The following discussion of our financial condition and results of operations of Aadi Bioscience, Inc. should be read in conjunction with the consolidated financial statements and the related notes to those statements thereto appearing elsewhere in this Annual Report for the year ending December 31, 2021. Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risk, uncertainties and assumptions. Our actual results could differ materially from those discussed in our forward-looking statements for many reasons, including those risks. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Annual Report. You should read this Annual Report completely, including the "Risk Factors" section under Part I, Item 1A of this Annual Report and the "Forward-Looking Statements" sections of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by our forward-looking statements contained in the following discussion and analysis. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Overview

We are a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes. Our lead drug product, FYARRO, nab-sirolimus, (sirolimus protein-bound particles for injectable suspension (albumin-bound)), is a form of sirolimus bound to albumin. Sirolimus is a potent inhibitor of the mTOR biological pathway, the activation of which pathway can promote tumor growth, and inhibits downstream signaling from mTOR.

In May 2021, we completed the filing of a rolling new drug application ("NDA") for FYARRO to the U.S. Food and Drug Administration (the "FDA"), for approval to treat patients with advanced malignant PEComa. The FDA accepted the NDA in July 2021 and granted us priority review designation with a Prescription Drug User Fee Act target action date in November 2021. The NDA was based on results from our Phase 2 registrational study, AMPECT (Advanced Malignant PEComa Trial), in advanced malignant PEComa.

In November 2021, the FDA approved FYARRO sirolimus protein-bound particles for injectable suspension (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced malignant PEComa. During the first quarter of 2022, we launched FYARRO in the United States for treatment of advanced malignant PEComa.

In addition to advanced malignant PEComa, based on data from the completed AMPECT trial and our expanded access program, we have initiated a registration-directed tumor-agnostic Phase 2 study ("PRECISION 1") of FYARRO in patients with Tuberous Sclerosis Complex 1 and 2 (TSC1 & TSC2) alterations. We have completed a Type B meeting with the FDA in which we discussed the initial trial design and the PRECISION 1 trial was opened for enrollment in the first quarter of 2022 in the United States.

For more information regarding our business, including FYARRO, the AMPECT trial and the PRECISION 1 trial, see Part I, Item 1 (Business).

For the fiscal year ended December 31, 2021, we recorded revenue of $1.1 million and net loss of $110.1 million. See "Results of Consolidated Operations" for further discussion of our results.

August 2021 Reverse Merger


    •   On May 16, 2021, at which time we were operating as "Aerpio
        Pharmaceuticals, Inc.," we entered into: (i) an Agreement and Plan of
        Merger ("Merger Agreement") with Aspen Merger Subsidiary, Inc., our
        wholly-owned subsidiary ("Merger Sub"), and Aadi Subsidiary, Inc.
        (formerly known as Aadi Bioscience, Inc. ("Private Aadi")); and (ii) a
        subscription agreement ("Subscription Agreement") with certain investors
        (the "PIPE Investors"), pursuant to which we agreed to sell shares of our
        common stock to the PIPE Investors concurrently with the closing of the
        Merger (as defined below) (the "PIPE Financing"). See Note 1 to our
        audited financial statements for more information about the Merger
        Agreement and the Subscription Agreement.


    •   On August 26, 2021, pursuant to the terms of the Merger Agreement and the
        Subscription Agreement:


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          o   Merger Sub merged with and into Private Aadi, with Private Aadi
              surviving as our wholly-owned subsidiary (the "Merger");


          o   in connection with and immediately prior to the Merger, we effected
              a reverse stock split of our common stock at a ratio of 15:1 and
              changed our name from "Aerpio Pharmaceuticals, Inc." to "Aadi
              Bioscience, Inc";


          o   at the effective time of the Merger, based on an exchange ratio of
              0.3172 (after taking into account the Reverse Stock Split), as
              calculated under the Merger Agreement (the "Exchange Ratio"), we
              issued an aggregate of 5,776,660 shares of common stock to the
              holders of Private Aadi common stock immediately prior to the
              Merger, including shares of Private Aadi common stock issuable upon
              the conversion of all shares of preferred stock and convertible
              promissory notes outstanding immediately prior to the Effective
              Time;


          o   at the closing of the Merger, we assumed all of the outstanding and
              unexercised options to purchase shares of Private Aadi common stock,
              which options were converted into options to purchase shares of our
              common stock, as adjusted pursuant to the Merger Agreement based on
              the Exchange Ratio;


          o   concurrently with the Closing of the Merger, we issued and sold
              11,852,862 shares of common stock to the PIPE Investors for total
              gross proceeds of $155 million and, immediately after the closing of
              the Merger and the PIPE Financing, the PIPE Investors and the
              Private Aadi investors as of immediately prior to the effective time
              of the Merger owned 55.6% and 29.2%, respectively, of our
              outstanding common stock on a fully-diluted basis; and


          o   we entered into a contingent value rights agreement ("CVR
              Agreement") pursuant to which each of our stockholders as of
              immediately prior to the effective time of the Merger became
              entitled to certain contingent value rights entitling them to
              receive 90% of the net proceeds (calculated as gross consideration
              minus certain permitted deductions), if any, received by us under
              the license agreement, dated June 24, 2018, with Gossamer Bio, Inc.,
              as amended, and certain other covered agreements, as specified in
              the CVR Agreement (see Note 1 to our audited financial statements
              for more information about the CVR Agreement).

