Allogene Therapeutics(ALLO)

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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
Financial Data and Key Metrics Changes - The company ended Q1 2023 with $514 million in cash, cash equivalents, and investments, indicating a strong balance sheet [22] - The net loss for Q1 2023 was $98.7 million, or $0.68 per share, which includes $18.8 million in non-cash stock-based compensation [23] - The company expects a decrease in cash, cash equivalents, and investments of approximately $230 million in 2023, with full-year GAAP operating expenses projected to be around $340 million [23] Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2023 were $80.2 million, including $9.2 million of non-cash stock-based compensation [23] - General and administrative expenses were $18.9 million for Q1 2023, which includes $9.6 million of non-cash stock-based compensation [23] Market Data and Key Metrics Changes - The company highlighted the growing demand for CAR T therapies, with an estimated 300,000 patients eligible for autologous CAR T therapy by 2030, yet only about 10% expected to receive treatment [8][9] - The company is focused on addressing the limitations of autologous therapies by providing a one-time infusion of AlloCAR T products, which can start treatment within days of enrollment [9][10] Company Strategy and Development Direction - The company aims to submit a Biologics License Application (BLA) for ALLO-501A upon completion of the ALPHA2 trial and is evaluating manufacturing processes for optimal clinical performance [10] - The addition of Tim Moore as Chief Technical Officer is expected to enhance the company's ability to deliver CAR T products at scale [11] - The company is exploring the potential of Dagger technology to prevent early rejection of AlloCAR T cells, which could lead to a next-generation allogeneic CAR T platform [21][55] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging market environment for biotech companies but emphasized that success will be driven by scientific innovation, experience, and financial stewardship [22] - The company remains confident in its clinical data and the impact of its products on patients, despite stock price fluctuations [7][8] Other Important Information - The company has initiated the Phase II EXPAND trial designed to support the licensure of ALLO-647 as a lymphodepleting agent for ALLO-501A in LBCL [16] - The company is focused on reviewing the manufacturing process for ALLO-715 and 605, with plans to potentially resume dosing in 2024 [35][59] Q&A Session Summary Question: Can you provide details on the ASCO update? - Management confirmed that they will present data at ASCO and aim to ensure that key opinion leaders and investigators have access to the data in a peer-reviewed format [26][28] Question: What is the progress of the pivotal ALPHA2 trial? - The study is open to enrollment and is progressing as expected, with completion of enrollment anticipated in the first half of next year [31][32] Question: How are patients being enrolled in the ALPHA2 and EXPAND trials? - Patients being enrolled are those eligible for original autologous CAR T studies, and the company is ensuring that the two studies do not compete for patient enrollment [34][38] Question: What is the expected timeline for data from the EXPAND trial? - Data from the EXPAND trial is expected to be available around the same time as the ALPHA2 trial results [76] Question: What are the plans for Dagger technology? - Dagger technology is being explored for use in both liquid and solid tumor indications, with ongoing development of next-generation constructs [47][55] Question: What is the company's approach to partnerships? - The company is open to partnerships to advance its allogeneic CAR T programs, particularly for BCMA and ALLO-316, to accelerate development [66][72]
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]
Allogene Therapeutics(ALLO) - 2022 Q4 - Annual Report
2023-02-27 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________ FORM 10-K _________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 001-38693 _________________________________ Allogen ...
Allogene Therapeutics (ALLO) Investor presntation - Slideshow
2022-11-16 17:50
Company Overview - Allogene has treated over 175 patients with AlloCAR T™ product candidates, more than any other allogeneic CAR T company[3] - The company held $637 million in cash, cash equivalents, and investments as of September 30, 2022[3] - Allogene operates a fully-integrated GMP facility with a projected capacity of approximately 20,000 patients annually[65] Clinical Programs & Data - Approximately 97% of patients treated with ALLO-501/ALLO-501A received treatment within 2-5 days of study enrollment[43] - The 6-month Complete Response (CR) rate for ALLO-501/501A in LBCL (mITT) was in the range of high 20s to 40%[43] - In the UNIVERSAL trial, approximately 90% of patients were treated within 5 days of study enrollment, obviating the need for bridging therapy[47] - In the UNIVERSAL trial, a 71% overall response rate and 46% VGPR+ was observed at the 320M cell dose of ALLO-715[48] - 92% of VGPR+ responses were MRD negative in the UNIVERSAL trial[48] Pipeline & Future Development - Allogene plans to initiate a potentially pivotal Phase 2 trial of ALLO-501A in r/r LBCL in mid-2022[64] - The company is developing ALLO-316, a CD70-targeted AlloCAR T for solid tumors, currently in Phase 1 (TRAVERSE trial)[65] - Doses from 40 million to 360 million cells are being tested in the TRAVERSE trial[60]