Aadi Bioscience, Inc. Files 2023 Annual Report (10-K)

TL;DR

<b>Aadi Bioscience, Inc. has filed its 2023 10-K report detailing its financial performance and business operations.</b>

AI Summary

Aadi Bioscience, Inc. (WHWK) filed a Annual Report (10-K) with the SEC on March 13, 2024. Aadi Bioscience, Inc. filed its 10-K for the fiscal year ending December 31, 2023. The company was formerly known as Aerpio Pharmaceuticals, Inc. and Zeta Acquisition Corp II. Aadi Bioscience is incorporated in Delaware. The company's principal business address is 17383 Sunset Avenue, Suite A250, Pacific Palisades, CA 90272. The filing covers the fiscal year 2023.

Why It Matters

For investors and stakeholders tracking Aadi Bioscience, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of Aadi Bioscience's financial health, operational risks, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's current standing and future prospects. Understanding the company's historical financial data, including revenue, net income, and debt levels, as presented in the 10-K, is essential for making informed investment decisions and evaluating its growth trajectory.

Risk Assessment

Risk Level: medium — Aadi Bioscience, Inc. shows moderate risk based on this filing. The company's financial performance and future prospects are subject to significant risks, including its status as a development-stage biopharmaceutical company with limited operating history and no history of profitability, as indicated by its retained earnings deficit.

Analyst Insight

Investors should carefully review the risk factors section of the 10-K to understand the potential challenges and uncertainties Aadi Bioscience faces in its drug development and commercialization efforts.

Key Numbers

• 2023-12-31 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 2024-03-13 — Filing Date (FILED AS OF DATE)
• 2023-01-01 — Fiscal Year Start (2023 FY)
• 2022-12-31 — Prior Year End (2022-12-31)
• 2021-12-31 — Prior Year End (2021-12-31)

Key Players & Entities

• Aadi Bioscience, Inc. (company) — COMPANY CONFORMED NAME
• Aerpio Pharmaceuticals, Inc. (company) — FORMER COMPANY
• ZETA ACQUISITION CORP II (company) — FORMER COMPANY
• DE (jurisdiction) — STATE OF INCORPORATION
• PACIFIC PALISADES (location) — CITY
• CA (location) — STATE
• 90272 (postal_code) — ZIP
• 424-473-8055 (phone_number) — BUSINESS PHONE

FAQ

Risk Factors

• Limited Operating History and Lack of Profitability [high — financial]: The company is a development-stage biopharmaceutical company with a limited operating history and has not generated significant revenue or achieved profitability, leading to a substantial deficit in retained earnings.

Industry Context

Aadi Bioscience operates in the pharmaceutical preparations industry, focusing on the development and commercialization of novel cancer therapies.

Regulatory Implications

The company is subject to extensive regulation by the Food and Drug Administration (FDA) and other health authorities regarding drug development, clinical trials, and marketing.

What Investors Should Do

1. Review the detailed financial statements and management's discussion and analysis in the 10-K.
2. Analyze the risk factors section for potential business and financial challenges.
3. Assess the company's strategic priorities and outlook for its drug pipeline.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-13: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This 10-K filing provides the annual update for the fiscal year 2023, following previous filings that would have detailed earlier periods and company developments.

Key Financial Figures

• $0.0001 — ange on which registered Common stock, $0.0001 par value per share AADI The Nasdaq Sto
• $24.4 million — oma and recognized net product sales of $24.4 million and $15.2 million for the years ended D
• $15.2 million — net product sales of $24.4 million and $15.2 million for the years ended December 31, 2023 a
• $1.0 billion — er. Abraxane has generated greater than $1.0 billion of sales in the United States every yea

