Corporate Overview
December 2021
NASDAQ: AADI
www.aadibio.com
Aadi Bioscience Inc., Pacific Palisades, CA 90272, USA1
Cautionary Note Regarding Forward-Looking Statements
Certain statements contained in this presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation
Act of 1995, known as the PSLRA. These include statements regarding management's intention, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Aadi Bioscience, Inc. ("Aadi") undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as "anticipates," "believes," "plans," "expects," "projects," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "continue," "guidance," and similar expressions to identify
these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA.
Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Aadi's plans to develop and commercialize its product candidates, including FYARRO™ (nab-sirolimus,ABI-009); Aadi's commercialization, marketing and manufacturing capabilities and strategy; the clinical utility, potential benefits and market acceptance of FYARRO and any other of Aadi's product candidates; risks related to the sufficiency Aadi's cash balance to fund
operations; the timing of initiation of Aadi's planned clinical trials; the timing of the availability of data from Aadi's clinical trials; Aadi's plans to research, develop and commercialize its current and future product candidates; Aadi's ability to successfully enter into collaborations, and to fulfill its obligations under any such collaboration agreements; Aadi's ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Aadi's competitors and our its industry; the impact of government laws and regulations; Aadi's ability to protect its intellectual property position; the impact of the COVID-19 outbreak on Aadi's operations, the biotechnology industry and the economy generally and Aadi's estimates regarding future revenue, expenses, capital requirements and need for additional financing.
These risks are described in detail under the caption "Risk Factors" in Aadi's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission (the "SEC") on November 10, 2021, and other documents filed from time to time with the SEC. Forward-looking statements included in this presentation are based on information available to Aadi as of the date of this presentation. Aadi undertakes any obligation to such forward-looking statements to reflect events or circumstances after the date of this presentation.
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FYARRO Granted Full Approval Following Priority Review by the FDA
FDA Approval Nov 22, 2021
First and only therapy approved to treat locally advanced unresectable or metastatic malignant PEComa
Albumin-boundmTOR inhibitor leveraging nab-technology to deliver a favorable clinical profile in an area of high unmet medical need
Efficacy defined by ORR and DOR in the prescribing information
Adverse event profile that is predictable and manageable
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Aadi Bioscience is a Commercial-Stage, Precision Oncology Company Re-engineering mTOR Inhibition
- Focused on the commercialization of FYARROTM (sirolimus protein-bound particles for injectable suspension [albumin-bound],nab-sirolimus), an albumin-bound mTOR inhibitor developed using the validated nanoparticle albumin-based (nab) platform proven with ABRAXANE®
- FYARRO™ now FDA approved as the only product indicated for locally advanced unresectable or metastatic malignant PEComa; commercial preparations underway ahead of Q1 2022 launch
NASDAQ: AADI
- New registrational study to be initiated pursuing a significant potential opportunity in tumor- agnostic TSC1 or TSC2 inactivating alterations in solid tumors - recent data (ASCO 2021) suggests encouraging activity of ABI-009
- Cash runway into 2024 to support commercialization and future clinical development of FYARRO™
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Leadership: We are Building a World-Class Team with Deep Expertise in Oncology Commercialization and Development
Neil Desai, PhD | Brendan Delaney, MBA | Scott Giacobello, CPA | Loretta Itri, MD |
Founder, CEO | Chief Operating Officer | Chief Financial Officer | Chief Medical Officer |
and President | |||
• Former Sr VP, Global | • Previously CCO at | • Previously CFO GW | • Previously CMO at |
R&D at Abraxis | Constellation Pharma | Pharmaceuticals | Immunomedics |
Bioscience | (acquired by MorphSys) | • Former CFO Chase | • Former EVP Global |
• Previously Vice | • Former CCO at | ||
Pharmaceutical Corp.; | Health Sciences & | ||
President, Strategic | Immunomedics | EVP&CFO VIZI Health | Regulatory Affairs, The |
Platforms, Celgene; | (acquired by Gilead); VP | Solutions; VP Finance- | Medicines Company; |
prior positions of | of US Hematology | Global R&D Allergan as | President, |
increasing seniority at | /Oncology at Celgene | well as VP Corporate | Pharmaceutical |
American BioScience, | • 25+ years commercial | Finance and VP Finance | Development, CMO |
Inc. | - Audit and Compliance | Genta, Inc.; SVP, WW | |
• Inventor of the nab | experience including | • 13+ years | Clinical Affairs at |
prior roles at Novartis | Johnson & Johnson, | ||
technology (Abraxane | Oncology and | pharmaceutical finance | Ortho Biotech |
and ABI-009) | Genentech | experience | • 40+ years drug |
• 25+ years in R&D | |||
development | |||
experience |
Mitchall Clark, | Lynn Samuel | Andrew Kwon, |
BPharm, MRPharmS | VP Manufacturing and | PhD, MBA |
SVP Regulatory Affairs and | Supply Chain | VP BD & Corporate |
Quality Assurance | Strategy | |
• Previously Chief | • Previously SVP Global | • Previously Principal, |
Regulatory / Quality | Supply Chain, Nant | Acsel Health; Director, |
Officer, Atara | BioScience | Syneos Health |
Biotherapeutics | • Former SVP Global | Consulting |
• Former SVP Regulatory | • Former Research | |
Quality Assurance, | ||
Affairs at Abraxis | ImmunityBio; VP | Scientist at Memorial |
Bioscience | Manuf. Operations, | Sloan Kettering Cancer |
• Worldwide regulatory | NantPharma; | Center |
• Sr. Dir., Nanotechnology | • 14+ years biotech | |
experience with | ||
Abraxane; 25+ years in | Program, Abraxis | industry experience |
regulatory affairs | BioScience; led | focused on Business |
Abraxane manufacturing | Development and | |
in >37 countries | Commercial Strategy in | |
• 40+ years in | oncology | |
pharmaceutical | ||
operations |
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Aadi Bioscience Inc. published this content on 07 December 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 December 2021 15:01:02 UTC.