On November 6, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended September 30, 2025. The Company continues to advance a portfolio that seeks to redefine access to cell therapy, bringing the power of CAR T earlier in disease, more reliably, and across a broader range of treatment settings.

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"With our unique allogeneic approach to CAR T, the field has the ability to shift from highly personalized, patient-specific therapies to a new era of readily available, off-the-shelf treatments that can reach more patients earlier in their disease and wherever they receive care," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Having treated hundreds of patients, we’ve gained valuable insight into how ex vivo manufacturing enables more precise definition and control of our cell products before they reach patients, enhancing consistency, safety, and quality. This transformation is evident and goes far beyond incremental progress, it begins to establish a scalable allogeneic CAR T paradigm built to reach more patients, expand into broader care settings, and unlock the full potential of cell therapy."

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The pivotal Phase 2 ALPHA3 trial with cema-cel is pioneering the use of allogeneic CAR T therapy in earlier-line treatment of LBCL, an approach that could expand access for patients before disease progression and simplify delivery across community and academic centers. By leveraging minimal residual disease (MRD) as a guide for treatment intervention, a rapidly emerging focus across oncology, the ALPHA3 trial aims to position Allogene at the forefront of a transformative shift toward earlier, more precise, treatment. More than 50 clinical sites are active across the United States and Canada, spanning both community cancer centers and leading academic institutions. Additional sites in Australia and South Korea are progressing toward activation and are expected to open in early 2026.

The next milestone will be the futility analysis comparing MRD conversion between the two arms comparing cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation, expected in the first half of 2026. At that time, the Company plans to share MRD conversion rates from the randomized portion of the study.

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID
The Phase 1 RESOLUTION trial with ALLO-329, a dual CD19/CD70 CAR incorporating Dagger technology, is enrolling in a basket trial across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. In this dose-escalation study, two treatment regimens are being explored: one with reduced intensity cyclophosphamide-only lymphodepletion, and the other with no lymphodepletion at all, a potential breakthrough for improving tolerability and enabling treatment in a broader patient population.

With its built-in lymphodepletion coming from the Dagger technology as well as its ability to target both B cells and activated T cells, key drivers of autoimmune pathology, ALLO-329 represents one of the first to investigate how allogeneic CAR T could be uniquely suited to treat autoimmune disease at scale, with reduced or without lymphodepletion to facilitate a broader CAR T adoption in autoimmune indications. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 remains the only allogeneic CAR T therapy to show clinically significant response rates and meaningful durability of response in a metastatic solid tumor. The TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, evaluating ALLO-316 in heavily pretreated patients. Updated data presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrated early signs of efficacy and tolerability.

2025 Third Quarter Financial Results

Research and development expenses were $31.2 million for the third quarter of 2025, which includes $2.8 million of non-cash stock-based compensation expense.
General and administrative expenses were $13.7 million for the third quarter of 2025, which includes $5.9 million of non-cash stock-based compensation expense.
Net loss for the third quarter of 2025 was $41.4 million, or $0.19 per share, including non-cash stock-based compensation expense of $8.7 million.
The Company had $277.1 million in cash, cash equivalents, and investments as of September 30, 2025.
The Company continues to expect its cash runway to extend into the second half of 2027. Guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately $150 million. GAAP Operating Expenses are expected to be approximately $230 million, including estimated non-cash stock-based compensation expense of approximately $45 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, NOV 6, 2025, View Source [SID1234659551])

On November 6, 2025 Alkermes plc (Nasdaq: ALKS) reported that management will participate in two upcoming investor conferences.

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Stifel 2025 Healthcare Conference
Date/Time: Thursday, Nov. 13, 2025 at 2:40 p.m. ET (7:40 p.m. GMT)

Jefferies Global Healthcare Conference in London
Date/Time: Wednesday, Nov. 19, 2025 at 11:30 a.m. ET (4:30 p.m. GMT)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

(Press release, Alkermes, NOV 6, 2025, View Source [SID1234659550])

On November 6, 2025 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported recent business progress and financial results for the third quarter 2025.

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"Our Phase 2 B-SUPREME study of pevifoscorvir sodium (pevy) is enrolling nicely, with subjects dosed across a number of countries, including the U.S., China, Hong Kong, and Canada," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "We are pleased with the progress to date and look forward to interim readouts in 2026. Importantly, we look forward to sharing additional pevy data next week at AASLD’s The Liver Meeting. We maintain our enthusiasm regarding the potential for pevy as well as our entire development pipeline, including ALG-055009, which is in continued discussions with potential partners for obesity and MASH."

