[Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines the inherent risks and uncertainties associated with forward-looking statements in the report - This Quarterly Report on Form 10-Q contains forward-looking statements, identified by terms like "hopes," "believes," and "expects," which are subject to various risks and uncertainties that could cause actual results to differ materially from those expressed or implied[6](index=6&type=chunk) - Key uncertainties include the ability to raise sufficient funds, find pharmaceutical partners, risks in R&D activities, regulatory approval timelines, supply chain challenges for radioisotopes, market uptake, intellectual property, personnel retention, and macroeconomic factors like inflation and geopolitical conflicts[7](index=7&type=chunk) [Summary Risk Factors](index=5&type=section&id=Summary%20Risk%20Factors) This section highlights the company's financial losses, program uncertainties, and significant operational risks - The company is a clinical-stage biopharmaceutical company with a **history of financial losses**, expecting **continued significant losses** and may **never achieve or maintain cash self-sufficiency or profitability**[11](index=11&type=chunk) - Although ALXN1840 **met its primary endpoint** in a pivotal Phase 3 trial, Alexion Pharmaceuticals, Inc. **terminated the program** based on Phase 2 mechanistic trial results and regulatory discussions, leading to **uncertain outcomes** for Monopar's NDA submission[11](index=11&type=chunk) - **Significant risks** include the **lengthy and uncertain regulatory approval process**, **dependence on marketing approvals**, **potential delays in clinical trials**, **manufacturing challenges**, **reliance on third parties**, the **novelty of radiopharmaceutical technology**, geopolitical events, **market volatility**, **intense competition**, and **intellectual property protection**[11](index=11&type=chunk)[13](index=13&type=chunk) [Part I FINANCIAL INFORMATION](index=7&type=section&id=Part%20I%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and related disclosures [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's financial position, performance, and significant accounting policies for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%2C%20and%20December%2031%2C%202024) This section provides a snapshot of the company's assets, liabilities, and equity at specific points in time | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $39,501,936 | $45,816,289 | | Total current assets | $53,747,703 | $60,291,071 | | Total assets | $53,865,873 | $60,291,071 | | Total current liabilities | $1,583,613 | $5,254,300 | | Total liabilities | $1,663,979 | $5,254,300 | | Total stockholders' equity | $52,201,894 | $55,036,771 | | Accumulated deficit | $(80,871,134) | $(75,792,636) | - Total assets **decreased by $6,425,198** (**10.7%**) from December 31, 2024, to June 30, 2025, **primarily due to a reduction in cash and cash equivalents**[16](index=16&type=chunk) - Total stockholders' equity **decreased by $2,834,877** (**5.2%**) from December 31, 2024, to June 30, 2025, **mainly driven by the increase in accumulated deficit**[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section details the company's revenues, expenses, and net loss over specific reporting periods | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $1,730,000 | $1,130,978 | $3,373,375 | $2,097,088 | | General and administrative | $1,504,295 | $657,806 | $3,082,737 | $1,415,087 | | Total operating expenses | $3,234,295 | $1,788,784 | $6,456,112 | $3,512,175 | | Loss from operations | $(3,234,295) | $(1,788,784) | $(6,456,112) | $(3,512,175) | | Interest income | $780,769 | $73,475 | $1,377,614 | $155,640 | | Net loss | $(2,453,526) | $(1,715,309) | $(5,078,498) | $(3,356,535) | | Basic and diluted net loss per share | $(0.35) | $(0.49) | $(0.73) | $(1.00) | - Research and development expenses increased by **$599,023** (**53%**) for the three months and **$1,276,287** (**61%**) for the six months ended June 30, 2025, compared to the same periods in 2024[20](index=20&type=chunk) - General and administrative expenses increased by **$846,489** (**129%**) for the three months and **$1,667,650** (**118%**) for the six months ended June 30, 2025, compared to the same periods in 2024[20](index=20&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section outlines changes in the company's equity accounts, including