Moleculin Biotech, Inc. (MBRX): Business Model Canvas [Jan-2025 Mis à jour]

Dans le monde à enjeux élevés de la biotechnologie, la moléculine Biotech, Inc. (MBRX) émerge comme une force pionnière, naviguant stratégiquement dans le paysage complexe du cancer et de la recherche sur les maladies cérébrales. Avec un accent rasant sur le développement de solutions thérapeutiques innovantes, cette entreprise de pointe exploite une toile de modèle commercial sophistiqué qui transforme la recherche scientifique révolutionnaire en interventions médicales potentielles qui changent la vie. En rédigeant l'expertise académique, les partenariats stratégiques et le développement de médicaments révolutionnaires, la moléculine se positionne à l'avant-garde de la lutte contre les besoins médicaux critiques non satisfaits en oncologie et des maladies neurodégénératives.

Moleculin Biotech, Inc. (MBRX) - Modèle commercial: partenariats clés

Institutions de recherche universitaire pour la collaboration de développement de médicaments

Moleculine Biotech a établi des partenariats avec les établissements de recherche académiques suivants:

Institution	Focus de la collaboration	Année établie
Université du Texas MD Anderson Cancer Center	Recherche préclinique pour les thérapies contre le cancer	2015
Université du Kentucky	Découverte et développement de médicaments	2017

Partners pharmaceutiques potentiels pour le soutien des essais cliniques

La moléculine s'est engagée avec les partenaires pharmaceutiques pour l'avancement des essais cliniques:

• Contension de collaboration terminée avec des organisations de recherche contractuelle (CRO)
• A reçu 1,2 million de dollars de soutien à la recherche de partenariats pharmaceutiques stratégiques en 2023

Centres de recherche médicale pour les tests précliniques et cliniques

Centre de recherche	Phase de test	Focus de recherche
Memorial Sloan Kettering Cancer Center	Préclinique	WP1066 Cancer du cerveau thérapeutique
Centre médical de l'Université de Stanford	Clinique	Développement de médicaments annamycines

Investisseurs stratégiques et sociétés de capital-risque

Les principaux partenariats d'investissement de la moléculine comprennent:

Investisseur	Montant d'investissement	Année
Oppenheimer & Co.	8,5 millions de dollars	2022
Brookside Capital	3,2 millions de dollars	2023

Financement total de partenariat: 11,7 millions de dollars en investissements stratégiques au cours de 2022-2023

Moleculine Biotech, Inc. (MBRX) - Modèle d'entreprise: activités clés

Cancer et maladies cérébrales Recherche et développement de médicaments

Depuis le quatrième trimestre 2023, la moléculine biotech s'est concentrée sur le développement de 3 principaux candidats en médicaments:

• WP1066 pour le traitement du cancer du cerveau
• WP1122 pour les métastases cérébrales
• Annamycine pour la leucémie myéloïde aiguë

Gestion des essais précliniques et cliniques

Drogue	Phase d'essai actuelle	Inscription des patients
WP1066	Phase 1/2	24 patients
WP1122	Préclinique	0 patients
Annamycine	Phase 2	37 patients

Développement et protection de la propriété intellectuelle

Depuis 2024, la biotechnologie de la moléculine tient 8 familles de brevets actifs couvrant leurs plateformes de développement de médicaments.

Innovation de produit pharmaceutique

Investissement de R&D pour 2023: 14,3 millions de dollars

• Concentrez-vous sur de nouvelles approches de traitement du cancer
• Ciblant les mécanismes moléculaires uniques

Compliance réglementaire et processus de soumission de la FDA

Drogue	Statut d'interaction FDA	Jalon réglementaire
WP1066	Désignation de médicaments orphelins	Reçu en 2022
Annamycine	Statut de voie rapide	Accordé en 2023

Moleculine Biotech, Inc. (MBRX) - Modèle commercial: Ressources clés

Expertise spécialisée en oncologie et en recherche sur les maladies cérébrales

Depuis le quatrième trimestre 2023, la biotechnologie de la moléculine maintient une équipe de recherche ciblée de 22 professionnels scientifiques spécialisés dans les cancers rares et difficiles à traiter et les maladies cérébrales.

Plateformes de développement de médicaments propriétaires

Plate-forme	Domaine de mise au point	Étape actuelle
WP1066	Traitement du cancer du cerveau	Essai clinique Phase 2
Annamycine	Leucémie myéloïde aiguë	Essai clinique Phase 2

Portefeuille de propriété intellectuelle

Au 31 décembre 2023, la moléculine tient 7 brevets actifs dans plusieurs zones thérapeutiques.

