Monopar Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Developments

Rhea-AI Summary

Monopar Therapeutics (MNPR) reported its Q4 and full-year 2024 financial results, highlighting a significant year marked by key developments. The company raised over $55 million in Q4 2024 through public offerings and private placements. Cash position stood at $60.2 million as of December 31, 2024, expected to fund operations through 2026.

Key developments include the in-licensing of ALXN1840 for Wilson disease with plans to submit an NDA in early 2026, and the initiation of two first-in-human radiopharma Phase 1 trials. The company reported a Q4 2024 net loss of $10.9 million ($2.23 per share) compared to $1.8 million in Q4 2023. Full-year 2024 net loss was $15.6 million ($4.11 per share) versus $8.4 million in 2023.

R&D expenses increased to $9.9 million in Q4 2024, primarily due to ALXN1840 in-licensing costs. G&A expenses rose slightly to $1.2 million in Q4 2024 from $0.9 million in Q4 2023.

Positive

• Raised over $55 million in Q4 2024 strengthening balance sheet
• Strong cash position of $60.2 million funding operations through 2026
• Successfully in-licensed ALXN1840 for Wilson disease treatment
• Initiated two first-in-human radiopharma Phase 1 clinical trials
• Phase 3 trial for ALXN1840 met primary endpoint

Negative

• Net loss increased to $10.9 million in Q4 2024 from $1.8 million in Q4 2023
• R&D expenses significantly increased to $9.9 million from $1.0 million year-over-year
• G&A expenses increased to $1.2 million from $0.9 million in Q4
• Issued 9.9% ownership stake to AstraZeneca as part of licensing deal

Insights

Financial Analyst

Monopar's Q4 and FY2024 results demonstrate improved financial positioning despite wider losses. The company significantly bolstered its balance sheet, ending 2024 with $60.2 million in cash and investments following two successful public offerings that netted over $55 million. This capital infusion extends runway through at least December 2026, substantially de-risking near-term financing concerns.

The increased net loss of $10.9 million for Q4 ($2.23 per share) and $15.6 million for FY2024 ($4.11 per share) was primarily driven by an $8.6 million expense related to the ALXN1840 in-licensing transaction with AstraZeneca. This strategic investment represents targeted capital allocation toward a late-stage asset with near-term regulatory potential rather than operational inefficiency.

The ALXN1840 deal structure appears favorable, with a modest $4 million upfront payment plus 9.9% equity stake to AstraZeneca in exchange for worldwide rights to a Phase 3-completed asset. The planned NDA filing in early 2026 presents a clearly defined value inflection point with potential commercialization by 2027, providing investors with a visible path to potential revenue generation.

The financing pattern reveals increasing investor confidence, with the December raise pricing at $23.79 per share compared to October's $16.25 - a 46% increase in just two months. Management's stated priorities for capital deployment across regulatory submission preparation, clinical advancement of radiopharmaceuticals, and pipeline expansion align with balanced risk management while maintaining multiple potential value drivers.

Biotech Expert

Monopar is executing a dual-track strategy focused on both near-term regulatory opportunities and longer-term pipeline development. The ALXN1840 in-licensing represents a strategic pivot into rare disease with a Phase 3-completed asset for Wilson disease. Crucially, this compound has already met its primary endpoint in Phase 3 testing as a copper binder and mobilizer - the fundamental mechanism needed to address this genetic disorder characterized by toxic copper accumulation.

The planned NDA submission in early 2026 positions ALXN1840 as the company's most advanced program with a relatively clear regulatory pathway. Wilson disease represents a serious unmet need where existing treatments have limitations in efficacy or tolerability. The fact that AstraZeneca maintained exposure through equity ownership and milestone/royalty arrangements suggests confidence in the asset's potential.

Simultaneously, Monopar's radiopharmaceutical platform targeting the urokinase plasminogen activator receptor (uPAR) is gaining clinical validation. The company has successfully transitioned both diagnostic (MNPR-101-Zr) and therapeutic (MNPR-101-Lu) candidates into first-in-human trials. Early imaging results presented at EANM 2024 demonstrated uPAR expression detection across multiple tumor types including breast, colorectal, pancreatic, adrenocortical, and ovarian cancers.

