Aadi Bioscience Announces Financial Results for the Fourth Quarter and Full-Year 2023 and Provides Corporate Update
- FYARRO sales showed impressive growth, reaching $6.3 million for Q4 2023 and $24.4 million for FY 2023.
- The PRECISION1 trial is progressing well, with enrollment expected to be completed by May 2024 and an interim analysis planned for Q3 2024.
- Phase 2 trials in Endometrial Cancer and Neuroendocrine Tumors are actively enrolling patients, demonstrating the company's commitment to developing therapies for mTOR-driven cancers.
- Aadi Bioscience maintains a solid financial position with cash, cash equivalents, and short-term investments of $108.8 million as of December 31, 2023, expected to fund operations into Q4 2025.
- The company's net loss increased slightly for the three months and full-year ended December 31, 2023, compared to the same periods in 2022, reflecting ongoing investment in research and development.
- A conference call is scheduled to discuss the financial results and recent corporate progress, providing investors and stakeholders with valuable insights into Aadi Bioscience's performance.
- None.
Insights
The reported sales growth for FYARRO® is a positive indicator of Aadi Bioscience's market penetration and product acceptance. A 21% quarterly and 60% annual increase reflect a robust demand trajectory, which is crucial for stakeholders evaluating the company's performance. This growth suggests that Aadi is effectively capitalizing on its niche in precision oncology, particularly for PEComa treatment.
Regarding the PRECISION1 trial, timely completion and the upcoming interim analysis are critical milestones. Positive results could lead to further regulatory approvals and expanded market opportunities. The development in endometrial cancer and neuroendocrine tumors represents strategic diversification within the oncology sector, potentially addressing unmet medical needs and opening additional revenue streams.
However, the increase in net loss year-over-year, despite rising sales, may raise concerns about the company's cost management and path to profitability. The cash runway extending into Q4 2025 provides some reassurance, but it is imperative for the company to work towards reducing losses and achieving a sustainable financial model.
From a financial perspective, Aadi Bioscience's cash reserves of $108.8 million, compared to the previous year's $172.6 million, highlight a significant burn rate. Investors should consider whether the current sales growth can eventually offset the operational costs before the cash runway depletes. The reported net losses underscore the need for a detailed assessment of the company's expense structure and potential cost-saving measures.
It's also important to examine the valuation implications of the clinical trial progress. Positive data from the PRECISION1 trial could be a catalyst for stock appreciation, as it may enhance the company's prospects and justify investment despite short-term losses. Conversely, any setbacks could have a disproportionate negative impact given the company's current financial state.
From a clinical standpoint, the ongoing trials are of considerable interest. The use of nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations represents a targeted approach in precision oncology. If successful, this could lead to improved outcomes for patients with these genetic profiles. The focus on rare diseases like neuroendocrine tumors, which have limited treatment options, is particularly noteworthy. Advancements in this area could have significant implications for patient care and, by extension, the company's clinical reputation.
For endometrial cancer, combining nab-sirolimus with letrozole could offer a novel therapeutic option if earlier promising results are confirmed. As the most common cancer of the female reproductive organs, advancements in treatment can have a broad impact, potentially positioning Aadi Bioscience as a leader in this therapeutic area.
FYARRO® sales of
Registration-directed PRECISION1 trial of nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations on track to complete enrollment by May; two-thirds interim analysis planned for Q3 2024
Phase 2 trials in Endometrial Cancer and Neuroendocrine Tumors (NETs) actively enrolling patients
Conference call to be held today at 8:30 am EDT
"With strong execution against our commercial and development goals, 2023 was a year of progress and momentum for Aadi," said Dave Lennon, President and CEO of Aadi Bioscience. "As the preferred treatment for malignant PEComa, FYARRO saw significant growth and high penetration in academic and community settings. Clinically, we were encouraged by the interim results from the registration-directed PRECISION1 trial, and look forward to the two-thirds readout expected in Q3. We also initiated enrollment of two Phase 2 trials in what we believe are promising mTOR-driven cancer targets, endometrial cancer and neuroendocrine tumors, as we further characterize the potential of nab-sirolimus. With a commercial foundation, bold development vision and solid cash runway in to Q4 2025, we believe we are well-positioned to realize our ambition of becoming a multi-indication precision oncology company."
Recent Operational Highlights
- FYARRO net product sales were
$6.3 million 21% growth over the prior year period, and$24.4 million 60% growth year-over-year. - PRECISION1 on track to complete enrollment by May 2024, with the two-thirds interim analysis expected in Q3 2024. Early data presented in December 2023 demonstrated sustained tumor reductions in heavily pre-treated population from investigator-assessed responses in first 40 patients across both arms. The safety profile was consistent with the nab-sirolimus label and the mTOR inhibitor drug class.
- Enrollment of two single-indication Phase 2 trials underway to investigate the potential of nab-sirolimus for difficult-to-treat mTOR-driven cancers: neuroendocrine tumors (NETs), and advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole.
- NETs are rare, ~3,500 cases a year, with low response rates to existing recommended treatments. Preclinical models indicate improved target suppression relative to other mTORs in the NETS population.
- Endometrial cancer is the most common cancer of the female reproductive organs and one of the few cancers with increasing mortality. There are an estimated 10,000 cases of EEC diagnosed annually. Prior clinical studies with mTOR inhibitors and letrozole have yielded promising results in EEC.
Fourth Quarter and Full-year 2023 Financial Results
- Cash, cash equivalents and short-term investments as of December 31, 2023, were
$108.8 million $172.6 million - Total revenue for the quarter ended December 31, 2023, was
$6.3 million $24.4 million - Net loss for the three months ended December 31, 2023, was
$16.3 million $13.9 million $65.8 million $60.5 million
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 fourth quarter and full-year 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 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-directed trial in mTOR inhibitor-naïve malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. Aadi is also exploring nab-sirolimus in two single-indication 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 full enrollment of the PRECISION 1 trial by May 2024 and the expected PRECISION 1 two-thirds interim analysis in 3Q 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; 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; failure to demonstrate the efficacy of FYARRO in clinical trials for additional indications; risks related to the release of interim, topline and preliminary data from clinical trials; 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 relating to the Company's reliance on third party suppliers, some of which are sole suppliers; 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," 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) | ||||
December 31, | December 31, | |||
2023 | 2022 | |||
Assets | ||||
Current assets: | ||||
Cash and cash equivalents | $ 62,888 | $ 39,019 | ||
Short-term investments | 45,957 | 133,541 | ||
Accounts receivable, net | 5,488 | 1,862 | ||
Inventory | 6,427 | 1,861 | ||
Prepaid expenses and other current assets | 3,826 | 3,746 | ||
Total current assets | 124,586 | 180,029 | ||
Property and equipment, net | 4,802 | 508 | ||
Operating lease right-of-use assets | 1,169 | 1,522 | ||
Other assets | 1,866 | 2,178 | ||
Total assets | $ 132,423 | $ 184,237 | ||
Liabilities and stockholders' equity | ||||
Current liabilities: | ||||
Accounts payable | $ 5,898 | $ 3,519 | ||
Accrued liabilities | 14,306 | 14,922 | ||
Operating lease liabilities, current portion | 434 | 394 | ||
Due to licensor payable | 5,757 | - | ||
Total current liabilities | 26,395 | 18,835 | ||
Operating lease liabilities, net of current portion | 833 | 1,267 | ||
Due to licensor | - | 5,757 | ||
Total liabilities | 27,228 | 25,859 | ||
Stockholders' equity: | ||||
Common stock | 2 | 2 | ||
Additional paid-in capital | 374,129 | 361,689 | ||
Accumulated other comprehensive income (loss) | 27 | (115) | ||
Accumulated deficit | (268,963) | (203,198) | ||
Total stockholders' equity | 105,195 | 158,378 | ||
Total liabilities and stockholders' equity | $ 132,423 | $ 184,237 | ||
AADI BIOSCIENCE, INC. | |||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
(In thousands, except share data and earnings per share amounts) | |||||||||
(Unaudited) | |||||||||
Three months ended | Twelve months ended | ||||||||
December 31, | December 31, | ||||||||
2023 | 2022 | 2023 | 2022 | ||||||
Revenue | |||||||||
Product sales, net | $ 6,326 | $ 5,227 | $ 24,354 | $ 15,216 | |||||
Total Revenue | 6,326 | 5,227 | 24,354 | 15,216 | |||||
Operating expenses | |||||||||
Selling, general and administrative | 10,345 | 11,106 | 44,549 | 40,176 | |||||
Research and development | 12,768 | 9,369 | 48,929 | 32,662 | |||||
Cost of goods sold | 927 | 222 | 2,809 | 1,335 | |||||
Impairment of acquired contract intangible asset | - | - | - | 3,724 | |||||
Total operating expenses | 24,040 | 20,697 | 96,287 | 77,897 | |||||
Loss from operations | (17,714) | (15,470) | (71,933) | (62,681) | |||||
Other income (expense) | |||||||||
Foreign exchange gain (loss) | 2 | - | (1) | - | |||||
Interest income | 1,500 | 1,606 | 6,400 | 2,398 | |||||
Interest expense | (57) | (57) | (231) | (230) | |||||
Total other income (expense), net | 1,445 | 1,549 | 6,168 | 2,168 | |||||
Loss before income tax expense | (16,269) | (13,921) | (65,765) | (60,513) | |||||
Income tax expense | - | 9 | - | - | |||||
Net loss | $ (16,269) | $ (13,912) | $ (65,765) | $ (60,513) | |||||
Net loss per share, basic and diluted | $ (0.60) | $ (0.52) | $ (2.44) | $ (2.69) | |||||
Weighted average number of common shares outstanding, basic and diluted | 26,965,909 | 26,839,033 | 26,917,967 | 22,511,237 | |||||
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SOURCE Aadi Bioscience
FAQ
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