EX-99.1 15 d119681dex991.htm EX-99.1 EX-99.1

Exhibit 99.1 Corporate Overview August 2021 NASDAQ: AADI www.aadibio.com Aadi Bioscience Inc., Pacific Palisades, CA 90272, USA 1Exhibit 99.1 Corporate Overview August 2021 NASDAQ: AADI www.aadibio.com Aadi Bioscience Inc., Pacific Palisades, CA 90272, USA 1


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, risks related to the sufficiency Aadi’s cash balance to fund operations; Aadi’s plans to develop and potentially commercialize its product candidates, including FYARRO™ (nab-sirolimus, ABI- 009); the timing of initiation of Aadi’s planned clinical trials; the timing of the availability of data from Aadi’s clinical trials; the timing of regulatory review of Aadi’s new drug application for FYARRO; 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; the clinical utility, potential benefits and market acceptance of FYARRO and any other of Aadi’s product candidates; Aadi’s commercialization, marketing and manufacturing capabilities and strategy; 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 the definitive proxy statement filed with the Securities and Exchange Commission (the “SEC”) on July 8, 2021 in connection with the Aerpio reverse merger with Aadi. Additional risks and uncertainties are identified and discussed in the “Risk Factors” section of Aerpio’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2021, and other documents filed from time to time with the SEC, including Aadi’s Quarterly Report on Form 10-Q to be filed with the SEC for the quarter-ended September 30, 2021. 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. 2Cautionary 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, risks related to the sufficiency Aadi’s cash balance to fund operations; Aadi’s plans to develop and potentially commercialize its product candidates, including FYARRO™ (nab-sirolimus, ABI- 009); the timing of initiation of Aadi’s planned clinical trials; the timing of the availability of data from Aadi’s clinical trials; the timing of regulatory review of Aadi’s new drug application for FYARRO; 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; the clinical utility, potential benefits and market acceptance of FYARRO and any other of Aadi’s product candidates; Aadi’s commercialization, marketing and manufacturing capabilities and strategy; 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 the definitive proxy statement filed with the Securities and Exchange Commission (the “SEC”) on July 8, 2021 in connection with the Aerpio reverse merger with Aadi. Additional risks and uncertainties are identified and discussed in the “Risk Factors” section of Aerpio’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2021, and other documents filed from time to time with the SEC, including Aadi’s Quarterly Report on Form 10-Q to be filed with the SEC for the quarter-ended September 30, 2021. 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. 2


AADI BIOSCIENCE, INC: INTRODUCTION Aadi-Aerpio Merger Closed • Aadi Bioscience, Inc. trading on Nasdaq under “AADI” following merger with Aerpio Pharmaceuticals, Inc. • The company will focus on advancing Aadi’s lead product candidate, FYARRO™ (nab-sirolimus, ABI-009) • Concurrent PIPE financing of $155 million led by Acuta and KVP and including Avoro, Venrock, BVF, Vivo, Alta, Rock Springs, RTW, Acorn, and Serrado • Cash balance post-closing of approximately $170 million with projected runway into 2024 • Total shares outstanding: 20.8 million 3AADI BIOSCIENCE, INC: INTRODUCTION Aadi-Aerpio Merger Closed • Aadi Bioscience, Inc. trading on Nasdaq under “AADI” following merger with Aerpio Pharmaceuticals, Inc. • The company will focus on advancing Aadi’s lead product candidate, FYARRO™ (nab-sirolimus, ABI-009) • Concurrent PIPE financing of $155 million led by Acuta and KVP and including Avoro, Venrock, BVF, Vivo, Alta, Rock Springs, RTW, Acorn, and Serrado • Cash balance post-closing of approximately $170 million with projected runway into 2024 • Total shares outstanding: 20.8 million 3


Aadi Board of Directors CEO Board of Directors Neil Desai, PhD Behzad Aghazadeh, PhD Caley Castelein, MD Anupam Dalal, MD Karin Hehenberger, MD, PhD Richard Maroun Founder, CEO and President Chairman • Former Sr VP, Global • Managing Partner & • Managing Director, KVP • Chief Investment Officer & • Founder & CEO, Lyfebulb • Partner, General Counsel, R&D at Abraxis Portfolio Manager, Capital and Kearny Portfolio Manager, Acuta Frazier Healthcare • 20+ years experience in Bioscience Avoro Capital Venture Partners Capital Partners the life sciences sector • Former Vice President, • 25+ years biopharma • 20+ years of healthcare • 18+ years of healthcare • 20+ years biopharma • Former executive at Strategic Platforms, industry experience experience as a principal experience as a principal industry experience Eyetech Pharmaceuticals Celgene investor investor • Former Executive & Coronado BioSciences • Former SVP and General • Inventor of the nab Chairman of • Board Member at • Former Managing Counsel, Aptalis • Previously held strategic technology (ABRAXANE Immunomedics (acquired ViewRay, Inc. (VRAY), Director at Kearny Pharmaceuticals management roles at and ABI-009) by Gilead in 2020) Newbridge Venture Partners and Johnson & Johnson, • Previously held senior Pharmaceuticals, and Principal at Flagship • Led development of • Extensive scientific JDRF, and McKinsey and executive roles at APP Aerpio Pharmaceuticals Pioneering ABRAXANE research and multibillion dollar Pharmaceuticals, Abraxis management consulting • Board Member at Aerpio investment funds Bioscience, and American • 25+ years in R&D experience Pharmaceuticals Bioscience Inc. 4Aadi Board of Directors CEO Board of Directors Neil Desai, PhD Behzad Aghazadeh, PhD Caley Castelein, MD Anupam Dalal, MD Karin Hehenberger, MD, PhD Richard Maroun Founder, CEO and President Chairman • Former Sr VP, Global • Managing Partner & • Managing Director, KVP • Chief Investment Officer & • Founder & CEO, Lyfebulb • Partner, General Counsel, R&D at Abraxis Portfolio Manager, Capital and Kearny Portfolio Manager, Acuta Frazier Healthcare • 20+ years experience in Bioscience Avoro Capital Venture Partners Capital Partners the life sciences sector • Former Vice President, • 25+ years biopharma • 20+ years of healthcare • 18+ years of healthcare • 20+ years biopharma • Former executive at Strategic Platforms, industry experience experience as a principal experience as a principal industry experience Eyetech Pharmaceuticals Celgene investor investor • Former Executive & Coronado BioSciences • Former SVP and General • Inventor of the nab Chairman of • Board Member at • Former Managing Counsel, Aptalis • Previously held strategic technology (ABRAXANE Immunomedics (acquired ViewRay, Inc. (VRAY), Director at Kearny Pharmaceuticals management roles at and ABI-009) by Gilead in 2020) Newbridge Venture Partners and Johnson & Johnson, • Previously held senior Pharmaceuticals, and Principal at Flagship • Led development of • Extensive scientific JDRF, and McKinsey and executive roles at APP Aerpio Pharmaceuticals Pioneering ABRAXANE research and multibillion dollar Pharmaceuticals, Abraxis management consulting • Board Member at Aerpio investment funds Bioscience, and American • 25+ years in R&D experience Pharmaceuticals Bioscience Inc. 4


