Aadi Bioscience, Inc. (NASDAQ:AADI) - Unlocking the Potential of mTOR Inhibition Through Innovative Nab-Sirolimus

Published on September 24, 2024 | Ticker: AADI

Aadi Bioscience, Inc. (NASDAQ:AADI) is a biopharmaceutical company focused on developing and commercializing precision therapies for cancers with alterations in the mTOR pathway. The company's lead drug product, FYARRO® (sirolimus protein-bound particles for injectable suspension (albumin-bound); nab-sirolimus), combines nanoparticle albumin-bound (nab) technology and the anti-cancer agent, sirolimus. Nab-sirolimus is a potent inhibitor of the mTOR biological pathway with demonstrated anti-cancer activity in Aadi's lead indication, advanced malignant perivascular epithelioid cell tumor (PEComa), a rare cancer.

Financials

In the first quarter of 2024, Aadi reported net product sales of $5.4 million for FYARRO, a decrease of 8.8% from the prior year period. The decrease was due in part to changes in distributor ordering patterns and fewer new commercial patient initiations in Q1 than the historical average. However, the company expects a return to sales growth in Q2 2024. FYARRO has cemented its position as the preferred treatment for malignant PEComa after just two years on the market, with the company seeing consistent addition of new accounts ordering FYARRO every quarter and more than 200 accounts ordering since launch.

For the full year 2023, Aadi reported annual revenue of $24.4 million and a net loss of $65.8 million. The company's annual operating cash flow was -$59.7 million, and its annual free cash flow was -$63.6 million. As of March 31, 2024, Aadi had $88.3 million in cash, cash equivalents, and short-term investments, which the company believes will fund its operations into the fourth quarter of 2025.

Business Overview

Aadi's clinical development pipeline is focused on unlocking the full potential of mTOR inhibition. The company's registration-directed PRECISION1 trial, which is now fully enrolled, is evaluating nab-sirolimus in patients with malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. This trial is a significant opportunity for Aadi, as the company estimates there are approximately 16,000 patients with these mutations across a variety of tumor types, representing a potential multibillion-dollar total addressable market.

In the first interim analysis of the PRECISION1 trial, which included data from the first 40 patients, Aadi reported an investigator-assessed overall response rate of 26% in the TSC1 arm. These responses appeared to be early, deep, and durable, which is particularly noteworthy given the heavily pretreated nature of the patient population. Aadi is on track to report a two-thirds interim analysis of the PRECISION1 trial, which will include data from 80 patients with a minimum of six months of follow-up, in the third quarter of 2024.

In addition to the PRECISION1 trial, Aadi is also evaluating nab-sirolimus in two Phase 2 trials. The first is assessing the combination of nab-sirolimus and the aromatase inhibitor letrozole in advanced or recurrent endometrioid-type endometrial cancer (EEC), and the second is evaluating nab-sirolimus as a monotherapy in neuroendocrine tumors (NETs). Both of these trials are expected to report initial data by the end of 2024.

Aadi's business overview can be summarized as follows:

1. Commercialization of FYARRO for advanced malignant PEComa:

FYARRO was approved by the FDA in November 2021 and launched commercially in the U.S. in February 2022. The drug has cemented its position as the preferred treatment for this rare and aggressive cancer.

2. Expansion of nab-sirolimus into additional indications:

Aadi is leveraging the unique properties of nab-sirolimus to explore its potential in a variety of mTOR-driven cancers, including TSC1/TSC2-mutant solid tumors, endometrial cancer, and neuroendocrine tumors.

3. Robust clinical development pipeline:

In addition to the PRECISION1 trial, Aadi has two ongoing Phase 2 trials evaluating nab-sirolimus in EEC and NETs, with initial data expected by the end of 2024.

Liquidity

Aadi's financial position remains strong, with $88.3 million in cash, cash equivalents, and short-term investments as of March 31, 2024. This cash runway is expected to fund the company's operations into the fourth quarter of 2025. However, Aadi's net loss for the full year 2023 was $65.8 million, and the company's annual operating and free cash flows were negative $59.7 million and $63.6 million, respectively.

Risks and Challenges

The company's key risks include the successful execution of its clinical development programs, regulatory approval for nab-sirolimus in additional indications, and the continued commercial success of FYARRO. Aadi also faces competition from other mTOR inhibitors and potential challenges in manufacturing and supply chain management.

Conclusion

Overall, Aadi Bioscience is well-positioned to capitalize on the potential of nab-sirolimus in a variety of mTOR-driven cancers. The company's robust clinical pipeline, led by the PRECISION1 trial, and the commercial success of FYARRO in advanced malignant PEComa provide a solid foundation for future growth. Investors will be closely watching the upcoming data readouts from Aadi's clinical trials, which could serve as significant catalysts for the company.

You may be interested in...

Pasithea Therapeutics Corp. (NASDAQ:KTTA): A Biotech Innovator Advancing Groundbreaking Treatments for CNS Disorders and Rare Diseases

Pasithea Therapeutics Corp. (NASDAQ:KTTA) is a clinical-stage biotechnology company at the forefront of developing innovative treatments for central nervous system (CNS) disorders and other diseases, including RASopathies. The company’s primary focus is on advancing its lead therapeutic candidate, PAS-004, a next-generation macrocyclic mitogen-activated protein kinase (MEK) inhibitor, which holds the potential to address the limitations and liabilities associated with existing drugs targeting a similar mechanism of action.

Aadi Bioscience (NASDAQ:AADI) – Unlocking the Full Potential of mTOR Inhibition

Aadi Bioscience is a biopharmaceutical company dedicated to developing and commercializing precision therapies for cancers driven by alterations in the mTOR pathway, a critical regulator of cell growth and cancer progression. The company’s lead product, FYARRO, combines nanoparticle albumin-bound (nab) technology with the potent mTOR inhibitor, sirolimus, to deliver better outcomes for patients with mTOR-dependent cancers.

Aileron Therapeutics (ALRN): Navigating the Frontiers of Orphan Pulmonary and Fibrosis Treatments

Aileron Therapeutics, Inc. (NASDAQ: ALRN) is a biopharmaceutical company at the forefront of developing novel therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. With a focus on pioneering first-in-class medicines, Aileron has built a promising pipeline that includes two product candidates in clinical development and multiple preclinical programs targeting critical fibrosis pathways.

Aprea Therapeutics (APRE): A Promising Oncology Player With a Robust Pipeline

Aprea Therapeutics, Inc. (NASDAQ:APRE) is a clinical-stage biopharmaceutical company at the forefront of precision oncology, leveraging the power of synthetic lethality to develop groundbreaking cancer therapies. With a focus on DNA damage response (DDR) pathways, Aprea has assembled a promising pipeline of novel product candidates poised to transform the treatment landscape for patients battling a wide range of malignancies.

Puma Biotechnology (NASDAQ: PBYI): Navigating Cancer Therapeutics with Innovation and Resilience

Puma Biotechnology, a biopharmaceutical company, has been at the forefront of developing innovative cancer treatments, with a particular focus on addressing the unmet needs of patients battling breast and lung cancer. Founded in 2010, the company’s journey has been marked by both challenges and triumphs, as it continues to navigate the dynamic landscape of the pharmaceutical industry.