Core Insights - Aadi Bioscience has entered into an exclusive license agreement for a three-asset antibody-drug conjugate (ADC) portfolio developed in collaboration with WuXi Biologics and HANGZHOU DAC [1][2] - The company is selling its FYARRO product and associated infrastructure to KAKEN Pharmaceutical for $100 million, with the transaction expected to close in the first half of 2025 [11][12] - Aadi has announced a PIPE financing of $100 million to support its operations and fund clinical data for the ADC portfolio [3][14] License Agreement Details - Aadi is granted exclusive rights to patents and know-how for three preclinical ADC programs targeting PTK7, MUC16, and SEZ6, with an upfront payment of $44 million [2] - Cumulative development milestone payments could reach up to $265 million, and commercial milestone payments could total up to $540 million, along with single-digit royalties on sales [2] PIPE Financing - Aadi's PIPE financing is expected to yield gross proceeds of approximately $100 million, selling 21,592,000 shares at $2.40 per share, representing a 3.4% premium to the closing price on December 19, 2024 [3][4] - The financing is led by Ally Bridge Group and includes participation from new and existing investors [4] ADC Portfolio Overview - The ADC assets utilize HANGZHOU DAC's CPT113 platform, which features a stable yet cleavable linker delivering a Topoisomerase I inhibitor payload [6] - The selected tumor targets are associated with high-potential cancer indications, with clinical efficacy demonstrated by first-generation ADCs [7] FYARRO Sale - KAKEN Pharmaceutical will acquire Aadi's subsidiary and assets related to FYARRO, which has generated $25.2 million in revenue over the past four quarters [11][12] - The sale is expected to provide Aadi with necessary capital to fund operations into late 2028 [14] Board Appointment - Baiteng Zhao, co-founder of ProfoundBio, has been appointed to Aadi's Board of Directors, bringing significant ADC expertise [15][16] - Zhao's experience includes a successful track record in ADC development, which will be instrumental for Aadi's future initiatives [17]

Financial Performance - FYARRO recognized net product sales of $7.2 million and $18.7 million for the three and nine months ended September 30, 2024, respectively[95]. - Product sales for the three months ended September 30, 2024, were $7.2 million, an increase of 20.9% compared to $6.0 million for the same period in 2023[114]. - Total revenue for the nine months ended September 30, 2024, was $18.7 million, compared to $18.0 million for the same period in 2023, reflecting strong demand for FYARRO[114]. - The accumulated deficit as of September 30, 2024, was $314.4 million, with net losses of $12.5 million for the three months ended September 30, 2024[123]. Operational Changes - The company halted the PRECISION1 trial based on interim analysis results, indicating it was unlikely to meet the efficacy threshold for accelerated approval[97]. - A workforce reduction of 22 employees, representing approximately 32% of the workforce, was approved by the Board of Directors[98]. - The company expects to decrease investment in research and development due to the halt of the PRECISION1 study and paused enrollment in two Phase 2 trials[103]. - Restructuring charges for the three and nine months ended September 30, 2024, were $2.6 million, resulting from a workforce reduction of 32%[120]. Cash and Investments - The company had $62.6 million in cash, cash equivalents, and short-term investments as of September 30, 2024, expected to fund operations into the second half of 2026[104]. - For the nine months ended September 30, 2024, cash used in operating activities was $44.5 million, resulting from a net loss of $45.4 million[125]. - Cash provided by investing activities for the nine months ended September 30, 2024 was $12.1 million, related to maturities of short-term investments of $50.0 million[128]. - The company received funding of $72.2 million from a private investment in public equity financing on September 22, 2022[124]. Strategic Initiatives - The company is conducting a comprehensive strategic review to maximize shareholder value[97]. - The company has a shelf registration statement allowing it to sell up to $150.0 million of various securities, providing flexibility for future capital needs[124]. - The company has sufficient supply of FYARRO for at least the next two years based on estimated demand and is seeking to enter into a new agreement for its manufacture[131]. Expenses - Selling, general and administrative expenses decreased by $4.0 million to $7.2 million for the three months ended September 30, 2024, compared to $11.2 million for the same period in 2023[115]. - Research and development expenses for the three months ended September 30, 2024, were $10.0 million, a decrease of $1.9 million from $11.9 million in 2023[119]. - Other income for the three months ended September 30, 2024, was $0.9 million, down from $1.5 million in 2023, primarily due to a decrease in short-term investments[122]. Legal and Compliance - The arbitration panel found that the company did not breach the EOC License Agreement, resulting in no liability for damages to EOC[98]. - The commercial sale of FYARRO was launched on February 22, 2022, marking a significant milestone in the company's operations[103].