Recent Business Progress

Pipeline Updates

Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

The Phase 2 B-SUPREME study (NCT06963710) of pevifoscorvir sodium in subjects with chronic HBV infection dosed its first patient in August 2025.
The study is designed as a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of pevifoscorvir sodium monotherapy compared with tenofovir disoproxil fumarate in approximately 200 untreated HBeAg+ or HBeAg- adult subjects with chronic HBV infection for 48 weeks. The primary endpoint in the HBeAg+ subjects is HBV DNA 96-weeks of dosing have been completed in the Phase 1 study (NCT04536337) and data readouts, including post-treatment data, will be presented at The Liver Meeting 2025 in November 2025.
Eight abstracts were accepted for presentation (four for pevifoscorvir sodium), including one oral presentation on the Phase 1 monotherapy study of pevifoscorvir sodium.
ALG-055009: Potential best-in-class small molecule THR-β for obesity, MASH

THR-β agonists under investigation from other companies have demonstrated significant enhancement in weight loss when administered in combination with incretin receptor agonists (RAs) for the treatment of obesity. Recently generated preclinical data combining ALG-055009 with incretin RAs in a diet-induced obese (DIO) mouse model exhibited profound synergistic effects in body weight loss when used in combination with semaglutide or tirzepatide. The combination therapy also demonstrated enhanced antihyperlipidemic effects as compared to monotherapy. These data are expected to be presented at a future scientific conference.
Evaluation of a variety of options to fund continued development, including potential out-licensing is ongoing.
Financial Results for the Third Quarter 2025

Cash, cash equivalents and investments totaled $99.1 million as of September 30, 2025, compared with $56.9 million as of December 31, 2024. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the third quarter of 2026.

Net loss for the three months ended September 30, 2025 was $31.5 million or basic and diluted net loss per common share of $(3.04), compared to net loss of $19.3 million or basic and diluted net loss per common share of $(3.07) for the three months ended September 30, 2024.

Research and development (R&D) expenses for the three months ended September 30, 2025 were $23.9 million, compared with $16.8 million for the same period of 2024. The increase was primarily due to an increase in third-party expenses for the pevifoscorvir sodium Phase 2a clinical trial. Total R&D stock-based compensation expense incurred for the three months ended September 30, 2025 was $0.8 million, compared with $1.2 million for the same period of 2024.

General and administrative (G&A) expenses for the three months ended September 30, 2025 were $5.2 million, compared with $4.6 million for the same period of 2024. The increase in G&A expenses for this comparative period is primarily due to an increase in legal and other related expenses. Total G&A stock-based compensation expense incurred for the three months ended September 30, 2025 was $0.7 million, compared with $0.9 million for the same period of 2024.

Interest and other income, net, was income of $1.1 million for each of the three months ended September 30, 2025 and September 30, 2024.

Change in fair value of 2023 common warrants for the three months ended September 30, 2025 was a loss of $4.2 million compared with a loss of $0.1 million for the same period of 2024.

(Press release, Aligos Therapeutics, NOV 6, 2025, View Source [SID1234659549])

On November 6, 2025 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported third quarter 2025 financial results and recent portfolio and business updates. As of September 30, 2025, Alector’s cash, cash equivalents, and investments totaled $291.1 million.

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"We are well-resourced to advance our portfolio of innovative drug candidates for the treatment of neurodegenerative diseases, with a sharpened focus on our differentiated Alector Brain Carrier (ABC) platform," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "ABC represents an important driver of innovation, with the versatility to deliver antibodies, enzymes and nucleic acid to the brain. Our ABC-enabled programs have demonstrated robust brain penetration through peripheral dosing, favorable safety, and good pharmacokinetics. We are advancing AL137, our ABC-enabled anti-amyloid beta antibody, AL050, our ABC-enabled GCase enzyme replacement therapy, and ADP064, our ABC-enabled Tau siRNA, toward IND-enabling studies, with IND submissions targeted in 2026 and 2027."