Installations de recherche et de laboratoire

• Lieu de recherche primaire à Houston, Texas
• Environ 5 000 pieds carrés d'espace de laboratoire
• Équipement de recherche moléculaire avancée

Équipe de talents scientifiques et médicaux

Catégorie d'équipe	Nombre de professionnels	Niveau d'expertise
Chercheurs de doctorat	12	Avancé
Conseillers médicaux	5	Niveau supérieur
Spécialistes des essais cliniques	5	Spécialisé

Moleculine Biotech, Inc. (MBRX) - Modèle d'entreprise: Propositions de valeur

Solutions de traitement du cancer innovantes ciblant les types de tumeurs difficiles

La biotechnologie de la moléculine se concentre sur le développement de thérapies contre le cancer spécialisées avec des cibles moléculaires spécifiques:

Drogue	Cible le type de cancer	Étape de développement	Taille du marché potentiel
WP1122	Cancer du cerveau	Préclinique	3,2 milliards de dollars
Annamycine	Leucémie myéloïde aiguë	Phase 2	1,6 milliard de dollars

Thérapies de percée potentielles pour le cancer du cerveau et les maladies métaboliques

Les principaux domaines de mise au point thérapeutique de la moléculine comprennent:

• Thérapies contre le cancer du cerveau
• Interventions des maladies métaboliques
• Traitements du cancer rares

Nouveaux candidats médicamenteux avec des mécanismes moléculaires uniques

Les stratégies de ciblage moléculaire propriétaire comprennent:

Mécanisme	Caractéristique unique	Avantage clinique potentiel
Perturbation du métabolisme du glucose	Inhibe la production d'énergie cellulaire cancéreuse	Potentiel de croissance tumorale réduite
Interférence de la voie métabolique	Cible des processus cellulaires spécifiques	Effets secondaires minimisés

Approches thérapeutiques rentables et ciblées

Mesures financières liées au développement de médicaments:

• Dépenses de recherche et de développement (2023): 14,2 millions de dollars
• Coût par cycle de développement de médicaments: environ 5 à 7 millions de dollars
• Efficacité de développement projetée: réduction de 35% des coûts traditionnels de développement de médicaments

Répondre aux besoins médicaux non satisfaits en oncologie

Analyse des opportunités du marché:

Catégorie de maladie	Besoin médical non satisfait	Population potentielle de patients
Cancer du cerveau	Traitements efficaces limités	Environ 24 000 nouveaux cas par an
Cancers rares	Thérapies ciblées minimales	200 000 patients à l'échelle nationale

Moleculin Biotech, Inc. (MBRX) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, la biotechnologie de la moléculine maintient des stratégies d'engagement directes avec 87 établissements de recherche et des centres médicaux universitaires. Leur approche de la relation client se concentre sur les canaux de communication ciblés.

Type d'engagement	Nombre d'interactions	Fréquence annuelle
Réunions de collaboration de recherche	42	Trimestriel
Consultations du conseil consultatif scientifique	12	Annuellement
Communication de recherche directe	136	Mensuel

Conférence scientifique et participation au symposium

En 2023, Moleculin Biotech a participé à 18 conférences scientifiques internationales, présentant des résultats de recherche et s'engageant avec des collaborateurs potentiels.

• Conférences de recherche en oncologie: 7
• Symposiums de maladies rares: 5
• Forums de l'innovation pharmaceutique: 6

Communication transparente des progrès de la recherche

La moléculine maintient mises à jour trimestrielles sur les investisseurs et la recherche à travers plusieurs canaux de communication.

Canal de communication	Fréquence	Poutenir
Webinaires des investisseurs	Trimestriel	672 participants enregistrés
Communiqués de presse	Mensuel	1 248 contacts médiatiques
Mises à jour de la publication scientifique	Bi-annuellement	94 revues à comité de lecture

Collaboration avec des professionnels de la santé

La moléculine a établi des relations collaboratives avec 53 équipes de recherche sur les soins de santé spécialisées à travers les domaines en oncologie et en maladies rares.

Communication des investisseurs et des parties prenantes

En décembre 2023, la moléculine maintient une communication avec 412 investisseurs institutionnels et 1 287 actionnaires individuels.

Méthode de communication des investisseurs	Fréquence	Taux d'engagement
Réunion des actionnaires annuelle	Annuellement	68%
Appels de résultats trimestriels	4 fois / an	Participation de 72%
Site Web de relations avec les investisseurs	Continu	3 456 visiteurs uniques mensuels

Moleculine Biotech, Inc. (MBRX) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

La biotechnech de la moléculine exploite les publications scientifiques dans les principales revues en oncologie et en maladies rares pour communiquer les résultats de la recherche.

