Cytarabine

Access the Moleculin CEO Corner here HOUSTON, Oct. 20, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. (Nasdaq: MBRX) (“Moleculin” or the “Company”) today announced that it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer. In this episode of CEO Corner, Moleculin Biotech Chairman and CEO Walter Klemp discusses the progress of the Company’s Phase 2/3 MIRACLE trial evaluating Annamycin in combination with high-dose cytarabine (HiDAC) for patients with second-line relapsed or refractory acute myeloid leukemia (AML). The discussion highlights the completion of enrollment in Part A, encouraging interim efficacy results, Annamycin’s potential to address treatment resistance and cardiac safety concerns associated with conventional anthracyclines, and the anticipated full 90-patient Part A data readout in the first quarter of 2027. Mr. Klemp also outlines the next steps toward the pivotal Part B expansion and the broader potential for Annamycin across AML and other cancers treated with anthracyclines. Access the CEO Corner on the Company’s website here . About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), has shown to be an efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company is conducting the MIRACLE ( M olecul i n R /R AML A nnAraC Cl inical E valuation) Trial (MB-108), a pivotal, adaptive design, multi-center, randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating Annamycin in combination with cytarabine (also referred to as “Ara-C”), together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway toward a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit and connect on X , LinkedIn and Facebook . Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential efficacy and safety of Annamycin and AnnAraC in R/R AML, expected timing of the comprehensive Part A data readout in Q1 2027, the anticipated composition of the Part A population including the expected approximate 50/50 split between fit and unfit subjects, the potential for Part A data to support dose selection for Part B, and the expectation that interim efficacy trends observed in a limited patient population will be confirmed in the full study population. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 MBRX@jtcir.com

Data featured as a Top Rated Oral Presentation at the 39th Annual Congress of the European Association of Nuclear Medicine First-in-human imaging performed in 10 patients with non-small cell lung cancer showed no tracer-related serious adverse events, high lesion contrast and tumor uptake that rose with c-MET expression, demonstrating high theranostic potential Global regulatory clearances support advancing [225Ac]Ac-FL-261 into Phase 1 clinical trials LONDON, Oct. 19, 2026 /PRNewswire/ -- Full-Life Technologies ("Full-Life", the "Company"), a privately held, fully integrated, clinical-stage global radiopharmaceutical company, today announced first-in-human imaging data for [111In]In-FL-261, its c-MET-targeted theranostic radionuclide drug conjugate ("RDC") program, in a Top Rated Oral Presentation at the 39th Annual Congress of the European Association of Nuclear Medicine ("EANM"), which is being held October 17 to 21, 2026, in Vienna, Austria. The presented data from patients with non-small cell lung cancer ("NSCLC") demonstrated high lesion contrast, no tracer-related serious adverse events and support the continued evaluation of [225Ac]Ac-FL-261 in clinical trials. Full-Life is also presenting an E-Poster, highlighting preclinical data in which [225Ac]Ac-FL-261 produced marked tumor regression in tumor cell-derived and patient-derived xenograft models with varying levels of c-MET expression. "We are excited to share, for the first time, clinical imaging data showing FL-261's potential for patients with c-MET-expressing NSCLC," said Debora Barton, MD, Chief Medical Officer of Full-Life Technologies. "These data demonstrate compelling FL-261 uptake in lesions with high contrast, no tracer-related serious adverse events and uptake that rose with c-MET expression in the patients studied, with favorable tumor to normal tissue ratios. Together with the recent regulatory clearances, the data provide strong support to advance [225Ac]Ac-FL-261 into the SumMET Phase 1 trial." "c-MET is an oncogenic driver and a mediator of resistance to treatment in lung cancer, which makes it a meaningful target for precision therapy," said Prof. Xiaoli Lan, Department of Nuclear Medicine, Union Hospital, Tongji Medical College. "Being able to see c-MET expression across the whole body, noninvasively in this first cohort, is an encouraging step toward matching radioligand therapy to the patients who can benefit." In September 2026, Full-Life announced that the U.S. Food and Drug Administration had cleared the Investigational New Drug application for [225Ac]Ac-FL-261 and that the program had also received regulatory clearances in Australia and China. Together, the clearances allow the