On May 12, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported the publication of an abstract at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress highlighting the cardiac safety profile of Annamycin (or as known in scientific journals "L-Annamycin"), the Company’s next-generation anthracycline currently in late-stage development for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML).

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 abstract titled, "Cardiac Safety of L-Annamycin Across High Cumulative Anthracycline Exposure: Implications for Relapsed/Refractory AML," will highlight pooled cardiac safety findings from five completed clinical trials evaluating Annamycin in heavily pretreated patients, including those with substantial prior anthracycline exposure. Importantly, the analysis demonstrated no clinically significant treatment-related cardiotoxicity across cumulative anthracycline-equivalent doses that exceeded conventional lifetime exposure limits associated with traditional anthracyclines.

Anthracyclines remain among the most effective agents in AML treatment, but their clinical utility is constrained by cumulative cardiac toxicity. This limitation is especially relevant in R/R AML, where patients often have prior anthracycline exposure and where currently available salvage therapies following venetoclax-based treatment have demonstrated limited efficacy.

The independent cardiac review, conducted by a cardio-oncology laboratory at the Cleveland Clinic, analyzed comprehensive cardiac monitoring data from 90 patients treated with Annamycin. Among 78 patients with source-data verified pre- and post-treatment ejection fraction assessments, no patients met criteria for clinically significant left ventricular dysfunction. Mean ejection fraction remained stable, and no association was observed between cumulative dose and cardiac function decline. Additional analyses of serial ECGs, troponins, and global longitudinal strain assessments similarly demonstrated no evidence of drug-induced cardiotoxicity.

Management believes these findings reinforce Annamycin’s potential to address a major unmet need in R/R AML by enabling continued anthracycline-based treatment without the cumulative cardiac limitations commonly associated with conventional agents.

"These data further strengthen the clinical rationale for Annamycin as a differentiated anthracycline with the potential to overcome one of the most significant barriers to treatment in AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "We believe the combination of encouraging efficacy observed to date and a favorable cardiac safety profile could position Annamycin as an important therapeutic option for heavily pretreated AML patients, including those previously exposed to anthracyclines and venetoclax-based regimens."

The Company believes the results published at EHA (Free EHA Whitepaper) may support broader clinical positioning opportunities for Annamycin in AML and potentially other oncology indications where anthracycline use is currently limited by cardiotoxicity concerns.

(Press release, Moleculin, MAY 12, 2026, View Source [SID1234665550])

On May 12, 2026 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported ten abstracts have been accepted for poster presentations at the European Association for the Study of the Liver (EASL) Congress 2026, being held May 27 – 30, 2026 in Barcelona, Spain. The abstracts released today can be found on the EASL website at View Source

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!

Details on the abstracts are as follows:

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

Abstract #: 588
Title: Sustained reduction of HBV antigen levels at ≥6 months follow-up in HBeAg-positive participants with chronic hepatitis B infection after 96 weeks of 300 mg pevifoscorvir sodium monotherapy
Presenter: Professor Lung-Yi Loey Mak, MBBS(HK), MD(HK), MRCP(UK), PDipID (HK), FHKCP, FHKAM (Medicine), FRCP (Glasg), FRCP (Edin), FRCP, Clinical Assistant Professor at The University of Hong Kong
Date/Time: May 27, 2026 at 8:30am – 5:00pm CET
Session: Viral Hepatitis B and D: New therapies, unapproved therapies or strategies

Abstract #: 602
Title: Pevifoscorvir sodium demonstrated profound antiviral activity in untreated HBeAg+ subjects, regardless of baseline ALT level
Presenter: Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong
Date/Time: May 27, 2026 at 8:30am – 5:00pm CET
Session: Viral Hepatitis B and D: New therapies, unapproved therapies or strategies