This broad expression profile potentially expands the addressable patient population for these targeted therapies. The concurrent advancement of both imaging and therapeutic agents follows the established theranostic paradigm that has proven successful in other radiopharmaceutical programs. The additional patent filing covering novel linker technology suggests ongoing innovation around the core platform that could potentially yield additional pipeline candidates.

WILMETTE, Ill., March 31, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, today announced fourth quarter and full-year 2024 financial results and summarized recent developments.

“2024 was a productive year for Monopar, with the in-licensing of ALXN1840, the initiation of two first-in-human radiopharma Phase 1 clinical trials, and the strengthening of our balance sheet with net proceeds of over $55 million from financings,” said Chandler Robinson, MD, Chief Executive Officer of Monopar. “We are especially grateful to the Wilson disease patients. Their testimonies and support are what provided the opportunity for Monopar to progress ALXN1840 toward an NDA filing.”

Recent Program Developments

ALXN1840 – Plan to Submit NDA with FDA for Wilson Disease in Early 2026

Wilson disease is a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised, leading to damage from toxic copper build-up in tissues and organs such as the liver and brain. ALXN1840 is a potent binder and mobilizer of copper, as demonstrated in a Phase 3 clinical trial that met its primary endpoint. In October 2024, Monopar announced the execution of a worldwide exclusive license to ALXN1840 with Alexion, AstraZeneca Rare Disease (“AZ”). As part of this transaction, AZ received a total cash payment of $4.0 million, was issued 9.9% ownership of Monopar’s outstanding common stock, and is entitled to receive regulatory approval and sales milestones along with a tiered royalty based on net sales.

MNPR-101 – Currently Enrolling Phase 1 Imaging and Therapeutic Oncology Trials

Imaging agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) and therapeutic agent MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) target the urokinase plasminogen activator receptor (“uPAR”), which is expressed in numerous aggressive cancers such as triple-negative breast, colorectal, and pancreatic cancers.

• Initiated Phase 1a clinical trial for novel therapeutic radiopharmaceutical MNPR-101-Lu in patients with advanced cancers

• Dosed first patient with MNPR-101-Lu in December 2024

• Presented encouraging human clinical imaging and dosimetry data of MNPR-101-Zr at the European Association of Nuclear Medicine (“EANM”) 2024 Annual Congress

• uPAR expression, as detected by MNPR-101-Zr, has been seen to date in breast, colorectal, pancreatic, adrenocortical carcinoma, and ovarian cancer patients

• Filed a patent application covering new therapeutic radiopharmaceuticals based on a novel family of linkers used to connect radioisotopes with targeting agents, including Monopar’s uPAR targeting antibody MNPR-101

Recent Financings

In Q4 2024, we raised net proceeds of over $55 million from the following financings:

• On October 30, 2024, pursuant to a placement agent agreement with Rodman & Renshaw LLC, we sold 1,181,540 shares of our common stock at $16.25 in a public offering, yielding net proceeds of approximately $17.8 million.

• On December 23, 2024, pursuant to an underwriting agreement with Piper Sandler & Co., we sold 798,655 shares of our common stock at $23.79 per share in a public offering. Concurrently with the public offering, we completed a private placement of 882,761 pre-funded warrants to purchase shares of common stock to an institutional investor at a purchase price of $23.789 per pre-funded warrant. The net proceeds of the December 23, 2024, public offering and private placement were approximately $37.4 million.

Results for the Fourth Quarter and Year Ended December 31, 2024, Compared to the Fourth Quarter and Year Ended December 31, 2023

Cash and Net Loss

Cash, cash equivalents and short-term investments as of December 31, 2024, were $60.2 million. Monopar expects that its current funds will be sufficient to continue operations at least through December 31, 2026, in order to: (1) assemble a regulatory package and file an NDA for ALXN1840; (2) continue to conduct and conclude its first-in-human imaging and dosimetry clinical trial with MNPR-101-Zr; (3) continue to conduct its first-in-human therapeutic clinical trial of MNPR-101-Lu; (4) advance its preclinical MNPR-101-Ac program into the clinic; and (5) invest in internal research and development projects to expand its radiopharma and rare disease pipeline.

