FYARRO® sales of $6.3
million for Q4 2023 and $24.4
million for FY 2023 representing year-over-year growth of
21% and 60%, respectively
Registration-directed PRECISION1 trial of
nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating
alterations on track to complete enrollment by May;
two-thirds interim analysis planned for Q3 2024
Phase 2 trials in Endometrial Cancer and
Neuroendocrine Tumors (NETs) actively enrolling patients
Conference call to be held today at 8:30
am EDT
LOS
ANGELES, March 13, 2024 /PRNewswire/ -- 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 fourth quarter and
full-year ended December 31, 2023,
and highlighted recent corporate progress.
"With strong execution against our commercial and development
goals, 2023 was a year of progress and momentum for Aadi," said
Dave Lennon, President and CEO of
Aadi Bioscience. "As the preferred treatment for malignant PEComa,
FYARRO saw significant growth and high penetration in academic and
community settings. Clinically, we were encouraged by the interim
results from the registration-directed PRECISION1 trial, and look
forward to the two-thirds readout expected in Q3. We also initiated
enrollment of two Phase 2 trials in what we believe are promising
mTOR-driven cancer targets, endometrial cancer and neuroendocrine
tumors, as we further characterize the potential of
nab-sirolimus. With a commercial foundation, bold
development vision and solid cash runway in to Q4 2025, we believe
we are well-positioned to realize our ambition of becoming a
multi-indication precision oncology company."
Recent Operational Highlights
- FYARRO net product sales were $6.3
million in the fourth quarter, or 21% growth over the
prior year period, and $24.4 million
for full-year 2023, representing 60% growth year-over-year.
- PRECISION1 on track to complete enrollment by May 2024, with the two-thirds interim
analysis expected in Q3 2024. Early data presented in December 2023 demonstrated sustained tumor
reductions in heavily pre-treated population from
investigator-assessed responses in first 40 patients across both
arms. The safety profile was consistent with the
nab-sirolimus label and the mTOR inhibitor drug class.
- Enrollment of two single-indication Phase 2 trials
underway to investigate the potential of nab-sirolimus
for difficult-to-treat mTOR-driven cancers: neuroendocrine tumors
(NETs), and advanced or recurrent endometrioid-type endometrial
cancer (EEC) in combination with letrozole.
- NETs are rare, ~3,500 cases a year, with low response rates to
existing recommended treatments. Preclinical models indicate
improved target suppression relative to other mTORs in the NETS
population.
- Endometrial cancer is the most common cancer of the female
reproductive organs and one of the few cancers with increasing
mortality. There are an estimated 10,000 cases of EEC diagnosed
annually. Prior clinical studies with mTOR inhibitors and letrozole
have yielded promising results in EEC.
Fourth Quarter and Full-year 2023 Financial Results
- Cash, cash equivalents and short-term investments as of
December 31, 2023, were $108.8 million as compared to $172.6 million as of December 31, 2022, which is expected to fund
operations into Q4 2025 based on current plans.
- Total revenue for the quarter ended December 31, 2023, was $6.3 million, and $24.4
million for the full-year ended December 31, 2023, resulting from sales of
FYARRO.
- Net loss for the three months ended December 31, 2023, was $16.3 million as compared to $13.9 million for the three months ended
December 31, 2022. Net loss for the
full-year ended December 31, 2023,
was $65.8 million, as compared to
$60.5 million for the same period in
2022.