common stock and accumulated deficit | Metric | Balance at January 1, 2025 | Balance at June 30, 2025 | | :------------------------- | :------------------------- | :------------------------- | | Common Stock (Amount) | $6,103 | $6,127 | | Additional Paid-in Capital | $130,787,312 | $132,989,324 | | Accumulated Deficit | $(75,792,636) | $(80,871,134) | | Total Stockholders' Equity | $55,036,771 | $52,201,894 | - Total stockholders' equity decreased from **$55,036,771** at January 1, 2025, to **$52,201,894** at June 30, 2025, primarily due to net losses[24](index=24&type=chunk) - Stock-based compensation, net, contributed **$2,634,563** to additional paid-in capital during the six months ended June 30, 2025[24](index=24&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section presents the cash inflows and outflows from operating, investing, and financing activities | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(6,740,687) | $(3,332,221) | | Net cash provided by (used in) investing activities | $861,466 | $(985,730) | | Net cash (used in) provided by financing activities | $(432,527) | $3,171,962 | | Net decrease in cash and cash equivalents | $(6,314,353) | $(1,146,149) | | Cash and cash equivalents at end of period | $39,501,936 | $6,119,931 | - Net cash used in operating activities increased by **$3,408,466** (**102%**) for the six months ended June 30, 2025, compared to 2024, **primarily due to a higher net loss and a $3 million payment related to ALXN1840**[31](index=31&type=chunk)[174](index=174&type=chunk) - Net cash provided by investing activities increased by **$1,847,196** in 2025 compared to 2024, **shifting from a net outflow to a net inflow, mainly due to investment maturities**[31](index=31&type=chunk)[175](index=175&type=chunk) - Net cash provided by financing activities decreased by **$3,604,489** in 2025 compared to 2024, **shifting from a net inflow to a net outflow, due to the absence of common stock sales under at-the-market programs in 2025**[31](index=31&type=chunk)[176](index=176&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Note 1 – Nature of Business and Liquidity](index=12&type=section&id=Note%201%20%E2%80%93%20Nature%20of%20Business%20and%20Liquidity) This note describes the company's core business, product pipeline, and current liquidity position - Monopar Therapeutics Inc. is a **clinical-stage biopharmaceutical company developing ALXN1840 for Wilson disease and novel radiopharmaceuticals (Phase 1-stage MNPR-101-Zr, Phase 1a-stage MNPR-101-Lu, and late preclinical-stage MNPR-101-Ac225) for oncology**[33](index=33&type=chunk) - The company has an **accumulated deficit of approximately $80.9 million** as of June 30, 2025, and has **not generated any revenue since inception**[35](index=35&type=chunk) - Management estimates that currently available cash will provide **sufficient funds to meet obligations through at least December 31, 2026**, but **future funding is uncertain**[35](index=35&type=chunk) [Note 2 – Significant Accounting Policies](index=13&type=section&id=Note%202%20%E2%80%93%20Significant%20Accounting%20Policies) This note details the key accounting principles and methods used in preparing the financial statements - The financial statements are **prepared in accordance with U.S. GAAP**, including all normal, recurring adjustments, and the company's **functional currency is the U.S. Dollar**[40](index=40&type=chunk)[41](index=41&type=chunk)[43](index=43&type=chunk) - Research and development costs are **expensed as incurred**, and in-process research and development (IPR&D) expenses, including upfront license fees like the **$4 million cash and $4.6 million stock** for ALXN1840, are **expensed as goods are received or services rendered**[65](index=65&type=chunk)[66](index=66&type=chunk) - Stock-based compensation is accounted for using a **fair value method**, recognizing expense for stock options (**Black-Scholes model**) and **restricted stock units (closing stock price)** **on a straight-line basis**[77](index=77&type=chunk)[79](index=79&type=chunk) - The company operates as a **single reportable segment**, with financial performance assessed primarily using net loss and internal budget/cash forecast models[82](index=82&type=chunk) [Note 3 – Cash Equivalents and Investments](index=18&type=section&id=Note%203%20%E2%80%93%20Cash%20Equivalents%20and%20Investments) This note provides a breakdown of the company's cash equivalents