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 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company accelerating potential high-impact therapies in autoimmune diseases and cancer, reported an update on recent and anticipated business highlights and announced its financial results for the third quarter ended September 30, 2025.

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"Cullinan is strategically focusing resources and development efforts on select, high-conviction clinical stage programs. We are well-positioned to further concentrate resources on CLN-978, a CD19xCD3 bispecific T cell engager, and we plan to share initial clinical data in autoimmune diseases in the first half of 2026. We are also particularly encouraged by the emerging efficacy profile of CLN-049, our FLT3xCD3 bispecific T cell engager, and we look forward to unveiling important clinical data in an oral presentation at the upcoming 2025 ASH (Free ASH Whitepaper) Annual Meeting in December. We believe the differentiated mechanism of CLN-049 supports its potential to address a broad population of AML patients regardless of mutational status, including those with poor prognostic features," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.

"Additionally, following a positive pre-NDA meeting with the FDA in October, our partner Taiho plans to initiate a rolling submission of an NDA for zipalertinib in relapsed EGFR ex20ins NSCLC by year-end and expects to complete enrollment of the frontline study REZILIENT3 in the first half of 2026. Finally, after reviewing emerging clinical data, we have decided not to pursue further development of CLN-619 and CLN-617. Notably, our core pipeline is now focused on T cell engagers applied to well-validated targets with transformative potential in immunology and oncology. This focused pipeline extends our cash runway into 2029 and provides us ample financial resources to deliver meaningful value-driving catalysts across our programs in 2026 and beyond."

Portfolio Highlights

Immunology

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CLN-978 (CD19xCD3 bispecific T cell engager): Systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren’s disease (SjD).
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The Phase 1 OUTRACE Program is enrolling and treating patients across the OUTRACE SLE, OUTRACE RA and OUTRACE SjD Studies. The Company plans to share initial safety and B cell depletion data in SLE and RA in the first half of 2026.
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The Company was issued a key composition of matter patent by the United States Patent and Trademark Office, which is expected to extend patent protection until at least 2042, excluding possible patent term extension.
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Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
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Genrix Bio, from whom Cullinan licensed velinotamig in June 2025, plans to initiate a Phase 1 study in China in patients with autoimmune diseases by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
Oncology

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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
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Following a positive Type B pre-NDA meeting with the U.S. Food and Drug Administration in October, Taiho plans to initiate a rolling submission of an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026.
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The Company shared updated efficacy and safety data demonstrating responses in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC.
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Taiho shared initial data from the REZILIENT2 cohort demonstrating the clinical activity of zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC.
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Taiho also shared initial data from the REZILIENT2 cohort demonstrating intracranial responses with zipalertinib in patients with active brain metastases at the ESMO (Free ESMO Whitepaper) Congress 2025.

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CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
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Enrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS. The Company recently shared clinical data in a published ASH (Free ASH Whitepaper) abstract and updated results will be shared in an oral presentation at the 2025 ASH (Free ASH Whitepaper) Annual Meeting on December 8, 2025. CLN-049 demonstrated promising anti-leukemic activity, including a ~30% CRc rate at clinically active target doses, in a heavily pretreated population of patients, regardless of FLT3 mutational status.
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Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.
Third Quarter 2025 Financial Results

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Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $475.5 million as of September 30, 2025. Cullinan expects its cash resources to provide runway into 2029 under its new operating plan.
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R&D Expenses: Research and development expenses were $42.0 million for the third quarter of 2025, compared to $35.5 million for the same period in 2024.
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G&A Expenses: General and administrative expenses were $13.6 million for the third quarter of 2025, compared to $13.3 million for the same period in 2024.
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Net Loss: Net loss attributable to Cullinan was $50.6 million for the third quarter of 2025, compared to $40.6 million for the same period in 2024.

(Press release, Cullinan Oncology, NOV 6, 2025, View Source [SID1234659564])

On November 6, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that Eric Risser, President and CEO of MacroGenics, will participate in a fireside chat at the Stifel 2025 Healthcare Conference on Thursday, November 13, 2025, at 4:00 pm ET in New York, NY.

