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, 2021 ☐ 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: 001-39070 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) DELAWARE 32-046 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Delaware 32-0463781 (I.R.S. employer For the transition period from to identification number) Commission File Number: 001-39070 (Mark One) MONOPAR THERAPEUTICS INC. ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (Exact name of registrant as specified in its charter) (State or other jurisdiction ...

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, 2021 ☐ 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: 001-39070 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Delaware 32-0463781 (State or other jurisdic ...

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 March 31, 2021 ☐ 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: 001-39070 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) DELAWARE 32-0463781 (State or other jurisdi ...

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, 2020 ☐ 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: 001-39070 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) DELAWARE 32-046 ...

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 September 30, 2020 ☐ 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: 001-39070 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) DELAWARE 32-0463781 (State or other jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) | DELAWARE | 32-0463781 | | --- | --- | | (State or other jurisdiction of incorporation or organization) | (I.R.S. employer | | | identification number) | | 1000 Skokie Blvd., Suite 350, Wilmette, IL | 60091 | | (Address of principal executive offices) | (zip code) | | (847) 388-0349 | | | (Registrant's telephone number, including area ...

Part I [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Q1 2020, detailing financial position, performance, cash flows, and notes on business, pipeline, and COVID-19's impact on the Validive trial [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2020, total assets were $12.84 million, primarily cash, with liabilities at $0.44 million and stockholders' equity at $12.40 million Condensed Consolidated Balance Sheet Data (Unaudited) | | March 31, 2020 ($) | December 31, 2019 ($) | | :--- | :--- | :--- | | **Total Current Assets** | $12,716,556 | $13,229,640 | | **Total Assets** | $12,838,937 | $13,352,021 | | **Total Current Liabilities** | $443,520 | $724,165 | | **Total Liabilities** | $443,520 | $724,165 | | **Total Stockholders' Equity** | $12,395,417 | $12,627,856 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2020, net loss improved to $1.09 million ($0.10 per share) from $1.38 million in Q1 2019, driven by reduced R&D expenses offsetting increased G&A costs Statement of Operations Highlights (Three Months Ended March 31) | Metric | 2020 ($) | 2019 ($) | | :--- | :--- | :--- | | Research and development | $344,407 | $835,600 | | General and administrative | $791,607 | $571,709 | | **Total operating expenses** | **$1,136,014** | **$1,407,309** | | **Net loss** | **($1,090,877)** | **($1,376,235)** | | **Net loss per share** | **($0.10)** | **($0.15)** | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased to $12.40 million by March 31, 2020, primarily due to a $1.09 million net loss, partially offset by $0.53 million from common stock issuance and $0.34 million in stock-based compensation - During Q1 2020, the company issued 33,903 shares of common stock under its Capital on Demand™ Sales Agreement, raising net proceeds of **$526,143** after commissions[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2020 saw $1.13 million net cash used in operations, offset by $0.51 million from financing, resulting in a $0.62 million net decrease in cash, ending at $12.59 million Cash Flow Summary (Three Months Ended March 31) | Cash Flow Activity | 2020 ($) | 2019 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,125,570) | $(995,972) | | Net cash provided by financing activities | $508,044 | $(13,855) | | **Net decrease in cash and cash equivalents** | **$(621,567)** | **$(1,011,708)** | | **Cash and cash equivalents at end of period** | **$12,592,362** | **$5,881,064** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail Monopar's business, liquidity, and accounting policies, highlighting its three clinical programs, sufficient cash through June 2021, and COVID-19's impact on Validive trial design and significant milestone commitments - The company is a clinical-stage biopharmaceutical firm focused on cancer therapeutics with three compounds in development: Validive®, camsirubicin, and MNPR-101[28](index=28&type=chunk) - Due to the COVID-19 pandemic, the company modified its Validive clinical trial from a Phase 3 to a Phase 2b/3 design to enable initiation without near-term financing[30](index=30&type=chunk) - The company has a clinical collaboration with Grupo Español de Investigación en Sarcomas (GEIS) for a Phase 2 trial of camsirubicin, for which Monopar will provide the study drug and financial support averaging approximately **$2 million to $3 million** per year[99](index=99&type=chunk) - The license agreement