PRECISION1 tumor-agnostic trial unlikely to
meet regulatory threshold to support an accelerated approval and
will be halted
Aadi will focus on FYARRO®
commercial business for its approved indication, PEComa, and
conduct a comprehensive strategic review to maximize shareholder
value
To further preserve cash position, Aadi
will adjust ongoing Phase 2 trials and reduce R&D headcount by
80%, thereby extending cash runway into at least 2H
2026
LOS
ANGELES, Aug. 20, 2024 /PRNewswire/ -- Aadi
Bioscience, Inc. (NASDAQ: AADI) today announced it will halt the
registration-intended PRECISION1 trial of nab-sirolimus in
patients with solid tumors harboring TSC1 or TSC2
inactivating alterations. An analysis by the Independent Data
Monitoring Committee demonstrated that the study was unlikely to
exceed an efficacy threshold necessary to support an accelerated
approval, the key goal of this Phase 2 study. The
approximately 25 patients in PRECISION1 who are still benefiting
from nab-sirolimus will be eligible for transition to a
planned expanded access protocol, and a complete analysis of the
PRECISION1 trial will be provided at a later date.
Aadi will now focus on preserving cash while maximizing its
commercial business. Aadi's marketed product,
FYARRO®, is the only preferred treatment for patients
with advanced malignant PEComa, a rare and aggressive cancer.
In the second quarter of this year, FYARRO delivered sales of
$6.2M.
To further preserve cash runway, Aadi will pause new
enrollment, but continue dosing previously enrolled patients, in
two, ongoing Phase 2 trials of nab-sirolimus for advanced or
recurrent endometrioid-type endometrial cancer (EEC) and
neuroendocrine tumors (NETs). Both studies have enrolled sufficient
patients (n=20 and n=10 for EEC and NETs, respectively) to assess
initial efficacy signals later this year. Aligned to these
pipeline adjustments, the Company is reducing its Research &
Development workforce by 80%. Together these actions extend
cash runway into at least 2H 2026.
"We are humbled by the effort of the investigators, support
staff, and most importantly, the patients and their families who
took part in PRECISION1. While nab-sirolimus showed
monotherapy activity in the study population, the trial fell short
of delivering what we believe would be required to support an
accelerated approval in the broad TSC1/TSC2 inactivating
mutations indication. We look forward to providing the full trial
analysis at a later date," said David
Lennon, President and CEO of Aadi Bioscience. "I want to
thank the dedicated Aadi employees who worked tirelessly on this
trial and are negatively impacted by this outcome. Given the change
in the development pipeline, we have taken the necessary steps to
immediately preserve cash runway, and have hired an advisory firm
to explore all options to maximize value for shareholders."
About Aadi Bioscience
Aadi is a precision oncology company focused on the
commercialization of FYARRO® for the treatment of adult patients
with locally advanced unresectable or metastatic malignant
perivascular epithelioid cell tumor (PEComa). More information on
the Company 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 second
half of 2026; the Company's strategic review; the Company's
workforce reduction; the anticipated timing of data releases of the
Company's clinical trials, including the analysis of the PRECISION1
trial and initial efficacy signals of the EEC and NETS trials; 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, risks associated with the ability to
successfully commercialize FYARRO; the risk that unforeseen adverse
reactions or side effects may occur in the course of
commercializing, developing and testing FYARRO; uncertainties
associated with the clinical development and regulatory approval of
FYARRO in additional indications; failure to demonstrate the
efficacy of FYARRO in clinical trials for additional indications;
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
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SOURCE Aadi Bioscience