Net loss for the fourth quarter of 2024 was $10.9 million or $2.23 per share compared to $1.8 million or $0.60 per share for the fourth quarter of 2023. Net loss for the year ended December 31, 2024, was $15.6 million or $4.11 per share compared to $8.4 million or $3.04 per share for the year ended December 31, 2023.

Research and Development (“R&D”) Expenses

R&D expenses for the fourth quarter of 2024 were $9.9 million compared to $1.0 million for the fourth quarter of 2023. This increase of $8.9 million was primarily due to: (1) an increase of $8.6 million related to the in-licensing of ALXN1840 and (2) an increase of $0.4 million in R&D salaries, partially offset by a net decrease of $0.1 million in other R&D expenses.

R&D expenses for the year ended December 31, 2024, were $13.0 million compared to $5.6 million for the year ended December 31, 2023. This increase of $7.4 million was primarily due to: (1) an increase of $8.6 million related to the in-licensing of ALXN1840; (2) an increase of $0.3 million in R&D personnel expenses; and (3) a net increase of $0.1 million in other R&D expenses, partially offset by a decrease of $1.6 million in trial closure related expenses.

General and Administrative (“G&A”) Expenses

G&A expenses for the fourth quarter of 2024 were $1.2 million, compared to $0.9 million for the fourth quarter of 2023. This increase of $0.3 million was primarily due to: (1) an increase of $0.1 million in G&A personnel salaries; (2) an increase of $0.1 million in G&A consulting fees; and (3) an increase of $0.1 million in Delaware franchise taxes.

G&A expenses for the year ended December 31, 2024, were $3.2 million, compared to $3.2 million for the year ended December 31, 2023.

About Monopar Therapeutics Inc. 

Monopar Therapeutics is a clinical-stage biotechnology company with late-stage ALXN1840 for Wilson disease, and radiopharma programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, and links to SEC filings that contain detailed financial information, visit: https://ir.monopartx.com/annual-reports.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include: that Monopar plans to submit an NDA for Wilson disease in early 2026; and that Monopar expects that its current funds will be sufficient to continue operations at least through December 31, 2026. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory discussions that Monopar intends to initiate related to ALXN1840 and the outcome thereof; that radiation dosimetry analytics in the future may not be consistent with the estimated data generated thus far; that Monopar may not find enough patients to successfully enroll its MNPR-101-Lu therapeutic study; that the Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr may not yield consistently satisfactory results; that future preclinical, including MNPR-101-Ac, or clinical data may not be as promising as the data to date; that MNPR-101-Zr and/or MNPR-101-Lu may cause unexpected serious adverse effects or fail to be effective against the cancer tumors in humans; that the trials could result in a clinical hold should there be a serious adverse event; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar’s ability to raise sufficient funds in order for the Company to support continued preclinical, clinical, regulatory, precommercial and commercial development of its programs and to make contractual milestone payments, as well as its ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.  

CONTACT:  

Monopar Therapeutics Inc.
Investor Relations  
Quan Vu  
Chief Financial Officer  
vu@monopartx.com  

Follow Monopar on social media for updates: 

X: @MonoparTx  LinkedIn: Monopar Therapeutics

FAQ

What is the current cash position of MNPR and how long will it last?

MNPR has $60.2 million in cash as of December 31, 2024, expected to fund operations through December 31, 2026.

When does Monopar (MNPR) plan to submit the NDA for ALXN1840?

Monopar plans to submit the NDA for ALXN1840 to treat Wilson disease in early 2026.

How much did MNPR's net loss increase in Q4 2024 compared to Q4 2023?

Net loss increased to $10.9 million in Q4 2024 from $1.8 million in Q4 2023.

How much capital did MNPR raise in Q4 2024?

MNPR raised over $55 million through public offerings and private placements in Q4 2024.

What caused the significant increase in MNPR's R&D expenses for Q4 2024?

R&D expenses increased primarily due to $8.6 million related to the in-licensing of ALXN1840.