Financial Performance - Aadi Bioscience reported a quarterly loss of $0.46 per share, which aligns with the Zacks Consensus Estimate, an improvement from a loss of $0.60 per share a year ago [1] - The company posted revenues of $7.21 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 10.11%, compared to $5.96 million in the same quarter last year [2] - The current consensus EPS estimate for the upcoming quarter is -$0.24 on revenues of $6.77 million, and for the current fiscal year, it is -$2.02 on revenues of $24.86 million [7] Market Performance - Aadi Bioscience shares have declined approximately 1.5% since the beginning of the year, contrasting with the S&P 500's gain of 21.2% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Aadi Bioscience belongs, is currently ranked in the top 38% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Sales Performance - FYARRO® sales reached $7.2 million in Q3 2024, reflecting a 21% year-over-year growth[1] - The net product sales of FYARRO increased by 17% from Q2 2024, driven by strong demand and a nearly 90% reorder rate[2] - Total revenue for the quarter ended September 30, 2024, was $7.2 million, resulting solely from FYARRO sales[5] Financial Position - Cash, cash equivalents, and short-term investments as of September 30, 2024, were $62.6 million, down from $108.8 million as of December 31, 2023[5] - Operating expenses for Q3 2024 were $20.6 million, a decrease from $23.8 million in the prior year quarter[6] - The net loss for Q3 2024 was $12.5 million, compared to a net loss of $16.3 million for the same period in 2023[6] - Aadi expects to fund operations into at least the second half of 2026 based on current plans[8] Strategic Initiatives - Aadi is conducting a comprehensive strategic review to maximize shareholder value, with no specific timeline provided for completion[4] - The Phase 2 trials of nab-sirolimus for advanced endometrial cancer and neuroendocrine tumors have enrolled 24 and 12 patients, respectively[4] - The company has transitioned patients from the halted PRECISION1 trial to an expanded access protocol, with a report expected in 2025[3]

Group 1 - Aadi Bioscience, Inc. will report its third quarter 2024 financial results on November 6, 2024 [1] - The company focuses on the commercialization of FYARRO® for treating adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa) [2]

Core Insights - Aadi Bioscience will halt the PRECISION1 trial due to its inability to meet the efficacy threshold for accelerated approval, focusing instead on its commercial product FYARRO® for PEComa treatment [1][2][3] - The company plans to preserve cash by reducing R&D headcount by 80% and pausing new patient enrollment in ongoing Phase 2 trials, extending its cash runway into at least the second half of 2026 [2][3] Company Focus - Aadi's marketed product, FYARRO®, is the only preferred treatment for advanced malignant PEComa, generating sales of $6.2 million in Q2 [2] - The company will continue dosing previously enrolled patients in two ongoing Phase 2 trials for advanced endometrial cancer and neuroendocrine tumors, which have sufficient patient enrollment to assess initial efficacy signals [2] Strategic Review - Aadi is conducting a comprehensive strategic review to maximize shareholder value and has engaged an advisory firm to explore options [3] - The company acknowledges the contributions of investigators and patients involved in the PRECISION1 trial while emphasizing the need for immediate actions to preserve cash [3]

Financial Data and Key Metrics Changes - FYARRO product sales were $6.2 million for Q2 2024, consistent with the prior year and up 15% from Q1 2024 [20] - Net loss for Q2 2024 was $14.6 million, an improvement from $18 million in Q2 2023 [22] - Cash, cash equivalents, and short-term investments totaled $78.6 million at the end of Q2 2024, supporting operations into Q4 2025 [21] Business Line Data and Key Metrics Changes - FYARRO has achieved cumulative sales of $51.1 million since its launch in February 2022, with a 14% increase in the number of ordering accounts compared to Q1 2024 [20] - Research and development expenses for Q2 2024 were $13.1 million, slightly down from $13.3 million in the prior year [21] - Selling, general, and administrative expenses decreased to $7.9 million from $11.8 million in Q2 2023, attributed to reduced commercial and legal expenses [21] Market Data and Key Metrics Changes - The market opportunity for TSC1 and TSC2 mutated cancers is projected to be between $300 million to $600 million in the U.S. alone [18] - Approximately 16,000 patients with TSC1 and TSC2 mutations exist across various tumor types, with nearly half of these tumors found in high NGS testing specialties [17] Company Strategy and Development Direction - The company is focused on expanding nab-sirolimus for larger indications across multiple types of mTOR-driven tumors, with ongoing trials in endometrial cancer and neuroendocrine tumors [8][9] - The PRECISION1 trial is a registration-intended tumor-agnostic study, fully enrolled with 120 patients, expected to complete by the end of the year [11][12] - The company aims to provide interim analysis results from PRECISION1 in Q3 2024, which could lead to discussions with the FDA regarding a potential submission [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical development plans and the potential for nab-sirolimus to address significant unmet needs in oncology [23] - The company anticipates a catalyst-heavy 2024 and 2025, with key data readouts expected to support future growth [10][23] Other Important Information - The company has seen a strong rebound in demand for FYARRO in Q2 2024, with expectations for continued incremental growth in Q3 and Q4 [38] - The design of the PRECISION1 trial aligns with the latest regulatory guidance for tumor-agnostic studies, enhancing confidence in its potential approval [15][16] Q&A Session Summary Question: Expectations for PRECISION1 interim data - Management indicated that the Q3 interim data will focus on the primary endpoint of overall response rate after a minimum of six months of follow-up [26] Question: Future adjustments to PRECISION1 trial - The trial is fully enrolled, and no adjustments are anticipated at this time, with results expected in early 2025 [36] Question: Growth expectations for FYARRO - Management remains positive about continued growth, citing strong demand and increased ordering accounts [38] Question: Specific tumor types for future trials - The company is conducting a tumor-agnostic trial and does not plan to bias enrollment towards specific tumor types [41] Question: Data disclosure for endometrial cancer program - Management plans to disclose overall response rates and any differences based on lines of treatment, depending on the data set [48] Question: Excitement in KOL community for nab-sirolimus - There is enthusiasm for both the TSC1/2 approach and the endometrial cancer program, with specialists looking for innovative treatments [56]

