Moleculin Engages Industry Veteran Adriano Treve to Explore Accelerated Strategic Partnerships
Moleculin Biotech (Nasdaq: MBRX) has appointed Adriano Treve as Strategic Advisor for partnerships. Treve brings over 40 years of experience from Roche, with extensive expertise in global healthcare markets and senior executive roles across multiple regions.
The appointment comes at a crucial time as Moleculin approaches key milestones in its Phase 2B/3 MIRACLE trial of Annamycin (naxtarubicin) in combination with cytarabine for acute myeloid leukemia (AML). The company expects the first unblinding of data for 45 patients in H2 2025, followed by a second unblinding in H1 2026.
Annamycin currently holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications, including relapsed or refractory AML and soft tissue sarcoma treatment.
Moleculin Biotech (Nasdaq: MBRX) ha nominato Adriano Treve come Consulente Strategico per le partnership. Treve vanta oltre 40 anni di esperienza presso Roche, con una profonda conoscenza dei mercati sanitari globali e ruoli dirigenziali senior in diverse regioni.
La nomina arriva in un momento cruciale, mentre Moleculin si avvicina a importanti traguardi nel suo trial MIRACLE di Fase 2B/3 con Annamycin (naxtarubicina) in combinazione con citarabina per la leucemia mieloide acuta (LMA). L'azienda prevede il primo svelamento dei dati relativi a 45 pazienti nella seconda metà del 2025, seguito da un secondo svelamento nella prima metà del 2026.
Annamycin detiene attualmente lo Status Fast Track e la Designazione di Farmaco Orfano sia dalla FDA che dall'EMA per diverse indicazioni, inclusi il trattamento della LMA recidivante o refrattaria e dei sarcomi dei tessuti molli.
Moleculin Biotech (Nasdaq: MBRX) ha designado a Adriano Treve como Asesor Estratégico para asociaciones. Treve aporta más de 40 años de experiencia en Roche, con amplia experiencia en mercados globales de salud y roles ejecutivos senior en múltiples regiones.
El nombramiento llega en un momento clave, ya que Moleculin se acerca a hitos importantes en su ensayo MIRACLE de Fase 2B/3 de Annamycin (naxtarubicina) en combinación con citarabina para la leucemia mieloide aguda (LMA). La compañía espera el primer desenmascaramiento de datos para 45 pacientes en la segunda mitad de 2025, seguido de un segundo desenmascaramiento en la primera mitad de 2026.
Annamycin actualmente cuenta con estatus Fast Track y designación de medicamento huérfano tanto de la FDA como de la EMA para varias indicaciones, incluyendo el tratamiento de LMA recidivante o refractaria y sarcoma de tejidos blandos.
Moleculin Biotech (나스닥: MBRX)는 Adriano Treve를 파트너십 전략 고문으로 임명했습니다. Treve는 Roche에서 40년 이상의 경력을 보유하고 있으며, 글로벌 헬스케어 시장과 여러 지역에서의 고위 임원 경험을 갖추고 있습니다.
이번 임명은 Moleculin이 급성 골수성 백혈병(AML) 치료를 위한 Annamycin(나스타루비신)과 시타라빈 병용의 2B/3상 MIRACLE 임상 시험의 주요 이정표에 다가가는 중요한 시점에 이루어졌습니다. 회사는 2025년 하반기에 45명의 환자 데이터 첫 번째 공개를, 2026년 상반기에 두 번째 공개를 예상하고 있습니다.
Annamycin은 현재 FDA와 EMA로부터 재발 또는 불응성 AML 및 연부 조직 육종 치료를 포함한 여러 적응증에 대해 패스트 트랙 지위 및 희귀 의약품 지정을 받고 있습니다.
Moleculin Biotech (Nasdaq : MBRX) a nommé Adriano Treve conseiller stratégique pour les partenariats. Treve apporte plus de 40 ans d'expérience chez Roche, avec une expertise approfondie des marchés mondiaux de la santé et des postes de direction senior dans plusieurs régions.
Cette nomination intervient à un moment crucial, alors que Moleculin s'approche des étapes clés de son essai MIRACLE de phase 2B/3 d'Annamycin (naxtarubicine) en combinaison avec la cytarabine pour la leucémie myéloïde aiguë (LMA). La société prévoit le premier démasquage des données pour 45 patients au second semestre 2025, suivi d'un second démasquage au premier semestre 2026.
Annamycin bénéficie actuellement du statut Fast Track et de la désignation de médicament orphelin de la FDA et de l'EMA pour plusieurs indications, y compris le traitement de la LMA récurrente ou réfractaire et des sarcomes des tissus mous.
Moleculin Biotech (Nasdaq: MBRX) hat Adriano Treve als Strategischen Berater für Partnerschaften ernannt. Treve bringt über 40 Jahre Erfahrung von Roche mit, mit umfassender Expertise in globalen Gesundheitsmärkten und leitenden Führungspositionen in verschiedenen Regionen.