Celgene License Agreement

In April 2014, Private Aadi entered into a license agreement (the "Celgene License Agreement") with Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, now Bristol Myers Squibb Company ("Celgene"), for exclusive rights for certain patents and a non-exclusive license for certain technology and know-how pertaining to ABI-009 (which we refer to as FYARRO). Under the Celgene License Agreement, as amended, Celgene is entitled to receive certain development milestone payments, royalties on net sales from licensed products under the agreement and any sublicense fees. No payments related to milestones or royalties under this agreement were paid during the twelve months ended December 31, 2021 and December 31, 2020. See Note 2 to the audited financial statements for more information about the Celgene License Agreement.

Under the terms of an August 2021 amendment to the Celgene License Agreement, we paid Celgene $5.8 million, representing 50% of the previously outstanding payment obligation under the terms of the Celgene License Agreement, following the effective time of the PIPE Financing. Pursuant to the terms of the amendment, the remaining portion of the previously outstanding payment obligation ($5.8 million), which is recorded on our balance sheet as a "payable to related party," is due on the third anniversary of the effective time plus any accrued and unpaid interest due thereon.

EOC License Agreement

In December 2020, we entered into a license agreement ("EOC License Agreement") with EOC Pharma (Hong Kong) Limited ("EOC") under which we received $14.0 million in January 2021 in non-refundable upfront consideration as partial payment for the rights and licenses granted to EOC by us for the further development and commercialization of FYARRO in the People's Republic of China, Hong Kong Special Administration Region, Macao Special Administrative Region and Taiwan (the "Licensed Territory"). See Note 8 to the audited financial statements for more information about the EOC License Agreement.



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In accordance with the Celgene License Agreement, we are required to pay 20% of all sublicense fees to Celgene. As such, we recognized $2.8 million of license expense in the fourth quarter of 2020 and had a corresponding $2.8 million sublicense payable to Celgene on the balance sheet as of December 31, 2020, which was paid in 2021.

During the fourth quarter of 2021, we recognized license revenue and received $1.0 million from EOC for achieving the FDA approval milestone in November 2021. In accordance with the Celgene License Agreement, we recognized $0.2 million of license expense in the fourth quarter of 2021 and had a corresponding $0.2 million sublicense payable to Celgene on the balance sheet as of December 31, 2021, which was paid in 2022.

Key Trends and Factors Affecting Comparability Between Periods


    •   Following FDA approval in November 2021, we have been actively engaged in
        commercial preparations to support the U.S. launch of FYARRO for the
        treatment of patients with advanced malignant PEComa. We have built a
        cross-functional commercial team consisting of marketing, market access,
        commercial operations, and sales to support our launch and are building a
        commercial infrastructure with capabilities designed to scale when
        necessary to support future commercial launches. Expenses related to our
        commercial launch including personnel expenses, sales support, and
        marketing are included in general and administrative expenses for the year
        ended December 31, 2021. We expect these expenses will continue to
        increase as we launch FYARRO and support future launches.


    •   We expect that our research and development costs will increase in 2022
        relative to 2021 as a result of anticipated significant expenses related
        to the PRECISION 1 trial.


    •   Following the Merger, we have incurred, and expect to continue to incur,
        significant additional expenses associated with being a public company
        that we did not incur as a privately-held company, including (i) costs to
        comply with the rules and regulations of the SEC and those of Nasdaq, (ii)
        legal, accounting and other professional services, (iii) insurance, (iv)
        investor relations activities and (v) other administrative and
        professional services.


    •   We accounted for the Merger as a reverse asset acquisition because
        substantially all of the fair value was concentrated in cash, working
        capital, and a long-lived contract intangible asset. Due to the
        significant excess purchase price being allocated over the fair value of
        the acquired contract intangible asset, we determined that an indicator of
        impairment was present and recognized in 2021 a non-cash impairment charge
        of $74.2 million, to bring the carrying amount of the contract intangible
        asset down to its estimated fair value of $3.9 million. The intangible
        asset is being amortized over the life of the underlying asset, 14.3
        years.


    •   The COVID-19 pandemic has resulted, and is likely to continue to result
        in, significant national and global economic disruption and may adversely
        affect our operations. Our clinical trials have been, and may continue to
        be, affected by the closure of offices, lack of resources or closure of
        borders, among other measures being put in place around the world. The
        inability to travel and conduct face-to-face meetings, as well as
        constraints surrounding hospital infrastructure and staff, can also make
        it more difficult to enroll and maintain patients in ongoing or planned
        clinical trials. We are actively monitoring the impact of COVID-19 and the
        possible effects on our financial condition, liquidity, operations,
        suppliers, industry and workforce. However, the full extent, consequences
        and duration of the COVID-19 pandemic and the resulting impact on us
        cannot currently be predicted. We will continue to evaluate the impact
        that these events could have on our operations, financial position,
        results of operations and cash flows in fiscal year 2022.

