What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2024-05-08 compared with 2023-11-08 · 159 added, 205 removed, 538 unchanged (40% of the section changed)

3 unchanged sentences

(In thousands, except share data and par value)

September 30,

2024 December 31,

18 unchanged sentences

Operating lease liabilities, net of current portion 738 833

Due to licensor (Note 8) — 5,757

Total liabilities 20,613 27,228

2 unchanged sentences

Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized;

issued and outstanding as of September 30, 2023 and December 31, 2022

issued and outstanding as of March 31, 2024 and December 31, 2023

Common stock, $ 0.0001 par value;

300,000,000 shares authorized;

and 24,435,007 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

shares issued and outstanding as of March 31, 2024 and December 31, 2023

Additional paid-in capital 377,718 374,129

Accumulated other comprehensive loss ( 16 ) ( 115 )

Accumulated other comprehensive (loss) income ( 8 ) 27

Accumulated deficit ( 287,252 ) ( 268,963 )

5 unchanged sentences

(In thousands, except share data and earnings per share amounts)

Three Months Ended September 30, Nine Months Ended September 30,

2023 2022 2023 2022

Three Months Ended March 31,

Product sales, net $ 5,353 $ 5,867

4 unchanged sentences

Cost of goods sold 652 529

Impairment of acquired contract intangible asset — — — 3,724

Total operating expenses 24,865 22,692

5 unchanged sentences

Total other income (expense), net 1,223 1,602

Loss before income tax expense ( 16,302 ) ( 14,474 ) ( 49,496 ) ( 46,591 )

Income tax expense — — — ( 9 )

Net loss $ ( 18,289 ) $ ( 15,223 )

Other comprehensive income (loss):

Change in unrealized loss on short-term investments 28 ( 99 ) 99 ( 99 )

Comprehensive income (loss) $ ( 16,274 ) $ ( 14,573 ) $ ( 49,397 ) $ ( 46,699 )

Other comprehensive (loss) income:

Unrealized (loss) income on available-for-sale debt securities ( 35 ) 83

Comprehensive loss ( 18,324 ) ( 15,140 )

Net loss per share, basic and diluted $ ( 0.68 ) $ ( 0.57 )

4 unchanged sentences

(In thousands, including share amounts)

For the Three and Nine Months Ended September 30, 2023

For the Three Months Ended March 31, 2024

Stockholders' Equity

5 unchanged sentences

Share-based compensation expense — — 3,589 — — 3,589

Issuance of common stock upon exercise of stock options 2 — 8 — — 8

Unrealized gain on investments, net of tax — — — 83 — 83

Net loss — — — — ( 15,223 ) ( 15,223 )

Balance at March 31, 2023 24,437 $ 2 $ 364,437 $ ( 32 ) $ ( 218,421 ) $ 145,986

Share-based compensation expense — — 3,054 — — 3,054

Issuance of common stock upon exercise of stock options 34 — 68 — — 68

Issuance of shares under the employee stock purchase plan 49 — 294 — — 294

Unrealized loss on investments, net of tax — — — ( 35 ) — ( 35 )

Net loss — — — — ( 18,289 ) ( 18,289 )

Balance at June 30, 2023 24,520 $ 2 $ 367,853 $ ( 44 ) $ ( 236,392 ) $ 131,419

Share-based compensation expense — — 3,049 — — 3,049

Issuance of common stock upon exercise of stock options 6 — 2 — — 2

Unrealized gain on investments, net of tax — — — 28 — 28

Net loss — — — — ( 16,302 ) ( 16,302 )

Balance at September 30, 2023 24,526 $ 2 $ 370,904 $ ( 16 ) $ ( 252,694 ) $ 118,196

For the Three and Nine Months Ended September 30, 2022

Balance at March 31, 2024 24,554 $ 2 $ 377,718 $ ( 8 ) $ ( 287,252 ) $ 90,460

For the Three Months Ended March 31, 2023

Stockholders' Equity

5 unchanged sentences

Share-based compensation expense — — 2,740 — — 2,740

Issuance of common stock upon exercise of warrants 7 — 54 — — 54

Issuance of common stock upon exercise of stock options 2 — 8 — — 8

Unrealized gain on investments, net of tax — — — 83 — 83

Net loss — — — — ( 15,223 ) ( 15,223 )

Balance at March 31, 2023 24,437 $ 2 $ 364,437 ( 32 ) $ ( 218,421 ) $ 145,986

Share-based compensation expense — — 2,235 — — 2,235

Issuance of common stock upon exercise of stock options 75 — 136 — — 136

Net loss — — — — ( 18,269 ) ( 18,269 )

Balance at June 30, 2022 21,017 $ 2 $ 283,539 $ — $ ( 174,811 ) $ 108,730

Share-based compensation expense — — 2,757 — — 2,757

Issuance of common stock upon exercise of stock options 5 — 16 — — 16

Private placement, net of transaction costs 3,373 — 72,178 — — 72,178

Other comprehensive loss — — — ( 99 ) — ( 99 )

Net loss — — — — ( 14,474 ) ( 14,474 )

Balance at September 30, 2022 24,395 $ 2 $ 358,490 $ ( 99 ) $ ( 189,285 ) $ 169,108

The accompanying notes are an integral part of these condensed consolidated financial statements.

