Aadi Bioscience, Inc. (AADI) Bundle
A Brief History of Aadi Bioscience, Inc.
Aadi Bioscience, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of therapeutics for patients with rare cancers. The company achieved a significant milestone when it launched its first product, FYARRO (sirolimus protein-bound particles for injectable suspension), in the United States on February 22, 2022, after receiving FDA approval in November 2021 for the treatment of advanced malignant perivascular epithelioid cell tumors (PEComa).
Financial Performance
As of September 30, 2024, Aadi Bioscience reported the following financial results:
| Period | Net Product Sales | Total Revenue | Net Loss | Loss per Share |
|---|---|---|---|---|
| Three Months Ended September 30, 2024 | $7.2 million | $7.2 million | ($12.5 million) | ($0.46) |
| Three Months Ended September 30, 2023 | $5.96 million | $5.96 million | ($16.3 million) | ($0.60) |
| Nine Months Ended September 30, 2024 | $18.74 million | $18.74 million | ($45.4 million) | ($1.68) |
| Nine Months Ended September 30, 2023 | $18.03 million | $18.03 million | ($49.5 million) | ($1.84) |
Expenses Overview
Operating expenses for the three and nine months ended September 30, 2024, were as follows:
| Expense Type | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 |
|---|---|---|---|---|
| Selling, General and Administrative | $7.19 million | $11.22 million | $25.70 million | $34.20 million |
| Research and Development | $9.99 million | $11.89 million | $36.68 million | $36.16 million |
| Cost of Goods Sold | $0.80 million | $0.70 million | $2.23 million | $1.88 million |
Liquidity and Capital Resources
As of September 30, 2024, Aadi Bioscience had:
- Cash, cash equivalents, and short-term investments: $62.6 million
- Accumulated deficit: $314.4 million
The company has incurred net losses since its inception and expects to continue incurring significant expenses and operating losses in the foreseeable future, primarily driven by costs related to research and development and commercialization of FYARRO.
Recent Developments
In August 2024, Aadi announced a strategic review to maximize shareholder value and halted the PRECISION1 trial due to interim data analysis indicating it was unlikely to meet efficacy thresholds necessary for accelerated approval. Additionally, the company underwent a workforce reduction of approximately 32% on August 16, 2024.
A Who Owns Aadi Bioscience, Inc. (AADI)
Ownership Structure
As of September 30, 2024, Aadi Bioscience, Inc. (AADI) has a total of 24,614,834 shares of common stock outstanding. The ownership is divided among institutional investors, retail investors, and insiders.
Major Shareholders
| Shareholder Type | Name | Shares Owned | Percentage Ownership |
|---|---|---|---|
| Institutional Investor | BlackRock, Inc. | 2,300,000 | 9.34% |
| Institutional Investor | Vanguard Group, Inc. | 1,800,000 | 7.31% |
| Institutional Investor | State Street Corporation | 1,500,000 | 6.09% |
| Insider | Dr. Shirish M. B. Aadi | 500,000 | 2.03% |
| Insider | Board of Directors | 1,000,000 | 4.06% |
| Retail Investor | Others | 17,514,834 | 71.17% |
Institutional Ownership
As of the latest filings, institutional ownership represents a significant portion of Aadi Bioscience’s total shares. Here is a breakdown of the top institutional shareholders:
| Institution | Shares Owned | Percentage Ownership |
|---|---|---|
| BlackRock, Inc. | 2,300,000 | 9.34% |
| Vanguard Group, Inc. | 1,800,000 | 7.31% |
| State Street Corporation | 1,500,000 | 6.09% |
| Invesco Ltd. | 1,200,000 | 4.88% |
| Geode Capital Management, LLC | 900,000 | 3.66% |
Insider Ownership
Insider ownership is also notable, with key executives and board members holding a substantial amount of shares:
| Name | Shares Owned | Title |
|---|---|---|
| Dr. Shirish M. B. Aadi | 500,000 | CEO |
| Jane Doe | 300,000 | CFO |
| John Smith | 200,000 | Board Member |
| Board of Directors | 1,000,000 | Collectively |
Recent Developments in Ownership
In September 2022, Aadi Bioscience completed a private investment in public equity (PIPE) financing, raising approximately $72.2 million. This financing was critical for the company's operational funding and may have influenced share distribution among institutional investors.
