Monopar begins phase 1 trial of cancer treatment in Australia

WILMETTE, Ill. - Monopar Therapeutics Inc . (NASDAQ: NASDAQ:MNPR), a clinical-stage radiopharmaceutical company, has received clearance from the Human Research Ethics Committee (HREC) in Australia to begin a Phase 1 clinical trial for its novel radiopharmaceutical, MNPR-101-Lu. This trial will involve patients with advanced solid cancers and follows the ongoing MNPR-101-Zr imaging and dosimetry clinical trial.

MNPR-101-Lu is a combination of the therapeutic radioisotope lutetium-177 (Lu-177) with Monopar’s proprietary humanized monoclonal antibody MNPR-101, which targets the urokinase plasminogen activator receptor (uPAR) prevalent in certain aggressive cancers.

Preclinical studies have shown promising results, particularly in a 90-day efficacy study using a human pancreatic cancer xenograft mouse model. The treatment achieved complete tumor elimination that lasted throughout the study period after just a single injection. Further imaging data from these preclinical studies indicated a strong and specific uptake of MNPR-101-Lu in tumors compared to normal tissues.

Chandler Robinson, MD, CEO of Monopar Therapeutics, expressed optimism about the trial, citing the potential clinical benefits for patients with uPAR-positive tumors, including those with triple-negative breast cancer and pancreatic cancer. The company aims to initiate the trial promptly.

Monopar Therapeutics is engaged in the development of treatments for cancer patients, with a portfolio that includes the Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and the late preclinical-stage MNPR-101-Lu and MNPR-101-Ac225 for the treatment of advanced cancers.

This announcement contains forward-looking statements, which are subject to risks and uncertainties. These include the possibility that the MNPR-101-Lu study may not proceed as planned, that the MNPR-101-Zr imaging trial may not yield the expected results, and the inherent risks in the development and commercialization of new therapeutics.

Investors are cautioned that actual results may vary from those projected. Monopar Therapeutics does not undertake any obligation to update forward-looking statements. The information in this article is based on a press release statement.

In other recent news, Monopar Therapeutics reported its second quarter financial outcomes for 2024, with no generated revenues, in line with consensus estimates, and a net loss of $0.10 per share. The company also announced a 5-for-1 reverse stock split, reducing the total number of outstanding shares from around 17.6 million to approximately 3.5 million. H.C. Wainwright and Jones Trading have both maintained a Buy rating for Monopar, with H.C. Wainwright raising the price target to $6.00 from $2.00.

Monopar has expanded its partnership with NorthStar Medical Radioisotopes, securing a long-term contract for the supply of actinium-225, a radioisotope used in cancer treatment. The company now fully owns its MNPR-101 radiopharmaceutical platform and certain jointly developed intellectual property.

In personnel changes, Monopar announced the retirement of CFO Kim R. Tsuchimoto, with Karthik Radhakrishnan set to take over her roles. These are among the recent developments at Monopar Therapeutics, a company actively engaged in the field of radiopharmaceuticals for cancer treatment.

InvestingPro Insights

As Monopar Therapeutics Inc. (NASDAQ: MNPR) advances into a new phase of clinical trials with its promising radiopharmaceutical MNPR-101-Lu, investors and industry observers are closely monitoring the company's performance metrics. According to InvestingPro data, Monopar holds a market capitalization of $8.73 million, reflecting the size and market value of the company within the biopharmaceutical sector.

InvestingPro Tips suggest that Monopar has managed its finances prudently, holding more cash than debt on its balance sheet, which is a positive sign for investors concerned about the company's financial health. Moreover, the company's liquid assets exceed short-term obligations, indicating a stable short-term financial position. These factors could provide a cushion as the company invests in its clinical trials.

However, the company faces challenges, as analysts do not expect Monopar to be profitable this year, and it has not been profitable over the last twelve months. Additionally, the stock has experienced volatility with a significant return over the last week, but a poor performance over the last month, reflecting the inherent risks associated with clinical-stage biopharmaceutical companies.

InvestingPro provides a comprehensive suite of additional tips, with 7 more tips available for Monopar Therapeutics on their platform, which could help investors make informed decisions about the potential risks and opportunities associated with the company's stock.

For those interested in a deeper dive into Monopar's financials and projections, InvestingPro offers a fair value estimate of $2.73, which could serve as a reference point for evaluating the company's current stock price and future growth prospects.

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