Monopar Therapeutics Announces Q2 2024 Financial Results and Updates

Monopar Therapeutics Inc., a clinical-stage radiopharmaceutical company dedicated to developing pioneering treatments for cancer patients, recently announced its financial results for the second quarter of 2024 and provided updates on its ongoing projects.

Monopar is advancing MNPR-101, a uPAR-targeting antibody designed for precision radiopharmaceutical applications in cancer imaging and treatment. MNPR-101-Zr, radiolabeled with Zirconium-89, is currently in an open-label Phase 1 clinical trial. This imaging agent has demonstrated high tumor uptake in preclinical studies across several uPAR-expressing cancers, including pancreatic, colorectal, and triple-negative breast cancers. This trial is active and enrolling patients, marking a significant step in Monopar's mission to innovate cancer treatment.

Another critical development for Monopar is the anticipated initiation of a Phase 1 clinical trial for MNPR-101-RIT, a therapeutic radiopharmaceutical, as early as the fourth quarter of 2024. Preclinical studies have shown promising results, with actinium-225 and lutetium-177 labeled MNPR-101 nearly eradicating uPAR-expressing tumors with a single injection. The company’s efforts in this area were recognized at the European Association of Nuclear Medicine (EANM) 2024 Annual Congress, where MNPR-101-RIT was selected for a Top-Rated Oral Presentation.

Monopar has secured a long-term supply agreement with NorthStar Medical Radioisotopes LLC for actinium-225, essential for its current and future developmental stages. Additionally, an amendment to the NorthStar collaboration agreement has given Monopar full ownership of the MNPR-101 radiopharmaceutical platform, strengthening its position in the radiopharmaceutical landscape.

In terms of corporate actions, the company's stockholders approved a reverse stock split on August 5, 2024. The Board of Directors authorized a 1-for-5 reverse stock split to help the company regain compliance with Nasdaq's listing requirements. The reverse stock split is expected to take effect on August 12, 2024, with the stock trading on a split-adjusted basis from August 13, 2024.

Financially, Monopar reported having $7.1 million in cash, cash equivalents, and short-term investments as of June 30, 2024. This funding is projected to sustain operations through at least August 31, 2025, allowing the company to continue its first-in-human MNPR-101-Zr trial and advance the MNPR-101-RIT program. However, Monopar will need additional funding to further progress these and other clinical and preclinical programs and intends to raise capital within the next 12 months.

For the second quarter of 2024, Monopar recorded a net loss of $1.7 million, compared to $2.2 million in the same period in 2023. Research and development (R&D) expenses decreased to $1,131,000 from $1,595,000 in the previous year, primarily due to the closure of the Validive trial and reduced camsirubicin manufacturing costs. This decrease was partially offset by increased expenses related to MNPR-101's radiopharmaceutical use.

General and administrative (G&A) expenses also saw a decline, dropping to $658,000 from $733,000 in the second quarter of 2023. The reduction was mainly due to lower stock-based compensation and decreased consulting and other G&A expenses.

Post-reverse stock split, the company will maintain 40,000,000 authorized shares, with approximately 3,520,366 shares issued and outstanding on a pro forma basis. The par value of $0.001 per share remains unchanged.

Monopar Therapeutics continues to focus on its innovative cancer treatment programs, notably the MNPR-101-Zr for imaging advanced cancers and MNPR-101-RIT for treating advanced cancers, as well as other early-stage development programs targeting solid tumors.

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