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Monopar Therapeutics reported second quarter 2026 results and highlighted regulatory progress for its lead Wilson disease candidate ALXN1840. On July 22, 2026, the company initiated a rolling New Drug Application (NDA) submission to the FDA for ALXN1840, and on June 30, 2026, the FDA granted Rare Pediatric Disease (RPD) designation, which could make Monopar eligible for a pediatric Priority Review Voucher if the NDA is ultimately approved.
Additional clinical data from Phase 2 and Phase 3 ALXN1840 studies were presented at major neurology and liver conferences, and a peer-reviewed Phase 2 manuscript was published, underscoring copper balance and clinical benefits in Wilson disease. Cash, cash equivalents and investments totaled $134.3 million as of June 30, 2026, and Monopar expects this to fund operations through at least December 31, 2027, including regulatory and potential commercial activities for ALXN1840 and continued MNPR-101 development.
Net loss for the quarter was $5.3 million, or $0.62 per share, compared with $2.5 million, or $0.35 per share, a year earlier, mainly driven by higher research and development spending. R&D expenses rose to $4,766,832 from $1,730,000, while G&A expenses increased to $1,877,831 from $1,504,295. Interest income increased to $1,299,205, reflecting earnings on U.S. Treasury securities, commercial paper and higher cash balances following a prior capital raise of approximately $91.9 million.
Monopar Therapeutics Inc. is a clinical-stage biopharmaceutical company developing ALXN1840 for Wilson disease and several radiopharmaceutical programs for advanced cancers. It remains pre-revenue and funds operations through prior equity raises, including common stock and pre-funded warrant offerings.
As of June 30, 2026, Monopar reported total assets of $134.98 million, including cash, cash equivalents and investments of $134.3 million, and total liabilities of $4.12 million. Stockholders’ equity was $130.85 million. The accumulated deficit reached approximately $98.7 million.
For the six months ended June 30, 2026, the company recorded a net loss of $9.21 million compared with $5.08 million a year earlier, driven mainly by higher research and development spending of $8.25 million versus $3.37 million. Net cash used in operating activities was $6.72 million. Management states that existing cash, cash equivalents and investments are expected to fund operations at least through December 31, 2027, and concludes there is no substantial doubt about the company’s ability to continue as a going concern within one year of issuance.
Monopar Therapeutics Inc. has begun a rolling submission of a New Drug Application to the U.S. Food and Drug Administration for ALXN1840 (tiomolibdate choline), a first-in-class albumin tripartite complex activator being developed to treat Wilson disease.
The FDA has authorized this rolling process and the first sections of the application have been submitted. In a pivotal Phase 3 trial, ALXN1840 met its primary endpoint, showing rapid and sustained copper mobilization significantly greater than standard of care over 48 weeks. Across the clinical development program, durable clinical improvement and favorable tolerability were observed over 645 patient-years in 266 patients. ALXN1840 holds Fast Track, Orphan Drug and Rare Pediatric Disease designations, which provide the potential, at the time of NDA approval, to receive a pediatric Priority Review Voucher.
MNPR received a Form 144/A filing indicating that Arthur Klausner may sell up to 5,000 shares of common stock through MLPFS at One Bryant Park, New York, with sales permissible on or after 07/08/2026 on NASDAQ. The shares relate to multiple restricted stock unit vestings granted as part of the issuer’s equity compensation plan between 09/30/2020 and 12/31/2023, each described as equity awards to Klausner.
Monopar Therapeutics’ Chief Financial Officer Vu Quan Anh reported routine equity compensation activity tied to restricted stock units. On the vesting date, 1,228 restricted stock units converted into the same number of common shares. The company withheld 507 shares to cover tax obligations, a non‑market disposition.
Following these transactions, Vu Quan Anh directly holds 2,221 shares of common stock. He also retains 8,598 unvested restricted stock units from a 9,826-unit grant awarded on December 2, 2025, which began vesting on June 30, 2026 and is scheduled to fully vest by December 31, 2029.
Monopar Therapeutics Chief Executive Officer Chandler Robinson reported compensation-related stock activity. On June 30, 2026, 12,873 restricted stock units vested and settled into the same number of common shares. The issuer withheld 4,084 shares at $92.59 per share to cover applicable tax obligations.
Following these transactions, Robinson holds 99,267 shares of Monopar common stock directly and 62,815 shares indirectly through the Chandler D. Robinson Irrevocable Trust U/A dated May 20, 2020. The filing reflects routine RSU vesting and associated tax-withholding dispositions, not open-market purchases or sales.
Monopar Therapeutics Chief Operating Officer Andrew Cittadine exercised and settled 5,254 restricted stock units on June 30, 2026, receiving 5,254 shares of common stock. 2,309 shares were withheld by the company at $92.59 per share to cover withholding taxes. Following these transactions, he directly owns 55,614 shares of Monopar common stock. The restricted stock units come from multi-year grants that vest in quarterly installments through December 2029.
Monopar Therapeutics director Nicole Sweeny received a grant of stock options, acquiring rights to 1,284 shares of common stock. The options have an exercise price of $87.68 per share and expire on June 26, 2036.
The grant vests in two equal installments, with 50% vesting on September 30, 2026 and the remaining 50% vesting on December 31, 2026. Following this grant, Sweeny holds options on 1,284 shares directly. This is a compensation-related award rather than an open-market stock purchase or sale.
Monopar Therapeutics director Nicole Sweeny filed an initial ownership report on Form 3. This filing establishes her status as an insider of the company but does not show any stock transactions, option exercises, or specific shareholdings in the provided data.