Dr. Rosenthal continued, "Additionally, together with GSK, we continue to advance the Phase 2 PROGRESS-AD trial for nivisnebart (AL101), an investigational monoclonal antibody being studied for the treatment of Alzheimer’s disease. We remain on track for an independent interim analysis planned for the first half of 2026."

Recent Program Updates

Alector Brain Carrier: Preclinical and Research Pipeline

A key pillar of Alector’s focus is its proprietary blood-brain barrier (BBB) technology platform, Alector Brain Carrier (ABC). Built on the core design principles of versatility, tunability, and differentiated binding to a distinct region of the transferrin receptor (TfR), ABC is intended to support the targeted delivery of therapeutics to the brain and to optimize safety and efficacy. The platform’s tunable TfR binding affinities allow adjustment of binding strength and drug configuration to align with the needs of diverse therapeutic cargos, including antibodies, enzymes, and siRNA, aiming to achieve efficient transport across the BBB with the goal of balancing brain uptake and safety.

AL137

Alector has selected lead candidate AL137 for its ABC-enabled anti-amyloid beta (Aβ) antibody in Alzheimer’s disease (AD) and is advancing it toward investigational new drug (IND)-enabling studies. The company is targeting an IND filing for AL137 in 2026.

AL137 is engineered for optimal brain uptake, potency, safety, and convenience. This candidate features a high-affinity, humanized antibody that selectively binds PyroGlu3, a validated epitope on the toxic form of Aβ found in plaques, a fully active effector function that enables maximal recruitment of myeloid cells to remove plaques, and Alector’s proprietary ABC with tuned affinity and binding epitope designed to facilitate brain penetration and plaque removal while minimizing hematologic adverse effects. In preclinical studies to date, AL137 has demonstrated robust brain penetration at low doses, supporting the potential for low dose, subcutaneous administration.
AL050

Alector has selected lead candidate AL050 for its ABC-enabled glucocerebrosidase (GCase) enzyme replacement therapy (ERT) in Parkinson’s disease (PD) and is advancing the candidate toward IND-enabling studies. The company is targeting submission of an IND application for AL050 in 2027.

AL050 is an ABC-enabled GCase ERT engineered to address the key challenges of enzyme replacement for the brain. It features an engineered GCase with improved activity and stability, a silenced effector function to maximize safety, and Alector’s tunable ABC with a TfR epitope and affinity designed to enhance delivery across the BBB. In preclinical studies to date, AL050 increased GCase activity in both rodents and NHPs and reduced toxic substrate accumulation in a rodent GBA disease model with no apparent hematologic findings, supporting its potential as a therapy for Parkinson’s disease and Lewy body dementia associated with GBA loss-of-function mutations.
ABC siRNA Platform

The company also continues to advance its ABC-enabled siRNA platform. The platform is designed for peripheral dosing, offering the potential for more convenient administration compared with traditional intrathecal or intracerebroventricular delivery, as well as homogeneous drug distribution throughout the brain. Current programs include Alector’s lead siRNA program, ADP064-ABC, an anti-tau siRNA for AD and other tauopathies, as well as ADP062-ABC, an alpha-synuclein siRNA for PD and eventually Lewy body dementia; and ADP065-ABC, an NLRP3 siRNA, for a range of neurodegenerative diseases.
Progranulin Programs (nivisnebart (AL101/GSK4527226) and latozinemab (AL001)) in Collaboration with GSK

Nivisnebart (AL101/GSK4527226)

The 76-week, global, randomized, double-blind, placebo-controlled PROGRESS-AD Phase 2 clinical trial of nivisnebart (AL101/GSK4527226) in early AD is ongoing, with enrollment completed in April 2025. An independent interim analysis is planned for the first half of 2026.

Nivisnebart is an investigational human monoclonal antibody (mAb) designed to block and internalize the sortilin receptor to elevate the concentrations of progranulin (PGRN) in the brain. It is distinct from latozinemab, with differentiated pharmacokinetic and pharmacodynamic properties that may make it suitable for the potential treatment of more prevalent neurodegenerative diseases.
Latozinemab

In October 2025, Alector and GSK announced topline results from the INFRONT-3 Phase 3 clinical trial of latozinemab for the potential treatment of frontotemporal dementia due to a GRN gene mutation (FTD-GRN). The study did not demonstrate clinical benefit. Based on these results, the open-label extension portion of the INFRONT-3 trial and the continuation study for latozinemab will be discontinued.
Corporate News

In October 2025, the company implemented a reduction in force of approximately 47% intended to focus the company’s resources on its highest-priority programs, to ensure continued progress across its portfolio, and extend cash runway through 2027.
Third Quarter 2025 Financial Results

Revenue. Collaboration revenue for the quarter ended September 30, 2025, was $3.3 million, compared to $15.3 million for the same period in 2024. The decrease was mainly due to the satisfaction of the performance obligation associated with the AL002 program and the latozinemab FTD-C9orf72 Phase 2 trial in the fourth quarter of 2024.

