On November 12, 2025 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, reported it will present leading-edge findings at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition happening Dec. 6-9 in Orlando and online.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Across 105 sessions, City of Hope experts will highlight advances in blood cancer research, cellular therapies and precision medicine.

The ASH (Free ASH Whitepaper) meeting is the world’s largest hematology gathering, attracting more than 30,000 hematology professionals globally.

"ASH is where the future of hematology takes shape," said Marcel van den Brink, M.D., Ph.D., City of Hope chief physician executive and president of City of Hope National Medical Center. "Our teams are proud to share discoveries that deepen scientific understanding and accelerate progress toward more effective, safer treatments for patients worldwide."

From innovative immunotherapies to strategies that improve transplant outcomes, City of Hope is leading progress in areas that matter most to patients.

ORAL ABSTRACT SESSIONS

Leukemia

Plenary 6: Results from paradigm – a phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia
Time: Sunday, Dec. 7, 3:45 p.m. EST
Senior Author: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

443: CD19-CAR T cell therapy as a definitive consolidation in older adults with b-ALL in CR1 is safe and induces durable MRD-remission
Time: Sunday, Dec. 7, 10:30 a.m. EST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Lymphoma

151: 3-year follow-up of the S1826 study confirms improved progression-free survival with nivolumab-AVD compared to brentuximab vedotin-AVD in advanced stage classic Hodgkin lymphoma
Time: Saturday, Dec. 6, noon EST
Presenter: Alex Herrera, M.D., City of Hope professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

268: BAFFR-CAR T cells (PMB-CT01) demonstrate durable responses and manageable toxicities in relapsed/refractory B-cell lymphomas with prior CD19-directed therapy failure or CD19-negative disease
Time: Saturday, Dec. 6, 2:45 p.m. EST
Presenter: Elizabeth Budde, M.D., Ph.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

883: Interim analysis of the phase II study of glofitamab, lenalidomide and venetoclax (GLOVe) in untreated patients w/ high-risk mantle cell lymphoma. Response and safety outcomes after the completion of stage 1 of 2 enrollment.
Time: Monday, Dec. 8 at 2:45 p.m. EST
Presenter: Tycel Phillips, M.D., associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

1013: CAR T cell therapy outcomes in adolescent and young adult patients with non-Hodgkin lymphoma
Time: Monday, Dec. 8, 5:30 p.m. EST
Presenter: Lindsey Murphy, M.D., M.S., City of Hope assistant professor, Department of Pediatrics

Myeloma

405: Safety and efficacy of out-of-specification ciltacabtagene autoleucel (cilta-cel) in relapsed/refractory multiple myeloma (RRMM)
Time: Saturday, Dec. 6, 4:30 p.m. EST
Presenter: Azra Borogovac, M.D., M.S., City of Hope assistant professor, Department of Hematology & Hematopoietic Cell Transplantation

Transplantation

376: Total marrow and lymphoid irradiation (TMLI) with fludarabine-melphalan (FM) conditioning for matched donor hematopoietic cell transplant (HCT) in older patients with relapsed/refractory (R/R) disease
Time: Saturday, Dec. 6, 4:45 p.m. EST
Presenter: Monzr M. Al Malki, M.D., City of Hope professor, Department of Hematology & Hematopoietic Cell Transplantation

276: First-in-human trial of allogeneic CD6-CAR tregs in patients with chronic graft-versus-host disease after allogeneic hematopoietic cell transplantation
Time: Saturday, Dec. 6, 3:15 p.m. EST
Presenter: Amandeep Salhotra, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

160: A TLR4-HSP70 efferocytic program in thymic macrophages sustains thymic homeostasis and T cell output
Time: Saturday, Dec. 6, 12:45 p.m. EST
Presenter: Andri Lemarquis, M.D., Ph.D., City of Hope staff scientist

CITY OF HOPE-LED EDUCATIONAL SESSIONS

14th Annual BMT & Cell Therapy Winter Workshop, co-chaired by Dr. Marcel van den Brink
Time: Friday, Dec. 5, 1:30 – 8 p.m. EST
Register for virtual attendance here.