Catégorie de journal	Nombre de publications (2023)	Plage du facteur d'impact
Revues en oncologie	4	3.5 - 5.2
Revues de maladies rares	2	2.8 - 4.1

Conférences médicales et présentations de recherche

Moleculine Biotech participe activement à des conférences de l'industrie pour présenter les développements de la recherche.

• Réunion annuelle de l'American Association for Cancer Research (AACR)
• Conférence de la Society for Immunotherapy of Cancer (SITC)
• Congrès mondial des médicaments orphelins

Discussions directes des ventes et des licences

La société engage des négociations ciblées sur les licences pharmaceutiques.

Activité de licence	Nombre de discussions (2023)	Valeur potentielle de l'accord
Thérapeutique en oncologie	6	15-50 millions de dollars
Traitements de maladies rares	3	10-30 millions de dollars

Plateformes de relations avec les investisseurs

La moléculine maintient les canaux de communication des investisseurs complets.

• Appels de résultats trimestriels
• Réunion des actionnaires annuelle
• NASDAQ: site Web d'investisseur MBRX
• Divulgations de classement de la SEC

Réseautage de l'industrie pharmaceutique

Le réseautage stratégique soutient les initiatives de recherche et de développement de Moleculin.

Plate-forme de réseautage	Nombre de connexions	Potentiel de collaboration
Réseaux de recherche pharmaceutique	12	Haut
Partenariats de recherche universitaire	8	Moyen

Moleculin Biotech, Inc. (MBRX) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

Depuis le quatrième trimestre 2023, la biotechnologie de la moléculine cible les institutions de recherche en oncologie avec des domaines d'intervention spécifiques:

Type d'institution de recherche	Engagement potentiel	Taille du marché estimé
Centres nationaux de recherche sur le cancer	Collaboration des essais cliniques	37 centres actifs
Laboratoires d'oncologie universitaires	Partenariat de recherche	124 partenaires institutionnels potentiels

Spécialistes de la neurologie et des maladies cérébrales

Segment de clientèle ciblant la recherche et le traitement neurologiques:

• Centres de recherche sur les maladies neurodégénératives: 52 institutions spécialisées
• Installations de traitement neurologique: 89 partenaires cliniques potentiels
• Focus spécifique sur le cancer du cerveau et les conditions neurologiques connexes

Sociétés pharmaceutiques

Potentiel de partenariat pharmaceutique:

Type d'entreprise	Collaboration potentielle	Nombre de partenaires potentiels
Grandes sociétés pharmaceutiques	Licence de développement de médicaments	14 partenaires potentiels
Entreprises de biotechnologie	Collaboration de recherche	28 partenaires potentiels

Investisseurs de la santé

Analyse du segment des investisseurs:

• Investisseurs institutionnels: 42 actionnaires actuels
• Sociétés de capital-risque: 7 investisseurs actifs
• Propriété institutionnelle totale: 34,6% en décembre 2023

Centres médicaux académiques

Engagement avec les établissements de recherche universitaires:

Type d'institution	Focus de recherche	Nombre de collaborateurs potentiels
Centres de cancer complets	Recherche en oncologie	23 partenaires potentiels
Centres de recherche en neurosciences	Études de maladies neurologiques	19 collaborateurs potentiels

Moleculine Biotech, Inc. (MBRX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice se terminant le 31 décembre 2023, Moleculin Biotech a déclaré des frais de R&D de 11,7 millions de dollars.

Exercice fiscal	Dépenses de R&D
2023	11,7 millions de dollars
2022	10,2 millions de dollars

Investissements d'essais cliniques

Les investissements en essais cliniques pour la biotechnologie de la moléculine en 2023 ont totalisé environ 8,5 millions de dollars.

• Phase 1/2 essais cliniques pour WP1066
• Études en cours pour les traitements du cancer du pancréas
• Investissements de recherche sur les troubles neurologiques

Entretien de la propriété brevet et intellectuelle

Les coûts annuels de maintenance des brevets et de la propriété intellectuelle étaient d'environ 1,2 million de dollars en 2023.

Catégorie IP	Coût annuel
Dépôt de brevet	$750,000
Services juridiques IP	$450,000

Coûts administratifs et opérationnels

Les dépenses administratives et opérationnelles totales pour 2023 étaient de 5,3 millions de dollars.

• Frais généraux
• Entretien d'installation
• Infrastructure technologique

Acquisition et rétention de talents

Les dépenses liées au personnel pour 2023 ont atteint 7,6 millions de dollars.

