Monopar filed an amendment to its IPO filing on 9/10/19. It has raised its upper estimate to $46 Million. The company will trade on NASDAQ under the symbol, “MNPR.” See original article here.

Monopar intends to begin a Phase 3 clinical development program for their lead product candidate, Validive (clonidine mucobuccal tablet; clonidine MBT), in the fourth quarter of 2019. Validive is designed to be used prophylactically to reduce the incidence, delay the time to onset, and decrease the duration of severe oral mucositis (“SOM”) in patients undergoing chemoradiotherapy (“CRT”) for oropharyngeal cancer (“OPC”).

Oral mucositis is one of the most common oral problems associated with cancer therapy. It occurs in 20 to 40% of adult cancer patients receiving conventional chemotherapy for solid tumors, about 80% of patients receiving high-dose chemotherapy before haematopoietic stem cell transplantation, and almost all patients receiving radiotherapy for head and neck cancer.

The OPC (oropharyngeal cancer) target population for Validive is the most rapidly growing segment of head and neck cancer (“HNC”) patients, with an estimated 40,000 new cases of OPC in the U.S alone in 2019. Validive is delivered in a mucobuccal tablet (“MBT”) formulation of clonidine that allows for prolonged and enhanced local delivery of drug in the regions of mucosal radiation damage.

Monopar’s pipeline also includes: camsirubicin, is a novel analog of doxorubicin, and MNPR-101, a novel first-in-class humanized monoclonal antibody to the urokinase plasminogen activator receptor.

The company plans to use the proceeds of the offering to advance Validive into Ph III trials, and to continue to develop camsirubicin and MNPR-101.