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Allogene Therapeutics Announces Participation in December Investor Conferences
GlobeNewswire News Room· 2024-11-19 13:30
Company Overview - Allogene Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases [3] - The company aims to provide "off-the-shelf" CAR T cell product candidates that are readily available on-demand, more reliably, and at greater scale to a larger patient population [3] Upcoming Events - Allogene will participate in two investor conferences in December 2024, including the Citizens JMP Hematology and Oncology Summit on December 2 and the 36th Annual Piper Sandler Healthcare Conference on December 3 [2] - The presentation time for the Jefferies London Healthcare Conference on November 20, 2024, has been updated to 11:30 AM GMT / 6:30 AM ET [2] Communication and Accessibility - Webcasts of the presentations will be available on the company's website under the Investors tab in the News and Events section, with replays accessible for approximately 30 days [2]
Allogene's Q3 Loss Narrower Than Expected, Sales Nil
ZACKS· 2024-11-08 16:15
Allogene Therapeutics (ALLO) incurred an adjusted loss (excluding impairment of long-lived asset) of 27 cents per share in third-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 34 cents.Inclusive of impairment charges, the company posted a loss of 32 cents per share in the quarter. In the year-ago period, the company reported a loss of 37 cents. There was no impairment charge in the year-ago period.Allogene did not generate revenues during the reported quarter. The Zacks Consensus Esti ...
Allogene Therapeutics(ALLO) - 2024 Q3 - Earnings Call Transcript
2024-11-08 01:59
Financial Data and Key Metrics Changes - The cash balance at the end of Q3 2024 was $403.4 million, extending the cash runway into the second half of 2026 [30] - Q3 2024 research and development expenses were $44.7 million, including $5.6 million in non-cash stock-based compensation [30] - General and administrative expenses for Q3 were $16.3 million, which included $7.8 million of non-cash stock-based compensation [30] - The net loss for Q3 2024 was $66.3 million, or $0.32 per share, including non-cash stock-based compensation of $13.4 million and $10.7 million in non-cash impairment of long-lived asset expense [31] Business Line Data and Key Metrics Changes - The pivotal Phase II ALPHA3 trial of cema-cel for large B cell lymphoma is advancing, with 27 of the planned 50 sites activated [17] - ALLO-316 showed a confirmed response rate of 33% and a best overall response rate of 50% in heavily pretreated patients with high CD70 expression [9][19] - ALLO-329 is designed to target both CD19 positive B cells and CD70 positive T cells, addressing a broader spectrum of autoimmune diseases [10] Market Data and Key Metrics Changes - The ALLO-316 program received RMAT designation from the FDA, indicating its potential as a treatment for advanced renal cell carcinoma [24] - The company is focusing on community centers for trial site activation to ensure broad accessibility for CAR T therapies [17] Company Strategy and Development Direction - The company aims to redefine cell therapy for cancer and autoimmune diseases, with a long-term vision for each program [13] - The strategy includes pursuing best-in-class therapies with differentiated development approaches to maximize the attributes of AlloCAR T [13] - The focus on ALLO-329 is to address the challenge of lymphodepleting chemotherapy, aiming to reduce or eliminate its need [12][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the advancements of the pivotal cema-cel trial and the promising data for ALLO-316 [15] - The company acknowledges the challenges in a highly competitive field but remains optimistic about the potential of its therapies [13] - Management highlighted the importance of understanding the differences in patient populations and indications when assessing safety and efficacy [40] Other Important Information - The company plans to present data on ALLO-316 at the International Kidney Cancer Symposium and the Society for Immunotherapy of Cancer annual meeting [25] - The company expects a cash burn of approximately $200 million for 2024, with full-year GAAP operating expenses projected at approximately $300 million [31] Q&A Session Summary Question: Insights on RCC data and expansion cohort timeline - Management indicated that approximately 20 patients are expected to be enrolled in the expansion cohort, with updates anticipated next year [35] Question: Safety in autoimmune settings and read-through from ALLO-316 data - Management expressed confidence in the safety profile for autoimmune applications, noting that the intensity of therapy required will be lower compared to oncology [39] Question: Grade 5 events and management algorithm for IECHS - Management acknowledged the complexity of adverse events in heavily pretreated patients and detailed the management algorithm for IECHS, which is similar to those used for CRS [42][43] Question: Enrollment dynamics in autoimmune studies - Management noted that enrollment in autoimmune studies is picking up, with a focus on engaging investigators who may lack CAR T experience [98]
