Allogene Therapeutics(ALLO)

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Allogene Therapeutics Announces 2024 Platform Vision to Redefine the Future of CAR T Led by ALPHA3, the Industry's First Pivotal Trial for Frontline Consolidation in Large B-Cell Lymphoma
Newsfilter· 2024-01-04 21:05
Four Core Programs Leverage Unique Attributes in Product Development and Trial Design to Demonstrate the Unmatched Potential of an Allogeneic CAR T Large B-Cell Lymphoma (LBCL): Groundbreaking ALPHA3 Trial has Potential to Leapfrog Other CAR Ts and Embed Cemacabtagene Ansegedleucel (Cema-Cel, Previously ALLO-501A) in First Line (1L) Treatment in Community Cancer Centers Where Most Newly Diagnosed Patients Seek CareChronic Lymphocytic Leukemia (CLL): New ALPHA2 Cohort Designed to Address a Limitation of Auto ...
Allogene Therapeutics to Host Conference Call Previewing its 2024 Platform Vision and Present at the 42nd Annual J.P. Morgan Healthcare Conference
Newsfilter· 2024-01-03 21:05
SOUTH SAN FRANCISCO, Calif., Jan. 03, 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, today announced that it will host a conference call to preview its 2024 Platform Vision focused on redefining the future of CAR T by leveraging the unique attributes of allogeneic CAR T products. The 2024 Platform Vision conference call will be hosted on Thursday, January 4, 2024, at 2 ...
Allogene Therapeutics(ALLO) - 2023 Q3 - Earnings Call Transcript
2023-11-03 03:13
Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q3 2023 Earnings Conference Call November 2, 2023 5:00 PM ET Company Participants Christine Cassiano – Chief Corporate Affairs and Brand Strategy Officer David Chang – President and Chief Executive Officer Zachary Roberts – Executive Vice President of Research and Development and Chief Medical Officer Geoff Parker – Chief Financial Officer Conference Call Participants Michael Yee – Jefferies Tyler Van Baron – TD Cowen Brian Cheng – JPMorgan Jack Allen – Baird Kelsey ...
Allogene Therapeutics(ALLO) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ________________________________________________________ FORM 10-Q ________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe ...
Allogene Therapeutics(ALLO) - 2023 Q2 - Earnings Call Transcript
2023-08-02 23:39
Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q2 2023 Earnings Conference Call August 2, 2023 5:00 PM ET Company Participants Christine Cassiano - Chief Communications Officer David Chang - President & Chief Executive Officer Zachary Roberts - Executive Vice President-Research and Development & Chief Medical Officer Eric Schmidt - Chief Financial Officer Conference Call Participants Tyler Van Baron - TD Cowen Michael Yee - Jefferies Brian Cheng - JPMorgan Kelsey Goodwin - Guggenheim John Newman - Canaccord Jack ...
Allogene Therapeutics(ALLO) - 2023 Q2 - Quarterly Report
2023-08-01 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ________________________________________________________ FORM 10-Q ________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 00 ...
Allogene Therapeutics(ALLO) - 2023 Q1 - Earnings Call Presentation
2023-05-04 03:51
The Next Revolution in Cell Therapy Leading Today, Creating Tomorrow Legal Disclaimers To the extent statements contained in this Presentation are not descriptions of historical facts regarding Allogene Therapeutics, Inc. (“Allogene,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Forward- looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels ...
Allogene Therapeutics(ALLO) - 2023 Q1 - Earnings Call Transcript
2023-05-04 03:49
Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q1 2023 Earnings Conference Call May 3, 2023 5:00 PM ET Company Participants Christine Cassiano - Chief Communications Officer Dr. David Chang - President and CEO Dr. Zachary Roberts - Executive Vice President, Research and Development and CMO Dr. Eric Schmidt - Chief Financial Officer Conference Call Participants Tyler Van Buren - TD Cowen Matt Borsch - Goldman Sachs Michael Yee - Jefferies Mark Breidenbach - OpCo Jack Allen - Baird Brian Cheng - JPMorgan John Newm ...
Allogene Therapeutics(ALLO) - 2023 Q1 - Quarterly Report
2023-05-02 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ________________________________________________________ FORM 10-Q ________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0 ...
