Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q3 2022 Earnings Conference Call November 2, 2022 5:00 PM ET Company Participants Christine Cassiano - CCO David Chang - President and CEO Rafael Amado - EVP, Research & Development and CMO Eric Schmidt - CFO Conference Call Participants Andrea Tan - Goldman Sachs Michael Yee - Jefferies Tyler Van Buren - Cowen Asthika Goonewardene - Truist Raju Prasad - William Blair Reni Benjamin - JMP Securities Mark Breidenbach - Oppenheimer John Newman - Canaccord Genuity Micha ...

[PART I: FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%3A%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of $83.1 million in Q3 2022, with total assets decreasing and an accumulated deficit of $1.1 billion [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $887.6 million from $1.04 billion, driven by reduced cash, while liabilities increased and equity declined Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $74,357 | $173,314 | | Total current assets | $569,061 | $471,323 | | Total assets | $887,572 | $1,038,634 | | Total current liabilities | $48,872 | $48,174 | | Total liabilities | $147,611 | $122,228 | | Total stockholders' equity | $739,961 | $916,406 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to $83.1 million in Q3 2022 and $237.8 million for the nine months, primarily due to higher R&D expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $49 | $49 | $196 | $38,438 | | Research and development | $63,641 | $58,720 | $180,968 | $166,193 | | General and administrative | $18,897 | $18,999 | $58,303 | $54,144 | | Loss from operations | ($82,489) | ($77,670) | ($239,075) | ($181,899) | | Net loss | ($83,148) | ($78,186) | ($237,785) | ($182,137) | | Net loss per share | ($0.58) | ($0.57) | ($1.67) | ($1.35) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $158.4 million for the nine months, while investing activities provided $56.6 million Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($158,423) | ($139,376) | | Net cash provided by investing activities | $56,562 | $134,405 | | Net cash provided by financing activities | $2,904 | $11,641 | | Net change in cash, cash equivalents and restricted cash | ($98,957) | $6,670 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail business, accounting policies, and financial arrangements, including capital sufficiency, collaboration agreements, and a significant milestone payment - The company is an immuno-oncology firm focused on allogeneic T cell therapies and has incurred cumulative net losses of **$1.1 billion** since inception through September 30, 2022[16](index=16&type=chunk)[17](index=17&type=chunk) - Management expects current cash, cash equivalents, and investments of **$637.3 million** are sufficient to fund operations for at least one year from the filing date[17](index=17&type=chunk)[18](index=18&type=chunk) - In September 2022, partner Servier discontinued its involvement in the development of CD19 products (UCART19, ALLO-501, ALLO-501A), granting Allogene the option to license these products outside the U.S.[56](index=56&type=chunk) - Total stock-based compensation expense was **$21.1 million** for Q3 2022 and **$66.4 million** for the first nine months of 2022[105](index=105&type=chunk) - Subsequent to the quarter's end, the company initiated the Phase 2 clinical trial of ALLO-501A, which requires an **$8.0 million** milestone payment to Servier, expected to be recognized in Q4 2022[116](index=116&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical progress, financial results, and liquidity, highlighting increased R&D expenses and sufficient cash reserves for the next year [Overview](index=24&type=section&id=Overview) Allogene, a clinical-stage CAR T cell therapy company, initiated a Phase 2 trial and faces strategic changes with Servier's CD19 program discontinuation - The company is progressing its pipeline, having initiated the Phase 2 ALPHA2 trial for ALLO-501A in R/R large B cell lymphoma (LBCL) and planning the EXPAND trial to demonstrate the contribution of its lymphodepletion agent, ALLO-647[121](index=121&type=chunk)[123](index=123&type=chunk) - Servier discontinued its involvement in the development of CD19 Products, giving Allogene the right to elect a license for these products outside the United States. This would cease Servier's **40% development cost reimbursement**[120](index=120&type=chunk) - As of September 30, 2022, the company had an accumulated deficit of **$1.1 billion** and cash, cash equivalents, and investments of **$637.3 million**[126](index=126&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Q3 2022 R&D expenses increased by $4.9 million due to higher personnel and facilities costs, while collaboration revenue significantly decreased Comparison of Operating Results (Three Months Ended Sep 30, in thousands) | Account | 2022 | 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $63,641 | $58,720 | $4,921 | 8% | | General and administrative | $18,897 | $18,999 | ($102) | (1)% | | Loss from operations | ($82,489) | ($77,670) | ($4,819) | 6% | - The **$4.9 million** increase in Q3 R&D expenses was driven by a **$5.9 million** rise in personnel costs and