Aadi Bioscience is a late-stage, precision oncology company re-engineering mTOR inhibition ™ FYARRO (nab-sirolimus, ABI-009) is a nanoparticle albumin-bound form of sirolimus ® • Similar technology platform to ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (Bristol Myers Squibb Corporation) • Albumin-based technology results in higher intratumoral concentrations, increased target suppression, and improved tumor growth inhibition and survival in animal models compared to other mTOR inhibitors Lead indication PEComa, a rare tumor with high frequency of TSC1 and TSC2 alterations • Endpoints met in registrational trial in patients with PEComa • Breakthrough therapy designation granted • NDA accepted for filing with Priority Review and November 26, 2021 PDUFA target action date • Commercial preparations underway to support U.S. launch Tumor-agnostic opportunity in TSC1 and TSC2 alterations • Strong mechanistic rationale; potential for validation with PEComa approval 1 • Preliminary EAP data presented at ASCO 2021 supportive of tumor-agnostic strategy 5 5 EAP = Expanded Access Program 1) MA Dickson. ASCO. 2021. Abstract # 3111Aadi Bioscience is a late-stage, precision oncology company re-engineering mTOR inhibition ™ FYARRO (nab-sirolimus, ABI-009) is a nanoparticle albumin-bound form of sirolimus ® • Similar technology platform to ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (Bristol Myers Squibb Corporation) • Albumin-based technology results in higher intratumoral concentrations, increased target suppression, and improved tumor growth inhibition and survival in animal models compared to other mTOR inhibitors Lead indication PEComa, a rare tumor with high frequency of TSC1 and TSC2 alterations • Endpoints met in registrational trial in patients with PEComa • Breakthrough therapy designation granted • NDA accepted for filing with Priority Review and November 26, 2021 PDUFA target action date • Commercial preparations underway to support U.S. launch Tumor-agnostic opportunity in TSC1 and TSC2 alterations • Strong mechanistic rationale; potential for validation with PEComa approval 1 • Preliminary EAP data presented at ASCO 2021 supportive of tumor-agnostic strategy 5 5 EAP = Expanded Access Program 1) MA Dickson. ASCO. 2021. Abstract # 3111


ABI-009 Advanced Oncology Pipeline Indication Phase 1b Phase 2 Registrational Upcoming Milestones Potential first FDA approval for PEComa, histology with high November 26, 2021 Single Agent Advanced Malignant PEComa PDUFA frequency of TSC1 and TSC2 alterations Single Agent Pan-Tumor TSC1 Inactivating Alterations File IND for tumor-agnostic pivotal study with independent arms for TSC1 or TSC2 inactivating mutations; trial to be initiated by year end 2021 Single Agent Pan-Tumor TSC2 Inactivating Alterations Expanded Access Program Provide access to ABI-009 pre-approval to patients with PEComa or Single Agent (Solid Tumors ± mTOR Pathway solid tumors with mTOR pathway mutations Alterations) Dose Finding Combination Studies Continue ongoing combination partner trials and initiate new trials with adjacent pathway combinations that may be synergistic (Multiple) Undisclosed indication: single agent Expand into a sub-population with strong mTOR mechanistic rationale expansion Ongoing To be initiated Planned/ initial stages


ABI-009: Leveraging Albumin to Improve mTOR Inhibition 7


Nanoparticle Albumin-Bound (nab) Technology Nab Platform (nab paclitaxel) paclitaxel sirolimus Artist impression Albumin Artist impression Albumin 1 1 2 • Proprietary, complex, multistep • Superior efficacy , safety , and PK/PD • Licensed from Celgene in 2014 manufacturing process with vs. standard formulation paclitaxel • Larger PK/PD differences vs. reference trade secrets 4 • Approved for breast cancer, NSCLC, drug than ABRAXANE 1 and pancreatic cancer • “nab” process adapted for sirolimus • Commercially successful with >$1B in • WW patent portfolio with issued patents 3 annual sales providing coverage to 2036 ® ABRAXANE is a registered trademark of Celgene Corporation 8 1) ABRAXANE prescribing information 2) N Desai et al., Clin Cancer Res. 2006;12(4):1317-1324. 3) Evaluate Pharma. Accessed April 2021 4) see following slides for detailsNanoparticle Albumin-Bound (nab) Technology Nab Platform (nab paclitaxel) paclitaxel sirolimus Artist impression Albumin Artist impression Albumin 1 1 2 • Proprietary, complex, multistep • Superior efficacy , safety , and PK/PD • Licensed from Celgene in 2014 manufacturing process with vs. standard formulation paclitaxel • Larger PK/PD differences vs. reference trade secrets 4 • Approved for breast cancer, NSCLC, drug than ABRAXANE 1 and pancreatic cancer • “nab” process adapted for sirolimus • Commercially successful with >$1B in • WW patent portfolio with issued patents 3 annual sales providing coverage to 2036 ® ABRAXANE is a registered trademark of Celgene Corporation 8 1) ABRAXANE prescribing information 2) N Desai et al., Clin Cancer Res. 2006;12(4):1317-1324. 3) Evaluate Pharma. Accessed April 2021 4) see following slides for details


ABI-009 Targets mTOR, a Key Signaling Pathway in Cancer PI3K/Akt/mTOR pathway Growth Insulin Factors PI3K Ras PTEN Raf Akt MEK ERK Frequently TSC1/ mutated in cancer TSC2 and/or validated target Rheb mTOR complex 1 mTOR ABI-009 (mTORC1) Raptor S6K 4EBP1 9ABI-009 Targets mTOR, a Key Signaling Pathway in Cancer PI3K/Akt/mTOR pathway Growth Insulin Factors PI3K Ras PTEN Raf Akt MEK ERK Frequently TSC1/ mutated in cancer TSC2 and/or validated target Rheb mTOR complex 1 mTOR ABI-009 (mTORC1) Raptor S6K 4EBP1 9


ABI-009 Achieves Larger PK/PD Difference vs Reference Drug Preclinical Tumor Exposure (AUC) Clinical Whole Blood AUC Fold Change vs. Reference Drug at Fold Change vs. Reference Drug at Equal Dose (Xenograft Model) Clinical Dose (Clinical Data) 50 18 16 43 45 16 40 14 35 12 30 10 25 8 20 6 15 4 10 1.2 2 5 1.3 0 0 1 2 3 4,5 Abraxane IV / paclitaxel IV ABI-009 IV / sirolimus PO Abraxane IV / paclitaxel IV ABI-009 IV / sirolimus PO* 2 2 2 Total dose = Total dose = 260 mg/m 175 mg/m 100 mg/m 5-6 mg/day 100 mg/kg over 5d 15 mg/kg over 7 days Note: FDA approved dosing & admin schedule used for Abraxane, paclitaxel, and sirolimus. PEComa registrational trial dose used for ABI-009 * Indirect comparison of ABI-009 clinical data to published clinical data for sirolimus 1) N Desai et al., Clin Cancer Res. 2006;12(4):1317-1324. 5) Sirolimus: Mean of the following two sources: 2) S Hou et al. AACR 2019. (a) A Jimeno et al., J Clin Oncol. 2008;26(25):4172-4179. and 3) A Sparreboom et al., Clin Cancer Res. 2006;11(11):4136-4143. (b) I Garrido-Laguna et al., Br J Cancer. 2010;103(5):649-655. 10 4) ABI-009: AM Gonzalez-Angulo et al., Clin Cancer Res 2013;19:5474-5484.ABI-009 Achieves Larger PK/PD Difference vs Reference Drug Preclinical Tumor Exposure (AUC) Clinical Whole Blood AUC Fold Change vs. Reference Drug at Fold Change vs. Reference Drug at Equal Dose (Xenograft Model) Clinical Dose (Clinical Data) 50 18 16 43 45 16 40 14 35 12 30 10 25 8 20 6 15 4 10 1.2 2 5 1.3 0 0 1 2 3 4,5 Abraxane IV / paclitaxel IV ABI-009 IV / sirolimus PO Abraxane IV / paclitaxel IV ABI-009 IV / sirolimus PO* 2 2 2 Total dose = Total dose = 260 mg/m 175 mg/m 100 mg/m 5-6 mg/day 100 mg/kg over 5d 15 mg/kg over 7 days Note: FDA approved dosing & admin schedule used for Abraxane, paclitaxel, and sirolimus. PEComa registrational trial dose used for ABI-009 * Indirect comparison of ABI-009 clinical data to published clinical data for sirolimus 1) N Desai et al., Clin Cancer Res. 2006;12(4):1317-1324. 5) Sirolimus: Mean of the following two sources: 2) S Hou et al. AACR 2019. (a) A Jimeno et al., J Clin Oncol. 2008;26(25):4172-4179. and 3) A Sparreboom et al., Clin Cancer Res. 2006;11(11):4136-4143. (b) I Garrido-Laguna et al., Br J Cancer. 2010;103(5):649-655. 10 4) ABI-009: AM Gonzalez-Angulo et al., Clin Cancer Res 2013;19:5474-5484.


