Allogene Therapeutics(US:ALLO)2024-11-07 21:13Clinical Trials and Product Development - Allogene Therapeutics is focused on developing genetically engineered allogeneic T cell product candidates for cancer and autoimmune diseases, with a pipeline targeting multiple hematological malignancies and solid tumors [90]. - The pivotal Phase 2 clinical trial (ALPHA3) for cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL) has initiated with almost 30 sites activated, targeting approximately 240 patients [90]. - The ALPHA3 trial aims to study the impact of treating minimal residual disease (MRD) positive patients, with a primary endpoint of event-free survival (EFS) and expected enrollment completion in the first half of 2026 [90]. - The Phase 1 trial (TRAVERSE) of ALLO-316 targeting CD70 in advanced renal cell carcinoma (RCC) has enrolled 39 patients, with 26 confirmed to have CD70 positive RCC [92]. - The best overall response rate (ORR) for ALLO-316 in patients with CD70 Tumor Proportion Score (TPS) of ≥50% was 50%, with a confirmed response rate of 33% [92]. - A biologics license application (BLA) submission for cema-cel is targeted for 2027, following efficacy analyses expected in 2026 [90]. - The Phase 1b expansion cohort for ALLO-316 is expected to include approximately 20 patients, with additional data anticipated in mid-2025 [92]. - The ALPHA2 trial for cema-cel has been deprioritized in favor of the earlier line ALPHA3 trial due to its potential [90]. - The company has implemented a diagnostic and treatment algorithm in the ALLO-316 trial to mitigate treatment-associated hyperinflammatory responses [92]. - The company plans to assess ALLO-647's contribution to the overall benefit-to-risk ratio in the pivotal ALPHA3 trial, with enrollment completion expected in mid-2025 [95]. - ALLO-329, a next-generation allogeneic CAR T cell product candidate, is expected to file an investigational new drug (IND) application in Q1 2025 and initiate a Phase 1 trial in mid-2025 [95]. - The company has significant development priorities focused on cema-cel (1L Consolidation), ALLO-316, and ALLO-329, while exploring partnership opportunities across its pipeline [95]. Financial Performance - The company reported net losses of $66.3 million and $197.7 million for the three and nine months ended September 30, 2024, respectively, with an accumulated deficit of $1.8 billion as of the same date [96]. - The company has $403.4 million in cash and cash equivalents, which is expected to fund operations into 2026 [96]. - The market opportunity for cema-cel is projected to increase by over 50%, expanding from more than $6.0 billion in the U.S. to over $9.5 billion across the U.S., European Union, and United Kingdom [96]. - For the three months ended September 30, 2024, collaboration revenue was $0, a decrease of 100% compared to $22,000 in the same period of 2023 [125]. - Research and development expenses for the three months ended September 30, 2024, were $44.7 million, a decrease of 3% from $46.0 million in the same period of 2023 [127]. - General and administrative expenses decreased to $16.3 million for the three months ended September 30, 2024, down 4% from $17.0 million in the same period of 2023 [130]. - The company recorded an impairment charge of $10.7 million for long-lived assets in the three months ended September 30, 2024, compared to no such expense in the same period of 2023 [131]. - Total operating expenses increased to $71.8 million for the three months ended September 30, 2024, up 14% from $63.0 million in the same period of 2023 [125]. - Interest and other income, net, increased to $6.7 million for the three months ended September 30, 2024, an increase of 8% from $6.2 million in the same period of 2023 [132]. - For the nine months ended September 30, 2024, total operating expenses were $212.7 million, a decrease of 12% from $242.7 million in the same period of 2023 [136]. - The net loss for the three months ended September 30, 2024, was $66.3 million, a 6% increase from a net loss of $62.3 million in the same period of 2023 [125]. - Research and development expenses decreased by $40.9 million to $147.3 million for the nine months ended September 30, 2024, compared to $188.3 million for the same period in 2023, primarily due to a $28.3 million reduction in personnel-related costs [138]. - General and administrative expenses were $49.7 million for the nine months ended September 30, 2024, down from $54.4 million in 2023, reflecting a decrease of $4.8 million mainly from personnel-related costs [139]. - Total impairment charges recognized during the nine months ended September 30, 2024, amounted to $15.7 million, with no such expense recorded in the same period of 2023 [140]. - Interest and other income increased by $5.1 million to $17.1 million for the nine months ended September 30, 2024, compared to $12.0 million in 2023, driven by higher yields on cash and investments [141]. - Cash used in operating activities was $163.6 million for the nine months ended September 30, 2024, an improvement from $184.0 million in 2023 [146]. - Net cash provided by investing activities was $20.8 million for the nine months ended September 30, 2024, compared to $95.8 million in 2023, reflecting a decrease in cash provided by investment maturities [149][150]. - Cash provided by financing activities increased to $110.9 million for the nine months ended September 30, 2024, from $95.5 million in 2023, primarily due to net proceeds from the issuance of common stock [151]. - The company sold 250,000 shares of common stock in ATM offerings during the nine months ended September 30, 2024, resulting in net proceeds of $1.0 million [144]. - As of September 30, 2024, the company had $403.4 million in cash and cash equivalents, sufficient to fund operations for at least the next 12 months [144]. - The company has non-cancellable purchase commitments of $2.3 million as of September 30, 2024, related to agreements with third-party contract manufacturers [153]. Internal Controls and Accounting - The company identified a material weakness in internal controls over financial reporting related to the technical accounting analysis of significant non-routine transactions [164]. - Remediation efforts for the identified material weakness are ongoing, with the engagement of third-party subject matter experts [164]. - Management concluded that the disclosure controls and procedures were not effective at a reasonable assurance level as of September 30, 2024 [163]. - There have been no new accounting pronouncements expected to materially impact the financial statements [158]. - The company does not utilize forward exchange contracts due to the uncertain timing of expected payments in foreign currencies [161]. - No significant changes in critical accounting policies and estimates have occurred compared to the previous annual report [157]. - The company believes that historical fluctuations in interest income have not been significant [160]. - A 10% change in interest rates would not have had a material effect on the fair market value of the company's cash equivalents and available-for-sale securities [160].