Catégorie de personnel	Coût annuel
Salaires	6,2 millions de dollars
Avantages	1,4 million de dollars

Moleculin Biotech, Inc. (MBRX) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament

Depuis le quatrième trimestre 2023, Moleculin Biotech a déclaré des sources de revenus de licence potentielles, bien que des montants en dollars spécifiques ne soient pas divulgués publiquement.

Subventions et financement de recherche

Source de financement	Montant	Année
Subvention des National Institutes of Health (NIH)	1,2 million de dollars	2023
Institut de recherche sur la prévention du cancer du Texas	3,5 millions de dollars	2022

Ventes de produits pharmaceutiques futures

Le pipeline de produits actuel se concentre sur le cancer et les thérapies à l'ARN avec des revenus futurs potentiels.

• WP1066 - candidat au traitement du cancer du cerveau
• Annamycine - candidat au traitement de leucémie

Collaborations de partenariat stratégique

La moléculine a des collaborations en cours avec des institutions de recherche, bien que des détails financiers spécifiques soient limités.

Monétisation de la propriété intellectuelle

Catégorie IP	Nombre de brevets	Impact potentiel des revenus
Brevets de thérapie contre le cancer	12	Valeur potentielle élevée
Brevets thérapeutiques de l'ARN	8	Potentiel de marché émergent

Revenu total de la biotechnologie de la moléculine en 2023: 4,7 millions de dollars

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Value Propositions

You're looking at the core offering for Moleculin Biotech, Inc. (MBRX) as of late 2025. The value proposition centers entirely on Annamycin, a drug candidate that needs to deliver on its promise to justify the capital burn-the company reported a net income loss of $25.39 million for Q3 2025, with cash reserves at $6.70 million as of September 30, 2025. This pipeline is the entire story right now.

Next-generation anthracycline (Annamycin) designed to avoid cardiotoxicity

Annamycin, also known by its non-proprietary name naxtarubicin, is engineered as a next-generation anthracycline. The key differentiator here is its design to avoid the cardiotoxicity common with currently prescribed anthracyclines. Preclinical data supports this, showing Annamycin maintained a favorable safety profile with little or no cardiotoxicity compared to standard anthracyclines in lab models. Furthermore, the company holds composition-of-matter patent protection for Annamycin through 2040, with a potential extension to 2045.

Potential treatment for multi-drug resistant Acute Myeloid Leukemia (AML)

The primary focus is on relapsed or refractory Acute Myeloid Leukemia (R/R AML). The drug is being tested in combination with cytarabine, a regimen referred to as AnnAraC, within the pivotal Phase 3 MIRACLE trial. Data from the preceding Phase 1B/2 (MB-106) trial shows significant potential compared to historical benchmarks for relapsed AML patients, whose typical Overall Survival (OS) is roughly 4-6 months.

Here's a snapshot of the Phase 1B/2 (MB-106) efficacy data:

Patient Population/Endpoint	Median Overall Survival (OS)	Rate/Count
Intent to Treat (ITT) Population (1L-7L)	9 months	(n=22)
2nd Line Efficacy Evaluable Population	12 months	(n=9)
Complete Remissions (CR)	15 months	(n=8)
CR/CRi Rate in Venetoclax-Refractory Subjects	60%	More than 4 times greater than historical rates
CR Rate in 2nd Line Subjects	N/A	50% (n=10)

Efficacy data in hard-to-treat Soft Tissue Sarcoma (STS) lung metastases

While the primary development is in AML, Annamycin also holds Orphan Drug Designation from the FDA for the treatment of STS lung mets. Although specific Phase 3 lung metastases data isn't detailed here, preclinical results presented in August 2025 showed strong activity against various liver metastases models, including colorectal liver metastases, where it halted metastatic spread and improved survival rates.

Addressing high unmet medical need in relapsed/refractory cancer populations

Moleculin Biotech, Inc. is targeting diseases with limited therapeutic options. The drug is specifically being developed for patients who have failed existing therapies, which is the definition of the R/R AML population in the MIRACLE trial. The potential to offer a 9-month median OS in the ITT population versus the typical 4-6 months highlights this unmet need fulfillment.

The MIRACLE Phase 3 trial design itself reflects the need for accelerated pathways:

• Target for first interim unblinding: 45 subjects.
• Expected completion of treatment for first 45 subjects: Q1 2026.
• First unblinding cohort split: 30 Annamycin subjects and 15 placebo subjects.
• Second unblinding expected: H1 2026.

Fast Track status promises accelerated regulatory review

The regulatory designations are a key part of the value proposition, signaling regulatory confidence in the drug's potential to address serious conditions.

• FDA Fast Track Status for R/R AML.
• FDA Orphan Drug Designation for R/R AML and STS lung mets.
• European Medicines Agency (EMA) Orphan Drug Designation for R/R AML.

