On August 6, 2025 NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, reported that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the 13th Annual Immuno-Oncology Summit (the "Summit") to be held in Philadelphia, PA, from August 11 – 13, 2025 (Press release, NKMax America, AUG 6, 2025, View Source [SID1234654868]).

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The Summit is a leading global event in cancer immunotherapy. Organized by Cambridge Healthtech Institute, the summit brings together top experts from industry and academia to explore the latest advances in cell therapies, innate immunity, bispecifics, and translational strategies. With multiple scientific tracks, high-impact presentations, and collaborative discussions, it serves as a premier forum for driving innovation and progress in the immuno-oncology field.

Presentation Details:

Title: Allogeneic Enhanced Natural Killer Cells without Lymphodepletion in Solid Tumors

Conference Track: Innate Immunity

Date and Time: Wednesday, August 13, 2025; 2:50 PM ET

Dr. Song’s presentation will focus on the pivotal role of natural killer (NK) cells as primary effector cells in the innate immune response against cancer. Traditional allogeneic donor-derived therapies often require lymphodepletion to prevent immunologic rejection, a process that can compromise combination strategies aimed at enhancing T cell activity. Dr. Song will present scientific data and early clinical findings on NKGen’s allogeneic NK cell therapy, SNK02, which is being evaluated in solid tumors without the need for lymphodepletion.

Previously disclosed Phase 1 data for SNK02 in solid tumors, which may not be included in this presentation, is available on the Scientific Publications page of the NKGen website under the "SNK02 Allogeneic" section.

On August 6, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its Birelentinib (DZD8586) for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor (Press release, Dizal Pharma, AUG 6, 2025, View Source [SID1234654887]).

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Patients with CLL/SLL treated with a BTK inhibitor or a BCL-2 inhibitor often relapse or progress due to two major resistance mechanisms: BTK C481X mutations and BTK-independent activation of BCR signaling pathway. No targeted therapy currently addresses both mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging anti-tumor activity in early CLL/SLL clinical studies, mutation-mediated resistance has already been reported, and degrader-associated toxicities may limit their long-term clinical application.

Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration. It has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting both BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-cell non-Hodgkin lymphomas (B-NHLs).

The Fast Track Designation is supported by data from a pooled analysis of two phase I/II studies of birelentinib in CLL/SLL patients previously treated with covalent/non-covalent BTK inhibitors and BTK degraders. The results were presented at 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and featured in oral presentations at both the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 18th International Conference on Malignant Lymphoma (ICML).

Birelentinib demonstrated significant anti-tumor efficacy in heavily pretreated CLL/SLL patients with an objective response rate (ORR) of 84.2%, with a good safety profile. Tumor responses were observed irrespective of prior treatment with covalent/non-covalent BTK inhibitors, BTK degraders, or BCL-2 inhibitors, including in patients harboring classic BTK resistance mutations (C481X) as well as other BTK mutations, such as kinase-dead mutations. Responses were durable, with an estimated 9-month duration of response (DOR) rate of 83.3%.

"The granting of Fast Track Designation underscores the U.S. FDA’s recognition of birelentinib’s potential to address an unmet medical need in patients with CLL/SLL," said Dr. Xiaolin Zhang, CEO of Dizal. "We look forward to working closely with the FDA to accelerate the global clinical development of birelentinib and bring this treatment option to patients as quickly as possible."

Fast Track Designation is an FDA program designed to facilitate the development and expedite the review of drugs for serious conditions that address unmet medical needs. The designation enables for frequent FDA interactions and may allow for rolling revie, priority review, or accelerated approval if criteria are met.

About Birelentinib (DZD8586)

Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

Birelentinib has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. In clinical studies, birelentinib exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

In August 2025, birelentinib was granted Fast Track Designation by the U.S. FDA for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

On August 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 second quarter 2025 (Press release, Aligos Therapeutics, AUG 6, 2025, View Source [SID1234654853]).