a **$4.3 million** increase in facilities/depreciation, offset by a **$5.9 million** decrease in external development and manufacturing costs[153](index=153&type=chunk) - Collaboration revenue for the nine months ended September 30, 2022, was **$0.2 million**, a sharp decrease from **$38.4 million** in the same period of 2021. The 2021 revenue was primarily from the license of intellectual property and delivery of know-how to Allogene Overland in Q1 2021[157](index=157&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $637.3 million in cash and investments, sufficient for over a year, with primary commitments tied to license agreements - The company anticipates its cash and investments of **$637.3 million** as of September 30, 2022, will be sufficient to maintain operations for at least one year from the filing date of this report[161](index=161&type=chunk) Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in Operating activities | ($158,423) | ($139,376) | | Net cash provided by Investing activities | $56,562 | $134,405 | | Net cash provided by Financing activities | $2,904 | $11,641 | - Material cash commitments include potential milestone payments under license agreements with Pfizer, Cellectis, Servier, and Notch, as well as obligations under a collaboration with MD Anderson and a solar power agreement[170](index=170&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk on its $637.3 million cash and investments, and foreign exchange risk from Euro-denominated payments - The company is exposed to interest rate risk on its cash and investment portfolio of **$637.3 million**[179](index=179&type=chunk) - Foreign exchange risk exists due to collaboration payments denominated in Euros with its partner Servier. As of September 30, 2022, the company had **$4.3 million** of receivables denominated in foreign currency[180](index=180&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective, while a new SAP system implementation is expected to change internal controls - The CEO and CFO concluded that disclosure controls and procedures were effective as of the end of the reporting period[181](index=181&type=chunk) - The company is implementing a new SAP enterprise resource planning system in phases, which is expected to cause changes to its internal control over financial reporting[182](index=182&type=chunk) [PART II: OTHER INFORMATION](index=36&type=section&id=PART%20II%3A%20OTHER%20INFORMATION) [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending legal claims or actions that would materially adversely affect its financial condition or operations - Management believes there are currently no pending legal proceedings that could have a material adverse effect on the company[185](index=185&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including financial losses, challenges in novel therapy development, reliance on partners, clinical trial failures, and complex manufacturing - **Financial Risk:** The company has a history of net losses (**$1.1B** accumulated deficit) and will require substantial additional financing to continue operations and develop its products[190](index=190&type=chunk)[275](index=275&type=chunk) - **Clinical & Development Risk:** The company's allogeneic T cell product candidates are a novel approach with significant challenges, including the risk of undesirable side effects, and clinical trials may fail to demonstrate safety and efficacy[194](index=194&type=chunk)[214](index=214&type=chunk)[221](index=221&type=chunk) - **Third-Party Reliance Risk:** The business is heavily reliant on partners, particularly Cellectis for TALEN gene-editing technology. Servier's discontinuation of its involvement in the CD19 programs introduces uncertainty and potential adverse consequences[204](index=204&type=chunk)[206](index=206&type=chunk) - **Manufacturing & Operational Risk:** The company may fail to successfully manufacture its product candidates at scale, operate its own facility, or obtain regulatory approval for its manufacturing processes, which could harm clinical trials and commercial viability[246](index=246&type=chunk) - **Regulatory Risk:** The regulatory approval process for novel cell therapies is lengthy, complex, and uncertain. The company may face substantial delays or may not be able to conduct trials on expected timelines[208](index=208&type=chunk)[228](index=228&type=chunk)[324](index=324&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the current reporting period - There were no unregistered sales of equity securities in the quarter[401](index=401&type=chunk) [Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents and officer certifications

Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q2 2022 Earnings Conference Call August 9, 2022 5:00 PM ET Company Participants Christine Cassiano – Chief Communications Officer David Chang – President and Chief Executive Officer Rafael Amado – Executive Vice President-Research and Development and Chief Medical Officer Eric Schmidt – Chief Financial Officer Conference Call Participants Tyler Van Buren – Cowen Salveen Richter – Goldman Sachs Michael Yee – Jefferies Kelsey Goodwin – Guggenheim Ren Benjamin – JMP Se ...