Role of Albumin in Tumor Targeting Albumin accumulation in tumors Labeled albumin can be used intraoperatively to established in multiple preclinical models guide surgical resection of tumors in humans Accumulation of the evans blue albumin complex • 5-Amino Fluorescein labelled Albumin administered IV (0.5-1 mg/kg) in 13 patients, 0.5-4 in subcutaneously growing sarcoma 180 tumors days before surgery over 72 h • Tumor fluorescence was bright in 11 patients (84%), resulting in complete resection in 9 patients (69%) Y Shahzad et al., Curr Cancer Drug Targets. 2014;14(8):752-63 P Kremer et al., Neurosurgery. 2009;64(3 Suppl):ons53-60; discussion ons60-1 11


Higher ABI-009 intratumoral concentrations drive increased target suppression and tumor growth inhibition in animal models Increased Target Stronger Inhibition of Tumor Growth Significantly Higher Intratumoral Suppression and Longer Survival in Animals Drug Accumulation 2000 1500 150000 12-fold,P < 0.0001 Saline Sirolimus (PO, 15 mg/kg/wk) 1000 43 fold,P < 0.0001 Everolimus (PO, 15 mg/kg/wk) ABI-009 (IV, 15 mg/kg/wk) 500 100000 Total Weekly dose: Oral sirolimus 0 Oral everolimus 0 5 10 15 15 mg/kg/wk Treatment Days 100 50000 50 0 ABI-009 IV Sirolimus PO Everolimus PO Saline Control ABI-009 (low dose) 0 0 10 20 30 40 Treatment Days Tumor concentration of ABI-009, oral sirolimus, and oral Tumor IHC pS6 suppression on D7 post dose at equal UMUC3 (aggressive human bladder cancer) Xenograft (n=8/group): everolimus measured over 7 days at equal weekly dose doses (15 mg/kg/wk). Oral Rapamycin and Everolimus 15 mg/kg/wk (3 mg/kg, 5x/wk); (15 mg/kg/wk) in mice bearing tumor xenografts pS6 is a downstream target of mTOR. IV ABI-009 15 mg/kg/wk (7.5 mg/kg, 2x/wk) ABI-009 vs oral sirolimus: P = 0.0001 (ANOVA) Tumor volume: ABI-009 vs oral sirolimus: P < 0.0001 (ANOVA) ABI-009 vs oral everolimus P – 0.0034 (ANOVA) ABI-009 vs oral everolimus P – 0.0023 (ANOVA) Survival: ABI-009 vs oral sirolimus: P < 0.05 (Log-rank test) ABI-009 vs oral everolimus P < 0.05 (Log-rank test) ABI-009 demonstrated enhanced anti-tumor activity vs. currently approved mTOR inhibitors in animal models at clinically relevant doses. 12 Source: S Hou et al., AACR. 2019 Tumor Tissue Sirolimus or Everolimus AUC (ng*hr/g) 3 Tumor Volume (mm ) Percent survivalHigher ABI-009 intratumoral concentrations drive increased target suppression and tumor growth inhibition in animal models Increased Target Stronger Inhibition of Tumor Growth Significantly Higher Intratumoral Suppression and Longer Survival in Animals Drug Accumulation 2000 1500 150000 12-fold,P < 0.0001 Saline Sirolimus (PO, 15 mg/kg/wk) 1000 43 fold,P < 0.0001 Everolimus (PO, 15 mg/kg/wk) ABI-009 (IV, 15 mg/kg/wk) 500 100000 Total Weekly dose: Oral sirolimus 0 Oral everolimus 0 5 10 15 15 mg/kg/wk Treatment Days 100 50000 50 0 ABI-009 IV Sirolimus PO Everolimus PO Saline Control ABI-009 (low dose) 0 0 10 20 30 40 Treatment Days Tumor concentration of ABI-009, oral sirolimus, and oral Tumor IHC pS6 suppression on D7 post dose at equal UMUC3 (aggressive human bladder cancer) Xenograft (n=8/group): everolimus measured over 7 days at equal weekly dose doses (15 mg/kg/wk). Oral Rapamycin and Everolimus 15 mg/kg/wk (3 mg/kg, 5x/wk); (15 mg/kg/wk) in mice bearing tumor xenografts pS6 is a downstream target of mTOR. IV ABI-009 15 mg/kg/wk (7.5 mg/kg, 2x/wk) ABI-009 vs oral sirolimus: P = 0.0001 (ANOVA) Tumor volume: ABI-009 vs oral sirolimus: P < 0.0001 (ANOVA) ABI-009 vs oral everolimus P – 0.0034 (ANOVA) ABI-009 vs oral everolimus P – 0.0023 (ANOVA) Survival: ABI-009 vs oral sirolimus: P < 0.05 (Log-rank test) ABI-009 vs oral everolimus P < 0.05 (Log-rank test) ABI-009 demonstrated enhanced anti-tumor activity vs. currently approved mTOR inhibitors in animal models at clinically relevant doses. 12 Source: S Hou et al., AACR. 2019 Tumor Tissue Sirolimus or Everolimus AUC (ng*hr/g) 3 Tumor Volume (mm ) Percent survival