Phase 1 SumMET trial (NCT07873450) of [²²⁵Ac]Ac-FL-261 to proceed at sites in these countries for patients with non-squamous NSCLC that expresses c-MET. First-in-human imaging data (Top Rated Oral Presentation, OP-442) The Top Rated Oral Presentation reports results from a prospective clinical trial of [111In]In-FL-261 in 10 patients with histologically confirmed NSCLC, designed to evaluate safety, biodistribution and diagnostic performance. Patients underwent SPECT/CT imaging 4, 24 and 72 hours after injection, and had a baseline [18F]FDG PET/CT for comparison. Mean patient age was 65.3 years (range 59 to 71), and nine of 10 patients were male. Histology was adenocarcinoma in five patients, squamous cell carcinoma in four and NSCLC not otherwise specified in one. One patient had MET exon 14 skipping and two had no MET alteration detected, and seven were not tested. Key findings c-MET-specific lesion uptake: Tumor SUVmax at 4, 24, and 72 hours was 13.8, 25.7 and 43.2 respectively for a patient with high c-MET immunohistochemistry (IHC) score and 12.7, 22.9 and 20.7 respectively for a patient with moderate IHC score. The ratio of tumor SUVmax versus kidney and bone marrow SUVmean was in the range of 2.8-20.3 and 17.4-72.4 respectively for these two patients at all acquired time points. Potential of c-MET diagnostic: Across six patients with available c-MET IHC scores, [111In]In-FL-261 uptake in the lesions showed a positive trend with c-MET expression (Spearman rho 0.82, P = 0.034), whereas [18F]FDG uptake did not (rho -0.13, P = 0.80). Normal organ biodistribution: The uptake of the tracer in normal organs was generally low and all with rapid washout. The organs with highest uptake were liver, spleen and kidneys. Safety: [111In]In-FL-261 was well tolerated in all patients, with no tracer-related serious adverse events. Preclinical data (E-Poster #0035) Full-Life is also presenting E-Poster #0035 "Development of FL-261 as a theranostic RDC vector for the diagnosis and treatment of c-MET positive cancers" at EANM. The E-Poster describes the discovery and preclinical characterization of FL-261. [111In]In-FL-261 showed potent, c-MET-specific binding and rapid internalization in c-MET-overexpressing cells and in tumor-bearing mice. Tumor uptake exceeded that of normal organs and was nearly completely blocked by unlabeled FL-261. [225Ac]Ac-FL-261 produced marked tumor regression in xenograft models with varying levels of c-MET expression, including a model derived from a patient previously treated with a c-MET-targeted antibody-drug conjugate, with no notable changes in body weight. Presentation details Top Rated Oral Presentation Title: First-in-human translation of the c-MET-targeting theranostic ligand FL-261 for imaging in NSCLC Number: OP-442 Session: Clinical Oncology Track - Lung (Session 1006) Date and time: Monday, October 19, 2026, 16:10 - 16:20 Location: Hall C E-Poster Title: Development of FL-261 as a theranostic RDC vector for the diagnosis and treatment of c-MET positive cancers Number: #0035 Session: EP-03 Dates: October 17 - 21, 2026 About [ 225 Ac]Ac-FL-261 [225Ac]Ac-FL-261 is Full-Life's first-in-class c-MET-targeted alpha radioconjugate for multiple solid tumor indications. It is designed to selectively bind c-MET-expressing tumor cells and deliver alpha-particle radiation directly to tumor lesions while sparing key normal tissues. It is currently being studied in Phase 1 trials in the U.S., Australia and China in patients with Non-Small Cell Lung Cancer (NSCLC). [225Ac]Ac-FL-261 is one of the various radiopharmaceutical assets discovered utilizing Full-Life's proprietary UniRDC™ discovery platform. About Full-Life Technologies Full-Life Technologies ("Full-Life") is a privately held, fully integrated, clinical-stage actinium-based global radiopharmaceutical company focused on developing next-generation targeted radioconjugate for patients. Full-Life has three clinical-stage programs: [225Ac]Ac-FL-020, a PSMA-targeted alpha radioconjugate currently being evaluated in a global Phase 1 trial for metastatic castration-resistant prostate cancer (mCRPC); [225Ac]Ac-FL-261, a potentially first-in-class c-MET-targeted alpha radioconjugate being developed for multiple solid tumor indications, with an initial focus on non-squamous non-small cell lung cancer (nsNSCLC); and an NTSR1-targeted small-molecule radioconjugate currently being evaluated in a Phase 1 clinical trial under a collaboration with a strategic partner. The Company has fully integrated capabilities spanning drug discovery, clinical development, actinium-225 (Ac-225) production, and manufacturing, and has completed the construction of a state-of-the-art GMP-compliant Ac-225 manufacturing and radiolabeling facility in Belgium. Media Contacts: Full-Life Email: [email protected] Website: Investor Contacts: ICR Healthcare Email: [email protected] SOURCE Full-Life Technologies 21% more press release views with Request a Demo