Financial Data and Key Metrics Changes - The company ended Q1 2022 with $733 million in cash, cash equivalents, and investments [22] - Research and development expenses for Q1 2022 were $60.2 million, including $11.1 million of non-cash stock-based compensation [22] - General and administrative expenses were $19.9 million for Q1 2022, which included $11.2 million of non-cash stock-based compensation [22] - The net loss for Q1 2022 was $79.9 million or $0.56 per share, including non-cash stock-based compensation expense of $22.3 million [22] - Full year 2022 operating expenses are expected to be between $360 million and $390 million, including an estimated non-cash stock-based compensation expense of $90 million to $100 million [22] Business Line Data and Key Metrics Changes - The company has treated more patients with its AlloCAR T candidates than any other player in the field, indicating a strong operational capacity [8] - ALLO-501A is projected to initiate a pivotal trial mid-year 2022, with ongoing enrollment in its Phase 1 study [13] - ALLO-715 and ALLO-605 are actively enrolling patients in trials for relapsed refractory multiple myeloma [13] Market Data and Key Metrics Changes - The market for second-line large B cell lymphoma and relapsed refractory multiple myeloma is large, consisting of many thousands of potentially suitable patients [11] - Autologous therapies have not been able to keep up with demand, creating a significant opportunity for allogeneic CAR-T products [11] - The company projects it can manufacture approximately 20,000 patient doses annually at scale, significantly reducing the number of required manufacturing runs compared to autologous therapies [11] Company Strategy and Development Direction - The company aims to industrialize cell therapy to serve tens of thousands of patients in a commercial setting [9] - The strategic importance of the Cell Forge 1 manufacturing facility is emphasized, as it supports clinical and commercial manufacturing [12] - The company is focused on advancing its AlloCAR T products into solid tumors and progressing multiple clinical programs [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial strength to weather the current biotech market downturn [21] - The company is optimistic about the competitive positioning of its BCMA program and expects to have data to make decisions by year-end [32] - Management highlighted the importance of addressing logistical challenges and manufacturing costs in the autologous CAR-T therapy space [10] Other Important Information - The company has welcomed a new Chief People Officer to oversee human resources efforts as it scales its teams [13] - The company is preparing to launch the EXPAND trial to support registration of ALLO-647, which is designed to enhance the expansion and persistence of AlloCAR T cells [16] Q&A Session Summary Question: What does the company need to show in the pivotal ALLO-501A trial for approval? - Management believes the data generated thus far shows comparable durability and complete response rates to autologous products, aiming to establish an off-the-shelf therapy for all patients [25] Question: What are the steps to starting the pivotal Phase 2 DLBCL study? - The pivotal study for ALLO-501A is on schedule to start mid-2022, with ongoing completion of CMC activities [28] Question: How confident is the company about proceeding with the BCMA program by year-end? - Management is pleased with the pace of the BCMA program and expects to have sufficient data to make decisions by year-end [32] Question: Will the pivotal Phase 2 portion of Alpha 2 need to start enrolling before the EXPAND study? - The EXPAND study will start after the Alpha 2 study, as the latter is the registration trial for ALLO-501A [37] Question: How does the company view competition with autologous products? - The company is confident in its manufacturing capabilities, estimating it can produce 20,000 doses annually, which is significantly more efficient than autologous manufacturing [49]

PART I: FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of $79.9 million in Q1 2022, primarily due to reduced collaboration revenue [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $964.6 million by March 31, 2022, mainly due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $84,514 | $173,314 | | Total current assets | $469,744 | $471,323 | | Total assets | $964,632 | $1,038,634 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $36,877 | $48,174 | | Total liabilities | $109,402 | $122,228 | | Total stockholders' equity | $855,230 | $916,406 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to $79.9 million in Q1 2022, primarily due to a significant drop in collaboration revenue Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Collaboration revenue | $61 | $38,345 | | Research and development | $60,156 | $55,183 | | General and administrative | $19,897 | $16,363 | | Loss from operations | ($79,992) | ($33,201) | | Net loss | ($79,850) | ($33,015) | | Net loss per share | ($0.56) | ($0.25) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $68.2 million in Q1 2022, reflecting a higher net