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Monopar Appoints Jeffrey D. Kent, M.D., as Executive Vice President, Head of Medical Affairs; Announces Two ALXN1840 Presentations at AASLD – The Liver Meeting® 2026

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Monopar (Nasdaq: MNPR) appointed Jeffrey D. Kent, M.D. as Executive Vice President, Head of Medical Affairs, effective September 1, 2026, to lead medical affairs as the company prepares for potential FDA review of its ALXN1840 New Drug Application for Wilson disease.

Monopar also reported that two abstracts on ALXN1840 (tiomolibdate choline, TMC), its late-stage albumin tripartite complex activator for Wilson disease, were accepted for presentation at AASLD – The Liver Meeting 2026 in Denver, November 5-9, 2026. One Phase 3 FoCus trial abstract on residual disease burden will be delivered as an oral presentation on November 8, and a second abstract on molybdenum balance and toxicity will be presented as a poster on November 5.

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Positive

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Negative

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Market Context

MNPR's active S-3 shelf permits future offerings up to $300,000,000, adding financing context to thi...
Analysis

MNPR's active S-3 shelf permits future offerings up to $300,000,000, adding financing context to this appointment and presentation update. Current data also indicates moderate short positioning, a volatility risk to monitor.

Key Figures

Appointment Effective Date: September 1, 2026 Abstracts Accepted: 2 abstracts Meeting Dates: November 5-9, 2026 +5 more
8 metrics
Appointment Effective Date September 1, 2026 Jeffrey D. Kent appointment
Abstracts Accepted 2 abstracts AASLD – The Liver Meeting 2026
Meeting Dates November 5-9, 2026 AASLD – The Liver Meeting 2026
Trial Phase Phase 3 FoCus trial baseline findings
Oral Presentation Date November 8, 2026 FoCus Phase 3 abstract
Poster Presentation Date November 5, 2026 TMC safety-profile abstract
Public Abstract Release October 5, 2026 AASLD public release
Biopharmaceutical Experience More than 20 years Jeffrey D. Kent

Historical Context

5 past events · Latest: Aug 12 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Aug 12 2Q26 earnings report Positive -0.1% Reported regulatory progress, cash resources, and continued funding expectations for ALXN1840 development.
Jul 22 Rolling NDA submission Positive -1.0% Initiated rolling NDA submission after FDA authorized the process for ALXN1840.
Jul 20 Leadership appointments Positive -4.7% Added commercial leadership and a board member ahead of potential ALXN1840 commercialization.
Jun 30 FDA designation Positive -2.1% Received Rare Pediatric Disease designation for ALXN1840 in Wilson disease.
Jun 26 Phase 3 clinical data Positive +7.8% Reported significant neurologic and global clinical improvements versus standard of care.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

MNPR historically diverged on four of the five selected announcements, with positive news generally followed by negative price reactions.

Key Terms

new drug application, albumin tripartite complex, phase 3 trial, molybdenum toxicity
4 terms
new drug application regulatory
"as Monopar prepares for potential U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)"
A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.
albumin tripartite complex technical
"its first-in-class albumin tripartite complex (ATC) activator drug candidate"
An albumin tripartite complex is a three-part molecular assembly in which human serum albumin—an abundant blood protein—carries two other attached components, such as a therapeutic molecule and a helper tag. For investors, this matters because using albumin as a transporter can act like a slow-release backpack, keeping drugs in circulation longer, improving delivery to target tissues and reducing dosing frequency, which can boost a drug candidate’s commercial prospects and pricing power.
phase 3 trial medical
"baseline findings from the FoCus Phase 3 trial"
A Phase 3 trial is a large, late-stage test of a new drug or medical treatment done on many people to make sure it really works and is safe. For investors, it matters because a successful Phase 3 usually means the company can ask regulators to sell the product and could earn lots of money, while failure can sharply reduce the company’s value.
molybdenum toxicity medical
"Neutral molybdenum balance and lack of molybdenum toxicity in subjects treated"
A condition caused by exposure to excessive amounts of the metal molybdenum, which can harm human or animal health and damage crops or soil. Like too much fertilizer that poisons a garden, molybdenum toxicity can trigger regulatory limits, cleanup costs, production losses, or legal and reputational consequences for companies involved in mining, manufacturing, or agriculture, making it a material environmental and operational risk for investors to monitor.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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WILMETTE, Ill., Aug. 19, 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 appointment of Jeffrey D. Kent, M.D., FACP, FACG, as Executive Vice President, Head of Medical Affairs, effective September 1, 2026. The Company also announced that two abstracts on ALXN1840 (tiomolibdate choline, TMC), its late-stage candidate for the treatment of Wilson disease, have been accepted for presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2026, taking place November 5-9, 2026, in Denver, Colorado.

Appointment of Jeffrey D. Kent, M.D., as Executive Vice President, Head of Medical Affairs

Upon joining Monopar, Dr. Kent will lead the Company’s medical affairs organization as Monopar prepares for potential U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for ALXN1840, its first-in-class albumin tripartite complex (ATC) activator drug candidate for the treatment of Wilson disease.

“Dr. Kent’s training as a gastroenterologist and hepatologist, combined with his deep experience in rare disease, regulatory strategy, and product launches, makes him an exceptional fit for Monopar as we prepare to bring ALXN1840 to patients with Wilson disease,” said Chandler Robinson, M.D., Chief Executive Officer of Monopar.

“The novel mechanism of action and compelling data package of ALXN1840 have the potential to meaningfully change how Wilson disease is treated,” said Dr. Kent. “I look forward to helping realize that potential for patients.”