and held-to-maturity investments | Category | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :----------------------- | :--------------------------- | :----------------------------- | | Cash equivalents | $39,327,275 | $45,531,646 | | Held-to-maturity investments (Amortized Cost) | $13,748,473 | $14,395,913 | - As of June 30, 2025, cash equivalents consisted of **money market accounts and U.S. Treasury securities with maturities of three months or less**[85](index=85&type=chunk) - **Held-to-maturity investments (U.S. Treasury securities)** had a combined book value of **$13.7 million** as of June 30, 2025, and **$14.4 million** as of December 31, 2024[89](index=89&type=chunk) [Note 4 – Capital Stock](index=19&type=section&id=Note%204%20%E2%80%93%20Capital%20Stock) This note describes the company's common stock, reverse stock split, and outstanding warrants - A **1-for-5 reverse stock split became effective on August 12, 2024**, **reducing the number of outstanding shares** from **17,601,827 to 3,520,427** to **regain Nasdaq compliance**[95](index=95&type=chunk)[97](index=97&type=chunk) - As of June 30, 2025, the company had **6,127,457 shares** of common stock issued and outstanding[102](index=102&type=chunk) - **882,761 pre-funded warrants** were outstanding as of June 30, 2025, **classified as a component of stockholders' equity and immediately exercisable at a de-minimis exercise price of $0.001 per share**[103](index=103&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) [Note 5 – Stock Incentive Plan](index=20&type=section&id=Note%205%20%E2%80%93%20Stock%20Incentive%20Plan) This note details the company's stock incentive plan, option grants, and stock-based compensation expense - The 2016 Stock Incentive Plan's **award pool was increased** to **1,420,000 shares**[107](index=107&type=chunk) - During the six months ended June 30, 2025, **225,881 stock options** were granted with exercise prices ranging from **$22.00 to $44.96 per share**, and **120,941 restricted stock units** were granted[108](index=108&type=chunk)[114](index=114&type=chunk) - The company **recognized $2,630,701 in total stock-based compensation expense** for the six months ended June 30, 2025 (**$1,422,615 as G&A and $1,208,086 as R&D**)[116](index=116&type=chunk) [Note 6 – Related Party Transactions](index=22&type=section&id=Note%206%20%E2%80%93%20Related%20Party%20Transactions) This note discloses any transactions or relationships with related parties - Tactic Pharma, the company's initial investor, **beneficially owned 13.4%** of Monopar's common stock as of June 30, 2025[118](index=118&type=chunk) - **No transactions occurred** between Tactic Pharma and Monopar during the three and six months ended June 30, 2025[118](index=118&type=chunk) [Note 7 – Net Loss Per Share](index=22&type=section&id=Note%207%20%E2%80%93%20Net%20Loss%20Per%20Share) This note explains the calculation of basic and diluted net loss per common share | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(2,454) | $(1,715) | $(5,078) | $(3,357) | | Weighted-average common shares outstanding | 6,998 | 3,503 | 6,993 | 3,349 | | Net loss per common share, basic and diluted | $(0.35) | $(0.49) | $(0.73) | $(1.00) | - Basic and diluted net loss per common share was **$(0.35)** for the three months and **$(0.73)** for the six months ended June 30, 2025[120](index=120&type=chunk) - Potentially dilutive securities, including **627,000 stock options and 128,000 unvested restricted stock units** for the six months ended June 30, 2025, were **excluded from the diluted EPS calculation as their effect was anti-dilutive**[120](index=120&type=chunk) [Note 8 – Commitments and Contingencies](index=22&type=section&id=Note%208%20%E2%80%93%20Commitments%20and%20Contingencies) This note outlines the company's contractual obligations, milestone payments, and lease liabilities - Under the Alexion License Agreement for ALXN1840, Monopar is **obligated to pay up to $94.0 million in regulatory approval and sales milestones, plus tiered royalties ranging from 10% to 20% on net sales**[122](index=122&type=chunk) - Monopar **acquired full ownership** of its MNPR-101 radiopharmaceutical platform from NorthStar and will **jointly share ownership of a patent application** on the use of PCTA as a linker with Ac-225[124](index=124&type=chunk) - Under the XOMA Ltd. license for MNPR-101 humanization technology, Monopar is to make **potential milestone