Differentiated Clinical PK Profile Compared to Other mTOR Inhibitors PK Comparison at Clinical Doses Half-life of mTOR Inhibitors Cmax of mTOR Inhibitors Weekly AUC of mTOR Inhibitors 70 3500 3227 50,000 63.1 44072 45,000 60 3000 40,000 50 2500 35,000 30,000 40 2000 30 25,000 30 1500 20,000 18.6 17.3 15,000 20 1000 661 10,000 5390 10 3598 500 2720 5,000 61 24.8 0 0 0 Sirolimus Everolimus Temsirolimus ABI-009 Sirolimus Everolimus Temsirolimus ABI-009 Sirolimus Everolimus Temsirolimus ABI-009 (5-6 mg/day) (10 mg/day) (25 mg/wk) (100 mg/m^2) (5-6 mg/day) (10 mg/day) (25 mg/wk) + (100 mg/m^2) (5-6 mg/day) (10 mg/day) (25 mg/wk) + (100 mg/m^2) metabolite metabolite ABI-009 achieves higher AUC, Cmax and longer half-life in humans at its clinical dose when compared with published clinical data for other mTOR inhibitors. 1) Mean of the following two sources: (a) A Jimeno et al., J Clin Oncol. 2008;26(25):4172-4179. and (b) I Garrido-Laguna et al., Br J Cancer. 2010;103(5):649-655. 13 2) R Danesi et al., Cancer Treatment Reviews. 2013;39:784–792. 3) ABI-009: AM Gonzalez-Angulo et al., Clin Cancer Res 2013;19:5474-5484. Hours Cmax (ng/mL) AUC (ng h/mL)Differentiated Clinical PK Profile Compared to Other mTOR Inhibitors PK Comparison at Clinical Doses Half-life of mTOR Inhibitors Cmax of mTOR Inhibitors Weekly AUC of mTOR Inhibitors 70 3500 3227 50,000 63.1 44072 45,000 60 3000 40,000 50 2500 35,000 30,000 40 2000 30 25,000 30 1500 20,000 18.6 17.3 15,000 20 1000 661 10,000 5390 10 3598 500 2720 5,000 61 24.8 0 0 0 Sirolimus Everolimus Temsirolimus ABI-009 Sirolimus Everolimus Temsirolimus ABI-009 Sirolimus Everolimus Temsirolimus ABI-009 (5-6 mg/day) (10 mg/day) (25 mg/wk) (100 mg/m^2) (5-6 mg/day) (10 mg/day) (25 mg/wk) + (100 mg/m^2) (5-6 mg/day) (10 mg/day) (25 mg/wk) + (100 mg/m^2) metabolite metabolite ABI-009 achieves higher AUC, Cmax and longer half-life in humans at its clinical dose when compared with published clinical data for other mTOR inhibitors. 1) Mean of the following two sources: (a) A Jimeno et al., J Clin Oncol. 2008;26(25):4172-4179. and (b) I Garrido-Laguna et al., Br J Cancer. 2010;103(5):649-655. 13 2) R Danesi et al., Cancer Treatment Reviews. 2013;39:784–792. 3) ABI-009: AM Gonzalez-Angulo et al., Clin Cancer Res 2013;19:5474-5484. Hours Cmax (ng/mL) AUC (ng h/mL)


Summary of ABI-009’s Mechanism of Action and Key Differences Compared to Existing mTOR Inhibitors Albumin Sirolimus ABI-009 nanoparticle albumin-bound sirolimus injectable suspension Potential to leverage albumin tumor Wider therapeutic window in Differentiated pharmacokinetic and targeting preclinical models clinical profile • Active caveolar transport • Higher intratumoral concentrations vs. existing • Higher AUC, Cmax and longer half-life than mTOR inhibitors at similar doses existing mTOR inhibitors (comparison vs • Enhanced permeability and retention effect, published data) leaky capillaries in tumor beds with reduced • Increased mTOR pathway suppression within lymphatic drainage the tumor at similar doses versus existing • New clinical dosing paradigm for sirolimus mTOR inhibitors (once weekly IV vs. daily oral) • Active catabolism of albumin in tumors • Improved tumor growth inhibition and survival • Evidence of antitumor activity in patients 1,2 for ABI-009 vs other mTOR inhibitors at previously exposed to mTOR inhibitors clinically relevant doses • High tumor concentrations have potential to bypass resistance mechanisms 14 1) AM Gonzalez-Angulo et al., Clin Cancer Res. 2013;19:5474-5484. 2) P Kopparthy and M Murphy. Cureus. 13(5):e14951. Summary of ABI-009’s Mechanism of Action and Key Differences Compared to Existing mTOR Inhibitors Albumin Sirolimus ABI-009 nanoparticle albumin-bound sirolimus injectable suspension Potential to leverage albumin tumor Wider therapeutic window in Differentiated pharmacokinetic and targeting preclinical models clinical profile • Active caveolar transport • Higher intratumoral concentrations vs. existing • Higher AUC, Cmax and longer half-life than mTOR inhibitors at similar doses existing mTOR inhibitors (comparison vs • Enhanced permeability and retention effect, published data) leaky capillaries in tumor beds with reduced • Increased mTOR pathway suppression within lymphatic drainage the tumor at similar doses versus existing • New clinical dosing paradigm for sirolimus mTOR inhibitors (once weekly IV vs. daily oral) • Active catabolism of albumin in tumors • Improved tumor growth inhibition and survival • Evidence of antitumor activity in patients 1,2 for ABI-009 vs other mTOR inhibitors at previously exposed to mTOR inhibitors clinically relevant doses • High tumor concentrations have potential to bypass resistance mechanisms 14 1) AM Gonzalez-Angulo et al., Clin Cancer Res. 2013;19:5474-5484. 2) P Kopparthy and M Murphy. Cureus. 13(5):e14951.


Initial Indication: PEComa 15Initial Indication: PEComa 15


PEComa Disease Overview and Current Standard of Care Advanced, Malignant Perivascular epithelioid cell tumors (PEComa) Current Standard of Care • No approved treatments and no prior clinical trials conducted • Ultra rare sarcoma • Retrospective data supports use of mTOR inhibition • Mesenchymal tumor (sarcoma) consisting of perivascular epithelioid cells • Often misdiagnosed and treated with other sarcoma treatments • Distinctive cells that show a focal association with 1 blood-vessel walls Currently Used (Unapproved) Treatments • Usually express both melanocytic and smooth 1 muscle markers 3 3 Chemotherapy mTOR Inhibitor (e.g., doxorubicin and ifosfamide) (e.g., everolimus, sirolimus) • Can arise at any site but most commonly at visceral (especially gastrointestinal and uterine), Standard sarcoma treatment; More frequently used in retroperitoneal, and abdominopelvic sites and more frequently used in academic setting and amongst with female predominance community setting despite high volume community treaters 2 minimal efficacy • Estimated survival of 12-16 months • Biological evidence of mTOR pathway activation • Estimated 100-300 new patients per year 4 in the US 1) Ben-Ami et al., Expert Opinion on Orphan Drugs. 2018 2) JS Bleeker, JF Quevedo, and AL Folpe, Sarcoma. 2012;541626. 3) Primary Oncologist Market Research (N=10) conducted July and August 2019 by Corsica 16 Life Sciences 4) No formal published epidemiology information; Aadi analysis based on multiple sources including Aadi internal data and external research conducted by Tessellon Group and Corsica Life Sciences PEComa Disease Overview and Current Standard of Care Advanced, Malignant Perivascular epithelioid cell tumors (PEComa) Current Standard of Care • No approved treatments and no prior clinical trials conducted • Ultra rare sarcoma • Retrospective data supports use of mTOR inhibition • Mesenchymal tumor (sarcoma) consisting of perivascular epithelioid cells • Often misdiagnosed and treated with other sarcoma treatments • Distinctive cells that show a focal association with 1 blood-vessel walls Currently Used (Unapproved) Treatments • Usually express both melanocytic and smooth 1 muscle markers 3 3 Chemotherapy mTOR Inhibitor (e.g., doxorubicin and ifosfamide) (e.g., everolimus, sirolimus) • Can arise at any site but most commonly at visceral (especially gastrointestinal and uterine), Standard sarcoma treatment; More frequently used in retroperitoneal, and abdominopelvic sites and more frequently used in academic setting and amongst with female predominance community setting despite high volume community treaters 2 minimal efficacy • Estimated survival of 12-16 months • Biological evidence of mTOR pathway activation • Estimated 100-300 new patients per year 4 in the US 1) Ben-Ami et al., Expert Opinion on Orphan Drugs. 2018 2) JS Bleeker, JF Quevedo, and AL Folpe, Sarcoma. 2012;541626. 3) Primary Oncologist Market Research (N=10) conducted July and August 2019 by Corsica 16 Life Sciences 4) No formal published epidemiology information; Aadi analysis based on multiple sources including Aadi internal data and external research conducted by Tessellon Group and Corsica Life Sciences


