Completed $72.5
million PIPE financing extending cash runway into
2025
PRECISION 1 trial on-track with preliminary
data expected in the first half of 2023
24% revenue growth of FYARRO® (nab-sirolimus)
over the second quarter 2022
Appointment of Neil
Desai to Executive Chairman and transition of Brendan Delaney to CEO effective January 1, 2023
Conference call to be held today at
8:30 am ET
LOS
ANGELES, Nov. 9, 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 third quarter of 2022.
"The last several months have been transformational for Aadi,
most recently having strengthened our balance sheet with a
$72.5 million PIPE financing. In
addition, we saw continued progress in patient enrollment for the
PRECISION 1 trial targeting TSC1 and TSC2
inactivating alterations, and we anticipate providing preliminary
data on a meaningful number of patients from PRECISION 1 in the
first half of 2023," said Neil
Desai, Ph.D., Founder and Chief Executive Officer of
Aadi. "We also expanded our pipeline through the recent
clinical collaboration with Mirati to explore the combination of
nab-sirolimus with the KRAS inhibitor adagrasib, which we
believe could potentially overcome tumor resistance."
"We have made great progress in the last year, positioning us
well for the next phase of growth. In preparation for the
advancements to come, we are also realigning our management
structure. We announced last evening that I am moving into
the role of Executive Chairman while our current COO, Brendan Delaney, will transition to President
and CEO," continued Desai. "Brendan's proven expertise, committed
leadership and broad strategic vision have been key drivers of our
success. Going forward, Brendan will assume leadership of the
Company while my personal focus will turn toward advancement of our
scientific initiatives."
Brendan Delaney, current Chief
Operating Officer of Aadi commented, "It's such an exciting time at
Aadi, and I couldn't be more pleased with the execution our team
has demonstrated. I am honored to have been selected to lead
this organization as we move forward and execute on the strategies
that will support further growth. Our oncology franchise is
growing, and I believe we are well-positioned to achieve our
goal of becoming a leading precision oncology company that delivers
on providing therapeutic benefit to patients in need."
Corporate Updates for the Third Quarter 2022 and Recent
Highlights
- Closed on a $72.5M
financing and extended cash runway into 2025. The
proceeds from the financing will be used to support the continued
advancement of the PRECISION 1 trial and growing FYARRO commercial
efforts, and to fund research and development of additional
clinical opportunities with FYARRO and for working capital and
general corporate purposes.
- Continued advancement of the PRECISION 1
registrational-directed trial. The PRECISION 1 Phase 2 trial in
patients with tumor agnostic TSC 1 and 2 inactivating mutations is
advancing and on track to deliver preliminary data in the first
half of 2023.
- Grew FYARRO net product sales. For the three months
ended September 30, 2022, net product
sales of FYARRO showed continued growth, ending with $4.2 million in sales in the third quarter, a 24%
increase over the second quarter.
- Leadership transition. Current CEO, Dr. Neil Desai, has been appointed Executive
Chairman, effective January 1, 2023.
Current COO, Brendan Delaney, will
transition to President and CEO, and will be joining the board of
directors, effective January 1,
2023.
- Signed a clinical collaboration agreement with Mirati
Therapeutics on combination of adagrasib with
nab-sirolimus. The companies will conduct an open-label
Phase 1/2 trial to determine the optimal dose and recommended Phase
2 dose for the combination of adagrasib and nab-sirolimus in
patients with KRASG12C - mutant solid tumors. The trial
builds on preclinical data showing enhanced anti-tumor efficacy
with the combination of adagrasib and nab-sirolimus relative
to either agent alone. Initiation of the Phase 1/2 trial is
expected in the first half of 2023.
- Presented combination data of KRAS inhibitors and
nab-sirolimus at the 34th EORTC-NCI-AACR
Symposium. The results of these studies showed that
combining nab-sirolimus with either of the
KRASG12C inhibitors sotorasib or adagrasib significantly
improved response against KRASG12C mutant lung cancer
and bladder cancer tumors in vivo and nab-sirolimus
also showed significantly greater potency in the combination
compared to everolimus.
Third Quarter 2022 Financial Results
- Cash, cash equivalents and short-term investments as of
September 30, 2022 were $183.0 million as compared to $149.0 million as of December 31, 2021, which is expected to fund
operations into 2025 based on current plans.
- Total revenue for the quarter ended September 30, 2022 was $4.2 million resulting from sales of FYARRO.
- Net loss for the three months ended September 30, 2022 was $14.5 million as compared to $87.1 million for the three months ended
September 30, 2021. The prior year
quarter included the non-cash impairment charge of $74.2 million related to the acquired contract
intangible asset incurred in conjunction with the Aerpio
merger.
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 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
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 of 2021 and in February of
2022 commercialized FYARRO® for the treatment of adult patients
with locally advanced unresectable or metastatic malignant
perivascular epithelioid cell tumor (PEComa).