Satellite Symposia fss25-93: Moving Forward in B-ALL: Insights on Modern and Emerging Standards With Off-the-Shelf Bispecific Antibodies
Time: Friday, Dec. 5, 7 a.m. EST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Scientific Workshop on State of the Art (ws25-58): Integrating Functional and Genomic Precision Medicine for Hematologic Malignancies
Time: Friday, Dec. 5, 3 p.m. EST
Chair: Pamela Becker, M.D., Ph.D., professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Scientific Workshop: Microbiome and Diet and Cancer Immunotherapy
Time: Friday, Dec. 5, 3:06 p.m. EST
Presenter: Marcel van den Brink, M.D., Ph.D., City of Hope chief physician executive

How I Treat: How I Incorporate Novel Therapies into Hodgkin Lymphoma Treatment: Frontline vs. Relapse
Time: Sunday, Dec. 7 at 8 a.m. EST
Presenter: Alex Herrera, M.D., City of Hope professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

Educational Spotlight: Measures to Minimize Infection Risk in Immunocompromised Patients after Cellular Therapies — How, for Whom, for How Long?
Time: Monday, Dec. 8, 4:30 p.m. EST
Presenter: Randy Taplitz, M.D., City of Hope professor, Department of Medicine

(Press release, City of Hope, NOV 12, 2025, View Source [SID1234659862])

On November 12, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the presentation of new data on MP0712, its lead Radio-DARPin targeting DLL3, at the Targeted Radiopharmaceuticals (TRP) Summit Europe, highlighting first encouraging human images and supporting mechanism of action data. MP0712 is being developed with strategic partner Orano Med for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. Molecular Partners presents an example case with images of a patient today as courtesy of the Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa. The NuMeRI team, led by Prof. Mike Sathekge, plans to report the full imaging and dosimetry data of MP0712 at the Theranostics World Congress (TWC) in January 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The images show targeted delivery of MP0712 into tumors and limited exposure in healthy organs of concern such as kidney and liver. This is an important milestone for MP0712, which is indicative of its potential performance in a clinical setting when carrying 212Pb as therapeutic radioactive payload and providing a strong basis for advancing its clinical development. We are continuing preparations for the upcoming Phase 1 trial with MP0712 and look forward to advancing additional Radio-DARPin programs in 2026," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

The presented case study of a patient who received 203Pb-MP0712 indicates specific uptake in the tumor lesions visible at 24 hours and sustained over 4 days, with limited accumulation in healthy organs, as intended. To promote tumor uptake via internalization over time, MP0712 is half-life engineered to maintain sufficient amounts of drug in the blood, visible at the early imaging time points. These early results are in line with previously presented pre-clinical data and further support the intended mechanism of action of MP0712.

203Pb and 212Pb are an element-equivalent pair of lead (Pb) isotopes, with 203Pb used for imaging and 212Pb for therapeutic applications (targeted alpha therapy, TAT). As a "matched pair", pre-treatment imaging with 203Pb provides a prediction of treatment behavior with 212Pb.

The imaged patient was initially diagnosed with Stage 3 small cell lung cancer and had a treatment history of radiotherapy and chemotherapy; the patient was then re-classified as Stage 4 post imaging with MP0712 due to observed liver metastases. This patient is a case example of a series of patients who received MP0712 for imaging use as part of a Named Patient Access Program under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). The Company believes that, due to the prior treatment and tumor stage of the patient, this case is illustrative of the patient population likely to be recruited in its planned Phase 1/2a in the US.

In addition to first-in-human images, the presentation at TRP highlights that MP0712 is rapidly internalized and accumulates intracellularly in DLL3-expressing cells in vitro. The data suggests that MP0712 can achieve high tumor uptake in spite of very low DLL3 expression levels, leveraging internalization and replenishment pathways of DLL3 as well as optimal binding properties and tunable half-life of the DLL3-binding DARPin.

The Phase 1 Investigational New Drug (IND) application for MP0712, for the treatment of small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers, has been filed. Dialogue with the FDA is ongoing and, pending regulatory clearance, the Phase 1 trial is expected to initiate by the end of 2025. The Phase 1/2a study is a multi-center study in the US, with the objectives to assess safety and determine a recommended phase 2 dose for MP0712 (labeled with 212Pb). The study contains an imaging and dosimetry step with 203Pb-labeled MP0712. The Company expects initial clinical data from the study in 2026.

