Monopar

What Monopar does

Monopar Therapeutics Inc. (NASDAQ: MNPR) is a clinical-stage biopharmaceutical company founded in 2014 and headquartered in Wilmette, Illinois, developing therapeutics for rare diseases and oncology. Its lead program, ALXN1840 (tiomolibdate choline), is a novel first-in-class Albumin Tripartite Complex (ATC) activator in-licensed from Alexion Pharmaceuticals/AstraZeneca Rare Disease in October 2024 for the treatment of Wilson disease, a rare genetic disorder affecting approximately 1 in 30,000 people worldwide. Phase 3 data demonstrated approximately 3x greater copper mobilization versus standard of care and statistically significant neurologic benefit (9% worsening vs 25%, p=0.038) across 266 patients with median 2.58 years on treatment; NDA submission is planned for mid-2026. The second pillar is the MNPR-101 radiopharmaceutical platform targeting the urokinase plasminogen activator receptor (uPAR) expressed in triple-negative breast, colorectal, pancreatic, and other aggressive cancers, comprising MNPR-101-Zr (Phase 1 imaging agent), MNPR-101-Lu (Phase 1a therapeutic, FDA IND-cleared September 2025), and MNPR-101-Ac (late preclinical), all leveraging proprietary linker technology.

Monopar operates as a pre-commercial company with no product revenue and a small team of 11-50 employees. The business model contemplates future revenue from direct commercialization of ALXN1840 through specialty pharmacy and specialty distributor channels typical of rare disease therapeutics, with tiered royalties owed to Alexion on net sales, plus milestone payments tied to regulatory approval and sales thresholds. The MNPR-101 platform is intended for future direct sales upon regulatory approval. As of March 31, 2026, the company held $137.5 million in cash, cash equivalents, and investments, providing runway through December 2027, funded by approximately $194M in gross proceeds from three public offerings between October 2024 and September 2025. Capital markets signals have been positive: stock returned 185.9% in 2025 and the company was added to the Russell 3000 and Russell 2000 indexes in June 2025. A Chief Commercial and Strategy Officer (Susan Rodriguez) was appointed in March 2026 to lead pre-launch commercial infrastructure build-out for ALXN1840.

Name

Monopar

Legal name

Monopar Therapeutics Inc.

Website

https://monopartx.com

Company type

Public

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Monopar Therapeutics is a clinical-stage biopharmaceutical company developing ALXN1840 for Wilson disease and a uPAR-targeted radiopharmaceutical platform (MNPR-101 series) for advanced solid tumors, with NDA submission planned for mid-2026.

Ownership category

akta.pro rank

Product category

Clinical-Stage Biopharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Theranostic Radiopharmaceutical Platforms (Paired Dx/Tx) (HLAIAGAC)

akta.pro secondary industry

Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE)

Keywords

• Orphan oncology therapeutics
• Radiopharmaceutical development
• Wilson disease treatment
• UPAR-targeted therapy
• Clinical-stage biopharmaceutical

Headquarters

HQ city

Wilmette

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations

Revenue model

1. ALXN1840 (Wilson Disease): Monopar plans to commercialize ALXN1840 for Wilson disease following FDA approval. The company has in-licensed ALXN1840 from Alexion, AstraZeneca Rare Disease with regulatory approval and sales milestones along with tiered royalties on net sales.
2. MNPR-101 Radiopharmaceuticals: Radiopharmaceutical programs in various stages of clinical development for cancer imaging and treatment. Revenue will come from potential future product sales upon regulatory approval.
3. Pre-commercial Stage: Monopar is a clinical-stage biopharmaceutical company with no commercialized products. The company has not yet generated product revenue and is focused on advancing its pipeline through clinical development and regulatory approval.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Monopar Therapeutics is a clinical-stage biopharmaceutical company developing ALXN1840 (tiomolibdate choline), a late-stage first-in-class Albumin Tripartite Complex activator for the treatment of Wilson disease in-licensed from Alexion/AstraZeneca. The company also develops a proprietary uPAR-targeted radiopharmaceutical platform comprising MNPR-101-Zr (PET imaging agent), MNPR-101-Lu (therapeutic, lutetium-177), and MNPR-101-Ac (therapeutic, actinium-225) for advanced solid tumors including triple-negative breast, colorectal, and pancreatic cancers.

Product overview

Monopar Therapeutics is a clinical-stage biopharmaceutical company developing targeted radiopharmaceuticals for oncology and a treatment for Wilson disease. The product portfolio consists of ALXN1840 (tiomolibdate choline), a late-stage treatment for Wilson disease that has completed Phase 3 trials and is planned for NDA submission in mid-2026, and the MNPR-101 radiopharmaceutical platform including MNPR-101-Zr for imaging, MNPR-101-Lu for therapy (both in Phase 1), and MNPR-101-Ac in late preclinical development. The radiopharmaceutical programs target uPAR-expressing aggressive cancers including triple-negative breast, colorectal, and pancreatic cancers.