Allogene Therapeutics(ALLO) - 2022 Q4 - Earnings Call Transcript
2023-03-01 02:40
Financial Data and Key Metrics - The company ended the year with $576 million in cash, cash equivalents, and investments, with no debt [29] - Full-year 2022 GAAP operating expenses were approximately $350 million, including $90 million in noncash stock-based compensation [30] - Research and development expenses for Q4 2022 were $75.4 million, with full-year expenses totaling $256.4 million [30] - General and administrative expenses for Q4 2022 were $21 million, with full-year expenses at $79.3 million [31] - The company reported a net loss of $332.6 million for 2022, or $2.32 per share [31] Business Line Data and Key Metrics - The CD19 program showed an overall response rate (ORR) of 57% and a complete response rate (CRR) of 58% in the Phase I trials [15] - The ongoing CR rate at 6 months was 50%, with all CRs at 6 months remaining durable at 12 months [15] - The BCMA program (ALLO-715) demonstrated an ORR of 67% and a very good partial response (VGPR) or better rate of 42% in the FCA60 cohort [18] - The median duration of response for ALLO-715 was 9.2 months, with the longest ongoing response at 24 months [18] - The CD70 program (ALLO-316) showed a 100% disease control rate in CD70-positive renal cell carcinoma patients, with 3 out of 9 patients achieving partial responses [22] Market Data and Key Metrics - The company is expanding its Phase II CD19 pivotal trial (ALPHA2) outside the U.S. into additional geographies [34] - The CD70 program is being evaluated for potential expansion into other CD70-expressing solid tumors and hematologic indications [24] - The company is preparing for a Phase III study in earlier-line large B-cell lymphoma, targeting trial initiation in the first half of 2024 [17] Company Strategy and Industry Competition - The company is focusing on executing its Phase II CD19 pivotal trials, evaluating the best path forward for multiple myeloma, and progressing the ALLO-316 trial in solid tumors [29] - The company is prioritizing the ALPHA2 study for ALLO-501A, with plans to potentially start an earlier-line study by 2024 [40] - The company is exploring the use of its Dagger platform, which may be deployed across additional CAR T products in both hematologic and solid tumors [50] Management Commentary on Operating Environment and Future Outlook - The company believes it has the operational capabilities, scientific insight, and capital resources needed to succeed in its endeavors [29] - The company is focused on improving manufacturing processes for its BCMA candidates (ALLO-715 and ALLO-605) to achieve optimal performance [19] - The company expects to present updated datasets on its CD19 and CD70 programs in 2023, with potential updates on the Alloy manufacturing process and BCMA program improvements [68] Other Important Information - The company has developed and validated a diagnostic assay for CD70 expression in renal cell carcinoma patients, which is being used for patient selection in the ALLO-316 study [86] - The company is not currently enrolling patients in the ALLO-605 Phase I study as it works on improving the manufacturing process [71] Q&A Session Summary Question: Enrollment and investigator feedback for the CD19 pivotal trial [32] - Enrollment in the ALPHA2 study is continuing according to plan, with expansion into additional geographies [34] - Investigators are enthusiastic about the trial and enrollment [34] Question: Rationale for prioritizing earlier-line large B-cell lymphoma trial [36] - The company sees an opportunity to advance the program to earlier lines, with discussions ongoing about the study design and population [37] Question: Regulatory discussions and pivotal trial status for multiple myeloma [39] - The potential pivotal study for multiple myeloma is likely to be pushed to 2024, with ongoing engagement with regulatory bodies and manufacturing process optimization [41] Question: Alloy process manufacturing and its role in the pivotal trials [43] - The Alloy process is being used in both pivotal trials for ALLO-501A, with all patients dosed using this manufacturing process [45] Question: Dagger platform and its potential deployment across the pipeline [47] - The Dagger platform may be expanded into additional CAR T products, with ongoing work to explore its use in both hematologic and solid tumors [50] Question: Ex-U.S. opportunity for ALLO-501A [52] - The company has the option to opt into ex-U.S. rights for ALLO-501A, with a decision based on financial and developmental factors [53] Question: Patient enrollment and outpatient treatment for pivotal studies [55] - Investigators are leveraging existing infrastructure for outpatient treatment, with patients selected based on their suitability for CAR T therapy [56][57] Question: Manufacturing tweaks for ALLO-605 and ALLO-715 [59] - The company is focusing on optimizing the manufacturing process for both ALLO-605 and ALLO-715, with potential reintroduction into the clinic in 2024 [60] Question: Timing of data readout for the CD19 pivotal trials [62] - The company targets data availability for both ALPHA2 and EXPAND trials at roughly the same time, following completion of enrollment in the first half of 2024 [63] Question: Manufacturing optimization for the BCMA program [65] - The company is reviewing the manufacturing process for both ALLO-715 and ALLO-605, with a decision on which product to take forward expected later [66] Question: 2023 catalysts and updates on the CD19 program and Alloy process [67] - The company plans to present updated datasets on its CD19 and CD70 programs, with potential updates on the Alloy manufacturing process and BCMA program improvements [68] Question: CD70 expression and potential expansion into liquid tumors [81] - CD70 is a target with wide distribution across malignancies, with potential expansion into additional solid tumors and hematologic indications [82][83] Question: Status of CD70 assay development and deployment [85] - The company has developed and validated a diagnostic assay for CD70 expression, which is being used for patient selection in the ALLO-316 study [86]