Abstract #: 586
Title: Population pharmacokinetics of pevifoscorvir sodium (ALG-000184) in healthy participants and participants with chronic hepatitis B in support of phase 2 dose selection
Presenter: Kha Le, PhD
Date/Time: May 27, 2026 at 8:30am – 5:00pm CET
Session: Viral Hepatitis B and D: New therapies, unapproved therapies or strategies

Abstract #: 570
Title: ALG-001075, the parent of pevifoscorvir sodium, exhibits potent in vitro antiviral properties compared to other HBV capsid assembly modulators in clinical development
Presenter: Yannick Debing, PhD
Date/Time: May 28, 2026 at 8:30am – 5:00pm CET
Session: Viral Hepatitis: Experimental and pathophysiology

Abstract #: 634
Title: Potent and durable off-treatment reduction of HBsAg levels and cccDNA-derived transcripts by the CAM-E ALG-001075 in cell-based experiments
Presenter: Professor Barbara Testoni, PhD, HDR, DR2 INSERM – Team Leader "Hepatitis Viruses and Liver pathogenesis". Université Claude Bernand Lyon 1, Inserm UMR 1350 – PaThLiv
Date/Time: May 28, 2026 at 8:30am – 5:00pm CET
Session: Viral Hepatitis: Experimental and pathophysiology

ALG-170675: Potential best-in-class antisense oligonucleotide (ASO) for chronic hepatitis B virus (HBV) infection

Abstract #: 587
Title: The potentially best-in-class HBV ASO ALG-170674 demonstrates additive to synergistic antiviral activities when combined with other anti-HBV modalities
Presenter: Jin Hong, PhD
Date/Time: May 28, 2026 at 8:30am – 5:00pm CET
Session: Viral Hepatitis: Experimental and pathophysiology

ALG-055009: Potential best-in-class small molecule THR-β Agonist for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Abstract #: 184
Title: Synergistic fat mass loss in diet-induced obese mice when thyroid hormone receptor-β agonist ALG-055009 was administered in combination with incretin receptor agonists
Presenter: Xuan Luong, PhD
Date/Time: May 30, 2025 at 8:30am – 4:00pm CET
Session: Poster – MASLD: Experimental and pathophysiology

Preclinical

Abstract #: 606
Title: Antisense oligonucleotide-based strategy to target hepatitis delta virus infections
Presenter: Julie Lucifora, PhD, HDR, Director of Research, INSERM, CIRI – Centre International de Recherche en Infectiologie
Date/Time: May 28, 2026 at 12:45 – 1:45pm CET; May 28, 2026 at 8:30am – 5:00pm CET
Session: Poster Tour – Track 8 – Viral Hepatitis; Viral Hepatitis: Experimental and pathophysiology

Abstract #: 610
Title: Discovery of novel HDV entry inhibitors with selectivity over bile acid inhibition
Presenter: David McGowan, MS
Date/Time: May 28, 2026 at 8:30am – 5:00pm CET
Session: Viral Hepatitis: Experimental and pathophysiology

Abstract #: 620
Title: Preclinical characterization of ALG-093940, a potent and orally bioavailable small molecule PD-1/PD-L1 inhibitor for the treatment of chronic hepatitis B infection and liver cancer
Presenter: Heleen Roose, PhD
Date/Time: May 28, 2026 at 8:30am – 5:00pm CET
Session: Viral Hepatitis: Experimental and pathophysiology

(Press release, Aligos Therapeutics, MAY 12, 2026, View Source [SID1234665566])

On May 12, 2026 MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company developing allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune disorders, reported data being presented at the American Society of Gene and Cell Therapy Annual Meeting (ASGCT 2026) in Boston, Massachusetts. The data demonstrate that agenT-797, MiNK’s off-the-shelf, allogeneic iNKT cell therapy produces fundamentally different, disease-appropriate immune responses in patients with solid tumors and patients with acute respiratory distress syndrome (ARDS), driven by the intrinsic biology of iNKT cells rather than genetic modification.

