Monopar Therapeutics Q3 2024 Financial Results and Updates

Monopar Therapeutics Inc., a clinical-stage biotechnology entity on the cutting edge of treatments for unmet medical needs, recently released its financial results for the third quarter of 2024 and highlighted several key developments.

In a major advancement, Monopar has secured an exclusive license from Alexion, AstraZeneca Rare Disease, to develop and commercialize ALXN-1840, a late-stage drug candidate for Wilson disease. Announced on October 23, 2024, this licensing deal grants Monopar worldwide rights to bis-choline tetrathiomolybdate, which has already completed a Phase 3 clinical trial. The company plans to compile a regulatory package and initiate discussions with the FDA, initially targeting Wilson disease patients with severe symptoms.

Another notable progress is in Monopar's radiopharmaceutical portfolio. The company received regulatory clearance in Australia in August 2024 to commence a first-in-human Phase 1a clinical trial of MNPR-101-Lu, a therapeutic radiopharmaceutical designed to target the urokinase plasminogen activator receptor (uPAR) in patients with advanced solid cancers. By October 2024, the first clinical trial site was activated and began enrolling patients.

Additionally, in September 2024, the company reported promising early data from its ongoing open-label Phase 1 imaging and dosimetry clinical trial of MNPR-101-Zr. These results, presented at the European Association of Nuclear Medicine Annual Congress 2024, demonstrated MNPR-101-Zr’s effective tumor-targeting capabilities in a patient with advanced ovarian cancer. The data showed substantial and durable tumor uptake and favorable biodistribution with minimal off-target binding.

Monopar is also broadening its radiopharmaceutical pipeline through internal research and development. In October 2024, the company filed a provisional patent application for new radiopharmaceutical compounds, including a family of linkers for attaching radioisotopes to targeting agents. This development could lead to the creation of proprietary radiopharmaceuticals aimed at established high-value cancer targets.

On the financial front, Monopar completed a public offering on October 30, 2024, issuing 1,181,540 shares of common stock at $16.25 per share. This generated net proceeds of approximately $17.7 million, which will support the company’s operations into the first half of 2026. These funds will be utilized to advance regulatory discussions for ALXN-1840, continue Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu, move the preclinical MNPR-101-Ac program into clinical trials, and invest in expanding the radiopharmaceutical pipeline.

As of September 30, 2024, Monopar reported cash and cash equivalents of $6.0 million. The third quarter of 2024 saw a net loss of $1.3 million, or $0.37 per share, an improvement from the $2.0 million, or $0.69 per share, net loss in the same period of 2023. Research and development expenses decreased to $984,000 from $1,317,000 in the prior year, primarily due to reduced costs associated with camsirubicin manufacturing and the closure of the Validive clinical trial. General and administrative expenses also saw a reduction, totaling $591,000 compared to $749,000 in the third quarter of 2023, largely due to decreased stock-based compensation expenses.

Monopar Therapeutics Inc. continues to focus on advancing its diverse pipeline, leveraging recent financial and strategic developments. The company remains committed to addressing significant unmet medical needs through its innovative therapeutic approaches.