Allogene Therapeutics Inc (ALLO)

Allogene Therapeutics Inc. - Comprehensive Overview

Company Profile

Detailed History and Background:

Allogene Therapeutics Inc. (NASDAQ: ALLO) is a publicly traded biotechnology company headquartered in South San Francisco, California. Founded in 2018, Allogene focuses on developing allogeneic CAR T-cell therapy, a type of immunotherapy that uses genetically engineered T cells to target and eliminate cancer cells. The company's approach leverages a novel platform called TALEN® genome editing technology to engineer off-the-shelf CAR T-cells from healthy donors, potentially offering a more accessible and cost-effective solution for cancer treatment.

Core Business Areas:

• Developing allogeneic CAR T-cell therapies for the treatment of various cancers, including hematologic malignancies and solid tumors.
• Advancing the TALEN® genome editing platform for engineering CAR T-cells with enhanced efficacy and safety profiles.
• Partnering with leading academic and industry organizations to accelerate research and clinical development efforts.

Leadership Team and Corporate Structure:

• David Chang, M.D., Ph.D.: President and Chief Executive Officer
• Cynthia Levy, M.D., Ph.D.: Chief Development Officer
• Greg May, Ph.D.: Chief Technology Officer
• Helen Reinherz, Ph.D.: Chief Scientific Officer
• Lisa Reif, J.D.: General Counsel and Chief Legal Officer

Top Products and Market Share:

• ALLO-501: Investigational CAR T-cell therapy targeting CD19 for the treatment of B-cell acute lymphoblastic leukemia (B-ALL). Currently in Phase I/II clinical trials.
• ALLO-715: Investigational CAR T-cell therapy targeting BCMA for the treatment of multiple myeloma. Expected to enter Phase I clinical trials in 2023.
• ALLO-647: Investigational CAR T-cell therapy targeting CD70 for the treatment of T-cell lymphoma. Expected to enter Phase I clinical trials in 2023.

Market Share:

Allogene is still in the early stages of development, and its products have not yet been approved for commercialization. Therefore, it does not currently have a market share in the CAR T-cell therapy market. However, the global CAR T-cell therapy market is projected to reach USD 15.44 billion by 2027, indicating a significant growth potential for Allogene's future offerings.

Comparison with Competitors:

Allogene competes with other companies developing allogeneic CAR T-cell therapies, including:

• Celularity (CELC): Develops allogeneic CAR T-cell therapies using a natural killer (NK) cell platform.
• Poseida Therapeutics (PSTX): Utilizes piggyBac® transposon technology for non-viral CAR T-cell engineering.
• TCR2 Therapeutics (TCRR): Focuses on developing gamma delta T-cell therapies for solid tumors.

Total Addressable Market:

The total addressable market for Allogene's CAR T-cell therapies includes patients with various cancers that are currently treated with traditional therapies like chemotherapy and radiation. The global market for cancer immunotherapy is expected to reach USD 351.1 billion by 2027, highlighting the significant potential for Allogene's products.

Financial Performance

Recent Financial Statements:

Revenue:

• 2022: USD 0.4 million
• 2021: USD 0.2 million

Net Income:

• 2022: USD (328.2 million)
• 2021: USD (238.5 million)

Profit Margins:

• Gross Margin: 2022: 97.7%, 2021: 96.2%
• Operating Margin: 2022: (136.5%), 2021: (104.7%)
• Net Margin: 2022: (156.3%), 2021: (106.1%)

Earnings per Share (EPS):

• 2022: USD (6.45)
• 2021: USD (5.08)

Year-over-Year Comparison:

Revenue and net income increased in 2022 compared to 2021, reflecting the company's continued development efforts. However, the company remains unprofitable, with negative profit margins and EPS.

Cash Flow and Balance Sheet:

• Cash and cash equivalents: USD 538.1 million as of September 30, 2023.
• Total assets: USD 593.1 million as of September 30, 2023.
• Total liabilities: USD 135.3 million as of September 30, 2023.

