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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 has joined Rosalind Franklin University's Helix 51 biomedical incubator community. The clinical-stage biotech company is developing personalized radiopharmaceuticals for cancer diagnosis and treatment, along with a late-stage drug for Wilson Disease.
The company will utilize Helix 51's labs and resources to advance its research objectives. Radiopharmaceuticals, which selectively target cancer cells with radioisotopes, are important in nuclear medicine, enabling precise diagnosis and treatment while minimizing damage to healthy tissues.
Helix 51 is Lake County, Illinois' only wet-and dry-lab based incubator, situated in a region hosting over 122 bioscience companies and 33,000 bioscience jobs. The facility is part of RFU's Innovation and Research Park, which offers research space and core facilities for drug, device, and diagnostic R&D.
Monopar Therapeutics (Nasdaq: MNPR) announced the pricing of a combined public offering and private placement totaling $40 million. The offering includes 798,655 shares of common stock at $23.79 per share and pre-funded warrants for 882,761 shares at $23.789 per warrant. The transaction, expected to close around December 23, 2024, features participation from notable investors including RA Capital Management, Janus Henderson Investors, Adage Capital Partners LP, and ADAR1 Capital Management. The company plans to use proceeds for general corporate purposes, including research and development, clinical trials, product manufacturing, and working capital.
Monopar Therapeutics (Nasdaq: MNPR) has announced the first-ever patient dosing of MNPR-101-Lu, a novel therapeutic radiopharmaceutical. The treatment combines MNPR-101 antibody targeting uPAR with lutetium-177 radioisotope. The first patient, who has metastatic pancreatic cancer, received the treatment under a compassionate use protocol in the US. The intravenous infusion was well-tolerated with no serious adverse reactions reported.
Prior to treatment, the patient's cancer was imaged using MNPR-101-Zr, showing uPAR expression. The company is currently conducting two Phase 1 clinical studies in Australia, evaluating MNPR-101-Zr for imaging and MNPR-101-Lu for treatment of advanced solid tumors.
Monopar Therapeutics (Nasdaq: MNPR) has announced its participation in the 36th Annual Piper Sandler Healthcare Conference. CEO Chandler Robinson will engage in a fireside chat and one-on-one meetings at the event. The presentation is scheduled for December 5, 2024, from 10:30-10:55 am Eastern Time at the Lotte New York Palace in New York. Monopar is a clinical-stage biotechnology company that develops innovative treatments for patients with unmet medical needs.
Monopar Therapeutics (Nasdaq: MNPR) reported Q3 2024 financial results and recent developments. Key highlights include the in-licensing of ALXN-1840, a late-stage Wilson disease drug candidate from Alexion, AstraZeneca Rare Disease. The company has two active radiophharma clinical trials enrolling patients with advanced solid cancers. A recent capital raise through a public offering generated net proceeds of $17.7 million. Q3 2024 showed a net loss of $1.3 million ($0.37 per share), compared to $2.0 million ($0.69 per share) in Q3 2023. Cash position was $6.0 million as of September 30, 2024, with current funds projected to sustain operations into first half of 2026.
Monopar Therapeutics (Nasdaq: MNPR) has closed its previously announced public offering of common stock, raising $19.2 million in gross proceeds. The shares were priced at $16.25 per share. Notable participants included Janus Henderson Investors and RA Capital Management. Rodman & Renshaw served as the exclusive placement agent. The company plans to use the proceeds for general corporate purposes, including research and development, clinical trials, product manufacturing, and working capital. The offering was made through a shelf registration statement previously filed with the SEC.
Monopar Therapeutics (Nasdaq: MNPR) has announced the pricing of a public offering of common stock at $16.25 per share, aiming to raise approximately $19.2 million in gross proceeds. The offering, expected to close on October 30, 2024, features participation from notable investors including Janus Henderson Investors and RA Capital Management. Rodman & Renshaw serves as the exclusive placement agent. The company plans to use the proceeds for general corporate purposes, including research and development, clinical trials, product manufacturing, and working capital.
Monopar Therapeutics (Nasdaq: MNPR) announced plans for a best efforts public offering of common stock. The clinical-stage biotech company intends to use the proceeds for general corporate purposes, including research and development, clinical trials, product manufacturing, and working capital. Rodman & Renshaw is serving as the exclusive placement agent. The offering will be conducted under a previously filed S-3 registration statement. The final terms will be disclosed in a prospectus supplement to be filed with the SEC.
Monopar Therapeutics (Nasdaq: MNPR) has secured an exclusive worldwide license from Alexion, AstraZeneca Rare Disease for ALXN-1840, a Wilson disease drug candidate that completed Phase 3 trials meeting its primary endpoint. The agreement involves an upfront payment combining cash and Monopar equity, plus future tiered royalties and milestone payments. Monopar will oversee all future global development and commercialization. This acquisition follows Alexion's 2023 termination of the ALXN-1840 program after reviewing Phase II mechanistic trials and regulatory discussions.
Monopar Therapeutics Inc. (Nasdaq: MNPR) is presenting encouraging data from its uPAR radiopharmaceutical program at the EANM 2024 Annual Congress. The presentation, recognized as a "Top-Rated Oral Presentation," showcases favorable human clinical dosimetry data for MNPR-101-Lu, derived from MNPR-101-Zr imaging studies.
Key highlights include:
- Favorable organ safety profile at high Lu-177 therapeutic dose levels
- Promising uPAR targeting in solid tumors
- Encouraging tumor uptake and low off-target binding
- Estimated favorable radiation dosimetry safety profile for off-target effects
The company's Phase 1a trial for MNPR-101-Lu (NCT06617169) and Phase 1 imaging and dosimetry trial for MNPR-101-Zr (NCT06337084) are ongoing.
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