PRECISION1 trial of nab-sirolimus in solid
tumors with TSC1 or TSC2 inactivating alterations on track
for presentation of early interim analysis by mid-December 2023; multiple 2024 catalysts
expected
Latest real-world, next generation sequencing
(NGS) analysis reinforces large unmet need in TSC1 and TSC2 mutated
cancers
FYARRO® sales of $6.0
million in the third quarter, an increase of 40%
year-over-year
Conference call to be held today at 8:30
am EST
LOS
ANGELES, Nov. 8, 2023 /PRNewswire/ -- 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 announced financial results for the quarter ended
September 30, 2023, and highlighted
recent corporate progress.
"The third quarter was marked by strong execution by our Aadi
Bio team. Our PRECISION1 tumor-agnostic trial continued rapid
enrollment, and we look forward to sharing an early interim
analysis on the first third of patients by mid-December," said
Dave Lennon, President and CEO of
Aadi Bioscience. "FYARRO continued to demonstrate the
importance of a tumor-targeting mTOR inhibitor for PEComa patients,
and we are progressing in our previously announced development
strategy with the initiation of new Phase 2 studies for endometrial
cancer and in neuroendocrine tumors."
Key Operational Highlights
- PRECISION 1 interim analysis on track for mid-December 2023. Presentation of an interim
analysis on the first third of trial participants (n=40) with a
minimum of 4.5 months of follow-up is planned for mid-December 2023. The presentation is expected
to include safety and investigator-assessed response in
approximately 20 patients in each of the TSC1 and TSC2 arms.
- PRECISION1 catalysts expected in 2024. The trial is
expected to reach full enrollment (n=120) with approximately 60
patients per arm in the spring of 2024 with trial completion
expected by the end of 2024. Presentation of an additional interim
analysis is planned when two-thirds of trial patients reach six
months of follow-up, currently anticipated in the third quarter of
2024.
- Presentations at 2023 EORTC-NCI-AACR International
Conference on Molecular Targets and Cancer Therapeutics highlight
real-world impact of TSC1 and TSC2 inactivating alterations in
cancer. Real-world NGS analysis of nearly 440,000 patients with
advanced cancer showed that TSC1 or TSC2 known or likely pathogenic
alterations occurred in approximately 2% of all advanced cancers.
TSC1 or TSC2 inactivating alterations most commonly occurred in
lung, gastrointestinal, genitourinary, breast and gynecological
tumors. Posters with this and other related data are available on
the Aadi Bio website under "Publications and Abstracts."
- Dave Lennon, Ph.D., appointed
President and CEO. In early October, Aadi announced the
appointment of Dave Lennon, Ph.D. as
President and Chief Executive Officer. Dr. Lennon brings more than
twenty years of experience leading global biotechnology and
pharmaceutical teams, with significant expertise in development and
commercialization in mTOR-driven diseases.
- Initiation of Phase 2 combination trial in endometrial
cancer. The Phase 2 trial investigating the combination of
nab-sirolimus with letrozole for the treatment of advanced
or recurrent endometrioid-type endometrial cancer (EEC) has been
initiated and is currently enrolling patients. The Company
presented a trials-in-progress poster on the EEC Phase 2 study at
the International Gynecologic Cancer Society (IGCS) 2023 Annual
Global Meeting earlier in November.
- Initiation of Phase 2 study in neuroendocrine tumors
(NETs). The Phase 2 study in neuroendocrine tumors (NETs) has
been initiated and is currently enrolling patients. This
multicenter, open-label, single-arm trial is evaluating
nab-sirolimus in adult patients with functional or
non-functional, well-differentiated, locally advanced unresectable
or metastatic NETs of the GI tract, lung, or pancreas who have
received no more than two prior lines of therapy.
Third Quarter 2023 Financial Results
- Total revenue resulting from sales of FYARRO for the quarter
ended September 30, 2023, was
$6.0 million. This compares to the
prior year period of $4.2
million.
- Cash, cash equivalents and short-term investments as of
September 30, 2023, were $119.3 million as compared to $172.6 million as of December 31, 2022, which is expected to fund
operations into 2025 based on current plans.
- Net loss for the three months ended September 30, 2023, was $16.3 million as compared to $14.5 million for the three months ended
September 30, 2022.
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 third quarter 2023.
Participants may access a live webcast of the call 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 FYARRO®
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 PRECISION1 Trial
The PRECISION1 trial is a multi-center, open-label,
tumor-agnostic registrational clinical trial of
nab-sirolimus. This tumor agnostic study will evaluate
approximately 60 mTOR inhibitor naïve patients in each of two
independent study arms, or approximately 120 in total, comprised of
patients with solid tumors harboring pathogenic inactivating
alterations in either TSC1 or TSC2 genes. In
November 2021, the FDA granted Fast
Track designation to evaluate nab-sirolimus for this patient
population.
nab-Sirolimus 100 mg/m2 is given weekly intravenously
over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary
endpoint is overall response rate per independent radiographic
review (IRR) using RECIST v1.1. Other endpoints include duration of
response, time to response, progression-free survival by IRR,
overall survival, patient-reported quality of life, and safety.