AMPECT PEComa Registrational Trial Met its Endpoints AMPECT Registrational Trial Outcome AMPECT PEComa Phase II Registrational Trial Design Independent Radiology Review Measures 39% (12/31) 2 ABI-009 100 mg/m IV Primary Endpoint: ORR Best Overall Response Rate (1CR*+11PR) Advanced Malignant 95% CI (22%, 58%) D1,8 q 21d until Secondary Endpoints: PEComa Patients progression or DOR, PFS at 6m, mPFS, Stable Disease 52% (16/31) (mTOR naïve) unacceptable toxicity mOS, Safety Progressive Disease 10% (3/31) >25.8 months* (not reached) Sample Size: Target ORR of ~30% in 30 evaluable patients to exclude Median Duration of Response (5.6 – 42.4+) the lower bound of the 95% CI of 14.7% % of Responders ongoing > 2y 58% (7/12) FDA Orphan, Fast-Track, and Breakthrough Therapy % of Responders ongoing >3y 25% (3/12) Designations granted Median Progression Free Survival 8.9 months * At 1 year follow-up after the May 2019 AJ Wagner, ASCO. 2020. primary analysis The AMPECT Trial met its primary endpoint, exceeding the 30% target ORR agreed upon by the FDA. NDA submission accepted in July 2021 with Priority Review status granted and PDUFA target action date of November 26, 2021. 17 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. AMPECT PEComa Registrational Trial Met its Endpoints AMPECT Registrational Trial Outcome AMPECT PEComa Phase II Registrational Trial Design Independent Radiology Review Measures 39% (12/31) 2 ABI-009 100 mg/m IV Primary Endpoint: ORR Best Overall Response Rate (1CR*+11PR) Advanced Malignant 95% CI (22%, 58%) D1,8 q 21d until Secondary Endpoints: PEComa Patients progression or DOR, PFS at 6m, mPFS, Stable Disease 52% (16/31) (mTOR naïve) unacceptable toxicity mOS, Safety Progressive Disease 10% (3/31) >25.8 months* (not reached) Sample Size: Target ORR of ~30% in 30 evaluable patients to exclude Median Duration of Response (5.6 – 42.4+) the lower bound of the 95% CI of 14.7% % of Responders ongoing > 2y 58% (7/12) FDA Orphan, Fast-Track, and Breakthrough Therapy % of Responders ongoing >3y 25% (3/12) Designations granted Median Progression Free Survival 8.9 months * At 1 year follow-up after the May 2019 AJ Wagner, ASCO. 2020. primary analysis The AMPECT Trial met its primary endpoint, exceeding the 30% target ORR agreed upon by the FDA. NDA submission accepted in July 2021 with Priority Review status granted and PDUFA target action date of November 26, 2021. 17 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States.


AMPECT Response Assessment Waterfall Plot of Target Lesion Response Independent Radiology Review Independent Review Best Overall Response 50 total may exceed 100% due to rounding 0 * -50 • PRs were observed in patients with following primary sites: uterine (3), kidney (3), retroperitoneal (2), pelvis (2) liver (1), small bowel (1) • Uterine PEComa: 3/7 (43%) had a PR -100 ** 1 3/34 treated patients were not evaluable - 2 pts confirmed as ‘not PEComa’ (misdiagnosis), 1 pt had no tissue for central confirmation of PEComa 2 All confirmed responses are PR * 1 patient had an unconfirmed PR and thus best response is an SD as per RECIST v1.1 ** Patient with CR in target lesion had a nonCR/nonPD nontarget lesion, thus overall assessment is a PR as per RECIST v1.1 18 MA Dickson, CTOS. 2019. Primary Data cut on May 22, 2019 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Maximal % of Target Lesion ReductionAMPECT Response Assessment Waterfall Plot of Target Lesion Response Independent Radiology Review Independent Review Best Overall Response 50 total may exceed 100% due to rounding 0 * -50 • PRs were observed in patients with following primary sites: uterine (3), kidney (3), retroperitoneal (2), pelvis (2) liver (1), small bowel (1) • Uterine PEComa: 3/7 (43%) had a PR -100 ** 1 3/34 treated patients were not evaluable - 2 pts confirmed as ‘not PEComa’ (misdiagnosis), 1 pt had no tissue for central confirmation of PEComa 2 All confirmed responses are PR * 1 patient had an unconfirmed PR and thus best response is an SD as per RECIST v1.1 ** Patient with CR in target lesion had a nonCR/nonPD nontarget lesion, thus overall assessment is a PR as per RECIST v1.1 18 MA Dickson, CTOS. 2019. Primary Data cut on May 22, 2019 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Maximal % of Target Lesion Reduction


AMPECT Safety Summary, Treatment-related Adverse Events (TR AEs) ** Any Grade >25% Grade 3 TR Serious AEs n (%) TR AEs n (%) n (%) Patients with Any TR SAE 8 (24) Patients with Any TR AEs 34 (100) Dehydration (G3) 2 (6) Hematologic TRAEs * Abdominal pain (G2) 1 (3) Anemia 16 (47) 4 (12) * Diarrhea (G2) 1 (3) Thrombocytopenia 11 (32) 1 (3) Edema (3) 1 (3) Nonhematologic TRAEs * Enteritis (G3) 1 (3) Stomatitis/Mucositis 27 (79) 6 (18) * Pancytopenia (G3) 1 (3) Rash 19 (56) -- Acute Coronary Syndrome (G3) 1 (3) Fatigue 20 (59) 1 (3) Acute Kidney Injury (G3) 1 (3) Nausea 16 (47) -- Diarrhea 13 (38) -- Weight Decreased 13 (38) -- § No grade 4 or 5 TR AEs * Hyperglycemia 12 (35) 3 (9) § No unexpected AEs * Hypertriglyceridemia 11 (32) 1 (3) § Pneumonitis 6/34 (18%), G1/G2 only * Hypercholesterolemia 11 (32) -- Decreased Appetite 11 (32) --§ Discontinuation due to AE: 2/34 (6%) patients * (grade 2 anemia and grade 1 cystitis) Dermatitis 10 (29) -- Dysgeusia 10 (29) -- § Dose reductions occurred in 13/34 (38%) of Headache 10 (29) -- patients; 11 patients had a dose reduction from 2 2 Peripheral Edema 9 (26) -- 100 mg/m to 75 mg/m and 2 patients had a dose 2 *Indicate Adverse Events of Special Interest and related preferred terms are grouped. reduction to 56 mg/m ** Additional G3 TRAEs were 6% hypokalemia, and 3% each of AST/ALT, amylase ↑, hypophosphatemia, insomnia, lipase ↑, lymphocyte ↓, skin infection, vomiting . 19 MA Dickson, CTOS. 2019. Primary Data cut on May 22, 2019 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. AMPECT Safety Summary, Treatment-related Adverse Events (TR AEs) ** Any Grade >25% Grade 3 TR Serious AEs n (%) TR AEs n (%) n (%) Patients with Any TR SAE 8 (24) Patients with Any TR AEs 34 (100) Dehydration (G3) 2 (6) Hematologic TRAEs * Abdominal pain (G2) 1 (3) Anemia 16 (47) 4 (12) * Diarrhea (G2) 1 (3) Thrombocytopenia 11 (32) 1 (3) Edema (3) 1 (3) Nonhematologic TRAEs * Enteritis (G3) 1 (3) Stomatitis/Mucositis 27 (79) 6 (18) * Pancytopenia (G3) 1 (3) Rash 19 (56) -- Acute Coronary Syndrome (G3) 1 (3) Fatigue 20 (59) 1 (3) Acute Kidney Injury (G3) 1 (3) Nausea 16 (47) -- Diarrhea 13 (38) -- Weight Decreased 13 (38) -- § No grade 4 or 5 TR AEs * Hyperglycemia 12 (35) 3 (9) § No unexpected AEs * Hypertriglyceridemia 11 (32) 1 (3) § Pneumonitis 6/34 (18%), G1/G2 only * Hypercholesterolemia 11 (32) -- Decreased Appetite 11 (32) --§ Discontinuation due to AE: 2/34 (6%) patients * (grade 2 anemia and grade 1 cystitis) Dermatitis 10 (29) -- Dysgeusia 10 (29) -- § Dose reductions occurred in 13/34 (38%) of Headache 10 (29) -- patients; 11 patients had a dose reduction from 2 2 Peripheral Edema 9 (26) -- 100 mg/m to 75 mg/m and 2 patients had a dose 2 *Indicate Adverse Events of Special Interest and related preferred terms are grouped. reduction to 56 mg/m ** Additional G3 TRAEs were 6% hypokalemia, and 3% each of AST/ALT, amylase ↑, hypophosphatemia, insomnia, lipase ↑, lymphocyte ↓, skin infection, vomiting . 19 MA Dickson, CTOS. 2019. Primary Data cut on May 22, 2019 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States.


