[8-K] Moleculin Biotech, Inc. Reports Material Event
Moleculin Biotech announced the start of EU enrollment in its pivotal Phase 2B/3 trial of Annamycin combined with cytarabine (AnnAraC) for adults with relapsed or refractory acute myeloid leukemia (R/R AML). The company reported that the first two subjects in the European Union have been enrolled and one subject has been treated, marking initiation of EU participation in a multi-center, randomized, double-blind, placebo-controlled, adaptive-design study.
The press release is attached as an exhibit to the company's report and is being furnished rather than filed. The disclosure focuses on clinical development progress鈥攕pecifically geographic expansion of patient enrollment in a late-stage trial evaluating Annamycin plus Ara-C for R/R AML.
Moleculin Biotech ha annunciato l'avvio delle arruolazioni nell'UE per il suo studio pivotale di fase 2B/3 su Annamycin in combinazione con citarabina (AnnAraC) destinato ad adulti con leucemia mieloide acuta recidivante o refrattaria (R/R AML). L'azienda ha riferito che i primi due soggetti nell'Unione Europea sono stati arruolati e uno di essi 猫 stato trattato, segnando l'inizio della partecipazione dell'UE a uno studio multicentrico, randomizzato, in doppio cieco, controllato con placebo e a disegno adattivo.
Il comunicato stampa 猫 allegato come documento alla relazione dell'azienda ed 猫 fornito come informazione piuttosto che depositato. La comunicazione si concentra sui progressi nello sviluppo clinico鈥攊n particolare sull'espansione geografica dell'arruolamento dei pazienti in uno studio avanzato che valuta Annamycin pi霉 Ara-C per R/R AML.
Moleculin Biotech anunci贸 el inicio del reclutamiento en la UE para su ensayo pivotal de fase 2B/3 de Annamycin combinado con citarabina (AnnAraC) en adultos con leucemia mieloide aguda en reca铆da o refractaria (R/R AML). La compa帽铆a inform贸 que los dos primeros sujetos en la Uni贸n Europea han sido reclutados y uno de ellos ha recibido tratamiento, marcando el inicio de la participaci贸n de la UE en un estudio multic茅ntrico, aleatorizado, doble ciego, controlado con placebo y de dise帽o adaptativo.
El comunicado de prensa se adjunta como anexo al informe de la compa帽铆a y se proporciona como informaci贸n en lugar de presentarse formalmente. La divulgaci贸n se centra en el avance del desarrollo cl铆nico鈥攅spec铆ficamente en la expansi贸n geogr谩fica del reclutamiento de pacientes en un ensayo en fase avanzada que eval煤a Annamycin m谩s Ara-C para R/R AML.
Moleculin Biotech電� 鞛皽靹� 霕愲姅 攵堨潙靹� 旮夓劚 瓿垬靹� 氚表槇氤�(R/R AML) 靹膘澑鞚� 雽�靸侅溂搿� 頃� 鞎勲倶毵堨澊鞁�(Annamycin)瓿� 鞁滍儉霛茧箞(cytarabine, AnnAraC)鞚� 欷戩稊鞝� 2B/3靸� 鞁滍棙鞐� 雽�頃� EU 雮� 霌彪鞚� 鞁滌瀾頄堧嫟瓿� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� 鞙犽熃鞐绊暕鞐愳劀 觳橃潓 霊� 氇呾潣 頂柬棙鞛愱皜 霌彪霅橃棃瓿� 攴胳 頃� 氇呾澊 旃橂毳� 氚涭晿雼り碃 氤搓碃頄堨溂氅�, 鞚措姅 雼り赴甏� 氍挫瀾鞙� 氚办爼, 鞚挫毵龟瞼, 鞙勳暯雽�臁�, 鞝侅潙順� 靹り硠 鞐瓣惮鞐� 雽�頃� EU 彀胳棳鞚� 鞁滌瀾鞚� 鞚橂頃╇媹雼�.
氤措弰鞛愲電� 須岇偓 氤搓碃靹滌棎 觳秬霅� 鞝勳嫓氍茧 鞝滉车霅橂┌ 鞝滌稖霅� 氍胳劀電� 鞎勲嫏雼堧嫟. 頃措嫻 瓿奠嫓電� 鞛勳儊 臧滊皽 歆勴枆鈥旐姽頌� 鞛皽靹�/攵堨潙靹� AML鞐� 雽�頃� Annamycin瓿� Ara-C 氤戩毄鞚� 韽夑皜頃橂姅 頉勱赴 鞁滍棙鞐愳劀 頇橃瀽 霌彪鞚� 歆�毽爜 頇曥灔鈥旍棎 齑堨爯鞚� 毵烄稊瓿� 鞛堨姷雼堧嫟.