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"Initiation of the Phase 2 B-SUPREME study of ALG-000184 is well underway with regulatory approvals across a number of countries, including the US, China, Canada, Taiwan, UK, New Zealand, and Moldova," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "Site activations are in progress, subjects are being screened, and we expect dosing to commence in the coming weeks. This pertinent study is the next step in our journey to potentially deliver better therapies for patients living with HBV infection and create value for our stakeholders. The Phase 1 data showcasing 96 weeks of treatment presented at the EASL meeting suggests that ALG-000184 has the potential to replace standard of care treatment for chronic suppression of HBV infection and may become the backbone of treatments aimed at a functional cure. We remain excited about the potential of ALG-000184 and the entirety of our pipeline, including ALG-055009 which remains in discussions with potential partners."

Recent Business Progress

Pipeline Updates

ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

The Phase 2 B-SUPREME study (NCT04746183) of ALG-000184 in subjects with chronic HBV infection recently began obtaining regulatory approvals, activating global sites, and screening subjects. Dosing is expected to commence in the coming weeks.
The study is designed as a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of ALG-000184 monotherapy compared with tenofovir disoproxil fumarate in approximately 200 untreated HBeAg+ and HBeAg- adult subjects with chronic HBV infection for 48 weeks. The primary endpoint in the HBeAg+ part will be HBV DNA 96-week dosing recently completed in the Phase 1 study and data readouts, including post-treatment data, are planned for scientific conferences this year. Interim data from up to 96 weeks following an oral daily dose of 300 mg ALG-000184 in both HBeAg+ and HBeAg- subjects with chronic HBV infection were presented at the European Association for the Study of the Liver (EASL) Congress 2025.
ALG-000184 administered for up to 96 weeks was well tolerated by study participants, exhibited a favorable PK profile, and suggested potentially best-in-class antiviral activity.
In HBeAg+ subjects with a very high mean HBV DNA level of 8.0 log10 IU/mL at baseline, all experienced profound and persistent HBV DNA reductions after receiving an oral daily dose of 300 mg ALG-000184 monotherapy. At Week 48, 6 of 10 subjects (60%) achieved HBV DNA < LLOQ (10 IU/mL, target detected or target not detected). With treatment extension, this rate increased to 9 of 9 subjects (100%) at Week 96. Additionally, HBV DNA level continuously declined to < LLOQ (10 IU/mL, target not detected) in 5 of 9 subjects at Week 96.
In HBeAg- subjects, all 11 (100%) had rapid decline in HBV DNA levels and achieved sustained HBV DNA suppression (HBV DNA < LLOQ (10 IU/mL, target detected or target not detected)) by Week 24. The HBV DNA suppression level was maintained in the ALG-000184 monotherapy cohort for up to 96 weeks, with further decline in HBV DNA to < LLOQ (10 IU/mL, target not detected), observed in all subjects (8/8) at Week 96.
Multi-log10 reductions in HBsAg, HBeAg, and HBcrAg were observed in HBeAg+ subjects, and HBcrAg decline was observed in HBeAg- subjects.
In both patient populations in this study, ALG-000184 was well tolerated with no viral breakthrough observed and no known CAM resistant mutations identified with monotherapy treatment.
ALG-055009: Potential best-in-class small molecule THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH)

The Phase 2a HERALD data were presented at EASL 2025, demonstrating that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at week 12 as measured by MRI-PDFF.
Additionally, new data demonstrated substantial, dose-dependent reductions in liver fat were observed across all key subgroups with 12 weeks of once daily ALG-055009 treatment. Statistically significant improvements in atherogenic lipids were achieved with 12 weeks of ALG-055009 treatment. Reductions in lipids/lipoproteins were observed even in the context of stable GLP-1 agonist or statin use. This data suggests a potential added benefit of ALG-055009 for patients at risk for cardiovascular disease in addition to the previously reported liver fat lowering properties in a MASLD/MASH population.
As shared previously, ALG-055009 demonstrated a favorable tolerability profile with no evidence of clinical hyper/hypothyroidism. Incidence of gastrointestinal-related treatment emergent adverse events were similar in ALG-055009 dose groups compared to placebo. Specifically, similar rates of diarrhea were observed in ALG-055009 dose groups compared to placebo, with no dose-response. Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B, were also observed (Loomba et al, AASLD 2024).
The company is continuing to evaluate a variety of options to fund continued development, including potential out-licensing.
ALG-097558: Potential best-in-class ritonavir-free small molecule pan-coronavirus protease inhibitor

The AGILE platform study (NCT04746183) assessing ALG-097558 monotherapy or in combination with remdesivir in high-risk subjects with COVID-19 began in 2024.
The NIAID is sponsoring a drug-drug interaction and relative bioavailability study of ALG-097558 in healthy volunteers that began dosing in the second quarter of 2025.
The company expects any future development of ALG-097558 to be funded by external sources.
Financial Results for the Second Quarter 2025

Cash, cash equivalents and investments totaled $122.9 million as of June 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 second half of 2026.

