What Monopar Therapeutics, Inc. told the SEC could break it.

Monopar's MNPR-101 radiopharmaceutical program depends on the availability and timely supply of radioisotopes (zirconium-89, lutetium-177); geopolitical disruptions (Russia-Ukraine, Middle East, Persian Gulf) could impair radioisotope sourcing and drug supply.

“Our contracted MNPR-101-Zr and MNPR-101-Lu manufacturing plant as well as our raw material supplier are currently located in the U.S., but the Russia-Ukraine war, the Israel-Hamas conflict, the developments in Venezuela, the conflict between the U.S., Israel and Iran and the ongoing instability in Persian Gulf states may adversely affect the sourcing of radioisotopes and timely supply of MNPR-101-Zr”

Monopar has no product revenue and expects substantial operating losses for years; it depends on equity raises and potential pharma partners to fund clinical, regulatory and pre-commercial activities.

“The Company has incurred losses since inception and expects to continue to incur substantial operating losses over the next several years.”

Monopar owns no manufacturing facilities and depends on third-party CMOs for all raw materials, API and finished product; some manufacturing materials are available from only one supplier, so a single-source interruption could disrupt development and commercialization.

“In certain cases, we may need to rely on a single supplier for a particular manufacturing material or service, and any interruption in or termination of service by such supplier could delay or disrupt the commercialization of our products. We rely on third-party suppliers for the materials used to manufacture our compounds. Some of these materials may at times only be available from one supplier.”