Partnership Will Utilize Foresight's Ultra-Sensitive MRD Technology to Identify Patients for Enrollment in Allogene's ALPHA3 Trial SAN FRANCISCO and BOULDER, Colo., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products, and Foresight Diagnostics (Foresight), the leader in the development of ultra-sensitive liquid biopsy circulating tumor DNA (ctDNA) detection today announced a st ...

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 ...

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, 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 ...

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, 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 ...

[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) Unaudited H1 2023 financial statements show decreased **total assets**, increased **net losses**, and **cash provided by financing activities** [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) **Total assets** decreased to **$771.0 million** by June 30, 2023, from **$817.1 million** at year-end 2022, due to reduced investments Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $154,758 | $61,904 | | Total current assets | $502,101 | $528,824 | | Total assets | $770,971 | $817,079 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $54,721 | $54,518 | | Total liabilities | $148,065 | $151,209 | | Total stockholders' equity | $622,906 | $665,870 | | Total liabilities and stockholders' equity | $770,971 | $817,079 | [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 **$77.9 million** for Q2 2023 and **$176.7 million** for H1 2023, primarily due to higher R&D expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $44 | $86 | $96 | $147 | | Research and development | $62,038 | $57,171 | $142,276 | $117,327 | | General and administrative | $18,524 | $19,509 | $37,408 | $39,406 | | Loss from operations | ($80,518) | ($76,594) | ($179,588) | ($156,586) | | Net loss | ($77,989) | ($74,787) | ($176,693) | ($154,637) | | Net loss per share | ($0.53) | ($0.52) | ($1.21) | ($1.09) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) **Stockholders' equity** decreased to **$622.9 million** by June 30, 2023, due to **net losses**, partially offset by **$87.9 million** from an ATM offering - During the **six months** ended June 30, 2023, the company issued **20,288,330 shares** of common stock from its ATM offering, resulting in **net proceeds of $87.9 million**[10](index=10&type=chunk) - The **accumulated deficit** increased from **$(1,236.0) million** at the end of 2022 to **$(1,412.7) million** as of June 30, 2023, reflecting the ongoing **net losses**[10](index=10&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) **Net cash used in operating activities** was **$128.5 million** for H1 2023, offset by **$130.1 million** from **investing activities** and **$91.3 million** from **financing activities** Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($128,496) | ($110,768) | | Net cash provided by investing activities | $130,095 | $31,657 | | Net cash provided by financing activities | $91,255 | $1,838 | | Net change in cash, cash equivalents and restricted cash | $92,854 | ($77,273) | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's immuno-oncology business, financial condition, **$544.5 million** **cash runway**, and the ongoing Servier dispute - The company is a clinical-stage immuno-oncology company focused on developing allogeneic T cell product candidates for cancer treatment[17](index=17&type=chunk) - As of June 30, 2023, the company had **$544.5 million** in cash, cash equivalents, and investments, and management expects this to be sufficient to fund operations for at least the next **12 months**[19](index=19&type=chunk)[20](index=20&type=chunk) - A dispute exists with Servier, which discontinued its involvement in the development of CD19 **products** in September 2022. Servier has disputed its obligation to continue development cost contributions and sent notices of **material breach**, which the company is disputing[59](index=59&type=chunk)[61](index=61&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses progress on allogeneic CAR T cell candidates, increased **net loss** for H1 2023, and a **cash runway** into H2 2025 - The company is progressing its pivotal Phase **2** ALPHA2 trial for ALLO-501A in R/R Large B Cell Lymphoma (LBCL) and expects to complete enrollment in H1 2024, with the first data readout by year-end 2024[127](index=127&type=chunk)[136](index=136&type=chunk) - A dispute with Servier over its discontinuation of involvement and cost-sharing for CD19 **products** is ongoing. Servier sent a second notice of **material breach** in July 2023, which Allogene disputes[142](index=142&type=chunk) Financial Results Comparison (in thousands) | Metric | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Research and development | $142,276 | $117,327 | | General and administrative | $37,408 | $39,406 | | Loss from operations | ($179,588) | ($156,586) | | Net Loss | ($176,693) | ($154,637) | - As of June 30, 2023, the company had **$544.5 million** in cash, cash equivalents, and investments, with an expected **cash runway** to fund operations into the second half of 2025[130](index=130&type=chunk)[174](index=174&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rate fluctuations on its **$544.5 million** in cash and investments, and foreign exchange rates - The primary market risks are interest rate fluctuations on its **$544.5 million** in cash and investments, and foreign exchange risk on Euro-denominated payments related to the Servier agreement[193](index=193&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were effective as of June 30, 2023, with ongoing phased implementation of a new SAP ERP system - Management concluded that disclosure controls and procedures were effective as of the end of the reporting period[197](index=197&type=chunk) - The company is undergoing a phased implementation of a new SAP ERP system, which is expected to result in changes to its internal control over financial reporting[198](index=198&type=chunk) [PART II: OTHER INFORMATION](index=37&type=section&id=PART%20II%3A%20OTHER%20INFORMATION) [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) No legal proceedings are expected to have a **material adverse effect** on operations, financial condition, or cash flows - There are currently no pending claims or actions against the company that management believes would have a **material adverse effect**[201](index=201&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Key risks include a history of **net losses**, unproven allogeneic therapies, partner reliance, the Servier dispute, and the need for substantial financing - The company has a history of **net losses** (**$1.4 billion accumulated deficit** as of June 30, 2023) and expects to incur substantial future **losses**[205](index=205&type=chunk) - A significant risk is the dispute with Servier following its discontinuation of involvement in CD19 **product** development, including disagreements over cost contributions and notices of **material breach** from Servier[216](index=216&type=chunk)[218](index=218&type=chunk) - The business is highly dependent on the success of its lead **product** candidates, which are based on novel technologies, making development time, cost, and regulatory approval difficult to predict[219](index=219&type=chunk)[225](index=225&type=chunk) - The company will need substantial additional financing to complete the development and commercialization of its **product** candidates[293](index=293&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=76&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the period - None[436](index=436&type=chunk) [Other Information](index=76&type=section&id=Item%205.%20Other%20Information) David M. Chang was appointed principal financial officer and Jack Chen as principal accounting officer, effective August 3, 2023 - David M. Chang, M.D., Ph.D., President and CEO, was appointed as principal financial officer effective August 3, 2023[437](index=437&type=chunk) - Jack Chen, Vice President and Controller, was appointed as principal accounting officer effective August 3, 2023[438](index=438&type=chunk) [Exhibits](index=78&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents and officer certifications

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 ...

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]

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 ...