Part 1: Performance Analysis

Aadi Bioscience, Inc. has reported strong financial performance for the quarter ended March 31, 2023. The company's lead drug product, FYARRO, was approved by the FDA in November 2021 for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (“PEComa”). Since the launch of the product in February 2022, the company has recognized net product sales of $5.9 million for the quarter ended March 31, 2023.

Apart from malignant PEComa, the company is also developing FYARRO for the treatment of patients with Tuberous Sclerosis Complex 1 and 2 (“TSC1 & TSC2”) alterations. The company has initiated the registration-directed tumor-agnostic Phase 2 study named “PRECISION 1” for this purpose. The study was opened for enrollment in the United States during the first quarter of 2022, and the company has reported good progress with well-balanced enrollment, and patients with over 15 discreet tumor types have been enrolled with no more than three of any type. Therefore, the company’s drug FYARRO has shown potential to produce transformational therapies to cancer patients with mTOR pathway driver alterations where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site.

In October 2022, the company entered into a collaboration and supply agreement with Mirati Therapeutics, Inc. to evaluate the combination of Mirati’s adagrasib, a KRAS G12C selective inhibitor, and FYARRO in KRAS G12C mutant non-small cell lung cancer (NSCLC) and other solid tumors. Under the terms of the agreement, Mirati will be responsible for sponsoring and operating the Phase 1/2 study and the company will supply study drug and jointly share the cost of the study. The trial will build on preclinical data showing enhanced anti-tumor efficacy with the combination of adagrasib and FYARRO relative to either agent alone.

Part 2: Forward-Looking Analysis

The company has shown potential for significant growth through its drug portfolio. However, the pharmaceutical industry is highly competitive, and the company needs to remain vigilant in its efforts to remain competitive. According to Neil Desai, the founder, director, and former President and CEO, the company expects to reveal additional clinical trial updates by the end of 2023, and these updates will provide more clarity as to FYARRO’s efficacy in treating patients with Tuberous Sclerosis Complex 1 and 2 (“TSC1 & TSC2”) alterations.

The company's management has also initiated an executive search for a successor Chief Executive Officer, and, therefore, the duties of Sandesh Seth, who served as CEO, will be fulfilled by Scott Giacobello, Chief Financial Officer and interim CEO and President, until a successor is appointed. While this creates a sense of uncertainty, the board has initiated an executive search, which is a positive sign on the path to find the right leader for the company.

Furthermore, as mentioned earlier, the pharmaceutical industry is an intensely competitive industry, and the company's success depends on developing new and innovative therapies that address unmet needs in cancer treatment. As such, the company’s collaboration with Mirati Therapeutics, Inc. to evaluate the combination of Mirati’s adagrasib, a KRAS G12C selective inhibitor, and FYARRO in KRAS G12C mutant non-small cell lung cancer (NSCLC) and other solid tumors has the potential to create a transformative therapy and drive future growth.

Overall, the company’s research has shown considerable promise. However, as with any biopharmaceutical company, the road to commercialization is long and highly uncertain, and results from its clinical trials are unpredictable. Therefore, investors should exercise caution while investing in the company.

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Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Aadi Bioscience Inc

Aadi Bioscience (ADIB) reports impressive Q1 2023 financial performance & potential growth with drug portfolio.

Aadi Bioscience, a biopharmaceutical company focused on developing precision therapies for genetically defined cancers, recently reported its financial results for the first quarter of 2023. The company's tumor-agnostic PRECISION 1 trial, a registration-directed Phase 2 study of nab-sirolimus in patients with solid tumors with pathogenic inactivating alterations in TSC1 or TSC2 genes, has shown promising results. Enrollment has been well-balanced, and the trial is accruing evenly between the TSC1 and TSC2 arms, with more than 15 discreet tumor types enrolled. The company plans to release the results of an efficacy analysis later this year when response data is unblinded in conjunction with a pre-planned interim analysis on 40 patients with appropriate follow-up. 

Additionally, the appointment of Mohammad Hirmand, M.D. to the Board of Directors is likely to provide valuable insights and expertise to the company's progress. Aadi presented its ongoing PRECISION 1 trial and nab-sirolimus biomarker analysis on response correlation with TSC1 and TSC2 inactivating alterations at various annual meetings, including AACR Annual Meeting and SGO Annual Meeting.  Furthermore, Aadi is expected to present a company-sponsored update from the PRECISION 1 Phase 2 study and combination data of nab-sirolimus and pazopanib (PAZO) from an ongoing Investigator Initiated Trial at ASCO 2023 in June. 

Aadi Bioscience ended the first quarter with approximately $151 million in cash and equivalents, which is expected to fund expected operations through 2025 based on current plans. The company also plans to launch a Phase 2 trial in KRASG12C with first patient dosing in the second quarter of 2023 to evaluate the combination of adagrasib with nab-sirolimus in collaboration with Mirati Therapeutics. 

Overall, Aadi Bioscience's first-quarter results indicate that the company is making progress in its focus on developing precision therapies for genetically defined cancers with promising enrollment in its PRECISION 1 trial as well as its additional partnership with Mirati Therapeutics. Investments in the firm for investors could prove fruitful if the positive trend continues.

