Monopar Therapeutics Inc. (MNPR): Business Model Canvas [Dec-2025 Updated]

You're looking at a pre-revenue biotech, and honestly, that means the business model is all about execution risk and pipeline value, not quarterly sales figures. For Monopar Therapeutics Inc., the core structure centers on advancing two major assets: getting ALXN1840 ready for an early 2026 NDA submission for Wilson Disease, and proving the MNPR-101 uPAR-targeted radiopharmaceutical platform in advanced cancers. Right now, they are funding this critical work with a $143.7 million cash position as of September 30, 2025, which is paying for the high-stakes R&D-like the $2.59 million in research costs during Q3 2025-while they wait for product revenue. This canvas shows you the precise partnerships and activities they are using to bridge that gap. It's a classic high-risk, high-reward structure. Dive into the nine building blocks below to see the full operational map.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Monopar Therapeutics Inc. relies on to push its pipeline, especially the radiopharmaceutical assets and the late-stage ALXN1840 program. These aren't just names on a slide; they represent critical operational dependencies and validation points for the business.

Clinical Research Organizations (CROs) for Global Trial Execution

The execution of clinical trials, like the ongoing Phase 1-stage MNPR-101-Zr imaging/dosimetry trial and the MNPR-101-Lu Phase 1a therapeutic trial in advanced cancers, requires external site support. You can see the financial commitment reflecting this activity in the reported expenses. For instance, in the first quarter of 2025, there was a $69,000 increase in clinical trial site activity related to MNPR-101 for radiopharmaceutical use compared to the first quarter of 2024. The trials are active and enrolling in Australia as of August 2025. The company's cash position as of September 30, 2025, at $143.7 million, is meant to fund the continuation and conclusion of these trials through at least December 31, 2027.

Academic Medical Centers and Key Opinion Leaders (KOLs) for Clinical Data Presentation

Presenting data at major medical congresses is a key partnership activity, lending credibility to the science. Monopar Therapeutics has leveraged KOLs for presentations on its key candidates in 2025:

• Matthew Lorincz, M.D., Ph.D., Professor of Neurology at the University of Michigan, presented new data on ALXN1840 at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025.
• Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Professor of Hepatology at King's College Hospital in London, shared results from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2025 on November 9, 2025.

NorthStar Medical Radioisotopes for Supply of Radioisotopes like Actinium-225

This is a foundational supply partnership for the radiopharma platform. Monopar Therapeutics and NorthStar Medical Radioisotopes, LLC, amended and extended their collaboration on June 11, 2024, establishing a long-term, non-exclusive master supply agreement. This agreement secures the supply of the therapeutic radioisotope Actinium-225 (Ac-225) for Monopar's development and potential future commercial programs, including MNPR-101. The amendment also clarified intellectual property rights; Monopar acquired full ownership of the MNPR-101 radiopharmaceutical platform rights from NorthStar. Both companies share ownership of the filed patent application covering the use of PCTA as a linker with Ac-225, which has shown superior binding and yield compared to DOTA. NorthStar is positioned to be the first commercial-scale producer of non-carrier-added (n.c.a.) Ac-225.

Contract Manufacturers for ALXN1840 and Radiopharmaceutical Drug Substance

While specific contract manufacturer names aren't public, the financial commitment to manufacturing is evident in the operating expenses. Research and Development (R&D) expenses for the third quarter of 2025 included a $937,582 increase attributed specifically to manufacturing activities related to ALXN1840 when compared to the third quarter of 2024. The net proceeds from the September 2025 financing are earmarked for the manufacture and supply of product.

Investment Banks (e.g., Morgan Stanley) for Capital Raises and Financing

Securing capital requires relationships with underwriters who manage the offerings. The September 23, 2025, underwritten public offering was managed by a syndicate of investment banks. Here are the key figures from that financing event:

The total gross proceeds from the offering before deducting underwriting discounts and commissions and the Share Repurchase were expected to be approximately $135 million. The remaining net proceeds, approximately $100 million, are designated for general corporate purposes, including clinical trial expenditures and product manufacture.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Key Activities

You're managing a clinical-stage biotech, so the key activities revolve around hitting critical regulatory and clinical milestones while keeping the lights on. For Monopar Therapeutics Inc. as of late 2025, the focus is clearly split between the late-stage Wilson disease asset and the emerging radiopharmaceutical franchise.