Details of the presentation at TRP:

Title: Internalisation of Targeted Radiopharmaceuticals: Strategic Imperative or Situational Choice?
Presenter: Daniel Steiner, PhD, SVP of Technology and Research
Time: Wednesday November 12 at 1.30pm CET
Location: Amsterdam, Netherlands

Webcast to be held today at 10am ET (4pm CET):

In addition to the presentation at TRP, Molecular Partners will host a webcast today to discuss the new data, as well as the upcoming clinical trial of MP0712 in the US. Details as follows:

For Participants who want to listen and view slides: Please register here.
For Participants who may want to ask a question following the presentation: Please register here.

Participants who wish to ask a question will be provided with additional dial-in instructions to join the live conference call. These participants will have the ability to "raise their hand" and ask a verbal question during the Q&A.

About 212Pb-based Radio-DARPins
Molecular Partners’ Radio-DARPin platform is being developed to provide a unique and innovative delivery system for radioactive payloads, with exquisite targeting capabilities of DARPins combined with the optimally balanced safety and tumor killing of 212Pb. DARPins are ideal vectors for efficient delivery of therapeutic radionuclides to solid tumors, while overcoming some historic limitations of radioligand therapy approaches, thanks to their small size as well as high specificity and affinity. Molecular Partners and Orano Med are developing targeted alpha radio-therapeutics against up to ten targets, including the tumor-associated protein Delta-like ligand 3 (DLL3) and mesothelin (MSLN).

(Press release, Molecular Partners, NOV 12, 2025, View Source [SID1234659758])

On November 12, 2025 BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported Q3 2025 financial results alongside clinical and corporate milestones.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With over 700 patients treated, Plinabulin continues to demonstrate a favorable safety profile and meaningful potential as an immune-modulating therapy with unique mechanism of dendritic cell (DC) maturation and T cell priming," said Dr. Lan Huang, Co-Founder, Chair and Chief Executive Officer of BeyondSpring. "With DC bridging innate and adaptive immunity, Plinabulin offers new hope for patients with NSCLC and other cancers whose disease progresses after checkpoint inhibitors, presented at recent SITC (Free SITC Whitepaper) conference. In addition, results from our global Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine, showed that Plinabulin in combination with docetaxel achieved durable survival benefits and reduced chemotherapy-induced neutropenia, reinforcing its potential to advance the standard of care and drive long-term value creation."

Dr. Huang added, "At SEED, which we co-founded with Lilly five years ago, we are excited that our RBM39 molecular-glue degrader has received IND clearance from both the US FDA and China NMPA. It is such an honor to be the only target protein degradation company nominated by the Prix Galien Foundation, recognizing our commitment to developing transformative medicine for patients. We are also grateful for the support of our investors and collaborators, including Lilly and Eisai, and clinicians from leading US institutions, as we work together to advance molecular glue development to address undruggable targets for patients with unmet medical needs."

Key Milestones:

Two SITC (Free SITC Whitepaper) 2025 Presentations on Plinabulin Anti-cancer Clinical Benefit:
Resensitize NSCLC Patients Who Progressed on Prior PD-1/L1 Inhibitors with Disease Control Rate of 85% in Phase 2 Clinical Study: New data from a phase 2 investigator-initiated study (NCT05599789, Peking Union Hospital China) evaluating Plinabulin, docetaxel, and pembrolizumab in metastatic NSCLC patients who progressed on prior PD-1/L1 inhibitors (n=47), showed encouraging efficacy and safety data. The combination demonstrated median progression-free survival (PFS) of 7.0 months, confirmed objective response rate (ORR) of 18.2%, duration of response (DOR) of 7.2 months, disease control rate (DCR) of 85%, and 12-month overall survival (OS) rate at 79%, and 24-month OS rate at 66% (median OS not reached).
Resensitize Patients with Eight Cancer Types Who Failed Prior PD-1/L1 Inhibitors with Disease Control Rate of 54% through DC Maturation and M1 Macrophage Polarization via GEF-H1-dependent Mechanism in Phase 1 Clinical Study: This phase 1 investigator-initiated study (NCT04902040, MD Anderdon Cancer Center) shows that in addition to potent DC maturation for a systemic immune response, plinabulin combined with radiation and PD-1 inhibitor promotes proinflammatory monocytes and M1 macrophage polarization via a Plinabulin specific GEF-H1-dependent mechanism with the potential of overcoming acquired resistance to immune checkpoint inhibitors from pro-tumor macrophages.

