Full Press Release Details
Aadi Bioscience Announces Financial Results for the Second Quarter of 2022 and Provides Corporate Update
FYARRO (nab-sirolimus) net product sales reached $3.4 million for
the second quarter of 2022
PRECISION 1 Phase 2 tumor-agnostic registration-directed trial continues enrollment and rapid site
activation at major cancer centers and large community networks; preliminary data expected 1H23
Conference call to be held today
LOS ANGELES, CA, August 10, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on
developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today provided a corporate update and announced financial results for the second quarter of 2022.
We continue to progress in key areas after our first full quarter following FYARRO s launch. We are excited to see FYARRO reaching more patients
through continued account adoption and steady growth in overall sales, said Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. We are also encouraged by the progress on our tumor agnostic PRECISION 1 trial
targeting TSC1 and TSC2 inactivating alterations which continues to ramp up, with activation of additional clinical trial sites and patient enrollment. We anticipate providing preliminary data on a meaningful number of patients in this
trial during the first half of 2023. In addition, we continue to evaluate strategies for new clinical indications of nab-sirolimus either as single agent or in combination with other targeted therapies with the potential for new programs as early as
Corporate Updates for the Second Quarter 2022
Second Quarter 2022 Financial Results
Conference Call Information
The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the
second quarter of 2022.
Participants may access a live webcast of the call on the Investors & News page of the Aadi Biosciences
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.
FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid
cell tumor (PEComa).
About the PRECISION 1 Trial
The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate
approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial will have two independent arms of 60 patients each to separately evaluate patients with
either TSC1 or TSC2 inactivating alterations. Aadi has received Fast Track designation to evaluate nab-sirolimus in this indication from the FDA. The first patient in the PRECISION 1 trial was dosed in March 2022.
About Aadi Bioscience
Aadi is a biopharmaceutical
company focused on precision therapies for genetically defined cancers. Aadi s primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations where other mTOR inhibitors have not or cannot be
effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. In November 2021, Aadi received FDA approval for FYARRO for
the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), and in February 2022 Aadi announced the commercial launch of FYARRO in this indication.
Based on exploratory data from AMPECT, Aadi s registrational study supporting approval in malignant PEComa, and following a pre-IND meeting with the FDA, Aadi has initiated PRECISION 1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-na ve malignant solid tumors
harboring TSC1 or TSC2 inactivating alterations. More information on Aadi 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 Biosciences that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements
regarding the Company s current beliefs and expectations; plans and potential for success relating to commercializing FYARRO; expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO; plans
related to further development and manufacturing of FYARRO; pricing and reimbursement of FYARRO; the rate and degree of market acceptance of FYARRO; anticipated reception of FYARRO in the physician community; the clinical results and timing of
additional clinical trials, including the registration-directed trial in patients harboring TSC1 or TSC2 inactivating alterations; the timing and likelihood of regulatory filings and approvals of FYARRO, including in potential
additional indications and potential filings in additional jurisdictions; and the sufficiency of our existing capital resources and the expected timeframe to fund our 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, those associated with the
ability to successfully commercialize FYARRO; risks related to reimbursement and pricing of FYARRO; 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; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing,
developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi s estimates
regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 pandemic on Aadi s operations, the biotechnology industry and the economy
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, 2021, including under the caption Item 1. Risk Factors and in
Aadi s subsequent Quarterly Reports on Form 10-Q filed on May 12, 2022 and August 10, 2022, 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.
AADI BIOSCIENCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 118,737 | $ | 148,989 | ||||
| Accounts receivable, net | 2,063 | |||||||
| Inventory | 727 | |||||||
| Prepaid expenses and other current assets | 2,808 | 2,283 | ||||||
| Total current assets | 124,335 | 151,272 | ||||||
| Property and equipment, net | 357 | 57 | ||||||
| Operating lease right-of-use assets | 1,653 | 557 | ||||||
| Intangible asset, net | 3,811 | |||||||
| Other assets | 2,291 | 2,213 | ||||||
| Total assets | $ | 128,636 | $ | 157,910 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,619 | $ | 6,439 | ||||
| Accrued liabilities | 8,653 | 8,703 | ||||||
| Operating lease liabilities, current portion | 324 | 131 | ||||||
| Total current liabilities | 12,596 | 15,273 | ||||||
| Other liabilities | 109 | |||||||
| Operating lease liabilities, net of current portion | 1,444 | 474 | ||||||
| Due to licensor | 5,757 | 5,757 | ||||||
| Total liabilities | 19,906 | 21,504 | ||||||
| Stockholders equity: | ||||||||
| Preferred stock | ||||||||
| Common stock | 2 | 2 | ||||||
| Additional paid-in capital | 283,539 | 279,089 | ||||||
| Accumulated deficit | (174,811 | ) | (142,685 | ) | ||||
| Total stockholders equity | 108,730 | 136,406 | ||||||
| Total liabilities and stockholders equity | $ | 128,636 | $ | 157,910 |
AADI BIOSCIENCE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except shares and earnings per share amounts)
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | ||||||||||||||||
| Product sales, net | $ | 3,437 | $ | $ | 5,744 | $ | ||||||||||
| Grant revenue | 120 | |||||||||||||||
| Total Revenue | 3,437 | 5,744 | 120 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Selling, general and administrative | 10,006 | 830 | 19,154 | 1,393 | ||||||||||||
| Research and development | 7,726 | 3,045 | 14,519 | 6,689 | ||||||||||||
| Cost of goods sold | 341 | 520 | ||||||||||||||
| Impairment of intangible asset | 3,724 | 3,724 | ||||||||||||||
| Total operating expenses | 21,797 | 3,875 | 37,917 | 8,082 | ||||||||||||
| Loss from operations | (18,360 | ) | (3,875 | ) | (32,173 | ) | (7,962 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Change in fair value of convertible promissory notes | 2,371 | 1,206 | ||||||||||||||
| Gain upon extinguishment of debt | 196 | 196 | ||||||||||||||
| Interest income | 158 | 1 | 171 | 1 | ||||||||||||
| Interest expense | (58 | ) | (227 | ) | (115 | ) | (451 | ) | ||||||||
| Total other income, net | 100 | 2,341 | 56 | 952 | ||||||||||||
| Loss before income tax expense | (18,260 | ) | (1,534 | ) | (32,117 | ) | (7,010 | ) | ||||||||
| Income tax expense | (9 | ) | (2 | ) | (9 | ) | (2 | ) | ||||||||
| Net loss | $ | (18,269 | ) | $ | (1,536 | ) | $ | (32,126 | ) | $ | (7,012 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.87 | ) | $ | (0.60 | ) | $ | (1.53 | ) | $ | (2.76 | ) | ||||
| Weighted average number of common shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted | 20,970,459 | 2,542,358 | 20,942,804 | 2,542,358 |