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Monopar Therapeutics Inc. (Nasdaq: MNPR) is a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics aimed at prolonging life and enhancing the quality of life for cancer patients. Founded in 2014 and headquartered in Wilmette, Illinois, the company has made significant strides in the oncology sector with a robust pipeline of innovative treatments.
Monopar's leading candidate, Validive®, is a clonidine mucobuccal tablet currently in Phase III clinical trials. It aims to treat severe oral mucositis in patients undergoing radiation therapy for oropharyngeal cancer. Another key product, camsirubicin, is a next-generation analog of doxorubicin designed to limit cardiotoxicity while retaining its anticancer efficacy. This compound is presently in a Phase 1b dose-escalation trial for soft tissue sarcoma.
Additionally, Monopar is developing MNPR-101, a humanized monoclonal antibody targeting the urokinase plasminogen activator receptor (uPAR) for the treatment of advanced solid tumors and severe COVID-19. The company's MNPR-101-Zr is currently enrolling patients in a Phase 1 dosimetry clinical trial to evaluate its safety and biodistribution in various advanced cancers.
Monopar has established strategic partnerships to bolster its research and development efforts. The collaboration with Grupo Español de Investigación en Sarcomas is pivotal for advancing camsirubicin, while the partnership with NorthStar Medical Radioisotopes focuses on developing radio-immuno-therapeutics, including the supply of actinium-225 (Ac-225) for MNPR-101.
Financially, Monopar reported significant progress in reducing net loss from $10.5 million in 2022 to $8.4 million in 2023. The company ended 2023 with $7.3 million in cash and additional funding of $3.2 million expected in Q1 2024. These resources are projected to sustain operations through June 2025, enabling Monopar to reach key clinical milestones.
For more information on Monopar Therapeutics and their groundbreaking work in oncology, visit www.monopartx.com.
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.
Monopar Therapeutics (Nasdaq: MNPR) and NorthStar Medical Radioisotopes announced a provisional patent application for a treatment targeting the Urokinase Plasminogen Activator Receptor (uPAR) in severe COVID-19 patients. This application aims to create precision radioimmunotherapeutics (uPRITs) that selectively destroy activated white blood cells, potentially reducing mortality rates from cytokine storms. The collaboration aims to leverage both companies' expertise to enhance treatment efficacy. If granted, the patent will provide exclusivity for the use of uPRITs in severe COVID-19 and respiratory diseases.
Monopar Therapeutics and NorthStar Medical Radioisotopes have formed a 50/50 collaboration to develop Radio-Immuno-Therapeutics (RITs) targeting severe COVID-19. This partnership aims to combine NorthStar's expertise in medical radioisotope production with Monopar's MNPR-101 antibody. The goal is to create a selective treatment that can kill aberrantly activated immune cells responsible for cytokine storms in COVID-19 patients. The collaboration plans to conduct development programs to potentially transform Monopar's monoclonal antibodies into effective RITs against severe COVID-19.
Monopar Therapeutics (Nasdaq: MNPR) reported its first quarter 2020 financial results, highlighting a net loss of $1.1 million ($0.10 per share), improved from a $1.4 million loss in Q1 2019. Cash and cash equivalents amounted to $12.6 million. The company is advancing its Validive Phase 2b/3 clinical trial, now set to start in the second half of 2020, with a focus on reducing enrollment challenges due to COVID-19. Additionally, the camsirubicin Phase 2 clinical trial is progressing in collaboration with GEIS, targeting advanced soft tissue sarcoma.
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