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A webcast of the presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of the webcast on its website for 30 days.

(Press release, MacroGenics, NOV 6, 2025, View Source [SID1234659580])

On November 6, 2025 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported third quarter 2025 results and provided a corporate update.

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"In September, we announced results from our Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). While we did not meet the primary endpoint, efzofitimod is the first investigational therapy to exhibit improvements in quality of life across multiple disease-related health outcomes while also reducing steroid burden in patients with pulmonary sarcoidosis," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "Treatment options for pulmonary sarcoidosis are limited and can include a significant reliance on the use of oral corticosteroids, which often have significant side effects. There remains an urgent need for a new safe and effective treatment for patients with chronic, symptomatic disease."

"Based on the findings from EFZO-FIT, we believe there is drug activity for efzofitimod as evidenced by improvements across multiple clinically relevant efficacy measures. Based on this, coupled with the ongoing high unmet medical need in pulmonary sarcoidosis, we plan to meet with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026 to review the results of the study and determine the path forward for efzofitimod in pulmonary sarcoidosis. We plan to provide an update regarding the next steps for the program following that meeting."

Third Quarter 2025 and Subsequent Period Highlights

Reported results from the global Phase 3 EFZO-FIT study to evaluate the efficacy and safety of 3.0 mg/kg and 5.0 mg/kg of efzofitimod or placebo in 268 patients with pulmonary sarcoidosis. The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48. Clinical benefit for 5.0 mg/kg efzofitimod was observed across multiple pre-specified study efficacy parameters at week 48 compared to placebo, including the King’s Sarcoidosis Questionnaire (KSQ)-Lung score, KSQ-General Health score, Fatigue Assessment Scale, and complete steroid withdrawal and improvement in KSQ-Lung score. Additionally, treatment with efzofitimod maintained lung function as a measure of forced vital capacity and was well-tolerated with a safety profile consistent with prior trials conducted to date. Based on these findings, the Company plans to meet with the FDA in the first quarter of 2026 to review the results and determine the path forward for efzofitimod in pulmonary sarcoidosis.
Presented the results from the Phase 3 EFZO-FIT study in a late-breaking oral abstract at the European Respiratory Society Congress 2025, which took place September 27 – October 1, 2025, in Amsterdam, Netherlands. Daniel Culver, D.O., Chair of the Department of Pulmonary Medicine at the Cleveland Clinic and principal investigator of the study, delivered the presentation, titled "EFZO-FIT: The Largest Ever Interventional Trial in Pulmonary Sarcoidosis."
Enrollment is progressing in the Phase 2 EFZO-CONNECT study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Promising interim data from the study were reported in the second quarter of 2025, and the Company expects to complete enrollment in the study in the first half of 2026.
Presented at the Federation of European Biochemical Societies (FEBS) Special Meeting, "Expanding frontiers in aminoacyl-tRNA synthetase research," which took place September 28 – October 3, 2025, in Dubrovnik, Croatia. Leslie Nangle, Ph.D., Vice President of Research at aTyr, delivered a presentation titled, "Advancing a therapeutic platform based on tRNA synthetases for treatment of fibrotic lung diseases."
Third Quarter 2025 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of September 30, 2025, were $92.9 million.
R&D Expenses: Research and development expenses were $22.1 million for the third quarter 2025, which consisted primarily of clinical trial costs for the Phase 3 EFZO-FIT and Phase 2 EFZO-CONNECT studies, manufacturing costs for a potential Biologics License Application (BLA) filing and commercial supply for the efzofitimod program, and research and development costs for the efzofitimod and discovery programs.
G&A Expenses: General and administrative expenses were $4.8 million for the third quarter 2025.
About Efzofitimod

Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. In addition to the global Phase 3 EFZO-FIT study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD, efzofitimod is also being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

(Press release, aTyr Pharma, NOV 6, 2025, View Source [SID1234659608])

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])