Moleculin Biotech, Inc. (MBRX): Business Model Canvas [Dec-2025 Updated]

You're digging into Moleculin Biotech, Inc. (MBRX) because you know its value isn't in current sales-it has zero revenue streams right now-but in the potential of Annamycin to finally crack multi-drug resistant Acute Myeloid Leukemia (AML) without the usual heart damage. Honestly, this is a classic biotech bet: high-risk, high-reward, and entirely dependent on executing that pivotal Phase 3 MIRACLE trial while managing a tight runway, evidenced by their $6.7 million cash position as of Q3 2025 against Q2 2025 operating burn of about $5.7 million ($3.6 million R&D plus $2.1 million G&A). This Business Model Canvas breaks down exactly how they partner, what resources they guard most closely, and where every dollar is currently being spent to get this next-generation therapy across the finish line. See how the key activities line up with their value proposition below.

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

You're looking at the ecosystem of external entities that Moleculin Biotech, Inc. (MBRX) relies on to push Annamycin through late-stage development and beyond. It's a web of specialized expertise, so let's lay out the key players and the numbers attached to those relationships as of late 2025.

Contract Research Organizations (CROs) for global Phase 3 trial execution

The pivotal, adaptive design Phase 3 MIRACLE trial for Annamycin plus cytarabine (AnnAraC) in relapsed or refractory AML relies on external CRO expertise. Moleculin Biotech engaged leading contract research organization Catalyst Clinical Research to help conduct this global study, which includes sites in the US, Europe and the Middle East. As of the second quarter of 2025, there were 4 active MIRACLE sites screening subjects in Ukraine, Georgia, Spain and the US. The trial expanded further, with regulatory approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia secured in July 2025, and the European Medicines Agency (EMA) approval adding nine additional countries. By the end of Q3 2025, Moleculin Biotech expected to add more than 20 additional clinical sites in the European Union (EU) and the US. As of November 2025, 60% of the first 45 subjects targeted for the initial unblinding had consented. The expected timeline for the first interim data readout, based on n=45 subjects, is the second half of 2025, with a second readout planned for 1H 2026 at approximately n=75-90 subjects. This trial structure, with input from the FDA, is intended to substantially de-risk the development pathway toward a potential AML approval. The company reported $6.70 million in cash as of September 30, 2025, and was actively seeking an additional $7 million to fund ongoing operations, including clinical trials.

Academic medical centers like Northwestern and Emory University for investigator-initiated trials

Moleculin Biotech leverages investigator-initiated studies (IITs) to explore Annamycin and other candidates like WP1066 in new settings. For Annamycin in third-line advanced pancreatic cancer, Moleculin is working with Atlantic Health on an investigator-initiated Phase 1B/2 single-arm study. Moleculin will supply the drug material and maintain the Investigational New Drug Application (IND) with the FDA, while Atlantic Health conducts and funds the study. Moleculin estimates the incremental trial costs associated with this study, mainly for drug supply and outside lab testing, to be approximately $1 million from 2026 into 2030.

For WP1066, an agreement was signed with Emory University to study various IV formulations in preclinical studies, with results anticipated in the second half of 2025. Separately, an IIT at Northwestern for an undisclosed indication has recruited 7 subjects to date, with Moleculin's main cost being drug product supply.

Here's a quick look at the IIT financial commitment:

Regulatory bodies (FDA, EMA) for Fast Track and Orphan Drug status approvals

Regulatory partnerships are crucial for expediting development pathways. Annamycin has secured significant designations that streamline its path to market for specific indications. The FDA has granted Annamycin Fast Track Status and Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia (AML).

• Annamycin also holds Orphan Drug Designation from the FDA for soft tissue sarcoma (STS).
• The European Medicines Agency (EMA) has granted Orphan Drug Designation for Annamycin in relapsed or refractory AML.
• The EMA approval also expanded the global MIRACLE trial, adding nine additional countries.
• Moleculin Biotech received positive FDA feedback on its pediatric study plan for Annamycin in children with R/R AML.

The company believes the input from the FDA following the Phase 1B/2 study substantially de-risked the development pathway for AML.

Manufacturing and supply chain partners for drug product (Annamycin)

Specific names of third-party contract manufacturing organizations (CMOs) or dedicated supply chain partners for large-scale commercial production of Annamycin were not publicly detailed in the latest filings. However, the operational partnerships require Moleculin Biotech to supply the drug product for clinical use. For instance, under the UNC agreement, Moleculin will supply Annamycin for the preclinical studies. Similarly, for the Atlantic Health IIT, Moleculin will supply Annamycin drug material. The Q3 2025 financial report showed total assets of $19.45 million, which covers the cost of supplying these clinical materials.