SEED, Co-founded by BeyondSpring with 38% Equity Share, Secured Financial Position and Achieved IND Clearance: SEED completed its $30 million Series A-3 financing and received U.S. FDA and China NMPA clearance of its Investigational New Drug (IND) application for its lead RBM39 degrader program. SEED was also named a finalist for the 2025 Prix Galien USA "Best Start-Up" Award and co-hosted a targeted protein degradation symposium at NYU Grossman School of Medicine honoring Co-Founder and Nobel Laureate Prof. Avram Hershko, with leading thought leaders in the TPD field as presenters.
Third Quarter Financial Results1
Continuing operations:

Research and development (R&D) expenses were $1.0 million for the quarter ended September 30, 2025 compared to $0.6 million for the quarter ended September 30, 2024. The $0.4 million increase was primarily due to higher drug manufacturing expenses, higher professional service expenses in regulatory affairs and higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.
General and administrative (G&A) expenses were $0.8 million for the quarter ending September 30, 2025 compared to $1.7 million for the quarter ended September 30, 2024. The $0.9 million decrease was primarily due to lower professional service costs in consulting for business development and partnership initiatives, and lower salary expenses driven by decrease in administrative headcount.
Net loss: $1.7 million for the quarter ended September 2025, compared to $2.2 million for the quarter ended September 2024
Cash and cash equivalents: $12.5 million as of September 30, 2025, compared to $2.9 million as of December 2024
Discontinued operations:

Net loss: $3.2 million for the quarter ended September 2025, compared to $2.4 million for the quarter ended September 2024
Current assets: $11.4 million as of September 2025, compared to $25.3 million as of December 2024
Year to Date Financial Results1
Continuing Operations:

Research and development (R&D) expenses were $2.9 million for the nine months ended September 30, 2025 compared to $2.2 million for the nine months ended September 30, 2024. The $0.7 million increase was primarily due to higher drug manufacturing expenses, higher professional service expenses in regulatory affairs, and higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.
General and administrative (G&A) expenses were $3.4 million for the nine months ended September 30, 2025, compared to $4.9 million for the nine months ended September 30, 2024. The $1.5 million decrease was primarily due to lower salary expenses resulting from decrease in administrative headcount, lower professional services in consulting for business development and partnership initiatives, and lower company overhead expenses mainly due to decrease in investor relations services and D&O insurance related costs.
Net loss: $6.2 million for the nine months ended September 2025, compared to $6.9 million for the nine months ended September 2024
Discontinued operations:

Net loss: $2.2 million for the nine months ended September 2025, compared to $5.0 million for the nine months ended September 2024
Note 1: Accounting Update
Following definitive agreements in January 2025 to sell the majority of its Series A-1 Preferred Shares in SEED Therapeutics, BeyondSpring now reports SEED’s financial results as discontinued operations under ASC 205-20. BeyondSpring currently owns approximately 38% of SEED and upon completion of the future sale transactions BeyondSpring would own approximately 14% of SEED’s outstanding shares.

(Press release, BeyondSpring Pharmaceuticals, NOV 12, 2025, View Source [SID1234659808])

On November 12, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, reported it has entered into research and material transfer agreement with the University of North Carolina at Chapel Hill (UNC) for investigator-initiated preclinical research evaluating Annamycin for the treatment of pancreatic cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement Moleculin will supply Annamycin and William C. Zamboni, PharmD, PhD, professor at the UNC Eshelman School of Pharmacy, UNC Lineberger Comprehensive Cancer Center, and Carolina Institute of Nanomedicine will conduct the planned preclinical research as part of a series of funded grants. The studies covered under this agreement will evaluate the ability of novel treatment agents and modalities to enhance the tumor delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin as compared to Doxil and Free-doxorubicin in the PDAC GEMM models.

