Allogene Therapeutics(ALLO) - 2024 Q2 - Quarterly Report

PART I: FINANCIAL INFORMATION Financial Statements The company's financial statements reflect its clinical-stage status with no product revenue, showing a reduced net loss for H1 2024 and increased assets, supported by recent capital raises Condensed Consolidated Balance Sheets Total assets increased slightly to $646.9 million by June 30, 2024, with cash and investments at $444.6 million, and a new $21.4 million escrow deposit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $170,667 | $83,155 | | Short-term investments | $273,961 | $365,542 | | Total current assets | $457,124 | $459,115 | | Total assets | $646,883 | $642,837 | | Liabilities & Equity | | | | Total current liabilities | $37,305 | $37,079 | | Total liabilities | $131,845 | $130,604 | | Total stockholders' equity | $515,038 | $512,233 | - A deposit of $21.4 million was placed in escrow as of June 30, 2024, which was not present at the end of 2023[6] Condensed Consolidated Statements of Operations and Comprehensive Loss For Q2 2024, net loss decreased to $66.4 million from $79.2 million in Q2 2023, driven by lower operating expenses despite a new impairment charge Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2024 | Q2 2023 | 6 Months 2024 | 6 Months 2023 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $— | $22 | $22 | $52 | | Research and development | $50,355 | $62,038 | $102,614 | $142,276 | | General and administrative | $16,087 | $18,524 | $33,354 | $37,408 | | Impairment of long-lived assets | $4,989 | $— | $4,989 | $— | | Loss from operations | $(71,431) | $(80,540) | $(140,935) | $(179,632) | | Net loss | $(66,358) | $(79,232) | $(131,358) | $(179,200) | | Net loss per share | $(0.35) | $(0.54) | $(0.73) | $(1.23) | Condensed Consolidated Statements of Stockholders' Equity Total stockholders' equity increased to $515.0 million by June 30, 2024, primarily due to $106.3 million from stock offerings, offset by net loss - In the first six months of 2024, the company issued common stock from an ATM offering and a registered offering, raising net proceeds of $1.0 million and $105.3 million, respectively[11][12] - Stock-based compensation expense for the first six months of 2024 totaled $25.5 million ($11.9M in Q1 and $13.6M in Q2)[11] - The accumulated deficit grew from $1.56 billion at the end of 2023 to $1.69 billion as of June 30, 2024, due to ongoing net losses[11][12] Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $119.5 million for H1 2024, offset by $96.7 million from investing and $110.3 million from financing activities Cash Flow Summary (Six Months Ended June 30, in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(119,487) | $(128,496) | | Net cash provided by investing activities | $96,746 | $130,095 | | Net cash provided by financing activities | $110,253 | $91,255 | | Net change in cash | $87,512 | $92,854 | - Financing activities in H1 2024 were significantly boosted by $105.3 million in net proceeds from a registered offering and $2.3 million from a CIRM award[16] - A key use of cash in operating activities was a $21.4 million deposit placed in escrow, related to a potential milestone payment[16] Notes to Condensed Consolidated Financial Statements The notes detail a $110 million registered offering, a $5.0 million impairment, and significant amendments to collaboration agreements with Servier and Notch - The company is a clinical-stage immuno-oncology firm developing allogeneic T cell product candidates for cancer and autoimmune diseases[19] - In May 2024, the company raised gross proceeds of $110.0 million through a registered offering of common stock[20] - Management expects that its cash, cash equivalents, and investments of $444.6 million as of June 30, 2024, are sufficient to fund operations for at least the next 12 months[21][22] - In June 2024, the company recognized a $5.0 million pre-tax impairment charge on a right-of-use asset and leasehold improvements for a building it decided to sublease[43] - In May 2024, the agreement with Servier was amended, expanding the licensed territory to the EU and UK and restructuring milestone payments, with a €20.0 million ($21.4 million) deposit placed in escrow for a potential future milestone[63][66] - In January 2024, the collaboration with Notch was amended, relinquishing rights to most original targets, and in May 2024, Allogene's ownership in Notch was diluted to 13%, no longer accounted for using the equity method[77][74] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses strategic focus on core programs, including the ALPHA3 trial, reduced H1 2024 net loss, and a cash runway into 2026, supported by recent financing Overview The company's 2024 Platform Vision prioritizes four CAR T cell programs, including the pivotal ALPHA3 trial, with a cash runway into 2026 despite accumulated deficits - The company's 2024 strategy focuses on four core programs: cema-cel (in LBCL and CLL), ALLO-316 (in RCC), and ALLO-329 (in autoimmune diseases)[143][150] - A pivotal Phase 2 clinical trial (ALPHA3) for cema-cel in first-line consolidation for LBCL patients was initiated in June 2024, with BLA submission targeted for 2027[144] - The company plans to file an IND for ALLO-329 in Q1 2025 for autoimmune diseases and initiate a Phase 1 trial in H1 2025[148] - As of June 30, 2024, the company had $444.6 million in cash and investments, with an expected cash runway to fund operations into 2026[152] Results of Operations Net loss significantly decreased for the three and six months ended June 30, 2024, primarily due to reduced R&D and G&A expenses, despite a new