UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Quarterly Period Ended June 30, 2019 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number: 000-55866 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) | DELAWARE | | 32-0463781 | | --- | --- | -- ...

Part I - Financial Information [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company reported a Q1 2019 net loss of $1.38 million with no revenue and a decrease in total assets to $6.35 million [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $6.35 million as of March 31, 2019, driven by a reduction in cash and cash equivalents Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2019 (unaudited) | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $5,881 | $6,893 | | Total current assets | $6,354 | $7,318 | | **Total assets** | **$6,354** | **$7,318** | | **Liabilities and Equity** | | | | Total current liabilities | $580 | $400 | | **Total liabilities** | **$580** | **$400** | | Total stockholders' equity | $5,774 | $6,918 | | **Total liabilities and stockholders' equity** | **$6,354** | **$7,318** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's Q1 2019 net loss increased to $1.38 million due to higher R&D and G&A operating expenses Condensed Consolidated Statements of Operations (Unaudited) | | Three months ended March 31, 2019 | Three months ended March 31, 2018 | | :--- | :--- | :--- | | Revenues | $ — | $ — | | Research and development | $835,600 | $457,141 | | General and administrative | $571,709 | $440,119 | | **Total operating expenses** | **$1,407,309** | **$897,260** | | Loss from operations | ($1,407,309) | ($897,260) | | **Net loss** | **($1,376,235)** | **($876,347)** | | Net loss per share (Basic and diluted) | ($0.15) | ($0.09) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased to $5.77 million, primarily driven by the quarterly net loss of $1.38 million - The change in stockholders' equity for the quarter ended March 31, 2019 was primarily due to the **net loss of $1,376,235** and **non-cash stock compensation of $233,776**[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $995,972, contributing to a total cash decrease of $1.01 million Cash Flow Summary (in thousands) | | Three months ended March 31, 2019 | Three months ended March 31, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(996) | $(809) | | Net cash used in financing activities | $(14) | $— | | **Net decrease in cash** | **$(1,012)** | **$(809)** | | Cash at end of period | $5,881 | $8,973 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's oncology-focused business, accounting policies, and potential future milestone payments - The company is focused on developing three main compounds: **Validive® (Phase 3-ready)**, **camsirubicin (Phase 2)**, and **MNPR-101 (pre-IND)**[27](index=27&type=chunk) - Management believes that currently available resources will provide sufficient funds to enable the Company to meet its **minimum obligations through June 2020**[29](index=29&type=chunk) - The company has potential future milestone payment obligations of **up to $108 million to Onxeo** and **up to $14.925 million to XOMA Ltd**[98](index=98&type=chunk)[104](index=104&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The analysis attributes the increased Q1 2019 net loss to higher R&D and G&A expenses for clinical trial preparations [Overview](index=23&type=section&id=Overview) The company is a clinical-stage biopharmaceutical firm with a pipeline including Validive®, camsirubicin, and MNPR-101 - The company intends to begin a **Phase 3 clinical development program for its lead product candidate, Validive®**, in the second half of 2019[126](index=126&type=chunk) - A larger, **randomized Phase 2 trial of camsirubicin** compared to doxorubicin is planned for patients with metastatic soft tissue sarcoma[131](index=131&type=chunk) - **IND-enabling work for MNPR-101 is nearly complete**, and the company anticipates requesting a pre-IND meeting with the FDA[132](index=132&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) The net loss increased by $500,000 year-over-year, driven by higher CRO fees and non-cash stock compensation Comparison of Operations (in thousands) | | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | Variance | | :--- | :--- | :--- | :--- | | Research and development expenses | $835 | $457 | $378 | | General and administrative expenses | $572 | $440 | $132 | | **Total operating expenses** | **$1,407** | **$897** | **$510** | | **Net loss** | **$(1,376)** | **$(876)** | **$(500)** | - The increase in R&D expenses was primarily due to a **$402,000 increase in CRO fees** and a **$134,000 increase in clinical materials manufacturing** for the Validive Phase 3 trial[157](index=157&type=chunk) - The increase in G&A expenses was mainly attributed to **higher non-cash stock-based compensation** for the Board ($82,000) and employees ($42,000) following August 2018 option grants[158](index=158&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) With an accumulated deficit of $23.0 million, current funds are expected to cover operations through June 2020 - The company has an **accumulated deficit of approximately $23.0 million** as of March 31, 2019[160](index=160&type=chunk) - The company anticipates that funds raised to-date will fund its **minimal required operations through June 2020**[160](index=160&type=chunk) Cash Flow Summary (in thousands) | | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | Variance | | :--- | :--- | :--- | :--- | | Cash used in operating activities | $(996) | $(809) | $(187) | | Cash used in financing activities | $(14) | — | $(14) | | **Net change in cash** | **$(1,012)** | **$(809)** | **$(203)** | [Future Funding Requirements](index=32&type=section&id=Future%20Funding%20Requirements) Significant expense increases are expected for clinical development, necessitating additional capital beyond June 2020 - The company expects to continue incurring **significant increases in expenses and operating losses** for the foreseeable future[170](index=170&type=chunk) - Key drivers of increased future spending include **advancing clinical development of Validive, camsirubicin, and MNPR-101**, seeking regulatory approvals, and potentially establishing sales and marketing infrastructure[171](index=171&type=chunk)[172](index=172&type=chunk) - Future cash needs will be financed through a combination of equity offerings, debt financings, strategic collaborations, and grant funding, and **failure to raise additional funds could require the company to delay, limit, or terminate its development programs**[175](index=175&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) The CEO and CFO concluded that disclosure controls and procedures were effective as of March 31, 2019 - Management, including the CEO and CFO, concluded that the company's **disclosure controls and procedures were effective** as of March 31, 2019[188](index=188&type=chunk) - **No changes in internal control over financial reporting occurred** during the three months ended March 31, 2019, that have materially affected, or are reasonably likely to materially affect, internal controls[190](index=190&type=chunk) Part II - Other Information [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not party to any material legal proceedings**[191](index=191&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the last Annual Report on Form 10-K - **No material changes in risk factors** have occurred since the company's last Annual Report on Form 10-K[192](index=192&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) Filed exhibits include required CEO/CFO certifications and XBRL interactive data files - Exhibits filed with the report include **CEO and CFO certifications** (Exhibits 31.1, 31.2, 32.1) and **XBRL interactive data files** (Exhibit 101 series)[195](index=195&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2018 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number: 000-55866 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) | DELAWARE | 32-0463781 | | --- | --- | | (State ...