0001422142FALSE00014221422024-08-072024-08-07

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
FORM 8-K
_____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 7, 2024
_____________________
AADI BIOSCIENCE, INC.
(Exact name of registrant as specified in its charter)
_____________________
Delaware
001-38560
61-1547850
(State or other jurisdiction of incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)
17383 Sunset Boulevard, Suite A250
Pacific Palisades, California
90272
(Address of principal executive offices)
(Zip code)
Registrant’s telephone number, including area code: (424) 744-8055
(Former name or former address, if changed since last report.)
_____________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, par value $0.0001 per share
AADI
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o


Item 2.02. Results of Operations and Financial Condition.
On August 7, 2024, Aadi Bioscience, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.
(d) Exhibits

Exhibit NumberDescription
99.1
104Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

August 7, 2024
/s/ Scott Giacobello
Scott Giacobello
Chief Financial Officer



PRESS RELEASE
Exhibit 99.1
aadilogo-pressrelease.jpg
Aadi Bioscience Announces Financial Results for the Second Quarter 2024 and Provides Corporate Update
FYARRO® sales of $6.2 million for Q2 2024, a 15% quarter over quarter sales growth
Interim analysis of two-thirds of fully enrolled PRECISION1 trial planned for Q3 2024
Conference call to be held today at 8:30 am EDT
LOS ANGELES, CA, August 7, 2024 – Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage, precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced financial results for the second quarter ended June 30, 2024, and highlighted recent corporate progress.
“The second quarter saw quarter over quarter sales growth for FYARRO, as anticipated, and an increase in demand across both new and existing accounts, including from major oncology centers. Approximately 80 percent of accounts have ordered multiple times already this year, reflecting the clinical value of FYARRO for patients with advanced malignant PEComa,” said Dave Lennon, President and CEO of Aadi Bioscience. “Looking ahead, we will provide the next interim update from PRECISION1, a tumor-agnostic study that enrolled any tumor type presenting with qualifying TSC1 or TSC2 inactivating alterations, later in the third quarter. With this study, nab-sirolimus has the potential to demonstrate a meaningful impact on the lives of patients who have already received standard therapies appropriate for their tumor type and stage of disease.”
Recent Operational Highlights
•FYARRO net product sales were $6.2 million in the second quarter, an increase of 15 percent from Q1 2024 and in line with the prior year period.
•Two-thirds interim analysis of registration-intended PRECISION1 trial is planned for Q3 2024. PRECISION1 is exploring nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations. The trial is fully enrolled, and study completion is expected by year-end.
•Enrollment into two additional Phase 2 trials is ongoing, with initial data expected by the end of the year. These tumor specific, open-label trials are investigating the potential of nab-sirolimus for difficult-to-treat mTOR-driven cancers: advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole, and neuroendocrine tumors (NETs) of the lung, gastrointestinal tract and pancreas.
Second Quarter 2024 Financial Results
•Cash, cash equivalents and short-term investments as of June 30, 2024, were $78.6 million as compared to $108.8 million as of December 31, 2023, which is expected to fund operations into Q4 2025 based on current plans.
•Total revenue for the quarter ended June 30, 2024, was $6.2 million, resulting from sales of FYARRO.
•Net loss for the three months ended June 30, 2024, was $14.6 million as compared to $18.0 million for the three months ended June 30, 2023.
Conference Call Information
The Aadi management team is hosting a conference call and webcast today at 8:30 am EDT (5:30 am PDT) to provide a corporate update and discuss results for the second quarter 2024.
Participants may access a live webcast of the call and the associated slide presentation on the “Investors & News” page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in



advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days.
About Aadi Bioscience
Aadi is a commercial-stage precision oncology company focused on the development and commercialization of therapies for cancers with alterations in the mTOR pathway, a key regulator of cell growth and cancer progression. To unlock the full potential of mTOR inhibition, Aadi uniquely combines nanoparticle albumin-bound (nab) technology with the potent mTOR inhibitor, sirolimus. Aadi received FDA approval and commercializes FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Aadi is exploring nab-sirolimus in PRECISION1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-naïve malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. Aadi is also exploring nab-sirolimus in two tumor specific Phase 2 trials for difficult-to-treat mTOR-driven cancers: neuroendocrine tumors (NETs) of the lung, gastrointestinal tract and pancreas, and advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole. More information on the Company's development pipeline is available on the Aadi website at www.aadibio.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains certain forward-looking statements regarding the business of Aadi Bioscience that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to: the Company’s cash runway extending into the fourth quarter of 2025; the anticipated timing of commencement, enrollment, data releases and completion of the Company's clinical trials, including the expected PRECISION1 two-thirds interim analysis in Q3 2024 and study completion by year-end and Phase 2 trials in EEC and NETs later in 2024; the Company's expectations regarding a return to sales growth and continued advancements, including in potential additional indications; expectations regarding the beneficial characteristics, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to FYARRO, including in TSC1, TSC2, NETs and EEC; plans and potential for success relating to commercializing FYARRO; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund the Company's future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, uncertainties associated with the clinical development and regulatory approval of FYARRO in additional indications, including potential delays in the commencement, enrollment and completion of clinical trials for additional indications; risks associated with the ability to successfully commercialize FYARRO; failure to demonstrate the efficacy of FYARRO in clinical trials for additional indications; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing, developing and testing FYARRO; and risks related to the Company's estimates regarding future expenses, capital requirements and need for additional financing.
Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including under the caption "Item 1A. Risk Factors," and in Aadi's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.
All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.



Contact:
IR@aadibio.com



aadilogo-pressrelease.jpg
AADI BIOSCIENCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
June 30, 2024December 31, 2023
Assets
Current assets:
Cash and cash equivalents$41,139 $62,888 
Short-term investments37,429 45,957 
Accounts receivable, net5,920 5,488 
Inventory6,098 6,427 
Prepaid expenses and other current assets2,419 3,826 
Total current assets93,005 124,586 
Property and equipment, net6,004 4,802 
Operating lease right-of-use assets982 1,169 
Other assets1,629 1,866 
Total assets$101,620 $132,423 
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable$2,265 $5,898 
Accrued liabilities13,751 14,306 
Operating lease liabilities, current portion374 434 
Due to licensor payable5,757 5,757 
Total current liabilities22,147 26,395 
Operating lease liabilities, net of current portion682 833 
Total liabilities22,829 27,228 
Stockholders’ equity:
Common stock2 2 
Additional paid-in capital380,651 374,129 
Accumulated other comprehensive (loss) income(27)27 
Accumulated deficit(301,835)(268,963)
Total stockholders’ equity78,791 105,195 
Total liabilities and stockholders’ equity$101,620 $132,423 



aadilogo-pressrelease.jpg
AADI BIOSCIENCE, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(In thousands, except shares and earnings per share amounts)
(Unaudited)
Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
Revenue
Product sales, net$6,179 $6,202 $11,532 $12,069 
Total revenue6,179 6,202 11,532 12,069 
Operating expenses
Selling, general and administrative7,892 11,776 18,512 22,983 
Research and development13,093 13,315 26,686 24,271 
Cost of goods sold778 656 1,430 1,185 
Total operating expenses21,763 25,747 46,628 48,439 
Loss from operations(15,584)(19,545)(35,096)(36,370)
Other income (expense)
Foreign exchange loss(2)(3)(3)(3)
Interest income1,061 1,635 2,343 3,295 
Interest expense(58)(58)(116)(116)
Total other income (expense), net1,001 1,574 2,224 3,176 
Net loss$(14,583)$(17,971)$(32,872)$(33,194)
Net loss per share, basic and diluted$(0.54)$(0.67)$(1.22)$(1.23)
Weighted average number of common shares outstanding, basic and diluted27,010,013 26,879,089 26,995,356 26,878,672 



v3.24.2.u1
Cover
Aug. 07, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Aug. 07, 2024
Entity Registrant Name AADI BIOSCIENCE, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-38560
Entity Tax Identification Number 61-1547850
Entity Address, Address Line One 17383 Sunset Boulevard
Entity Address, Address Line Two Suite A250
Entity Address, City or Town Pacific Palisades
Entity Address, State or Province CA
Entity Address, Postal Zip Code 90272
City Area Code 424
Local Phone Number 744-8055
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol AADI
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001422142
Amendment Flag false
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