Bis-choline tetrathiomolybdate

WILMETTE, Ill., March 27, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar,” the “Company,” “we”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced the fourth quarter and full-year 2025 financial results and provided a summary of recent developments. “2025 was a productive year for Monopar, marked by multiple ALXN1840 data presentations, an important publication, a strengthened balance sheet and continued progress toward a planned New Drug Application submission for ALXN1840 in Wilson disease,” said Chandler Robinson, MD, Chief Executive Officer of Monopar. “We also recently strengthened our leadership team with the addition of Susan Rodriguez as Chief Commercial and Strategy Officer as we prepare for the potential launch of ALXN1840. We are grateful to the Wilson disease patients and their families whose experiences have informed our efforts to advance ALXN1840.” Recent Program Developments ALXN1840 – NDA Submission Planned for Mid-2026 for Wilson Disease Wilson disease is a rare genetic disorder characterized by impaired copper elimination, resulting in toxic accumulation in organs such as the liver and brain. ALXN1840 binds and mobilizes copper and has a novel mechanism of action as an albumin tripartite complex (“ATC”) activator that differentiates it from currently available first-line therapies. Based on recent interactions with the U.S. Food and Drug Administration (“FDA”), Monopar plans to submit a New Drug Application (“NDA”) for ALXN1840 in mid-2026. ALXN1840 updates: EASL 2025: Presented pooled long-term efficacy and safety data (n=255; median treatment duration 2.63 years), with additional safety data (n=266) supporting a favorable safety profile, as a late-breaking abstract ANA 2025: Presented data demonstrating long-term neurological benefit; the abstract was selected for oral and poster presentation and designated an “Abstract of Distinction” Journal of Hepatology / AASLD 2025: Reported statistically significant improvement in copper balance, with sustained improvement in daily copper balance driven by increased fecal copper excretion EL-PFDD: Attended externally led patient-focused drug development (“EL-PFDD”) meeting with the FDA on January 29, 2026. During the meeting, patients and caregivers described the burden of Wilson disease, shared their experience with the currently available treatments, and highlighted the urgent need for additional treatment options Upcoming 2026 presentations: Abstracts accepted for presentation at EASL 2026 and the American Academy of Neurology (“AAN”) 2026 Annual Meeting, including: Tiomolybdate choline stabilizes liver disease and improves neurological symptoms as well as quality of life in treatment-experienced Wilson disease patients (EASL 2026 oral presentation) Greater clinical benefit with tiomolybdate choline versus standard-of-care in neurologic Wilson disease patients in the Phase 3 FoCus Trial (AAN 2026 late-breaking oral and poster presentation) Tiomolybdate choline stabilizes liver disease and improves neurological symptoms as well as quality of life in treatment-experienced Wilson disease patients (EASL 2026 oral presentation) Greater clinical benefit with tiomolybdate choline versus standard-of-care in neurologic Wilson disease patients in the Phase 3 FoCus Trial (AAN 2026 late-breaking oral and poster presentation) MNPR-101 Radiopharmaceutical Programs MNPR-101-Zr (zirconium-89), MNPR-101-Lu (lutetium-177), and MNPR-101-Ac (actinium-225) target the urokinase plasminogen activator receptor (“uPAR”), which is expressed in multiple aggressive cancers, including triple-negative breast, colorectal, and pancreatic cancers. MNPR-101 platform update: Ongoing Phase 1 clinical activity in Australia for MNPR-101-Zr and MNPR-101-Lu Investigational new drug ("IND") clearance received for MNPR-101-Lu to initiate a Phase 1 clinical trial in the US FDA-authorized physician-sponsored Expanded Access Program at Excel Diagnostics and Nuclear Oncology Center (“EDNOC”) in Houston, Texas Preclinical development of MNPR-101-Ac Financings In 2025, Monopar strengthened its balance sheet through the following financing activities: Completed an underwritten public offering generating approximately $91.9 million, after a concurrent repurchase of common stock but before offering expenses Results for the Fourth Quarter and Year Ended December 31, 2025, Compared to the Fourth Quarter and Year Ended December 31, 2024 Cash and Net Loss Cash, cash equivalents and short-term investments as of December 31, 2025, were $140.4 million. Monopar expects its current funds to support operations through at least December 31, 2027, including: (1) regulatory and potential commercial activities for ALXN1840; (2) continued development of MNPR-101 programs; and (3) internal research and development. Net loss for the fourth quarter of 2025 was $5.2 million, or $0.61 per share, compared to $10.9 million, or $2.23 per share, for the fourth quarter of 2024. Net loss for the year ended December 31, 2025, was $13.7 million, or $1.85 per share, compared to $15.6 million, or $4.11 per share, for the year ended December 31, 2024. Research and Development (“R&D”) Expenses R&D expenses for the fourth quarter of 2025 were $3.9 million compared to $9.9 million for the fourth quarter of 2024. The decrease was primarily due to the absence of one-time expenses incurred in connection with the in-licensing of ALXN1840 in 2024, partially offset by higher R&D personnel expenses (driven by increased headcount and compensation), increased clinical material and manufacturing costs for the ALXN1840 program, and higher other R&D expenses. R&D expenses for the year ended December 31, 2025, were $9.9 million compared to $13.0 million for the year ended December 31, 2024. The decrease was primarily due to the absence of one-time expenses incurred in connection with the in-licensing of ALXN1840 in 2024, as well as lower radiopharmaceutical clinical trial costs reflecting a shift in focus following the in-licensing, partially offset by higher R&D personnel expenses (driven by increased headcount and compensation), increased clinical material and manufacturing costs for the ALXN1840 program, and higher other R&D expenses. General and Administrative (“G&A”) Expenses G&A expenses for the fourth quarter of 2025 were $2.2 million compared to $1.2 million for the fourth quarter of 2024. The increase was primarily due to higher Board of Directors (the “Board”) and G&A personnel expenses (including stock-based compensation and bonuses), higher patent legal fees, and other increases in G&A expenses. G&A expenses for the year ended December 31, 2025, were $6.8 million compared to $3.2 million for the year ended December 31, 2024. The increase was primarily due to higher Board and G&A personnel expenses (including stock-based compensation and bonuses), higher patent legal fees, and other increases in G&A expenses. About Monopar Therapeutics Inc. Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical 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-Ac for the treatment of advanced cancers. For more information, including links to SEC filings containing detailed financial information, please visit: Annual Reports :: Monopar Therapeutics Inc. (MNPR). 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 statements concerning: that Monopar is making continued progress toward a planned New Drug Application ("NDA") submission for ALXN1840 in Wilson disease; that Monopar is preparing for the potential launch of ALXN1840; that Monopar plans to submit an NDA for ALXN1840 to the FDA in mid-2026; and that Monopar expects its current funds to support operations through at least December 31, 2027. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840, including the submission of the NDA to the FDA, and the outcome thereof; 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 Released March 27, 2026

WILMETTE, Ill., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced third quarter 2025 financial results and recent developments. Recent Developments ALXN1840 for Wilson Disease On September 14-15, 2025, the Company presented new data on the long-term neurological efficacy and safety of ALXN1840 (tiomolybdate choline) at the 150th American Neurological Association (ANA) Annual Meeting. Matthew Lorincz, M.D., Ph.D., Professor of Neurology and Co-Director of the Wilson Disease Center of Excellence at the University of Michigan delivered the poster and oral presentations. The new findings presented at ANA highlight the long-term neurological benefit of ALXN1840, and follow the European Association for the Study of the Liver (EASL) International Liver Congress presentation in May on the long-term hepatic and systemic safety and efficacy data. Together, these findings underscore the potential of ALXN1840 to favorably impact both neurological and hepatic manifestations of Wilson disease. On November 9, 2025, the Company presented new data and analyses from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2025. In an oral presentation titled “Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline,” Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Professor of Hepatology and Consultant Hepatologist at the Institute of Liver Studies at King’s College Hospital in London, shared results showing that treatment with ALXN1840 led to a rapid and sustained improvement in daily copper balance in patients with Wilson disease, primarily through increased fecal copper excretion. Monopar is preparing to submit a New Drug Application (“NDA”) to the FDA in early 2026. MNPR‐101 for Radiopharmaceutical Use On September 26, 2025, Monopar received FDA clearance on its IND application for MNPR-101-Lu, which covers the protocol titled “Phase 1, Open-Label, Multicenter, Dosimetry and Dose-Escalation Trial to Characterize the Safety, Tolerability, and Anti-Tumor Activity of Fractionated MNPR-101-Lu Dosing in the Treatment of uPAR-Expressing Advanced or Metastatic Solid Tumors.” This IND incorporates the Company’s proprietary