Monopar Therapeutics

MNPRPhase 3

Wilmette, United StatesFounded 2014monopartx.com

Monopar Therapeutics is a publicly traded biotech company (NASDAQ: MNPR) advancing a pipeline of novel oncology candidates. Its most advanced asset, Validive (clonidine HCl mucoadhesive buccal tablet), is designed to prevent a debilitating side effect of cancer treatment and has received Fast Track and Orphan Drug designations from the FDA. The company's strategy centers on developing targeted therapies for underserved oncology indications with high unmet medical need.

Market Cap

$368.9M

Founded

2014

Employees

1-10

Focus

Biotech

MNPR · Stock Price

USD 55.21+42.66 (+339.92%)

Historical price data

AI Company Overview

Technology Platform

Asset-centric development of novel therapeutics, with expertise in localized drug delivery systems for oncology and cancer supportive care indications.

Pipeline Snapshot

5 drugs in pipeline, 1 in Phase 3

Drug	Indication	Stage
Clonidine HCl Mucoadhesive Buccal Tablet + Placebo Mucoadhesive Buccal Tablet	Chemoradiotherapy-Induced Severe Oral Mucositis	Phase 2/3
MNPR-101-DFO*-89Zr	Solid Tumor, Adult	Phase 1
MNPR-101-PCTA-177Lu	Solid Tumor, Adult	Phase 1
Camsirubicin	Advanced Soft-tissue Sarcoma	Phase 1
MNPR-101-PCTA-177Lu	Cancer	Pre-clinical

Funding History

Total raised: $12M

IPO$12MUndisclosedOct 11, 2019

Opportunities

Validive addresses a large, underserved market in cancer supportive care with multi-billion dollar potential.

Successful Phase 3 data could lead to a strategic partnership or acquisition.

The uPAR-targeting MNPR-101 program represents a future growth driver in solid tumor oncology.

Risk Factors

High dependency on the success of a single lead candidate (Validive) in late-stage trials.

Need to raise significant capital to fund Phase 3 development, posing dilution risk.

Inherent regulatory and clinical trial execution risks associated with drug development.

Competitive Landscape

Validive faces limited direct competition in the prophylactic treatment of severe oral mucositis, with prior late-stage candidates failing. Its main competition is the reactive standard of care. For its preclinical programs, it will compete with other targeted oncology therapies, requiring clear differentiation in efficacy or safety.

Publications

Patents

Pipeline