Company Overview
Allogene Therapeutics, a clinical-stage biotechnology company, has emerged as a pioneering force in the realm of allogeneic CAR T (AlloCAR T™) therapy, a groundbreaking approach that is poised to redefine the treatment of cancer and autoimmune diseases. With a robust pipeline of innovative product candidates and a steadfast commitment to scientific excellence, Allogene has carved out a unique position in the highly competitive biopharmaceutical industry.
Company History
Allogene's journey began on November 30, 2017, when the company was incorporated in the State of Delaware and established its headquarters in South San Francisco, California. The company's founding vision was to develop genetically engineered allogeneic T cell product candidates for the treatment of cancer, recognizing the immense potential of this technology to overcome the limitations of autologous CAR T therapies.
A pivotal moment in Allogene's history came in April 2018 when the company acquired certain assets from Pfizer, including contracts and intellectual property related to the development and administration of CAR T cells for cancer treatment. This strategic acquisition provided Allogene with a strong foundation, granting the company rights to agreements with Cellectis S.A. for TALEN gene-editing technology and Servier for CD19 CAR T products.
In October 2018, Allogene took a significant step forward by completing its initial public offering, successfully raising $288 million. This infusion of capital provided the company with the necessary resources to advance its pipeline of allogeneic CAR T cell product candidates and fuel its ambitious research and development efforts.
Manufacturing and Infrastructure
Allogene's commitment to innovation and manufacturing excellence is evident in the construction of its own manufacturing facility, CF1. This state-of-the-art facility supports the production of Allogene's product candidates, enabling the company to maintain control over its manufacturing processes and scale its operations to meet future demand.
Regulatory Challenges and Resilience
The company's resilience was put to the test in October 2021 when the FDA placed all of Allogene's clinical trials on hold due to an observation of a chromosomal abnormality in one patient. Demonstrating its scientific rigor and commitment to patient safety, Allogene conducted a thorough investigation, which concluded that the chromosomal abnormality was not related to its manufacturing or gene editing processes. As a result, the FDA lifted the clinical hold in January 2022, allowing Allogene to resume its clinical programs and continue its mission to advance allogeneic CAR T therapies.
Product Pipeline and Clinical Development
Allogene's pipeline has continued to evolve, with multiple allogeneic CAR T cell product candidates advancing into clinical development. Notable among these are cema-cel (previously ALLO-501A) for the treatment of large B-cell lymphoma, ALLO-316 for renal cell carcinoma, and ALLO-715 for multiple myeloma. Each of these candidates represents a potential breakthrough in their respective indications, showcasing the breadth and depth of Allogene's scientific capabilities.
ALPHA3 Trial
The ALPHA3 trial represents a significant milestone for Allogene, as it aims to position cema-cel as the first CAR T therapy to be integrated into the frontline treatment paradigm for LBCL. By leveraging the company's proprietary MRD (minimal residual disease) assay, the trial is designed to identify patients who are most likely to benefit from cema-cel, potentially transforming the way LBCL is managed and setting a new standard for patient outcomes. Allogene expects to complete enrollment in the first half of 2026, with efficacy analyses, including an Independent Data Safety Monitoring Board interim analysis on event-free survival, expected in 2026. A biologics license application (BLA) submission for cema-cel is targeted for 2027.
Solid Tumor Program
Allogene's pipeline extends beyond hematological malignancies, with its solid tumor program featuring the promising ALLO-316, a CAR T product candidate targeting the CD70 antigen for the treatment of advanced or metastatic renal cell carcinoma (RCC). The TRAVERSE Phase 1 trial has demonstrated remarkable results, with a best overall response rate of 50% and a confirmed response rate of 33% in heavily pretreated patients with high CD70 expression. These findings have led to the FDA's granting of Regenerative Medicine Advanced Therapy (RMAT) designation for ALLO-316, underscoring its potential as a breakthrough therapy for advanced RCC. Allogene plans to continue evaluating the safety and efficacy of ALLO-316 at the Phase 1b dose level in 2025.
Autoimmune Disease Program
Allogene's innovation extends into the realm of autoimmune diseases, where the company's ALLO-329 program has emerged as a game-changer. ALLO-329 is a dual-targeted CAR T product candidate that simultaneously addresses CD19-positive B cells and CD70-positive T cells, two key drivers of autoimmune dysfunction. Designed with Allogene's proprietary Dagger® technology, ALLO-329 has the potential to overcome the challenge of immune rejection, potentially reducing or eliminating the need for lymphodepleting chemotherapy, a significant barrier to the broader adoption of CAR T therapy in autoimmune indications. Allogene plans to file an investigational new drug (IND) application for ALLO-329 in the first quarter of 2025 and initiate a Phase 1 trial in mid-2025, with proof-of-concept expected by the end of 2025.
Financials
Allogene's financial position, as of September 30, 2024, reflects a robust cash and investment balance of $403.4 million, providing the company with a cash runway that extends into the second half of 2026. This financial resilience has enabled Allogene to invest heavily in its research and development efforts, with $44.7 million in R&D expenses recorded in the third quarter of 2024, including $5.6 million in non-cash stock-based compensation.
For the most recent fiscal year (2023), Allogene reported revenue of $95,000, a net loss of $327.3 million, operating cash flow of -$237.7 million, and free cash flow of -$239.2 million. In the most recent quarter (Q3 2024), the company reported no revenue and a net loss of $66.3 million.
For the full year 2024, Allogene expects a cash burn of approximately $200 million and GAAP operating expenses of approximately $300 million, which includes estimated non-cash, stock-based compensation expense of approximately $60 million. This guidance excludes any impact from potential business development activities.
Liquidity
Allogene's financial health is further demonstrated by its strong liquidity position. The company's debt-to-equity ratio stands at 0.18, indicating a conservative approach to leverage. With $403.4 million in cash and investments, Allogene maintains a solid financial foundation to support its ongoing research and development initiatives. The company's current ratio and quick ratio both stand at 9.35, reflecting a strong ability to meet short-term obligations.
The company's commitment to innovation is further evidenced by its strategic collaborations and partnerships. Allogene has forged alliances with industry-leading organizations, such as Cellectis, Servier, and Foresight Diagnostics, to leverage complementary technologies and expertise in the pursuit of groundbreaking therapies.
Challenges and Resilience
However, Allogene's journey has not been without its challenges. In 2021, the company faced a clinical hold on its trials due to an observation of a chromosomal abnormality, which was ultimately determined to be unrelated to the manufacturing process. The company's ability to navigate this hurdle and regain regulatory clearance underscores its resilience and the strength of its scientific and operational capabilities.
Future Outlook and Strategic Priorities
Looking ahead, Allogene remains focused on advancing its pipeline and expanding the reach of its allogeneic CAR T technology. The company's strategic priorities include the successful completion of the ALPHA3 trial for cema-cel, the continued development of ALLO-316 in solid tumors, and the anticipated IND filing and proof-of-concept for ALLO-329 in autoimmune diseases by the end of 2025.
Allogene's commitment to innovation, coupled with its robust financial position and experienced leadership team, positions the company as a driving force in the evolving landscape of cell therapy. As the company continues to navigate the complex regulatory and competitive environment, its ability to unlock the full potential of allogeneic CAR T technology will be a crucial factor in shaping the future of cancer and autoimmune disease treatment.