Aadi Bioscience Announces Financial Results and Operational Update for the First Quarter 2023 and Provides Update on PRECISION 1 Tumor Agnostic Trial
Total 1Q 2023 revenue on FYARRO® sales of
PRECISION 1 tumor agnostic trial enrolling equally in TSC1 and TSC2 arms with more than 15 discreet tumor types represented
Interim analysis on 40 patients with appropriate follow-up in PRECISION 1 trial expected by end of 2023
Conference call to be held today at 8:30 am EDT
"We are excited about the uptake of FYARRO and its continued sales growth after our first year on the market and believe we are operating from a position of strength with solid cash balances into 2025," said
First Quarter 2023 Updates and Recent Operational Highlights
- Based on initial information from the PRECISION 1 trial, enrollment is well-balanced, and the trial is accruing evenly between the TSC1 and TSC2 arms. More than 15 discreet tumor types have been enrolled with no more than three of any type, supporting the thesis that TSC1 and TSC2 alterations occur broadly across different solid tumors. A pre-planned interim analysis on 40 patients with appropriate follow-up is expected by the end of 2023.
- FYARRO net product sales were
$5.9 million in the first quarter, continued double-digit growth of 12% quarter-over-quarter.
- The appointment of
Mohammad Hirmand , M.D., to Board of Directors.Dr. Hirmand , previously Chief Medical Officer ofTurning Point Therapeutics prior to its acquisition by BMS, is the co-founder ofAvenzo Therapeutics, Inc. , and serves as executive vice president and chief medical officer of this privately held biotechnology company focused on oncology therapeutics.
- Multiple presentations at AACR Annual Meeting 2023. Aadi presented an encore trials-in-progress (TIP) poster for the ongoing PRECISION 1 trial; results on the anti-tumor activity of nab-sirolimus in combination with KRASG12C inhibitors in xenograft models; and results of a biomarker analysis from AMPECT correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations. The AACR posters can be found here on the Aadi website.
- Multiple presentations at SGO Annual Meeting 2023. Aadi presented a TIP poster for the ongoing PRECISION 1 trial and additional data with nab-sirolimus from its AMPECT trial at SGO 2023. The SGO posters can be found here on the Aadi website.
- Upcoming presentations at ASCO Annual Meeting 2023. Aadi will present a company-sponsored TIP update from the PRECISION 1 Phase 2 study and combination data of nab-sirolimus and pazopanib (PAZO) from an ongoing Investigator Initiated Trial at ASCO 2023, taking place
June 2-6, 2023 , inChicago . Following Aadi's presentation at ASCO, the posters will be made available on the investor relations page of the Aadi website at www.aadibio.com.
- Initiation of Phase 1/2 trial in KRASG12C is expected to begin with first patient dosing in the second quarter of 2023. The study will evaluate the combination of adagrasib with nab-sirolimus in collaboration with Mirati Therapeutics. 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.
First Quarter 2023 Financial Results
- Total revenue resulting from sales of FYARRO for the quarter ended
March 31, 2023 was$5.9 million . This compares to the prior year period of$2.3 million and$5.2 million in the fourth quarter 2022.
- Cash, cash equivalents and short-term investments as of
March 31, 2023 were$151.2 million as compared to$172.6 million as ofDecember 31, 2022 , which is expected to fund operations into 2025 based on current plans.
- Net loss for the three months ended
March 31, 2023 was$15.2 million as compared to$13.9 million for the three months endedMarch 31, 2022 .
Conference Call Information
The Aadi management team is hosting a conference call and webcast today at
Participants may access a live webcast of the call on the "Investors & News" page of the
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 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
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 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 is conducting the PRECISION 1 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 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
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
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
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CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
(Unaudited) |
|||||
|
|
||||
2022 |
2022 |
||||
Assets |
|||||
Current assets: |
|||||
Cash and cash equivalents |
$ 34,046 |
$ 39,019 |
|||
Short-term investments |
117,128 |
133,541 |
|||
Accounts receivable, net |
5,565 |
1,862 |
|||
Inventory |
3,803 |
1,861 |
|||
Prepaid expenses and other current assets |
4,388 |
3,746 |
|||
Total current assets |
164,930 |
180,029 |
|||
Property and equipment, net |
2,225 |
508 |
|||
Operating lease right-of-use assets |
1,437 |
1,522 |
|||
Other assets |
2,062 |
2,178 |
|||
Total assets |
$ 170,654 |
$ 184,237 |
|||
Liabilities and stockholders' equity |
|||||
Current liabilities: |
|||||
Accounts payable |
$ 6,510 |
$ 3,519 |
|||
Accrued liabilities |
10,833 |
14,922 |
|||
Operating lease liabilities, current portion |
404 |
394 |
|||
Total current liabilities |
17,747 |
18,835 |
|||
Operating lease liabilities, net of current portion |
1,164 |
1,267 |
|||
Due to licensor |
5,757 |
5,757 |
|||
Total liabilities |
24,668 |
25,859 |
|||
Stockholders' equity: |
|||||
Common stock |
2 |
2 |
|||
Additional paid-in capital |
364,437 |
361,689 |
|||
Accumulated other comprehensive loss |
(32) |
(115) |
|||
Accumulated deficit |
(218,421) |
(203,198) |
|||
Total stockholders' equity |
145,986 |
158,378 |
|||
Total liabilities and stockholders' equity |
$ 170,654 |
$ 184,237 |
|
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(In thousands, except shares and earnings per share amounts) |
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(Unaudited) |
|||||||
Three months ended |
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|
|||||||
2023 |
2022 |
||||||
Revenue |
|||||||
Product sales, net |
$ 5,867 |
$ 2,307 |
|||||
Total Revenue |
5,867 |
2,307 |
|||||
Operating expenses |
|||||||
Selling, general and administrative |
11,207 |
9,148 |
|||||
Research and development |
10,956 |
6,794 |
|||||
Cost of goods sold |
529 |
179 |
|||||
Total operating expenses |
22,692 |
16,121 |
|||||
Loss from operations |
(16,825) |
(13,814) |
|||||
Other income (expense) |
|||||||
Interest income |
1,660 |
15 |
|||||
Interest expense |
(58) |
(58) |
|||||
Total other income (expense), net |
1,602 |
(43) |
|||||
Net loss |
$ (15,223) |
$ (13,857) |
|||||
Net loss per share attributable to common stockholders, basic and diluted |
|||||||
$ (0.57) |
$ (0.66) |
||||||
Weighted average number of common shares outstanding used in |
26,862,646 |
20,914,812 |
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