About Aadi Bioscience
Aadi is a commercial-stage biopharmaceutical company focused on
precision therapies for genetically defined cancers to bring
transformational therapies to cancer patients with mTOR pathway
driver alterations. Aadi received FDA approval and has
commercialized FYARRO® for the treatment of adult
patients with locally advanced unresectable or metastatic malignant
perivascular epithelioid cell tumor (PEComa).
Aadi has also initiated PRECISION1, a Phase 2 tumor-agnostic
registration-intended trial in mTOR inhibitor-naïve malignant solid
tumors
harboring TSC1 or TSC2 inactivating
alterations. 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: potential 2024 catalysts based on PRECISION1 data and
expected enrollment; the Company's anticipated growth and continued
advancements, including in potential additional indications;
expectations regarding the beneficial characteristics, safety,
efficacy and therapeutic effects of FYARRO; expectations regarding
the size of the potential targeted markets for FYARRO, including
the market for patients harboring TSC1 and TSC2
inactivating alterations; and the timing and clinical results of
the registration-directed PRECISION1 trial in patients harboring
TSC1 and TSC2 inactivating alterations and the
additional clinical trials in NETs and EEC, including the
enrollment timing and the release of data with respect thereto.
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 related to the release of interim,
topline and preliminary data from clinical trials; 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; and risks related to the
Company's estimates regarding future expenses, capital requirements
and need for additional financing.
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:
Marcy
Graham
IR@aadibio.com
|
AADI BIOSCIENCE,
INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
2023
|
|
2022
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
$
68,803
|
|
$
39,019
|
|
Short-term investments
|
50,532
|
|
133,541
|
|
Accounts receivable, net
|
5,717
|
|
1,862
|
|
Inventory
|
3,615
|
|
1,861
|
|
Prepaid expenses and other current assets
|
4,217
|
|
3,746
|
|
Total current
assets
|
132,884
|
|
180,029
|
|
Property and equipment,
net
|
3,601
|
|
508
|
|
Operating lease
right-of-use assets
|
1,260
|
|
1,522
|
|
Other assets
|
|
1,914
|
|
2,178
|
|
Total
assets
|
$
139,659
|
|
$
184,237
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
$
2,605
|
|
$
3,519
|
|
Accrued liabilities
|
11,732
|
|
14,922
|
|
Operating lease liabilities, current portion
|
423
|
|
394
|
|
Due
to licensor payable
|
5,757
|
|
-
|
|
Total current
liabilities
|
20,517
|
|
18,835
|
|
Operating lease
liabilities, net of current portion
|
|
946
|
|
1,267
|
|
Due to
licensor
|
|
-
|
|
5,757
|
|
Total
liabilities
|
21,463
|
|
25,859
|
|
Stockholders'
equity:
|
|
|
|
|
Common stock
|
2
|
|
2
|
|
Additional paid-in capital
|
370,904
|
|
361,689
|
|
Accumulated other comprehensive loss
|
(16)
|
|
(115)
|
|
Accumulated deficit
|
(252,694)
|
|
(203,198)
|
|
Total stockholders'
equity
|
118,196
|
|
158,378
|
|
Total liabilities
and stockholders' equity
|
$
139,659
|
|
$
184,237
|
|
AADI BIOSCIENCE,
INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share data and earnings per share
amounts)
(Unaudited)
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
|
|
|
September
30,
|
|
September
30,
|
|
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
Revenue
|
|
|
|
|
|
Product sales, net
|
|
$
5,959
|
|
$
4,245
|
|
$
18,028
|
|
$
9,989
|
|
Total
Revenue
|
|
5,959
|
|
4,245
|
|
18,028
|
|
9,989
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
11,221
|
|
9,915
|
|
34,204
|
|
29,069
|
|
Research and development
|
|
11,890
|
|
8,773
|
|
36,161
|
|
23,292
|
|
Cost of goods sold
|
|
697
|
|
593
|
|
1,882
|
|
1,113
|
|
Impairment of acquired contract intangible asset
|
|
-
|
|
-
|
|
-
|
|
3,724
|
|
Total operating
expenses
|
|
|
23,808
|
|
19,281
|
|
72,247
|
|
57,198
|
|
Loss from
operations
|
|
(17,849)
|
|
(15,036)
|
|
(54,219)
|
|
(47,209)
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
Foreign exchange loss
|
|
-
|
|
-
|
|
(3)
|
|
-
|
|
Interest income
|
|
1,605
|
|
620
|
|
4,900
|
|
791
|
|
Interest expense
|
|
(58)
|
|
(58)
|
|
(174)
|
|
(173)
|
|
Total other income
(expense), net
|
|
|
1,547
|
|
562
|
|
4,723
|
|
618
|
|
Loss before income
tax expense
|
|
(16,302)
|
|
(14,474)
|
|
(49,496)
|
|
(46,591)
|
|
Income tax expense
|
|
-
|
|
-
|
|
-
|
|
(9)
|
|
Net
loss
|
|
$ (16,302)
|
|
$ (14,474)
|
|
$
(49,496)
|
|
$
(46,600)
|
|
Net loss per share,
basic and diluted
|
|
|
|
|
|
|
|
|
|
|
$
(0.60)
|
|
$
(0.68)
|
|
$
(1.84)
|
|
$
(2.21)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding,
basic and diluted
|
|
26,946,683
|
|
21,269,163
|
|
26,901,810
|
|
21,052,786
|
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SOURCE Aadi Bioscience