Monopar Therapeutics

Monopar Therapeutics is a U.S.-based clinical-stage biopharmaceutical company developing drug candidates for Wilson disease and advanced cancers. Its pipeline centers on ALXN1840, a late-stage Wilson disease asset, and MNPR-101 radiopharmaceutical programs for imaging and treating solid tumors.

51.35

51.35

— Monopar Therapeutics
%
Wilson disease therapy35% Late-stage investigational treatment for Wilson disease, centered on ALXN1840.
Radiopharmaceutical imaging25% MNPR-101-based diagnostic imaging and dosimetry programs for advanced cancers.
Radiopharmaceutical therapeutics25% Therapeutic radioisotope programs designed to treat uPAR-expressing solid tumors.
Preclinical pipeline and discovery10% Earlier-stage assets and internal R&D to expand the oncology pipeline.
Licensing and development services5% In-licensing, collaboration, and regulatory development activities supporting the pipeline.

Monopar does not yet sell approved products, so its near-term customers are clinical investigators, trial sites,...

  • Regulators and clinical trial ecosystemprimary

    FDA, CROs, and trial sites that enable development and approval of ALXN1840 and MNPR-101 programs.

  • Wilson disease treatment providersprimary

    Specialist physicians and treatment centers that would prescribe ALXN1840 if approved.

  • Advanced cancer care centerssecondary

    Hospitals and oncology centers that could use MNPR-101 imaging or therapeutic agents.

  • Strategic licensing partnersprimary

    Pharma partners that may out-license, co-develop, or commercialize assets with Monopar.

Monopar is headquartered in the United States and its development, financing, and clinical operations are primarily U.S...

  • •Headquartered in the United States
  • •Clinical trials and regulatory work are primarily U.S.-based
  • •NDA filing is being prepared for the FDA
  • •Potential future commercialization could expand beyond the U.S.
  • •Management has prior FDA and EMA experience

Monopar’s strategy is to advance a small number of high-value assets through late-stage development, starting with an...

01
Prepare ALXN1840 NDA submissionshort-term

Regulatory approval is the key value inflection point for the Wilson disease asset.

02
Advance MNPR-101 radiopharmaceutical pipelinemedium-term

The imaging and therapeutic programs could create a second value driver in oncology.

03
Preserve financing flexibilityshort-term

As a pre-revenue biotech, Monopar must fund R&D until approval or partnering monetization.

Monopar is a pre-revenue biotech, so its business depends on successful clinical development, regulatory approval, and...

high

Clinical development failure or delay

Pipeline value depends on positive trial outcomes for ALXN1840 and MNPR-101 programs.

Scope
ALXN1840, MNPR-101-Zr, MNPR-101-Lu, MNPR-101-Ac225
Materiality
High
high

Financing and dilution risk

The company has not generated product revenue and expects to fund operations externally.

Scope
Equity raises, debt, collaborations, grants
Materiality
High
high

Regulatory approval risk

Commercialization depends on FDA approval of a late-stage rare disease asset and oncology candidates.

Scope
NDA filing for ALXN1840
Materiality
High
medium

Competition and market adoption risk

Competing therapies could limit uptake or reduce the commercial potential of the pipeline.

Scope
Wilson disease and oncology markets
Materiality
Medium
medium

Manufacturing and supply chain risk

Radiopharmaceutical and clinical supply chains are complex and must meet quality standards.

Scope
Clinical and future commercial supply
Materiality
Medium
Clinical trial accruals
Can cause quarter-to-quarter swings in R&D expense
Stock-based compensation
Can inflate non-cash operating expenses
Treasury securities and interest income
Affects net loss and liquidity presentation
Equity financing and share issuance
Changes share count and cash runway

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: 28.4.2026