Research institutions like UNC-Chapel Hill for grant-funded preclinical work

Moleculin Biotech entered a research and material transfer agreement with the University of North Carolina at Chapel Hill (UNC), effective November 12, 2025, to support investigator-initiated preclinical research for Annamycin in pancreatic cancer. This work is being conducted as part of a series of funded grants. UNC investigators, led by William C. Zamboni, PharmD, PhD, will evaluate the ability of novel agents and modalities to enhance the tumor delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin. The studies will compare these formulations against Doxil and Free-doxorubicin in PDAC GEMM models (pancreatic ductal adenocarcinoma genetically engineered mouse models).

This collaboration aligns with Moleculin's strategy to advance Annamycin through multiple IITs. The company's EPS for Q3 2025 was -3.52, reflecting ongoing investment in these development activities.

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

You're looking at the core engine driving Moleculin Biotech, Inc. right now-the day-to-day, make-or-break actions required to push their pipeline, especially Annamycin, toward commercial viability. It's all about execution on clinical milestones and keeping the lights on through strategic financing.

Executing the pivotal Phase 3 MIRACLE trial for R/R AML

The primary activity centers on the pivotal, adaptive design Phase 2B/3 "MIRACLE" study of Annamycin in combination with cytarabine for refractory or relapsed Acute Myeloid Leukemia (R/R AML). As of November 13, 2025, Moleculin Biotech, Inc. reported 60% enrollment for this trial, meaning 60% of the target subjects for the first interim unblinding had consented. The targeted number for this initial unblinding milestone is 45 subjects. The company expects to complete treatment for these first 45 subjects in the first quarter of 2026, with the initial unblinded data release anticipated shortly thereafter. The second unblinding is expected in the first half of 2026. This global, multi-center trial is tracked under clinicaltrials.gov identifier NCT06788756 and euclinicaltrials.eu identifier 2024-518359-47-00. The operational focus has been site expansion; as of the Q2 2025 update, there were 4 active sites screening patients in Ukraine, Georgia, Spain, and the US, with plans to add more than 20 additional sites by the end of Q3 2025. The company is also advancing its pediatric plan, having received positive FDA feedback on the study plan, setting the start of that trial in 2027. This trial is the linchpin for potential accelerated NDA filing as early as 2027. It's a high-stakes race against the calendar.

Research and development (R&D) of pipeline candidates like WP1066 and WP1122

Beyond Annamycin, Moleculin Biotech, Inc. is actively managing the R&D for its other candidates. WP1066, an Immune/Transcription Modulator designed to inhibit p-STAT3, targets brain tumors and pancreatic cancer; the company is preparing to announce its IV delivery formulation by year-end 2025. WP1122, part of their antimetabolite portfolio, is being developed for pathogenic viruses and certain cancer indications. The financial commitment to this work is reflected in the R&D spend. For the three months ended June 30, 2025, Research and development expense was $3.6 million, down from $4.1 million in the same period of 2024, mainly due to a reduction in clinical trial activity. Furthermore, the company is leveraging data from other trials to support pipeline breadth. Positive topline results from the Phase 1B/2 trial (MB-107, identifier NCT04887298) for soft tissue sarcoma lung metastases showed a median overall survival (OS) of 13.5 months. That's a concrete number showing potential across indications.

• WP1066: Preparing IV delivery formulation announcement by year-end 2025.
• WP1122: Development focus on pathogenic viruses and certain cancer indications.
• MB-107 (STS lung mets) Median OS: 13.5 months (n=36).
• Q2 2025 R&D Expense: $3.6 million.

Securing and maintaining global intellectual property (IP) and patents

Protecting the platform is a constant, crucial activity. Moleculin Biotech, Inc. has been successful in bolstering its global IP position for Annamycin throughout 2025. In May 2025, the USPTO granted two new U.S. patents, bringing the total U.S. patents related to Annamycin to four. Both of these new patents have a base term extending until June 2040. More recently, in July 2025, the company received a Notice of Intent to Grant for a European patent application covering a preliposomal Annamycin lyophilizate, with a base term extending into 2040. To top that off, in October 2025, IP Australia granted Patent No. 2024203598 for a similar lyophilizate, also with a base term extending until June 2040. This layered protection across major jurisdictions is key to future value capture.