Allogene Therapeutics(ALLO) - 2024 Q3 - Quarterly Report
2024-11-07 21:13
Clinical Trials and Product Development - Allogene Therapeutics is focused on developing genetically engineered allogeneic T cell product candidates for cancer and autoimmune diseases, with a pipeline targeting multiple hematological malignancies and solid tumors [90]. - The pivotal Phase 2 clinical trial (ALPHA3) for cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL) has initiated with almost 30 sites activated, targeting approximately 240 patients [90]. - The ALPHA3 trial aims to study the impact of treating minimal residual disease (MRD) positive patients, with a primary endpoint of event-free survival (EFS) and expected enrollment completion in the first half of 2026 [90]. - The Phase 1 trial (TRAVERSE) of ALLO-316 targeting CD70 in advanced renal cell carcinoma (RCC) has enrolled 39 patients, with 26 confirmed to have CD70 positive RCC [92]. - The best overall response rate (ORR) for ALLO-316 in patients with CD70 Tumor Proportion Score (TPS) of ≥50% was 50%, with a confirmed response rate of 33% [92]. - A biologics license application (BLA) submission for cema-cel is targeted for 2027, following efficacy analyses expected in 2026 [90]. - The Phase 1b expansion cohort for ALLO-316 is expected to include approximately 20 patients, with additional data anticipated in mid-2025 [92]. - The ALPHA2 trial for cema-cel has been deprioritized in favor of the earlier line ALPHA3 trial due to its potential [90]. - The company has implemented a diagnostic and treatment algorithm in the ALLO-316 trial to mitigate treatment-associated hyperinflammatory responses [92]. - The company plans to assess ALLO-647's contribution to the overall benefit-to-risk ratio in the pivotal ALPHA3 trial, with enrollment completion expected in mid-2025 [95]. - ALLO-329, a next-generation allogeneic CAR T cell product candidate, is expected to file an investigational new drug (IND) application in Q1 2025 and initiate a Phase 1 trial in mid-2025 [95]. - The company has significant development priorities focused on cema-cel (1L Consolidation), ALLO-316, and ALLO-329, while exploring partnership opportunities across its pipeline [95]. Financial Performance - The company reported net losses of $66.3 million and $197.7 million for the three and nine months ended September 30, 2024, respectively, with an accumulated deficit of $1.8 billion as of the same date [96]. - The company has $403.4 million in cash and cash equivalents, which is expected to fund operations into 2026 [96]. - The market opportunity for cema-cel is projected to increase by over 50%, expanding from more than $6.0 billion in the U.S. to over $9.5 billion across the U.S., European Union, and United Kingdom [96]. - For the three months ended September 30, 2024, collaboration revenue was $0, a decrease of 100% compared to $22,000 in the same period of 2023 [125]. - Research and development expenses for the three months ended September 30, 2024, were $44.7 million, a decrease of 3% from $46.0 million in the same period of 2023 [127]. - General and administrative expenses decreased to $16.3 million for the three months ended September 30, 2024, down 4% from $17.0 million in the same period of 2023 [130]. - The company recorded an impairment charge of $10.7 million for long-lived assets in the three months ended September 30, 2024, compared to no such expense in the same period of 2023 [131]. - Total operating expenses increased to $71.8 million for the three months ended September 30, 2024, up 14% from $63.0 million in the same period of 2023 [125]. - Interest and other income, net, increased to $6.7 million for the three months ended September 30, 2024, an increase of 8% from $6.2 million in the same period of 2023 [132]. - For the nine months ended September 30, 2024, total operating expenses were $212.7 million, a decrease of 12% from $242.7 million in the same period of 2023 [136]. - The net loss for the three months ended September 30, 2024, was $66.3 million, a 6% increase from a net loss of $62.3 million in the same period of 2023 [125]. - Research and development expenses decreased by $40.9 million to $147.3 million for the nine months ended September 30, 2024, compared to $188.3 million for the same period in 2023, primarily due to a $28.3 million reduction in personnel-related costs [138]. - General and administrative expenses were $49.7 million for the nine months ended September 30, 2024, down from $54.4 million in 2023, reflecting a decrease of $4.8 million mainly from personnel-related costs [139]. - Total impairment charges recognized during the nine months ended September 30, 2024, amounted to $15.7 million, with no such expense recorded in the same period of 2023 [140]. - Interest and other income increased by $5.1 million to $17.1 million for the nine months ended September 30, 2024, compared to $12.0 million in 2023, driven by higher yields on cash and investments [141]. - Cash used in operating