Net loss for the three months ended June 30, 2025 was $15.9 million or basic and diluted net loss per common share of $(1.53), compared to net income of $5.1 million or basic and diluted net income per common share of $0.81 for the three months ended June 30, 2024.

Research and development (R&D) expenses for the three months ended June 30, 2025 were $14.0 million, compared with $21.1 million for the same period of 2024. The decrease was primarily due to a decrease in third-party expenses due to reduced clinical study costs as a result of the completion of the MASH Phase 2a clinical trial, partially offset by increased spend in the chronic HBV infection program. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2025 was $0.6 million, compared with $1.2 million for the same period of 2024.

General and administrative (G&A) expenses for the three months ended June 30, 2025 were $5.6 million, compared with $6.4 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third-party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2025 was $0.5 million, compared with $0.9 million for the same period of 2024.

Interest and other income, net, was income of $1.2 million each for the three months ended June 30, 2025 and June 30, 2024.

Change in fair value of 2023 common warrants for the three months ended June 30, 2025 was income of $1.7 million compared with income of $30.4 million for the same period of 2024.

On August 6, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported financial results for the three months ended June 30, 2025 (Press release, Purple Biotech, AUG 6, 2025, View Source [SID1234654869]).

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"Our CAPTN-3 tri-specific antibody platform is differentiated not only by its masked CD3 arm for conditional T cell activation, but also by the addition of an NKG2A arm for additional T cell and NK cell activation, and a third arm targeting the tumor-associated antigen. This approach is supported by other masked TCEs showing early safety and efficacy signals," stated Purple Biotech CEO Gil Efron. "We are focusing our activities on advancing IM1240, our first CAPTN-3 antibody, through IND-enabling studies, with the goal of initiating a Phase 1 study in 2026. Additionally, we have now established a clear path forward for CM24 for its Phase 2b study, utilizing the predictive biomarkers we observed in the Phase 2 trial, and we are seeking partners or investment to support this next study."

Recent Clinical and Corporate Highlights:

CAPTN-3 Tri-Specific Antibody Platform

● Showcased comprehensive in vivo and ex vivo data at EACR 2025, highlighting the synergistic activity of the platform’s masked CD3, NKG2A, and tumor-associated antigen arms

● Platform was spotlighted by Dr. Amir Horowitz at ASGCT (Free ASGCT Whitepaper) 2025 for its approach to targeting the HLA-E/NKG2A axis to selectively activate NK and CD8+ T cells, potentially addressing treatment resistance

● First investigational new drug (IND) application from the CAPTN-3 platform, for IM1240 capped-CD3x5T4xNKG2A antibody, is expected to be submitted in 2026

CM24 (α-CEACAM1 monoclonal antibody)

● Final Phase 2 data for CM24 study presented at AACR (Free AACR Whitepaper) Annual Meeting 2025

● Statistically significant efficacy in biomarker subgroup analyses was observed:

● 78% reduction in risk of death and 81% reduction in risk of progression or death in patients with defined pretreatment ranges of serum or tumor CEACAM1 and 37.5% objective response rate (ORR) in this subgroup compared to 0% in the respective control group.

● 61% reduction in risk of death and 72% reduction in risk of progression or death in patients with defined pretreatment ranges of serum CEACAM1 or myeloperoxidase (MPO) and 31% ORR in this subgroup compared to 0% in the respective control group.

