Continued growth in total revenue on FYARRO®
with sales of $6.2 million for 2Q
2023
On-track for interim analysis on 40 patients
in PRECISION1 trial before the end of 2023
Expanding pipeline to include programs in
Endometrial Cancer and Neuroendocrine Tumors (NETs)
Conference call to be held today at 8:30
am EST
LOS
ANGELES, Aug. 9, 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 provided a corporate update and announced financial results
for the second quarter of 2023.
"We are seeing continued growth in FYARRO sales and are pleased
with the positive feedback we are receiving from the treatment
community," said Scott Giacobello,
Interim CEO and President and CFO of Aadi. "The PRECISION1 trial is
progressing well, and we are looking forward to providing results
of an interim analysis on 40 patients with appropriate follow-up
before the end of the year. We expect to complete enrollment
as planned in the spring of 2024."
"With PRECISION1 on track, we are excited to announce the
expansion of our pipeline to further investigate mTOR pathway
inhibition in endometrial cancer and NETs," continued Giacobello.
"We are encouraged by the positive feedback received from
clinicians, and we believe our preclinical data supporting these
programs is promising. We look forward to harnessing the
unique pharmacology of nab-sirolimus, both in combination
and as monotherapy, to provide enhanced therapeutic benefit in
these indications with meaningful patient populations and high
unmet need."
Second Quarter 2023 Updates and Recent Operational
Highlights
- Interim analysis from PRECISION1 expected before the end of
2023. An interim analysis from the tumor agnostic
PRECISION1 trial on 40 patients with appropriate follow-up is on
track with data expected before the end of 2023. Enrollment
continues to be well-balanced between the two arms, and as
previously reported, more than 15 discrete tumor types have been
enrolled, supporting the thesis that TSC1 and TSC2
alterations occur broadly across different solid tumors.
- FYARRO net product sales were $6.2
million in the second quarter, reflecting growth of
approximately 6% over Q1 2023 and 80% over the prior year
quarter.
- Planned initiation of Phase 2 combination trial in
endometrial cancer. The Company is initiating a Phase 2
trial investigating the combination of nab-sirolimus with
letrozole for the treatment of advanced or recurrent
endometrioid-type endometrial cancer (EEC). This is a Phase 2
open-label, multi-institutional study to evaluate the efficacy and
safety of nab-sirolimus and letrozole in patients with
advanced or recurrent endometrioid endometrial carcinoma.
Prior clinical studies with mTOR inhibitors and letrozole in
endometrial cancer patients have yielded promising results. In
preclinical models, intravenous nab-sirolimus demonstrates
significantly higher tumor growth inhibition, intra-tumoral drug
accumulation, and greater mTOR target suppression compared with
oral inhibitors. The Company is exploring whether the combination
of nab-sirolimus with endocrine therapy may produce
synergistic anti-tumor activity in patients with EEC. Initiation of
this trial is expected in the fourth quarter of 2023.
- Planned initiation of Phase 2 study in neuroendocrine
tumors (NETs). The Phase 2 study is a multicenter,
open-label, single-arm trial that is evaluating 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. In
preclinical animal models, nab-sirolimus demonstrated
improved target suppression relative to similar weekly doses of
sirolimus and everolimus, supporting further exploration of
nab-sirolimus in NETs. Initiation of this trial is
expected in the fourth quarter of 2023.
- Initiated Phase 1/2 trial in KRASG12C in
collaboration with Mirati Therapeutics. The first patient
has been dosed in a Phase 1/2 trial evaluating the combination
of adagrasib with nab-sirolimus in this collaborative
study. The open-label Phase 1/2 trial is intended to determine the
optimal dose and recommended Phase 2 dose in patients with
KRASG12C mutant solid tumors.
- Multiple posters presented at ASCO Annual Meeting
2023. Aadi presented a company-sponsored TIP update from
the PRECISION1 Phase 2 study and combination data
of nab-sirolimus and pazopanib (PAZO) from an ongoing
Investigator Initiated Trial at ASCO 2023. The posters are
available on the investor relations page of the Aadi website
at www.aadibio.com.
Second Quarter 2023 Financial Results
- Total revenue resulting from sales of FYARRO for the quarter
ended June 30, 2023, was $6.2 million. This compares to the prior year
period of $3.4 million.
- Cash, cash equivalents and short-term investments as of
June 30, 2023, were $134.9 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 June
30, 2023, was $18.0 million as
compared to $18.3 million for the
three months ended June 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 second 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 in November 2021, and
in February 2022 commenced commercialization of
FYARRO® for the treatment of adult patients with
locally advanced unresectable or metastatic malignant perivascular
epithelioid cell tumor (PEComa).