Preparing and submitting the ALXN1840 New Drug Application (NDA) to the FDA in early 2026

This is the near-term value driver. Monopar Therapeutics Inc. is actively assembling the regulatory package for ALXN1840, targeting an NDA submission to the U.S. Food and Drug Administration (FDA) in early 2026. You should note the internal target to engage with the FDA by the end of 2025. This activity followed the official transfer of the investigational new drug (IND) application sponsorship from Alexion Pharmaceuticals, which was effective as of June 6, 2025, with the FDA acknowledging the change on July 29, 2025. The R&D expenses for the third quarter of 2025 reflected this focus, hitting $2,589,749, which included a $937,582 increase in manufacturing activities related to ALXN1840 compared to the prior year period.

Conducting Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu in advanced cancers

The radiopharmaceutical pipeline is in active execution mode. The Phase 1 trials for both the imaging agent MNPR-101-Zr and the therapeutic agent MNPR-101-Lu are running. Here's the status:

• MNPR-101-Zr (imaging and dosimetry) and MNPR-101-Lu (therapeutic Phase 1a) clinical trials are active and enrolling in Australia.
• The physician-sponsored Expanded Access Program (EAP) for both MNPR-101-Zr and MNPR-101-Lu is active and enrolling in the U.S. at Excel Diagnostics and Nuclear Oncology Center (EDNOC).
• The FDA cleared the IND application for the MNPR-101-Lu Phase 1 dose-escalation trial on September 26, 2025.

Internal research and development to expand the radiopharmaceutical pipeline

Beyond the current Phase 1 trials, Monopar Therapeutics Inc. is investing in future assets. The company continues preclinical work on the MNPR-101-Ac program, with plans to advance it into the clinic. The commitment to this expansion is reflected in the operating expenses.

• Research and Development (R&D) expenses for the third quarter of 2025 totaled $2,589,749.
• This Q3 2025 R&D spend was an increase of $1,605,471 compared to the third quarter of 2024.

Managing regulatory compliance and intellectual property (IP) portfolio

Compliance is non-negotiable, especially with the ALXN1840 IND now fully under Monopar Therapeutics Inc.'s responsibility. On the IP front, the company is building a defensive moat around its novel targeting technology. You need to track the IP filings alongside the clinical progress.

• Full responsibility for the ALXN1840 IND was assumed following the transfer effective June 6, 2025.
• A provisional patent application for new radiopharmaceutical compounds and a family of linkers was filed in October 2024.

Securing capital through public offerings and managing investor relations

Keeping the cash runway long enough to hit the NDA target is a core activity. Monopar Therapeutics Inc. executed a significant capital raise in September 2025 to bolster operations through the expected NDA filing and beyond. General and Administrative (G&A) expenses also reflect investor relations and corporate management costs.

Here's the quick math on the September 2025 financing event:

The September offering, which priced shares at $67.67, was a key activity to extend the runway, which management now projects will last at least through December 31, 2027. This cash position is critical to fund the ALXN1840 NDA preparation and the ongoing radiopharmaceutical trials. Finance: review the burn rate against the $143.7 million cash balance by next Tuesday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Key Resources

The Key Resources for Monopar Therapeutics Inc. as of late 2025 are centered on its financial position, late-stage clinical assets, and proprietary technology platforms.

The balance sheet strength provides operational runway. Cash, cash equivalents, and investments stood at $143.7 million as of September 30, 2025. Monopar Therapeutics expects these current funds to be sufficient to continue operations at least through December 31, 2027.

The company's pipeline assets represent critical intellectual and development resources:

The proprietary technology platform underpins the radiopharmaceutical programs. This includes the proprietary MNPR-101 uPAR-targeted monoclonal antibody and linker technology. The MNPR-101 antibody targets the urokinase plasminogen activator receptor (uPAR), expressed in numerous tumor types. The linker technology is specifically designed to enhance the stability and biodistribution of therapeutic radiopharmaceuticals.