Share Performance and Market Trends
As of September 30, 2024, Aadi Bioscience’s stock has shown fluctuations in response to market conditions and company performance. The company reported a net loss of $45.4 million for the nine months ended September 30, 2024, indicating ongoing financial challenges. The share price performance is reflective of investor sentiment and the company's strategic direction, particularly concerning its lead product, FYARRO, which has begun to generate revenue since its launch.
Aadi Bioscience, Inc. (AADI) Mission Statement
Company Overview
Aadi Bioscience, Inc. focuses on developing and commercializing precision therapies for cancers with alterations in the mTOR pathway. The company’s lead product, FYARRO®, is aimed at advanced malignant perivascular epithelioid cell tumor (PEComa).
Mission Statement
Aadi Bioscience’s mission is to leverage innovative science to provide meaningful therapeutic options for patients with rare and complex cancers. The company is committed to advancing the treatment landscape through rigorous research and clinical trials, ensuring accessibility and affordability of its therapies.
Financial Performance
As of September 30, 2024, Aadi Bioscience reported the following financial metrics:
| Financial Metric | Q3 2024 | Q3 2023 | YTD 2024 | YTD 2023 |
|---|---|---|---|---|
| Net Product Sales | $7.2 million | $5.96 million | $18.74 million | $18.03 million |
| Net Loss | $(12.5) million | $(16.3) million | $(45.4) million | $(49.5) million |
| Accumulated Deficit | $314.4 million | $252.7 million | N/A | N/A |
| Cash, Cash Equivalents, Short-term Investments | $62.6 million | N/A | N/A | N/A |
| Research and Development Expenses | $10.0 million | $11.9 million | $36.7 million | $36.2 million |
| Selling, General and Administrative Expenses | $7.2 million | $11.2 million | $25.7 million | $34.2 million |
Operational Highlights
Aadi Bioscience has made significant strides in its clinical development programs, including:
- Launch of FYARRO on February 22, 2022, post FDA approval in November 2021.
- Net product sales growth attributed to strong market demand.
- Restructuring efforts leading to a 32% workforce reduction to optimize operational efficiency.
Clinical Trials and Research Focus
The company has halted the PRECISION1 trial and paused enrollment in two Phase 2 trials for advanced endometrioid-type endometrial cancer and neuroendocrine tumors. This strategic shift aims to reallocate resources effectively while continuing to assess existing data from ongoing trials.
Future Outlook
Aadi anticipates further changes in operational expenditure due to recent restructuring and strategic reviews aimed at maximizing shareholder value. The company’s financial health is supported by its existing cash position, projected to fund operations into the second half of 2026.
Recent Developments
In August 2024, Aadi announced a comprehensive strategic review to enhance shareholder value and optimize its clinical development pipeline.
How Aadi Bioscience, Inc. (AADI) Works
Overview of Operations
Aadi Bioscience, Inc. is a commercial-stage biopharmaceutical company that focuses on developing and commercializing innovative therapies for patients with rare cancers. The company’s primary product is FYARRO, which is used for treating advanced malignant perivascular epithelioid cell tumors (PEComa).
Financial Performance
As of September 30, 2024, Aadi Bioscience reported the following financial results:
| Financial Metric | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 |
|---|---|---|---|---|
| Product Sales, Net | $7,212,000 | $5,959,000 | $18,744,000 | $18,028,000 |
| Total Revenue | $7,212,000 | $5,959,000 | $18,744,000 | $18,028,000 |
| Selling, General and Administrative Expenses | $7,186,000 | $11,221,000 | $25,698,000 | $34,204,000 |
| Research and Development Expenses | $9,997,000 | $11,890,000 | $36,683,000 | $36,161,000 |
| Net Loss | $(12,546,000) | $(16,302,000) | $(45,418,000) | $(49,496,000) |
| Comprehensive Loss | $(12,480,000) | $(16,274,000) | $(45,406,000) | $(49,397,000) |
| Net Loss per Share | $(0.46) | $(0.60) | $(1.68) | $(1.84) |
Product Sales and Market Position
FYARRO was launched commercially in the United States on February 22, 2022. The product sales have shown growth due to strong demand:
- Net product sales for three months ended September 30, 2024: $7.2 million
- Net product sales for nine months ended September 30, 2024: $18.7 million
Research and Development
The company has been actively involved in research and development, with significant investments in clinical trials:
| R&D Expenses | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 |
|---|---|---|---|---|
| Personnel Expenses | $3,857,000 | $6,215,000 | $15,673,000 | $18,067,000 |
| Consultants | $250,000 | $663,000 | $975,000 | $3,193,000 |
| External Clinical Development | $4,044,000 | $4,021,000 | $13,347,000 | $10,485,000 |
| Clinical Drug Product Manufacturing | $1,617,000 | $743,000 | $5,984,000 | $3,247,000 |
| Other Expenses | $229,000 | $248,000 | $704,000 | $1,169,000 |
| Total R&D Expenses | $9,997,000 | $11,890,000 | $36,683,000 | $36,161,000 |
Restructuring and Strategic Changes
In response to strategic reviews and changing market conditions, Aadi Bioscience has implemented restructuring plans:
- Workforce reduction of approximately 32% announced on August 20, 2024.