R&D Expenses. Total research and development expenses for the quarter ended September 30, 2025, were $29.4 million, compared to $48.0 million for the quarter ended September 30, 2024. The decrease was mainly due to a decrease in research and development expenses for the AL002 program as well as a decrease in personnel related costs as a result of the reductions in force.

G&A Expenses. Total general and administrative expenses for the quarter ended September 30, 2025, were $11.5 million, compared to $15.8 million for the quarter ended September 30, 2024. The decrease was mainly driven by the absence of impairment charges related to the right-of-use asset and leasehold improvements recognized in the third quarter of 2024. No comparable impairment occurred in the current period. Additionally, personnel-related costs declined as a result of the reductions in force.

Net Loss. For the quarter ended September 30, 2025, Alector reported a net loss of $34.7 million, or $0.34 per share, compared to a net loss of $42.2 million, or $0.43 net loss per share, for the same period in 2024.

Cash Position. Cash, cash equivalents, and investments were $291.1 million as of September 30, 2025. This includes approximately $14.7 million in net proceeds raised through the company’s at-the-market (ATM) equity offering in September. In October 2025, the company raised $5.3 million in ATM equity offerings. Management anticipates that its current cash position will be sufficient to fund Alector’s operations through 2027.

2025 Guidance. The company continues to anticipate collaboration revenue to be between $13 million and $18 million, total research and development expenses to be between $130 million and $140 million, and total general and administrative expenses to be between $55 million and $65 million.

(Press release, Alector, NOV 6, 2025, View Source [SID1234659548])

On November 6, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer reported it will present a poster on its proprietary VacDesignR computational tool at the upcoming ESMO (Free ESMO Whitepaper) AI & Digital Oncology 2025 conference, held in Berlin, Germany, from 12-14 November 2025.

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The presentation will highlight how VacDesignR streamlines the design and production of recombinant Modified Vaccinia Ankara (MVA)-based vectors, enabling faster and more reliable manufacturing of individualized neoantigen therapeutic vaccines (INTV).
The individualized immunotherapies developed through the myvac platform, currently being evaluated in a Phase I/II clinical trial (NCT04183166), are based on an MVA viral vector and their design already leverages the VacDesignR tool.

Developed in-house, VacDesignR is a computational design engine that optimizes recombinant plasmid architecture for MVA vectors, a core component of Transgene’s myvac platform. By minimizing unwanted homologous recombination and intelligently selecting peptide sequences for cassette assembly, VacDesignR significantly improves production reliability and vector quality.

Future iterations of VacDesignR will incorporate AI-based components to further improve performance and scalability, supporting Transgene’s strategy to accelerate production timelines for individualized therapeutic vaccines, including its lead candidate TG4050 designed to treat HPV-negative head and neck cancers following surgery and adjuvant therapy.

"Participating at the first edition of the ESMO (Free ESMO Whitepaper) AI & Digital Oncology meeting highlights Transgene’s pioneering role in combining viral vector-based individualized cancer vaccines with its vaccine design tool to optimize product performance and redefine the future of oncology treatment", commented Maurizio Ceppi, Chief Scientific Officer of Transgene.

Title of the abstract: "VacDesignR: a computational tool to optimize viral-based individualized neoantigen therapeutic vaccine production"

Title of the poster: "VacDesignR: a tool for optimizing recombinant poxvirus vaccine production"

Poster and Abstract number: 385P
Session: Drug development
Date: November 12, 2025
Author: B. Grellier
The poster presentation will take place on November 12 at ESMO (Free ESMO Whitepaper)-AI conference and will be available that day on Transgene’s website.

VacDesignR is a computer-assisted method protected through patent and patent applications derived from WO2021/130210.

(Press release, Transgene, NOV 6, 2025, View Source [SID1234659484])