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Based on the provided financial report, the title of the article is likely: "Monopar Therapeutics Inc. (MNPR) 2024 Annual Report (Form 10-K)

Press release·03/31/2025 12:15:02
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Based on the provided financial report, the title of the article is likely: "Monopar Therapeutics Inc. (MNPR) 2024 Annual Report (Form 10-K)

Based on the provided financial report, the title of the article is likely: "Monopar Therapeutics Inc. (MNPR) 2024 Annual Report (Form 10-K)

Monopar Therapeutics Inc. reported its financial results for the year ended December 31, 2024. The company had total assets of $14.3 million, total liabilities of $6.1 million, and total stockholders’ equity of $8.2 million. Revenue was $0, and the company reported a net loss of $1.5 million. The company had cash and cash equivalents of $2.9 million as of December 31, 2024. The company also reported that it had 40 million shares of common stock outstanding as of December 31, 2024. The company’s financial statements have been prepared in accordance with generally accepted accounting principles (GAAP) and include the notes to the financial statements, which provide additional information about the company’s financial position and results of operations.

Overview

We are a clinical-stage biopharma company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs, including Phase 1-stage MNPR-101-Zr for imaging advanced cancers along with Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. We leverage our scientific and clinical experience to help reduce the risk and accelerate the clinical development of our drug product candidates.

Financial Status

As of December 31, 2024, our cash, cash equivalents and investments were $60.2 million. We expect our current funds will be sufficient at least through December 31, 2026 to:

  1. Assemble a regulatory package and file an NDA for the in-licensed ALXN1840 investigational drug candidate for Wilson disease.
  2. Continue to conduct and conclude our first-in-human imaging and dosimetry clinical trial with MNPR-101-Zr.
  3. Continue to conduct our first-in-human therapeutic clinical trial of MNPR-101-Lu.
  4. Advance our preclinical MNPR-101-Ac program into the clinic.
  5. Invest in internal R&D projects to expand our radiopharmaceutical pipeline.

Prior to the fourth quarter of 2024, our primary funding source was sales of our common stock under at-the-market sales programs. In 2024, we also completed public offerings in October and December that raised a total of $55.2 million in net proceeds.

ALXN1840 for Wilson Disease

ALXN1840 is an investigational once-daily, orally-administered drug candidate in development for the treatment of Wilson disease. It is designed to selectively and tightly bind and remove copper from the body’s tissues and blood. ALXN1840 has been granted Orphan Drug Designation and Fast Track designation in the U.S. and orphan designation in the EU.

A pivotal Phase 3 clinical trial of ALXN1840 in Wilson disease patients met its primary endpoint, demonstrating three-times greater copper mobilization compared to standard-of-care. The data also suggested ALXN1840 may reduce the risk of neurological worsening when compared to standard-of-care.

After Alexion terminated the ALXN1840 program, we in-licensed the program in October 2024 and plan to pursue regulatory approval and commercialization.

MNPR-101 for Radiopharmaceutical Use, Development Update

We have a proprietary first-in-class humanized monoclonal antibody, MNPR-101, that targets the urokinase plasminogen activator receptor (uPAR). We have conjugated MNPR-101 to imaging and therapeutic radioisotopes to create radiopharmaceutical agents.

In 2024, we received regulatory clearance and launched first-in-human Phase 1 clinical trials for our MNPR-101-Zr imaging agent and MNPR-101-Lu therapeutic agent in patients with advanced cancers. We also presented positive preclinical and early clinical data on the tumor-targeting ability of our MNPR-101 radiopharmaceuticals.

We are actively expanding our radiopharmaceutical pipeline through internal development efforts, including filing a provisional patent application for new radiopharmaceutical compounds and linkers.

Our Strategy

Our key strategic goals are to:

  • Assemble a regulatory package and file an NDA for ALXN1840 in Wilson disease.
  • Advance the development of MNPR-101 radiopharmaceuticals as both therapeutic and diagnostic agents.
  • Expand our pipeline through internal R&D and in-licensing/acquisition of new product candidates.
  • Leverage our team’s expertise in drug development and commercialization to establish ourselves as a leading biopharma company.

Revenues

We are a microcap biopharma company with no approved drugs and no revenues to date. We do not anticipate revenues until we complete testing and development of one of our drug candidates and obtain marketing approval, or out-license a candidate to another party.

Key Financial Highlights

  • R&D expenses increased by $7.4 million in 2024, primarily due to the in-licensing of ALXN1840 and continued clinical development.
  • G&A expenses decreased by $0.1 million in 2024 due to lower equity compensation.
  • We raised $59.2 million in net proceeds from financing activities in 2024, including public offerings in October and December.
  • Our cash, cash equivalents and investments totaled $60.2 million as of December 31, 2024, which we expect will fund operations at least through December 31, 2026.

In summary, we are a clinical-stage biopharma company focused on advancing our late-stage Wilson disease program and radiopharmaceutical pipeline. We have a strong cash position to fund our planned operations through at least the end of 2026 as we work towards potential regulatory approvals and commercialization.

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