Moleculin Biotech a annonc茅 le lancement des enr么lements dans l'UE pour son essai pivotal de phase 2B/3 d'Annamycin en association avec la cytarabine (AnnAraC) chez des adultes atteints de leuc茅mie my茅lo茂de aigu毛 en rechute ou r茅fractaire (R/R AML). La soci茅t茅 a rapport茅 que les deux premiers sujets dans l'Union europ茅enne ont 茅t茅 enr么l茅s et qu'un sujet a 茅t茅 trait茅, marquant le d茅but de la participation de l'UE 脿 une 茅tude multicentrique, randomis茅e, en double aveugle, contr么l茅e par placebo et 脿 conception adaptative.
Le communiqu茅 de presse est joint en annexe au rapport de la soci茅t茅 et est fourni 脿 titre d'information plut么t que d茅pos茅. La diffusion porte sur les progr猫s du d茅veloppement clinique鈥攑lus pr茅cis茅ment l'expansion g茅ographique de l'enr么lement des patients dans un essai de phase avanc茅e 茅valuant Annamycin plus Ara-C pour le R/R AML.
Moleculin Biotech hat den Beginn der EU-Rekrutierung f眉r seine entscheidende Phase-2B/3-Studie von Annamycin in Kombination mit Cytarabin (AnnAraC) f眉r Erwachsene mit rezidivierter oder refrakt盲rer akuter myeloischer Leuk盲mie (R/R AML) bekannt gegeben. Das Unternehmen meldete, dass die ersten beiden Probanden in der Europ盲ischen Union eingeschlossen wurden und ein Proband behandelt wurde, womit die Teilnahme der EU an einer multizentrischen, randomisierten, doppelblinden, placebokontrollierten Studie mit adaptivem Design begonnen hat.
Die Pressemitteilung ist dem Bericht des Unternehmens als Anlage beigef眉gt und wird zur Verf眉gung gestellt, nicht jedoch eingereicht. Die Bekanntgabe konzentriert sich auf den Fortschritt der klinischen Entwicklung 鈥� insbesondere auf die geografische Ausweitung der Patientenrekrutierung in einer sp盲ten Phase, die Annamycin plus Ara-C f眉r R/R AML untersucht.
- Initiation of EU enrollment in the pivotal Phase 2B/3 study expands geographic reach for patient recruitment
- First treated subject in the EU demonstrates site activation and initial dosing capability
- Study design is randomized, double-blind, placebo-controlled and adaptive, appropriate for assessing Annamycin plus Ara-C in R/R AML
- None.
Insights
TL;DR: EU enrollment and first treated subject indicate trial operational progress and regulatory/operational readiness in Europe.
This update shows the pivotal Phase 2B/3 study has moved beyond U.S.-only activity to include European sites, which can accelerate patient accrual and broaden regulatory relevance. The trial's randomized, double-blind, placebo-controlled, adaptive design is appropriate for assessing safety and efficacy in R/R AML, and initial EU treatment suggests site activation and supply chain processes functionally in place. The announcement is procedural and does not provide outcome data or enrollment pace beyond the first two EU subjects.
TL;DR: Early EU enrollment is a modest positive operational milestone but lacks financial or efficacy details.
The company reports operational progress by enrolling two EU subjects and treating one in its pivotal trial of AnnAraC. This is a constructive clinical development milestone because successful multinational enrollment can shorten timelines and support regulatory filings across jurisdictions. However, no efficacy, safety, enrollment rate, or timeline guidance was disclosed, so investor impact is limited until further data or broader enrollment metrics are provided.
Moleculin Biotech ha annunciato l'avvio delle arruolazioni nell'UE per il suo studio pivotale di fase 2B/3 su Annamycin in combinazione con citarabina (AnnAraC) destinato ad adulti con leucemia mieloide acuta recidivante o refrattaria (R/R AML). L'azienda ha riferito che i primi due soggetti nell'Unione Europea sono stati arruolati e uno di essi 猫 stato trattato, segnando l'inizio della partecipazione dell'UE a uno studio multicentrico, randomizzato, in doppio cieco, controllato con placebo e a disegno adattivo.
Il comunicato stampa 猫 allegato come documento alla relazione dell'azienda ed 猫 fornito come informazione piuttosto che depositato. La comunicazione si concentra sui progressi nello sviluppo clinico鈥攊n particolare sull'espansione geografica dell'arruolamento dei pazienti in uno studio avanzato che valuta Annamycin pi霉 Ara-C per R/R AML.
Moleculin Biotech anunci贸 el inicio del reclutamiento en la UE para su ensayo pivotal de fase 2B/3 de Annamycin combinado con citarabina (AnnAraC) en adultos con leucemia mieloide aguda en reca铆da o refractaria (R/R AML). La compa帽铆a inform贸 que los dos primeros sujetos en la Uni贸n Europea han sido reclutados y uno de ellos ha recibido tratamiento, marcando el inicio de la participaci贸n de la UE en un estudio multic茅ntrico, aleatorizado, doble ciego, controlado con placebo y de dise帽o adaptativo.
El comunicado de prensa se adjunta como anexo al informe de la compa帽铆a y se proporciona como informaci贸n en lugar de presentarse formalmente. La divulgaci贸n se centra en el avance del desarrollo cl铆nico鈥攅spec铆ficamente en la expansi贸n geogr谩fica del reclutamiento de pacientes en un ensayo en fase avanzada que eval煤a Annamycin m谩s Ara-C para R/R AML.