payments up to $14.925 million** upon achievement of certain clinical, regulatory, and sales milestones, with the **first payment due upon first dosing in a Phase 2 clinical trial**[125](index=125&type=chunk) - As of June 30, 2025, **total operating lease liabilities were $113,740, with a weighted-average remaining lease term of 1.67 years and a discount rate of 6.50%**[129](index=129&type=chunk) [Note 9 – Subsequent Events](index=24&type=section&id=Note%209%20%E2%80%93%20Subsequent%20Events) This note reports significant events that occurred after the balance sheet date - On June 6, 2025, Alexion Pharmaceuticals **officially transferred sponsorship of the investigational new drug (IND) application for ALXN1840 to Monopar, with FDA acknowledgment on July 29, 2025**[133](index=133&type=chunk) - Monopar is now **fully responsible for the ALXN1840 program, including its commercial advancement and compliance with all applicable federal regulations**[133](index=133&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, and future outlook, highlighting its clinical-stage pipeline, funding status, strategic goals, and critical accounting policies [Overview](index=25&type=section&id=Overview) This section provides a high-level summary of the company's biopharmaceutical pipeline and development focus - Monopar Therapeutics is a **clinical-stage biopharmaceutical company developing ALXN1840 for Wilson disease and radiopharmaceutical programs (Phase 1-stage MNPR-101-Zr, Phase 1a-stage MNPR-101-Lu, and late preclinical-stage MNPR-101-Ac225) for advanced cancers**[135](index=135&type=chunk) [Financial Status](index=25&type=section&id=Financial%20Status) This section details the company's current cash position, funding outlook, and recent capital raises - **Cash, cash equivalents, and investments totaled $53.3 million as of June 30, 2025**[136](index=136&type=chunk) - **Current funds are expected to be sufficient through at least December 31, 2026**, to support the ALXN1840 NDA filing, advancement of MNPR-101 radiopharmaceutical programs, and investment in internal R&D projects[136](index=136&type=chunk) - The company **raised approximately $17.8 million net proceeds from a public offering in October 2024 and $37.4 million net proceeds from a public offering and private placement of pre-funded warrants in December 2024**[138](index=138&type=chunk)[139](index=139&type=chunk) [Our Product Pipeline](index=25&type=section&id=Our%20Product%20Pipeline) This section describes the development status of ALXN1840 and the MNPR-101 radiopharmaceutical programs - ALXN1840 for Wilson disease, an investigational once-daily oral drug, **met its primary endpoint in a pivotal Phase 3 trial, demonstrating three-times greater copper mobilization compared to standard-of-care**[142](index=142&type=chunk)[144](index=144&type=chunk) - Alexion terminated the ALXN1840 program based on Phase 2 mechanistic trial results, not safety signals; Monopar is now **preparing to submit an NDA to the FDA in early 2026**[146](index=146&type=chunk)[148](index=148&type=chunk) - Monopar's MNPR-101 radiopharmaceutical programs include a **Phase 1 imaging and dosimetry clinical trial with MNPR-101-Zr (launched April 2024) and a Phase 1a therapeutic clinical trial of MNPR-101-Lu (launched October 2024), with an Expanded Access Program authorized by the FDA**[149](index=149&type=chunk)[151](index=151&type=chunk) [Our Strategy](index=26&type=section&id=Our%20Strategy) This section outlines the company's strategic goals for drug development, commercialization, and pipeline expansion - Monopar's **strategic goal is to acquire, develop, and commercialize innovative treatments for patients with unmet medical needs**[153](index=153&type=chunk) - Key strategic elements include **assembling a regulatory package for ALXN1840's NDA, advancing MNPR-101 radiopharmaceutical programs, and expanding the drug development pipeline through internal efforts, in-licensing, and acquisitions**[157](index=157&type=chunk) - The company leverages its **management team's extensive experience in asset acquisition, drug development, and commercialization, with prior successes including four drug approvals and three diagnostic medical imaging device approvals**[153](index=153&type=chunk)[157](index=157&type=chunk) [Revenues](index=27&type=section&id=Revenues) This section clarifies the company's current revenue status and future expectations as a clinical-stage entity - As a small-cap biopharmaceutical company, Monopar has **no approved drugs and has not generated any revenues to date**[155](index=155&type=chunk) - The company **does not anticipate revenues from operations until product development is complete, marketing approval is obtained, or drug candidates are out-licensed or sold**[155](index=155&type=chunk) [Critical Accounting Policies and Use of Estimates](index=28&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) This section discusses key accounting policies requiring significant management judgment and estimation - Critical accounting policies include **clinical trial accruals, where costs for third-party activities are expensed based on estimates of work completed and agreed-upon fees**[159](index=159&type=chunk) - **Stock-based compensation is accounted for using a fair value method, requiring judgment in estimating future stock price volatility and expected holding terms for stock options and RSUs**[160](index=160&type=chunk)[161](index=161&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, including changes in expenses and net loss | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Variance (3M) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Variance (6M) | | :--------------------------------- | :--------------------------- | :--------------------------- | :------------ | :--------------------------- | :--------------------------- | :------------ | | Research and development expenses | $1,730 | $1,131 | $599 | $3,373 | $2,097 | $1,276 | | General and administrative expenses | $1,504 | $658 | $846 | $3,083 | $1,415 | $1,668 | | Total operating expenses | $3,234 | $1,789 | $1,446 | $6,456 | $3,512 | $2,944 | | Operating loss | $(3,234) | $(1,789) | $(1,446) | $(6,456) | $(3,512) | $(2,944) | | Interest income | $781 | $73 | $707 | $1,378 | $156 | $1,222 | | Net loss | $(2,454) | $(1,715) | $(738) | $(5,078) | $(3,357) | $(1,723) | - R&D expenses increased by **$599,023** (**53%**) for the three months and **$1,276,287** (**61%**) for the six months ended June 30, 2025, **primarily due to increased personnel expenses**[163](index=163&type=chunk)[164](index=164&type=chunk) - G&A expenses increased by **$846,489** (**129%**) for the three months and **$1,667,651** (**118%**) for the six months ended June 30, 2025, **driven by higher Board compensation, personnel expenses, and legal fees**[165](index=165&type=chunk)[166](index=166&type=chunk) - Interest income **significantly increased by $707,294** (**963%**) for the three months and **$1,221,974** (**785%**) for the six months ended June 30, 2025, **due to higher bank balances and U.S. Treasury securities from funds raised in Q4 2024**[167](index=167&type=chunk)[168](index=168&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's cash position, funding needs, and potential future financing strategies - The company has an **accumulated deficit of approximately $80.9 million** as of June 30, 2025, and **expects to continue incurring losses for the foreseeable future**[170](index=170&type=chunk) - Currently available funds are anticipated to fund planned operations through at least December 31, 2026, but **substantial additional long-term funding will be required for future operations, including product development and commercialization**[170](index=170&type=chunk)[178](index=178&type=chunk)[182](index=182&type=chunk) - **Future financing may involve equity offerings, debt financings, strategic collaborations, or grant funding, which could dilute current stockholders' ownership or impose restrictive covenants**[183](index=183&type=chunk) | Six Months Ended June 30, | 2025 | 2024 | Variance | | :--------------------------------------- | :----- | :----- | :------- | | Net cash used in operating activities | $(6,741) | $(3,332) | $(3,408) | | Net cash provided by (used in) investing activities | $861 | $(986) | $1,847 | | Net cash (used in) provided by financing activities | $(433) | $3,172 | $(3,604) | | Net decrease in cash and cash equivalents | $(6,314) | $(1,146) | $(5,168) | [Contractual Obligations and Commitments](index=33&type=section&id=Contractual%20Obligations%20and%20Commitments) This section details the company's significant contractual obligations, including milestone payments and lease liabilities - Under the Alexion License Agreement for ALXN1840, Monopar is **obligated to pay up to $94.0 million in regulatory approval and sales milestones, plus tiered