Liquidity and Capital Resources

We have incurred net losses in each year since inception and as of December 31, 2021 we had an accumulated deficit of $142.7 million. These losses have resulted principally from costs incurred in connection with research and development activities, general and administrative costs associated with our operations, and costs associated with the Merger. We expect to continue to incur significant expenses and operating losses for the foreseeable future due to the cost of research and development, including identifying and designing product candidates and conducting preclinical studies and clinical trials, the regulatory approval process for our product candidates and the commercial launch of FYARRO. As of December 31, 2021, we had $149.0 million of cash and cash equivalents. Based on our current plans, we believe our existing cash and cash equivalents will enable us to conduct our planned operations into 2024.



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Key Management Changes

Upon the closing of the Merger, Neil Desai, Ph.D. became our President and Chief Executive Officer. Following the Merger, we appointed Brendan Delaney as our Chief Operating Officer (September 2021), Loretta M. Itri, M.D. as our Chief Medical Officer (October 2021), and Scott Giacobello as our Chief Financial Officer (November 2021). Additionally, in September 2021, we appointed Emma Reeve to serve as a Class III director and as Chair of the Audit Committee.

Basis of Presentation

The following discussion highlights our results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described and provides information that management believes is relevant for an assessment and understanding of the consolidated balance sheets and statements of operation and comprehensive loss presented herein. The following discussion and analysis are based on our consolidated financial statements contained in this Annual Report, which we have prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). You should read the discussion and analysis together with such consolidated financial statements and the related notes thereto.

Components of Statements of Operations and Comprehensive Loss

Revenue

EOC Pharma License Revenue

In December 2020, we entered into the EOC License Agreement with EOC pursuant to which, we granted EOC exclusive rights to develop and commercialize FYARRO in the Licensed Territory for human use in specified indications. EOC is obligated to pay royalties to us on sales of licensed products in the Licensed Territory. Under the terms of the EOC License Agreement, EOC has agreed to use commercially reasonable efforts to develop and commercialize FYARRO in the Licensed Territory and to obtain and maintain regulatory approval.

Unless earlier terminated, the EOC License Agreement will remain in effect until all milestones are achieved and royalty payment obligations are fulfilled as provided for in the EOC License Agreement. Prior to the expiration of the EOC License Agreement, EOC has the right to terminate the agreement for any reason upon a specified number of days advance written notice. Either party may terminate the EOC License Agreement in the event that the other party materially breaches the agreement and fails to cure the breach, or experiences certain events of financial distress. We may terminate the EOC License Agreement if EOC or its affiliates challenge the licensed patents in a legal, administrative or arbitration proceeding.

In December 2020, we recognized revenue of $14.0 million related to the upfront payment which was paid in January 2021. We are eligible to receive up to an additional $257.0 million in the aggregate upon achievement of certain development, regulatory and sales milestones, as well as tiered royalties on net sales in the Licensed Territory, which royalties are potentially subject to various reductions. EOC is responsible for controlling the filing for and obtaining all regulatory approvals, with our reasonable cooperation, and for bearing all costs associated with those approvals. In November 2021, we achieved the FDA approval milestone and recognized $1.0 million of revenue, which was paid in December 2021.

We assessed the EOC License Agreement and concluded that EOC is a customer. Additionally, we identified the license of FYARRO provided to EOC as the sole performance obligation. The $14.0 million upfront payment received from EOC is non-refundable and non-creditable and is considered fixed consideration.

Both the milestones and royalty payments under the EOC License Agreement are considered variable consideration and, with respect to revenue recognition, are constrained until we receive notification from EOC that the milestones and royalty payments have been achieved.

Grant Revenue

Grant revenue is derived from federal grants, primarily with the FDA. We have determined that the government agencies providing grants to us are not customers. Grant revenue is recognized when there is reasonable assurance of compliance with the conditions of the grant and reasonable assurance that the grant revenue will be received. We recognize grant revenue as reimbursable grant costs are incurred. The costs associated with these reimbursements are reflected as a component of research and development expense in the accompanying statements of operations and comprehensive loss.



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With respect to grant revenue derived from reimbursement of direct out-of-pocket expenses for research costs associated with federal contracts, where we act as principal with discretion to choose suppliers, bear credit risk and perform part of the services required in the transaction, we record revenue for the gross amount of the reimbursement. The costs associated with these reimbursements are reflected as a component of research and development expense in the accompanying statements of operations and comprehensive loss.

Operating Expenses

Research and Development Expenses

Research and development expenses, which consist primarily of costs associated with our product research and development efforts, are expensed as incurred. Research and development expenses consist primarily of: (i) employee related costs, including salaries, benefits and stock-based compensation expense for employees engaged in scientific research and development functions; (ii) third-party contract costs relating to research, formulation, manufacturing, nonclinical studies and clinical trial activities; (iii) external costs of outside consultants who assist with technology development, regulatory affairs, clinical development and quality assurance; (iv) payments made under our third-party licensing agreements; and (v) allocated facility-related costs.