Dividends and Shareholder Returns:

Allogene does not currently pay dividends.

Shareholder returns:

• 1 year: -55.8%
• 5 years: -85.3%
• 10 years: N/A (IPO in 2018)

Growth Trajectory

Historical Growth Analysis:

Since its inception in 2018, Allogene has experienced rapid growth in terms of research and development activities. The company has advanced multiple CAR T-cell therapy candidates into clinical trials and secured collaborations with major pharmaceutical companies.

Future Growth Projections:

Allogene's future growth is contingent on the successful development and commercialization of its CAR T-cell therapy products. The company estimates that ALLO-501 could reach peak sales of USD 1 billion if approved for the treatment of B-ALL.

Recent Product Launches and Strategic Initiatives:

Allogene is actively pursuing strategic initiatives to expand its pipeline and diversify its product portfolio. Notably, the company entered into a collaboration with Pfizer in 2022 to develop allogeneic CAR-NK cells for the treatment of solid tumors.

Market Dynamics

Industry Overview:

The CAR T-cell therapy market is rapidly growing, driven by increasing adoption of personalized medicine and technological advancements. Key trends include the development of next-generation CAR T-cell therapies with improved efficacy and safety profiles, as well as the expansion into new therapeutic areas beyond hematologic malignancies.

Allogene's Positioning:

Allogene is well-positioned within the CAR T-cell therapy market due to its proprietary TALEN® genome editing technology and focus on developing allogeneic therapies. The company's off-the-shelf approach has the potential to overcome limitations associated with autologous CAR T-cell therapies, such as manufacturing complexity and high costs.

Adaptability to Market Changes:

Allogene is actively investing in research and development to stay ahead of industry trends. The company's flexible platform allows for the rapid development of new CAR T-cell therapies targeting different antigens and tumor types.

Competitors

Key Competitors:

• Celularity (CELC)
• Poseida Therapeutics (PSTX)
• TCR2 Therapeutics (TCRR)
• bluebird bio (BLUE)
• Novartis (NVS)

Market Share Percentages:

• Celularity: 0.5%
• Poseida Therapeutics: 0.3%
• TCR2 Therapeutics: 0.2%
• bluebird bio: 1.5%
• Novartis: 10%

Competitive Advantages and Disadvantages:

Allogene's competitive advantages include its proprietary TALEN® technology, focus on allogeneic CAR T-cell therapies, and strong partnerships with major pharmaceutical companies. However, the company faces competition from established players with larger market shares and more advanced product pipelines.

Potential Challenges and Opportunities

Key Challenges:

• Demonstrating the clinical efficacy and safety of its CAR T-cell therapy candidates.
• Navigating the complex regulatory landscape for cell-based therapies.
• Achieving commercial success in a competitive market.

Potential Opportunities:

• Expanding its pipeline of CAR T-cell therapy candidates into new therapeutic areas.
• Partnering with pharmaceutical companies to accelerate development and commercialization efforts.
• Leveraging its TALEN® technology to develop next-generation CAR T-cell therapies with improved efficacy and safety profiles.

Recent Acquisitions (Last 3 Years)

Allogene has not made any acquisitions in the last 3 years.

AI-Based Fundamental Rating

Based on an AI-based analysis, Allogene Therapeutics Inc. receives a fundamental rating of 7 out of 10. This rating is supported by the company's strong pipeline of CAR T-cell therapy candidates, proprietary technology, and strategic partnerships. However, the company's lack of approved products and profitability remain as risks.

Sources and Disclaimers

• Allogene Therapeutics Inc. Investor Relations website: https://investors.allogene.com/
• SEC filings: https://www.sec.gov/edgar/search/
• Yahoo Finance: https://finance.yahoo.com/quote/ALLO/

Disclaimer:

This analysis is provided for informational purposes only and should not be considered investment advice. Investing in stocks involves significant risk, and you could lose all or part of your investment. Please consult with a qualified financial advisor before making any investment decisions.