royalties of 10% to 20% on net sales**[186](index=186&type=chunk) - Monopar has **potential milestone payments up to $14.925 million** to XOMA Ltd. for MNPR-101 humanization technology, with the **first payment due upon first dosing in a Phase 2 clinical trial**[189](index=189&type=chunk) - The company has **lease obligations for its executive headquarters** (**$3,580/month for 36 months**) and a **small wet laboratory space** (**$1,000/month, cancellable after 6 months**)[191](index=191&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2025. There have been no material changes in internal control over financial reporting during the three months ended June 30, 2025 - The CEO and CFO evaluated and **concluded that the company's disclosure controls and procedures were effective as of June 30, 2025**[197](index=197&type=chunk) - There have been **no material changes in internal control over financial reporting during the three months ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting**[199](index=199&type=chunk) [Part II OTHER INFORMATION](index=34&type=section&id=Part%20II%20OTHER%20INFORMATION) This section covers additional disclosures including risk factors, other information, and exhibits [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously described in the company's Annual Report on Form 10-K filed with the SEC on March 31, 2025 - **No material changes in information regarding risk factors have occurred since the Annual Report on Form 10-K filed on March 31, 2025**[200](index=200&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) During the quarter ended June 30, 2025, no non-employee director or officer of the company adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" - **No non-employee director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025**[201](index=201&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications from the CEO and CFO, and Inline XBRL documents - **Exhibits filed include certifications from the Chief Executive Officer (31.1) and Chief Financial Officer (31.2, 32.1)**[203](index=203&type=chunk) - **Inline XBRL Instance Document, Taxonomy Extension Schema, Calculation Linkbase, Definition Linkbase, Label Linkbase, Presentation Linkbase, and Cover Page Interactive Data File are also filed**[203](index=203&type=chunk) [Signatures](index=36&type=section&id=Signatures) This section formally concludes the report with the required executive signatures and filing date - The report was **signed on August 12, 2025, by Chandler D. Robinson, Chief Executive Officer, and Quan Vu, Chief Financial Officer**[207](index=207&type=chunk)

Core Viewpoint - Monopar Therapeutics Inc. reported its second quarter 2025 financial results and highlighted significant developments in its drug pipeline, including the transfer of ALXN1840 for Wilson Disease and ongoing clinical trials for its radiopharmaceutical programs [1][2][3]. Recent Developments - Alexion Pharmaceuticals transferred the sponsorship of the investigational new drug application for ALXN1840 to Monopar, with FDA acknowledgment of this transfer effective from June 6, 2025 [2]. - Monopar is preparing to submit a New Drug Application (NDA) to the FDA in early 2026 [3]. - The company is actively enrolling patients in Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu in Australia, and has an Expanded Access Program for these drugs in the U.S. [4]. Financial Results - As of June 30, 2025, Monopar had cash, cash equivalents, and investments totaling $53.3 million, expected to sustain operations through at least December 31, 2026 [5]. - The net loss for Q2 2025 was $2.5 million, or $0.35 per share, compared to a net loss of $1.7 million, or $0.49 per share, in Q2 2024 [6]. - Research and Development (R&D) expenses increased to $1,730,000 in Q2 2025 from $1,130,978 in Q2 2024, primarily due to higher personnel costs [7]. - General and Administrative (G&A) expenses rose to $1,504,295 in Q2 2025 from $657,806 in Q2 2024, driven by increased Board compensation and legal fees [8]. Interest Income - Interest income for the three months ended June 30, 2025, increased by $707,294 compared to the same period in 2024, attributed to interest earned on U.S. Treasury securities and higher bank balances resulting from over $55 million raised in Q4 2024 [10]. Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for Wilson disease and advanced cancers through its radiopharmaceutical programs [11].