Walter Klemp, Chairman and CEO of Moleculin, commented, "We are pleased to establish this agreement with the team at UNC-Chapel Hill, a leading institution in oncology innovation and translational research, and take another important step in our strategy to advance and develop Annamycin through multiple investigator-initiated studies to realize its full potential. Pancreatic cancer remains one of the most lethal and underserved cancers, with limited effective treatment options and a clear need for new therapeutic approaches. Evaluating Annamycin in collaboration with UNC’s world-class translational scientists dovetails well with our recently announced investigator-funded clinical trial in pancreatic cancer patients."

"Annamycin has a demonstrated high affinity for and ability to concentrate in the pancreas, and recently published data reveals that the upregulation of topoisomerase II, the primary target of Annamycin, is highly correlated with poor survival in pancreatic cancer patients," continued Mr. Klemp. "This is why we believe targeting pancreatic cancer in addition to acute myeloid leukemia and soft tissue sarcoma provides a critical strategic opportunity to expand the potential clinical applications of our technology into an indication with significant unmet need and market potential. We look forward to generating data that will help define Annamycin’s role in pancreatic cancer and further strengthen our oncology development pipeline as we work to deliver meaningful value for patients and shareholders."

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.

Moleculin is currently conducting pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study of Annamycin in combination with cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global approval trial, including sites in the US, Europe and the Middle East.

For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU is on euclinicaltrials.eu and the reference identifier there is 2024-518359-47-00.

(Press release, Moleculin, NOV 12, 2025, View Source [SID1234659824])

On November 12, 2025 Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported financial results for its fiscal second quarter ended September 30, 2025, and provided an update on recent developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key Highlights

Maintained Nasdaq Listing: Compliance matters resolved, Aethlon remains in good standing with Nasdaq.
Clinical Progress: Recruitment underway for Cohort 2 of the Australian oncology trial under amended protocol.
Scientific Advancement: Ongoing collaboration with UCSF on Long COVID research, with a manuscript in preparation for peer-reviewed journal.
Technology Development: Initiated evaluation of Hemopurifier compatibility with a simplified blood treatment system
Operational Efficiency: Operating expenses reduced by 48%, reflecting disciplined cost management.
Clinical and Corporate Update

Clinical Progress in Cancer Trial

Aethlon continues to advance its clinical, scientific, and operational initiatives in support of its mission to develop therapeutic devices for cancer and infectious diseases. Nasdaq compliance matters have been resolved, and the company remains listed on the Capital Market.

Recruitment has begun for the second cohort of the Australian oncology trial of the Hemopurifier is underway under the amended protocol that allows patients receiving combination therapies with Pembrolizumab (Keytruda) or Nivolumab (Opdivo). The study is designed to evaluate safety, feasibility, and dose-finding in patients with solid tumors who have not responded to PD-1 therapy. Additional cohorts will examine whether sequential Hemopurifier treatments decrease extracellular vesicle (EV) concentrations and enhance the body’s immune response against tumor cells.

As previously reported, the laboratory of Professor Georges Grau at the University of Sydney analyzed EVs and lymphocyte counts in samples from patients in the first cohort before and after Hemopurifier treatment. EVs are nanoparticles that are involved in cell-to-cell communication and are implicated in the spread of cancer (metastasis), growth of new blood vessels to the tumor, (angiogenesis), cell death (apoptosis), and inhibition of the body’s T cells, which are important for killing tumor cells. Two of the three participants in the trial showed decreases in large EVs, also known as microvesicles, following the Hemopurifier treatment. Decreases were observed in large and small platelet-derived EVs in two of the three patients. We observed decreases in the subset of large EVs carrying PD-L1 in all three participants during the Hemopurifier treatment. Persistently elevated counts of EVs with PD-L1 have been associated with lack of response to anti-PD-1 agents.

