Allogene Therapeutics, Inc. (NASDAQ: ALLO) is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. The company has made significant strides in advancing its pipeline of "off-the-shelf" CAR T cell product candidates, which are designed to target and kill cancer cells in patients or eliminate pathogenic autoreactive cells in patients with autoimmune disorders.

Financials

Allogene has sustained operating losses since its inception, reporting a net loss of $327.3 million for the year ended December 31, 2023. The company's revenue for the same period was $95,000. Allogene's annual operating cash flow and free cash flow were negative $237.7 million and $239.2 million, respectively.

For the first quarter of 2024, Allogene reported a net loss of $65.0 million, with collaboration revenue of $22,000. The company's research and development expenses for Q1 2024 were $52.3 million, while general and administrative expenses were $17.3 million.

Allogene ended the first quarter of 2024 with $397.3 million in cash, cash equivalents, and investments. The company recently announced a $110 million equity financing, which will increase its cash balance to approximately $500 million and extend its cash runway into the second half of 2026.

Business Overview

Allogene was founded in 2017 and is headquartered in South San Francisco, California. The company is focused on developing a pipeline of allogeneic CAR T cell product candidates, which are derived from healthy donor T cells and engineered to express CARs. This approach is designed to enable the delivery of readily available treatments faster, more reliably, at greater scale, and to more patients compared to autologous CAR T therapies, which are derived from a patient's own cells.

Allogene's pipeline includes several product candidates targeting various cancers, including large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL), and renal cell carcinoma (RCC), as well as an autoimmune disease program targeting lupus and other indications. The company's lead product candidate, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the pivotal Phase 2 ALPHA3 trial as a first-line consolidation treatment for LBCL patients who remain positive for minimal residual disease (MRD) after completing standard chemoimmunotherapy.

Cema-cel's potential to become the standard "7th cycle" of frontline treatment for LBCL patients with MRD represents a significant market opportunity for Allogene. The company estimates the U.S. market opportunity for cema-cel in first-line LBCL consolidation and relapsed/refractory CLL to be more than $6 billion. With the recent expansion of Allogene's rights to include the European Union and the United Kingdom, the total market opportunity for cema-cel has increased to over $9.5 billion.

Allogene's ALLO-316 program is also advancing, with the company recently receiving a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of this allogeneic CAR T cell product candidate targeting CD70 for the treatment of advanced or metastatic renal cell carcinoma. The company plans to provide a Phase 1 data update from the TRAVERSE trial of ALLO-316 by the end of 2024.

In the autoimmune disease space, Allogene is developing ALLO-329, a next-generation allogeneic CAR T cell product candidate targeting both CD19 and CD70. The company expects to file an investigational new drug (IND) application for ALLO-329 in the first quarter of 2025 and initiate a Phase 1 trial in early 2025, with proof-of-concept data anticipated by the end of 2025.

Risks and Challenges

Allogene's product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and the likelihood of obtaining regulatory approval. The company's success is heavily dependent on the clinical and commercial success of its lead product candidates, particularly cema-cel. Any delays or setbacks in the development of these product candidates could have a significant impact on Allogene's business.

The company also faces challenges in manufacturing and scaling its allogeneic CAR T cell products, as well as potential competition from other biotechnology and pharmaceutical companies developing similar therapies. Allogene's ability to successfully navigate the regulatory landscape and obtain necessary approvals for its product candidates is also a key risk factor.

Outlook

Allogene has provided the following financial guidance for 2024: - Cash burn of approximately $200 million - GAAP operating expenses of approximately $300 million, including an estimated $60 million in non-cash stock-based compensation expense

The company expects several key milestones and data readouts across its pipeline in the coming years, including: - Completion of enrollment in the pivotal Phase 2 ALPHA3 trial of cema-cel in first-line LBCL consolidation in the first half of 2026 - Interim efficacy analysis and primary event-free survival (EFS) analysis of the ALPHA3 trial in 2026, with a potential BLA submission for cema-cel targeted for 2027 - Initial data readout from the Phase 1 cohort of the ALPHA2 trial of cema-cel in relapsed/refractory CLL by the end of 2024 - Phase 1 data update from the TRAVERSE trial of ALLO-316 in renal cell carcinoma by the end of 2024 - IND filing for ALLO-329 in autoimmune disease in the first quarter of 2025 and proof-of-concept data by the end of 2025

Conclusion

Allogene Therapeutics is a clinical-stage biotechnology company that is pioneering the development of allogeneic CAR T cell therapies for the treatment of cancer and autoimmune diseases. The company's lead product candidate, cema-cel, has the potential to become a standard of care in the first-line consolidation setting for LBCL patients, representing a significant market opportunity. Allogene's expanded rights to cema-cel in the European Union and the United Kingdom further increase the product's commercial potential.

While Allogene faces the typical risks and challenges associated with a clinical-stage biotech company, the company's strong cash position, diversified pipeline, and upcoming milestones suggest it is well-positioned to continue advancing its innovative allogeneic CAR T cell therapies and potentially transform the treatment landscape for patients.