FIVE FIRST-YEAR MILESTONES BRINGING ALLOGENE CLOSER TO ITS GOAL OF REVOLUTIONIZING CANCER TREATMENT

One year ago this week, we officially launched Allogene Therapeutics. In only 12 months, we have made tremendous strides toward achieving our number one goal of making allogeneic chimeric antigen receptor (CAR) T cell therapy – or what we call AlloCAR T™ therapy – available to cancer patients. I couldn’t be prouder of what our world-class team has accomplished to date. Reflecting on this momentous milestone, five noteworthy clinical, regulatory and manufacturing accomplishments stand out as laying the foundation for the possibility of a new revolution in cancer treatment.

1)    A World-Class Leadership Team

We created a strong, powerhouse of a management team with world-class expertise. Across the company, we started out with approximately 40 employees and now have approximately 130 employees in South San Francisco, as well as new SSF corporate headquarters, all dedicated to AlloCAR T therapy. I would like to thank each of them for helping us get to where we are today. Ultimately one of our most important achievements to date has been building an experienced, knowledgeable team committed to making CAR T therapy ‘on demand’ and more broadly accessible to patients at critical stages in their disease treatment. We also secured a site to serve as our headquarters in South San Francisco.

2)    One of The Largest Initial Public Offerings in Biotechnology

In 2018, to help advance the clinical development of our robust pipeline of “off-the-shelf” AlloCAR T cell therapy candidates and build out our manufacturing facility, we completed a Series A and subsequent financing totaling $420 million and in October, an initial public offering (IPO) raising $372.6 million in gross proceeds – one of the largest biotechnology IPOs in history. 

3)    Advancing Allogeneic CAR T (AlloCAR T™) Therapy

At our first significant medical meeting, the 60th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, our collaborator, Servier, and Allogene presented an updated analysis of pooled clinical data from two ongoing Phase 1 trials of UCART19, the first allogeneic CAR T-cell therapy in clinical evaluation, in pediatric (the PALL study) and adult (the CALM study) patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). The analysis suggested that an anti-CD52 mAb may be an important contributor for AlloCAR T™ cell expansion.

We also presented data from a preclinical study of ALLO-715, our AlloCAR T™ therapy targeting B-cell maturation antigen (BCMA). The findings demonstrated the potential of ALLO-715 as a novel AlloCAR T™ therapy for multiple myeloma and other BCMA-positive malignancies. 

Earlier this month, we also presented results at the 2019 American Association for Cancer Research (AACR) Annual Meeting from a preclinical study of our AlloCAR T™ program targeting CD70, a cancer target that is expressed on both hematologic and solid tumor cells. The results showed that anti-CD70 AlloCAR T™ could be optimized to eliminate both CD70 low and high expressing target cells, and manufactured in a large-scale process.

4)    Clearance of Our First Investigational New Drug Application for ALLO-501

In January 2019, the U.S. Food and Drug Administration (FDA) cleared our first Investigational New Drug (IND) application for ALLO-501 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). Our Phase 1 ALPHA study is designed to assess the safety and tolerability of ALLO-501 in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). The study will also evaluate the safety and tolerability of ALLO-647, our proprietary anti-CD52 mAb lymphodepletion agent, with an ultimate goal of determining the optimal dose of ALLO-501 for the Phase 2 study. Allogene will lead the manufacturing of ALLO-501 and ALLO-647 and ALPHA study operations.

5)    Establishing In-House, State-of-the-Art Manufacturing

Building world-class manufacturing capabilities is at the core of our strategy to deliver readily-available cell therapy faster, more reliably and at greater scale. Since Allogene was conceptualized, our goal has been to differentiate ourselves from other companies by our ability to handle the complex manufacturing of AlloCAR T therapies in a regulatory compliant manner, under GMP conditions in a facility equipped for a commercial launch. We moved toward achieving that goal when we entered into a lease agreement in February 2019 to develop a 118,000 square foot state-of-the-art cell therapy manufacturing facility in Newark, Calif. We also secured approximately 15,000 square feet of space to serve as a GMP quality control laboratory.

It has certainly been a productive first year for Allogene. We are very proud of what we have accomplished in our first year of operation, and even more excited about 2019. We will not lose sight of our goal to make AlloCAR T therapy a real option for cancer patients.

Cautionary Note on Forward-Looking Statements

This posting contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The posting may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to progress ALLO-501 clinical trials and obtain regulatory approval for ALLO-501, the ability of an anti-CD52 mAb to contribute to AlloCAR T™ cell expansion, the ability to complete the build-out of the manufacturing facility, the ability to manufacture AlloCAR T™ therapies, the ability to initiate and progress additional clinical trials of AlloCAR T™ therapies, and the potential benefits of AlloCAR T™ therapy. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including without limitation in its Form 10-K for the year ended December 31, 2018. Any forward-looking statements that are made in this posting speak only as of the date of this posting. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this posting.