Die Ernennung erfolgt zu einem entscheidenden Zeitpunkt, da Moleculin wichtige Meilensteine in seiner Phase 2B/3 MIRACLE-Studie mit Annamycin (Naxtarubicin) in Kombination mit Cytarabin bei akuter myeloischer Leukämie (AML) erreicht. Das Unternehmen erwartet die erste Datenentblindung für 45 Patienten in der zweiten Hälfte 2025, gefolgt von einer zweiten Entblindung in der ersten Hälfte 2026.
Annamycin besitzt derzeit den Fast Track Status und die Orphan Drug Designation von sowohl der FDA als auch der EMA für verschiedene Indikationen, einschließlich der Behandlung von rezidivierender oder refraktärer AML und Weichteilsarkomen.
- Strategic appointment of Adriano Treve brings 40+ years of Roche leadership experience
- Upcoming milestone: First unblinding of Phase 2B/3 MIRACLE trial data in H2 2025
- Annamycin has secured Fast Track Status and Orphan Drug Designations from FDA and EMA
- Increased interest from potential strategic partners ahead of Phase 3 data
- None.
Insights
Moleculin's strategic advisor hire signals preparation for partnership deals ahead of crucial Phase 3 AML therapy data readouts.
Moleculin Biotech has made a strategic move by appointing Adriano Treve, a 40-year Roche veteran, as Strategic Advisor for partnerships. This appointment comes at a critical juncture as the company approaches the first unblinding of data from its Phase 2B/3 MIRACLE trial for Annamycin (naxtarubicin) in acute myeloid leukemia (AML) expected in H2 2025.
The timing of this hire strongly suggests Moleculin is positioning itself for potential partnership deals. Management explicitly states that "interest from potential strategic partners has significantly increased" with the approaching Phase 3 data readout. Treve's extensive experience in international markets and expanding access to treatments in underserved regions could be particularly valuable for a small biotech seeking global commercialization partnerships.
This announcement reveals important strategic context around Moleculin's lead asset. Annamycin has secured both Fast Track Status and Orphan Drug Designation from the FDA and EMA, regulatory advantages that enhance its commercial potential. The company is clearly preparing for what it hopes will be positive clinical results, with two data readouts scheduled: the first unblinding (45 subjects) in H2 2025 and a second unblinding in H1 2026.
For a small-cap biotech like Moleculin, securing the right partnership terms could significantly impact valuation, particularly if Annamycin demonstrates positive efficacy in AML, a disease with substantial unmet needs. The company appears to be building a dedicated team focused on partnership discussions, with Treve joining existing Business Advisor Dennis McNamara who specializes in strategic transactions for emerging life sciences companies.
40+ year career at Roche founded on dedication to bringing new innovative medicines to patients and making them accessible
HOUSTON, July 17, 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 the appointment of Adriano Treve as a Strategic Advisor for partnerships.
With over four decades of experience at Roche, Mr. Treve brings exceptional leadership and a deep understanding of global healthcare markets. He has held senior executive roles across diverse regions, including overseeing U.S. supply chains and serving in General Management positions in Portugal, Brazil, Turkey, and most recently as Area Head for Turkey, Russia, Iran, Central Asia, the Caucasus, Eastern Europe, and the Indian Subcontinent, where he played a pivotal role in broadening access to innovative treatments in underserved markets. Mr. Treve’s extensive expertise in international operations and market access is expected to be instrumental in advancing Moleculin’s strategic partnerships as the Company moves toward key milestones in its ongoing clinical trials.
In light of the upcoming unblinding of data for 45 patients in the Phase 2B/3 MIRACLE trial with Annamycin (naxtarubicin) in combination with cytarabine as second line treatment for acute myeloid leukemia (AML), Mr. Treve’s insights are anticipated to enhance its strategic positioning.
“Adriano’s extensive experience will be invaluable as we look to secure partnerships that optimize the value of Annamycin which we believe can potentially impact the global oncology drug market significantly,” stated Walter Klemp, Chairman and CEO.
Mr. Treve added, “I am excited to work closely with the Moleculin team to advance crucial solutions for patients with significant unmet medical needs. With the continued global expansion of the Phase 3 MIRACLE trial, positive feedback from investigators and the promising data demonstrated to date, I believe the Company is well positioned for strategic partnership opportunities.”
Mr. Klemp concluded, “With the timeline now visible for our Phase 3 data, interest from potential strategic partners has significantly increased. Adding Mr. Treve alongside our Business Advisor Mr. Dennis McNamara, with over 30 years’ experience with strategic transactions for emerging life sciences companies, is a combination that should significantly expand opportunities for Moleculin going into 2026 and is intended to help accelerate the development of key partnerships that could create a significant value inflection for Moleculin shareholders.”
Moleculin is currently advancing its 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. The Company expects to reach the first unblinding (45 subjects) in the second half of 2025, in addition to the second unblinding, which is expected in the first half of 2026.
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 acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia 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.
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 is also engaged in the development of 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, the timing of the release of the initial data on the first 45 subjects in the trial and the Company’s ability to reconcile the US and EU protocols with the FDA and EMA, respectively. 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
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