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Aadi Bioscience Inc

For the period ended Dec 31, 2023. Filed Mar 13, 2024.

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About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2023 · Filed Mar 13, 2024

WHWK$3.13+3.6%Stored close · as of Nov 6, 2026
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Contents

Table of Contents

Page
PART I
Item 1.Business4
Item 1A.Risk Factors35
Item 1B.Unresolved Staff Comments100
Item 1C.Cybersecurity100
Item 2.Properties101
Item 3.Legal Proceedings101
Item 4.Mine Safety Disclosures101
PART II
Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities102
Item 6.[Reserved]102
Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations103
Item 7A.Quantitative and Qualitative Disclosures About Market Risk113
Item 8.Financial Statements and Supplementary Data113
Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure141
Item 9A.Controls and Procedures141
Item 9B.Other Information141
Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspection141
Part III
Item 10.Directors, Executive Officers and Corporate Governance142
Item 11.Executive Compensation142
Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters142
Item 13Certain Relationships and Related Transactions, and Director Independence142
Item 14Principal Accountant Fees and Services142
PART IV
Item 15.Exhibits and Financial Statement Schedules143
Item 16.Form of 10-K Summary145

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 advanced malignant PEComa in foreign jurisdictions and any additional indications we may pursue and any other product candidates we may develop in the future;

the timing, scope or likelihood of regulatory filings and approvals for FYARRO for advanced malignant PEComa in foreign jurisdictions and any additional indications we may pursue and any other product candidates we may develop in the future;

our commercialization, marketing and manufacturing capabilities and strategy;

the pricing and reimbursement of FYARRO and any other product candidates we may develop in the future, if approved;

the rate and degree of market acceptance of FYARRO and any other product candidates we may develop in the future, if approved;

the timing, progress and results of preclinical studies and clinical trials for our programs and product candidates, the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

our ability to recruit and enroll suitable patients in our clinical trials;

the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO and any other product candidates that we may develop in the future;

our ability to develop and advance product candidates into, and successfully complete, clinical studies;

the implementation of our business model and our strategic plans for our business;

our ability to establish or maintain collaborations or strategic relationships or obtain additional funding;

our ability to contract with and rely on third parties to assist in conducting our clinical trials and manufacturing FYARRO and any other product candidates we may develop in the future;

the size and growth potential of the markets for FYARRO and any other product candidates we may develop in the future, if approved, and our ability to serve those markets, either alone or in partnership with others;

our ability to obtain funding for our operations, including funding necessary to commercialize FYARRO and to complete further development, approval and, if approved, commercialization of FYARRO in additional indications and any other product candidates we may develop in the future;

the period over which we anticipate our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements;

the potential for our business development efforts to maximize the potential value of our portfolio;

our ability to compete with other companies currently marketing or engaged in the development of treatments for the indications that we are pursuing for FYARRO and any other product candidates we may develop in the future;

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates;

our financial performance;

statements regarding the legal proceedings related to the termination of the EOC License Agreement (as defined herein);

our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and

other factors including but not limited to those detailed under the section entitled “Risk Factors.”

Forward-looking statements are not historical facts, but rather are based on current expectations, estimates, assumptions, and projections about the business and future financial results of the pharmaceutical industry, and other legal, regulatory and economic developments. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “intend,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential,” “continue,” “likely,” and similar expressions (including their use in the negative) intended to identify forward-looking statements although not all forward-looking statements contain these identifying words. Actual results could differ materially from the results contemplated by these forward-looking statements due to a number of factors, including, but not limited to, those described in Part I, Item 1A (Risk Factors) of this Annual Report.

You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance. You should read this Annual Report and the documents that we reference in this Annual Report and have filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements.

The forward-looking statements in this Annual Report represent our views as of the date of this Annual Report. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Annual Report.

References in the following discussion to“we,” “our,” “us,” or“Aadi” refer to Aadi Bioscience, Inc. and its subsidiary.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.