Response to ABI-009 in metastatic uterine primary PEComa 67-year-old woman 67-year-old woman • Primary site: Uterus; metastatic to spleen, colon, perigastric, pulmonary area • Primary site: Uterus, metastatic to pelvis and lung st st • PR occurred at 1 restaging (6 weeks) • PR occurred at 1 restaging (6 weeks) • Patient currently on treatment (>1.5 years on therapy) • Patient received 10 cycles of treatment Baseline (12/2016) Baseline (2/8/2018) Cycle 6 (5/2017) Cycle 6 (6/21/2018) 20 MA Dickson, CTOS. 2019. Primary Data cut on May 22, 2019 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Images courtesy of Kristen Ganjoo, MD (Stanford University) Images courtesy of Andrew Wagner, MD, PhD (Dana Farber)


Response to ABI-009 in metastatic retroperitoneal primary PEComa 70-year-old woman 55-year-old man • Primary site: Retroperitoneum, metastatic to lung and liver • Primary site: Retroperitoneum, metastatic to lung st st • PR occurred at 1 restaging (6 weeks) • PR occurred at 1 restaging (6 weeks) • Patient currently on treatment (>2 years on therapy) • Patient currently on treatment (>2.5 years on therapy) Baseline (9/19/2016) Baseline (08/2017) Cycle 42 (2/28/2019) Cycle 22 (01/2019) 21 MA Dickson, CTOS. 2019. Primary Data cut on May 22, 2019 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Images courtesy of Richard Riedel, MD (Duke Univ) Images courtesy of Lee Cranmer, MD (Univ of Washington) Response to ABI-009 in metastatic retroperitoneal primary PEComa 70-year-old woman 55-year-old man • Primary site: Retroperitoneum, metastatic to lung and liver • Primary site: Retroperitoneum, metastatic to lung st st • PR occurred at 1 restaging (6 weeks) • PR occurred at 1 restaging (6 weeks) • Patient currently on treatment (>2 years on therapy) • Patient currently on treatment (>2.5 years on therapy) Baseline (9/19/2016) Baseline (08/2017) Cycle 42 (2/28/2019) Cycle 22 (01/2019) 21 MA Dickson, CTOS. 2019. Primary Data cut on May 22, 2019 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Images courtesy of Richard Riedel, MD (Duke Univ) Images courtesy of Lee Cranmer, MD (Univ of Washington)


Response to ABI-009 in metastatic kidney primary PEComa 47-year-old man • Primary site: kidney, metastatic to kidney and pelvis st • PR occurred at 1 restaging (6 weeks) • Patient received 12 cycles of treatment Baseline (9/1/2016) Cycle 10 (4/7/2017) Images courtesy of Brian Van Tine, MD (Washington University) 22 MA Dickson, CTOS. 2019. Primary Data cut on May 22, 2019 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Response to ABI-009 in metastatic kidney primary PEComa 47-year-old man • Primary site: kidney, metastatic to kidney and pelvis st • PR occurred at 1 restaging (6 weeks) • Patient received 12 cycles of treatment Baseline (9/1/2016) Cycle 10 (4/7/2017) Images courtesy of Brian Van Tine, MD (Washington University) 22 MA Dickson, CTOS. 2019. Primary Data cut on May 22, 2019 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States.


PEComa Commercial Strategy and Launch Plan ABI-009 PEComa Launch Strategy Target PEComa Patients at Major Centers • Majority of PEComa patients treated at top Establish ABI-009 as the standard of care for cancer centers treatment of advanced malignant PEComa • Focus on high-volume sarcoma centers including NCCN member institutions Drive awareness and proper diagnosis of and NCI designated cancer PEComa across all key stakeholders centers Price ABI-009 according to value in ultra-orphan PEComa indication and ensure smooth access Build a Lean but Effective Commercial Infrastructure • Commercial infrastructure build out ongoing including field team (e.g., MSLs, sales reps, account managers, etc.) Capture eligible PEComa patients by targeting key sarcoma centers with an efficient field team • On track for H1 2022 commercial launch NCCN = National Comprehensive Cancer Network NCI = National Cancer Institute 23PEComa Commercial Strategy and Launch Plan ABI-009 PEComa Launch Strategy Target PEComa Patients at Major Centers • Majority of PEComa patients treated at top Establish ABI-009 as the standard of care for cancer centers treatment of advanced malignant PEComa • Focus on high-volume sarcoma centers including NCCN member institutions Drive awareness and proper diagnosis of and NCI designated cancer PEComa across all key stakeholders centers Price ABI-009 according to value in ultra-orphan PEComa indication and ensure smooth access Build a Lean but Effective Commercial Infrastructure • Commercial infrastructure build out ongoing including field team (e.g., MSLs, sales reps, account managers, etc.) Capture eligible PEComa patients by targeting key sarcoma centers with an efficient field team • On track for H1 2022 commercial launch NCCN = National Comprehensive Cancer Network NCI = National Cancer Institute 23


Tumors with TSC1 and TSC2 Inactivating Alterations 24Tumors with TSC1 and TSC2 Inactivating Alterations 24