Aadi is conducting the PRECISION1 trial, a Phase 2
tumor-agnostic registration-directed study in patients with mTOR
inhibitor-naïve 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 Bioscience 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; the Company's
anticipated growth and continued advancements, including
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 and
the release of data with respect thereto, and the clinical trials
in endometrioid-type endometrial cancer and neuroendocrine tumors;
the potential of nab-sirolimus to generate improved target
suppression in EEC, in combination with letrozole, and NETs; the
timing and likelihood of regulatory filings and approvals of
FYARRO, including in potential additional indications and potential
filings in additional jurisdictions; plans regarding clinical
trials, including those in collaboration with Mirati Therapeutics,
for the combination of adagrasib and nab-sirolimus in
patients with KRASG12C-mutant tumors and related timing
and expectations regarding the efficacy of the combination; 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 the
Company's collaborations; 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," filed on March 29,
2023 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:
Marcy
Graham
IR@aadibio.com
AADI BIOSCIENCE, INC.
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
|
(In thousands, except share data and earnings per
share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Six months ended
|
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
Revenue
|
|
|
|
|
|
|
Product sales, net
|
|
$
6,202
|
|
$
3,437
|
|
$
12,069
|
|
$
5,744
|
|
|
Total Revenue
|
|
6,202
|
|
3,437
|
|
12,069
|
|
5,744
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
11,776
|
|
10,006
|
|
22,983
|
|
19,154
|
|
|
Research and development
|
|
13,315
|
|
7,726
|
|
24,271
|
|
14,519
|
|
|
Cost of goods sold
|
|
656
|
|
341
|
|
1,185
|
|
520
|
|
|
Impairment of acquired contract intangible asset
|
|
-
|
|
3,724
|
|
-
|
|
3,724
|
|
|
Total operating expenses
|
|
25,747
|
|
21,797
|
|
48,439
|
|
37,917
|
|
|
Loss from operations
|
|
(19,545)
|
|
(18,360)
|
|
(36,370)
|
|
(32,173)
|
|
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange loss
|
|
(3)
|
|
-
|
|
(3)
|
|
-
|
|
|
Interest income
|
|
1,635
|
|
158
|
|
3,295
|
|
171
|
|
|
Interest expense
|
|
(58)
|
|
(58)
|
|
(116)
|
|
(115)
|
|
|
Total other income (expense),
net
|
|
1,574
|
|
100
|
|
3,176
|
|
56
|
|
|
Loss before income tax expense
|
|
(17,971)
|
|
(18,260)
|
|
(33,194)
|
|
(32,117)
|
|
|
Income tax expense
|
|
-
|
|
(9)
|
|
-
|
|
(9)
|
|
|
Net loss
|
|
$ (17,971)
|
|
$ (18,269)
|
|
$
(33,194)
|
|
$
(32,126)
|
|
|
Net loss per share, basic and
diluted
|
|
|
|
|
|
|
|
|
|
|
|
$
(0.67)
|
|
$
(0.87)
|
|
$
(1.23)
|
|
$
(1.53)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares
outstanding, basic and diluted
|
|
26,879,089
|
|
20,970,459
|
|
26,878,672
|
|
20,942,804
|
|
AADI BIOSCIENCE, INC.
|
CONDENSED CONSOLIDATED BALANCE
SHEETS
|
(In thousands)
|
(Unaudited)
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
2023
|
|
2022
|
Assets
|
|
|
|
Current assets:
|
|
|
|
Cash and cash equivalents
|
$
68,162
|
|
$
39,019
|
Short-term investments
|
66,727
|
|
133,541
|
Accounts receivable, net
|
3,676
|
|
1,862
|
Inventory
|
3,457
|
|
1,861
|
Prepaid expenses and other current assets
|
2,901
|
|
3,746
|
Total current
assets
|
144,923
|
|
180,029
|
Property and
equipment, net
|
3,005
|
|
508
|
Operating lease
right-of-use assets
|
1,349
|
|
1,522
|
Other
assets
|
1,951
|
|
2,178
|
Total assets
|
$
151,228
|
|
$
184,237
|
|
|
|
|
Liabilities and stockholders'
equity
|
|
|
|
Current liabilities:
|
|
|
|
Accounts payable
|
$
2,898
|
|
$
3,519
|
Accrued liabilities
|
9,685
|
|
14,922
|
Operating lease liabilities, current portion
|
413
|
|
394
|
Total current
liabilities
|
12,996
|
|
18,835
|
Operating lease
liabilities, net of current portion
|
1,056
|
|
1,267
|
Due to
licensor
|
5,757
|
|
5,757
|
Total
liabilities
|
19,809
|
|
25,859
|
Stockholders' equity:
|
|
|
|
Common stock
|
2
|
|
2
|
Additional paid-in capital
|
367,853
|
|
361,689
|
Accumulated other comprehensive loss
|
(44)
|
|
(115)
|
Accumulated deficit
|
(236,392)
|
|
(203,198)
|
Total stockholders' equity
|
131,419
|
|
158,378
|
Total liabilities and stockholders'
equity
|
$
151,228
|
|
$
184,237
|
|
|
|
|
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SOURCE Aadi Bioscience