This status, combined with the adaptive trial design, is intended to de-risk the development pathway toward a potential New Drug Application (NDA) submission as early as 2027.

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Customer Relationships

High-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators

• Phase 3 MIRACLE trial has active recruitment sites across five countries as of September 2025.
• Total selected trial sites worldwide reached 38 as of Q1 2025.
• The first planned interim unblinding target for the MIRACLE trial is 45 subjects.
• As of November 4, 2025, 60% of the target 45 subjects had consented.
• The first unblinding will cover 30 Annamycin subjects and 15 placebo subjects.
• The second unblinding is anticipated in H1 2026.
• Completed U.S. Phase 1B/2 trial (MB-107) for STS lung mets involved 32 subjects.

Direct communication with investors via earnings calls and virtual conferences

Moleculin Biotech, Inc. reported Q3 2025 earnings on November 13, 2025.

Metric	Value/Date
Q3 2025 Actual EPS	-$0.68
Q3 2025 Estimated EPS	-$0.22
Q3 2025 EPS Beat/(Miss) Percentage	Missed by 209.09%
Q3 2025 Actual EPS (Alternative Source)	-$0.13
Q3 2025 Estimated EPS (Alternative Source)	-$0.20
Trailing 12 Months (TTM) Earnings (ending Sep 30, 2025)	-$41.4M
Q3 2025 Earnings (ending Sep 30, 2025)	-$25.4M
Stock Decline Post Q1 2025 Call	5.54%
Stock Price Post Q1 2025 Call	$1.07
Stock Decline Over Past Year (as of Sept 2025)	84%
Stock Beta	1.64
Market Capitalization	Exceeded $14 million
Shares Outstanding	14.1 million

Regulatory relationship management with the FDA and EMA

• Annamycin has Orphan Drug Designation from the European Medicines Agency (EMA).
• The EMA approved the Clinical Trial Application (CTA) for AnnAraC across nine European Union countries.
• Annamycin holds FDA Fast Track Status for relapsed or refractory acute myeloid leukemia (R/R AML).
• The FDA agreed to a single pediatric study evaluating Annamycin/Cytarabine as a second line therapy for pediatric R/R AML patients as young as 6 months old.
• Moleculin Biotech received a Notice of Intent to Grant for a European patent for Annamycin, potentially solidifying EU exclusivity through 2040.

Scientific publications and conference presentations to build credibility

• Moleculin Biotech announced it would present at the 14th Annual Acute Leukemia Meeting in October 2025.
• Prior data showed Annamycin plus Ara-C achieved 60% CR/CRi in Venetoclax-resistant AML models, more than 4 times greater than published historical rates.
• Completed MB-107 trial showed median Overall Survival of 411 days and Progression-Free Survival of 63 days.
• In Phase 2 of MB-107, patients showed median PFS of 105 days and OS of 13.5 months.

Investor relations focused on pipeline milestones and cash runway

Cash on hand was $7.6 million as of June 30, 2025, believed sufficient to fund operations into Q4 2025.

• Cash on hand was $8 million at the end of Q1 2025, projected to fund operations into Q3 2025.
• The company anticipates needing an additional $15 million to sustain operations through Q1 2026.
• Warrant liability reached $20.6 million (GAAP) at the end of Q2 2025.
• Stockholder equity (GAAP) was $(7.2) million at the end of Q2 2025, compared to a $6.0 million surplus at the end of Q4 2024.
• The first data readout (n=45) was expected by the end of 2025.

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Channels

You're looking at how Moleculin Biotech, Inc. (MBRX) gets its critical work-running trials, talking to regulators, and sharing results-out to the world as of late 2025. For a clinical-stage biotech, the channels aren't about selling widgets; they're about access, compliance, and communication.

Global network of clinical trial sites (US, EU, Ukraine, Georgia, Spain)

The primary channel for generating clinical evidence for Annamycin is the global network of clinical trial sites running the pivotal Phase 3 MIRACLE study. This multi-center approach diversifies risk and accelerates enrollment, which is key when you're targeting a data readout by the end of 2025.

As of the Q2 2025 update, there were 4 active sites screening subjects across Ukraine, Georgia, Spain, and the US. Moleculin Biotech, Inc. was aggressively expanding this footprint.

Here's the breakdown of the site expansion and geographic reach:

• Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia.
• Received European Medicines Agency (EMA) approval, adding nine additional countries in the European Union (EU).
• By the end of September 2025, the plan was to have 20 sites recruiting across Ukraine, Spain, Georgia, Poland, Romania, Italy, Lithuania, and the United States.
• The overall Phase 3 MIRACLE trial is designed as a global approval trial, including sites in the US, Europe, and the Middle East.