TSC1 and TSC2 Alterations: Optimal Targets for ABI-009 Inactivating genomic alterations in TSC1 and TSC2 drive mTOR PI3K/Akt/mTOR pathway pathway activation and tumor growth Growth • TSC1 and TSC2 form a tumor suppressor complex that down Insulin Factors PI3K Ras regulates mTOR activity • TSC1 and TSC2 alterations occur at varying frequencies across a PTEN Raf broad range of cancers Akt MEK • No approved therapies for patients with TSC1 or TSC2 alterations but numerous case reports with durable responses to mTOR ERK Frequently mutated inhibition TSC1/ in cancer and/or validated target TSC2 • Standard CLIA-certified NGS panels already capture TSC1 and TSC2 alterations Rheb Rationale for ABI-009 use in patients with Tumor-agnostic TSC1 and mTOR complex 1 mTOR ABI-009 TSC2 Inactivating Alterations (mTORC1) Raptor • Evidence of responses in PEComa patients with TSC1 and TSC2 alterations in completed AMPECT registrational trial S6K 4EBP1 • Emerging signals in non-PEComa patients with TSC1 and TSC2 alterations in Expanded Access Program presented at ASCO 2021 25TSC1 and TSC2 Alterations: Optimal Targets for ABI-009 Inactivating genomic alterations in TSC1 and TSC2 drive mTOR PI3K/Akt/mTOR pathway pathway activation and tumor growth Growth • TSC1 and TSC2 form a tumor suppressor complex that down Insulin Factors PI3K Ras regulates mTOR activity • TSC1 and TSC2 alterations occur at varying frequencies across a PTEN Raf broad range of cancers Akt MEK • No approved therapies for patients with TSC1 or TSC2 alterations but numerous case reports with durable responses to mTOR ERK Frequently mutated inhibition TSC1/ in cancer and/or validated target TSC2 • Standard CLIA-certified NGS panels already capture TSC1 and TSC2 alterations Rheb Rationale for ABI-009 use in patients with Tumor-agnostic TSC1 and mTOR complex 1 mTOR ABI-009 TSC2 Inactivating Alterations (mTORC1) Raptor • Evidence of responses in PEComa patients with TSC1 and TSC2 alterations in completed AMPECT registrational trial S6K 4EBP1 • Emerging signals in non-PEComa patients with TSC1 and TSC2 alterations in Expanded Access Program presented at ASCO 2021 25


TSC1 and TSC2 Alterations Represent Significant Opportunities Projected Annual Incidence of Cancers with TSC1 and TSC2 Alterations st Estimated US Patients Available for 1 Line Therapy in 2030 Likely or Definite Impact Alterations TSC1 Alterations (across all cancers) Definite Impact Alterations Likely or Definite Impact Alterations TSC2 Alterations (across all cancers) Definite Impact Alterations 0 2,500 5,000 7,500 10,000 12,500 15,000 17,500 20,000 Definitions: Likely Impact Alterations (harmful missense variants): missense mutations predicted to be deleterious by SIFT or possibly or probably damaging by PolyPhen Definite Impact Alterations (truncating and deep deletions): out-of-frame frameshift insertions/deletions, nonsense mutations, splice-site mutations, and deep deletions (e.g. copy number -2 in cBioPortal) 26 Source: analysis of TCGA, cBioPortal, and SEER databases conducted by Tessellon Group in June 2021TSC1 and TSC2 Alterations Represent Significant Opportunities Projected Annual Incidence of Cancers with TSC1 and TSC2 Alterations st Estimated US Patients Available for 1 Line Therapy in 2030 Likely or Definite Impact Alterations TSC1 Alterations (across all cancers) Definite Impact Alterations Likely or Definite Impact Alterations TSC2 Alterations (across all cancers) Definite Impact Alterations 0 2,500 5,000 7,500 10,000 12,500 15,000 17,500 20,000 Definitions: Likely Impact Alterations (harmful missense variants): missense mutations predicted to be deleterious by SIFT or possibly or probably damaging by PolyPhen Definite Impact Alterations (truncating and deep deletions): out-of-frame frameshift insertions/deletions, nonsense mutations, splice-site mutations, and deep deletions (e.g. copy number -2 in cBioPortal) 26 Source: analysis of TCGA, cBioPortal, and SEER databases conducted by Tessellon Group in June 2021


Exploratory Analysis in AMPECT Suggests Activity in TSC1 or TSC2 Alterations 40 20 0 -- -- -- + -- + -- -- -- + + + -- + + + + + + + + + + + + -20 * -40 +/-- indicates pS6 status -60 TSC2 mutation TSC1 mutation -80 No TSC1 or TSC2 mutation UNK mutational status -100 * 1 patient with TSC2 mutation had an unconfirmed PR and thus best response is an SD as per RECIST 1.1 27 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. AJ Wagner. CTOS. 2020. Data represents 1 year follow-up to primary data cut on May 22, 2019 Max % of Target Lesion ReductionExploratory Analysis in AMPECT Suggests Activity in TSC1 or TSC2 Alterations 40 20 0 -- -- -- + -- + -- -- -- + + + -- + + + + + + + + + + + + -20 * -40 +/-- indicates pS6 status -60 TSC2 mutation TSC1 mutation -80 No TSC1 or TSC2 mutation UNK mutational status -100 * 1 patient with TSC2 mutation had an unconfirmed PR and thus best response is an SD as per RECIST 1.1 27 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. AJ Wagner. CTOS. 2020. Data represents 1 year follow-up to primary data cut on May 22, 2019 Max % of Target Lesion Reduction


Durability of Response in TSC1 or TSC2 Altered PEComa 40 20 TSC2 mutations TSC1 mutations 0 No TSC1/2 mutations Not Evaluable for TSC1/2 -20 -40 -60 -80 -100 Baseline 6 12 18 24 30 36 42 48 54 66 78 90 102 114 126 138 150 162 174 186 Weeks 28 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. AJ Wagner. CTOS. 2020. Data represents 1 year follow-up to primary data cut on May 22, 2019 Percent Change in Target Tumor MeasurementsDurability of Response in TSC1 or TSC2 Altered PEComa 40 20 TSC2 mutations TSC1 mutations 0 No TSC1/2 mutations Not Evaluable for TSC1/2 -20 -40 -60 -80 -100 Baseline 6 12 18 24 30 36 42 48 54 66 78 90 102 114 126 138 150 162 174 186 Weeks 28 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. AJ Wagner. CTOS. 2020. Data represents 1 year follow-up to primary data cut on May 22, 2019 Percent Change in Target Tumor Measurements


Early Experience in Non-PEComa Patients with TSC1 or TSC2 Inactivating Alterations from Expanded Access Program (presented at ASCO 2021) • Study Design: Multi-institutional Expanded Access for an Intermediate-size Population • N=8 patients with TSC1 or TSC2 inactivating alterations o 6 mTOR-naïve o 2 previously treated with an mTORi 2 • 100 mg/m ABI-009 (nab-sirolimus) given D1, D8 of a 21-day cycle • Response Analysis: RECIST v1.1 * After initial SD, Pt# 4 had treatment break due to infection/surgery/healing, totaling ~ 2.5 months. Subsequent imaging showed PR in target lesions along with new lesions. The patient resumed therapy with ongoing benefit § Progressed on mTORi prior to receiving ABI-009 ¥ Pt #6 had a progressive retroperitoneal mass 29 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Source: MA Dickson. ASCO. 2021. Abstract # 3111