impairment charge Comparison of Operating Results (in thousands) | Period | Metric | 2024 | 2023 | Change | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | | 3 Months | R&D Expenses | $50,355 | $62,038 | $(11,683) | (19)% | | | G&A Expenses | $16,087 | $18,524 | $(2,437) | (13)% | | | Net Loss | $(66,358) | $(79,232) | $12,874 | (16)% | | 6 Months | R&D Expenses | $102,614 | $142,276 | $(39,662) | (28)% | | | G&A Expenses | $33,354 | $37,408 | $(4,054) | (11)% | | | Net Loss | $(131,358) | $(179,200) | $47,842 | (27)% | - The decrease in R&D expenses for the six months ended June 30, 2024, was primarily driven by a $21.9 million decrease in personnel costs and a $14.4 million decrease in external costs related to product candidate development and manufacturing[202] - An impairment charge of $5.0 million was recorded in Q2 2024 after the company decided to sublease one of its leased buildings in South San Francisco[194] Liquidity and Capital Resources The company holds $444.6 million in cash and investments, projecting a cash runway into 2026, supported by recent equity sales and financing activities - The company had $444.6 million in cash, cash equivalents, and investments as of June 30, 2024, and expects this to fund operations into 2026[207][152] - In May 2024, a registered offering provided net proceeds of $105.2 million, with ATM offerings providing an additional $1.0 million during H1 2024[208] Cash Flow Summary (Six Months Ended June 30, in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(119,487) | $(128,496) | | Net cash provided by investing activities | $96,746 | $130,095 | | Net cash provided by financing activities | $110,253 | $91,255 | Quantitative and Qualitative Disclosures About Market Risk The company faces interest rate risk on its $444.6 million cash and investments, and foreign exchange risk from Euro-denominated liabilities, though material impact is not expected - The company is exposed to interest rate risk on its $444.6 million portfolio of cash, cash equivalents, and available-for-sale securities[228] - Foreign exchange risk exists due to milestone payments denominated in Euros under the Servier agreement, with a $21.4 million escrow deposit and $5.8 million of current liabilities denominated in foreign currency as of June 30, 2024[229] Controls and Procedures Management concluded disclosure controls were ineffective as of June 30, 2024, due to a material weakness in technical accounting for non-routine transactions, with remediation ongoing - Management concluded that as of June 30, 2024, the company's disclosure controls and procedures were not effective at a reasonable assurance level[231] - The ineffectiveness is due to a material weakness identified in the internal controls over financial reporting concerning the technical accounting for significant non-routine transactions[231] - Remediation efforts are ongoing and include engaging third-party subject matter experts, with the material weakness not considered remediated until new controls have operated effectively for a sufficient period[232] PART II: OTHER INFORMATION Legal Proceedings The company is not currently involved in any legal proceedings expected to have a material adverse effect on its financial condition or operations - Management believes there are currently no pending claims or actions that could have a material adverse effect on the company[236] Risk Factors The company faces significant financial, operational, developmental, and legal risks, including a history of losses, reliance on novel technology, and a new lawsuit impacting a key trial - The company has a history of net losses ($1.7 billion accumulated deficit as of June 30, 2024) and will need substantial additional financing to continue operations[247][249] - The business is highly dependent on the success of its lead product candidates (cema-cel, ALLO-316), which are based on novel and unproven allogeneic T cell technologies[270][262] - A new risk has emerged from a lawsuit by Roche against Foresight Diagnostics, the company's partner for the MRD assay used in the ALPHA3 trial, where an adverse outcome could significantly delay or prevent the trial's completion[452][453] - The company relies heavily on partners for critical technology, such as TALEN gene editing from Cellectis, and faces risks from disputes between its partners, such as the ongoing arbitration between Servier and Cellectis[368][373] - A material weakness in internal control over financial reporting has been identified, which could affect the ability to report financial results accurately and on time[485] Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities were reported during the period - No unregistered sales of equity securities were reported for the period[499] Defaults Upon Senior Securities The company reported no defaults upon senior securities - No defaults upon senior securities were reported[499] Mine Safety Disclosures This section is not applicable to the company - This item is not applicable[499] Other Information No other information required to be disclosed was reported - No information was reported under this item[499] Exhibits This section lists filed exhibits, including charter documents, various collaboration agreements, and certifications by principal officers - Filed exhibits include the Share Exchange Agreement with Allogene Overland, the Amendment and Settlement Agreement with Servier, and amendments to agreements with Notch and Foresight Diagnostics[498][501] - Certifications by the Principal Executive Officer and Principal Financial Officer pursuant to SEC rules are included as exhibits[501]