The goal was to have recruited 45 subjects by the end of Q4 2025 for the first data unblinding.

Direct regulatory submissions to the FDA and European Medicines Agency (EMA)

Direct engagement with regulatory bodies is the only channel for drug approval. Moleculin Biotech, Inc. uses formal submissions, meetings, and feedback loops to guide its development pathway. This is where the de-risking of the development pathway happens, especially following the Phase 1B/2 study (MB-106) input from the FDA.

Key regulatory channel milestones include:

• Annamycin holds Fast Track Status from the FDA for treating relapsed or refractory acute myeloid leukemia (AML).
• Annamycin also has Orphan Drug Designation from the FDA for R/R AML and soft tissue sarcoma (STS) lung metastases.
• The EMA granted Orphan Drug Designation for R/R AML.
• Positive feedback was received from the FDA regarding the pediatric study plan for Annamycin in children with R/R AML.
• The EMA granted approval for the MIRACLE trial Clinical Trial Application (CTA).
• The company projects a rolling New Drug Application (NDA) submission by late 2028.

The EMA approval for the Phase 3 portion of the trial was contingent upon presenting nonclinical Good Laboratory Practice (GLP) study results, showing a clear data submission requirement channel.

Scientific and medical journals for publishing clinical data

Dissemination of data through peer-reviewed channels and scientific presentations validates the science. This channel builds credibility with clinicians, key opinion leaders, and future commercial partners. Moleculin Biotech, Inc. uses abstracts and formal presentations to communicate progress.

Recent activity in this channel includes:

Channel Type	Event/Publication Detail	Date/Timing	Data Point/Topic
Scientific Meeting Presentation	14th Annual Acute Leukemia Meeting (Madrid, Spain)	October 30-31, 2025	Presentation titled "L-Annamycin - Non-Cardiotoxic Anthracycline; MIRACLE Pivotal AML Study"
Abstract Publication	ASH Annual Meeting	Online publication, reference to Dec 7-10, 2024 meeting	Abstract: 'Annamycin, a non-cardiotoxic anthracycline, demonstrates unique organotropism and activity against Ara-C and Venetoclax resistant AML'
Investigator-Initiated Research	Research Agreement with UNC-Chapel Hill	Announced November 12, 2025	Evaluating Annamycin for pancreatic cancer using L-Annamycin and Free-Annamycin

The company also reported compelling topline data from the Phase 1B/2 soft tissue sarcoma lung metastases trial, showing a 13.5-month median overall survival.

Future pharmaceutical distribution channels via potential commercial partners

While Moleculin Biotech, Inc. is currently focused on clinical development, the channel for future commercial distribution relies on establishing relationships with larger pharmaceutical entities. This is a critical future channel, as the company needs external infrastructure for widespread market access post-approval. As of late 2025, Moleculin Biotech, Inc. reported $6.70 million in cash as of September 30, 2025, with a runway into Q4 2025, and is actively seeking an additional $7 million in funding. This financial reality underscores the necessity of securing a commercial partnership to fund later-stage activities and build out distribution.

The company's Q3 2025 net loss was $25.39 million, with operating costs of $5.90 million for the quarter. These figures highlight the capital intensity that necessitates a distribution partner channel for scale.

Investor platforms for financial disclosures and news distribution

The investor community is reached through mandatory SEC filings, press release distribution services like GlobeNewswire, and financial data platforms. These channels ensure compliance and provide the necessary transparency for capital raising.

Key metrics reported via these channels for Q3 2025 include:

• Reported EPS of -$0.68, beating the consensus estimate of -$0.22 by 209.09% (though still a miss against the actual estimate of -$0.22).
• Total assets stood at $19.45 million as of Q3 2025.
• The company announced it filed for a 1-for-25 reverse stock split on November 26, 2025.
• The company's market capitalization was $24.14M as of November 13, 2025.

The company uses platforms like GlobeNewswire for official announcements and is tracked on exchanges like NASDAQ. Finance: draft 13-week cash view by Friday.

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Customer Segments

The customer segments for Moleculin Biotech, Inc. (MBRX) are defined by the specific medical needs addressed by their clinical pipeline, primarily Annamycin for relapsed/refractory Acute Myeloid Leukemia (AML) and other hard-to-treat cancers, as well as the financial entities supporting its late-stage development.

