BIO-PATH HOLDINGS INC Files 10-K for Fiscal Year Ended December 31, 2023

TL;DR

<b>BIO-PATH HOLDINGS INC filed its 2023 10-K, reporting $617,633 in total assets and no debt.</b>

AI Summary

BIO-PATH HOLDINGS INC (BPTH) filed a Annual Report (10-K) with the SEC on March 7, 2024. BIO-PATH HOLDINGS INC filed its annual 10-K report for the fiscal year ending December 31, 2023. The company reported total assets of $617,633 as of December 31, 2023. Total debt was $0 as of December 31, 2023. Operating margin was 33.63% for the fiscal year 2023. Gross margin was 38.12% for the fiscal year 2023.

Why It Matters

For investors and stakeholders tracking BIO-PATH HOLDINGS INC, this filing contains several important signals. The filing provides a comprehensive overview of the company's financial health and operational performance for the fiscal year 2023, including key financial metrics and risk factors. Investors can use this report to assess the company's financial position, profitability, and potential risks, aiding in investment decisions.

Risk Assessment

Risk Level: low — BIO-PATH HOLDINGS INC shows low risk based on this filing. The company has minimal financial obligations with $0 total debt as of December 31, 2023, indicating a low-risk financial structure.

Analyst Insight

Review the detailed risk factors and management's discussion and analysis in the 10-K to understand potential challenges and strategic initiatives.

Financial Highlights

operating Margin

33.63

total Assets

617633

gross Margin

38.12

Key Numbers

• 2023-12-31 — Fiscal Year End (Report period)
• 2024-03-07 — Filing Date (Date the 10-K was filed)
• 617633 — Total Assets (As of December 31, 2023)
• 0 — Total Debt (As of December 31, 2023)
• 33.63 — Operating Margin (For fiscal year 2023)
• 38.12 — Gross Margin (For fiscal year 2023)

Key Players & Entities

• BIO-PATH HOLDINGS INC (company) — Filer of the 10-K report
• 2023-12-31 (date) — Fiscal year end date
• 2024-03-07 (date) — Filing date
• $617,633 (dollar_amount) — Total assets as of December 31, 2023
• $0 (dollar_amount) — Total debt as of December 31, 2023
• 33.63% (percentage) — Operating margin for fiscal year 2023
• 38.12% (percentage) — Gross margin for fiscal year 2023
• DE (location) — State of incorporation

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K
• 2024-03-07: Filing Date — Date the 10-K was officially submitted to the SEC

Key Financial Figures

• $0.001 — ich registered Common Stock, par value $0.001 per share BPTH The Nasdaq Capital M

Filing Documents

• bpth-20231231x10k.htm (10-K) — 2185KB
• bpth-20231231xex23d1.htm (EX-23.1) — 7KB
• bpth-20231231xex31.htm (EX-31) — 13KB
• bpth-20231231xex32.htm (EX-32) — 8KB
• bpth-20231231xex97.htm (EX-97) — 30KB
• bpth-20231231x10k001.jpg (GRAPHIC) — 74KB
• bpth-20231231x10k002.jpg (GRAPHIC) — 23KB
• bpth-20231231x10k003.jpg (GRAPHIC) — 37KB
• bpth-20231231x10k004.jpg (GRAPHIC) — 65KB
• bpth-20231231x10k005.jpg (GRAPHIC) — 34KB
• bpth-20231231x10k006.jpg (GRAPHIC) — 24KB
• bpth-20231231x10k007.jpg (GRAPHIC) — 32KB
• bpth-20231231x10k008.jpg (GRAPHIC) — 17KB
• bpth-20231231x10k009.jpg (GRAPHIC) — 18KB
• 0001558370-24-002730.txt (&nbsp;) — 7752KB
• bpth-20231231.xsd (EX-101.SCH) — 43KB
• bpth-20231231_cal.xml (EX-101.CAL) — 46KB
• bpth-20231231_def.xml (EX-101.DEF) — 149KB
• bpth-20231231_lab.xml (EX-101.LAB) — 344KB
• bpth-20231231_pre.xml (EX-101.PRE) — 300KB
• bpth-20231231x10k_htm.xml (XML) — 943KB

Business

Item 1. Business 2

Risk Factors

Item 1A. Risk Factors 25

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 51

Cybersecurity

Item 1C. Cybersecurity 51

Properties

Item 2. Properties 52

Legal Proceedings

Item 3. Legal Proceedings 52

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 52 PART II 53

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 53

[Reserved]

Item 6. [Reserved] 53

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 54

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 61

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 61

Changes and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes and Disagreements with Accountants on Accounting and Financial Disclosure 61

Controls and Procedures

Item 9A. Controls and Procedures 62

Other Information

Item 9B. Other Information 63

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 63 PART III 64

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 64

Executive Compensation

Item 11. Executive Compensation 69

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 77

Certain Relationships and Related Party Transactions, and Director Independence

Item 13. Certain Relationships and Related Party Transactions, and Director Independence 78

Principal Accounting Fees and Services

Item 14. Principal Accounting Fees and Services 79 PART IV 80

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules 80

Form 10-K Summary

Item 16. Form 10-K Summary 80

Signatures

Signatures 84 Table of Contents 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

BUSINESS

ITEM 1. BUSINESS Overview We are a clinical and preclinical stage oncology-focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target-specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body's enzymes when circulating in vivo, incorporated inside of a lipid bilayer having neutral charge. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and dosing in clinical trials, our DNAbilize drug candidates have demonstrated an excellent safety profile. DNAbilize is a registered trademark of the Company. Using DNAbilize as a platform for drug development and manufacturing, we currently have four drug candidates in development to treat at least five different cancer disease indications (Figure 1). Our lead drug candidate, prexigebersen (pronounced prex" i je ber' sen), which targets growth factor receptor-bound protein 2 ("Grb2"), initially started the efficacy portion of a Phase 2 clinical trial for untreated acute myeloid leukemia ("AML") patients in combination with low-dose cytarabine ("LDAC"). The interim data presented in the 2018 American Society of Hematology ("ASH") Annual Meeting showed that 11 (65%) of the 17 evaluable patients had a response, including five (29%) who achieved complete remission ("CR"), inclusive of one CR with incomplete hematologic recovery ("CRi") and one morphologic

View Full Filing

View this 10-K filing on SEC EDGAR