Costs for certain activities, such as manufacturing, nonclinical studies and clinical trials are generally recognized based on the evaluation of the progress of completion of specific tasks using information and data provided by our vendors and collaborators. Research and development activities are central to our business. We expect to increase our investment in research and development in order to advance our product candidates through clinical trials. As a result, we expect that our research and development expenses will increase substantially in the foreseeable future as we continue to invest in research and development activities, pursue clinical development of our product candidates and expand our product candidate pipeline.

The process of commercialization and conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Accordingly, to the extent that our product candidates continue to advance into clinical trials, including larger and later-stage clinical trials, our expenses will increase substantially and may become more variable.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, finance, business development, sales and marketing, and other corporate functions. Other general and administrative expenses include professional fees for legal, auditing, tax and business consulting services, insurance costs, intellectual property and patent costs, facility costs and travel costs. We expect that general and administrative expenses will increase in the future as we expand our operating activities. Additionally, we will incur significant additional expenses associated with being a public company that we did not incur as a privately-held company, including (i) costs to comply with the rules and regulations of the SEC and those of Nasdaq, (ii) legal, accounting and other professional services, (iii) insurance, (iv) investor relations activities and (v) other administrative and professional services.

Impairment of Acquired Contract Intangible Asset

Impairment of acquired contract intangible asset relates to a write down of the acquired contract intangible asset to fair value. The contract intangible asset was assessed for recoverability using an undiscounted cash flow model, which resulted in undiscounted cash flows below the carrying amount. We recognized an impairment of $74.2 million to bring the carrying amount of the contract intangible asset down to its estimated fair value of $3.9 million at August 26, 2021. The fair value determination of the contract intangible asset was based upon a discounted cash flow valuation of the milestone payments and Monte Carlo valuation for the sales royalties.

Other Income (Expense), Net

Other income (expense) consists of the change in fair value of convertible promissory notes and interest expense related to such notes. These expenses are partially offset by interest income earned on cash and cash equivalents and gain on extinguishment of debt.



Income Taxes

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During the years ending December 31, 2021 and 2020, we recognized state tax payments as income tax expense on the statement of operations and comprehensive loss. Since our formation in 2011, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned tax credits, due to our uncertainty of realizing a benefit from those items.

Results of Consolidated Operations



The following table presents the results of operations for the periods indicated
(amounts in thousands):

                                                   Years Ended December 31,
                                                      2021              2020
Revenue
License revenue                                  $        1,000       $ 14,000
Grant revenue                                               120            580
Total revenue                                             1,120       $ 14,580
Operating expenses
Research and development                                 19,670         15,008
General and administrative                               18,511          2,121
Impairment of acquired contract intangible asset         74,156              -
Total operating expenses                                112,337         17,129
Loss from operations                                   (111,217 )       (2,549 )
Other income (expense), net                               1,129           (927 )
Loss before income taxes                               (110,088 )       (3,476 )
Income tax expense                                           (2 )           (2 )
Net and comprehensive loss                       $     (110,090 )     $ (3,478 )

Comparison of Years Ended December 31, 2021 and 2020

License Revenue

License revenue for the years ended December 31, 2021 and 2020 relate to payments received from EOC Pharma as consideration pursuant to the License Agreement. This revenue was recognized when earned. During the year ended December 31, 2021, we recognized $1.0 million of revenue upon achieving the FDA approval milestone on November 22, 2021.

During the year ended December 31, 2020, we recognized $14.0 million of revenue, related to the non-refundable upfront payment for the rights and license granted to EOC for the further development and commercialization of FYARRO in the Licensed Territory.

Grant Revenue

Grant revenue amounts can vary from period to period depending on the funding and work performed. Grant revenue decreased by $0.5 million for the year ended December 31, 2021, compared to the same period in 2020, primarily due to a decrease in the eligible expenses for grant reimbursement incurred during 2021 compared to 2020.

Operating Expenses

Research and Development Expenses

The following table presents our research and development expenses for the periods indicated (amounts in thousands):



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                                                 Years Ended December 31,
                                                  2021               2020

Clinical drug product manufacturing expense $ 6,654 $ 3,803 External clinical development expense

                6,697              5,282
License fee                                            200              2,800
Personnel and other expenses                         6,119              3,123

Total research and development expense $ 19,670 $ 15,008

Research and development expenses for the year ended December 31, 2021, were $19.7 million, an increase of $4.7 million, compared to $15.0 million for the year ended December 31, 2020. The increase was primarily driven by a $2.9 million increase in clinical drug manufacturing costs to prepare for our commercial launch of FYARRO, a $1.4 million increase for external clinical development, and a $3.0 million increase in headcount, consultants, and other expenses offset by a reduction of $2.6 million in license fee expense paid to Celgene.