Raising capital through public offerings and warrant exercises

Sustaining multi-year clinical trials requires aggressive capital management. Moleculin Biotech, Inc. has actively engaged in financing activities. In June 2025, the company priced a public offering to raise approximately $5.9 million in gross proceeds by selling 16.08 million shares at $0.37 each. This activity is reflected in the Q3 2025 cash flow statement, which showed Net Cash from Financing Activities of $9.099M, with Equity Issuance/Repurchase at $5.221M. Financially, the position is tight; cash and cash equivalents stood at $6.70 million as of September 30, 2025, which the company noted was insufficient, actively seeking an additional $7 million to fund operations. This compares to $7.6 million cash on hand as of June 30, 2025, which was sufficient to fund operations only into Q4 2025. Overall, Moleculin Biotech has raised a total of $9.69M over 6 funding rounds historically. You definitely need to watch the cash burn rate here.

Managing regulatory submissions and clinical site expansion

Regulatory navigation is inseparable from site expansion. A major win in May 2025 was securing European Medicines Agency (EMA) approval to run the MIRACLE trial in nine additional European Union countries, including Belgium, France, Germany, Italy, Poland, and Spain. This expanded the global footprint significantly. Annamycin already holds Fast Track Status and Orphan Drug Designation from the FDA for R/R AML, plus Orphan Drug Designation from the EMA for the same indication. The operational team is focused on reconciling protocols between the FDA and EMA to maintain momentum across the US, Europe, and the Middle East sites. The goal is to keep the site count growing, aiming to move from 4 active sites in Q2 2025 to over 20 by the end of Q3 2025.

• FDA Designations: Fast Track Status and Orphan Drug Designation (R/R AML).
• EMA Designations: Orphan Drug Designation (R/R AML).
• EU Countries Approved for MIRACLE Trial: 9 (as of May 2025).
• Total Regions for MIRACLE Trial: US, Europe, and the Middle East.

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

You're assessing the core assets Moleculin Biotech, Inc. (MBRX) relies on to execute its late-stage development plan. Here's a breakdown of the tangible and intangible resources as of late 2025, grounded in the latest figures.

The most critical resource is the lead drug candidate itself, Annamycin. It is currently in a pivotal Phase 3 trial, known as the MIRACLE trial, for acute myeloid leukemia (AML). This program carries significant regulatory advantages, specifically Orphan Drug Designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for relapsed or refractory AML.

The clinical evidence supporting Annamycin is a major resource, differentiating it from older anthracyclines by addressing cardiotoxicity concerns. Here are the key statistical demonstrations of efficacy and safety:

• Median overall survival (OS) for complete remission subjects in the Phase 1B/2 AML trial: 15 months.
• Median OS for second-line AML patients in the Phase 1B/2 trial: 12 months.
• Complete Remission (CR) rate achieved in the total AML Phase 1B/2 population: 36%.
• CR rate achieved in second-line AML patients: 50%.
• Median duration of CR in the AML trial: 10 months.
• Observed cardiotoxicity in clinical subjects: Zero.
• Median OS for subjects treated with Annamycin for STS lung metastases (7th line therapy): 13.5 months.

The intellectual property (IP) portfolio provides the necessary market exclusivity to realize future revenue. This is considered the gold standard for protection in the sector. The composition of matter patent for Annamycin secures exclusivity at least through the year 2040. Moleculin Biotech, Inc. actively bolstered this by securing two new U.S. patents in May 2025, bringing the total U.S. patents covering Annamycin to four. The company also has additional patent applications pending globally.

The financial runway is a finite, yet crucial, resource. As of the end of the third quarter of 2025, Moleculin Biotech, Inc. reported cash and cash equivalents of approximately $6,703,000. This figure was up from $4,278,000 at the end of the prior year-end, aided by equity transactions.

The team's expertise underpins the ability to manage these complex assets. Here is a snapshot of the human capital resources:

The company also has other pipeline assets that represent potential future resources, though Annamycin is the primary focus:

• WP1066: p-STAT3 inhibitor targeting brain tumors, in Phase 2 and Phase 1/2.
• WP1122: Antimetabolite for pathogenic viruses, in Phase 2.
• WP1220: Targeting T-cell lymphoma, in Phase 1.

Finance: draft 13-week cash view by Friday.

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:

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.

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:

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).

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:

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):

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.