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| PART I | 2 | |
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| Item 1. Business | 2 | |
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| Item 1A. Risk Factors | 25 | |
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| Item 1B. Unresolved Staff Comments | 51 | |
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| Item 1C. Cybersecurity | 51 | |
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| Item 2. Properties | 52 | |
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| Item 3. Legal Proceedings | 52 | |
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| Item 4. Mine Safety Disclosures | 52 | |
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| PART II | 53 | |
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| Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 53 | |
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| Item 6. [Reserved] | 53 | |
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| Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 54 | |
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| Item 7A. Quantitative and Qualitative Disclosures About Market Risk | 61 | |
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| Item 8. Financial Statements and Supplementary Data | 61 | |
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| Item 9. Changes and Disagreements with Accountants on Accounting and Financial Disclosure | 61 | |
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| Item 9A. Controls and Procedures | 62 | |
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| Item 9B. Other Information | 63 | |
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| Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 63 | |
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| PART III | 64 | |
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| Item 10. Directors, Executive Officers and Corporate Governance | 64 | |
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| Item 11. Executive Compensation | | 69 |
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| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 77 | |
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| Item 13. Certain Relationships and Related Party Transactions, and Director Independence | 78 | |
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| Item 14. Principal Accounting Fees and Services | | 79 |
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| PART IV | 80 | |
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| Item 15. Exhibits and Financial Statement Schedules | 80 | |
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| Signatures | 84 | |
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Unless the context requires otherwise, references in this Annual Report on Form 10-K to “we,” “our,” “us,” “the Company” and “Bio-Path” refer to Bio-Path Holdings, Inc. and its subsidiary. Bio-Path Holdings, Inc.’s wholly-owned subsidiary, Bio-Path, Inc., is sometimes referred to herein as “Bio-Path Subsidiary.”
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K 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”). Forward-looking statements can be identified by words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” “project,” “goal,” “strategy,” “future,” “likely,” “may,” “should,” “will” and variations of these words and similar references to future periods, although not all forward-looking statements contain these identifying words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances, including those discussed in “Item 1A. Risk Factors” of this Annual Report on Form 10-K and in other reports or documents we file with the U.S. Securities and Exchange Commission (“SEC”). As a result, our actual results and financial condition may differ materially from those expressed or forecasted in the forward-looking statements, and you should not rely on such forward-looking statements. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following:
| ● | our lack of significant revenue to date, our history of recurring operating losses and our expectation of future operating losses; |
| ● | our need for substantial additional capital and our need to delay, reduce or eliminate our drug development and commercialization efforts if we are unable to raise additional capital; |
| ● | the highly-competitive nature of the pharmaceutical and biotechnology industry and our ability to compete effectively; |
| ● | the success of our plans to use collaboration arrangements to leverage our capabilities; |
| ● | our ability to retain and attract key personnel; |
| ● | the risk of misconduct of our employees, agents, consultants and commercial partners; |
| ● | disruptions to our operations due to expansions of our operations; |
| ● | the costs we would incur if we acquire or license technologies, resources or drug candidates; |
| ● | risks associated with product liability claims; |
| ● | our reliance on information technology systems and the liability or interruption associated with cyber-attacks or other breaches of our systems; |
| ● | our ability to use net operating loss carryforwards; |
| ● | provisions in our charter documents and state law that may prevent a change in control; |
| ● | work slowdown or stoppage at government agencies could negatively impact our business; |
| ● | the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith; |
| ● | our need to complete extensive clinical trials and the risk that we may not be able to demonstrate the safety and efficacy of our drug candidates; |
| ● | risks that our clinical trials may be delayed or terminated; |
| ● | our ability to obtain domestic and/or foreign regulatory approval for our drug candidates; |
| ● | changes in existing laws and regulations affecting the healthcare industry; |
| ● | our reliance on third parties to conduct clinical trials for our drug candidates; |
| ● | our ability to maintain orphan drug exclusivity for our drug candidates; |
| ● | our reliance on third parties for manufacturing our clinical drug supplies; |
| ● | risks associated with the manufacture of our drug candidates; |
| ● | our ability to establish sales and marketing capabilities relating to our drug candidates; |
| ● | market acceptance of our drug candidates; |
| ● | third-party payor reimbursement practices; |
| ● | our ability to adequately protect the intellectual property of our drug candidates; |
| ● | infringement on the intellectual property rights of third parties; |
| ● | costs and time relating to litigation regarding intellectual property rights; |
| ● | our ability to adequately prevent disclosure by our employees or others of trade secrets and other proprietary information; |
| ● | our need to raise additional capital; |
| ● | the volatility of the trading price of our common stock; |
| ● | our common stock being thinly traded; |
| ● | our ability to issue shares of common or preferred stock without approval from our stockholders; |
| ● | our ability to pay cash dividends; |
| ● | costs and expenses associated with being a public company; |
| ● | our ability to maintain effective internal controls over financial reporting; and |
| ● | our ability to maintain compliance with the listing standards of the Nasdaq Capital Market. |
Please also refer to “Item 1A. Risk Factors” of this Annual Report on Form 10-K and other reports or documents we file with the SEC for a discussion of risks and factors that could cause our actual results and financial condition to differ materially from those expressed or forecasted in this Annual Report on Form 10-K.
Any forward-looking statement made by us in this Annual Report on Form 10-K is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking
statement, whether as a result of new information, future developments or otherwise. However, you should carefully review the risk factors set forth in other reports or documents we file from time to time with the SEC.
