Moleculin Announces New Annamycin Collaboration in Brain Tumors
Rhea-AI Summary
Moleculin (Nasdaq: MBRX) entered a research and material transfer agreement dated December 8, 2025 with CIC biomaGUNE to support investigator-initiated preclinical studies of Annamycin in glioblastoma multiforme (GBM).
The collaboration will evaluate intra-arterial delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin versus Doxil and Free-doxorubicin in mouse GBM models. Moleculin will supply Annamycin and CIC biomaGUNE will conduct the planned studies under Principal Investigator Jesús Ruiz-Cabello.
Annamycin holds FDA Fast Track status and multiple Orphan Drug designations (FDA and EMA) and has shown prior clinical activity in AML and soft tissue sarcomas per the announcement.
Positive
- Signed material transfer agreement with CIC biomaGUNE on Dec 8, 2025
- Annamycin has FDA Fast Track status
- Multiple Orphan Drug designations from FDA and EMA
- Prior clinical activity reported in AML and soft tissue sarcomas
Negative
- GBM work is preclinical; no clinical GBM efficacy data reported
- Study results and timelines not disclosed, leaving near-term impact uncertain
Key Figures
Market Reality Check
Peers on Argus 1 Up 1 Down
Key biotech peers showed mixed moves: LPTX up 238.84%, KZIA up
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 26 | Investor presentation | Neutral | -22.0% | Announcement of CEO participation in Virtual Investor Closing Bell event. |
| Nov 26 | Reverse stock split | Negative | -22.0% | 1-for-25 reverse split to consolidate shares and maintain listing. |
| Nov 13 | Clinical trial update | Positive | -6.9% | Reported 60% consent toward first 45 subjects in MIRACLE trial. |
| Nov 12 | Preclinical collaboration | Positive | +1.8% | Grant-funded pancreatic cancer Annamycin research with UNC-Chapel Hill. |
| Oct 30 | Conference showcase | Positive | -5.8% | Presentation on L-Annamycin and MIRACLE AML trial at leukemia meeting. |
Recent Moleculin news has often been followed by negative price reactions, even on clinically or strategically positive updates, indicating a pattern of skepticism or overhang in the shares.
Over the past months, Moleculin has highlighted its pivotal Phase 2B/3 MIRACLE AML program and expanded preclinical work around Annamycin, including a grant-funded pancreatic cancer collaboration at UNC-Chapel Hill. Despite these clinically constructive updates, shares fell after the MIRACLE consent milestone and AML conference exposure. Corporate actions, including a 1-for-25 reverse split and a virtual investor event on Dec 2, 2025, also coincided with sharp declines. Today’s GBM-focused collaboration continues the theme of broadening Annamycin’s potential applications.
Regulatory & Risk Context
The company has an active S-3 shelf registration dated 2025-09-19 expiring on 2028-09-19. It is currently noted as not effective, with 0 recorded usages, indicating authorized capacity exists but has not yet been drawn upon per the provided data.
Market Pulse Summary
This announcement details a new investigator-initiated collaboration to test Annamycin, including liposomal formulations, in GBM models against comparators like Doxil and free doxorubicin. It builds on prior Annamycin work in AML and pancreatic cancer, and leverages existing FDA and EMA designations. Historically, Moleculin has emphasized its pivotal MIRACLE AML trial, financing activities, and Nasdaq listing status. Investors tracking this story may focus on resulting preclinical data quality, subsequent clinical trial decisions, and how these developments intersect with the company’s capital structure and regulatory footing.
Key Terms
central nervous system medical
acute myeloid leukemia medical
orphan drug designation regulatory
AI-generated analysis. Not financial advice.
Investigator-Initiated Preclinical studies at CIC biomaGUNE aimed at combatting Glioblastoma Multiforme
Research will evaluate effects of intra-arterial delivery of Annamycin
HOUSTON, Dec. 08, 2025 (GLOBE NEWSWIRE) -- 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, today announced it has entered into a research and material transfer agreement with CIC biomaGUNE, a non-profit research organization created to promote scientific research and technological innovation at the highest levels in the Basque Country, Spain, for investigator-initiated preclinical research evaluating Annamycin for the treatment of glioblastoma multiforme (GBM), a form of brain cancer.
Under the terms of the agreement Moleculin will supply Annamycin and Jesús Ruiz-Cabello, Principal Investigator at CIC biomaGUNE will conduct the planned preclinical research. The studies covered under this agreement will evaluate tumor progression following intra-arterial delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin as compared to Doxil and Free-doxorubicin in mouse models.
Walter Klemp, Chairman and CEO of Moleculin, commented, “We are excited to further expand our efforts to advance and develop Annamycin across a number of investigator-initiated studies. Annamycin has demonstrated clinical activity in acute myeloid leukemia and soft tissue sarcomas while also showing potential in preclinical models in pancreatic, GBM, and certain liver cancers amongst others.”
Mr. Klemp continued, “GBM remains an area of profound unmet medical need, with current therapies offering only limited survival benefit and no meaningful long-term solutions. Collaborating with the premier research team at CIC biomaGUNE provides an important opportunity to explore Annamycin’s potential to overcome the challenges of drug delivery and resistance in central nervous system tumors. This work highlights the potential breadth of Annamycin and underscores our commitment to advancing innovative therapies for patients facing cancers with few or no effective options.”
Glioblastoma is a common type of tumor originating in the brain. The average annual age-adjusted incidence rate of glioblastoma is 3.19 per 100,000 persons in the United States.1 Glioblastoma is the most aggressive malignant primary brain tumor with a median survival of only 15 months2. It is the most common malignant primary brain tumor making up
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 metastases. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.
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, is a next-generation highly 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 has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, 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 towards 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.
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.
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 www.moleculin.com 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, statements regarding the research to be conducted at UNC, the potential outcomes of such research, and the timing of the commencement of the investigator-initiated clinical trial described. 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. 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
1 Thakkar J, Dolecek TA, Horbinski C, Ostrom QT, Lightner DD, Barnholtz-Sloan JS, et al. Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol. Biomarkers Rev. 2014;23(10):1985-96.
2 Koshy M, Villano JL, Dolecek TA, Howard A, Mahmood U, Chmura SJ, et al. Improved survival time trends of glioblastoma using the SEER 17 population-based registries. J Neuro Oncol. 2012;107(1):207-12
3 Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, et al. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006-2010. Neuro Oncol. 2013;15 Suppl:2ii-56.
4 De Vleeschouwer S, editor. Brisbane (AU): Codon Publications; 2017 Sep 27.
FAQ
What did Moleculin announce on December 8, 2025 about MBRX and CIC biomaGUNE?
What will the CIC biomaGUNE studies of Annamycin (MBRX) evaluate in GBM?
Does Annamycin (MBRX) have any regulatory designations that affect investors?
Has Annamycin (MBRX) shown clinical activity in cancers prior to these GBM studies?
Will the CIC biomaGUNE collaboration create immediate clinical implications for MBRX shareholders?