Human capital is a core resource, represented by the:

• Experienced management team with drug development and regulatory expertise.
• Team preparing to assemble a regulatory package and file an NDA for ALXN1840.
• Collaboration with investigators like Dr. Ebrahim S. Delpassand, MD, for the U.S. EAP.

Regulatory milestones also serve as key resources, specifically the FDA-cleared Investigational New Drug (IND) application for MNPR-101-Lu, which was cleared on September 26, 2025.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Value Propositions

You're looking at the core value Monopar Therapeutics Inc. is trying to deliver to its customer segments-patients and prescribers-through its distinct pipeline assets. This isn't just about having drugs; it's about what those drugs do that others don't, or don't do as well. The value propositions center on two main areas: a late-stage treatment for a rare disease and a novel radiopharmaceutical platform for oncology.

Here's the quick math on the pipeline assets that define the current value proposition:

For ALXN1840, the value is in providing a potential once-daily oral treatment that addresses both neurological and hepatic manifestations of Wilson Disease, a rare genetic condition causing toxic copper buildup. Data presented in late 2025 pooled efficacy from three trials (n=255) and safety from four trials (n=266). Specifically, in the Phase 2 ALXN1840-WD-204 copper balance study, treatment led to a rapid and sustained improvement in daily copper balance among the eight treated patients. This is critical because the 7 major Wilson Disease markets were valued at USD 326.0 Million in 2024, with projections suggesting growth to around USD 452.8 Million by 2034.

The radiopharmaceutical programs, MNPR-101-Lu (therapy) and MNPR-101-Zr (imaging), offer a targeted approach to advanced oncology. The value here is precision: using MNPR-101 to selectively target the urokinase plasminogen activator receptor (uPAR), which is found in aggressive tumors. This selectivity aims to deliver the therapeutic payload (lutetium-177 in MNPR-101-Lu) to kill cancer cells while minimizing damage to healthy tissue. The overall Solid Tumor Therapeutics Market was valued at USD 207.29 billion in 2025, expected to reach USD 307.41 billion by 2030.

Monopar Therapeutics Inc. is positioning itself to address these high unmet needs with a focused financial runway. The company reported cash, cash equivalents and investments of $143.7 million as of September 30, 2025. This funding is expected to support operations, including the NDA assembly for ALXN1840 and the continuation of the MNPR-101 trials, at least through December 31, 2027. The R&D expenses for the third quarter of 2025 were $2,589,749, up from $984,278 in Q3 2024, reflecting increased manufacturing and personnel costs. The net loss for Q3 2025 was $3.4 million, or $0.48 per share.

The value proposition is built on these tangible milestones and market opportunities:

• ALXN1840: Potential for long-term neurological and hepatic benefit in Wilson Disease patients.
• MNPR-101-Lu: First-in-human therapeutic trial for a uPAR-targeted radiopharma in advanced solid tumors.
• MNPR-101-Zr: Tool to select patients likely to benefit from the Lu-177 therapy.
• Addressing Rare Disease Market: Targeting a market segment valued at roughly $500 million in 2025.
• Addressing Oncology Market: Targeting the broad Solid Tumor Therapeutics Market, valued at USD 207.29 billion in 2025.
• Financial Runway: Expectation to continue operations through December 31, 2027 with current cash reserves.

The company is defintely focused on de-risking these assets through clinical data presentations at major meetings like AASLD 2025 and ANA 2025.

Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so your key customers aren't just patients; they're the investigators driving the science and the investors funding the journey. Monopar Therapeutics Inc. focuses its relationship strategy on these critical groups.

High-touch, direct engagement with clinical investigators and key medical experts

Direct engagement with the medical community is central to Monopar Therapeutics Inc.'s strategy, especially as its radiopharmaceutical programs, MNPR-101-Zr (imaging) and MNPR-101-Lu (therapy), are in Phase 1/Phase 1a clinical trials in Australia.

This relationship building involves presenting clinical data at major medical meetings to engage key opinion leaders. For instance, new data on ALXN1840 for Wilson Disease was presented at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025, and again at The Liver Meeting® 2025 (AASLD) on November 9, 2025.

The nature of these interactions is highly specialized, focusing on scientific exchange with experts like Professor Matthew Lorincz and Professor Aftab Ala.