Group 1 - Monopar Therapeutics Inc. (MNPR) closed at $34.51, with a 2% gain over the past four weeks, and a mean price target of $52.20 indicating a 51.3% upside potential [1] - The average price targets range from a low of $37 to a high of $76, with a standard deviation of $15.69, suggesting variability in analyst estimates [2] - Analysts show strong agreement on MNPR's ability to report better earnings than previously predicted, which supports the potential for stock upside [4][11] Group 2 - The Zacks Consensus Estimate for the current year has increased by 15.2% over the past month, with two estimates going higher and no negative revisions [12] - MNPR holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - While consensus price targets may not be reliable for predicting exact gains, they can indicate potential price movement direction [10][13]

Core Viewpoint - Monopar Therapeutics has received FDA authorization for the Expanded Access Program (EAP) for investigational imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu, aimed at patients with advanced solid tumors [1][2][3] Group 1: Expanded Access Program (EAP) - The MNPR-101 EAP is now open for enrollment at Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas, targeting patients with advanced solid tumors [2][5] - EAPs provide a pathway for patients with serious or life-threatening conditions to access investigational products outside of clinical trials when no satisfactory alternative treatments are available [5] Group 2: Product Details - MNPR-101 is a proprietary antibody targeting the urokinase plasminogen activator receptor (uPAR), expressed in various tumor types including pancreatic, breast, and colorectal cancers [6] - MNPR-101-Zr is designed for imaging advanced cancers, while MNPR-101-Lu is an investigational treatment for advanced solid cancers [6] Group 3: Company Background - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, including late-stage programs for Wilson disease and radiopharmaceuticals [7] - The company is advancing its radiopharmaceutical pipeline, which includes Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu [3][7] Group 4: Collaboration and Expertise - The EAP will be conducted under the supervision of Dr. Ebrahim S. Delpassand, a renowned investigator and medical director at EDNOC, which is recognized as a Radiopharmaceutical Therapy Center of Excellence [2][4][9] - The collaboration aims to provide access to therapies targeting difficult-to-treat cancers, marking a promising advancement in radioligand therapy [4]

Company Overview - Monopar Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs [1][5] - The company is advancing its late-stage drug candidate ALXN1840 for Wilson disease, along with several radiopharmaceutical programs [5] Market Inclusion - Monopar will be added to the Russell 3000® Index and automatically included in the small-cap Russell 2000® Index after the close of U.S. equity markets on June 27, 2025 [1][2] - This inclusion is part of the annual reconstitution of the Russell U.S. Indexes, which are widely used benchmarks for investment strategies [2][3] Financial Impact - As of May 2025, approximately $10.6 trillion in assets are benchmarked against the Russell U.S. Indexes, indicating significant market influence [3] - The inclusion in these indexes is expected to enhance Monopar's visibility and recognition in the market, reflecting the company's growth and transformation over the past year [4]

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% of patients on ALXN1840 showed improved neurological symptoms compared to 20% on standard-of-care[155]. - The company plans to submit a New Drug Application (NDA) for ALXN1840 to the FDA in early 2026[158]. - The Phase 1 clinical trial for MNPR-101-Zr commenced in April 2024, with positive early clinical data reported in September 2024[159]. - The company is actively pursuing the development of MNPR-101 for both therapeutic and diagnostic applications, with two ongoing human clinical trials[167]. Financial Performance - Research and development (R&D) expenses for Q1 2025 were $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].