2 unchanged sentences

(In thousands)

Nine Months Ended September 30,

Three Months Ended March 31,

Cash flows from operating activities:

1 unchanged sentence

Adjustments to reconcile net loss to net cash used in operating activities:

Impairment of acquired contract intangible asset — 3,724

Share-based compensation expense 3,589 2,740

Amortization of premiums and discounts on short-term investments, net ( 2,650 ) ( 149 )

Discount amortization on short-term investments ( 422 ) ( 1,200 )

Non-cash interest expense 58 58

13 unchanged sentences

Maturity of short-term investments 18,940 40,750

Net cash provided by (used in) investing activities 79,557 ( 48,507 )

Net cash provided by investing activities 10,555 16,329

Cash flows from financing activities:

Proceeds from sale of common stock and prefunded warrants — 72,500

Issuance of common stock upon exercise of stock options — 8

Proceeds from issuance of common stock under employee stock purchase plan 294 —

Issuance of common stock upon exercise of warrants — 54

Deferred offering costs paid for financing ( 10 ) —

Net cash provided by financing activities 246 72,727

Net increase (decrease) in cash, cash equivalents and restricted cash 29,784 ( 14,110 )

Cash, cash equivalents and restricted cash, beginning of year 39,083 148,989

Net cash (used in) provided by financing activities ( 10 ) 8

Net decrease in cash, cash equivalents and restricted cash ( 9,108 ) ( 4,973 )

Cash, cash equivalents and restricted cash at beginning of period 62,952 39,083

Cash, cash equivalents and restricted cash, end of period $ 53,844 $ 34,110

1 unchanged sentence

Interest paid during the period $ 58 $ 58

Taxes paid during the period $ — $ 9

Supplemental disclosure of non-cash activities:

Costs incurred in connection with Private Placement included in accounts payable $ — $ 322

Deferred transaction costs included in accounts payable and accrued liabilities $ 9 $ 75

Accrued property and equipment $ 540 $ 387

Operating lease liability arising from obtaining right-of-use asset $ — $ 1,210

The accompanying notes are an integral part of these condensed consolidated financial statements.

2 unchanged sentences

Aadi Bioscience, Inc.

(together with its subsidiaries, the “Company” or “Aadi”) is a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes.

Aadi’s lead drug product, FYARRO ® , 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.

(together with its subsidiaries, the “Company” or “Aadi”) is 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.

Aadi’s lead drug product, FYARRO ® , 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 Aadi's lead indication, advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (“PEComa”), a rare cancer.

In November 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 adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor ( “ PEComa ” ).

On February 22, 2022, Aadi launched FYARRO in the United States for treatment of advanced malignant PEComa.

FYARRO is licensed to Aadi by Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of Bristol-Myers Squibb Company ("BMS").

The Company’s historical operations have consisted principally of performing research and development activities and raising capital.

The Company’s historical operations have consisted principally of sales of FYARRO after receiving FDA approval, performing research and development activities and raising capital.

The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.

1 unchanged sentence

The Company has experienced net losses since its inception and expects to continue to incur net losses into the foreseeable future.

The Company had an accumulated deficit of $ 252.7 million as of September 30, 2023.

For the three months ended September 30, 2023 and 2022, the Company had a net loss of $ 16.3 million and $ 14.5 million, respectively.

For the nine months ended September 30, 2023 and 2022, the Company had a net loss of $ 49.5 million and $ 46.6 million, respectively.

The Company had an accumulated deficit of $ 287.3 million as of March 31, 2024 and a net loss of $ 18.3 million and $ 15.2 million for the three months ended March 31, 2024 and 2023, respectively.

To date, these operating losses have been funded primarily from outside sources of invested capital through the issuance of convertible promissory notes, grant funding, the sale of securities, and proceeds from license agreements.

The Company had cash, cash equivalents and short-term investments of $ 119.3 million at September 30, 2023.

The Company had cash, cash equivalents and short-term investments of $ 88.3 million at March 31, 2024.

Management believes the Company’s current cash, cash equivalents and short-term investments will provide sufficient funds to enable the Company to meet its obligations for at least twelve months from the filing date of this report.

4 unchanged sentences

Any sales under the Sales Agreement may result in dilution to existing shareholders.

As of September 30, 2023 , no shares of common stock had been sold under this Sales Agreement.

As of March 31, 2024 , no shares of common stock had been sold under this Sales Agreement.

Summary of Significant Accounting Policies

22 unchanged sentences

Concentration of Credit Risk

Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash and cash equivalents and investments in money market funds, United States government treasury bills, commercial paper, corporate bonds, and government agency debt securities.

Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash and cash equivalents, and available-for-sale marketable debt securities.

The Company maintains deposits in federally insured financial institutions in excess of federally insured limits.

8 unchanged sentences

Customer Concentration

For the three months ended September 30, 2023 and 2022, two customers represented 56 % and 44 %, and 55 % and 45 % of the Company's revenue, respectively.

For the nine months ended September 30, 2023 and 2022, two customers represented 54 % and 46 %, and 50 % and 48 % of the Company’s revenue, respectively.

Additionally, two customers accounted for 61 % and 39 % of net accounts receivable as of September 30, 2023.

For the three months ended March 31, 2024, two customers represented 48 % and 52 % of the Company’s revenue.

For the three months ended March 31, 2023, two customers represented 51 % and 48 % of the Company’s revenue.

Additionally, two customers accounted for 51 % and 49 % of net accounts receivable as of March 31, 2024.

Cash, Cash Equivalents and Restricted Cash

The Company considers all highly liquid marketable securities purchased with original maturities of three months or less at the time of purchase date to be cash equivalents.

As of September 30, 2023 and December 31, 2022, cash and cash equivalents including money market investments totaled $ 66.3 million and $ 32.0 million, respectively.

Restricted cash consists of a letter of credit secured by restricted cash in connection with one of the Company's office leases described in Note 6, and is included in other assets on the condensed consolidated balance sheets.

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets (in thousands):

September 30, 2023 December 31, 2022

March 31, 2024 December 31, 2023

Cash and cash equivalents $ 53,780 $ 62,888

32 unchanged sentences

terms of the customer contracts.