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 data, to be presented in Poster 3371 on May 14, 2026, by Dr. Yan demonstrates that the same agenT-797 product, manufactured from the same donor batch and administered without modification, drove a TH1 pro-inflammatory immune program in 34 patients with solid tumors and a TH2 anti-inflammatory immune response in 20 patients with ARDS. The findings were consistent across multiple manufacturing batches and donors, establishing platform reproducibility at scale.

"The same off-the-shelf cell — from the same donor, same manufacturing batch — drives inflammation in a tumor and restores immune homeostasis in a failing lung. Without modification. Without engineering. That is intrinsic iNKT biology, and it is the foundation of a scalable platform we believe is applicable across oncology, critical illness, and beyond. To our knowledge, no prior cellular therapy platform has demonstrated this type of disease-directed immune response across two fundamentally different diseases from a single manufacturing run," said, Jennifer Buell, Ph.D., President and Chief Executive Officer, MiNK Therapeutics.

These findings further support the scalability and consistency of MiNK’s proprietary manufacturing platform, which is designed to isolate donor-derived iNKT cells and reproducibly expand them to billions of cells per donor while preserving intrinsic biological activity across disease settings. agenT-797 is cryopreserved, HLA-independent, and requires no lymphodepletion, supporting potential use across acute critical care, oncology, and post-transplant immune dysfunction.

ASGCT Poster 3371: Context-Dependent Immune Reprogramming in Cancer and ARDS

Clinical evidence of effector function: agenT-797 was associated with tumor clearance and durable response in patients with cancer, including complete resolution of metastatic disease in germ cell testicular cancer treated with agenT-797 plus anti-PD-1 (Garmezy et al., Oncogene, 2025). In ARDS, agenT-797 was associated with improved survival and radiographic resolution of ARDS relative to in-hospital controls, including clearance of carbapenem-resistant Pseudomonas pneumonia in a 21-year-old patient on veno-venous ECMO.
In 34 solid tumor patients (NCT05108623), agenT-797 infusion produced rapid IFN-gamma elevation — a TH1 pro-inflammatory signature consistent with anti-tumor immune activation.
In 20 ARDS patients (NCT04582201), the same product from the same manufacturing donor batch produced IL-4 and IL-13 elevation — a TH2 anti-inflammatory signature consistent with immune restoration and lung injury recovery.
Favorable safety profile: Immune activation across both oncology and ARDS settings occurred without evidence of uncontrolled cytokine release syndrome or pathologic hyperinflammation, supporting a favorable therapeutic index appropriate for the ICU setting.

"What makes these findings compelling is that we are observing the same unmodified iNKT cell product generate fundamentally different immune responses across distinct disease states in a biologically coherent and clinically relevant manner," said Terese C. Hammond, MD, Head of Inflammatory and Pulmonary Diseases, MiNK Therapeutics. "These findings support the idea that iNKT cells function as coordinated immune effectors capable of dynamically modulating inflammatory and restorative pathways based on the disease environment. In critical illness, effective therapy may require coordinated immune activation, restoration, and pathogen-directed response occurring simultaneously. The Phase 1/2 clinical data suggested this biology was possible; the ASGCT (Free ASGCT Whitepaper) findings now provide mechanistic evidence supporting how agenT-797 may achieve those effects."

(Press release, MiNK Therapeutics, MAY 12, 2026, View Source [SID1234665582])

On May 12, 2026 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported that management will participate in the following investor conferences:

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!

H.C. Wainwright 4th Annual BioConnect Investor Conference: Biomea will participate in a fireside chat from 3:00–3:30 PM ET and in one-on-one meetings on May 19, 2026, in New York, NY.

2026 Jefferies Global Healthcare Conference: Biomea will participate in a fireside chat from 8:10–8:40 AM ET and in one-on-one meetings on June 4, 2026, in New York, NY.

An audio webcast of the fireside chats will be available here or by visiting the News & Events page under the Investors & Media section of Biomea’s website. A replay of the webcasts will be available following the live event.