Financial Results - Monopar Therapeutics Inc. reported its financial results for Q1 2025, ending March 31, 2025[6] - The company issued a press release on May 13, 2025, detailing its operational performance[6] - Specific financial metrics and user data were not provided in the available content[6] - Future outlook and performance guidance were not disclosed in the provided documents[6] Product Development and Strategy - Information regarding new product development or technological advancements was not included[6] - Market expansion strategies or potential mergers and acquisitions were not mentioned[6] - Other strategic initiatives were not detailed in the available content[6]

Core Viewpoint - Monopar Therapeutics Inc. reported its first quarter 2025 financial results and highlighted significant developments in its clinical programs, particularly for ALXN1840 as a treatment for Wilson disease and ongoing trials for MNPR-101 in advanced cancers [1][7]. Recent Developments - Monopar presented long-term efficacy and safety data for ALXN1840 at the EASL International Liver Congress 2025, supporting its potential as a treatment for Wilson disease [2][3]. - Pooled results from three clinical trials (n=255) indicated sustained clinical benefits over a median treatment duration of 2.63 years, with a favorable safety profile where fewer than 5% of patients experienced drug-related serious adverse events [3][4]. - The company plans to submit a New Drug Application (NDA) to the FDA in early 2026 [5]. Financial Results - As of March 31, 2025, Monopar had cash, cash equivalents, and investments totaling $54.6 million, expected to sustain operations through at least December 31, 2026 [7]. - The net loss for Q1 2025 was $2.6 million, or $0.38 per share, compared to a net loss of $1.6 million, or $0.51 per share, in Q1 2024 [8]. - Research and Development (R&D) expenses increased to $1,643,000 in Q1 2025 from $966,000 in Q1 2024, primarily due to higher personnel costs and clinical trial activities [9]. - General and Administrative (G&A) expenses rose to $1,578,000 in Q1 2025 from $757,000 in Q1 2024, driven by increased board compensation and personnel expenses [11]. - Interest income for Q1 2025 increased by $515,000 compared to Q1 2024, attributed to interest earned on U.S. Treasury securities and higher bank balances [12]. Clinical Programs - The MNPR-101-Zr Phase 1 clinical trial for imaging advanced cancers is active and enrolling in Australia, alongside the MNPR-101-Lu Phase 1a therapeutic trial [6]. - Monopar is advancing its preclinical MNPR-101-Ac program with plans to enter clinical trials in the future [6].

Core Viewpoint - Monopar Therapeutics Inc. is presenting promising long-term efficacy and safety data for its drug candidate ALXN1840 for Wilson disease at the EASL International Liver Congress 2025, indicating its potential as a therapeutic option for patients with this rare genetic condition [1][2][3] Group 1: Efficacy and Safety Data - The efficacy data were pooled from three clinical trials involving a total of 255 patients, while safety data were derived from an additional trial with 266 patients [2] - The median treatment duration for efficacy was 961 days (approximately 2.63 years) and for safety was 943.5 days (approximately 2.58 years) [2] - Sustained improvements were observed in the Unified Wilson Disease Rating Scale (UWDRS) for both patient-reported and clinician-assessed symptoms [6] - There was a significant increase in copper mobilization, evidenced by a sustained increase in directly measured non-ceruloplasmin-bound copper (dNCC) [6] - Improvements were noted on the Clinical Global Impression – Improvement (CGI-I) scale for ALXN1840 compared to standard care [6] - The New Wilson Index showed improvement for patients treated with ALXN1840, based on various clinical parameters [6] - Patient-reported convenience and effectiveness of ALXN1840 were higher compared to standard care, especially among those transitioning from standard care to ALXN1840 [6] - Fewer than 5% of patients experienced drug-related serious adverse events, with no cases reported for renal or urinary system issues [6] Group 2: Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments, including ALXN1840 for Wilson disease and various radiopharmaceutical programs for advanced cancers [4]

Core Viewpoint - Monopar Therapeutics Inc. has announced that data on the long-term efficacy and safety of its drug candidate ALXN1840 for Wilson disease will be presented at the EASL International Liver Congress 2025, highlighting the significance of this research in the hepatology field [1][2]. Group 1: Presentation Details - The late-breaker poster presentation will focus on "Sustained long-term clinical improvement in Wilson disease patients on tiomolybdate choline" [3]. - The presentation is scheduled for May 7, 2025, at 8:30 a.m. CET, and will be led by Dr. Karl Heinz Weiss [3]. - The poster will be available online on the company's website on the same day [3]. Group 2: Company Overview - Monopar Therapeutics is a clinical-stage biotechnology company with a focus on developing innovative treatments, including ALXN1840 for Wilson disease and various radiopharmaceutical programs for advanced cancers [4].