for Validive with Onxeo includes potential clinical, regulatory, and sales milestones up to **$108 million**, plus royalties, while the license for MNPR-101 technology from XOMA Ltd. includes potential milestones up to **$14.925 million**[86](index=86&type=chunk)[90](index=90&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business, pipeline, and financing, highlighting the Validive trial's Phase 2b/3 adjustment due to COVID-19, improved Q1 2020 net loss from reduced R&D, and the need for substantial capital within 12-18 months to advance clinical programs [Overview and Product Candidates](index=21&type=section&id=Overview%20and%20Product%20Candidates) Monopar, an oncology-focused biopharmaceutical company, details its lead candidate Validive® (Phase 2b/3 for SOM), camsirubicin (Phase 2 for ASTS), and MNPR-101 (pre-IND monoclonal antibody), with trial initiations planned for H2 2020 - The company adjusted its clinical plan for Validive to a Phase 2b/3 trial to allow for a near-term data readout and to initiate the trial without requiring immediate new financing[113](index=113&type=chunk) - A Phase 2 trial of camsirubicin, in collaboration with GEIS, will evaluate it head-to-head against doxorubicin in approximately **170 ASTS patients**, with enrollment anticipated to begin in H2 2020[120](index=120&type=chunk) - Validive® demonstrated a **26.3% absolute reduction** in SOM incidence in a prior Phase 2 trial for the 100 µg dose group[115](index=115&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2020 net loss decreased to $1.09 million from $1.38 million in Q1 2019, driven by a $491,000 reduction in R&D expenses, despite a $220,000 increase in G&A costs due to IPO-related expenses Comparison of Operations (in thousands) | | Three Months Ended March 31, 2020 ($ in thousands) | Three Months Ended March 31, 2019 ($ in thousands) | Variance ($ in thousands) | | :--- | :--- | :--- | :--- | | Research and development expenses | $344 | $835 | $(491) | | General and administrative expenses | $792 | $572 | $220 | | **Net loss** | **$(1,091)** | **$(1,376)** | **$285** | - The decrease in R&D expenses was mainly due to a reduction in Validive clinical trial planning and accrued material costs of approximately **$531,000**[130](index=130&type=chunk) - The increase in G&A expenses was primarily attributed to higher stock-based compensation, legal, patent, and audit fees, and other general costs of operations[131](index=131&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2020, the company had a $27.0 million accumulated deficit, with funds sufficient through June 2021, but requires substantial additional capital within 12-18 months for Phase 3 Validive trial and other development, to be sought via equity, debt, or collaborations - The company anticipates needing to raise additional capital in the next 12 to 18 months to fund its operations, particularly the Phase 3 portion of the Validive trial[134](index=134&type=chunk) - Available funds as of April 30, 2020, are expected to fund planned operations past June 2021[143](index=143&type=chunk) - Future funding is needed to advance clinical development for Validive, camsirubicin, and MNPR-101, and to potentially acquire or license additional drug candidates[144](index=144&type=chunk)[145](index=145&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2020, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2020[162](index=162&type=chunk) - There were no material changes in the company's internal control over financial reporting during the first quarter of 2020[164](index=164&type=chunk) Part II [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors related to the COVID-19 pandemic, highlighting its adverse impact on stock price, fundraising ability, product manufacturing, and clinical trial conduct, potentially delaying development programs - The COVID-19 pandemic has negatively impacted the company's stock price and its ability to raise significant funds in the near-term[167](index=167&type=chunk)[168](index=168&type=chunk) - The pandemic poses risks to the company's ability to manufacture product candidates and conduct clinical trials due to potential quarantines, site closures, and supply chain disruptions[168](index=168&type=chunk) - In response to COVID-19, the Validive trial was modified to a Phase 2b/3 design, with commencing the Phase 3 portion contingent on raising **millions or tens of millions of dollars**, which may be challenging in the current environment[168](index=168&type=chunk) [Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including CEO and CFO certifications required by Sarbanes-Oxley Act, and XBRL data files - The exhibits filed with the report include CEO and CFO certifications (Exhibits 31.1, 31.2, 32.1) and XBRL interactive data files[171](index=171&type=chunk) Signatures The report concludes with formal signatures of the company's principal executive and financial officers, as required by the Securities Exchange Act of 1934 - The report was duly signed on **May 7, 2020**, by **Chandler D. Robinson, Chief Executive Officer**, and **Kim R. Tsuchimoto, Chief Financial Officer**[176](index=176&type=chunk)[177](index=177&type=chunk)

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)