candidates; |
| Ø | quality problems could delay or prevent delivery of our materials for clinical trials or to the market; |
| Ø | changes in methods of therapeutic candidate manufacturing or formulation may result in additional costs or delays; |
| Ø | our therapeutic candidates may cause undesirable side effects or death or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences; |
| Ø | if we are unable to advance our therapeutic candidates to clinical development, obtain regulatory approval and ultimately commercialize our therapeutic candidates or if we experience significant delays in doing so, our business will be materially harmed; |
| Ø | even if we receive regulatory approval of TTX-MC138 or any of our other therapeutic candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense. We may be subject to penalties if we fail to comply with regulatory requirements; |
| Ø | obtaining and maintaining regulatory approval for our therapeutic candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval for that or of any of our other therapeutic candidates in other jurisdictions; |
| Ø | we expect to rely on third-parties to manufacture and supply materials we require for research and development, preclinical studies and clinical trials which could result in supplies that are limited or interrupted or which may not be of satisfactory quantity or quality or other delays or disruptions; |
| Ø | our ability to import drug product from outside the U.S. which may be expensive and require extensive regulatory approval resulting in potential delays in conducting clinical trials or commercial launch; |
| Ø | ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and consolidated results of operations; |
| Ø | we face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do; |
| Ø | the price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock; |
| Ø | we are subject to geopolitical risks, economic volatility, anti-corruption laws, export and import restrictions, local regulatory authorities and the laws and medical practices in foreign jurisdictions; |
| Ø | we have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our consolidated financial condition or consolidated results of operations, which may adversely affect our business and the trading price of our common stock, and |
| Ø | other risks and uncertainties, including those listed under the caption “Risk Factors” in this Annual Report on Form 10-K and in our other regulatory filings. |
Reverse Stock Splits
On May 23, 2023, we effected a reverse split of our common stock, either issued and outstanding or held by us as treasury stock, (the “2023 Reverse Split”) previously approved by our board of directors (the “Board”) and our stockholders. The 2023 Reverse Split was at a ratio of one share for every 20 shares previously held with no change in the par value per share. The 2023 Reverse Split did not change the number of authorized shares of common stock.
On January 16, 2024, we effected a reverse split of our common stock, either issued and outstanding or held by us as treasury stock, (the “January 2024 Reverse Split”) previously approved by our Board and stockholders. The January 2024 Reverse Split was at a ratio of one share for every 40 shares previously held with no change in the par value per share. The January 2024 Reverse Split did not change the number of authorized shares of common stock.
On December 4, 2024, we effected a reverse split of our common stock, either issued and outstanding or held by us as treasury stock, (the “December 2024 Reverse Split”) previously approved by our Board and stockholders. The December 2024 Reverse Split was at a ratio of one share for every 33 shares previously held with no change in the par value per share. The December 2024 Reverse Split did not change the number of authorized shares of common stock.
On May 15, 2025, we effected a reverse split of our common stock, either issued and outstanding or held by us as treasury stock, (the “May 2025 Reverse Split”) previously approved by our Board and stockholders. The May 2025 Reverse Split was at a ratio of one share for every 28 shares previously held with no change in the par value per share. The May 2025 Reverse Split did not change the number of authorized shares of common stock.
All common stock share and per share data, and exercise price data for applicable common stock equivalents, included in our consolidated financial statements have been retroactively adjusted to reflect the 2023 Reverse Split, the January 2024 Reverse Split, the December 2024 Reverse Split, and the May 2025 Reverse Split.