(Press release, Biomea Fusion, MAY 12, 2026, View Source [SID1234665526])

On May 12, 2026 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing IKT-001 for Pulmonary Arterial Hypertension ("PAH"), reported financial results for the quarter ended March 31, 2026, and highlighted 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!

"We were excited to enroll the first patient in our registrational IMPROVE-PAH study last month, and are very pleased with our early progress obtaining country regulatory approvals to support initiation of clinical sites, including being one of the first companies to successfully take advantage of the new European Medicines Agency FAST-EU (Facilitating and Accelerating Strategic Trials in the European Union) initiative to accelerate multinational clinical trials," said Mark Iwicki, Chief Executive Officer of Inhibikase. "With the recent approvals obtained in the first 16 countries worldwide, Inhibikase is well-positioned to initiate clinical site activations and seek to advance enrollment of IMPROVE-PAH. Later this week, we also look forward to the first of two new presentations of Phase 1 and pre-clinical studies of IKT-001 at the American Thoracic Society International Conference, to be held in Orlando, Florida."

Recent Developments

In late April 2026, Inhibikase received confirmation from the European Medicines Agency that the Company is permitted to initiate our Phase 3 study in PAH, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332), in 12 countries in the European Union. This approval brings the total country approvals for IMPROVE-PAH to 16, including the United States, Canada, New Zealand and Argentina, and further enables the Company to leverage this approval to seek the approval of an additional 3 countries in the European Union over the coming months to supplement our ongoing broader global country regulatory approval efforts.
The global IMPROVE-PAH study is a two-part adaptive Phase 3 study incorporating an initial 12-week dose titration phase designed to enable patients to get to the highest tolerable dose of IKT-001.
Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of change in Pulmonary Vascular Resistance ("PVR") at Week 24.
Part B of IMPROVE-PAH seamlessly begins following the last patient in Part A being enrolled and adopts an identical format to Part A, except the primary endpoint will be change in 6-minute walk distance ("6MWD") at Week 24 in approximately 346 patients.
In addition to the titration benefits mentioned above, IMPROVE-PAH has the advantage of uninterrupted enrollment between Part A and Part B, together with the opportunity to undertake a sample size re-estimation for Part B based on Part A findings, if necessary.
In April 2026, Inhibikase announced that IMPROVE-PAH has been initiated with the recent activation of our first clinical sites in the United States, together with the enrollment of the first patient in the United States. Following the recent country approvals mentioned above, efforts to initiate clinical sites outside of the United States are now advancing.
In April 2026, Inhibikase submitted an Orphan Drug Designation ("ODD") application to the U.S. Food and Drug Administration for IKT-001 for treatment of PAH recognizing that PAH is a high unmet medical need impacting approximately 50,000 Americans.
Upcoming Presentations

IKT-001 pre-clinical and Phase 1 data will be featured into two presentations at the American Thoracic Society (ATS) International Conference in Orlando, Florida on May 17 and 20, 2026:
Safety, Tolerability, and Pharmacokinetics of IKT-001, a Novel Prodrug of Imatinib, in Healthy Volunteers, on May 17, 2026
In Vitro Pharmacology and Preclinical Efficacy of IKT-001 in Pulmonary Arterial Hypertension, on May 20, 2026.
Financial Results

Cash Position: As of March 31, 2026, cash, cash equivalents and marketable securities were $170.4 million.

Net Loss: Net loss for the quarter ended March 31, 2026, was $16.4 million, or $0.10 per share, compared to a net loss of $13.7 million, or $0.15 per share in the quarter ended March 31, 2025.

R&D Expenses: Research and development expenses were $10.8 million for the quarter ended March 31, 2026, compared to $10.5 million for the quarter ended March 31, 2025, which included a one-time (non-cash) charge of $7.4 million for the acquired IPR&D related to the CorHepta acquisition.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2026 were $7.4 million, compared to $5.2 million for the quarter ended March 31, 2025.

(Press release, Inhibikase Therapeutics, MAY 12, 2026, View Source [SID1234665541])