Q2 2024 Results Presentation August 7, 2024 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 ...

Financial Performance - FYARRO recognized net product sales of $6.2 million and $11.5 million for the three and six months ended June 30, 2024, respectively[101]. - Product sales for the three months ended June 30, 2024, were $6.2 million, consistent with the same period in 2023, while sales for the six months were $11.5 million, down from $12.1 million in 2023[119]. - Selling, general, and administrative expenses decreased to $7.9 million for the three months ended June 30, 2024, from $11.8 million in 2023, and to $18.5 million for the six months from $23.0 million[120]. - Research and development expenses for the three months ended June 30, 2024, were $13.1 million, slightly down from $13.3 million in 2023, while expenses for the six months increased to $26.7 million from $24.3 million[123]. - Other income for the three months ended June 30, 2024, was $1.0 million, down from $1.6 million in 2023, and for the six months, it was $2.2 million compared to $3.2 million[125]. - The company reported net losses of $14.6 million and $18.0 million for the three months ended June 30, 2024 and 2023, respectively, and $32.9 million and $33.2 million for the six months ended June 30, 2024 and 2023, respectively[126]. - Cash used in operating activities for the six months ended June 30, 2024 was $28.8 million, compared to $38.1 million for the same period in 2023[129]. - Cash provided by investing activities for the six months ended June 30, 2024 was $7.0 million, significantly lower than $66.9 million for the same period in 2023[130]. - Cash provided by financing activities for the six months ended June 30, 2024 was $0.1 million, compared to $0.3 million for the same period in 2023[131]. - The accumulated deficit as of June 30, 2024, was $301.8 million, primarily due to research and development costs and administrative expenses[109]. - The company has an accumulated deficit of $301.8 million as of June 30, 2024[126]. Research and Development - Research and development costs are expected to increase in 2024 due to significant expenses related to the PRECISION1 trial and other clinical programs[107]. - The company plans to increase investment in research and development to advance FYARRO in additional indications through clinical trials[114]. - The company is currently enrolling patients in Phase 2 trials for advanced or recurrent endometrioid endometrial cancer and neuroendocrine tumors[108]. - The PRECISION1 trial was fully enrolled in April 2024 and is expected to be completed by the end of 2024, with results anticipated in early 2025[102]. - The company has contracts with various organizations for research and development activities, including clinical trial management and drug manufacturing[132]. Commercialization and Sales - The company has built a cross-functional commercial team and expects a decrease in commercialization expenses compared to prior periods[107]. - The decrease in product sales for the six months ended June 30, 2024, was attributed to distributor ordering patterns and fewer new patient initiations[119]. - Royalties on net product sales under the BMS License Agreement were $0.5 million for the three months ended June 30, 2024, consistent with the same period in 2023[103]. - A payment of $5.8 million to BMS is due no later than August 26, 2024, under the BMS License Agreement[108]. - The EOC arbitration process is expected to yield a decision in the second half of 2024, which may significantly impact sales, general, and administrative expenses[108]. Cash and Financial Position - As of June 30, 2024, the company had $78.6 million in cash, cash equivalents, and short-term investments, expected to fund operations into Q4 2025[109]. - The company has a shelf registration statement allowing it to sell up to $150.0 million of various securities, providing flexibility for future capital needs[127]. - The company entered into a lease for 10,615 square feet of office space in Morristown, New Jersey, with a term of seventy-three months[132]. Collaboration and Partnerships - The company terminated its collaboration with Mirati Therapeutics in May 2024, discontinuing enrollment in the Phase 1/2 trial[102].

Aadi Bioscience, Inc. (AADI) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $0.71. This compares to loss of $0.67 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 23.94%. A quarter ago, it was expected that this company would post a loss of $0.66 per share when it actually produced a loss of $0.68, delivering a surprise of -3.03%.Over the last four quarters, the company has su ...