Monopar Therapeutics 10-K for FY2021

Monopar Therapeutics (MNPR)

10-K 2022-03-24 For: 2021-12-31

Added on April 10, 2026

About this 10-K

Monopar Therapeutics filed this 10-K on March 24, 2022, covering the fiscal year ended December 31, 2021 (FY2021).

Headline figures

Fiscal year ended December 31, 2021, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $9.1M; compared with a net loss of $6.3M a year earlier

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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)

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

Class		Number of shares outstanding
Common stock, par value $0.001 per share		12,604,514

			Page
Part I
	Item 1.	Business	5
	Item 1A.	Risk Factors	32
	Item 2.	Properties	65
	Item 3.	Legal Proceedings	65

Part II
	Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	66
	Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	67
	Item 8.	Financial Statements and Supplementary Data	76
	Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosures	76
	Item 9A.	Control and Procedures	76

Part III
	Item 10.	Directors, Executive Officers and Corporate Governance	78
	Item 11.	Executive Compensation	78
	Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	78
	Item 13.	Certain Relationships and Related Transactions and Director Independence	78
	Item 14.	Principal Accountant Fees and Services	78

Part IV
	Item 15.	Exhibits and Financial Statement Schedules	79

	●	Patients on Validive experienced a delay in the time to onset of SOM. Patients receiving placebo experienced a median time to onset of SOM of 37 days; patients receiving Validive (50 µg one per day) experienced a 45-day median time to onset of SOM; and patients receiving Validive (100 µg once per day) did not reach a median time to onset. A comparison of hazards for time to onset demonstrated that patients that received Validive 100 µg had a hazard ratio (HR)=0.48 compared to placebo.

	●	Patients receiving Validive experienced a decrease in the median duration of SOM. In patients that developed SOM, a 15.5-day reduction (by 37.8%) in the median duration of SOM was observed in patients treated with Validive 100 µg (41-day median duration with placebo, 34 days in the Validive 50 µg group, and 25.5 days in the Validive 100 µg group). Median duration across all patients, inclusive of both those that did and did not develop SOM, was 17 days in the placebo group and 0 days in each of the Validive 50 and 100 µg groups.

	●	Severe drinking, eating, and speaking limitations due to mouth and throat soreness (“MTS”) score were also reduced in the Validive 100 µg treated cohort.

	●	Improvements in other indicators of clinical benefit, including decreased weight loss, decreased opiate use and increased cumulative dose of radiation received, strongly favored the Validive 100 µg treated group.

	●	A dose response was observed with the Validive 100 µg dose, demonstrating a trend toward superiority over the Validive 50 µg dose as well as placebo. Individual patient-level data supports advancing the Validive 100 µg dose into Phase 2b/3.

	●	is selectively expressed on metastatic tumor, tumor-associated immune, and angiogenic endothelial cells, but not on most normal cells. Several Phase 1 positron emission tomography (“PET”) imaging studies in human advanced cancer patients show that uPAR can only be detected in the tumor and not in normal tissues;

	●	is central to several extracellular and intracellular oncogenic pathways required for metastasis (inhibiting the uPA system in turn inhibits many other downstream targets, such as MAPK, AKT, MEK, and FAK, that are currently being targeted by other companies);

	●	is expressed on immune cells that allow the tumor to evade recognition by the immune system;

	●	is expressed by aberrantly activated immune cells in the context of respiratory disease and chronic inflammation (i.e., severe COVID-19);

	●	mediates antibody-dependent cellular cytotoxicity (ADCC); and

	●	has the potential to interfere at several different signaling pathways that converge at uPAR.

	●	Completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices (“GLP”), and other applicable regulations;

	●	Submission to the FDA of an Investigational New Drug application (“IND”), which must become effective before human clinical studies may begin;

	●	Performance of adequate and well-controlled human clinical studies according to the FDA’s current Good Clinical Practices (“GCP”), to establish the safety, efficacy and optimum dose of the proposed pharmaceutical product for its intended use;

	●	Submission to the FDA of a New Drug Application (“NDA”) or Biologics License Application (“BLA”), for a new pharmaceutical product;


	●	Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the pharmaceutical product is produced to assess compliance with the FDA’s current Good Manufacturing Practice standards (“cGMP:”), to assure that the facilities, methods and controls are adequate to preserve the pharmaceutical product’s identity, strength, quality and purity;

	●	FDA audits of the preclinical and clinical study sites that generated the data in support of the NDA or BLA; and

	●	FDA review and approval of the NDA.