As of September 30, 2023 and December 31, 2022, recorded customer allowances for chargebacks were $ 1.5 million and $ 0.1 million, respectively.

There were no allowances for credit losses and no receivables were written off for the periods ended September 30, 2023 and December 31, 2022, respectively.

Accounts receivable are net of $ 0.1 million and $ 0.2 million, of customer allowances for chargebacks as of March 31, 2024 and December 31, 2023, respectively.

There were no allowances for credit losses and no receivables were written off for the periods ended March 31, 2024 and December 31, 2023.

Inventory is stated at the lower of cost or estimated net realizable value.

3 unchanged sentences

Details of inventory are presented as follows (in thousands):

September 30, 2023 December 31, 2022

March 31, 2024 December 31, 2023

Raw materials $ 3,606 $ 4,640

7 unchanged sentences

Details of property and equipment are presented as follows (in thousands):

September 30, 2023 December 31, 2022

March 31, 2024 December 31, 2023

Computers and Software $ 471 $ 464

6 unchanged sentences

Property and equipment, net $ 5,686 $ 4,802

Construction in process mainly consists of lab, production, and testing equipment.

Depreciation expense on property, plant, and equipment amounted to $ 50,000 and $ 38,000 for the three months ended March 31, 2024 and 2023, respectively.

At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time.

6 unchanged sentences

Operating lease assets represent a right to use an underlying asset for the lease term and operating lease liabilities represent an obligation to make lease payments arising from the lease.

Operating lease liabilities with a term greater than one year and their corresponding right-of-use assets are recognized at the commencement date of the lease based on the present value of lease payments over the expected lease term.

Operating lease liabilities with a term greater than one year and their

corresponding right-of-use assets are recognized at the commencement date of the lease based on the present value of lease payments over the expected lease term.

Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received.

8 unchanged sentences

When no amount within the range is a better estimate than any other amount the Company accrues the minimum amount in the range.

The Company has no t recorded any such liabilities as of September 30, 2023 and December 31, 2022 .

The Company has no t recorded any such liabilities as of March 31, 2024 and December 31, 2023 .

Revenue Recognition and Related Allowances

25 unchanged sentences

The SDs and SP charge back to the Company the difference between the price initially paid by the SDs and SP and the discounted price paid to the SDs and SP by these entities.

If actual future chargebacks vary from these estimates, the Company may need to adjust prior period accruals, which would affect product sales in the period of adjustment.

If actual future

chargebacks vary from these estimates, the Company may need to adjust prior period accruals, which would affect product sales in the period of adjustment.

Co-Payment Assistance:

8 unchanged sentences

In arriving at its estimate, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry.

The total amount deducted from gross product sales for the allowances described above for the three months ended September 30, 2023, and 2022, was $ 1.3 million and $ 0.8 million, respectively, and for the nine months ended September 30, 2023 and 2022 was $ 3.4 million and $ 1.8 million, respectively.

The total amount deducted from gross product sales for the allowances described above for the three months ended March 31, 2024, and 2023, was $ 1.1 million and $ 1.0 million, respectively.

The following table sets forth the changes in the accrued revenue allowances (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,

2023 2022 2023 2022

As of March 31,

Balance at beginning of period $ 1,065 $ 1,434

10 unchanged sentences

Share-Based Compensation

The Company recognizes all share-based payments to employees, including grants of employee stock options in the condensed consolidated statements of operations and comprehensive loss based on their fair values.

The Company recognizes all share-based payments to employees, including grants of employee stock options and restricted stock units in the consolidated statements of operations and comprehensive loss based on their fair values.

All of the Company’s share-based awards, to employees, non-employees, officers, and directors, are subject only to service-based vesting conditions.

The Company estimates the fair value of its share-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 and (iv) expected dividends.

Compensation expense for awards to employees is calculated on a straight-line basis by recognizing the fair value over the associated service period of the award, which is generally the vesting term.

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 the Company’s securities and a lack of company-specific historical and implied volatility data, the Company has based its 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 the Company, including stage of product development and life science industry focus.

The Company believes the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of the Company.

The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted to employees, officers, and directors using the simplified method, which represents the average of the contractual

term of the stock option and its weighted-average vesting period, to calculate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term for options granted to employees, and utilizes the contractual term for options granted to non-employees.

The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population.

The risk-free interest rate is 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.

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.

Employee Stock Purchase Plan

10 unchanged sentences

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period.

Basic and diluted weighted average shares of common stock outstanding for the three and nine months ended September 30, 2023, includes the weighted average effect of 2,426,493 Pre-Funded Warrants (as defined below), which were issued in September 2022, for the purchase of shares of common stock, for which the remaining unfunded exercise price is $ 0.0001 per share.

Basic and diluted weighted average shares of common stock outstanding for the three months ended March 31, 2024, includes the weighted average effect of 2,426,493 Pre-Funded Warrants, which were issued in September 2022, for the purchase of shares of common stock, for which the remaining unfunded exercise price is $ 0.0001 per share.

See Note 8 for more information on the Pre-Funded Warrants.

Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares and common share equivalents outstanding for the period.

Common stock equivalents are only included when their effect is dilutive.

The Company’s potentially dilutive securities, which include outstanding stock options and warrants have been excluded from the computation of diluted net loss per share as they would be anti-dilutive.

The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive (in thousands):

Three and Nine Months Ended September 30,

The Company’s potentially dilutive securities, which include outstanding stock options, restricted stock units, and warrants have been excluded from the computation of diluted net loss per share as they would be anti-dilutive.