Filing Documents

• aadi-20231231.htm (10-K) — 1982KB
• aadi-20231231xex41.htm (EX-4.1) — 31KB
• aadi-20231231xex211.htm (EX-21.1) — 3KB
• aadi-20231231xex231.htm (EX-23.1) — 2KB
• aadi-20231231xex311.htm (EX-31.1) — 10KB
• aadi-20231231xex312.htm (EX-31.2) — 10KB
• aadi-20231231xex321.htm (EX-32.1) — 5KB
• aadi-20231231xex322.htm (EX-32.2) — 5KB
• aadi-20231231xex971.htm (EX-97.1) — 38KB
• aadi-20231231_g1.jpg (GRAPHIC) — 195KB
• aadi-20231231_g2.jpg (GRAPHIC) — 166KB
• aadi-20231231_g3.jpg (GRAPHIC) — 37KB
• aadi-20231231_g4.jpg (GRAPHIC) — 80KB
• aadi-20231231_g5.jpg (GRAPHIC) — 475KB
• aadi-20231231_g6.jpg (GRAPHIC) — 465KB
• aadi-20231231_g7.jpg (GRAPHIC) — 34KB
• aadi-20231231_g8.jpg (GRAPHIC) — 31KB
• aadi-20231231_g9.jpg (GRAPHIC) — 161KB
• 0001628280-24-010901.txt (&nbsp;) — 12264KB
• aadi-20231231.xsd (EX-101.SCH) — 50KB
• aadi-20231231_cal.xml (EX-101.CAL) — 72KB
• aadi-20231231_def.xml (EX-101.DEF) — 240KB
• aadi-20231231_lab.xml (EX-101.LAB) — 619KB
• aadi-20231231_pre.xml (EX-101.PRE) — 441KB
• aadi-20231231_htm.xml (XML) — 894KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 35 Item 1B. Unresolved Staff Comments 100

C

Item 1 C . Cybersecurity 100 Item 2.

Properties

Properties 101 Item 3.

Legal Proceedings

Legal Proceedings 101 Item 4. Mine Safety Disclosures 101 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 102 Item 6. [Reserved] 102 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 103 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 113 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 113 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 141 Item 9A.

Controls and Procedures

Controls and Procedures 141 Item 9B. Other Information 141 Item 9C. Disclosure Regarding Foreign Jurisdictions that Pre v ent Inspection 141 Part III Item 10. Directors, Executive Officers and Corporate Governance 142 Item 11.

Executive Compensation

Executive Compensation 142 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 142 Item 13 Certain Relationships and Related Transactions, and Director Independence 142 Item 14 Principal Accountant Fees and Services 142 PART IV Item 15. Exhibits and Financial Statement Schedules 143 Item 16. Form of 10-K Summary 145 1 Table of Contents

Forward-Looking Statements

Forward-Looking Statements This Annual Report on Form 10-K ("Annual Report") contains express or implied forward-looking statements which are made pursuant to the safe harbor provisions 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"), that are based on our management's belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or 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. Forward-looking statements in this Annual Report include, but are not limited to, statements about: our ability to maintain regulatory approval for FYARRO in advanced malignant perivascular epithelioid cell tumor ("PEComa"), or to obtain and maintain regulatory approval for FYARRO in additional indications, or any other product candidates we may develop in the future, and any related restrictions, limitations or warnings in the label of an approved product candidate; our plans and potential for success relating to commercializing FYARRO, or any other product candidate that we may develop, if approved; the anticipated timing of releasing data for current or future clinical trials; the anticipated timing of commencement, enrollment, and completion of any current or future clinical trials for FYARRO in additional indications, or any other product candidates we may develop in the future; our plans related to the further development and manufacturing of FYARRO; the timing, scope or likelihood of regulatory filings and approvals for FYARRO for

Business

Item 1. Business. Overview We are a biopharmaceutical company focused on developing and commercializing precision therapies for cancers with alterations in the mTOR pathway, a key regulator of cell growth and cancer progression. Our lead drug product, FYARRO (sirolimus protein-bound particles for injectable suspension (albumin-bound); nab -sirolimus), combines two established technologies - nanoparticle albumin-bound ( nab ) technology and the anti-cancer agent, sirolimus. Nab -sirolimus is a potent inhibitor of the mTOR biological pathway with demonstrated anti-cancer activity in our lead indication, advanced malignant perivascular epithelioid cell tumor ("PEComa"), a rare cancer. We believe our approach to utilizing the novel combination of technologies has the potential to produce transformational therapies for patients with cancers beyond PEComa that have known mTOR pathway activation and/or cancers in which other mTOR inhibitors have not been fully exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. We exclusively license FYARRO, previously called ABI-009, nab -sirolimus, from Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of Bristol-Myers Squibb Company ("BMS"). Throughout this document we refer to FYARRO ( nab -sirolimus, sirolimus protein-bound particles for injectable suspension (albumin-bound)) as FYARRO in the context of commercialization for the treatment of advanced malignant PEComa, investigational use, our clinical trials, regulatory matters such as orphan drug designation and our license agreement with BMS and collaboration agreement with Mirati Therapeutics, Inc. ("Mirati"), all further discussed below and throughout this document. On November 22, 2021, the U.S. Food and Drug Administration (the "FDA") approved FYARRO sirolimus protein-bound particles for injectable suspension (albumin-bound) for the treatment of adu

View Full Filing

View this 10-K filing on SEC EDGAR