loss Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($68,237) | ($49,328) | | Net cash (used in) provided by investing activities | ($22,377) | $96,798 | | Net cash provided by financing activities | $1,814 | $6,044 | | **Net change in cash, cash equivalents and restricted cash** | **($88,800)** | **$53,514** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's immuno-oncology business, financial liquidity, and key collaboration agreements - The company is an immuno-oncology company focused on developing and commercializing genetically engineered allogeneic T cell therapies for cancer[17](index=17&type=chunk) - As of March 31, 2022, the company had cash, cash equivalents, and investments of **$733.1 million** and believes this is sufficient to fund operations for at least one year[18](index=18&type=chunk)[19](index=19&type=chunk) - The company has significant potential future milestone payments, including up to **$2.8 billion** to Cellectis per the Cellectis Agreement and up to **$137.5 million** in regulatory milestones to Servier[45](index=45&type=chunk)[55](index=55&type=chunk) - In January 2022, the company entered into a collaboration and license agreement with Antion Biosciences, making a **$3.5 million** upfront payment and a **$3.0 million** equity investment[72](index=72&type=chunk)[75](index=75&type=chunk) - Collaboration revenue of **$38.3 million** was recognized in Q1 2021 related to the license agreement with Allogene Overland, with negligible revenue from this source in Q1 2022[71](index=71&type=chunk)[102](index=102&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2022 net loss from reduced collaboration revenue and higher expenses, confirming capital sufficiency - The company is pioneering the development of allogeneic (off-the-shelf) T cell product candidates, derived from healthy donors for use in any patient, to treat cancer[111](index=111&type=chunk) - The company plans to seek FDA agreement to proceed to the Phase 2 portion of the ALPHA2 trial (ALLO-501A) in adult patients with R/R large B-cell lymphoma in mid-2022[113](index=113&type=chunk) Results of Operations Comparison (in thousands) | Metric | Q1 2022 | Q1 2021 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $61 | $38,345 | ($38,284) | NM | | Research and development | $60,156 | $55,183 | $4,973 | 9% | | General and administrative | $19,897 | $16,363 | $3,534 | 22% | | **Net Loss** | **($79,850)** | **($33,015)** | **($46,835)** | **142%** | - The decrease in collaboration revenue was due to the one-time recognition of revenue from the license of intellectual property to Allogene Overland in Q1 2021[141](index=141&type=chunk) - As of March 31, 2022, the company had **$733.1 million** in cash, cash equivalents, and investments, which is expected to fund operations for at least one year from the filing date[145](index=145&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate and foreign exchange risks, with management assessing no material impact from a **10%** change - The company's primary market risks are interest rate fluctuations on its **$733.1 million** in cash and investments, and foreign exchange risk from Euro-denominated payments with its partner Servier[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) - Management concluded that a hypothetical **10%** change in interest rates or foreign exchange rates would not materially impact the company's financial statements as of March 31, 2022[163](index=163&type=chunk)[164](index=164&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective, with ongoing implementation of a new SAP ERP system - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[166](index=166&type=chunk) - The company is undergoing a phased implementation of a new SAP enterprise resource planning (ERP) system, which is expected to result in changes to internal control over financial reporting over time[167](index=167&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect - There are currently no pending claims or actions against the company that management believes would have a material adverse effect on its business[170](index=170&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including historical losses, novel technology, partner reliance, and regulatory uncertainties - **Financial Risk:** The company has a history of net losses (**$983.2 million** accumulated deficit as of March 31, 2022) and will require substantial additional financing to continue operations[174](index=174&type=chunk)[256](index=256&type=chunk) - **Technology & Clinical Risk:** Product candidates are based on novel allogeneic T cell and gene-editing technologies, which face significant development, manufacturing, and regulatory challenges. Clinical trials may be delayed, fail to show efficacy, or reveal undesirable side effects like CRS, GvHD, or neurotoxicity[177](index=177&type=chunk)[180](index=180&type=chunk)[198](index=198&type=chunk) - **Dependency Risk:** The business is heavily reliant on partners, particularly Cellectis for TALEN gene-editing technology and Servier for the development of anti-CD19 candidates. Termination of these agreements would significantly harm the business[186](index=186&type=chunk)[189](index=189&type=chunk)[336](index=336&type=chunk) - **Manufacturing