The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive:

Three Months Ended March 31,

Options to purchase common stock 5,372,887 3,846,365

Restricted Stock Units to purchase common stock 341,258 —

Warrants to purchase common stock 29,167 29,167

5 unchanged sentences

This ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years for smaller reporting companies.

The Company is currently evaluating the impact the adoption of ASU 2020-06 will have on the Company’s consolidated financial statements.

In 2016, the FASB issued ASU 2016-13 “ Financial Instruments - Credit Losses” which (i) significantly changes the impairment model for most financial assets that are measured at amortized cost and certain other instruments from an incurred loss model to an expected loss model which will be based on an estimate of current expected credit loss;

and (ii) provides for recording credit losses on available-for-sale debt securities through an allowance account.

The standard also requires certain incremental disclosures.

Subsequently, the FASB issued several ASUs to clarify, improve, or defer the adoption of ASU 2016-13.

The Company adopted ASU 2016-13 beginning in January 2023.

The Company determined that the adoption of this standard did not result in a material impact to the condensed consolidated financial statements.

ASU 2020-06 is not applicable to the Company’s consolidated financial position and results of operations.

In December 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures.

The new standard requires a company to disclose incremental segment information on an annual and interim basis, including significant segment expenses and measures of profit or loss that are regularly provided to the chief operating decision maker.

The standard is effective for the Company beginning in fiscal year 2024 and interim periods within fiscal year 2025, with early adoption permitted.

The standard is not expected to have a material impact to the Company's condensed consolidated financial statements.

In December 2023, the FASB also issued ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures.

The new standard requires a company to expand its existing income tax disclosures, specifically related to the rate reconciliation and income taxes paid.

The standard is effective for the Company beginning in fiscal year 2025, with early adoption permitted.

The Company does not expect to early adopt the new standard.

The new standard is expected to be applied prospectively, but retrospective application is permitted.

The Company is currently evaluating the impact of ASU 2023-09 on the consolidated financial statements and related disclosures.

Fair Value Measurement

The following table sets forth the recurring fair value of the Company’s financial assets and liabilities, allocated into the Level 1, Level 2 and Level 3 hierarchy that were measured at fair value on a recurring basis (in thousands):

Fair Value Measurements as of September 30, 2023

Fair Value Measurements as of March 31, 2024

Level 1 Level 2 Level 3 Total

3 unchanged sentences

Corporate bonds — 11,495 — 11,495

Government agency — 10,877 — 10,877

Total financial assets $ 67,451 $ 18,964 $ — $ 86,415

8 unchanged sentences

(1) Included in cash and cash equivalents in the accompanying condensed consolidated balance sheets.

As of September 30, 2023, net unrealized loss on investments was $ 16,000 .

All marketable securities had a contractual maturity of less than one year as of September 30, 2023.

(2) Includes $ 1.1 million of corporate bonds in cash and cash equivalent in the accompanying consolidated balance sheet.

As of March 31, 2024, net unrealized loss on investments was $ 8,000 .

All marketable securities had a contractual maturity of less than one year as of March 31, 2024.

Short-Term Investments and Cash Equivalents

The following table summarizes the Company's short-term investments (in thousands):

As of September 30, 2023

As of March 31, 2024

Maturity (In Years) Amortized Cost Unrealized Gains Unrealized Losses Fair Value

3 unchanged sentences

Corporate bonds Less than 1 11,495 3 ( 3 ) 11,495

Government agency Less than 1 10,885 — ( 8 ) 10,877

Total $ 86,423 $ 6 $ ( 14 ) $ 86,415

7 unchanged sentences

Total $ 108,111 $ 33 $ ( 6 ) $ 108,138

Intangible Asset

On August 26, 2021, the Company closed its reverse merger pursuant to which the Company’s wholly-owned subsidiary merged with and into Aadi Subsidiary, Inc.

(formerly Aadi Bioscience, Inc.) (“Private Aadi”), with Private Aadi surviving as a wholly owned subsidiary of the Company (the “Merger”).

The Company recorded a long-lived contract intangible asset as a result of the Merger, related to the license agreement, dated June 24, 2018, with Gossamer Bio, Inc.

(“Gossamer”), as amended (the “Gossamer License Agreement”), which was assumed in the Merger.

In accordance with GAAP, for asset acquisitions, the excess purchase price over the fair value of the acquired assets and liabilities was ascribed to the acquired contract intangible asset.

Due to the significant excess purchase price being allocated over the fair value of the acquired contract intangible asset, the Company determined that an indicator of impairment was present.

The contract intangible asset was assessed for recoverability using an undiscounted cash flow model, which resulted in undiscounted cash flows below the carrying amount.

At the effective time of the Merger, the Company 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.

The fair value estimate of the intangible asset related to contingent cash flows expected from the out-licensing arrangement, of which 90 % of any future net cash proceeds will be remitted to each holder of common stock of the Company’s predecessor, Aerpio, as of immediately prior to the closing of the Merger and paid through the contingent value rights (“CVRs”) pursuant to a Contingent Value Rights Agreement, dated as of August 26, 2021 (the “CVR Agreement”).

The useful life of the intangible asset was estimated to be approximately 14.3 years.

On April 25, 2022, the Company received a formal notice of termination from Gossamer for the Gossamer License Agreement, relating to Gossamer’s GB004 product candidate, a legacy product candidate of Aerpio, after Gossamer announced that its Phase 2 SHIFT-UC clinical trial studying GB004 in patients with mild-to-moderate active ulcerative colitis did not meet the primary or secondary endpoints at week 12 and the study was being terminated for lack of treatment benefit.

The Gossamer License Agreement terminated effective July 24, 2022.

Based on the termination of the Gossamer License Agreement, the Company fully impaired the intangible asset, $ 3.7 million, of which the Gossamer License Agreement is the underlying asset, during the year ended December 31, 2022.