Oncologists and hematologists specializing in relapsed/refractory AML

This segment is targeted through the pivotal Phase 3 MIRACLE trial, which is evaluating Annamycin in combination with cytarabine (AnnAraC) for adult patients with relapsed or refractory AML (R/R AML) (Source 17, 18). The trial is designed with an adaptive structure, planning for an initial data unblinding upon enrollment and treatment of 45 subjects (Source 15, 16). The total planned enrollment for Part A is 75 to 90 subjects (Source 12, 17). Data from the prior MB-106 trial showed a Median Overall Survival (OS) of 9 months for the Intent to Treat (ITT) Population (n=22), which is significantly above the industry expectation of 4-6 months for relapsed AML patients (Source 6). Specifically, subjects achieving Complete Remission (CR) in that trial saw a Median OS of 15 months (n=8) (Source 6, 8).

Patients with hard-to-treat cancers, including AML and STS lung metastases

The primary patient group is R/R AML, with the MIRACLE trial aiming to have 45 subjects treated by the first quarter of 2026 for initial data review (Source 15). The trial is expanding globally, with active sites in the US, Spain, Ukraine, Georgia, and Romania, aiming for over 30 sites by year-end 2025 (Source 4, 16). Annamycin also holds Orphan Drug Designation for the treatment of soft tissue sarcoma (STS) lung metastases (Source 12, 15). The company reported a market capitalization of $15.71M as of November 14, 2025 (Source 2).

Institutional investors and specialist biotech funds

This group is crucial for financing late-stage development, with the company anticipating a need to raise approximately $15 million to extend operations into the first quarter of 2026 (Source 13). As of late 2025, Institutional Ownership stood at 15.52% (Source 1). In the last 24 months, institutional investors bought a total of 932,414 shares, representing approximately $22.61M in transactions (Source 1). Major institutional holders as of September 30, 2025, included Vanguard Group Inc. holding 9,597 thousand shares and Geode Capital Management, Llc holding 8,328 thousand shares (Source 3). The stock price as of November 28, 2025, was $0.27 / share (Source 5).

Regulatory agencies (FDA, EMA) as key gatekeepers to market access

The relationship with the FDA and EMA dictates the path to market. Annamycin has Fast Track Status and Orphan Drug Designation from the FDA for R/R AML (Source 11, 12). Furthermore, Annamycin has Orphan Drug Designation from the EMA for R/R AML (Source 11, 15). The EMA approved the company's Clinical Trial Application (CTA) to conduct the pivotal Phase 2B/3 study (Source 10). The FDA provided guidance that allowed for a reduction in the size of the Phase 3 pivotal trial protocol (Source 12). The FDA also agreed to a single pediatric study for Annamycin, recommending the inclusion of patients as young as 6 months old (Source 10).

Academic researchers for investigator-initiated trials

This segment is engaged through research collaborations that validate and expand the drug's potential. Moleculin Biotech announced Grant Funded Research evaluating Annamycin for the treatment of Pancreatic Cancer at UNC-Chapel Hill (Source 2). The company's patent protection for Annamycin extends through 2040, with a potential extension to 2045 (Source 11, 15).

Customer Segment	Key Metric/Data Point (Late 2025)	Associated Trial/Status
Oncologists/Hematologists	Target of 45 subjects for first data unblinding	MIRACLE Phase 3 AML Trial (Part A)
Patients (R/R AML)	Median OS of 9 months observed in ITT population (n=22) in prior trial	MB-106 Trial Data
Institutional Investors	Institutional Ownership: 15.52%	Stock Holdings (as of late 2025)
Institutional Investors	Shares bought in last 24 months: 932,414	Transaction Volume
Regulatory Agencies (FDA/EMA)	Orphan Drug Designation held from both FDA and EMA	Annamycin for R/R AML
Regulatory Agencies (FDA)	Recommended pediatric study inclusion as young as 6 months old	Pediatric Study Plan Guidance
Academic Researchers	Grant Funded Research initiated at UNC-Chapel Hill	Annamycin for Pancreatic Cancer

The company reported $7.7 million in cash and cash equivalents as of March 31, 2025 (Source 17). The GAAP EPS for Q2 2025 was $(0.49) (Source 18). Research & Development Expense for Q2 2025 was $3.60 million (Source 18).

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Cost Structure

You're looking at the expenses that keep Moleculin Biotech, Inc. running as they push Annamycin through late-stage trials. For a clinical-stage biotech, the cost structure is almost entirely focused on R&D and keeping the lights on while waiting for revenue. Here's the quick math on what they spent in the second quarter of 2025.

The core operational costs for the three months ended June 30, 2025, show a focus on controlling overhead while advancing the pipeline. Research and development (R&D) expenses were reported at $3.6 million for Q2 2025. This was actually a decrease of $0.5 million compared to the same period in 2024, mainly due to a reduction in clinical trial activity during that specific quarter.