General and Administrative Expenses

General and administrative expenses for the year ended December 31, 2021, were $18.5 million, an increase of $16.4 million, compared to $2.1 million for the year ended December 31, 2020.

The increase was primarily driven by the following in support of our increased headcount, preparation of our commercial launch and expenses related to being a public company. We expect these expenses to continue to increase as we commercialize FYARRO and future launches:

$2.8 in personnel related expenses due to increased headcount, incentive
        bonuses and share-based compensation. Sales and administrative headcount
        increased to 17 employees at December 31, 2021 from two employees at
        December 31, 2020;


    •   $2.0 million of compensation related expenses to former Aerpio executives
        related to the Merger;


    •   $3.6 million of consulting expenses to support the growth of the
        organization;


  • $5.4 million of commercialization readiness and marketing expenses;


  • and $2.6 million of legal, insurance and other office related expenses.

Impairment of Acquired Contract Intangible Asset

During the year ended December 31, 2021, as a result of the excess fair value ascribed to the acquired contract intangible asset related to the Merger, we recorded a $74.2 million impairment charge to reduce the carrying value of the intangible asset to its fair value at August 26, 2021. No impairments were recognized during the year ended December 31, 2020.

Other Income (Expense), Net

The following table sets forth our other income (expense), net:


                                                        Years Ended December 31,
                                                         2021               2020

Change in fair value of convertible promissory notes $ 1,585 $ (153 ) Gain upon extinguishment of debt

                               196                 -
Interest income                                                 13                41
Interest expense                                              (665 )            (815 )
Total other income (expense)                         $       1,129       $      (927 )



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Other income (expense), net for the year ended December 31, 2021, were $1.1 million of income, compared to $0.9 million of expense for the year ended December 31, 2020. The change was primarily driven by an increase of $1.7 million of non-cash income related to the change in fair value of the convertible promissory notes and a $0.2 million gain recognized on the extinguishment of the Paycheck Protection Program loan forgiven by the Small Business Administration in April 2021.

Liquidity and Capital Resources

We have incurred net losses in each year since inception and as of December 31, 2021, we had an accumulated deficit of $142.7 million. Our net losses were $110.1 million and $3.5 million for the years ended December 31, 2021 and 2020, respectively. These losses have resulted principally from costs incurred in connection with research and development activities, general and administrative costs associated with our operations, and costs associated with the Merger. Additionally, during the year ended December 31, 2021, we recognized a non-cash impairment charge of $74.2 million on the contract intangible asset acquired in the Merger. We expect to continue to incur significant expenses and operating losses for the foreseeable future due to the cost of research and development, including identifying and designing product candidates and conducting preclinical studies and clinical trials, and the regulatory approval process for our product candidates. We expect our expenses, and the potential for losses, to increase substantially as we conduct clinical trials of FYARRO, seek to expand our pipeline, and operate as a public company.

From inception through December 31, 2021, we received funding of $25.4 million from our initial seed financing and the sale of Series A convertible preferred stock, $9.1 million from the issuance of convertible promissory notes, $145.4 million, net from the PIPE Financing in connection with the Merger and $29.7 million of cash assumed in the Merger. As of December 31, 2021, we had $149.0 million of cash and cash equivalents. Based on our current plans, we believe our existing cash and cash equivalents will enable us to conduct our planned operations into 2024.

The following table summarizes our cash flows for the years presented:



                                                         Year Ended December 31,
                                                           2021             2020
Net cash used in operating activities                  $    (22,423 )     $ (12,701 )
Net cash provided by investing activities                    25,153               -
Net cash provided by financing activities                   141,804           1,194

Net increase (decrease) in cash and cash equivalents $ 144,534 $ (11,507 )

Operating Activities

Our net cash used in operating activities primarily results from our net loss adjusted for non-cash expenses, changes in working capital components, amounts due to contract research organizations to conduct our clinical programs and employee-related expenditures for research and development and general and administrative activities. Our cash flows from operating activities will continue to be affected by spending to advance and support our product candidates in the clinic and other operating and general administrative activities, including operating as a public company.

For the year ended December 31, 2021, cash used in operating activities was $22.4 million and resulted from (i) our net loss of $110.1 million offset by non-cash adjustments totaling $75.4 million, which was primarily related to impairment of the acquired contract intangible asset of $74.2 million, and (ii) a $12.3 million net increase in our working capital accounts, primarily driven by the receipt of the $14.0 million upfront payment from EOC under the EOC License Agreement.

For the year ended December 31, 2020, cash used in operating activities was $12.7 million and resulted from (i) our net loss of $3.5 million, and (ii) a $10.5 million net decrease in our working capital accounts, offset by (ii) $1.3 million in non-cash expenses related to interest expense on convertible promissory notes, stock-based compensation expense, lease expense and depreciation and amortization expense.

Investing Activities



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Cash provided by investing activities for the year ended December 31, 2021 related to cash acquired in connection with the Merger partially offset by transaction related expenses and purchases of property and equipment. There were no investing activities for the year ended December 31, 2020.