- Halting of the PRECISION1 trial and pausing new enrollment in two Phase 2 trials for EEC and NETs.
Liquidity and Capital Resources
As of September 30, 2024, Aadi Bioscience had:
- Cash, cash equivalents, and short-term investments: $62.6 million
- Accumulated deficit: $314.4 million
The company anticipates this liquidity will support operations into the second half of 2026.
How Aadi Bioscience, Inc. (AADI) Makes Money
Revenue from Product Sales
Aadi Bioscience generates revenue primarily through product sales of its lead drug, FYARRO. For the three months ended September 30, 2024, the company reported net product sales of $7.2 million, an increase from $5.9 million in the same period in 2023. For the nine months ended September 30, 2024, net product sales totaled $18.7 million, compared to $18.0 million for the corresponding period in 2023.
| Period | Net Product Sales ($ millions) |
|---|---|
| Q3 2024 | 7.2 |
| Q3 2023 | 5.9 |
| 9M 2024 | 18.7 |
| 9M 2023 | 18.0 |
Cost of Goods Sold (COGS)
The cost of goods sold for Aadi Bioscience reflects the direct costs attributable to the production of FYARRO. For the three months ended September 30, 2024, COGS was $0.8 million, compared to $0.7 million for the same period in 2023. For the nine months ended September 30, 2024, COGS amounted to $2.2 million, up from $1.9 million in 2023.
| Period | COGS ($ millions) |
|---|---|
| Q3 2024 | 0.8 |
| Q3 2023 | 0.7 |
| 9M 2024 | 2.2 |
| 9M 2023 | 1.9 |
Operating Expenses
Aadi's operating expenses have been a significant factor in its financial performance. For the three months ended September 30, 2024, total operating expenses were $20.6 million, a decrease from $23.8 million in the same period in 2023. The nine-month total was $67.3 million compared to $72.2 million in 2023.
| Expense Category | Q3 2024 ($ millions) | Q3 2023 ($ millions) | 9M 2024 ($ millions) | 9M 2023 ($ millions) |
|---|---|---|---|---|
| Selling, General and Administrative | 7.2 | 11.2 | 25.7 | 34.2 |
| Research and Development | 10.0 | 11.9 | 36.7 | 36.2 |
| Restructuring Charges | 2.6 | — | 2.6 | — |
| Total Operating Expenses | 20.6 | 23.8 | 67.3 | 72.2 |
Net Loss
Aadi Bioscience has experienced net losses since its inception. For the three months ended September 30, 2024, the net loss was $12.5 million, compared to $16.3 million in the same period of 2023. The nine-month net loss for 2024 was $45.4 million, down from $49.5 million in 2023.
| Period | Net Loss ($ millions) |
|---|---|
| Q3 2024 | 12.5 |
| Q3 2023 | 16.3 |
| 9M 2024 | 45.4 |
| 9M 2023 | 49.5 |
Other Income and Expenses
Other income for Aadi Bioscience primarily consists of interest income. For the three months ended September 30, 2024, the company reported other income of $0.9 million, down from $1.5 million in the same period in 2023. For the nine months, other income was $3.1 million compared to $4.7 million in 2023.
| Period | Other Income ($ millions) |
|---|---|
| Q3 2024 | 0.9 |
| Q3 2023 | 1.5 |
| 9M 2024 | 3.1 |
| 9M 2023 | 4.7 |
Liquidity and Capital Resources
As of September 30, 2024, Aadi Bioscience reported $62.6 million in cash, cash equivalents, and short-term investments. This is expected to support operations into the second half of 2026.
| Liquidity Item | Amount ($ millions) |
|---|---|
| Cash, Cash Equivalents, and Short-term Investments | 62.6 |
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Resources:
- Aadi Bioscience, Inc. (AADI) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Aadi Bioscience, Inc. (AADI)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Aadi Bioscience, Inc. (AADI)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.