• Phase 1/1a clinical trials for MNPR-101 are active and enrolling in Australia.
• Data presentations target specialized audiences like hepatologists and neurologists.
• Engagement supports the development of the late-preclinical stage MNPR-101-Ac program.

Regulatory relationship management with the FDA for NDA submission

Managing the relationship with the U.S. Food and Drug Administration (FDA) is a high-stakes, formal process. Monopar Therapeutics Inc. is actively preparing for a significant regulatory milestone with its late-stage asset, ALXN1840, for Wilson Disease.

The company is preparing to submit a New Drug Application (NDA) to the FDA in early 2026. This follows the official transfer of the Investigational New Drug (IND) application sponsorship for ALXN1840 from Alexion Pharmaceuticals, effective June 6, 2025, and acknowledged by the FDA on July 29, 2025. Furthermore, Monopar Therapeutics Inc. received FDA clearance on its IND application for MNPR-101-Lu on September 26, 2025.

Here's a quick look at key regulatory interactions as of late 2025:

Investor relations and communication via SEC filings and press releases

Investor relationships are managed through transparent, regular reporting, which is crucial for a clinical-stage company that relies on capital markets. You need to keep the street informed on cash position and development progress.

As of September 30, 2025, Monopar Therapeutics Inc. reported $143.7 million in cash, cash equivalents, and investments. The company projects these funds will be sufficient to continue operations at least through December 31, 2027. The third quarter of 2025 General & Administrative (G&A) expenses were $1,503,326. The Chief Financial Officer, Quan Vu, serves as the primary contact for investor relations inquiries.

Key communication touchpoints include:

• Filing the Quarterly Earnings Report (10-Q) on November 13, 2025, for the period ended September 30, 2025.
• Filing a shelf registration statement on Form S-3 on August 29, 2025, for up to $300,000,000 in securities.
• Shareholder support for executive compensation at the June 2025 Annual Meeting was 99.8% (4,382,795 votes for).

Expanded Access Program (compassionate use) for MNPR-101 in the U.S.

For patients with serious or life-threatening conditions where no satisfactory alternative exists, the Expanded Access Program (EAP) provides a direct, albeit limited, relationship channel. Monopar Therapeutics Inc. established this program in collaboration with Excel Diagnostics and Nuclear Oncology Center (EDNOC).

The physician-sponsored EAP for the investigational imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu received authorization to proceed from the FDA on June 11, 2025. This program is active and enrolling patients in the U.S.. The agents are designed to target challenging cancers, including triple-negative breast, pancreatic, and colorectal cancers.

The EAP is intended to serve as a potential pathway for access outside of formal clinical trials preceding FDA approval. Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Channels

You're looking at how Monopar Therapeutics Inc. gets its clinical data and, eventually, its products to the right people. For a clinical-stage company, the channels are heavily weighted toward research and regulatory interaction right now, but the groundwork for commercialization is being laid.

Clinical trial sites in Australia and the United States for drug development

The primary channels for Monopar Therapeutics Inc.'s drug development are the active clinical trial sites. For the radiopharmaceutical pipeline targeting advanced cancers, the focus is on the MNPR-101 program.

The MNPR-101-Zr Phase 1 (imaging and dosimetry) and MNPR-101-Lu (therapeutic) Phase 1a clinical trials are actively enrolling patients in Australia. The first site activated for the MNPR-101-Lu trial was the Melbourne Theranostic Innovation Centre (MTIC) in Australia. In the U.S., access is currently provided through a physician-sponsored Expanded Access Program (EAP) for MNPR-101-Zr and MNPR-101-Lu, which is authorized by the FDA and enrolling at Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas.

Here's a quick look at the current trial structure supporting these channels:

The investment in these channels is visible in the financials; R&D expenses for the first quarter of 2025 included a $69,000 increase attributed to clinical trial site activity related to MNPR-101.

Scientific and medical conferences (e.g., AASLD, ANA) for data dissemination

Disseminating clinical data is a critical channel for building credibility and attracting future partners or investors. Monopar Therapeutics Inc. has actively used major medical meetings for its late-stage ALXN1840 program for Wilson disease.

The key dissemination events as of late 2025 include:

• Presented long-term efficacy and safety data for ALXN1840 at the European Association for the Study of the Liver (EASL) International Liver Congress 2025 on May 7, 2025.
• Presented new data on ALXN1840 neurological efficacy at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025.
• Presented new data from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2025 on November 9, 2025.