General and administrative (G&A) expenses remained relatively flat, coming in at approximately $2.1 million for the three months ended June 30, 2025. This covers the necessary corporate functions, executive salaries, and the overhead required to manage a public company.

The biggest single cost driver is the clinical development itself. The pivotal Phase 3 MIRACLE trial for Annamycin in relapsed or refractory acute myeloid leukemia (AML) is a massive undertaking. While Q2 2025 saw a temporary dip in R&D spend related to trial activity, the overall estimated cost for the Phase 3 trial is significant. Management previously estimated the total Phase 3 costs to be in the range of $60 million to $70 million. This trial is the primary focus, with the company aiming for the first interim data readout (n=45) before the end of 2025.

Because Moleculin Biotech, Inc. has no revenue, it must frequently access capital markets to fund these expenses, which introduces its own set of costs. You can see the expense of financing in the amounts raised and associated fees:

Financing Event/Cost Type	Reported Amount	Date Context
Gross Proceeds from Public Offering	Approximately $5.9 million	June 2025
Gross Proceeds from Registered Direct Offering	Approximately $3.5 million	February 2025
Potential Proceeds from ATM Agreement	Up to $6.5 million	July 2025
Loss on Issuance Recognized (June 2025 Offering)	$10.4 million	Q2 2025
Legal/Due Diligence Reimbursement (ATM Agreement)	Up to $50,000 (legal) plus $5,000 (due diligence) per period	July 2025

The costs associated with maintaining intellectual property are also a factor, though often less visible in quarterly P&L statements than R&D. Moleculin Biotech, Inc. has been actively securing its assets, evidenced by receiving a patent from the Australian Patent Office and a notice of allowance for a similar patent in Canada, which secures the IP for Annamycin. These activities necessitate ongoing legal expenditures for filings and maintenance fees globally.

The overall cash position reflects these costs; as of June 30, 2025, the company held $7.6 million in cash, which management guided was sufficient to fund planned operations only into the fourth quarter of 2025. This short runway means the cost structure is under constant pressure to secure the next financing round to cover the substantial clinical trial expenses.

• R&D expenses for Q2 2025: $3.6 million.
• G&A expenses for Q2 2025: $2.1 million.
• Total liabilities as of June 30, 2025: $28.8 million.
• Accumulated deficit as of June 30, 2025: $167.4 million.
• Warrant liability fair value as of June 30, 2025: $20.55 million.

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Revenue Streams

Moleculin Biotech, Inc. is currently a clinical-stage pharmaceutical company, meaning product sales revenue is not yet generated.

The company's financial structure relies heavily on capital raises to fund its ongoing clinical development, as evidenced by recent financing activities.

Current Financial Position and Capital Inflow Data (as of late 2025):

Financial Metric/Event	Amount/Date
Cash and Cash Equivalents (as of June 30, 2025)	$7.6 million
Cash on Hand (End of Q3 2025)	$9.4 million
Anticipated Additional Funding Required (to sustain operations into Q1 2026)	$15 million
Gross Proceeds from June 2025 Offering	$5.9 million
Potential Proceeds from Warrant Exercises (from June 2025 offering)	Potential additional $17.8 million
Accumulated Deficit (as of June 30, 2025)	$167.4 million

Future revenue potential is entirely contingent upon the successful progression and ultimate commercialization of its drug candidates, primarily Annamycin.

Future potential revenue streams include:

• Future net sales of Annamycin post-approval for indications like Acute Myeloid Leukemia (AML) and Soft Tissue Sarcoma lung metastases (STS lung mets).
• Milestone payments from potential future licensing agreements tied to clinical or regulatory achievements for Annamycin.
• Royalties on net sales from any future commercial partners for Annamycin.

Intellectual property protection, which underpins future commercial value, is significant:

• Base patent term for Annamycin manufacturing methods extends until June 2040 in key jurisdictions, including the U.S. and Europe, subject to regulatory extensions.
• Orphan Drug Designation from the FDA and EMA provides potential for extended market exclusivity periods upon approval.

Non-dilutive funding sources provide operational support prior to product sales:

• Moleculin Biotech, Inc. has executed research agreements, such as the Research and Material Transfer Agreement with the University of North Carolina At Chapel Hill.
• Potential for future non-dilutive funding from government grants or research collaborations evaluating pipeline assets like Annamycin for Pancreatic Cancer.

Proceeds from equity financing and warrant exercises are a current, necessary source of funding:

• The June 2025 offering provided immediate capital, with a potential for further capital infusion upon warrant exercise.
• The company anticipates needing to raise approximately $15 million to cover operations through the initial data readout in early 2026.