	●	Phase 1. The pharmaceutical product is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.

	●	Phase 2. The pharmaceutical product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases, to determine dosage tolerance, optimal dosage and dosing schedule and to identify patient populations with specific characteristics where the pharmaceutical product may be more effective.

	●	Phase 3. Clinical studies are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These clinical studies are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. The studies must be well-controlled and usually include a control arm for comparison. One or two Phase 3 studies are required by the FDA for an NDA or BLA approval, depending on the disease severity and other available treatment options.

	●	Post-approval studies, or Phase 4 clinical studies, may be conducted after initial marketing approval. These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication.

	●	Progress reports detailing the results of the clinical studies must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects. Phase 1, Phase 2 and Phase 3 clinical studies may not be completed successfully within any specified period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend a clinical study at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the IRB’s requirements or if the pharmaceutical product has been associated with unexpected serious harm to patients.

	●	receiving less funding than we require;

	●	higher than expected costs to manufacture and ship our active pharmaceutical ingredient and our product candidates;

	●	higher than expected costs for preclinical testing;

	●	an increase in the number, size, duration, and/or complexity of our clinical trials;

	●	slower than expected progress in developing Validive, camsirubicin, MNPR-101, MNPR-101 RIT, MNPR-202 or other product candidates, including without limitation, additional costs caused by program delays;

	●	higher than expected costs associated with attempting to obtain regulatory approvals, including without limitation additional costs caused by additional regulatory requirements or larger clinical trial requirements;

	●	higher than expected personnel, consulting or other costs, such as adding personnel or industry expert consultants or pursuing the licensing/acquisition of additional assets; and

	●	higher than expected costs to protect our intellectual property portfolio or otherwise pursue our intellectual property strategy.

	●	Clinical trials may not yield sufficiently conclusive results for regulatory agencies to approve the use of our products.

	●	Our products may fail to be more effective than current therapies, or to be effective at all.

	●	We may discover that our products have adverse side effects, which could cause our products to be delayed or precluded from receiving regulatory approval or reduce the effective size of our target patient population or otherwise expose us to significant commercial and legal risks.

	●	It may take longer than expected to determine whether or not a treatment is safe and effective.

	●	Patients involved in our clinical trials may suffer severe adverse side effects even up to death, whether as a result of treatment with our products, the withholding of such treatment, or other reasons which may not include the effects of our treatment (whether within or outside of our control).

	●	We may fail to be able to enroll a sufficient number of patients in our clinical trials to meet trial statistical plans and gain statistical significance, or it may take longer than expected to enroll.

	●	Patients enrolled in our clinical trials may not have the safety or efficacy characteristics necessary to obtain regulatory approval for a particular indication or patient population.

	●	We may be unable to produce sufficient quantities of product to complete the clinical trials.

	●	Even if we are successful in our clinical trials, required governmental approvals may still not be obtained or, if obtained, may not be maintained.

	●	If approval for commercialization is granted, it is possible the authorized use will be more limited than is necessary for commercial success, or that approval may be conditioned on completion of further clinical trials or other activities, which will cause a substantial increase in costs and which we might not succeed in performing or completing.

	●	If granted, approval may be withdrawn or limited if problems with our products emerge or are suggested by the data arising from their use or if there is a change in law or regulation.

	●	regulatory authorities may withdraw their approval of the product, which would force us to remove Validive from the market;

	●	regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication, or field alerts to physicians and pharmacies;

	●	we may be required to change instructions regarding the way the product is administered, conduct additional clinical trials or change the labeling of the product;

	●	we may be subject to limitations on how we may promote the product;

	●	sales of the product may decrease significantly;

	●	we may be subject to litigation or product liability claims; and

	●	our reputation may suffer.

