Fully enrolled registration-intended
PRECISION1 trial; two-thirds interim analysis
planned for Q3 2024
FYARRO® sales of $5.4
million for Q1 2024, reflects distributor ordering
patterns and fewer commercial patient initiations at the start of
the year
Conference call to be held today at 8:30
am EDT
LOS
ANGELES, May 8, 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 first quarter ended
March 31, 2024, and highlighted
recent corporate progress.
"I'm pleased to announce that PRECISION1 is now fully enrolled
across a broad array of tumor types and our promising development
plan continues to gain momentum. We look forward to providing the
two-thirds interim analysis in the third quarter, and full results
in early 2025. Additionally, the recently initiated Phase 2 trials
in EEC and NETs are enrolling well, and we anticipate initial data
from these later this year," said Dave
Lennon, President and CEO of Aadi Bioscience. "On the
commercial side, FYARRO continues to perform well and has cemented
its position as the preferred treatment for malignant PEComa after
just two years on the market. The impacts to sales in the first
quarter are well-understood events and we expect to return to sales
growth in Q2."
Recent Operational Highlights
- FYARRO net product sales were $5.4
million in the first quarter of 2024. This decrease of
8.8% from the prior year period reflects impacts from distributor
ordering patterns and fewer new patient initiations than the
historical average, which we anticipate will correct in subsequent
quarters.
- Registration-intended PRECISION1 trial is now fully
enrolled. PRECISION1 is
exploring nab-sirolimus in solid tumors with
TSC1 or TSC2 inactivating alterations. The two-thirds
interim analysis is expected in Q3 2024, and study completion is
expected by year-end.
- Enrollment into two Phase 2 trials ongoing. These
tumor specific 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).
- At Aadi's request, Mirati/Bristol Myers Squibb and Aadi
mutually agreed to terminate their collaboration and clinical
supply agreement. Aadi is prioritizing investment in its Phase 2
trials in EEC and NETs. The Phase 1/2 trial with
Mirati/Bristol Myers Squibb evaluated the combination of
nab-sirolimus + adagrasib in non-small cell lung cancer with
a KRASG12C mutation.
First Quarter 2024 Financial Results
- Cash, cash equivalents and short-term investments as of
March 31, 2024, were $88.3 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 March 31, 2024, was $5.4
million, resulting from sales of FYARRO.
- Net loss for the three months ended March 31, 2024, was $18.3
million as compared to $15.2
million for the three months ended March 31, 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 first quarter 2024.
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-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), 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 PRECISION 1 two-thirds interim
analysis in Q3 2024 and full results in early 2025 and Phase 2
trials in EEC and NETs later in 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; 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
AADI BIOSCIENCE,
INC
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
2024
|
|
2023
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
53,780
|
|
$
62,888
|
Short-term
investments
|
34,491
|
|
45,957
|
Accounts receivable,
net
|
4,933
|
|
5,488
|
Inventory
|
5,936
|
|
6,427
|
Prepaid expenses and other
current assets
|
3,433
|
|
3,826
|
Total current
assets
|
102,573
|
|
124,586
|
Property and equipment,
net
|
5,686
|
|
4,802
|
Operating lease
right-of-use assets
|
1,077
|
|
1,169
|
Other assets
|
|
1,737
|
|
1,866
|
Total
assets
|
$
111,073
|
|
$
132,423
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable
|
$
3,095
|
|
$
5,898
|
Accrued liabilities
|
10,598
|
|
14,306
|
Operating lease liabilities,
current portion
|
425
|
|
434
|
Due to licensor
payable
|
5,757
|
|
5,757
|
Total current
liabilities
|
19,875
|
|
26,395
|
Operating lease
liabilities, net of current portion
|
|
738
|
|
833
|
Total
liabilities
|
20,613
|
|
27,228
|
Stockholders'
equity:
|
|
|
|
Common stock
|
2
|
|
2
|
Additional paid-in
capital
|
377,718
|
|
374,129
|
Accumulated other comprehensive
(loss) income
|
(8)
|
|
27
|
Accumulated deficit
|
(287,252)
|
|
(268,963)
|
Total stockholders'
equity
|
90,460
|
|
105,195
|
Total liabilities
and stockholders' equity
|
$
111,073
|
|
$
132,423
|
AADI BIOSCIENCE,
INC
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except share data and earnings per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
|
|
|
|
March
31,
|
|
|
|
|
|
2024
|
|
2023
|
|
|
Revenue
|
|
|
|
|
Product sales, net
|
|
$
5,353
|
|
$
5,867
|
|
|
Total
Revenue
|
|
5,353
|
|
5,867
|
|
|
Operating
expenses
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
10,620
|
|
11,207
|
|
|
Research and
development
|
|
13,593
|
|
10,956
|
|
|
Cost of goods sold
|
|
652
|
|
529
|
|
|
Total operating
expenses
|
|
|
24,865
|
|
22,692
|
|
|
Loss from
operations
|
|
(19,512)
|
|
(16,825)
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
Foreign exchange
loss
|
|
(1)
|
|
-
|
|
|
Interest income
|
|
1,282
|
|
1,660
|
|
|
Interest expense
|
|
(58)
|
|
(58)
|
|
|
Total other income
(expense), net
|
|
|
1,223
|
|
1,602
|
|
|
Net
loss
|
|
$ (18,289)
|
|
$ (15,223)
|
|
|
Net loss per share,
basic and diluted
|
|
|
|
|
|
|
|
$
(0.68)
|
|
$
(0.57)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding, basic and
diluted
|
|
26,980,698
|
|
26,862,646
|
|
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SOURCE Aadi Bioscience