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| PART I | | | |
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| | ITEM 1. | Business | 5 |
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| | ITEM 1A. | Risk Factors | 65 |
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| | ITEM 1B. | Unresolved Staff Comments | 115 |
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| | ITEM 1C. | Cybersecurity | 115 |
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| | ITEM 2. | Properties | 116 |
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| | ITEM 3. | Legal Proceedings | 116 |
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| | ITEM 4. | Mine Safety Disclosures | 116 |
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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 | 117 |
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| | ITEM 6. | Reserved | 117 |
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| | ITEM 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 117 |
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| | ITEM 7A. | Quantitative and Qualitative Disclosures About Market Risk | 126 |
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| | ITEM 8. | Financial Statements and Supplementary Data | 127 |
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| | ITEM 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 149 |
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| | ITEM 9A. | Controls and Procedures | 149 |
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| | ITEM 9B. | Other Information | 150 |
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| | ITEM 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 150 |
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| PART III | | | |
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| | ITEM 10. | Directors, Executive Officers and Corporate Governance | 151 |
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| | ITEM 11. | Executive Compensation | 151 |
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| | ITEM 12. | Security Ownership of Certain Beneficial Owners and Management Related Stockholder Matters | 151 |
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| | ITEM 13. | Certain Relationships and Related Party Transactions, and Director Independence | 151 |
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| | ITEM 14. | Principal Accountant Fees and Services | 151 |
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| PART IV | | | |
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| | ITEM 15. | Exhibits | 152 |
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| | | Signatures | 157 |
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FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this Annual Report)contains forward-looking statements within the meaning of 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 (the Exchange Act). All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies, clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Annual Report include, but are not limited to, statements about:
| ● | our financial performance; |
| ● | our ability to obtain additional cash and the sufficiency of our existing cash, cash equivalents and marketable securities to fund our future operating expenses and capital expenditure requirements; |
| ● | the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
| ● | the scope, progress, results and costs of developing denifanstat, TVB-3567 or any other drug candidates or combination therapies we may develop, and conducting preclinical studies and clinical trials; |
| ● | our ability to advance drug candidates into, and successfully complete, clinical trials within anticipated timelines; |
| ● | the timing and costs involved in obtaining and maintaining regulatory approval of denifanstat, TVB-3567 or any other drug candidates or combination therapies we may develop, and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations or accelerated approvals for our drug candidates for various indications; |
| ● | current and future agreements with third parties in connection with the development and commercialization of denifanstat, TVB-3567 or any other future drug candidate or combination therapy; |
| ● | our estimate of the number of patients in the United States who suffer from the diseases we target and the number of subjects that will enroll in our clinical trials; |
| ● | our relationship with Ascletis BioScience Co. Ltd. (Ascletis), and its affiliate Gannex Pharma Co., Ltd. (Gannex), and the success of their development and registration efforts for denifanstat in China; |
| ● | the ability of our clinical trials to demonstrate the safety and efficacy of denifanstat, TVB-3567 and any other drug candidates or combination therapies we may develop; |
| ● | our plans relating to commercializing denifanstat, TVB-3567 and any other drug candidates or combination therapies we may develop, if approved, including the geographic areas of focus and our ability to build a commercial organization; |
| ● | the success of competing therapies that are or may become available; |
| ● | developments relating to our competitors and our industry, including competing drug candidates and therapies; |
| ● | our plans relating to the further development and manufacturing of denifanstat, TVB-3567 and any other drug candidates or combination therapies we may develop, including additional indications that we may pursue for denifanstat, TVB-3567 or other drug candidates or combination therapies; |
| ● | our ability to obtain sufficient funding or enter into a strategic collaboration to initiate future clinical trials for our combination of denifanstat and resmetirom in metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH); |
| ● | existing regulations and regulatory developments in the United States and other jurisdictions; |
| ● | our potential and ability to successfully manufacture and supply denifanstat, TVB-3567 and any other drug candidates or combination therapies we may develop for clinical trials and for commercial use, if approved; |
| ● | the rate and degree of market acceptance of denifanstat, TVB-3567 and any other drug candidates or combination therapies we may develop, as well as the pricing and reimbursement of denifanstat, TVB-3567 and any other drug candidates or combination therapies we may develop, if approved; |
| ● | our expectations regarding our ability to obtain, maintain, protect and enforce intellectual property protection for denifanstat, TVB-3567 and for any other future drug candidate or combination therapy; |
| ● | our ability to realize the anticipated benefits of any strategic transactions; |
| ● | our ability to attract and retain the continued service of our key personnel and to identify, hire, and then retain additional qualified personnel and our ability to attract additional collaborators with development, regulatory and commercialization expertise; |
| ● | the impact of macroeconomic conditions and geopolitical turmoil on our business and operations; |
| ● | our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; and |
| ● | our anticipated use of our existing cash, cash equivalents and marketable securities. |
We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Annual Report and are subject to a number of risks, uncertainties and assumptions described in Part I, Item 1A. “Risk Factors” and elsewhere in this Annual Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein until after we distribute this Annual Report, whether as a result of any new information, future events or otherwise.
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 Annual 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.
Part I