The data shared at EASL included pooled results from three clinical trials (n=255) and safety data from an additional Phase 2 study with n=266 patients. These presentations are key to demonstrating the potential of ALXN1840 over the standard of care.

Direct communication with regulatory bodies (FDA) for drug approval

Direct engagement with the U.S. Food and Drug Administration (FDA) is the most crucial channel for bringing a drug to market. Monopar Therapeutics Inc. is managing two major regulatory tracks.

For ALXN1840, the company is preparing to submit a New Drug Application (NDA) to the FDA in early 2026. This program required a formal transfer of the Investigational New Drug (IND) application sponsorship from Alexion Pharmaceuticals, which the FDA acknowledged as effective on June 6, 2025.

For the radiopharmaceutical program, Monopar Therapeutics Inc. received FDA clearance on its IND application for MNPR-101-Lu on September 26, 2025, covering the protocol for a Phase 1, Open-Label, Multicenter, Dosimetry and Dose-Escalation Trial.

The company's current cash position, reported at $143.7 million as of September 30, 2025, is expected to fund operations, including assembling the regulatory package and filing the NDA for ALXN1840, through at least December 31, 2027.

Future commercial sales channel through specialty pharmacy and distribution networks

While the current focus is on clinical execution and regulatory submission, the path to commercialization for ALXN1840 involves establishing future sales channels. Monopar Therapeutics Inc. took full responsibility for the ALXN1840 program, including its commercial advancement. The company anticipates marketing products in the EU, the United Kingdom, and other jurisdictions in addition to the U.S. if approved. If successful, the commercial channel is expected to involve hiring sales representatives and conducting physician and patient association outreach outside the U.S.. Specific financial commitments or established contracts with specialty pharmacy or distribution networks as of late 2025 are not detailed in recent public filings, but the expectation of commercialization is baked into the funding runway extending through at least December 31, 2027.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Customer Segments

You're looking at the core groups Monopar Therapeutics Inc. (MNPR) needs to serve to get its pipeline to market, especially as they push for an NDA filing in early 2026. Here's the breakdown of those key customer segments based on late 2025 data.

Patients with Wilson Disease, a rare genetic disorder

This segment is focused on patients needing a treatment like ALXN1840 (tiomolybdate choline) for Wilson Disease, a rare genetic condition causing toxic copper buildup. The clinical evidence base is substantial, which directly informs this customer group.

• Pooled results from three clinical trials showed sustained clinical benefits over a median treatment duration of 2.63 years.
• Safety data, which included an additional Phase 2 study, involved n=266 patients.
• The Phase 2 ALXN1840-WD-204 copper balance study included 8 patients showing significant copper balance reduction.

The company is preparing to submit a New Drug Application (NDA) to the FDA for ALXN1840 in early 2026.

Oncology patients with uPAR-expressing advanced or metastatic solid tumors

This segment targets patients with aggressive cancers where the urokinase plasminogen activator receptor (uPAR) is expressed. The focus is on the MNPR-101 radiopharmaceutical programs.

Cancers mentioned as expressing uPAR include triple-negative breast, colorectal, and pancreatic cancers.

Clinical investigators and physicians specializing in hepatology, neurology, and oncology

These are the key opinion leaders and trial sites that validate and prescribe the treatments. While the exact number of specialists isn't public, their engagement is demonstrated by scientific presentations.

• Data on ALXN1840 were presented at the 150th American Neurological Association (ANA) Annual Meeting in September 2025.
• New data on ALXN1840 were presented at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2025 in November 2025.
• Data on ALXN1840 were presented at the European Association for the Study of the Liver (EASL) International Liver Congress 2025 in May 2025.

The company's R&D expenses for Q3 2025 were $2,589,749, reflecting ongoing clinical trial site activity and personnel costs.

Institutional and retail investors funding the pre-revenue operations

This segment provides the necessary capital to fund the clinical development and regulatory path. The company's financial position as of the end of Q3 2025 is a key data point for this group.