activities was $163.6 million for the nine months ended September 30, 2024, an improvement from $184.0 million in 2023 [146]. - Net cash provided by investing activities was $20.8 million for the nine months ended September 30, 2024, compared to $95.8 million in 2023, reflecting a decrease in cash provided by investment maturities [149][150]. - Cash provided by financing activities increased to $110.9 million for the nine months ended September 30, 2024, from $95.5 million in 2023, primarily due to net proceeds from the issuance of common stock [151]. - The company sold 250,000 shares of common stock in ATM offerings during the nine months ended September 30, 2024, resulting in net proceeds of $1.0 million [144]. - As of September 30, 2024, the company had $403.4 million in cash and cash equivalents, sufficient to fund operations for at least the next 12 months [144]. - The company has non-cancellable purchase commitments of $2.3 million as of September 30, 2024, related to agreements with third-party contract manufacturers [153]. Internal Controls and Accounting - The company identified a material weakness in internal controls over financial reporting related to the technical accounting analysis of significant non-routine transactions [164]. - Remediation efforts for the identified material weakness are ongoing, with the engagement of third-party subject matter experts [164]. - Management concluded that the disclosure controls and procedures were not effective at a reasonable assurance level as of September 30, 2024 [163]. - There have been no new accounting pronouncements expected to materially impact the financial statements [158]. - The company does not utilize forward exchange contracts due to the uncertain timing of expected payments in foreign currencies [161]. - No significant changes in critical accounting policies and estimates have occurred compared to the previous annual report [157]. - The company believes that historical fluctuations in interest income have not been significant [160]. - A 10% change in interest rates would not have had a material effect on the fair market value of the company's cash equivalents and available-for-sale securities [160].
Allogene Therapeutics(ALLO) - 2024 Q3 - Quarterly Results
2024-11-07 21:05
Exhibit 99.1 Allogene Therapeutics Reports Third Quarter 2024 Financial Results and Business Update • Cemacabtagene Ansegedleucel (Cema-Cel): 1L Consolidation Large B-Cell Lymphoma (LBCL) ◦ Pivotal Phase 2 ALPHA3 Trial Continuing with Site Activation and Patient Screening/Enrollment ◦ Lymphodepletion Selection Planned for Mid-2025 ◦ Enrollment Completion Expected in 1H 2026 with Primary EFS Data by YE 2026 ◦ Potential BLA Submission in 2027 • ALLO-329 in Autoimmune Disease (AID) ◦ Pre-Clinical Data Highligh ...
Allogene Therapeutics Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCS
GlobeNewswire News Room· 2024-11-07 15:00
Phase 1 TRAVERSE Trial Demonstrated a Single Infusion of ALLO-316 Can Yield an Overall Response Rate of 50% and Confirmed Response Rate of 33% in Patients with CD70 Tumor Proportion Score (TPS) of Greater than 50%TRAVERSE Trial Highlights the Ability of CD70 Dagger® Technology to Promote Robust Expansion and Persistence of ALLO-316 with Standard Lymphodepletion, Validating its Potential as the Next Generation Allogeneic Platform ALLO-316 Demonstrated a Manageable Safety Profile; Newly Implemented Diagnostic ...
Allogene Therapeutics to Report Third Quarter 2024 Financial Results and Provide Business Update
GlobeNewswire News Room· 2024-10-30 12:30
Conference Call and Webcast Scheduled for November 7, 2024 at 2:00 p.m. PT/5:00 p.m. ET SOUTH SAN FRANCISCO, Calif., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that it will report third quarter 2024 financial results and provide a business update on November 7, 2024, after the close of the market. The announcement wi ...
Allogene Therapeutics (ALLO) Stock Drops Over 5% Amid Market Activity
GuruFocus· 2024-10-02 20:11
Allogene Therapeutics, Inc. (ALLO, Financial) saw a significant drop in its stock price, falling 5.06% to $2.54 per share. The trading volume reached 1.41 million shares, with a turnover rate of 0.67% and a volatility of 4.49%.Recent financial reports show that the company recorded no revenue, a net loss of $66.36 million, an earnings per share (EPS) of -$0.35, and a gross loss of $3.64 million, resulting in a price-to-earnings (P/E) ratio of -1.60. Among the 18 institutions covering the stock, 72% recommen ...
Poseida: Interim P-BCMA-ALLO1 Data Bodes Well For Phase 1B Advancement
Seeking Alpha· 2024-09-30 15:47
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Allogene Therapeutics Announces Participation in the Goldman Sachs Cell Therapy Day Conference
GlobeNewswire News Room· 2024-09-30 12:30
SOUTH SAN FRANCISCO, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that it will participate in panel focused on innovations in the allogeneic cell therapy landscape during the Goldman Sachs Cell Therapy Day on October 1, 2024 in New York. Goldman Sachs Cell Therapy DayTuesday, October 1, 2024Panel Discussion: 1 ...