UNITED STATES Commission File Number: 001-39070 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 19 For the Fiscal Year Ended December 31, 2019 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to ____________ MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) DELAWARE 32-0463781 (State ...

Part I: Financial Information This section provides the company's financial statements, management's analysis of financial condition, and details on internal controls [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Monopar Therapeutics Inc. presents unaudited condensed consolidated financial statements, reporting no revenue and a net loss of $3.02 million for the nine months ended September 30, 2019 Condensed Consolidated Balance Sheet Data (Unaudited) | Account | September 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $4,494,540 | $6,892,772 | | Total current assets | $5,108,621 | $7,317,955 | | Total liabilities | $483,666 | $399,551 | | Total stockholders' equity | $4,624,955 | $6,918,404 | | **Total liabilities and stockholders' equity** | **$5,108,621** | **$7,317,955** | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Research and development | $219,846 | $1,384,740 | | General and administrative | $539,602 | $1,714,126 | | **Loss from operations** | **($759,448)** | **($3,098,866)** | | **Net loss** | **($736,080)** | **($3,018,015)** | | Net loss per share (Basic and diluted) | ($0.08) | ($0.32) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Account | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,348,975) | ($2,161,275) | | Net cash used in financing activities | ($39,458) | $0 | | **Net decrease in cash and cash equivalents** | **($2,398,232)** | **($2,163,660)** | | Cash and cash equivalents at end of period | $4,494,540 | $7,618,265 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail Monopar's biopharmaceutical business, accounting policies, and financial position, including an accumulated deficit of $24.7 million and key licensing agreements - The company is an emerging biopharmaceutical firm developing three main cancer drug candidates: **Validive®** (Phase 3-ready), **camsirubicin** (Phase 2), and **MNPR-101** (pre-IND)[30](index=30&type=chunk) - As of September 30, 2019, the company has an accumulated deficit of approximately **$24.7 million**, with current cash expected to fund minimum obligations through December 2020, requiring additional future funding[32](index=32&type=chunk) - A license agreement for Validive with Onxeo S.A. includes potential milestone payments up to **$108 million** and royalties of **5-10%**, with **$1 million** paid to date[97](index=97&type=chunk) - Monopar entered a clinical collaboration with GEIS in June 2019 for a Phase 2 camsirubicin trial, providing study drug and financial support averaging **$1 million to $2 million per year**[110](index=110&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Monopar's clinical-stage biopharmaceutical focus, detailing development plans for Validive® and camsirubicin, increased operating expenses, and the need for additional capital beyond December 2020 [Overview](index=23&type=section&id=Overview) Monopar is a clinical-stage biopharmaceutical company advancing Validive® (Phase 3), camsirubicin (Phase 2), and MNPR-101 (pre-IND) for cancer treatment - Lead product candidate **Validive®** is planned to start a Phase 3 clinical program in **Q1 2020** for severe oral mucositis, holding U.S. fast track and EU orphan designations[124](index=124&type=chunk) - Second product candidate, **camsirubicin**, a doxorubicin analog, is expected to begin a Phase 2 trial in collaboration with GEIS in **Q1 2020** for advanced soft tissue sarcoma[128](index=128&type=chunk)[129](index=129&type=chunk) - Third product candidate, **MNPR-101**, a first-in-class humanized monoclonal antibody for advanced cancers, has nearly completed IND-enabling work[130](index=130&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Total operating expenses increased to **$3.1 million** for the nine months ended September 30, 2019, driven by higher G&A and R&D costs, resulting in a net loss of **$3.0 million** Comparison of Operating Results (in thousands) | | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | Variance | | :--- | :--- | :--- | :--- | | Research and development expenses | $1,385 | $1,253 | $132 | | General and administrative expenses | $1,714 | $1,151 | $563 | | **Total operating expenses** | **$3,099** | **$2,404** | **$695** | | **Net loss** | **($3,018)** | **($2,337)** | **($681)** | - R&D expenses for the nine months ended Sep 30, 2019, increased by **$132,000** year-over-year, primarily due to higher CRO fees for Validive Phase 3 trial preparation and employee stock-based compensation[155](index=155&type=chunk)[156](index=156&type=chunk) - G&A expenses for the nine months ended Sep 30, 2019, increased by **$563,000** year-over-year, mainly due to increased board and employee stock-based compensation[157](index=157&type=chunk)[158](index=158&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company has an accumulated deficit of **$24.7 million** as of September 30, 2019, with available funds expected to cover minimal operations through December 2020, and increased net cash used in operating activities - The company has an accumulated deficit of approximately **$24.7 million** as of September 30, 2019, and anticipates continued losses[160](index=160&type=chunk) - Available funds as of November 12, 2019, are expected to fund minimal operations through **December 2020**, requiring additional capital for strategic execution[160](index=160&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | | Cash used in operating activities | ($2,349) | ($2,161) | | Cash used in financing activities | ($39) | $0 | | **Net change in cash** | **($2,398)** | **($2,164)** | [Future Funding Requirements](index=33&type=section&id=Future%20Funding%20Requirements) The company anticipates significant expense increases for clinical programs, requiring additional capital through equity, debt, or collaborations to fund operations beyond 2020 - The company expects a significant increase in expenses and operating losses as it advances clinical development for **Validive**, **camsirubicin**, and **MNPR-101**[169](index=169&type=chunk)[171](index=171&type=chunk) - Expenditures are expected to increase starting in **Q1 2020** for the Validive Phase 3 trial, camsirubicin manufacturing, and increased employee compensation[174](index=174&type=chunk) - Future cash needs will be financed through equity offerings, debt financings, or strategic collaborations, potentially leading to stockholder dilution or relinquishing technology rights[175](index=175&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) As of September 30, 2019, the CEO and CFO concluded the company's disclosure controls and procedures were effective, with no material changes to internal controls - Management, including the CEO and CFO, concluded disclosure controls and procedures were effective as of **September 30, 2019**[190](index=190&type=chunk) - No material changes to internal control over financial reporting occurred during the nine months ended **September 30, 2019**[192](index=192&type=chunk) Part II: Other Information This section covers legal proceedings, risk factors, and exhibits filed with the quarterly report [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the report date, the company is not involved in any material legal proceedings[193](index=193&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred regarding the company's risk factors since the Annual Report on Form 10-K filed February 26, 2019 - No material changes have occurred regarding the company's risk factors since the last Annual Report on Form 10-K[194](index=194&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report, including CEO and CFO certifications and XBRL data files - The exhibits filed with this report include CEO and CFO certifications (Exhibits **31.1**, **31.2**, **32.1**) and XBRL interactive data files[197](index=197&type=chunk)

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 ...