	●	delays in U.S. or foreign regulatory approvals to start the clinical trial;

	●	coordination with clinical research organizations to enroll and administer the clinical trials;

	●	coordination and recruitment of collaborators and investigators at individual sites;

	●	size of the patient population and the effectiveness of the process for identifying patients;

	●	design of the clinical trial protocol;

	●	eligibility and exclusion criteria;

	●	perceived therapeutic risks and benefits of the product candidates under study;

	●	availability of competing commercially available therapies and other competing products’ clinical trials;

	●	time of year in which the trials are initiated or conducted;

	●	severity and prognosis of the diseases under investigation;

	●	ability to obtain and maintain subject consents;

	●	ability to enroll and treat patients in a timely manner;

	●	risk that enrolled subjects will drop out before completion of the trials;

	●	proximity and availability of clinical trial sites for prospective patients;

	●	ability to monitor subjects adequately during and after treatment;

	●	patient referral practices of physicians; and

	●	potential effects of the COVID-19 pandemic.

	●	withdrawal of clinical trial volunteers;

	●	decreased demand for our products when approved;

	●	injury to our reputation and significant, adverse media attention; and

	●	potentially significant litigation costs, including without limitation, any damages awarded to the plaintiffs if we lose or settle claims.

	●	Comparative superiority of the efficacy and safety in the treatment of the disease indication compared to alternative treatments;

	●	Less incidence, less prevalence and more severity of adverse side effects;

	●	Potential advantages over alternative treatments;

	●	Cost effectiveness;

	●	Convenience and ease of administration, stability and shelf life, for distributor, physician and patient;

	●	Sufficient third-party coverage and/or reimbursement;

	●	Strength of sales, marketing and distribution support; and

	●	Our ability to provide acceptable and compelling evidence of safety and efficacy.

	●	Patents that may be issued or licensed may be challenged, invalidated, or circumvented; or may not provide any competitive advantage for other reasons.

	●	Our licensors may terminate or breach our existing or future license agreements, thereby reducing or preventing our ability to exclude competition; termination of such license agreements may also subject us to risk of patent infringement of patents to which we no longer have a license.

	●	Our competitors, many of which have substantially greater resources than us and have made significant investments in competing technologies, may seek, or may already have obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our potential products either in the U.S. or in international markets.

	●	As a matter of public policy regarding worldwide health concerns, there may be significant pressure on the U.S. government and other international governmental bodies to limit the scope of domestic and international patent protection for cancer treatments that prove successful.

	●	Countries other than the U.S. may have less restrictive patent laws than those upheld by the U.S. courts; therefore, non-U.S. competitors could exploit these laws to create, develop, and market competing products. In some countries, the legal compliance with pharmaceutical patents, patent applications and other intellectual property regulations is very weak or actively evaded in some cases with government aid.

	●	exposure to unknown technologies, product candidates, medical conditions and indications, product manufacturing challenges and uncertainties, and other unknown factors of potential high risk;

	●	disruption of our business and diversion of our management’s time and attention in order to develop acquired products, product candidates or technologies;

	●	incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions;

	●	higher-than-expected acquisition and integration costs;

	●	write-downs of assets, goodwill or impairment charges;

	●	increased amortization expenses;

	●	difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;

	●	impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and

	●	inability to retain key employees of any acquired businesses or for our current business based on changed circumstances.

	●	multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements, and other governmental approvals, permits and licenses which can vary jurisdictions to jurisdiction with different degrees of review and enforcement;

	●	failure by us to obtain and maintain regulatory approvals for the use of our products in various countries;

	●	rejection or qualification of foreign clinical trial data by the competent authorities of other countries;

	●	additional potentially relevant third-party patent and other intellectual property rights that may be necessary to develop and commercialize our products and drug candidates;

	●	complexities and difficulties in obtaining, maintaining, enforcing and defending our patent and other intellectual property rights;

	●	difficulties in staffing and managing foreign operations by a small-scale organization;

	●	complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

	●	limits, as a U.S.-based company, in our ability to penetrate international markets;

	●	financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations;

	●	natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions, implementation of tariffs;

	●	certain expenses including, among others, expenses for travel, translation and insurance; and

	●	regulatory and compliance risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its accounting provisions or its anti-bribery provisions or provisions of anti-corruption or anti-bribery laws in other countries.

	●	provide that all vacancies on our Board may only be filled by our Board and not by stockholders;

	●	allow the holders of a plurality of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose; and

	●	provide that special meetings of our stockholders may be called only by our Board.