Financing Activities

Cash provided by financing activities for the year ended December 31, 2021 includes $155.0 million gross cash proceeds from our PIPE Financing and $0.8 million from exercise of stock options, partially offset by $9.6 million of issuance costs related to the PIPE Financing, and $4.4 million of dividends paid to preferred stockholders. Net cash provided by financing activities for the year ended December 31, 2020 includes $1.0 million related to the issuance of convertible promissory notes and $0.2 million related to proceeds from our PPP Loan.

Contractual Obligations and Commitments

In August 2021, we entered into an amendment to extend the lease of our 2,760 square feet of office space in Pacific Palisades, California. We exercised an option, under our prior lease agreement, to extend the term of the lease for an additional three-year period. Included in the renewal were nine months of rent abatement and a rent escalation clause. Rent expense is being recorded on a straight- line basis. Rent expense related to this lease was $0.2 million for each of the years ended December 31, 2021 and December 31, 2020.

On April 9, 2014, we entered into a license agreement (the "Celgene License Agreement") with Celgene for exclusive rights for certain patents and a non-exclusive license for certain technology and know-how pertaining to FYARRO. On November 15, 2019, we entered into an amendment to the Celgene License Agreement ("Amended Celgene License Agreement") to terminate certain of Celgene's FYARRO product supply obligations and to transfer control over certain regulatory filings under the original Celgene License Agreement to us. This amendment also waived the obligations related to certain development milestone payments and waived the liability related to 2016 and 2017 licensed drug manufacturing costs. On August 30, 2021, we entered into Amendment No. 1 (the "Amendment") to the Amended Celgene License Agreement related to certain intellectual property rights of Celgene pertaining to the compound known as FYARRO. Celgene is entitled to receive certain development milestone payments, royalties on net sales from licensed products under the agreement and any sublicense fees.

On December 8, 2020, we entered into a license agreement ("EOC License Agreement") with EOC Pharma (Hong Kong) Limited ("EOC") for the rights and licenses granted to EOC by us for the further development and commercialization of FYARRO in the People's Republic of China, Hong Kong Special Administration Region, Macao Special Administrative Region and Taiwan (the "Licensed Territory"). In accordance with the Celgene License Agreement, we are required to pay 20% of all sublicense fees to Celgene.

On January 13, 2022, we entered into a Negotiated Purchase Order Terms and Conditions for Clinical and Commercial Product (the "Fresenius Agreement") with Fresenius Kabi, LLC ("Fresenius Kabi") pursuant to which Fresenius Kabi will manufacture FYARRO for us, and we will purchase FYARRO as a finished drug product from Fresenius Kabi, on a purchase-order basis. Under the Agreement, which shall be effective through December 22, 2022 (or such later date as may be agreed between the parties in writing and currently being discussed), we may purchase FYARRO for either clinical or commercial purposes for use in the United States and Canada. In addition to manufacturing, Fresenius Kabi will perform specified labeling, packaging and serialization activities in respect of FYARRO for our benefit. The price of FYARRO will be fixed, subject to the ability of Fresenius Kabi to increase pricing under specified circumstances. We have an obligation to purchase certain minimum quantities of FYARRO. Failure to purchase those minimum quantities will result in an additional payment from us to Fresenius Kabi.

We also have contracts with various organizations to conduct research and development activities, including clinical trial organizations to manage clinical trial activities and manufacturing companies to manufacture the drug product used in the clinical trials. The scope of the services under these research and development contracts can be modified and the contracts cancelled by us upon written notice. In the event of a cancellation, we would be liable for the cost and expenses incurred to date as well as any close out costs of the service arrangement.

With respect to our obligations under the CVR Agreement, certain events specified in the CVR Agreement need to occur for us to receive funds, and it is currently uncertain whether any funds will be received under the CVR Agreement. We do not have any commitment or obligation under the CVR Agreement unless and until funds are received.



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Critical Accounting Policies and Estimates

Our management's discussion and analysis of financial position and results of consolidated operations are based on consolidated financial statements prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and related disclosures. On an ongoing basis, we evaluate our estimates and judgments, including those related to prepaid and accrued research and development expenses, revenue recognition and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our consolidated financial statements.

Merger and Acquired Contractual Intangible Asset

Aerpio issued common stock in the Merger based on the terms of the Merger Agreement. For accounting purposes, however, we concluded under GAAP that Private Aadi has acquired Aerpio. We based this conclusion having evaluated the terms of the Merger Agreement and other factors including: (i) the stockholders of Private Aadi owned approximately 66.8% of the voting rights of the Company as of immediately following the Merger (but prior to the PIPE Financing); (ii) three (3) of seven (7) members of the board of directors of the Company post-Merger were composed of directors designated by Private Aadi under the terms of the Merger Agreement, and one (1) member of the board of directors of the Company post-Merger was a director mutually designated by Private Aadi and Aerpio; (iii) existing members of Private Aadi's management became the management of the Company post-Merger; (iv) the PIPE Investors consist of individuals and funds, and for purpose of this analysis, while they owned approximately 55.6% on a fully-diluted basis, as of immediately following the Merger (and after giving effect to the PIPE Financing), no one individual or fund held more shares than the holders of Private Aadi collectively owned immediately following the Merger and they are not considered to be a single voting group; and (v) following the Merger, the Company is headquartered in Pacific Palisades, California, and all ongoing operations of the combined company are those of Private Aadi.

