Monopar Therapeutics Inc. - MNPR STOCK NEWS

Monopar Therapeutics (MNPR) announced the initiation of its Phase 2b/3 VOICE clinical trial for Validive®, aimed at preventing severe oral mucositis (SOM) in oropharyngeal cancer patients undergoing chemoradiotherapy. The trial is actively recruiting up to 260 patients across multiple sites, following a completed Phase 2 trial that showed a 40% reduction in SOM incidence among those treated with Validive. With more than 40,000 new cases expected in the U.S. in 2021, there is a significant unmet medical need for effective SOM therapies.

Monopar Therapeutics (MNPR) announced key updates from its third quarter 2020. The Phase 2b/3 clinical trial of its lead product, Validive, targeting severe oral mucositis, is set to start before year-end. New patents have been issued for Validive, enhancing its market position. Additionally, a Phase 2 clinical trial for camsirubicin is anticipated to begin by early 2021. As of September 30, 2020, the company holds $18.0 million in cash, expected to fund operations through 2021. However, fundraising will be essential for the Phase 3 trial of Validive.

Monopar Therapeutics (Nasdaq: MNPR) has announced the issuance of new patents for Validive, its lead product candidate, which is currently in Phase 2b/3 trials. The patents extend protection to 2035, enhancing Validive’s use in preventing adverse chemotherapy effects such as gastrointestinal and respiratory disorders. With around 650,000 U.S. cancer patients undergoing chemotherapy annually, this expands Validive's application beyond oral mucositis treatment. The clinical trial for oropharyngeal cancer patients is set to commence by year-end 2020.

Monopar Therapeutics (Nasdaq: MNPR) announced that CEO Chandler D. Robinson will present a corporate update at the H.C. Wainwright 22nd Annual Global Investment Conference, focusing on healthcare and biotech. The virtual conference is scheduled for September 16, 2020, at 1:30 PM EDT. Monopar is a clinical-stage biopharmaceutical company that develops therapeutics aimed at improving the life quality of cancer patients, with a pipeline including Validive, camsirubicin, and MNPR-101.

Monopar Therapeutics (Nasdaq: MNPR) and NorthStar Medical Radioisotopes, LLC have partnered with The University of Texas Health Science Center at Tyler to develop urokinase plasminogen activator receptor targeted radio-immunotherapeutics (uPRITs) for severe COVID-19 treatment. UTHSCT will conduct essential preclinical and clinical studies, leveraging a $2 million NIH grant aimed at improving outcomes for hospitalized COVID-19 patients. This collaboration aims to expedite the development of uPRITs for potential first-in-human trials at UTHSCT.

Monopar Therapeutics (MNPR) announced a partnership with Aragen Bioscience to accelerate the development of urokinase plasminogen activator receptor targeted radio-immunotherapeutics (uPRITs) for treating severe COVID-19. The collaboration aims to select a lead uPRIT candidate based on the MNPR-101 antibody scaffold, advancing towards IND-enabling studies. This partnership is crucial in targeting aberrantly activated immune cells to combat severe lung injury associated with COVID-19. The initiative reflects a strong commitment to innovative therapeutic solutions amidst ongoing health challenges.

Monopar Therapeutics (Nasdaq: MNPR) announced its initiative to develop a COVID-19 test aimed at triaging patients based on their risk of severe respiratory failure. The test will utilize Monopar's antibody, ATN-658, to measure soluble urokinase plasminogen activator receptor (suPAR) levels in patient plasma. Preliminary studies suggest elevated suPAR correlates with a 17-fold increase in severe outcomes. Monopar is also collaborating with NorthStar Medical Radioisotopes on a precision therapeutic targeting aberrant immune cells in severe COVID-19 cases, potentially improving patient management.

Monopar Therapeutics (MNPR) has announced a strategic partnership with NorthStar Medical Radioisotopes and IsoTherapeutics Group to develop Radio-Immuno-Therapeutics (RITs) aimed at treating severe COVID-19. The collaboration will utilize Monopar’s experimental antibody MNPR-101, modified by IsoTherapeutics to couple with therapeutic radioisotopes from NorthStar. This initiative seeks to advance clinical trials that target immune cells implicated in severe COVID-19 outcomes. The partnership builds on previous successful collaborations and aims to improve patient outcomes significantly.

Monopar Therapeutics (MNPR) reported a net loss of $1.4 million, or $0.14 per share, for Q2 2020, an increase from a $0.9 million loss in Q2 2019. Cash and cash equivalents stood at $12.5 million. Key developments include a 50/50 collaboration with NorthStar to create Radio-Immuno-Therapeutics to treat severe COVID-19, utilizing Monopar's MNPR-101. Both the Validive and camsirubicin clinical trials are on track to commence dosing in H2 2020. R&D expenses rose to $0.8 million due to clinical preparations and staffing.