There was no amortization expense for the three and nine months ended September 30, 2023.

Amortization expense was $ 0 and $ 87,000 for the three and nine months ended September 30, 2022.

The following table shows the amortization expense and impairment of the finite lived intangible asset for the nine months ended September 30, 2022 (in thousands):

September 30,

Intangible asset, December 31, 2021 $ 3,811

Less amortization ( 87 )

Impairment of contract intangible ( 3,724 )

Intangible asset, net $ —

Accrued Liabilities

Details of accrued liabilities are presented as follows (in thousands):

September 30,

2024 December 31,

4 unchanged sentences

Accrued contract manufacturing 3,279 4,315

Advanced customer payments — 1,571

Accrued other - sales related 738 772

11 unchanged sentences

The following table summarizes information related to the Company’s leases (in thousands):

September 30, 2023 December 31, 2022

March 31, 2024 December 31, 2023

Operating lease right-of-use assets $ 1,077 $ 1,169

2 unchanged sentences

Total operating lease liabilities $ 1,163 $ 1,267

Rent expense for the three and nine months ended September 30, 2023 and 2022 is presented on the following table (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,

2023 2022 2023 2022

Operating leases rent expense $ 115 $ 112 $ 346 $ 270

Cash paid for leases and included in operating cash flows for the nine months ended September 30, 2023 and 2022 is presented on the following table (in thousands):

Nine Months Ended September 30,

Rent expense for the three months ended March 31, 2024 and 2023 is presented on the following table (in thousands):

Three Months Ended March 31,

Operating lease rent expense $ 115 $ 116

Cash paid for leases and included in operating cash flows for the three months ended March 31, 2024 and 2023 is presented on the following table (in thousands):

Three Months Ended March 31,

Cash paid included in operating cash flows $ 126 $ 124

The future minimum lease payments required under the operating leases as of September 30, 2023, are summarized below (in thousands):

The future minimum lease payments required under the operating leases as of March 31, 2024, are summarized below (in thousands):

Future Minimum Lease Payments:

Thereafter 109

Total minimum lease payments $ 1,326

5 unchanged sentences

Incremental borrowing rate 7.55 %

The Company includes the option to renew the lease as part of the right of use lease asset and liability when it is reasonably certain the Company will exercise the option.

In general, the Company is not reasonably certain to exercise such options.

L icense Agreements

3 unchanged sentences

Under the terms of the BMS License Agreement, BMS agreed to supply the Company with licensed products of FYARRO necessary for clinical or non-clinical development.

Under the terms of the BMS License Agreement, BMS is entitled to receive certain development milestone payments, royalties on net sales from licensed products under the agreement and any sublicense fees.

During the three months ended September 30, 2023 and 2022, royalties on net product sales were $ 0.4 million and $ 0.3 million, respectively.

During the nine months ended September 30, 2023 and 2022, royalties on net product sales were $ 1.3 million and $ 0.7 million, respectively.

No payments related to development milestones were paid during the three and nine months ended September 30, 2023 or 2022.

Under the terms of the BMS License Agreement, BMS is entitled to receive royalties on net sales from licensed products under the agreement and any sublicense fees.

During the three months ended March 31, 2024 and 2023, royalties on net product sales were $ 0.4 million.

No payments related to sublicense fees were paid during the three months ended March 31, 2024 or 2023.

On August 30, 2021, the Company and BMS entered into Amendment No.

1 (the “Amendment”) to the BMS License Agreement related to certain intellectual property rights of BMS pertaining to the compound known as FYARRO.

Under the terms of the Amendment, the Company paid BMS $ 5.8 million representing 50 % of the previously outstanding payment obligation under the terms of the BMS License Agreement, following the effective time of the 2021 private

investment in public equity financing (the “2021 PIPE Financing”).

Pursuant to the terms of the Amendment, the remaining previously outstanding payment obligation of $ 5.8 million, is due on the third anniversary of the effective time of the 2021 PIPE Financing, or August 26, 2024 plus any accrued and unpaid interest due thereon (the “Balloon Payment”).

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Either party had the right to terminate the EOC License Agreement in the event that the other party breaches the agreement and fails to cure the breach, becomes insolvent or challenges certain of the intellectual property rights licensed under the agreement.

Stockholders’ Equity (Deficit)

Stockholders’ Equity

Preferred Stock

As of September 30, 2023 and December 31, 2022 , under the Company’s certificate of incorporation, as amended and restated, the Company has 10,000,000 shares of preferred stock, par value $ 0.0001 per share, in authorized capital with no shares outstanding.

As of March 31, 2024 and December 31, 2023 , under the Company’s certificate of incorporation, as amended and restated, the Company has 10,000,000 shares of preferred stock, par value $ 0.0001 per share, in authorized capital with no shares outstanding.

Common Stock and Pre-Funded Warrants

As of September 30, 2023 and December 31, 2022, the Company had 300,000,000 shares of authorized common stock, par value of $ 0.0001 per share, under the Company's certificate of incorporation, as amended and restated.

As of September 30, 2023 and December 31, 2022, the shares of common stock outstanding were 24,525,860 and 24,435,007 , respectively.

As of March 31, 2024 and December 31, 2023, the Company had 300,000,000 shares of authorized common stock, par value of $ 0.0001 per share, under the Company's certificate of incorporation, as amended and restated.

As of March 31, 2024 and December 31, 2023, the shares of common stock outstanding were 24,554,205 .

In March 2022, the Company entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company LLC (“Cowen”) , with respect to an “at the market offering” program pursuant to which the Company may offer and sell, from time to time at its sole discretion, shares of common stock having aggregate gross proceeds of up to $ 75.0 million through Cowen as its sales agent .