	·	Leverage data generated from the Phase 2 Validive clinical trial to complete the execution of a successful VOICE clinical program for Validive for SOM in OPC. In the prior Phase 2 clinical trial the absolute incidence of SOM in OPC patients was reduced by 26.3%, the time to SOM onset was delayed, and the duration of disease in patients that developed SOM was decreased by 15.5 days in the Validive 100 µg cohort versus placebo. In addition to the data from the Phase 2 clinical trial, we believe the guidance from our key opinion leaders (“KOLs”) as well as from the FDA and EMA, and our own internal clinical trial design expertise, position us well for an effective VOICE clinical trial program.

	·	Obtain FDA and EMA approval of Validive to maximize the commercial potential of Validive in both the U.S. and the EU, and seek partnerships outside these markets. If the VOICE clinical program of Validive is successful and FDA and EMA approvals are obtained, we currently intend to commercialize Validive in the U.S. and the EU ourselves, which may include establishing our own specialty sales force and seeking partnerships outside of these territories for regulatory approval and drug sales and distribution.

	·	Advance the clinical development of camsirubicin, by pursuing indications where doxorubicin has demonstrated efficacy. ASTS will be the first indication, which is anticipated to allow camsirubicin to go head-to-head against doxorubicin, the current first-line treatment. In this indication, camsirubicin previously demonstrated clinical benefit (stable disease or partial response) in 52.6% of patients evaluable for tumor progression in a single-arm Phase 2 study. Clinical benefit was proportional to dose and was consistently observed at higher cumulative doses of camsirubicin (>1000 mg/m²). Camsirubicin was very well tolerated in this Phase 2 study and underscored the ability to potentially administer camsirubicin without restriction as to cumulative dose (doxorubicin is limited due to heart toxicity to 450 mg/m² cumulative dose). Our current ongoing Phase 1b clinical trial continues towards establishing a new, higher recommended dose for the next Phase 2 ASTS clinical trial.

	·	Continue the development of MNPR-101, MNPR-101 RIT and related molecules as therapeutic, diagnostic and imaging agents. We plan to continue the development of MNPR-101, MNPR-101 RIT and related molecules for diagnostic, imaging, and therapeutic use in cancer and severe COVID-19.

	·	Continue the development of MNPR-202 and related analogs in multiple types of cancers. The 2-pyrrilino camsirubicin analog (MNPR-202) and related analogs represent proprietary compositions of matter designed to retain the non-cardiotoxic backbone of camsirubicin yet exhibit novel features in terms of antitumor activity and mechanism that distinguish these analogs from camsirubicin as well as from doxorubicin.

	·	Expand our drug development pipeline through advancing current assets, in-licensing, and acquisition of oncology product candidates. We plan to continue the expansion of our drug development pipeline through acquiring or in-licensing additional oncology product candidates, particularly those that leverage existing scientific and clinical data that helps reduce the risks of the next steps in clinical development.

	·	Utilize the expertise and prior experience of our team in the areas of asset acquisition, drug development and commercialization to establish ourselves as a leading biopharmaceutical company. Our senior executive team has relevant experience in biopharmaceutical in-licensing and acquisitions as well as developing product candidates through approval and commercialization. In aggregate, our team has co-founded BioMarin Pharmaceutical (Nasdaq: BMRN), Sensant Corp (acquired by Siemens), American BioOptics (assets acquired by Olympus), Raptor Pharmaceuticals ($800 million sale to Horizon Pharma), and Tactic Pharma, LLC (“Tactic Pharma”) (sale of lead asset, choline tetrathiomolybdate, was ultimately acquired by Alexion in June 2018 for $764 million; Alexion was subsequently acquired by AstraZeneca).

	Years Ended December 31,
(in thousands)	2021			2020			Variance
Research and development expenses	$	6,493		$	4,065		$	2,428
General and administrative expenses		2,634			2,444			190
Total operating expenses		9,127			6,509			2,618
Operating loss		(9,127	)		(6,509	)		(2,618	)
Other income from PPP loan forgiveness		-			122			(122	)
Interest income		24			82			(58	)
Net loss	$	(9,103	)	$	(6,305	)	$	(2,798	)

·	advance the clinical development and execute the regulatory strategy for Validive;

·	advance the clinical development and execute the regulatory strategy for camsirubicin;

·	continue the preclinical activities and potentially enter clinical development of MNPR-101 and MNPR-101-derived radioimmunotherapeutics and companion diagnostics, to treat cancer and severe COVID-19 (patients with SARS-CoV-2 infection);

