Monopar Therapeutics(MNPR) - 2025 Q1 - Quarterly Report

Financial Position - As of March 31, 2025, the company's cash, cash equivalents, and investments totaled $54.6 million, expected to last through at least December 31, 2026[146]. - The company sold 1,181,540 shares at$16.25 per share on October 30, 2024, yielding net proceeds of approximately $17.8 million[148]. - A subsequent offering on December 23, 2024, sold 798,655 shares at$23.79 per share, along with pre-funded warrants, generating approximately $37.4 million in net proceeds[149]. - The accumulated deficit as of March 31, 2025, was approximately$78.4 million, with expectations of continued losses in the foreseeable future[178]. - The company anticipates that available funds as of April 30, 2025, will support operations at least through December 31, 2026[178]. - Net cash used in operating activities for Q1 2025 was $5,663,000, an increase of$4,008,000 from $1,655,000 in Q1 2024[181]. Research and Development - The pivotal Phase 3 trial for ALXN1840 demonstrated three times greater copper mobilization compared to standard-of-care, with a Least Square Mean Difference of 2.18 µmol/L (p< 0.0001)[154]. - In the same trial, 45$1,643,000, an increase of $677,000 from$966,000 in Q1 2024[174]. - General and administrative (G&A) expenses for Q1 2025 were $1,578,000, up$821,000 from $757,000 in Q1 2024[175]. - Net loss for Q1 2025 was$2,625,000, compared to a net loss of $1,641,000 in Q1 2024, reflecting an increase of$984,000[173]. - Interest income for Q1 2025 increased by $515,000 to$597,000, attributed to higher bank balances and interest on U.S. Treasury securities[176]. - The company has not generated any approved drugs and has not generated any revenues to date, focusing on drug development and collaboration agreements[165]. - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained for drug candidates[185]. Agreements and Obligations - A License Agreement with Alexion was executed on October 23, 2024, granting an exclusive worldwide license for ALXN1840, with an upfront cash payment of $4 million[194]. - Future capital requirements will depend on the progress of drug candidates, including ALXN1840 and MNPR-101, and the need for substantial additional funding for commercialization efforts[187]. - The company is obligated to make milestone payments of up to$94.0 million for regulatory approval and sales-related milestones[195]. - A long-term, non-exclusive master supply agreement was entered into with NorthStar for the supply of actinium-225 (Ac-225) for therapeutic use[196]. - The company has taken a non-exclusive license to XOMA's humanization technology, with potential milestone payments totaling up to $14.925 million[197]. - As of April 30, 2025, no milestone payments have been made to XOMA, and the first payment is due upon the first dosing of a human patient in a Phase 2 clinical trial[197]. Management and Operations - The management team has extensive experience, having co-founded companies that achieved four drug approvals and a sale of a biopharmaceutical company for$800 million[163]. - The company has entered into a 36-month lease for its executive headquarters at a monthly rate of $3,580, along with additional month-to-month leases[199]. - A lease for a small wet laboratory space has been established at a rate of$1,000 per month, cancellable after 6 months[199]. - The company has acquired full ownership of the MNPR-101 radiopharmaceutical platform and jointly shares ownership of a filed patent application related to Ac-225[196]. - The company has not been a party to any adverse material legal proceedings to date[201]. - There are indemnification obligations to officers and non-employee directors, with no claims made to date[203].