The Company will pay Cowen 3.0 % of the aggregate gross proceeds from each sale of shares of

common stock under the Sales Agreement.

As of September 30, 2023 , no shares of common stock had been sold pursuant to the Sales Agreement.

The Company will pay Cowen 3.0 % of the aggregate gross proceeds from each sale of shares of common stock under the Sales Agreement.

As of March 31, 2024 , no shares of common stock had been sold pursuant to the Sales Agreement.

On September 22, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) for a private investment in public equity financing (the “2022 PIPE Financing”) with certain investors (the “2022 PIPE Investors”) for the sale by the Company of (i) 3,373,526 shares of the Company’s common stock for a price of $ 12.50 per share and (ii) pre-funded warrants to purchase an aggregate of 2,426,493 shares of the Company's common stock (the "Pre-Funded Warrants") at a purchase price of $ 12.4999 per Pre-Funded Warrant.

The Pre-Funded Warrants are exercisable at an exercise price of $ 0.0001 and will be exercisable until exercised in full.

The holders of Pre-Funded Warrants may not exercise a Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 4.99 % of the number of shares of the Company's common stock outstanding immediately after giving effect to such exercise;

provided, that the holders of Pre-Funded Warrants may increase or decrease such percentages not in excess of 19.99 % by providing at least 61 days’ prior notice to the Company.

The 2022 PIPE Financing closed on September 26, 2022.

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The Pre-Funded Warrants meet the criteria to be classified within stockholders’ equity.

As of September 30, 2023, all Pre-Funded Warrants are still outstanding.

As of March 31, 2024, all Pre-Funded Warrants are still outstanding.

The holders of common stock are entitled to receive cash dividends, if and when declared by the board of directors of the Company (the “board of directors”).

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In the event of any voluntary or involuntary liquidation, dissolution, or winding-up of the Company, the holders of common stock are entitled to share ratably in the Company’s assets.

The holders of common stock are entitled to one vote at all meetings of stockholders for each share of common stock held by such stockholder as of the record date.

The holders of common stock are entitled to one vote at all meetings of stockholders for each share of common stock held by such stockholders as of the record date.

Share-Based Compensation

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Subject to the adjustment provisions contained in the 2021 Plan and the evergreen provision described below, a total of 2,070,784 shares of common stock were initially reserved for issuance pursuant to the 2021 Plan.

shares of common stock granted under the Prior Plans that are forfeited or repurchased by the Company, and (ii) any shares of common stock subject to stock options or similar awards granted under the Private Aadi Plan that were assumed in the Merger (provided that the maximum number of shares that may be added to the 2021 Plan pursuant to this sentence is 764,154 shares).

In addition, the shares reserved for issuance under the 2021 Plan include any shares of common stock (i) subject to awards of stock options or other awards granted under the Prior Plans that expire or otherwise terminate without having been exercised in full and shares of common stock granted under the Prior Plans that are forfeited or repurchased by the Company, and (ii) any shares of common stock subject to stock options or similar awards granted under the Private Aadi Plan that were assumed in the Merger (provided that the maximum number of shares that may be added to the 2021 Plan pursuant to this sentence is 764,154 shares).

The number of shares available for issuance under the 2021 Plan will include an annual increase, or the evergreen feature, on the first day of each of the Company’s fiscal years, beginning with the Company’s fiscal year 2022, equal to the least of:

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• such number of shares as the board of directors or its designated committee may determine.

As a result of the evergreen increase, a total of 977,400 shares of common stock were added to the 2021 Plan on January 1, 2023.

As a result of the evergreen increase, a total of 982,168 shares of common stock were added to the 2021 Plan on January 1, 2024 and 977,400 shares of common stock were added to the 2021 Plan on January 1, 2023.

Shares issuable under the 2021 Plan are authorized, but unissued, or reacquired shares of common stock.

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The Company reserved 600,000 shares of common stock for issuance under the Inducement Plan.

The only persons eligible to receive awards under the Inducement Plan are individuals who are new employees and satisfy the standards for inducement grants under applicable Nasdaq listing rules.

As of September 30, 2023, 256,456 , 99,025 and 3,761,029 shares were outstanding under the Private Aadi Plan, 2017 Plan and 2021 Plan, respectively.

As of September 30, 2023, no shares were outstanding under the 2011 Plan and the 2023 Inducement Equity Incentive Plan.

The following table summarizes the stock option activity during the nine months ended September 30, 2023:

only persons eligible to receive awards under the Inducement Plan are individuals who are new employees and satisfy the standards for inducement grants under applicable Nasdaq listing rules.

As of March 31, 2024, 256,456 , 37,921 , 4,929,768 , and 490,000 shares were outstanding under the 2014 Private Aadi Plan, 2017 Plan , 2021 Plan, and 2023 Inducement Plan, respectively.

As of March 31, 2024, no shares were outstanding under the 2011 Plan.

The following table summarizes the stock option activity during the three months ended March 31, 2024:

Shares Weighted Average

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Expired/cancelled ( 294,831 ) 12.52

Outstanding as of September 30, 2023 4,116,510 $ 15.32 8.45 $ 510

Options exercisable as of September 30, 2023 1,345,041 $ 17.82 7.34 $ 489

Vested and expected to vest as of September 30, 2023 4,116,510 $ 15.32 8.45 $ 510

As of September 30, 2023, the aggregate intrinsic value of options outstanding was $ 0.5 million.

For the nine months ended September 30, 2023, and 2022, the weighted-average grant-date fair value of options granted was $ 7.78 and $ 9.93 per share, respectively.

