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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) 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.
Monopar Therapeutics Inc. (Nasdaq: MNPR) has filed a provisional patent for new therapeutic radiopharmaceuticals based on a family of linkers connecting radioisotopes with targeting agents, including Monopar's uPAR targeting antibody MNPR-101. The patent filing covers:
- Composition of Matter: Claims for a family of linkers and Monopar's uPAR targeting agents linked with these and therapeutic radioisotopes
- Stability and Biodistribution: Proprietary new linkers designed to enhance stability and biodistribution of Monopar's therapeutic radiopharmaceuticals
- Versatility: The new linker family works with various isotopes and targeting molecules, including small molecules/peptides and antibodies
The company believes these linkers could create new proprietary radiopharmaceuticals targeting high-value cancer targets and potentially lead to licensing and development collaborations in the industry.
Monopar Therapeutics Inc. (Nasdaq: MNPR) has initiated a Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu in patients with advanced cancers. The open-label dose-escalation study will recruit patients with solid tumors, focusing on those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry trial. The first clinical site activated is the Melbourne Theranostic Innovation Centre (MTIC) in Australia.
MNPR-101 is Monopar's proprietary antibody targeting the urokinase plasminogen activator receptor (uPAR), expressed in various tumor types. The company aims to deliver targeted radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue. Recent clinical and preclinical data have shown highly specific and durable tumor uptake of MNPR-101-Zr.
This trial may be the world's first uPAR-targeted therapeutic radiopharma clinical trial, with the goal of identifying tumors using MNPR-101-Zr and treating them with MNPR-101-Lu.
Monopar Therapeutics Inc. (Nasdaq: MNPR) announced positive early data from its ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial, validating the tumor targeting ability of MNPR-101-Zr in humans. The trial focuses on MNPR-101, a proprietary first-in-class humanized monoclonal antibody targeting cancers expressing the urokinase plasminogen activator receptor (uPAR).
Key findings include:
- Highly preferential uptake of MNPR-101-Zr in metastatic tumors relative to normal tissue
- Specificity and durability of MNPR-101-Zr in tumor targeting
- Alignment of MNPR-101-Zr uptake with previously observed metastatic tumors on FDG PET imaging
Monopar also received clearance in Australia to initiate an MNPR-101-Lu Phase 1 therapeutic clinical trial, scheduled for Q4 2024. Additional data will be presented at the European Association of Nuclear Medicine 2024 Annual Congress in October.
Monopar Therapeutics (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative cancer treatments, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. Chandler D. Robinson, MD, Monopar's CEO, will present at the conference. Key details include:
- Presentation will be webcast starting Monday, September 9, 2024 at 7:00 a.m. ET
- In-person one-on-one meetings will be held at the Lotte New York Palace, NY
- Conference dates: September 9 - 11, 2024
This event provides Monopar an opportunity to showcase its progress and connect with potential investors, potentially impacting its stock performance (MNPR).
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