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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), a clinical-stage radiopharma company, has regained compliance with Nasdaq's minimum bid price requirement. The company received notice from Nasdaq that it has met the listing rule 5550(a)(2), which requires a minimum bid price of $1.00 per share for at least 10 consecutive trading sessions. This development ensures Monopar's continued listing on the Nasdaq stock exchange, maintaining its visibility and access to capital markets. The compliance status is important for the company's ongoing efforts in developing innovative cancer treatments.
Monopar Therapeutics Inc. (Nasdaq: MNPR) has received Human Research Ethics Committee (HREC) clearance in Australia to begin a Phase 1 therapeutic trial of its novel radiopharmaceutical MNPR-101-Lu. This treatment combines lutetium-177 with Monopar's proprietary humanized monoclonal antibody MNPR-101, which targets the urokinase plasminogen activator receptor (uPAR). The trial will enroll patients with advanced solid cancers and follows the ongoing MNPR-101-Zr imaging and dosimetry clinical trial.
Preclinical studies have shown promising results, with MNPR-101-Lu demonstrating durable antitumor effects in a human pancreatic cancer xenograft mouse model. The treatment achieved complete tumor elimination after a single injection, lasting throughout the 90-day study. Imaging data also revealed high specificity and durable uptake of MNPR-101-Lu in tumors relative to normal tissue.
Monopar Therapeutics Inc. (Nasdaq: MNPR) has announced initial data from the first patient dosed in its Phase 1 clinical trial of MNPR-101-Zr, a uPAR-targeted imaging radiopharmaceutical. The drug was well-tolerated with no serious adverse reactions reported. Preliminary analysis suggests low radiation dose to healthy tissue, aligning with preclinical data. Dosimetry analysis showed absorbed organ doses well below accepted safety limits, with red bone marrow radiation dose about 150 times less than the generally accepted limit. No unanticipated or excessive uptake was observed in critical organs. The study aims to include patients with cancers known for high uPAR expression to gain insight into MNPR-101-Zr's tumor uptake profile.
Monopar Therapeutics Inc. (Nasdaq: MNPR) reported its Q2 2024 financial results and recent developments. Key highlights include:
1. Initiated and enrolling patients in MNPR-101-Zr First-in-Human Phase 1 Radiopharma Clinical Trial.
2. MNPR-101 radio-immuno-therapeutic (RIT) Clinical Trial on track to start in Q4 2024.
3. Cash position of $7.1 million as of June 30, 2024, sufficient to operate through August 31, 2025.
4. Net loss of $1.7 million ($0.10 per share) in Q2 2024, compared to $2.2 million ($0.16 per share) in Q2 2023.
5. R&D expenses decreased to $1,131,000 in Q2 2024 from $1,595,000 in Q2 2023.
6. G&A expenses decreased to $658,000 in Q2 2024 from $733,000 in Q2 2023.
7. Approved 1-for-5 reverse stock split, effective August 12, 2024, to regain Nasdaq compliance.
Monopar Therapeutics (Nasdaq: MNPR) has announced a 1-for-5 reverse stock split of its common stock, effective August 12, 2024. The split aims to regain compliance with Nasdaq's listing rules. Trading on a split-adjusted basis will begin on August 13, 2024, under the new CUSIP number 61023L207. The reverse split will reduce outstanding shares from approximately 17.6 million to 3.5 million. Stockholders' ownership percentages will remain unchanged, except for adjustments due to fractional shares. The split will not affect the number of authorized shares or par value. VStock Transfer will manage the exchange process for physical share certificates, while book-entry holders need not take action.
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.
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.
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.
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.
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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