As of September 30, 2023, there was $ 26.9 million of unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 2.6 years.

The total intrinsic value of the options exercised during the three months ended September 30, 2023 and 2022, was $ 31,000 and $ 45,000 , respectively.

The total intrinsic value of the options exercised during the nine months ended September 30, 2023 and 2022 was $ 0.2 million and $ 1.6 million , respectively.

As of September 30, 2023, and December 31, 2022, 663,441 and 853,760 shares were reserved for issuance under the 2021 Plan, respectively.

Outstanding as of March 31, 2024 5,372,887 $ 11.68 8.56 $ 504

Options exercisable as of March 31, 2024 2,285,885 $ 13.92 8.02 $ 244

Vested and expected to vest as of March 31, 2024 5,372,887 $ 11.68 8.56 $ 504

As of March 31, 2024, there was $ 21.3 million of unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 2.32 years.

The total intrinsic value of the options exercised during the three months ended March 31, 2024, and 2023, was $ 0 and $ 16,000 , respectively

As of March 31, 2024, and December 31, 2023, 647,974 and 657,734 shares were reserved for issuance under the 2021 Plan, respectively.

As of March 31, 2024 and December 31, 2023, 110,000 shares were reserved for issuance under the 2023 Inducement Plan.

Restricted Stock Units

Restricted stock consists of restricted stock unit awards (RSUs) which have been granted to employees.

The value of an RSU award is based on the Company’s stock price on the date of grant.

Employee grants vest over four years .

of RSUs are recognized as they occur.

The shares underlying the RSU awards are not issued until the RSUs vest.

Upon vesting, each RSU converts into one share of the Company’s common stock.

Activity with respect to the Company’s restricted stock units during the three months ended March 31, 2024 is as follows:

Shares Weighted Average

Grant Date Fair Value

Nonvested shares at January 1, 2024 32,558 $ 4.30

Granted 308,700 1.92

Vested/Issued — —

Forfeited — —

Nonvested shares at current period end 341,258 $ 2.15

As of March 31, 2024, there was $ 0.7 million of unrecognized compensation cost related to restricted stock units, which is expected to be recognized over a weighted average period of 3.55 years.

Compensation Expense Summary

The Company recognized the following compensation cost related to employee and non-employee share-based compensation activity for the periods presented (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,

2023 2022 2023 2022

Three Months Ended March 31,

Selling, general and administrative $ 2,342 $ 1,640

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Total $ 3,589 $ 2,740

The Company uses the Black-Scholes option pricing model to determine the estimated fair value for share-based awards.

The Company uses the Black-Scholes option pricing model to determine the estimated fair value for share-based option awards.

Option pricing and models require the input of various assumptions, including the option’s expected life, expected dividend yield, price volatility and risk-free interest rate of the underlying stock.

Forfeitures are recognized and accounted for as they occur.

The calculation was based on the following assumptions:

Three Months Ended September 30, Nine Months Ended September 30,

2023 2022 2023 2022

Three Months Ended March 31,

Weighted average grant date fair value (per share) $ 1.43 $ 8.57

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3.42 % - 4.17 %

3.42 % - 4.33 %

1.46 % - 3.38 %

Expected volatility 89.22 % - 91.46 %

89.94 % - 95.72 %

89.94 % - 101.03 %

85.91 % - 87.85 %

Expected term (in years) 5.0 - 6.1

Expected dividend yield — —

The Company determines the assumptions used in the option pricing model in the following manner:

Risk-Free Interest Rate – For the determination of the risk-free interest rates, the Company utilizes the U.S.

Treasury yield curve for instruments in effect at the time of measurement with a term commensurate with the expected term assumption.

Expected Volatility – The Company based its estimate of expected volatility on a weighted average using the Company's limited historical stock price volatility data, supplemented with the estimated and expected volatilities of a guideline group of publicly traded companies.

For these analyses, the Company selected companies with comparable characteristics including enterprise value, risk profiles, and with historical share price information sufficient to meet the expected life of the share-based awards.

The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its share-based awards.

The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available.

Expected Dividend – The expected dividend yield is assumed to be zero because the Company has never paid dividends and does not have current plans to pay any dividends on its common stock.

Expected Term – The Company estimates the expected term of its stock options granted to employees and non-employee directors using the simplified method, whereby, the expected term equals the average of the vesting term and the original

contractual term of the option.

The Company utilizes this method since it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term.

Merger Warrants to Purchase Common Stock

The Company had warrants outstanding for the purchase of 29,167 shares of the Company’s common stock at both September 30, 2023, and December 31, 2022.

The Company had warrants outstanding for the purchase of 29,167 shares of the Company’s common stock at both March 31, 2024, and December 31, 2023.

These warrants were assumed in the Merger and were issued by Aerpio in October 2019, for the purchase of 40,000 shares (after taking into account the reverse stock split of the Company’s common stock at a ratio of 15:1 effected on August 26, 2021 immediately prior to the closing of the Merger, (the "Reverse Stock Split")) of the Company’s common stock at an exercise price of $ 7.29 per share (after taking into account the Reverse Stock Split).

These warrants were fully vested as of the date of the Merger and expire on October 24, 2024.

No warrants were exercised during the nine months ended September 30, 2023.

No warrants were exercised during the three months ended March 31, 2024.

At the grant date, the fair value of these awards was determined using a Black-Scholes option pricing model.

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Black-Scholes models require the input of various assumptions, including the expected life, expected dividend yield, price volatility and risk-free interest rate of the underlying stock.

The expected volatility used in calculating the estimated fair value for purchases under the 2021 ESPP is based on the historical volatility of the Company's common stock.

