AN2 Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>AN2 Therapeutics, Inc. has submitted its 2023 annual 10-K filing detailing its financial and operational status.</b>

AI Summary

AN2 Therapeutics, Inc. (ANTX) filed a Annual Report (10-K) with the SEC on March 29, 2024. AN2 Therapeutics, Inc. filed its annual report for the fiscal year ended December 31, 2023. The company's principal executive offices are located at 1800 El Camino Real, Suite D, Menlo Park, CA 94027. The filing is made under the Securities Exchange Act of 1934. The company's Standard Industrial Classification code is Pharmaceutical Preparations [2834]. The filing includes data related to various equity incentive plans and stock transactions.

Why It Matters

For investors and stakeholders tracking AN2 Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of AN2 Therapeutics' financial performance, operational activities, and risk factors for the fiscal year 2023, which is crucial for investors to assess the company's current standing and future prospects. The detailed information within the filing, including financial statements and disclosures on executive compensation and risk factors, is essential for stakeholders to make informed investment decisions and understand the company's strategic direction.

Risk Assessment

Risk Level: medium — AN2 Therapeutics, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, lengthy development cycles, and substantial R&D costs, posing inherent risks to financial performance and market success.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand AN2 Therapeutics' financial health and the specific challenges it faces in the pharmaceutical sector.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-29 — Filing Date (Filed as of date)
• 001-41331 — SEC File Number (SEC File Number)
• 2834 — SIC Code (Standard Industrial Classification)

Key Players & Entities

• AN2 Therapeutics, Inc. (company) — Filer name
• 1800 El Camino Real, Suite D, Menlo Park, CA 94027 (location) — Business address
• 1934 Act (regulation) — SEC Act
• 2834 (industry_code) — Standard Industrial Classification
• 20231231 (date) — Conformed period of report
• 20240329 (date) — Filed as of date

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by government authorities, which can impact product development, approval, manufacturing, and marketing.
• Research and Development Costs [high — financial]: The company incurs substantial costs for research and development, and there is no assurance that these investments will lead to successful product commercialization.
• Competition [medium — market]: The company faces intense competition from other pharmaceutical and biotechnology companies, which could affect its ability to gain market share.
• Dependence on Key Personnel [medium — operational]: The success of the company may depend on the continued service of its key scientific and management personnel.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the annual financial statements.
• 2024-03-29: Filing Date — Date the 10-K report was officially submitted to the SEC.

Key Financial Figures

• $0 — 0,375 shares of common stock, par value $0.00001, outstanding. DOCUMENTS INCORPO
• $17.8 million — nder which we are able to receive up to $17.8 million in cost reimbursements to advance the d

Filing Documents

• antx-20231231.htm (10-K) — 2403KB
• antx-ex10_3.htm (EX-10.3) — 299KB
• antx-ex10_5.htm (EX-10.5) — 74KB
• antx-ex10_6.htm (EX-10.6) — 150KB
• antx-ex23_1.htm (EX-23.1) — 5KB
• antx-ex31_1.htm (EX-31.1) — 14KB
• antx-ex31_2.htm (EX-31.2) — 14KB
• antx-ex32_1.htm (EX-32.1) — 8KB
• antx-ex32_2.htm (EX-32.2) — 8KB
• antx-ex97_1.htm (EX-97.1) — 56KB
• img91092122_0.jpg (GRAPHIC) — 34KB
• 0000950170-24-038681.txt (&nbsp;) — 9227KB
• antx-20231231.xsd (EX-101.SCH) — 1169KB
• antx-20231231_htm.xml (XML) — 1222KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 26 Item 1B. Unresolved Staff Comments 78 Item 1C. Cybersecurity 78 Item 2.

Properties

Properties 79 Item 3.

Legal Proceedings

Legal Proceedings 79 Item 4. Mine Safety Disclosures 79 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 80 Item 6. [Reserved] 81 Item 7.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 82 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 93 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 93 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 93 Item 9A.

Controls and Procedures

Controls and Procedures 93 Item 9B. Other Information 96 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 96 PART III Item 10. Directors, Executive Officers and Corporate Governance 97 Item 11.

Executive Compensation

Executive Compensation 97 Item 12.

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

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 97 Item 13. Certain Relationships and Related Transactions, and Director Independence 97 Item 14. Principal Accounting Fees and Services 97 PART IV Item 15. Exhibits, Financial Statement Schedules 98 Item 16 Form 10-K Summary 98

Signatures

Signatures 101 i SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K ("Annual Report") contains forward-looking statements. 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, product candidates, planned preclinical and nonclinical studies and clinical trials, results of preclinical and nonclinical 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 Form 10-K include, but are not limited to, statements about: the initiation, timing, progress, and results of our preclinical and nonclinical studies and clinical trials, and our research and development programs, including the manufacture of clinical trial material and drug product for launch; the sufficiency of our existing cash to fund our future operating expenses and capital expenditure requirements; the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing; our use of the net proceeds from financing activities; the ability of our Phase 2/3 clinic

. Business

Item 1 . Business. Overview AN2 Therapeutics, Inc. (also referred to in this document as "AN2," "we," the "Company" or the "Registrant") is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. Our initial candidate is epetraborole, which we are studying as a potential once-daily, oral treatment with a novel mechanism of action for patients with non-tuberculous mycobacterial ("NTM") lung disease, a rare, chronic and progressive infectious disease caused by bacteria known as mycobacteria, which leads to irreversible lung damage and can be fatal. In February 2024, we voluntarily paused Phase 3 enrollment in the seamless Phase 2/3 clinical trial ("EBO-301") evaluating epetraborole in treatment-refractory MAC lung disease, pending further study-data review and discussion with the FDA, due to potentially lower-than-expected efficacy results following a blinded aggregate analysis. The decision to pause enrollment was not due to safety concerns. We met with the study's independent Data Safety Monitoring Board ("DSMB") in March 2024 and plan to meet with the FDA in the coming months. In the meantime, patients enrolled in the study before the enrollment pause will continue to be dosed with blinded study drug and undergo all study assessments. The Phase 2 portion of the trial has completed enrollment, with topline data expected in August 2024. Epetraborole is designed to produce broad-spectrum antimycobacterial activity through inhibition of an essential and universal step in bacterial protein synthesis. Its novel mechanism of action is enabled by boron chemistry, our core technology approach. We in-licensed the exclusive worldwide development and commercialization rights for epetraborole from Anacor, acquired by Pfizer Inc. ("Pfizer") in 2019. The FDA granted us Fast Track designation to investigate epetraborole for treatment-refractory MAC lung disease, Qualified Infectious Diseas

View Full Filing

View this 10-K filing on SEC EDGAR