Further, under GAAP we have accounted for the Merger as a reverse asset acquisition rather than a business combination. Accounting as an asset acquisition is significantly different than the accounting for a merger transaction as a business combination. Among other things, we have not recognized any goodwill on our consolidated balance sheet as there may have been had the Merger been accounted for as a business combination. A central element to the accounting model conclusion is the determination of whether a business or an asset or a group of assets is acquired. A business is defined in ASC 805, Business Combinations, as an integrated set of inputs and processes that are capable of generating outputs that have the ability to provide a return to its investors or owners. Typical inputs include long-lived assets (including intangible assets or rights to use long-lived assets), intellectual property and the ability to obtain access to required resources. Typical processes include strategic, operational and resource management processes that are typically documented or evident through an organized workforce. We considered all of the above factors when determining whether a business was acquired in the Merger and concluded that Aerpio did not meet the definition of a business.

Upon closing of the Merger, substantially all of the fair value is concentrated in cash, working capital and a long-lived contract intangible asset related to Aerpio's license agreement with Gossamer Bio. Inc., under which 90% of any future net cash proceeds will be remitted to CVR Holders and paid through the CVRs. In accordance with GAAP for asset acquisitions, the excess purchase price over the fair value of the acquired assets and liabilities ($78.1 million) was ascribed to the acquired contract intangible asset. However, due to the significant excess purchase price being allocated over the fair value of the acquired contractual intangible asset, we determined that an indicator of impairment was present, and we assessed the contract intangible asset as compared to expectations of contingent future cash flows. We concluded that our estimate of gross cash flows potentially accruing to us under the license agreement is likely to be less than the excess purchase price of the fair value of the acquired assets and liabilities ascribed to the acquired contract intangible asset. As a result, we performed a valuation of the acquired contract intangible asset and recognized an impairment of $74.2 million to adjust the carrying amount of the contractual intangible asset to its estimated fair value of $3.9 million.



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The license agreement with Gossamer Bio. Inc. includes potential payments to us in the event of certain development and commercialization milestones and sales-based royalties. Our fair value determination of the intangible asset utilized a scenario-based, risk-adjusted, discounted cash flow model with respect to the potential development milestone payments and a Monte Carlo option-pricing model with respect to the sales-based milestone and royalty payments:


    •   We determined fair value of the potential development milestone payments
        under the license agreement with inputs based on certain subjective
        assumptions, including (a) the probability of clinical success determined
        with reference to various academic studies reporting probabilities of
        approval for clinical trials; (b) an estimate of the time to achievement
        of the clinical milestones; and (c) a counterparty credit risk premium
        determined with reference to the borrowing costs of a benchmark group of
        comparable market participants.


    •   Application of the Monte Carlo simulation model in valuing the potential
        sales-based milestone and royalties involves making assumptions for (a)
        the probability of clinical success determined with reference to various
        academic studies reporting probabilities of approval for clinical trials;
        (b) our forecast of potential revenues, revenue uptake rate and the period
        of time from a prospective commercial launch to peak sales, and an
        estimate of peak sales for each successfully commercialized product
        covered under the license agreement; (c) drift equal to the risk free rate
        on revenues following a multivariate Geometric Brownian Motion; (d) a
        counterparty credit risk premium determined with reference to the
        borrowing costs of a benchmark group of comparable market participants;
        and (e) a revenue metric risk premium determined with reference to a
        long-term risk-free rate, a weighted-average cost of capital, revenue
        volatility and asset volatility.

Research and Development Costs

We incur substantial expenses associated with clinical trials. Accounting for clinical trials relating to activities performed by CROs and other external vendors requires us to exercise significant estimates in regard to the timing and accounting for these expenses. We estimate costs of research and development activities conducted by service providers, which include, the conduct of preclinical studies, contract manufacturing activities and clinical activities. The diverse nature of services being provided under CRO and other vendor arrangements, the different terms and milestone arrangements that exist for each type of service and the lack of timely information related to certain clinical activities complicates the estimation of accruals for services rendered by CROs and other vendors in connection with clinical trials. We record the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and include these costs in the accrued and other current liabilities or prepaid expenses, as applicable, on the balance sheets and within research and development expense on the consolidated statements of operations. In estimating the duration of a clinical study, we evaluate the start-up, treatment and wrap-up periods, payment arrangements and services rendered attributable to each clinical trial and fluctuations are regularly tested against payment plans and trial completion assumptions.