● 90% reduction in risk of death and 81% reduction in risk of progression or death in high tumor CEACAM1 and low PD-L1 combined positive score (CPS) subgroup

● The biomarkers identified in the CM24 Phase 2 study are planned to be used for patient selection in the Phase 2b study

NT219 (IRS1/2 degrader and STAT3 blocker)

● Biomarker insights from the Phase 1 study were presented at AACR (Free AACR Whitepaper) Annual Meeting 2025

● Initiated NT219 Phase 2 study in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) to evaluate NT219 in combination with pembrolizumab (Keytruda) or cetuximab (Erbitux)

● Phase 2 study is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program, and Principal Investigator Dr. Alice Weaver, at the University of Colorado Anschutz Medical Campus.

Financial Results for the Three Months Ended June 30, 2025

Research and Development Expenses were $0.6 million for the three months ended June 30, 2025, reflecting a decrease of $1.8 million, or 76.9%, from $2.4 million in the same period of 2024. The decrease was primarily due to reduced costs associated with the CM24 Phase 2 study.

General and Administrative Expenses were $0.7 million for the three months ended June 30, 2025, compared to $1.1 million in the same period of 2024, representing a decrease of $0.4 million, or 36.0%, mainly due to a $0.2 million decrease in a non-cash expense and $0.2 million reduction in cash and non-cash salaries and related expenses.

Operating Loss was $1.2 million for the three months ended June 30, 2025, a decrease of $2.2 million, or 64.3%, compared to $3.5 million in the same period of 2024, mainly due to the decrease in the CM24 Phase 2 study expenses.

Adjusted Operating Loss (as reconciled below) was $1.2 million for the three months ended June 30, 2025, a decrease of $2.0 million, compared to $3.2 million in the same period of 2024, primarily due to the decrease in the CM24 Phase 2 study expenses.

Finance Income, net was $0.1 million for the three months ended June 30, 2025, compared to $1.0 million in the same period of 2024, representing a decrease of $0.9 million, primarily attributable to a decrease in non-cash gain resulting from the revaluation of outstanding warrants.

Net Loss was $1.1 million, or $0.40 per basic and diluted ADS for the three months ended June 30, 2025, compared to a net loss of $2.4 million, or $1.80 per basic and diluted ADS, in the same period of 2024. The decrease in net loss was mainly due to the $2.2 million decrease in operating expenses and $0.9 million decrease in finance income, net.

As of June 30, 2025, Purple Biotech had cash and cash equivalents and short-term deposits of $5.6 million. The Company cash runway is expected into the third quarter of 2026.

On August 6, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported a new study in Communications Medicine, a Nature portfolio journal, demonstrating that Caris’ AI-based image analysis model has the potential to more accurately predict cancer biomarkers and patient survival than the conventional companion diagnostic (CDx) methods (Press release, Caris Life Sciences, AUG 6, 2025, View Source [SID1234654888]). By analyzing hematoxylin and eosin (H&E) images, the study demonstrated that Caris’ AI model can improve the assessment of critical cancer biomarkers and impact patient survival outcomes in breast and colorectal cancers.

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For this study, Caris’ AI model analyzed data from over 35,000 patients in the Caris clinico-genomic database. In breast cancer, the AI model scored PD-L1 positive phenotype status using an H&E image alone and assessed overall survival of patients treated with pembrolizumab, achieving a hazard ratio (HR) for overall survival of 0.511 (p<0.001), compared to an HR of 0.882 (p>0.1) for traditionally scored PD-L1 IHCs, a result consistent with an almost doubling of overall survival for patients treated with pembrolizumab. In colorectal cancer, AI predicted mismatch repair deficiency (MMRd) and microsatellite instability (MSI) equivalent to traditional scoring.

"Traditional PD-L1 testing can undercall positive cases, especially near the 1% threshold," said Matthew Oberley, MD, PhD, SVP, Chief Clinical Officer and Pathologist-in-Chief at Caris. "Caris’ AI model enhances predictive accuracy, integrating features from both staining methods, and exhibits superior prognostic precision compared to current biomarker assessments. Clinical adoption of this tool could improve the precision and efficiency of cancer patient evaluation and aid clinical decision making."

"This study highlights how AI can significantly improve the accuracy and efficiency of tissue sample evaluation, and down the line, this has the potential to guide immunotherapy decisions and enhance patient outcomes," said George W. Sledge, Jr., MD, Caris EVP and Chief Medical Officer.

The publication can be viewed in its entirety on the Caris Life Sciences website.