Decreases were observed in seven out of ten microRNAs examined in two of the three participants following a single 4-hour Hemopurifier treatment. MicroRNAs are one component of the cargo of extracellular vesicles, previously reported to promote cancer growth and metastasis.

Improvements in laboratory ratios associated with responses to immunotherapy including Neutrophil, Lymphocyte, Monocyte, Albumin and Systemic Immune-Inflammation were observed in at least two participants after a single 4-hour treatment. Increases were noted in total T cell numbers, CD8 and CD4 T cell subsets, and tumor specific T cells (CD137 +ve) in participants following Hemopurifier treatment without a consistent pattern in terms of timing of improvement.

Additional data from the subsequent two cohorts will help determine whether these observations are reproducible, and whether there is a dose response with additional Hemopurifier treatments in terms of the magnitude and duration of the changes.

We believe the unmet need remains significant: currently, only approximately 30-40% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors are believed to contribute to both cancer progression and resistance to anti-PD-1 therapies.

The study’s primary endpoint is safety. The study will enroll approximately 9 to 18 participants. Eligible patients with solid tumors with stable or progressive disease receive escalating doses of Hemopurifier treatment across sequential cohorts – one, two, and three Hemopurifier treatments administered over the course of a single week. In addition to evaluating safety, the study is designed to assess whether reducing the concentration of EVs may improve the body’s own natural ability to attack tumor cells. These exploratory findings are expected to inform the design of future efficacy and safety trials, including a Premarket Approval (PMA) study.

Scientific Collaboration in Long COVID Research and Technology Development

Analysis of EV cargo from Long COVID patient samples continues in collaboration with the University of California, San Francisco (UCSF). These studies build on prior findings showing that the Hemopurifier can bind and remove large and small EVs from Long COVID patients. A manuscript detailing these results is being prepared for submission to a peer-reviewed journal.

We also initiated an evaluation to study the compatibility of the Hemopurifier with an alternative blood treatment system that uses a single small-lumen catheter and simplified blood pump compared to traditional hemodialysis setups. This research could lead to simplified system for performing Hemopurifier treatments in Oncology units in the future.

Operational Achievements

Operating expenses decreased by 48% during the quarter, reflecting the Company’s ongoing efforts to reduce costs while advancing its clinical and research programs.

"We remain focused on executing our clinical and research strategy while maintaining operational discipline," said James Frakes, CEO and CFO of Aethlon Medical. "Our ongoing trial progress, research collaborations, and technology initiatives continue to support our long-term goal of developing therapeutic solutions for cancer and life-threatening infectious diseases."

Financial Results for the Fiscal Second Quarter Ended September 30, 2025

As of September 30, 2025, Aethlon had a cash balance of approximately $5.8 million.

Consolidated operating expenses for the three months ended September 30, 2025 were approximately $1.5 million, down by approximately $1.4 million or 48%, from $2.9 million in the same period in 2024. The decreases were reflected across payroll, general and administrative and professional fees.

Payroll and related expenses decreased by approximately $778,000, reflecting lower headcount, reduced bonus accruals, and absence of prior-year severance charges.
General and Administrative expenses declined by approximately $437,000 driven by lower clinical trial costs, in part due to a $218,000 R&D tax incentive, as well as reductions in supplies, insurance, and other operational costs.
Professional fees decreased by approximately $177,000, mainly from reduced investor relations and contract labor expenses, partially offset by higher legal, tax, audit and financial services costs.
As a result of these factors, operating loss for the quarter decreased to $1.5 million compared to $2.8 million in the prior-year period.

Other income totaled $22,730 for the three months ended September 30, 2025, compared to $95,146 in the prior-year period. In both quarters, other income was primarily interest income earned on cash balances.

The consolidated balance sheets for September 30, 2025 and March 31, 2025, along with the consolidated statements of operations for the three and six months ended September 30, 2025 and 2024, are included at the end of this release.

Conference Call

Management will host a conference call today, Wednesday, November 12, 2025, at 4:30 p.m. ET to review the Company’s financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference call by navigating to View Source Please note that registered participants will receive their dial-in number upon registration.

(Press release, Aethlon Medical, NOV 12, 2025, View Source [SID1234659847])