FYARRO® (nab-sirolimus) net
product sales reached $3.4 million
for the second quarter of 2022
PRECISION 1 Phase 2 tumor-agnostic
registration-directed trial continues enrollment and rapid site
activation at major cancer centers and large community networks;
preliminary data expected 1H23
Conference call to be held today at 8:30
am EDT
LOS
ANGELES, Aug. 10, 2022 /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 2022.
"We continue to progress in key areas after our first full
quarter following FYARRO's launch. We are excited to see FYARRO
reaching more patients through continued account adoption and
steady growth in overall sales," said Neil
Desai, Ph.D., Founder, President and Chief Executive Officer
of Aadi. "We are also encouraged by the progress on our tumor
agnostic PRECISION 1 trial targeting TSC1 and TSC2
inactivating alterations which continues to ramp up, with
activation of additional clinical trial sites and patient
enrollment. We anticipate providing preliminary data on a
meaningful number of patients in this trial during the first half
of 2023. In addition, we continue to evaluate strategies for
new clinical indications of nab-sirolimus either as single agent or
in combination with other targeted therapies with the potential for
new programs as early as 2023."
Corporate Updates for the Second Quarter 2022
- FYARRO net product sales for the three months ended
June 30, 2022 were $3.4 million, the first full quarter of sales
following the product launch late in the first quarter.
- A product-specific permanent J-code (J9331) for FYARRO from
Centers for Medicare and Medicaid Services (CMS) became effective
on July 1, 2022. This code is
expected to further facilitate reimbursement for FYARRO.
- The Company announced its addition to both the U.S. small cap
Russell 2000® Index and broad-market Russell
3000® Index at the conclusion of the 2022 Russell
indexes annual reconstitution, which captures the 4,000 largest
U.S. stocks, ranking them by total market capitalization.
- Partnerships with prominent next generation sequencing (NGS)
providers and leaders in genomic testing and profiling was
announced during the quarter, which included Foundation Medicine,
Tempus and others. The Company is leveraging these partnerships to
expedite patient identification and recruitment for the ongoing
PRECISION 1 trial of nab-sirolimus in patients harboring tumors
with inactivating alterations in TSC1 or TSC2 genes,
and is making significant progress toward opening the trial in at
least 20 major cancer centers and upward of 120 treatment sites in
the U.S. by the end of 2022.
- A poster presentation entitled, "nab-Sirolimus for
patients with advanced malignant PEComa with or without prior mTOR
inhibitors: Biomarker results from AMPECT and an expanded access
program" was presented at the 2022 American Society of Clinical
Oncology (ASCO) Annual Meeting. The data included exploratory
biomarker results reported from the final analysis of mTOR
inhibitor-naïve advanced malignant PEComa patients treated with
nab-sirolimus in the Advanced Malignant PEComa Trial
(AMPECT) trial as well as an analysis of prior mTOR inhibitor
exposed advanced malignant PEComa patients treated with
nab-sirolimus in the Expanded Access Program (EAP) through
June 2021. Findings from both the
AMPECT study and the EAP showed greater clinical benefit in
patients with TSC1 or TSC2 inactivating alterations
who received nab-sirolimus compared to all evaluable
patients, regardless of prior mTOR inhibitor exposure.
- The Company sponsored a poster at the Annual Meeting of the
American Association for Cancer Research (AACR) which indicated the
incidence of advanced cancer patients
carrying TSC1 or TSC2 inactivating gene alterations
numbered approximately 12,000 annually in the US, thus potentially
rendering these patients eligible for nab-sirolimus therapy.
Second Quarter 2022 Financial Results
- Cash and cash equivalents on June 30,
2022 were $118.7 million,
compared to $149.0 million as of
December 31, 2021. Based on current
plans, the Company expects cash and cash equivalents to fund
operations into 2024.
- Total revenue for the quarter ended June
30, 2022 was $3.4 million
resulting from sales of FYARRO.
- In the second quarter of 2022, the Company recorded a non-cash
impairment charge of $3.7 million to
write-off the value of an intangible asset related to the Gossamer
license agreement with the Company's predecessor, Aerpio.
- Net loss for the three months ended June
30, 2022 was $18.3 million
compared to $1.5 million for the
three months ended June 30,
2021.
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 of 2022.
Participants may access a live webcast of the call on the
"Investors & News" page of the Aadi Biosciences 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 PRECISION 1 Trial
The PRECISION 1 trial is a multi-center, open-label,
tumor-agnostic pivotal study, of nab-sirolimus designed as a
basket trial that will evaluate approximately 120 adult and
adolescent patients with solid tumors harboring pathogenic
inactivating alterations in TSC1 or TSC2 genes. The
trial will have two independent arms of 60 patients each to
separately evaluate patients with either TSC1 or TSC2
inactivating alterations. Aadi has received Fast Track designation
to evaluate nab-sirolimus in this indication from the
FDA. The first patient in the PRECISION 1 trial was dosed in
March 2022.
About Aadi Bioscience
Aadi is a biopharmaceutical company focused on precision
therapies for genetically defined cancers. Aadi's primary goal is
to bring transformational therapies to cancer patients with mTOR
pathway driver alterations where other mTOR inhibitors have not or
cannot be effectively exploited due to problems of pharmacology,
effective drug delivery, safety, or effective targeting to the
disease site. In November 2021, Aadi
received FDA approval for FYARRO® for the treatment
of adult patients with locally advanced unresectable or metastatic
malignant perivascular epithelioid cell tumor (PEComa), and in
February 2022 Aadi announced the
commercial launch of FYARRO in this indication.