Moleculin Biotech電� 鞛皽靹� 霕愲姅 攵堨潙靹� 旮夓劚 瓿垬靹� 氚表槇氤�(R/R AML) 靹膘澑鞚� 雽�靸侅溂搿� 頃� 鞎勲倶毵堨澊鞁�(Annamycin)瓿� 鞁滍儉霛茧箞(cytarabine, AnnAraC)鞚� 欷戩稊鞝� 2B/3靸� 鞁滍棙鞐� 雽�頃� EU 雮� 霌彪鞚� 鞁滌瀾頄堧嫟瓿� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� 鞙犽熃鞐绊暕鞐愳劀 觳橃潓 霊� 氇呾潣 頂柬棙鞛愱皜 霌彪霅橃棃瓿� 攴胳 頃� 氇呾澊 旃橂毳� 氚涭晿雼り碃 氤搓碃頄堨溂氅�, 鞚措姅 雼り赴甏� 氍挫瀾鞙� 氚办爼, 鞚挫毵龟瞼, 鞙勳暯雽�臁�, 鞝侅潙順� 靹り硠 鞐瓣惮鞐� 雽�頃� EU 彀胳棳鞚� 鞁滌瀾鞚� 鞚橂頃╇媹雼�.
氤措弰鞛愲電� 須岇偓 氤搓碃靹滌棎 觳秬霅� 鞝勳嫓氍茧 鞝滉车霅橂┌ 鞝滌稖霅� 氍胳劀電� 鞎勲嫏雼堧嫟. 頃措嫻 瓿奠嫓電� 鞛勳儊 臧滊皽 歆勴枆鈥旐姽頌� 鞛皽靹�/攵堨潙靹� AML鞐� 雽�頃� Annamycin瓿� Ara-C 氤戩毄鞚� 韽夑皜頃橂姅 頉勱赴 鞁滍棙鞐愳劀 頇橃瀽 霌彪鞚� 歆�毽爜 頇曥灔鈥旍棎 齑堨爯鞚� 毵烄稊瓿� 鞛堨姷雼堧嫟.
Moleculin Biotech a annonc茅 le lancement des enr么lements dans l'UE pour son essai pivotal de phase 2B/3 d'Annamycin en association avec la cytarabine (AnnAraC) chez des adultes atteints de leuc茅mie my茅lo茂de aigu毛 en rechute ou r茅fractaire (R/R AML). La soci茅t茅 a rapport茅 que les deux premiers sujets dans l'Union europ茅enne ont 茅t茅 enr么l茅s et qu'un sujet a 茅t茅 trait茅, marquant le d茅but de la participation de l'UE 脿 une 茅tude multicentrique, randomis茅e, en double aveugle, contr么l茅e par placebo et 脿 conception adaptative.
Le communiqu茅 de presse est joint en annexe au rapport de la soci茅t茅 et est fourni 脿 titre d'information plut么t que d茅pos茅. La diffusion porte sur les progr猫s du d茅veloppement clinique鈥攑lus pr茅cis茅ment l'expansion g茅ographique de l'enr么lement des patients dans un essai de phase avanc茅e 茅valuant Annamycin plus Ara-C pour le R/R AML.
Moleculin Biotech hat den Beginn der EU-Rekrutierung f眉r seine entscheidende Phase-2B/3-Studie von Annamycin in Kombination mit Cytarabin (AnnAraC) f眉r Erwachsene mit rezidivierter oder refrakt盲rer akuter myeloischer Leuk盲mie (R/R AML) bekannt gegeben. Das Unternehmen meldete, dass die ersten beiden Probanden in der Europ盲ischen Union eingeschlossen wurden und ein Proband behandelt wurde, womit die Teilnahme der EU an einer multizentrischen, randomisierten, doppelblinden, placebokontrollierten Studie mit adaptivem Design begonnen hat.
Die Pressemitteilung ist dem Bericht des Unternehmens als Anlage beigef眉gt und wird zur Verf眉gung gestellt, nicht jedoch eingereicht. Die Bekanntgabe konzentriert sich auf den Fortschritt der klinischen Entwicklung 鈥� insbesondere auf die geografische Ausweitung der Patientenrekrutierung in einer sp盲ten Phase, die Annamycin plus Ara-C f眉r R/R AML untersucht.
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(State or Other Jurisdiction of
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(Commission File No.)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c))
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Regulation FD Disclosure
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Exhibit
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Description
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99.1
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Press Releasedated September 8, 2025
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104
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Cover page Interactive Data File (formatted as Inline XBRL document)
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MOLECULIN BIOTECH, INC.
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Date:
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September 8, 2025
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Jonathan P. Foster
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FAQ
What did Moleculin Biotech (MBRX) announce about its AnnAraC trial?
Does the filing include clinical results or safety data for AnnAraC?
Is the press release attached to the 8-K filed or furnished?
What is the design of the pivotal trial mentioned by MBRX?
