On March 8, 2019 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported fourth quarter and full-year 2018 financial results for the periods ended December 31, 2018 (Press release, Allogene, MAR 8, 2019, View Source [SID1234534130]).

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"We are very proud of what Allogene has accomplished in just ten months. Every move we have made has been toward achieving one goal, making allogeneic CAR T therapy available to patients," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We are excited to soon embark upon our first company sponsored trial for ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) and progress the buildout of our planned state-of-the-art manufacturing facility in Newark, California. With our focus and drive to progress our pipeline of cell therapy candidates, which includes the planned IND submission of ALLO-715 in multiple myeloma (MM) later this year, we feel confident in Allogene’s ability to be a leader in the development of AlloCAR T therapies."

2018 and Recent Highlights

Corporate

In September 2018, the company completed a $120.2 million private financing and in October 2018, Allogene’s Initial Public Offering (IPO) raised $372.6 million in gross proceeds.

In February 2019, Allogene entered into a lease agreement to develop a 118,000 square foot state-of-the-art cell therapy manufacturing facility in Newark, California. World class manufacturing is core to the Allogene strategy to deliver readily available cell therapy faster, more reliably and at greater scale. The manufacturing facility is being designed for both clinical and commercial supply, upon potential regulatory approval, of AlloCAR T therapy.

ALLO-501 (Allogene-Sponsored Program in Collaboration with Servier)

In January, the U.S. Food & Drug Administration (FDA) cleared Allogene’s first Investigational New Drug (IND) application for ALLO-501 in patients with relapsed/refractory NHL.

The planned Phase 1 study will utilize ALLO-647, Allogene’s proprietary anti-CD52 monoclonal antibody (mAb) as a part of the lymphodepletion regimen.

Site qualification is underway, and the trial is on-track to initiate in the 1H of 2019.

The Phase 1 portion will enroll approximately 24 patients with relapsed/refractory large B-cell lymphoma or follicular lymphoma.

The primary objective of the study is to evaluate the safety and tolerability of ALLO-501 and ALLO-647.

The Phase 1 portion of the trial is designed to determine the optimal dose of ALLO-501 for the Phase 2 portion of the trial.

ALLO-715

On track to file an IND application in 2019 for ALLO-715, a wholly-owned CAR T product candidate targeting B cell maturation antigen (BCMA) for multiple myeloma.

UCART19 (Servier-Sponsored Program in Collaboration with Allogene)

Servier and Allogene presented pooled data from the Phase 1 trials of UCART19 in relapsed/refractory acute lymphoblastic leukemia (ALL) at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting. The analysis suggested that an anti-CD52 mAb may be an important contributor for AlloCAR T cell expansion, and the use of anti-CD52 mAb will now be mandated in the UCART19 trials.

Fourth Quarter and Full Year 2018 Financial Results

Research and development expenses were $18.5 million for the fourth quarter of 2018, which includes $1.3 million of non-cash stock-based compensation expense. For the full year of 2018, research and development expenses were $151.9 million which includes $109.4 million related to the asset acquisition from Pfizer. The total research and development expense for the year includes $1.7 million of non-cash stock-based compensation expense.

General and administrative expenses were $14.5 million for the fourth quarter of 2018, which includes $4.6 million of non-cash stock-based compensation expense. For the full year of 2018, general and administrative expenses were $41.0 million, which includes $16.9 million of non-cash stock-based compensation expense.

Net loss for the fourth quarter of 2018 was $30.5 million, or $0.37 per share, including non-cash stock-based compensation expense of $5.9 million. For the full year of 2018, net loss was $211.5 million, or $7.31 per share, including non-cash stock-based compensation expense of $18.6 million.

As of December 31, 2018, Allogene had $721.4 million in cash, cash equivalents, and investments.

2019 Financial Guidance

Allogene expects full year 2019 net losses to be between $200 million and $210 million including estimated non-cash stock-based compensation expense of $45 million to $50 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details

Allogene will host a live conference call and webcast today at 5:30 AM Pacific Time/8:30 AM Eastern Time to discuss financial results and provide a business update. To access the live

conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 3589112. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.