We estimate these costs based on factors such as estimates of the work completed and budget provided and in accordance with agreements established with our collaboration partners and third-party service providers. We make significant judgments and estimates in determining the accrued liabilities and prepaid expense balances in each reporting period. As actual costs become known, we adjust our estimates and related accounts on the balance sheet. We have not experienced any material differences between accrued costs and actual costs incurred since our inception.

Our expenses related to clinical trials are based on estimates of patient enrollment and related expenses at clinical investigator sites as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that may be used to conduct and manage clinical trials on our behalf. We generally accrue expenses related to clinical trials based on contracted amounts applied to the level of patient enrollment and activity. If timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we modify our estimates of accrued expenses accordingly on a prospective basis.

Revenue Recognition

We account for revenue related to the EOC License Agreement and Grant Revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers ("ASC 606"). Under ASC 606, we recognize revenue when the defined customer, under ASC 606, transfers promised goods or services in an amount that reflects the consideration



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to which we expect to be entitled in exchange for goods or services. To determine revenue recognition for contracts with customers, we perform the following five steps: (i) identify the promised goods or services in the contract; (ii) identify the performance obligation in the contract, including whether they are distinct in the context of the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligation. We recognize revenue when our customer obtains control of promised goods or services in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. We only apply the five-step model to contracts when it is probable that we will collect consideration to which we are entitled in exchange for the goods or services we transfer to the customer.

Stock­Based Compensation

We recognize all stock-based payments to employees, including grants of employee stock options in the consolidated statements of operations and comprehensive loss based on their fair values. All of our share-based awards, to employees, non-employees, officers, and directors, are subject only to service-based vesting conditions. We estimate the fair value of its stock-based awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (i) the expected stock price volatility, (ii) the calculation of expected term of the award, (iii) the risk-free interest rate based on the U.S. Treasury yield in effect at the time of the grant for zero-coupon U.S. treasury notes with maturities approximately equal to the expected term of the stock options and (iv) expected dividends. Options granted during the year have a maximum contractual term of ten years. Forfeitures are recognized and accounted for as they occur.

Due to the historical lack of a public market for the trading of our common stock and a lack of company-specific historical and implied volatility data, we have based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to ours, including stage of product development and life science industry focus. We believe the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of us.

We have limited historical stock option activity and therefore estimate the expected term of stock options granted to employees, officers, and directors using the simplified method, which represent the average of the contractual term of the stock option and its weighted-average vesting period, to calculate the expected term, as we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted to employees, and utilize the contractual term for options granted to non-employees. The expected term is applied to the stock option grant group as a whole, as we do not expect substantially different exercise or post-vesting termination behavior among our employee population.

Compensation expense related to awards to employees is calculated on a straight-line basis by recognizing the grant date fair value over the associated service period of the award, which is generally the vesting term. For the years ended December 31, 2021 and December 31, 2020, we recognized stock­based compensation expense, net of estimated forfeitures, in the statements of operations and comprehensive loss as follows (amounts in thousands):


                              Year Ended December 31,
                               2021              2020

Research and development $ 657 $ 94 General and administrative 1,449

              45
Total                      $       2,106       $     139

As of December 31, 2021, total unamortized stock­based compensation was $22.1 million which we expect to recognize over a weighted average period of 2.9 years. The intrinsic value of all outstanding stock options as of December 31, 2021 was $10.0 million.

Income Taxes

We have accounted for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax



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assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

When uncertain tax positions exist, we recognize the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. We recognize interest and penalties related to uncertain tax positions, if any exist, in income tax expense.

During the years ending December 31, 2021 and 2020, we recognized state tax payments as income tax expense on the statement of operations and comprehensive loss. Since our formation in 2011, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned tax credits, due to our uncertainty of realizing a benefit from those items. Due to our lack of earnings history and uncertainties surrounding our ability to generate future taxable income, the net deferred tax assets have been fully offset by a valuation allowance. The deferred tax assets were primarily comprised of federal and state tax net operating losses ("NOL"). Pursuant to Section 382 and 383 of the Internal Revenue Code ("IRC"), utilization of our NOL carryforwards and research and development credits may be subject to annual limitations in the event of any significant future changes in our ownership structure. These annual limitations may result in the expiration of NOL carryforwards and research and development credits prior to utilization. As of December 31, 2021, we have completed an IRC Section 382 analysis through the date of the Merger. Ownership changes were identified that will result in annual limitations on future utilization of NOLs and research and development credit carryforwards. To the extent such limitations will cause NOL and R&D credit carryforwards to expire unused, these tax attributes have been removed from deferred tax assets. As of December 31, 2021, we have federal and state net operating loss carryforwards of approximately $150.9 million and $55.8 million, respectively. We also have federal and state research credit carryforwards of approximately $3.1 million and $1.7 million, respectively, as of December 31, 2021. Ownership changes may occur in the future which can result in future limitations of the available NOL and R&D credit carryforwards.

JOBS Act Accounting Election

We are an "emerging growth company" within the meaning of the JOBS Act. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies that are not emerging growth companies.

Recent Accounting Pronouncements

See Note 3 to the consolidated financial statements for a discussion of recent accounting pronouncements.

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