·	continue the preclinical activities, and potentially later-on enter clinical development, of MNPR-202 (and related analogs) for various cancer indications;

·	acquire and/or license additional pipeline drug product candidates and pursue the future preclinical and/or clinical development of such drug product candidates;

·	seek regulatory approvals for any of our current and future drug product candidates that successfully complete registration clinical trials;

·	establish or purchase the services of a sales, marketing and distribution infrastructure to commercialize any products for which we obtain marketing approval;

·	develop or contract for manufacturing/quality capabilities or establish a reliable, high quality supply chain sufficient to support our clinical requirements and to provide sufficient capacity to launch and supply the market for any product for which we obtain marketing approval; and

·	add or contract for required operational, financial and management information systems and capabilities and other specialized expert personnel to support our drug product candidate development and planned commercialization efforts.

·	the progress of clinical development and regulatory interactions and approvals of Validive;

·	the progress of clinical development and regulatory interactions and approvals of camsirubicin;

·	the costs, timing and outcomes of seeking, obtaining, and maintaining FDA and international regulatory approvals;

·	the progress of preclinical and clinical development of MNPR-101 and MNPR-101-derived radioimmunotherapeutics and companion diagnostics, to treat cancer and severe COVID-19 (patients with SARS-CoV-2 infection), including activities through our collaboration with NorthStar;

·	the progress of preclinical and potentially clinical development of MNPR-202 (and related analogs);

·	the number and characteristics of other drug product candidates that we may license, acquire, invent or otherwise pursue;

·	the scope, progress, timing, cost and results of research, preclinical development and clinical trials of future drug product candidates;

·	the costs associated with manufacturing/quality requirements and establishing or contracting for sales, marketing and distribution capabilities;

·	our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make in connection with the licensing, filing, defense and enforcement of any patents or other intellectual property rights;

·	our need and ability to hire or contract for additional management, administrative, scientific, medical, sales and marketing, and manufacturing/quality and other specialized personnel or external expertise;


·	the effect and timing of entry of competing products or new therapies that may limit market penetration or prevent the introduction of our drug product candidates or reduce the commercial potential of our product portfolio;

·	our need to implement additional required internal systems and infrastructure; and

·	the economic and other terms, timing and success of our existing collaboration and licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future, including the timing of receipt of or payment to or from others of any milestone or royalty payments under these arrangements.

·	clinical research services and clinical site fees for our VOICE clinical program, including, if required, completing a second Phase 3 confirmatory clinical trial;

·	process development, manufacturing costs, clinical trial expenses and clinical database management of camsirubicin in connection with the Phase 1b dose escalation clinical trial and other future clinical development;

·	support of the development of MNPR-101-derived radioimmunotherapeutics and companion diagnostics to treat cancer and severe COVID-19 (patients with SARS-CoV-2 infection), including activities through our collaboration with NorthStar;

·	preclinical studies (and if successful, clinical studies) of MNPR-101, MNPR-202 (and related analogs); and

·	employee compensation and consulting fees to support our product candidate programs including Validive, camsirubicin, MNPR-101, MNPR-101 RIT (uPRIT and related compounds) and companion diagnostics and MNPR-202 (and related analogs).

		Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 207)		F-2
Consolidated Balance Sheets as of December 31, 2021 and 2020		F-3
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2021 and 2020		F-4
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2020 and 2021		F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021 and 2020		F-6
Notes to Consolidated Financial Statements		F-7 to F-21