Aadi has also 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 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 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; the Company's
anticipated growth; plans and potential for success relating to
commercializing FYARRO; expectations regarding the beneficial
characteristics, safety, efficacy and therapeutic effects of
FYARRO; expectations regarding management's performance; 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; plans regarding
clinical trials, 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 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 1A. Risk Factors," and in Aadi's subsequent Quarterly Reports
on Form 10-Q filed on May 12, 2022,
August 10, 2022 and November 9, 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)
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2022
|
|
2021
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash equivalents
|
$
134,815
|
|
$
148,989
|
Short-term investments
|
48,192
|
|
-
|
Accounts receivable, net
|
2,261
|
|
-
|
Inventory
|
734
|
|
-
|
Prepaid expenses and other current assets
|
3,861
|
|
2,283
|
Total current
assets
|
189,863
|
|
151,272
|
Property and equipment,
net
|
457
|
|
57
|
Operating lease
right-of-use assets
|
1,573
|
|
557
|
Intangible asset,
net
|
-
|
|
3,811
|
Other assets
|
|
2,210
|
|
2,213
|
Total
assets
|
$
194,103
|
|
$
157,910
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable
|
$
3,920
|
|
$
6,439
|
Accrued liabilities
|
13,597
|
|
8,703
|
Operating lease liabilities, current portion
|
374
|
|
131
|
Total current
liabilities
|
17,891
|
|
15,273
|
Operating lease
liabilities, net of current portion
|
|
1,347
|
|
474
|
Due to
licensor
|
|
5,757
|
|
5,757
|
Total
liabilities
|
24,995
|
|
21,504
|
Stockholders'
equity:
|
|
|
|
Preferred stock
|
-
|
|
-
|
Common stock
|
2
|
|
2
|
Additional paid-in capital
|
358,490
|
|
279,089
|
Accumulated other comprehensive loss
|
(99)
|
|
|
Accumulated deficit
|
(189,285)
|
|
(142,685)
|
Total stockholders'
equity
|
169,108
|
|
136,406
|
Total liabilities
and stockholders' equity
|
$
194,103
|
|
$
157,910
|
AADI BIOSCIENCE,
INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
|
(In thousands,
except shares and earnings per share amounts)
|
(Unaudited)
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
|
|
|
September
30,
|
|
September
30,
|
|
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
Revenue
|
|
|
|
|
|
Product sales, net
|
|
$
4,245
|
|
$
-
|
|
$
9,989
|
|
$
-
|
|
Grant revenue
|
|
|
|
-
|
|
-
|
|
120
|
|
Total
Revenue
|
|
4,245
|
|
-
|
|
9,989
|
|
120
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
9,915
|
|
7,401
|
|
29,069
|
|
8,793
|
|
Research and development
|
|
8,773
|
|
5,754
|
|
23,292
|
|
12,443
|
|
Cost of goods sold
|
|
593
|
|
-
|
|
1,113
|
|
-
|
|
Impairment of intangible asset
|
|
-
|
|
74,156
|
|
3,724
|
|
74,156
|
|
Total operating
expenses
|
|
|
19,281
|
|
87,311
|
|
57,198
|
|
95,392
|
|
Loss from
operations
|
|
(15,036)
|
|
(87,311)
|
|
(47,209)
|
|
(95,272)
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
Change in fair value of convertible promissory
notes
|
|
-
|
|
380
|
|
-
|
|
1,585
|
|
Gain upon extinguishment of debt
|
|
-
|
|
-
|
|
-
|
|
196
|
|
Interest income
|
|
620
|
|
-
|
|
791
|
|
1
|
|
Interest expense
|
|
(58)
|
|
(157)
|
|
(173)
|
|
(608)
|
|
Total other income,
net
|
|
|
562
|
|
223
|
|
618
|
|
1,174
|
|
Loss before income
tax expense
|
|
(14,474)
|
|
(87,088)
|
|
(46,591)
|
|
(94,098)
|
|
Income tax expense
|
|
-
|
|
-
|
|
(9)
|
|
(2)
|
|
Net
loss
|
|
(14,474)
|
|
(87,088)
|
|
(46,600)
|
|
(94,100)
|
|
Other comprehensive
loss
|
|
|
|
|
|
|
|
|
|
Change in unrealized loss on short-term
investments
|
|
(99)
|
|
-
|
|
(99)
|
|
-
|
|
Comprehensive
loss
|
|
$
(14,573)
|
|
$
(87,088)
|
|
$
(46,699)
|
|
$
(94,100)
|
|
Net loss per share
attributable to common stockholders,
basic and diluted
|
|
|
|
|
|
|
|
|
|
|
$
(0.68)
|
|
$
(9.17)
|
|
$
(2.21)
|
|
$
(19.37)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding
used in computing net loss per share attributable to common
stockholders, basic and diluted
|
|
21,269,163
|
|
9,510,379
|
|
21,052,786
|
|
4,890,556
|
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