Bis-choline tetrathiomolybdate

WILMETTE, Ill., July 20, 2026 (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 the addition of seasoned commercial leaders to support the anticipated launch of the Company’s first commercial product, ALXN1840, pending U.S. Food and Drug Administration (FDA) approval. Nicole Sweeny, former Chief Commercial Officer of KalVista Pharmaceuticals, was elected to the Board of Directors at the Company’s Annual Meeting of Stockholders on June 22, 2026. In addition, Monopar has appointed Sharon Funk as Senior Vice President, Sales and Marketing, and Daniel Olmstead as Senior Vice President, Market Access, Distribution and Patient Services. ALXN1840 is a first-in-class Albumin Tripartite Complex (ATC) activator for the treatment of Wilson disease that has demonstrated clinical safety, efficacy and tolerability across a robust clinical development program. The Company plans to submit an FDA New Drug Application (NDA) for ALXN1840 in mid-2026. Nicole Sweeny ’s 20-plus years of commercial leadership and rare disease launch experience will provide valuable strategic guidance as Monopar prepares for the potential commercialization of ALXN1840. “I’m pleased to join the Monopar Board of Directors as the Company prepares for its next, important phase of growth,” said Ms. Sweeny. “Throughout my career, I’ve seen firsthand the importance of pairing scientific innovation with thoughtful commercial strategy and disciplined execution. I look forward to contributing my experience alongside my fellow directors and the management team as the Company advances its mission, navigates the opportunities ahead and works to create lasting value for patients and shareholders.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Monopar also continued the build-out of its commercial organization with the appointments of Sharon Funk and Daniel Olmstead. Ms. Funk brings more than 20 years of biopharmaceutical commercial leadership experience, with a proven track record of successful scale up and product launches, most recently playing a key role in the commercialization of LUMRYZ at Avadel Pharmaceuticals, acquired by Alkermes Q1 2026. Mr. Olmstead brings more than 30 years of experience creating best-in-class market access, distribution and patient services strategies, most recently instrumental to the successful launches of novel therapies by Ardelyx and Akebia Therapeutics. “This is a pivotal time for Monopar as we advance ALXN1840 toward an NDA submission and prepare for a potential commercial launch,” said Susan Rodriguez, Chief Commercial and Strategy Officer of Monopar. “Sharon and Dan are highly experienced commercial leaders with a proven track record of successful launches of innovative therapies in the rare disease and specialty therapy space. I am also very pleased to welcome Nicole to the Monopar Board of Directors, who brings an invaluable commercial perspective to our Board and management team as we quickly advance our commercial readiness activities. These additions meaningfully deepen the commercial expertise at Monopar as we work to bring ALXN1840 to the Wilson disease community.” About Monopar Therapeutics Inc. Monopar is a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs. ALXN1840 is a first-in-class Albumin Tripartite Complex (ATC) activator for the treatment of Wilson disease in late-stage development. MNPR-101, a first-in-class targeted anti-uPAR (urokinase plasminogen activator receptor) antibody platform in Phase 1 development, is designed to enable targeted radiopharmaceutical imaging and therapy against aggressive solid tumors associated with multiple cancer types. For more information, visit and connect with us on X (formerly known as Twitter) and LinkedIn . 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: Monopar’s plans to support the anticipated launch of the Company’s first commercial product, ALXN1840, pending U.S. Food and Drug Administration (FDA) approval; that the Company plans to submit an FDA New Drug Application (NDA) for ALXN1840 in mid-2026; that Monopar prepares for the potential commercialization of ALXN1840; that Monopar advances ALXN1840 toward an NDA submission and prepare[s] for a potential commercial launch; and that Monopar works to bring ALXN1840 to the Wilson disease community. The forward-looking statements involve risks and uncertainties including, but not limited to, the following: 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

WILMETTE, Ill., June 30, 2026 (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 that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to ALXN1840 (tiomolibdate choline, TMC), the Company’s late-stage candidate for the treatment of Wilson disease. The FDA grants RPD designation to therapies intended to treat serious or life-threatening diseases that primarily affect children from birth to 18 years of age. The designation provides the Company with the potential at the time of NDA approval to receive a pediatric Priority Review Voucher (PRV), which can be used to obtain priority review of a subsequent marketing application or sold or transferred to another sponsor. Priority review can reduce the FDA’s target review time by several months. “Receiving Rare Pediatric Disease designation for ALXN1840 underscores the serious impact that Wilson disease has on patients and reinforces the urgency of bringing forward a new treatment option,” said Chandler Robinson, M.D., Chief Executive Officer of Monopar. About Wilson Disease Wilson disease is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. It is caused by mutations in the ATP7B gene, which impairs the body’s ability to excrete copper. It is characterized by toxic accumulation of copper in the liver, brain, and other organs, leading to progressive and potentially fatal outcomes if untreated. About ALXN1840 ALXN1840 (tiomolibdate choline, TMC) is a novel first-in-class albumin tripartite complex (ATC) activator under investigation for the treatment of Wilson disease. ALXN1840 rapidly mobilizes and tightly sequesters excess copper in ATCs, suppressing its redox reactivity, limiting oxidative damage, and blocking transport across the blood–brain barrier. Clinical data demonstrate that ALXN1840 improves copper balance by increasing fecal copper excretion. In the Phase 3 pivotal trial, ALXN1840 met the primary endpoint by demonstrating rapid and sustained copper mobilization significantly greater than standard of care over 48 weeks in both previously treated and untreated patients. Durable clinical improvement and a favorable safety and tolerability pro observed across 645 patient-years of follow-up in 266 patients. ALXN1840 is an oral tablet with a once-a-day dosing regimen. About Monopar Therapeutics Inc. Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including MNPR-101-Zr (Phase 1) for imaging advanced cancers along with MNPR-101-Lu (Phase 1a) and MNPR-101-Ac (late preclinical) for the treatment of advanced cancers. For more information, visit: . 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. An example of a forward-looking statement includes the statement concerning: that the designation (RPD) provides the Company with the potential at the time of (ALXN1840) NDA approval to receive a pediatric Priority Review Voucher (PRV). The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to whether the ALXN1840 marketing application will receive marketing approval and, if approved, whether Monopar will be awarded a Priority Review Voucher; whether, if awarded, the Priority Review Voucher can be used to obtain priority review of a subsequent marketing application or sold or transferred to another sponsor; the continued authorization and availability of the Rare Pediatric Disease Priority Review Voucher program; 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 Source: Monopar Therapeutics Inc.