Based on exploratory data from AMPECT, Aadi's registrational
study supporting approval in malignant PEComa, and following a
pre-IND meeting with the FDA, Aadi has initiated PRECISION 1, a
Phase 2 tumor-agnostic registration-intended trial in 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 Biosciences 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; 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; the timing and likelihood of regulatory filings and
approvals of FYARRO, including in potential additional indications
and potential filings in additional jurisdictions; 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 Aadi's
estimates regarding future expenses, capital requirements and need
for additional financing; and risks related to the impact of the
COVID-19 pandemic on Aadi's operations, the biotechnology industry
and the economy generally.
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, 2021, including under the caption
"Item 1. Risk Factors" and in Aadi's subsequent Quarterly Reports
on Form 10-Q filed on May 12, 2022
and August 10, 2022, 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 BALANCE SHEETS
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
2022
|
|
2021
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
$
118,737
|
|
$
148,989
|
|
Accounts receivable, net
|
2,063
|
|
-
|
|
Inventory
|
727
|
|
-
|
|
Prepaid expenses and other current assets
|
2,808
|
|
2,283
|
|
Total current
assets
|
124,335
|
|
151,272
|
|
Property and equipment,
net
|
357
|
|
57
|
|
Operating lease
right-of-use assets
|
1,653
|
|
557
|
|
Intangible asset,
net
|
-
|
|
3,811
|
|
Other assets
|
|
2,291
|
|
2,213
|
|
Total
assets
|
$
128,636
|
|
$
157,910
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
$
3,619
|
|
$
6,439
|
|
Accrued liabilities
|
8,653
|
|
8,703
|
|
Operating lease liabilities, current portion
|
324
|
|
131
|
|
Total current
liabilities
|
12,596
|
|
15,273
|
|
Other
liabilities
|
109
|
|
-
|
|
Operating lease
liabilities, net of current portion
|
|
1,444
|
|
474
|
|
Due to
licensor
|
|
5,757
|
|
5,757
|
|
Total
liabilities
|
19,906
|
|
21,504
|
|
Stockholders'
equity:
|
|
|
|
|
Preferred stock
|
-
|
|
-
|
|
Common stock
|
2
|
|
2
|
|
Additional paid-in capital
|
283,539
|
|
279,089
|
|
Accumulated deficit
|
(174,811)
|
|
(142,685)
|
|
Total stockholders'
equity
|
108,730
|
|
136,406
|
|
Total liabilities
and stockholders' equity
|
$
128,636
|
|
$
157,910
|
AADI BIOSCIENCE,
INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except shares and earnings per share amounts)
|
(Unaudited)
|
|
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
|
|
June
30,
|
|
June
30,
|
|
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
Revenue
|
|
|
|
|
|
Product sales, net
|
|
$
3,437
|
|
$
-
|
|
$
5,744
|
|
$
-
|
|
Grant revenue
|
|
|
|
-
|
|
|
|
120
|
|
Total
Revenue
|
|
3,437
|
|
-
|
|
5,744
|
|
120
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
10,006
|
|
830
|
|
19,154
|
|
1,393
|
|
Research and development
|
|
7,726
|
|
3,045
|
|
14,519
|
|
6,689
|
|
Cost of goods sold
|
|
341
|
|
-
|
|
520
|
|
-
|
|
Impairment of intangible asset
|
|
3,724
|
|
-
|
|
3,724
|
|
-
|
|
Total operating
expenses
|
|
|
21,797
|
|
3,875
|
|
37,917
|
|
8,082
|
|
Loss from
operations
|
|
(18,360)
|
|
(3,875)
|
|
(32,173)
|
|
(7,962)
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
Change in fair value of convertible promissory
notes
|
|
-
|
|
2,371
|
|
-
|
|
1,206
|
|
Gain upon extinguishment of debt
|
|
-
|
|
196
|
|
-
|
|
196
|
|
Interest income
|
|
158
|
|
1
|
|
171
|
|
1
|
|
Interest expense
|
|
(58)
|
|
(227)
|
|
(115)
|
|
(451)
|
|
Total other income,
net
|
|
|
100
|
|
2,341
|
|
56
|
|
952
|
|
Loss before income
tax expense
|
|
(18,260)
|
|
(1,534)
|
|
(32,117)
|
|
(7,010)
|
|
Income tax expense
|
|
(9)
|
|
(2)
|
|
(9)
|
|
(2)
|
|
Net
loss
|
|
$
(18,269)
|
|
$
(1,536)
|
|
$
(32,126)
|
|
$
(7,012)
|
|
Net loss per share
attributable to common stockholders, basic
and diluted
|
|
|
|
|
|
|
|
|
|
|
$
(0.87)
|
|
$
(0.60)
|
|
$
(1.53)
|
|
$
(2.76)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding
used in computing net loss per share attributable to common
stockholders, basic and diluted
|
|
20,970,459
|
|
2,542,358
|
|
20,942,804
|
|
2,542,358
|
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SOURCE Aadi Bioscience