Risk:** The company may fail to successfully manufacture its product candidates at scale, operate its new facility, or obtain regulatory approval for it. It also relies on a limited number of third-party suppliers for critical raw materials[231](index=231&type=chunk)[291](index=291&type=chunk)[297](index=297&type=chunk) - **Regulatory Risk:** The regulatory pathway for allogeneic cell therapies is complex and uncertain. The FDA may disagree with regulatory plans, require additional trials, or not grant approval for product candidates or the co-developed lymphodepletion agent, ALLO-647[191](index=191&type=chunk)[303](index=303&type=chunk)[312](index=312&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[384](index=384&type=chunk) [Defaults Upon Senior Securities](index=69&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[384](index=384&type=chunk) [Mine Safety Disclosures](index=70&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[385](index=385&type=chunk) [Other Information](index=70&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item - None[385](index=385&type=chunk) [Exhibits](index=70&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and XBRL data - The report includes standard filings such as officer certifications (**31.1, 31.2, 32.1**) and XBRL data files[386](index=386&type=chunk)

Financial Data and Key Metrics Changes - The company ended 2021 with $810 million in cash, cash equivalents, and investments, with no debt [27] - For the full year 2021, research and development expenses were $220.2 million, including $39.6 million in non-cash stock-based compensation [29] - General and administrative expenses for 2021 were $74.1 million, which included $41.2 million of non-cash stock-based compensation [29] - The net loss for 2021 was $257.0 million or $1.89 per share, including non-cash stock-based compensation expense of $80.8 million [29] Business Line Data and Key Metrics Changes - The company is advancing three clinical programs: a pivotal trial in non-Hodgkin's lymphoma, a mid-stage program in multiple myeloma, and a solid tumor clinical program [7][8] - The ALPHA trials demonstrated that 98% of enrolled patients received treatment within a median time of two to five days from enrollment [10] - The company aims to minimize delays in biologic license application submissions and has invested heavily in in-house manufacturing capabilities [12][28] Market Data and Key Metrics Changes - The marketplace for autologous cell therapy is constrained by treatment delays and supply limitations, which Allogene aims to overcome with its AlloCAR T products [9][10] - The company is focusing on the multiple myeloma market, where there is a significant need for effective therapies [17][19] Company Strategy and Development Direction - Allogene is focused on becoming a leader in allogeneic cell therapy, leveraging its manufacturing capabilities to deliver off-the-shelf CAR T therapies [12][28] - The company plans to start the ALLO-501A pivotal trial for relapsed refractory large B cell lymphoma in mid-2022 [12][14] - The strategy includes launching a standalone registrational trial for ALLO-647 alongside the ALLO-501A pivotal trial [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to start pivotal trials by mid-year and emphasized the importance of CMC (Chemistry, Manufacturing, and Controls) in the development process [14][42] - The management highlighted the need for more therapy options in the market, particularly for patients who cannot tolerate autologous therapies [19][76] - The company is optimistic about the potential of its anti-BCMA program, which has shown unprecedented response rates in multiple myeloma [17][19] Other Important Information - The FDA removed the clinical hold on Allogene's AlloCAR T clinical trials, allowing the company to resume patient enrollment [14][15] - The company is focused on ensuring product quality and minimizing variability in its manufacturing processes to support future regulatory submissions [25][26] Q&A Session Summary Question: Insights on CMC and pivotal CD19 study - Management discussed the importance of Cell Forge 1 in supporting commercialization and ensuring supply for the pivotal study [34][35] Question: Update on myeloma data - Management expressed excitement about the data presented at ASH and the potential for further updates by the end of the year [38][39] Question: Ongoing discussions with the FDA - Management confirmed advanced discussions with the FDA regarding the pivotal ALPHA2 trial and the co-development of ALLO-647 [42][43] Question: Details on ALLO-647 registrational trials - Management emphasized the need to demonstrate the benefit-risk profile of ALLO-647 in a randomized trial [46][47] Question: Update on CD70 program and TRAVERSE trial size - Management acknowledged the excitement around the CD70 program and clarified that the increase in trial size was for flexibility in study design [62][64] Question: Manufacturing capabilities and partnerships - Management confirmed that they do not plan to monetize manufacturing capabilities and are focused on investing in their Cell Forge 1 facility [64][66]