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Monopar Therapeutics Inc. - MNPR STOCK NEWS

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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.

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Monopar Therapeutics (Nasdaq: MNPR) has enrolled the first patient in its first-in-human Phase 1 trial for MNPR-101-Zr, a novel radiopharmaceutical imaging agent. This agent combines Monopar's antibody, MNPR-101, which targets the urokinase plasminogen activator receptor (uPAR) with the radioisotope zirconium-89. The trial, led by Prof. Rodney Hicks at the Melbourne Theranostic Innovation Centre, aims to assess the safety and dosimetry in up to 12 patients with advanced cancers. uPAR is a target in aggressive cancers such as pancreatic, triple-negative breast, and colorectal cancers. Preclinical results have been promising.

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Monopar Therapeutics (Nasdaq: MNPR) has announced that their abstract on MNPR-101-RIT has been selected as a top-rated oral presentation at the European Association of Nuclear Medicine (EANM) 2024 Annual Congress in Hamburg, Germany. The abstract showcases preclinical data on MNPR-101-RIT, a novel radio-immuno-therapeutic targeting urokinase plasminogen activator receptor (uPAR) for treating cancers such as triple-negative breast, colorectal, and pancreatic. The data highlights significant anti-tumor benefits using therapeutic radioisotopes Lutetium-177 and Actinium-225. Additionally, Monopar has started a Phase 1 clinical trial for MNPR-101-Zr in advanced cancer patients.

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Monopar Therapeutics (Nasdaq: MNPR) and NorthStar Medical Radioisotopes have expanded their collaboration to include a long-term supply agreement for actinium-225 (Ac-225). This strategic move aligns intellectual property rights and leverages NorthStar's expertise in Ac-225 production with Monopar's promising preclinical results using Ac-225 in its MNPR-101 radiopharma program. Monopar has acquired full ownership of MNPR-101's radiopharmaceutical applications, while both companies will share a patent application for a new linker technology. This collaboration aims to support Monopar's current and future cancer therapy developments.

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Monopar Therapeutics (Nasdaq: MNPR) is presenting data on its lead radiopharma program MNPR-101-Zr at the 2024 SNMMI Annual Meeting. The data demonstrates the potential of urokinase plasminogen activator receptor (uPAR) as a target for radiopharma cancer treatment. In preclinical trials on mice with human tumor xenografts, MNPR-101-Zr showed strong and durable tumor uptake in triple-negative breast, colorectal, and pancreatic cancers, with minimal accumulation in bone and healthy tissues. Monopar has started a Phase 1 clinical trial for MNPR-101-Zr in advanced cancer patients, led by Prof. Rodney Hicks. The trial details are available under study identifier NCT06337084.

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Monopar Therapeutics (Nasdaq: MNPR), a clinical-stage radiopharmaceutical company, announced the retirement of CFO Kim R. Tsuchimoto after a 35-year career. Her last day will be June 30, 2024, but she will stay on the Board of Directors. Karthik Radhakrishnan, with over 20 years of financial experience, will succeed her starting July 1, 2024. Radhakrishnan's background includes roles as CFO of Santalis Pharmaceuticals and CEO of Asylia Therapeutics. CEO Chandler Robinson acknowledged Tsuchimoto's contributions and expressed enthusiasm for Radhakrishnan's appointment, highlighting his consulting work with Monopar over the past six months.

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Monopar Therapeutics Inc. reported its first-quarter 2024 financial results and a strategic focus on its radiopharma pipeline. The company initiated the MNPR-101-Zr Phase 1 clinical trial and aims to launch the MNPR-101-RIT Phase 1 trial by Q4 2024 or Q1 2025. Monopar is winding down non-radiopharma programs to concentrate resources on radiopharma assets. The company is well-funded till at least June 30, 2025, with a net loss of $1.6 million for Q1 2024. R&D expenses decreased, while G&A expenses saw a slight drop.

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Monopar Therapeutics Inc. announced that its abstract on the preclinical data for its radiopharmaceutical program MNPR-101-Zr has been selected for a presentation at the Society of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting in Toronto, Canada. The event, scheduled from June 8 to June 11, 2024, is a significant platform for showcasing innovative treatments for cancer patients.
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Monopar Therapeutics Inc. files a provisional patent application for MNPR-101 radiopharma optimization findings, aiming to enhance the clinical profile of the construct and strengthen intellectual property. The company focuses on developing innovative cancer treatments, with recent advancements in the MNPR-101-Zr construct and Phase 1 dosimetry clinical trial initiation.
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Monopar Therapeutics Inc. announces the activation of its Phase 1 dosimetry clinical trial for MNPR-101-Zr, a radiopharmaceutical imaging agent targeting uPAR in various cancers. The trial, led by Professor Rodney Hicks at MTIC, aims to evaluate safety and dosimetry in advanced cancer patients.
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Monopar Therapeutics Inc. (Nasdaq: MNPR) reported its fourth quarter and full-year 2023 financial results, along with recent developments. The company announced the initiation of a Phase 1 dosimetry clinical trial for its MNPR-101 Radiopharmaceutical Program targeting uPAR. Positive preclinical data support the potential of MNPR-101 to provide significant clinical benefits. Monopar also shared biodistribution data using therapeutic radioisotopes conjugated to MNPR-101, showing promising results in tumor elimination. The company is enrolling patients in the fifth dose level cohort for its Camsirubicin Phase 1b Dose-Escalation Trial. Financially, Monopar reported $7.3 million in cash and short-term investments as of December 31, 2023, with a net loss of $1.8 million for the fourth quarter of 2023. Research and Development expenses decreased, while General and Administrative expenses slightly increased.
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FAQ

What is Monopar Therapeutics Inc.?

Monopar Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients.

What are the key products in Monopar's pipeline?

Monopar's pipeline includes Validive® for severe oral mucositis, camsirubicin for soft tissue sarcoma, MNPR-101 for advanced cancers and severe COVID-19, and MNPR-101-Zr for imaging advanced cancers.

What is the status of Validive®?

Validive® is in Phase III clinical trials aimed at treating severe oral mucositis in oropharyngeal cancer patients undergoing radiation therapy.

Who are Monopar's key partners?

Monopar has partnered with Grupo Español de Investigación en Sarcomas for camsirubicin development and NorthStar Medical Radioisotopes for radio-immuno-therapeutics.

What financial position does Monopar hold?

As of December 31, 2023, Monopar had $7.3 million in cash with an additional $3.2 million expected in Q1 2024. These funds are projected to sustain operations through June 2025.

What is MNPR-101?

MNPR-101 is a humanized monoclonal antibody targeting uPAR for treating advanced solid tumors and severe COVID-19, currently in a Phase 1 dosimetry clinical trial.

How has Monopar reduced its net loss?

Monopar's net loss decreased from $10.5 million in 2022 to $8.4 million in 2023, primarily due to reductions in R&D and clinical trial expenses.

What are the future plans for MNPR-101?

Monopar plans to expand the clinical trial for MNPR-101-Zr or initiate new studies testing its efficacy with a therapeutic radioisotope based on Phase 1 results.

What collaborations support Monopar's MNPR-101 development?

Monopar collaborates with NorthStar Medical Radioisotopes, which supplies Ac-225 and aids in the development of MNPR-101 for radiopharmaceutical applications.

Where can I find more information about Monopar?

For more information, visit Monopar's official website at www.monopartx.com.

Monopar Therapeutics Inc.

Nasdaq:MNPR

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