Here's the quick math on liquidity as of September 30, 2025:

Alexion, AstraZeneca Rare Disease ("AZ") is a significant stakeholder, having received 9.9% ownership of Monopar's outstanding common stock in October 2024 for the ALXN1840 license. The net loss for Q3 2025 was $0.48 per share. Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Cost Structure

You're looking at the expenses that fuel Monopar Therapeutics Inc.'s pipeline, which is heavily weighted toward clinical development and regulatory readiness as of late 2025. The cost structure is dominated by the push to get ALXN1840 ready for its targeted early 2026 New Drug Application (NDA) submission to the FDA, alongside advancing the radiopharmaceutical programs.

The operating expenses saw a significant step-up following the September 2025 capital raise, which was partly intended to cover these costs and extend the cash runway to at least December 31, 2027. The net loss for the nine months ending September 30, 2025, reached $8.5 million, up from $4.7 million in the same prior-year period, reflecting this accelerated burn rate.

Here's a look at the key components driving the cost base for the third quarter of 2025:

High research and development (R&D) expenses were reported at $2,589,749 in Q3 2025. This figure is a direct reflection of the increased activity across the pipeline.

General and administrative (G&A) costs totaled $1,503,326 for the third quarter of 2025. This increase, compared to $590,624 in Q3 2024, shows the cost of scaling up the corporate infrastructure to manage late-stage assets.

Clinical trial costs for Phase 1 programs and NDA preparation for ALXN1840 are embedded within the R&D spend. Monopar Therapeutics Inc. is actively conducting its first-in-human trials for the radiopharmaceuticals:

• MNPR-101-Zr Phase 1 (imaging and dosimetry) trial is active and enrolling.
• MNPR-101-Lu (therapeutic) Phase 1a clinical trial is active and enrolling in Australia.
• The company is focused on assembling the regulatory package for the ALXN1840 NDA submission targeted for early 2026.

Manufacturing costs for drug substance and finished product for clinical/regulatory use are a major component of the R&D increase. Specifically, manufacturing activities related to ALXN1840 accounted for an increase of $937,582 year-over-year in the R&D line item for Q3 2025.

Legal and regulatory fees associated with FDA submissions and IP protection contribute to the G&A structure. While Q3 data isn't broken out granularly for legal fees, Q2 2025 saw a $114,322 increase in legal fees year-over-year, indicating ongoing investment in regulatory navigation and intellectual property maintenance.

Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Revenue Streams

Monopar Therapeutics Inc. is currently operating as a pre-commercial entity, meaning product sales are not yet a source of revenue.

For the third quarter of 2025, Monopar Therapeutics Inc. reported $0 in product sales revenue.

The primary non-equity income stream for Monopar Therapeutics Inc. as of late 2025 is interest income generated from its cash and investments balance. As of September 30, 2025, the company held $143.7 million in cash, cash equivalents, and investments. This substantial cash position supported an interest income of $655K for the third quarter of 2025.

Future revenue potential is tied to the successful clinical development and subsequent commercialization or partnering of its pipeline assets. The two main anticipated sources are:

• Future potential revenue from commercial sales of ALXN1840 post-FDA approval.
• Future potential revenue from commercial sales of MNPR-101 radiopharmaceuticals.

The company is preparing to submit a New Drug Application (NDA) for ALXN1840 to the U.S. Food and Drug Administration (FDA) in early 2026. Analysts have speculated on the peak sales potential for ALXN1840, estimating it could reach approximately $500 million if approved.

The radiopharmaceutical pipeline, centered on MNPR-101, is advancing through clinical trials, which represents another significant, though less quantified, future revenue vector. This includes the MNPR-101-Lu therapeutic agent in Phase 1a trials and the MNPR-101-Ac program in late preclinical stages.

Here's a look at the current and near-term potential revenue components for Monopar Therapeutics Inc.:

Future revenue streams from licensing or collaboration agreements for pipeline assets are an inherent part of the model, given the company holds global rights to its PRIT platform, initially developed through academic partnerships. The company is focused on advancing its pipeline to maximize this potential.

The near-term focus is on achieving the NDA submission for ALXN1840, which is the clearest path to generating product revenue. If onboarding takes longer than expected, the cash runway extends to at least December 31, 2027, based on current funds. Finance: draft 13-week cash view by Friday.