Monopar Therapeutics(MNPR) - 2025 Q3 - Quarterly Report

Financial Position - As of September 30, 2025, the company's cash, cash equivalents, and investments totaled $143.7 million, expected to last through at least December 31, 2027[144]. - The company reported a net cash inflow of $81.86 million for the nine months ended September 30, 2025, compared to a net cash outflow of $1.25 million for the same period in 2024, marking an increase of $83.11 million[187]. - Cumulative negative cash flows from operations resulted in an accumulated deficit of approximately $84.3 million as of September 30, 2025[184]. - Cash used in investing activities increased by $1,264,561 during the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to net investments in U.S. Treasury securities[189]. - Cash flow provided by financing activities increased by $88,803,654 during the nine months ended September 30, 2025, mainly due to net proceeds of approximately $91.9 million from the September 2025 capital raise and share repurchase[190]. Share Transactions - The company sold 1,181,540 shares at $16.25 per share on October 30, 2024, yielding net proceeds of approximately $17.8 million[146]. - A public offering on December 23, 2024, resulted in the sale of 798,655 shares at $23.79 per share, generating net proceeds of approximately $37.4 million[147]. - On September 23, 2025, the company sold 1,034,433 shares at $67.67 per share, with net proceeds of approximately $91.9 million after a $35 million share repurchase[148]. Research and Development - ALXN1840 for Wilson disease has shown three-times greater copper mobilization compared to standard-of-care in a Phase 3 trial, with a Least Square Mean Difference of 2.18 µmol/L (p< 0.0001)[152]. - The company plans to submit a New Drug Application (NDA) for ALXN1840 to the FDA in early 2026[159]. - MNPR-101-Zr has received regulatory clearance in Australia for a Phase 1 imaging trial, with positive early clinical data reported[160]. - The FDA cleared the IND application for MNPR-101-Lu on September 26, 2025, for a Phase 1 trial targeting uPAR-expressing tumors[163]. - The company is actively exploring opportunities to expand its radiopharmaceutical pipeline through internal development efforts[164]. - The company has two active human clinical trials for its MNPR-101 radiopharmaceutical program, focusing on advanced cancers[170]. - Research and development (R&D) expenses for Q3 2025 were $2.59 million, a 163% increase from $0.98 million in Q3 2024, primarily due to increased manufacturing activities related to ALXN1840[177]. - R&D expenses for the nine months ended September 30, 2025, were $5.96 million, a 93% increase from $3.08 million in the same period in 2024[178]. General and Administrative Expenses - General and administrative (G&A) expenses for Q3 2025 were $1.50 million, up 154% from $0.59 million in Q3 2024, mainly due to increased Board compensation and personnel expenses[179]. - G&A expenses for the nine months ended September 30, 2025, were $4.59 million, up 129% from $2.01 million in the same period in 2024[180]. Financial Performance - The net loss for Q3 2025 was $3.44 million, compared to a net loss of $1.30 million in Q3 2024, reflecting a variance of $2.13 million[176]. - Interest income for Q3 2025 increased by $556,129 compared to Q3 2024, attributed to higher bank balances and interest earned on U.S. Treasury securities[181]. - The company has not generated any revenue from product sales to date and does not expect to do so until regulatory approval and commercialization of drug candidates are achieved[191]. - Anticipated expenses are expected to increase significantly as the company continues research, development, and clinical trials for current and future drug candidates[192]. Obligations and Agreements - The company has obligations to pay Alexion milestone payments of up to $94.0 million for regulatory approval and sales-related milestones, along with tiered royalties based on net sales ranging from 10% to 20%[200]. - A long-term, non-exclusive master supply agreement with NorthStar for the therapeutic radioisotope actinium-225 was established, clarifying economic terms and jointly-developed intellectual property rights[202]. - The company has a non-exclusive license with XOMA Ltd. for humanization technology, with potential milestone payments totaling up to $14.925 million, but no payments have been made as of October 31, 2025[203]. Future Financing - The company expects to finance future cash needs primarily through equity offerings, debt financings, strategic collaborations, and grant funding, which may dilute current stockholders' ownership[197]. Lease and Legal Proceedings - The company entered into a 36-month lease for executive headquarters at a monthly rate of $3,580, along with additional leases for laboratory space[205]. - The company has not been involved in any adverse material legal proceedings to date[206]. Management Experience - The management team has extensive experience, having achieved four drug approvals and three diagnostic device approvals in the U.S. and EU[165].