linker technology, which has been designed to enhance the stability and biodistribution of its therapeutic radiopharmaceuticals. Recent Financing Capital Raise and Share Repurchase On September 23, 2025, the Company priced an underwritten public offering (the “Offering”) consisting of (i) 1,034,433 shares of its common stock and (ii) pre-funded warrants to purchase 960,542 shares of common stock, pursuant to an underwriting agreement (the “Underwriting Agreement”) with Morgan Stanley & Co. LLC, Leerink Partners LLC, and Barclays Capital Inc. (the “Underwriters”). The public offering price was $67.67 per share and $67.669 per pre-funded warrant, which represents the per share offering price less a $0.001 per share exercise price. The aggregate net proceeds from the Offering were approximately $126.9 million, after deducting underwriting discounts and commissions but before offering expenses and the Share Repurchase (as defined below). On September 24, 2025, the Company entered into a share purchase agreement (the “Share Purchase Agreement”) with Tactic Pharma LLC (“Tactic Pharma”), an existing significant stockholder that held approximately 13.4% of the Company’s common stock prior to the Offering and Share Repurchase. Pursuant to the Share Purchase Agreement, the Company used $35 million of the Offering proceeds to repurchase 550,229 shares of its common stock from Tactic Pharma at a purchase price of $63.6098 per share, which equals the public offering price per share less underwriting discounts and commissions (the “Share Repurchase”). After giving effect to the Share Repurchase, the Company's net proceeds from the Offering were approximately $91.9 million, before estimated offering expenses. Financial Results for the Third Quarter Ended September 30, 2025, Compared to the Third Quarter Ended September 30, 2024 Cash and Net Loss Cash, cash equivalents and investments as of September 30, 2025, were $143.7 million. Monopar expects that its current funds will be sufficient to continue operations at least through December 31, 2027, in order to: (1) assemble a regulatory package and file an NDA for the 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, continue to conduct our first-in-human therapeutic clinical trial of MNPR-101-Lu, and advance our preclinical MNPR-101-Ac program into the clinic; and (3) invest in internal R&D projects to expand our radiopharmaceutical pipeline. Net loss for the third quarter of 2025 was $3.4 million or $0.48 per share compared to net loss of $1.3 million or $0.37 per share for the third quarter of 2024. Research and Development (“R&D”) Expenses R&D expenses for the third quarter of 2025 were $2,589,749, compared to $984,278 for the third quarter of 2024. This represents an increase of $1,605,471 attributed to (1) a $937,582 increase in manufacturing activities related to ALXN1840, (2) a $617,667 increase in R&D personnel expenses including stock-based compensation and (3) a net increase of $50,223 in other R&D expenses. General and Administrative (“G&A”) Expenses G&A expenses for the third quarter of 2025 were $1,503,326, compared to $590,624 for the third quarter of 2024. This represents an increase of $912,702 primarily attributed to (1) a $369,959 increase in Board compensation resulting from the grant of stock options in March 2025 (no stock options were granted to the Board in 2024), (2) a $287,749 increase in G&A personnel expenses including stock-based compensation, and (3) a net increase of $254,993 in other G&A expenses. Interest Income Interest income for the third quarter of 2025 increased by $556,129 compared to the same period in 2024. The increase is attributed to interest earned on U.S. Treasury securities and higher bank balances in 2025, as a result of the approximately $91.9 million raised in the Offering after giving effect to the Share Repurchase, deducting underwriting discounts and commissions but before offering expenses. About Monopar Therapeutics Inc. Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical 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-Ac for the treatment of advanced cancers. For more information, and links to SEC filings that contain detailed financial information, visit: https://ir.monopartx.com/quarterly-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 statements concerning: that together, these findings underscore the potential of ALXN1840 to favorably impact both neurological and hepatic manifestations of Wilson disease; that Monopar is preparing to submit a New Drug Application (“NDA”) to the FDA in early 2026; that the MNPR-101-Lu IND incorporates the Company’s proprietary linker technology, which has been designed to enhance the stability and biodistribution of its therapeutic radiopharmaceuticals; and that Monopar expects that its current funds will be sufficient to continue operations at least through December 31, 2027. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840 and the outcome thereof; 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