Dr. Kent brings more than 20 years of biopharmaceutical leadership experience across medical affairs, clinical development and regulatory strategy, with expertise spanning rare diseases, hepatology and gastroenterology, immunology and specialty therapeutics. Most recently, he served as Chief Medical Officer of Sling Therapeutics, where he led the Phase 2b clinical program evaluating linsitinib in thyroid eye disease. Previously, Dr. Kent spent more than a decade at Horizon Therapeutics, including serving as Executive Vice President, Medical Affairs, and as a member of the Executive Committee. During his tenure, he built and scaled Horizon’s global medical affairs organization and supported key programs, including the KRYSTEXXA franchise and the TEPEZZA Biologics License Application (BLA) and its successful FDA Advisory Committee meeting. Earlier in his career, Dr. Kent led global medical affairs for HUMIRA at Abbott Laboratories and served on the CELEBREX clinical development team at Searle/Pharmacia.

AASLD – The Liver Meeting® 2026 Presentations

The abstract, titled “Residual hepatic, neurologic, and psychiatric disease burden in treatment-experienced patients with Wilson disease: baseline findings from the FoCus Phase 3 trial,” was selected for an oral presentation, a distinction reserved for a small share of accepted abstracts. Frederick K. Askari, M.D., Ph.D., lead author of the abstract and Associate Professor of Internal Medicine and Director of the Wilson Disease Program at the University of Michigan Health System, will present the findings on Sunday, November 8, 2026, from 12:15 p.m. to 12:30 p.m. MT. The presentation will highlight the significant unmet need that persists despite years of treatment with currently available therapies, underscoring the importance of novel treatment options in Wilson disease.

Additionally, a second abstract, titled “Neutral molybdenum balance and lack of molybdenum toxicity in subjects treated with tiomolibdate choline supports safety profile of TMC,” was selected for a poster presentation. Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Consultant Hepatologist at The Roger Williams Institute of Liver Studies, King’s College London, and King’s College Hospital, London, will present the poster during the Metabolic and Genetic Disease poster session on Thursday, November 5, 2026, from 12:00 p.m. to 1:00 p.m. MT.

The abstracts are scheduled to be released publicly by AASLD on October 5, 2026, and will be published in the October supplement of Hepatology. Presentation materials will be made available on the Monopar website concurrently with each presentation.

About Wilson Disease

Wilson disease is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. Caused by mutations in the ATP7B gene, the disease impairs the body’s ability to excrete copper, resulting in toxic copper accumulation in the liver, brain, and other organs 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 profile were observed across 645 patient-years of follow-up in 266 patients.

About Monopar Therapeutics Inc.

Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage candidate 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: www.monopartx.com.

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 the following: that Dr. Kent will lead the medical affairs organization in preparation for potential U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for ALXN1840; that Monopar is preparing to bring ALXN1840 to patients with Wilson disease; and that the novel mechanism of action and compelling data package of ALXN1840 have the potential to meaningfully change how Wilson disease is treated. The forward-looking statements involve risks and uncertainties including, but not limited to: the risk that Dr. Kent does not commence employment as expected or that the anticipated benefits of his appointment are not realized; uncertainties related to the regulatory process, including the rolling NDA submssion, that Monopar has initiated for 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 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 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.


FAQ

What leadership change did Monopar (MNPR) announce on August 19, 2026?

Monopar announced that Jeffrey D. Kent, M.D. will become Executive Vice President, Head of Medical Affairs, effective September 1, 2026. According to Monopar, Dr. Kent will lead medical affairs as the company prepares for a potential FDA decision on ALXN1840 for Wilson disease.

Who is Jeffrey D. Kent, M.D., newly appointed Head of Medical Affairs at Monopar (MNPR)?

Jeffrey D. Kent, M.D. is a gastroenterologist and hepatologist with over 20 years of biopharmaceutical leadership experience. According to Monopar, he previously held senior roles at Sling Therapeutics, Horizon Therapeutics, Abbott Laboratories, and Searle/Pharmacia across medical affairs, clinical development, and regulatory strategy.

What is ALXN1840 (tiomolibdate choline, TMC) in Monopar’s (MNPR) pipeline?

ALXN1840, or tiomolibdate choline (TMC), is Monopar’s late-stage candidate for treating Wilson disease. According to Monopar, it is described as a first-in-class albumin tripartite complex activator, and the company is preparing a New Drug Application (NDA) for potential U.S. FDA approval.

Which ALXN1840 Phase 3 data will Monopar present at AASLD – The Liver Meeting 2026?

Monopar will present an oral abstract on baseline findings from the FoCus Phase 3 trial in treatment-experienced Wilson disease patients. According to Monopar, this presentation focuses on residual hepatic, neurologic and psychiatric disease burden despite existing therapies, highlighting persistent unmet medical need.

When and where will Monopar’s ALXN1840 presentations occur at AASLD – The Liver Meeting 2026?

According to Monopar, the oral FoCus Phase 3 presentation is scheduled for November 8, 2026, 12:15–12:30 p.m. MT, and the safety-focused poster for November 5, 2026, 12:00–1:00 p.m. MT, during AASLD – The Liver Meeting 2026 in Denver.

When will Monopar’s ALXN1840 AASLD 2026 abstracts and materials be publicly available?

According to Monopar, the ALXN1840 abstracts will be released by AASLD on October 5, 2026 and published in the October supplement of Hepatology. Presentation materials are planned to be posted on Monopar’s website at the time of each conference presentation.