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 fourth quarter and full-year
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 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-directed trial in mTOR inhibitor-naïve
malignant solid tumors harboring TSC1 or TSC2 inactivating
alterations. Aadi is also exploring nab-sirolimus in two
single-indication Phase 2 trials for difficult-to-treat mTOR-driven
cancers: neuroendocrine tumors (NETs), 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 full enrollment of the PRECISION 1
trial by May 2024 and the expected
PRECISION 1 two-thirds interim analysis in 3Q 2024; the Company's
anticipated 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 NETs and EEC; 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; failure
to demonstrate the efficacy of FYARRO in 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; risks relating to the
Company's reliance on third party suppliers, some of which are sole
suppliers; 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, 2022, 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
AADI BIOSCIENCE,
INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
2023
|
|
2022
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
62,888
|
|
$
39,019
|
|
Short-term
investments
|
45,957
|
|
133,541
|
|
Accounts receivable,
net
|
5,488
|
|
1,862
|
|
Inventory
|
6,427
|
|
1,861
|
|
Prepaid expenses and
other current assets
|
3,826
|
|
3,746
|
Total current
assets
|
124,586
|
|
180,029
|
Property and equipment,
net
|
4,802
|
|
508
|
Operating lease
right-of-use assets
|
1,169
|
|
1,522
|
Other assets
|
1,866
|
|
2,178
|
Total
assets
|
$
132,423
|
|
$
184,237
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
5,898
|
|
$
3,519
|
|
Accrued
liabilities
|
14,306
|
|
14,922
|
|
Operating lease
liabilities, current portion
|
434
|
|
394
|
|
Due to licensor
payable
|
5,757
|
|
-
|
Total current
liabilities
|
26,395
|
|
18,835
|
Operating lease
liabilities, net of current portion
|
833
|
|
1,267
|
Due to
licensor
|
-
|
|
5,757
|
Total
liabilities
|
27,228
|
|
25,859
|
Stockholders'
equity:
|
|
|
|
|
Common stock
|
2
|
|
2
|
|
Additional paid-in
capital
|
374,129
|
|
361,689
|
|
Accumulated other
comprehensive income (loss)
|
27
|
|
(115)
|
|
Accumulated
deficit
|
(268,963)
|
|
(203,198)
|
Total stockholders'
equity
|
105,195
|
|
158,378
|
Total liabilities
and stockholders' equity
|
$
132,423
|
|
$
184,237
|
AADI BIOSCIENCE,
INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except share data and earnings per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Twelve months
ended
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenue
|
|
|
|
|
|
Product sales,
net
|
|
$
6,326
|
|
$
5,227
|
|
$
24,354
|
|
$
15,216
|
Total
Revenue
|
|
6,326
|
|
5,227
|
|
24,354
|
|
15,216
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
10,345
|
|
11,106
|
|
44,549
|
|
40,176
|
|
Research and
development
|
|
12,768
|
|
9,369
|
|
48,929
|
|
32,662
|
|
Cost of goods
sold
|
|
927
|
|
222
|
|
2,809
|
|
1,335
|
|
Impairment of acquired
contract intangible asset
|
|
-
|
|
-
|
|
-
|
|
3,724
|
Total operating
expenses
|
|
24,040
|
|
20,697
|
|
96,287
|
|
77,897
|
Loss from
operations
|
|
(17,714)
|
|
(15,470)
|
|
(71,933)
|
|
(62,681)
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
Foreign exchange gain
(loss)
|
|
2
|
|
-
|
|
(1)
|
|
-
|
|
Interest
income
|
|
1,500
|
|
1,606
|
|
6,400
|
|
2,398
|
|
Interest
expense
|
|
(57)
|
|
(57)
|
|
(231)
|
|
(230)
|
Total other income
(expense), net
|
|
1,445
|
|
1,549
|
|
6,168
|
|
2,168
|
Loss before income
tax expense
|
|
(16,269)
|
|
(13,921)
|
|
(65,765)
|
|
(60,513)
|
|
Income tax
expense
|
|
-
|
|
9
|
|
-
|
|
-
|
Net
loss
|
|
$ (16,269)
|
|
$ (13,912)
|
|
$ (65,765)
|
|
$ (60,513)
|
|
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted
|
|
$
(0.60)
|
|
$
(0.52)
|
|
$
(2.44)
|
|
$
(2.69)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding, basic and
diluted
|
|
26,965,909
|
|
26,839,033
|
|
26,917,967
|
|
22,511,237
|
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SOURCE Aadi Bioscience