Differentiator

Problem solved

Functional benefit

Products and services

• ALXN1840 (tiomolibdate choline) A novel first-in-class Albumin Tripartite Complex (ATC) activator in-licensed from Alexion for treatment of Wilson disease, a rare genetic disorder causing toxic copper buildup. Phase 3 complete; NDA submission planned mid-2026.
• MNPR-101-Zr A radiopharmaceutical imaging agent consisting of MNPR-101 antibody conjugated to zirconium-89 for PET imaging of uPAR-expressing advanced solid tumors including triple-negative breast, colorectal, and pancreatic cancers. Currently in Phase 1.
• MNPR-101-Lu A radiopharmaceutical therapeutic agent consisting of MNPR-101 conjugated to lutetium-177 for treatment of uPAR-expressing advanced solid tumors. Currently in Phase 1a with FDA IND clearance.
• MNPR-101-Ac A late-preclinical stage radiopharmaceutical therapeutic agent conjugated to actinium-225 for treatment of advanced cancers as part of the uPAR-targeted platform.

Quantifiable outcome

• 9% neurologic worsening with ALXN1840 vs 25% with standard of care at Week 48 (p=0.038)
• +5 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• Excel Diagnostics and Nuclear Oncology Center (EDNOC)coreStrategic or Co-development Partner · 11 June 2025Collaboration for Expanded Access Program (EAP) for MNPR-101-Zr and MNPR-101-Lu in advanced cancers. EDNOC is a premier diagnostic medical imaging and therapeutic nuclear medicine center in Houston, Texas, designated as a Radiopharmaceutical Therapy Center of Excellence by SNMMI. Patients treated under supervision of Dr. Ebrahim S. Delpassand.
• Alexion Pharmaceuticals (AstraZeneca Rare Disease)coreStrategic or Co-development Partner · 1 October 2024Worldwide exclusive license to ALXN1840 (tiomolibdate choline) for Wilson disease. Alexion received $4.0 million cash payment, 9.9% ownership of Monopar's outstanding common stock, and is entitled to regulatory approval and sales milestones along with tiered royalties on net sales. IND sponsorship was officially transferred to Monopar in June 2025.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Lantheus Holdings: Leading pure-play radiopharmaceutical company with diagnostic and therapeutic agents (e.g., PNT2002/PNT2003, Definity). Directly comparable to Monopar's theranostic MNPR-101 platform given its paired imaging/therapy model and uPAR-adjacent oncology focus.
• Fusion Pharmaceuticals: Clinical-stage radioconjugate company developing targeted alpha therapies (acquired by AstraZeneca in 2024). Directly comparable to Monopar's MNPR-101-Ac actinium-225 program in mechanism, stage, and target indications.
• Perspective Therapeutics: Clinical-stage radiopharmaceutical company developing alpha and beta-emitting therapies targeting solid tumors. Comparable to Monopar's MNPR-101 platform given overlapping mechanism (targeted radionuclide therapy) and cancer indications.
• ITM Isotope Technologies Munich: Radiopharmaceutical company developing targeted radionuclide therapies for cancer. Comparable to Monopar on theranostic platform model with both diagnostic (Tc-99m) and therapeutic (Lu-177) offerings.
• Soleno Therapeutics: Clinical-stage rare disease biopharma developing once-daily Diazoxide Choline ER for Prader-Willi syndrome. Closely comparable to Monopar on company size, rare disease focus, late-stage orphan asset awaiting FDA approval, and similar capital profile.
• Travere Therapeutics: Mid-cap rare disease biopharmaceutical company with approved products (Filspari, Chenodal) and pipeline targeting rare kidney and metabolic conditions. Comparable to Monopar on company size, rare disease focus, and pre-commercial pipeline.
• Ultragenyx Pharmaceutical: Commercial-stage rare disease company with multiple approved orphan drugs and a pipeline of biologics, gene therapies, and small molecules for ultra-rare conditions. Comparable to Monopar on rare disease focus and similar pre-launch scale.
• Telix Pharmaceuticals: Commercial-stage radiopharmaceutical company with approved imaging agents (Illuccix) and late-stage therapeutic programs (TLX591, TLX101). Closely comparable to Monopar on theranostic pipeline strategy and target indications in oncology.

Broad incumbents

• BridgeBio Pharma: Late-stage rare disease biopharma with multiple programs targeting genetic conditions including Wilson disease (bindeprinim alfa gene therapy). Directly comparable on rare disease strategy and Wilson disease competitive overlap.
• BioMarin Pharmaceutical: Established rare disease biopharma co-founded by Monopar's Executive Chairman Christopher Starr. Comparable as a much larger rare disease commercial organization with a track record of orphan drug launches in similar disease areas.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/MonoparTx
• LinkedInlinkedin.com/company/monopar-therapeutics-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds4 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Monopar