Form 8-K - Current report - Item 2.02 Item 9.01

$AADI Reports Promising Enrollment and Financial Results in Q1 2023 for Precision Cancer Therapy Development

PART 1: Performance Analysis

Aadi Bioscience, Inc. performed well during the period, reporting net revenue from product sales of $15.2 million for the fiscal year ended December 31, 2022. This revenue is due to FDA approval of FYARRO sirolimus protein-bound particles, a form of sirolimus bound to albumin, for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (“PEComa”). The company launched FYARRO in the United States on February 22, 2022, for the treatment of advanced malignant PEComa. Additionally, the company recorded $72.2 million in net proceeds from its 2022 private placement (PIPE) financing, which will fund working capital and other general corporate purposes.

Aadi Bioscience, Inc. has also shown a strong focus on future growth with the initiation of registration-directed tumor-agnostic Phase 2 study (“PRECISION 1”) of FYARRO in patients with Tuberous Sclerosis Complex 1 and 2 (“ TSC1 & TSC2 ”) alterations. The company has completed a Type B meeting with the FDA and began enrollment in the United States during the first quarter of 2022, with preliminary data expected during the second quarter of 2023. The company has also entered into a collaboration and supply agreement with Mirati Therapeutics, Inc. to evaluate the combination of adagrasib and FYARRO in KRAS G12C mutant non-small cell lung cancer (NSCLC) and other solid tumors.

PART 2: Forward-Looking Analysis

Aadi Bioscience, Inc. is well positioned for future success with its focus on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes. The expedited FDA approval of FYARRO for the treatment of advanced malignant PEComa demonstrates the potential of the albumin-bound sirolimus approach to produce transformational therapies to cancer patients with mTOR pathway driver alterations. The company's collaboration with Mirati Therapeutics, Inc. to evaluate the combination of adagrasib and FYARRO in KRAS G12C mutant non-small cell lung cancer and other solid tumors further expands the potential applications of the products.

The successful completion of the PRECISION 1 trial and the expansion into new target populations could provide a significant boost to the company's revenue stream in the future. Moreover, the net proceeds from the recently completed PIPE financing will provide the company with funds to support its research and development activities.

However, the success of Aadi Bioscience, Inc. is predicated on the continued success of its product, FYARRO, which is still in early stages. The competitive landscape of the cancer treatment industry and the regulatory environment could also impact the company's future success. Therefore, investors should carefully consider the risks associated with investing in Aadi Bioscience, Inc. before making any decisions.

Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405]

EX-10.4 - AMENDED AND RESTATED EXECUTIVE AGREEMENT, NEIL DESAI

EX-15.15 - BRE SUNSET COAST LLC, OFFICE LEASE

Aadi Bioscience reports strong revenue in FDA-approved cancer drug FYARRO with strong growth potential.

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Form 8-K/A - Current report: [Amend] - Item 5.02

Announcement: AADI 8-K/A Special Filing Amendment

Aadi Bioscience, a precision therapy-focused biopharmaceutical firm, has shared its financial results for 2022, with $15.2 million in sales being reported for the 10-month period. Additionally, the company's cash reserves will last until 2025. In terms of research and development, Aadi's collaboration with Mirati Therapeutics will be commencing in Q2 2023, and the results of their PRECISION 1 trial will be shared around the same time. The trial's independent TSC1 and TSC2 patient groups are both comprised of 60 individuals. Dr. Mohammad Hirmand has also been announced as a new member of the Board of Directors. CEO Scott Giacobello is optimistic about the company's progress, and Aadi Bioscience appears to have a bright road ahead.

Form 8-K - Current report - Item 2.02 Item 5.02 Item 9.01

$AADI reports $15.2M sales & strong cash reserves, sets new R&D collaboration & welcomes new board member

Form 8-K - Current report - Item 5.02 Item 7.01 Item 9.01

Aadi Bioscience (ADIB) reports impressive Q1 2023 financial performance & potential growth with drug portfolio.

Aadi Bioscience (ADIB) reports impressive Q1 2023 financial performance & potential growth with drug portfolio.

$AADI Reports Promising Enrollment and Financial Results in Q1 2023 for Precision Cancer Therapy Development

$AADI Reports Promising Enrollment and Financial Results in Q1 2023 for Precision Cancer Therapy Development

Aadi Bioscience reports strong revenue in FDA-approved cancer drug FYARRO with strong growth potential.

Aadi Bioscience reports strong revenue in FDA-approved cancer drug FYARRO with strong growth potential.

Announcement: AADI 8-K/A Special Filing Amendment

Announcement: AADI 8-K/A Special Filing Amendment

$AADI reports $15.2M sales & strong cash reserves, sets new R&D collaboration & welcomes new board member

$AADI reports $15.2M sales & strong cash reserves, sets new R&D collaboration & welcomes new board member

Announcement: AADI 8-K Special Filing

Announcement: AADI 8-K Special Filing