Exhibit	Document	Incorporated by Reference From:
3.1	Second Amended and Restated Certificate of Incorporation	Form 10-K filed on March 26, 2018
3.2	Amended and Restated Bylaws	Form 10-K filed on March 26, 2018
4.1	Description of Registered Securities	Filed herewith as Exhibit 4.1
10.1*	License Agreement with XOMA Ltd.	Form 10-K filed on March 26, 2018
10.2*	Option and License Agreement with Onxeo S.A.	Form 10-K filed on March 26, 2018
10.3*	Contribution Agreement (351) – Containing Registration Rights with TacticGem	Form 10-K filed on March 26, 2018
10.4	2016 Stock Incentive Plan, as amended	Filed herewith as Exhibit 10.1
10.5	Form of Incentive Stock Option Agreement	Filed herewith as Exhibit 10.2
10.6	Form of Non-qualified Stock Option Agreement	Filed herewith as Exhibit 10.3
10.7	Form of Restricted Stock Unit Agreement	Filed herewith as Exhibit 10.4
10.8	Form of Restricted Stock Unit Grant Notice	Form 10-K filed on March 26, 2018
10.9	Employment Agreement of Andrew P. Mazar – effective November 1, 2017	Form 10-K filed on March 26, 2018
10.10	Employment Agreement of Kim R. Tsuchimoto – effective November 1, 2017	Form 10-K filed on March 26, 2018
10.11	Amendment One to Employment Agreement of Kim R. Tsuchimoto – effective March 1, 2018	Form 10-K filed on March 26, 2018
10.12	Consulting Agreement of pRx Consulting (Patrice Rioux) – effective January 1, 2021	Filed herewith as Exhibit 10.5
10.13	Consulting Agreement of pRx Consulting (Patrice Rioux) – effective October 1, 2021	Filed herewith as Exhibit 10.6
10.14	Amendment No 1 to Consulting Agreement of pRx Consulting (Patrice Rioux) – effective October 1, 2021	Filed herewith as Exhibit 10.7
10.15	Consulting Agreement of Christopher M. Starr – effective January 1, 2022	Filed herewith as Exhibit 10.8
21.1	Subsidiaries of Monopar Therapeutics Inc. as of December 31, 2021	Filed herewith as Exhibit 21.1
23.1	Consent of Independent Registered Public Accounting Firm	Filed herewith as Exhibit 23.1
24.1	Power of Attorney (included in the signature page hereto)
31.1	Certification of Chandler D. Robinson, Chief Executive Officer	Filed herewith as Exhibit 31.1
31.2	Certification of Kim R. Tsuchimoto, Chief Financial Officer	Filed herewith as Exhibit 31.2
32.1	Certification of Chandler D. Robinson, Chief Executive Officer and Kim R. Tsuchimoto, Chief Financial Officer	Filed herewith as Exhibit 32.1

101.INS		Inline XBRL Taxonomy Extension Schema
101.SCH		Inline XBRL Taxonomy Extension Schema
101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase
101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase
101.LAB		Inline XBRL Taxonomy Extension Label Linkbase
101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase
104		Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

	MONOPAR THERAPEUTICS INC

Dated: March 24, 2022	By:	/s/ Kim R. Tsuchimoto
		Name: Kim Tsuchimoto
		Title: Chief Financial Officer
		(Principal Financial Officer)

Signatures	Title	Date

/s/ Chandler D. Robinson		March 24, 2022
Chandler Robinson	Chief Executive Officer and Director (Principal Executive Officer)

/s/ Kim R. Tsuchimoto		March 24, 2022
Kim Tsuchimoto	Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

/s/ Andrew P. Mazar		March 24, 2022
Andrew Mazar	Chief Scientific Officer and Director

/s/ Christopher M. Starr		March 24, 2022
Christopher Starr	Executive Chairman of the Board and Director

/s/ Raymond W. Anderson		March 24, 2022
Raymond W. Anderson	Director

/s/ Michael J. Brown		March 24, 2022
Michael Brown	Director

/s/ Arthur J. Klausner		March 24, 2022
Arthur Klausner	Director

	December 31, 2021			December 31, 2020
Assets
Current assets:
Cash and cash equivalents	$	20,303,869		$	16,737,109
Other current assets		217,745			62,690
Total current assets		20,521,614			16,799,799

Other non-current assets		-			68,858
Total assets	$	20,521,614		$	16,868,657
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable, accrued expenses and other current liabilities	$	1,580,543		$	1,176,666
Total current liabilities and total liabilities		1,580,543			1,176,666

Commitments and contingencies (Note 7)
Stockholders’ equity:
Common stock, par value of $0.001 per share, 40,000,000 shares authorized, 12,598,125 and 11,453,465 shares issued and outstanding at December 31, 2021, and December 31, 2020, respectively		12,598			11,453
Additional paid-in capital		60,220,016			47,873,570
Accumulated other comprehensive loss		(3,160	)		(7,873	)
Accumulated deficit		(41,288,383	)		(32,185,159	)
Total stockholders’ equity		18,941,071			15,691,991
Total liabilities and stockholders’ equity	$	20,521,614		$	16,868,657