Allogene Therapeutics, Inc. - ALLO STOCK NEWS

Allogene Therapeutics (Nasdaq: ALLO) will present pre-clinical data for ALLO-329, its next-generation investigational AlloCAR T candidate for autoimmune indications, at the ACR Convergence 2024. ALLO-329 is a CD19/CD70 dual AlloCAR T product designed to target both B-cells and T-cells implicated in autoimmune diseases. It utilizes CRISPR-based site-specific integration and incorporates the Dagger® technology to potentially reduce or eliminate the need for lymphodepletion.

The company aims to address challenges in CAR T therapy for autoimmune diseases by making it available off-the-shelf and potentially reducing chemotherapy conditioning. Allogene plans to file an IND application in Q1 2025 and expects proof-of-concept by year-end 2025.

Allogene Therapeutics (Nasdaq: ALLO), a clinical-stage biotechnology company focused on developing allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases, has announced its participation in two upcoming investor conferences:

1. Canaccord Genuity 44th Annual Growth Conference on Tuesday, August 13, 2024, at 7:00 AM PT/10:00 AM ET

2. Baird 2024 Global Healthcare Conference on Wednesday, September 11, 2024, at 7:15 AM PT/10:15 AM ET

Webcasts, if available, will be accessible on the company's website at www.allogene.com under the Investors tab in the News and Events section. Replays will be available for approximately 30 days after the live webcasts.

Allogene Therapeutics reported Q2 2024 financial results and provided business updates. Key highlights include:

1. Initiation of pivotal Phase 2 ALPHA3 trial for cema-cel in 1L LBCL consolidation, with enrollment completion expected in 1H 2026 and potential BLA submission in 2027.

2. ALLO-329 IND application for autoimmune diseases on track for Q1 2025, with proof-of-concept data expected by YE 2025.

3. ALLO-316 Phase 1 TRAVERSE data update in RCC planned for YE 2024.

4. Q2 2024 ended with $444.6M in cash, cash equivalents, and investments, with runway projected into 2H 2026.

5. Q2 2024 net loss of $66.4M, or $0.35 per share.

6. 2024 guidance unchanged, expecting a decrease in cash of ~$200M and GAAP Operating Expenses of ~$300M.

Allogene Therapeutics (Nasdaq: ALLO), a clinical-stage biotechnology company focused on developing allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases, has announced its plans to report second quarter 2024 financial results and provide a business update. The company will host a conference call and webcast on August 7, 2024, at 2:00 p.m. PT/5:00 p.m. ET, following the market close.

Investors and interested parties can access the listen-only webcast on Allogene's website under the Investors tab in the News and Events section. A replay will be available for approximately 30 days. Those wishing to participate in the Q&A session during the conference call must register separately to receive a personal PIN for access.

Allogene Therapeutics (Nasdaq: ALLO) has activated three community cancer centers for its pivotal Phase 2 ALPHA3 trial of cemacabtagene ansegedleucel (cema-cel) for large B-cell lymphoma (LBCL). The trial aims to improve 1L cure rates for patients with minimal residual disease (MRD). The centers include Rocky Mountain Cancer Centers, Astera Cancer Care, and Norton Cancer Institute. Detection of MRD will use the Foresight CLARITY IUO MRD test, powered by PhasED-Seq. Enrollment is expected to complete by 1H 2026, with a potential BLA submission in 2027. The trial could expand access to CAR T therapies in community settings, where 80% of patients are treated.

Community-based practices are first to enroll in ALPHA3, signaling a move to broader CAR T adoption. This trial addresses two key questions: can circulating tumor DNA predict relapse, and does cema-cel improve cure rates compared to conventional methods? With over 19 locations in Colorado, RMCC provides comprehensive cancer care. ACC, part of OneOncology, serves over 22,000 patients annually through 13 locations. Norton Cancer Institute, with 21 locations, treats over 4,000 new patients yearly.

Allogene Therapeutics has initiated the pivotal Phase 2 ALPHA3 trial to evaluate cemacabtagene ansegedleucel (cema-cel) as part of the first-line treatment for large B-cell lymphoma (LBCL) patients likely to relapse. The trial aims to improve cure rates by using Foresight Diagnostics' CLARITY™ test to identify patients with minimal residual disease (MRD) who need further treatment. Enrollment is expected to be completed in the first half of 2026, with a Biologics License Application (BLA) submission anticipated in 2027. The trial will enroll approximately 240 patients and will assess the efficacy of cema-cel in improving event-free survival (EFS) compared to the current standard of care.

Allogene Therapeutics (Nasdaq: ALLO), a clinical-stage biotech company specializing in allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases, will participate in the TD Cowen 5th Annual Oncology Innovation Summit.

The event is scheduled for May 28, 2024, at 9:30 am PT/12:30 pm ET. A webcast will be available on the company's website under the Investors section. Replays of the webcast will be accessible for approximately 30 days.

Allogene Therapeutics (Nasdaq: ALLO), a clinical-stage biotech firm, announced a $110 million common stock offering, pricing 37,931,035 shares at $2.90 each. The offering, backed by mutual funds, institutional investors, and the company's board and executives, is expected to close by May 16, 2024. Managed by Goldman Sachs, the offering is under a shelf registration statement filed in March and declared effective by the SEC in April 2024. The proceeds will be used for continued development of their AlloCAR T™ products for cancer and autoimmune diseases.

Allogene Therapeutics reported first-quarter 2024 financial results and significant business updates. Key highlights include the expansion of CD19 oncology rights to all EU member states and the UK, increasing the potential market for Cema-Cel from $6 billion in the US to $9.5 billion combined. The pivotal Phase 2 ALPHA3 trial for LBCL is set to begin mid-2024, with initial data from the Phase 1 CLL trial expected by year-end 2024. The company also announced plans for ALLO-329, targeting autoimmune diseases, with IND submission by Q1 2025 and proof-of-concept data by YE 2025. Additionally, a $15 million grant from CIRM will support the Phase 1 TRAVERSE trial in RCC, with data updates expected by YE 2024. Financially, Allogene reported a net loss of $65 million for the quarter, with $397.3 million in cash and a projected cash runway into 2026.