Early Experience in Non-PEComa Patients with TSC1 or TSC2 Inactivating Alterations from Expanded Access Program (presented at ASCO 2021) Efficacy: 8 patients treated, 7 evaluable for response Safety • Treatment-emergent AEs (≥30%) included edema, infections, mucositis, and pain (71% each), nail changes and vomiting (57% each), and hypertension and nausea (43% each). • Majority of events were G1/G2 • Treatment-related SAEs were reported in 2 patients and included hyperglycemia and infection (Pt#4) and acute kidney injury (Pt#7) possibly secondary to administration of contrast • Dose reductions occurred in 3/8 patients (38%) from 2 2 100 mg/m to 75 mg/m 30 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Source: MA Dickson. ASCO. 2021. Abstract # 3111Early Experience in Non-PEComa Patients with TSC1 or TSC2 Inactivating Alterations from Expanded Access Program (presented at ASCO 2021) Efficacy: 8 patients treated, 7 evaluable for response Safety • Treatment-emergent AEs (≥30%) included edema, infections, mucositis, and pain (71% each), nail changes and vomiting (57% each), and hypertension and nausea (43% each). • Majority of events were G1/G2 • Treatment-related SAEs were reported in 2 patients and included hyperglycemia and infection (Pt#4) and acute kidney injury (Pt#7) possibly secondary to administration of contrast • Dose reductions occurred in 3/8 patients (38%) from 2 2 100 mg/m to 75 mg/m 30 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Source: MA Dickson. ASCO. 2021. Abstract # 3111


Early Experience in Non-PEComa Patients with TSC1 or TSC2 Inactivating Alterations from Expanded Access Program (presented at ASCO 2021) 31 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Source: MA Dickson. ASCO. 2021. Abstract # 3111Early Experience in Non-PEComa Patients with TSC1 or TSC2 Inactivating Alterations from Expanded Access Program (presented at ASCO 2021) 31 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Source: MA Dickson. ASCO. 2021. Abstract # 3111


Early Experience in Non-PEComa Patients with TSC1 or TSC2 Inactivating Alterations from Expanded Access Program (presented at ASCO 2021) Pt #2: Ovarian Cancer with Pt #7: High-grade Sarcoma with TSC2 Pt #4: Angiosarcoma with TSC1 mutation (2 prior lines TSC1 mutation (4 prior lines mutation (5 prior lines Rx). Metastasis to Rx) involving right atrium, pericardium and with Rx). Retroperitoneal and lung, bone, and soft tissue; pulmonary metastasis pelvic metastases Li-Fraumeni syndrome 2/19/2020 (Baseline) 6/8/2020 (Baseline) 7/30/2020 (Week 5) 5/6/2020 (W11) 8/12/2020 9/21/2020 (Baseline) (Week 6) 32 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Source: MA Dickson. ASCO. 2021. Abstract # 3111Early Experience in Non-PEComa Patients with TSC1 or TSC2 Inactivating Alterations from Expanded Access Program (presented at ASCO 2021) Pt #2: Ovarian Cancer with Pt #7: High-grade Sarcoma with TSC2 Pt #4: Angiosarcoma with TSC1 mutation (2 prior lines TSC1 mutation (4 prior lines mutation (5 prior lines Rx). Metastasis to Rx) involving right atrium, pericardium and with Rx). Retroperitoneal and lung, bone, and soft tissue; pulmonary metastasis pelvic metastases Li-Fraumeni syndrome 2/19/2020 (Baseline) 6/8/2020 (Baseline) 7/30/2020 (Week 5) 5/6/2020 (W11) 8/12/2020 9/21/2020 (Baseline) (Week 6) 32 ABI-009 is an investigational new drug and has not been approved for commercial distribution in the United States. Source: MA Dickson. ASCO. 2021. Abstract # 3111


ABI-009 Tumor-Agnostic TSC1 or TSC2 Alterations Registrational Trial Registrational Phase 2 Tumor-Agnostic Study Key Eligibility Criteria (to be finalized) for Patients with Nonhematologic Malignancies having TSC1 or TSC2 • Metastatic or locally advanced disease ineligible for surgery Inactivating Alterations • Naïve to mTOR inhibitor treatment • Pathogenic* TSC1 or TSC2 alterations identified through NGS • FDA Type B meeting conducted on Oct 20, 2020 to discuss study design and strategy † † TSC1 Arm : TSC2 Arm : • Two independent arms proposed, each with Pathogenic TSC1 inactivating mutations Pathogenic TSC2 inactivating mutations ~50-70 patients • Patient accrual at sites based on local NGS 2 ABI-009 IV qw2/3 at 100 mg/m until progression or toxicity results • Diagnostic partnerships in discussion with largest NGS platforms to enhance precision • Primary Endpoint: Best Overall Response of patient selection • Secondary Endpoints: DOR, DCR (% of patients with CR, PR, or SD≥16weeks) • Study initiation planned by end of 2021 * Criteria in development † Exploratory arm under consideration including other types of TSC1 or TSC2 alterations and patients with other actionable mutations or TMB ≥10 mutations/Mb 33ABI-009 Tumor-Agnostic TSC1 or TSC2 Alterations Registrational Trial Registrational Phase 2 Tumor-Agnostic Study Key Eligibility Criteria (to be finalized) for Patients with Nonhematologic Malignancies having TSC1 or TSC2 • Metastatic or locally advanced disease ineligible for surgery Inactivating Alterations • Naïve to mTOR inhibitor treatment • Pathogenic* TSC1 or TSC2 alterations identified through NGS • FDA Type B meeting conducted on Oct 20, 2020 to discuss study design and strategy † † TSC1 Arm : TSC2 Arm : • Two independent arms proposed, each with Pathogenic TSC1 inactivating mutations Pathogenic TSC2 inactivating mutations ~50-70 patients • Patient accrual at sites based on local NGS 2 ABI-009 IV qw2/3 at 100 mg/m until progression or toxicity results • Diagnostic partnerships in discussion with largest NGS platforms to enhance precision • Primary Endpoint: Best Overall Response of patient selection • Secondary Endpoints: DOR, DCR (% of patients with CR, PR, or SD≥16weeks) • Study initiation planned by end of 2021 * Criteria in development † Exploratory arm under consideration including other types of TSC1 or TSC2 alterations and patients with other actionable mutations or TMB ≥10 mutations/Mb 33


Summary and Milestones 34Summary and Milestones 34


A Catalyst-Rich Path Forward Aadi is pursuing the use of mTOR inhibition with a precision medicine approach targeting tumors that have established Combination driver alterations in the mTOR pathway studies targeting adjacent biology Other mTOR driven cancers • H2 2022 – H1 2023: Initiate Tumor additional trials of ABI-009 in Agnostic TSC1 & TSC2 rational combinations with other Mutations targeted agents PEComa • H2 2022: Initiate additional trials in other cancer sub- • Evaluate potential in-licensing or populations with strong M&A opportunities focusing on • H2 2021: Registrational trial mTOR mechanistic rationale assets with synergistic potential • H2 2021: FDA approval initiation with mTOR inhibition • H1 2022: Commercial • H1 2024: Final data launch anticipated 35A Catalyst-Rich Path Forward Aadi is pursuing the use of mTOR inhibition with a precision medicine approach targeting tumors that have established Combination driver alterations in the mTOR pathway studies targeting adjacent biology Other mTOR driven cancers • H2 2022 – H1 2023: Initiate Tumor additional trials of ABI-009 in Agnostic TSC1 & TSC2 rational combinations with other Mutations targeted agents PEComa • H2 2022: Initiate additional trials in other cancer sub- • Evaluate potential in-licensing or populations with strong M&A opportunities focusing on • H2 2021: Registrational trial mTOR mechanistic rationale assets with synergistic potential • H2 2021: FDA approval initiation with mTOR inhibition • H1 2022: Commercial • H1 2024: Final data launch anticipated 35


Contact Information Contacts Investors and Media: Irina Koffler ikoffler@lifesciadvisors.com 36