The calculation was based on the following assumptions:

Three Months Ended September 30, Nine Months Ended September 30,

2023 2022 2023 2022

Three Months Ended March 31, 2024

Strike price (per share) $ 4.00

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Expected term (in years) 0.5

As of September 30, 2023, and December 31, 2022, 687,491 and 492,361 shares of common stock were available for issuance under the 2021 ESPP, respectively.

The Company had an outstanding liability of $ 0.1 million and $ 0.1 million as of September 30, 2023, and December 31, 2022, respectively, which will be recognized over six months .

As of September 30, 2023 and December 31, 2022, 49,220 and 27,202 shares were issued under the 2021 ESPP, respectively.

The Company recorde d no income tax expense for the three months ended September 30, 2023 and 2022.

The Company recorded no income tax expense for the nine months ended September 30, 2023 and $ 9,000 for the nine months ended September 30, 2022.

Expected dividend yield —

As of March 31, 2024, and December 31, 2023, 904,688 and 659,146 shares of common stock were available for issuance under the 2021 ESPP, respectively.

The Company had an outstanding liability of $ 0.2 million and $ 0.1 million as of March 31, 2024, and December 31, 2023 , respectively, which will be recognized over six months .

No shares were issued under the 2021 ESPP during the three months ended March 31, 2024, and 2023 , respectively.

The Company recorded income tax expense of zero for the three months ended March 31, 2024 and 2023, respectively.

The Company continues to maintain a full valuation allowance.

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The Company intends to defend itself vigorously in this matter and pursue all relief to which the Company is entitled.

The Company is unable to estimate the possible loss or range of loss, therefore no amounts have been accrued as of September 30, 2023.

The Company is unable to estimate the possible loss or range of loss.

No amounts have been accrued as of March 31, 2024.

See Note 7 for more information about the EOC License Agreement and its termination.

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These contracts are generally cancellable, with notice, at the Company’s option.

The Company recorded accrued expenses of $ 2.4 million and $ 2.8 million for expenditures incurred by clinical and contract manufacturing vendors as of September 30, 2023, and December 31, 2022, respectively.

At September 30, 2023, the Company was party to a Negotiated Purchase Order Terms and Conditions for Clinical and Commercial Product, as amended effective as of August 1, 2022 (the "Fresenius Agreement"), with Fresenius Kabi that contains specific activities including non-cancellable commitments, minimum purchase commitments, and binding annual forecasts.

As of September 30, 2023, there were non-cancellable purchase commitments under the Fresenius Agreement related to the purchase of inventory for $ 3.6 million to be paid in 2023.

The Company recorded accrued expenses of $ 4.7 million and $ 5.7 million for expenditures incurred by clinical and contract manufacturing vendors as of March 31, 2024, and December 31, 2023, respectively.

At March 31, 2024, the Company was party to a Negotiated Purchase Order Terms and Conditions for Clinical and Commercial Product, as amended effective as of August 1, 2022 and March 31, 2024 (the "Fresenius Agreement"), with Fresenius Kabi that contains specific activities including non-cancellable commitments, minimum purchase commitments, and binding annual forecasts.

As of March 31, 2024, there were non-cancellable purchase commitments related to the purchase of inventory for $ 3.8 million to be paid in 2024.

Mirati Collaboration

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(“Mirati”) to evaluate the combination of Mirati’s adagrasib, a KRAS G12C selective inhibitor, and FYARRO in KRAS G12C mutant non-small cell lung cancer (NSCLC) and other solid tumors.

Under the terms of the agreement, Mirati will be responsible for sponsoring and operating the Phase 1/2 study and the Company will supply study drug and jointly share the cost of the study.

The primary objective of this multi-center, single-arm, open-label Phase 1/2 trial is to determine the optimal dose and recommended Phase 2 dose for the combination of adagrasib and FYARRO in patients with KRAS G12C mutant solid tumors.

In addition, the study will investigate the safety, tolerability and efficacy of adagrasib and FYARRO in

combination in patients both with and without prior exposure to a KRAS G12C inhibitor.

The trial will build on preclinical data showing enhanced anti-tumor efficacy with the combination of adagrasib and FYARRO relative to either agent alone.

For the three and nine months ended September 30, 2023, the Company incurred $ 0.1 million and $ 0.7 million in expenses related to the Mirati collaboration.

In May 2024, the Company announced the mutually agreed upon termination of the collaboration and supply agreement with Mirati and the discontinuation of the Phase 1/2 study.

Under the terms of the agreement, Mirati was responsible for sponsoring and operating the Phase 1/2 study and the Company supplied study drug and jointly shared the cost of the study.

The primary objective of this multi-center, single-arm, open-label Phase 1/2 trial was to determine the optimal dose and recommended Phase 2 dose for the combination of adagrasib and FYARRO in patients with KRAS G12C mutant solid tumors.

In addition, the study was intended to investigate the safety, tolerability and efficacy of adagrasib and FYARRO in combination in patients both with and without prior exposure to a KRAS G12C inhibitor.

The trial was built on preclinical data showing enhanced anti-tumor efficacy with the combination of adagrasib and FYARRO relative to either agent alone.

For the three months ended March 31, 2024 and 2023, the Company incurred $ 0.2 million and $ 0.4 million in expenses related to the Mirati collaboration, respectively.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

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Forward-looking statements in this Quarterly Report include, but are not limited to, statements about:

• our ability to maintain regulatory approval for FYARRO ® in advanced malignant perivascular epithelioid cell tumors (“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 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 any current or future clinical trials;

• 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;

• our commercialization, marketing and manufacturing capabilities and strategy;

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• 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, including the impact of the COVID-19 pandemic, 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;

• 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;

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• our financial performance;

• the legal proceedings related to the termination of the EOC License Agreement;

• 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;

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements