Whitehawk Therapeutics, Inc. (NASDAQ: WHWK)

Aadi Bioscience, Inc., with the ticker symbol AADI, operates in the biopharmaceutical industry. The company is dedicated to developing and commercializing precision therapies for cancers with alterations in the mTOR pathway. Its primary drug product, FYARRO (sirolimus protein-bound particles for injectable suspension (albumin-bound); nab-sirolimus), is a potent inhibitor of the mTOR biological pathway, demonstrating anti-cancer activity in its lead indication, advanced malignant perivascular epithelioid cell tumor (PEComa).

Aadi Bioscience's main business activities revolve around the development and commercialization of FYARRO. The company is currently exploring the application of FYARRO as a monotherapy and combination therapy with other agents. They are also establishing capabilities and partnerships outside the United States to effectively commercialize and maximize the value of FYARRO. The company operates in the United States and is evaluating strategic partnerships to expand its reach internationally.

The company generates revenue primarily from the sales of FYARRO. FYARRO is a form of sirolimus bound to albumin, which takes advantage of the protein albumin's ability to accumulate in tumors. The company believes that FYARRO's differentiated clinical pharmacologic and pharmacokinetic profile, high tumor accumulation, and ability to effectively inhibit important targets in the mTOR pathway make it a well-positioned drug to address resistance and suboptimal efficacy of existing mTOR inhibitors. Aadi Bioscience's primary customers are cancer patients and healthcare providers.

Within the industry, Aadi Bioscience positions itself as a leader in the development of precision therapies for cancers with alterations in the mTOR pathway. The company's competitive advantages include its proprietary nanoparticle albumin-bound (nab) technology, which allows for high tumor accumulation and effective inhibition of the mTOR pathway. Key competitors for Aadi Bioscience include other biopharmaceutical companies developing mTOR inhibitors, such as Pfizer's Sutent and Novartis's Afinitor.

Aadi Bioscience's product portfolio includes FYARRO, a potent inhibitor of the mTOR biological pathway. The company's intellectual property consists of twelve (12) issued patents in the United States and other countries, as well as relying on trade secret protection for its proprietary information that is not amenable to, or that it does not consider appropriate for, patent protection.

In terms of manufacturing, Aadi Bioscience does not own or operate any manufacturing facilities and relies on third-party manufacturers to produce FYARRO. The company has a fully validated commercial manufacturing process in place for FYARRO at Fresenius Kabi's Grand Island Manufacturing facility.

Government regulation plays a significant role in Aadi Bioscience's operations. The company must comply with applicable regulations, including the Federal Food, Drug, and Cosmetic Act, and its implementing regulations, as well as other federal, state, and local statutes and regulations. Before approving an NDA, the FDA typically conducts a pre-approval inspection of the manufacturing facilities for the new drug to determine whether they comply with cGMPs. The FDA may also require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product's safety and effectiveness after commercialization and may limit further marketing of the product based on the results of these post-marketing studies. Aadi Bioscience received approval for the commercial sale of FYARRO from the FDA to treat patients with advanced (metastatic or locally advanced) PEComas in November 2021. The company may explore opportunities for FYARRO, such as fast track designation, priority review, accelerated approval, and breakthrough therapy designation, as appropriate.