Monopar Therapeutics 10-K for FY2023

Monopar Therapeutics (MNPR)

10-K 2024-03-28 For: 2023-12-31

Added on April 10, 2026

About this 10-K

Monopar Therapeutics filed this 10-K on March 28, 2024, covering the fiscal year ended December 31, 2023 (FY2023).

Headline figures

Fiscal year ended December 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $8.4M; compared with a net loss of $10.52M 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		17,454,925

			Page
Part I
	Item 1.	Business	7
	Item 1A.	Risk Factors	23
	Item 1C.	Cybersecurity	23
	Item 2.	Properties	58
	Item 3.	Legal Proceedings	58

Part II
	Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	59
	Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	59
	Item 8.	Financial Statements and Supplementary Data	69
	Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	69
	Item 9A.	Controls and Procedures	70
	Item 9B.	Other Information	70

Part III
	Item 10.	Directors, Executive Officers and Corporate Governance	71
	Item 11.	Executive Compensation	74
	Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	80
	Item 13.	Certain Relationships and Related Transactions and Director Independence	83
	Item 14.	Principal Accountant Fees and Services	84

Part IV
	Item 15.	Exhibits and Financial Statement Schedules	85

	●	the uncertain impact any resurgence of COVID-19 or another pandemic could have on our ability to advance our clinical programs and raise additional financing;

	●	the cumulative impact of domestic and global inflation, volatility in financial markets and/or the potential for an economic recession increasing our costs of obtaining goods and services or making financing more difficult to obtain on acceptable terms or at all;

	MONOPAR THERAPEUTICS INC.
	(Exact name of registrant as specified in its charter)

	●	If we or our licensees, development collaborators, or suppliers are unable to manufacture our products in sufficient quantities or at defined quality specifications, or are unable to obtain regulatory approvals for the manufacturing facility, we may be unable to develop and/or meet demand for our products as well as lose time to market and potential revenues.

	●	We rely on qualified third parties to conduct our active pharmaceutical ingredient manufacturing, our drug product manufacturing, non-clinical studies, and our clinical trials. If these third parties do not or cannot successfully carry out their contractual duties and meet expected deadlines or performance goals, the initiation or conduct of our clinical trials would be delayed and we may be unable to obtain regulatory approval for, or commercialize, our current product candidates or any future products, and our financial condition would be adversely affected.

	●	Radiopharmaceutical technology is a relatively novel approach to cancer imaging and treatment, which may create significant and potentially unpredictable challenges for it, including the availability of radioisotopes, potential misconception about the safety of radiopharmaceuticals, and low market uptake due to its novelty. Perceptions of these challenges may make it more difficult to raise funding as we focus efforts on our radiopharmaceutical program.

	●	The Russia-Ukraine war, and resulting sanctions against Russia and Russian entities, and Russian reduction in gas shipments to the EU and other allies, have increased fuel costs, reduced access to critical supplies and may cause shipping delays. Separately, the Israel-Hamas war has created additional uncertainties. The broader economic, trade and financial market consequences are uncertain at this time, which may increase the cost of supplies for our clinical materials, delay the manufacture of our clinical materials, restrict the availability of radioisotopes, increase costs of other goods and services or make it more difficult or costly to raise additional financing, any of which could cause an adverse effect on our clinical programs and on our financial condition.

	●	Market variables, such as inflation of product costs, labor rates and fuel, freight and energy costs, as well as geopolitical events could likely cause us to suffer significant increases in our operating and administrative expenses.

	●	Unstable market and economic conditions, such as volatility in the markets due to concerns about bank stability and economic challenges due to inflation, may have serious adverse consequences on our ability to raise funds, which may cause us to delay, restructure or cease our operations.

	●	The effects of economic and political pressure to lower pharmaceutical prices are a major threat to the economic viability of new research-based pharmaceutical products, and any significant decrease in drug prices could materially and adversely affect the financial appeal of our products and prospects for us to raise additional capital.

	●	We face significant competition from other radiopharmaceutical, biotechnology and pharmaceutical companies, and from research-based academic medical institutions, in our targeted medical indications, and our operating results would be adversely affected if we fail to compete effectively. Many competitors in our industry have greater organizational capabilities, much higher available capital resources, and established marketing and sales resources and experience in the targeted markets. Competition and technological change may make our product candidates obsolete or non-competitive.

	●	Pre-submission: before submitting an application, potential sponsors should ensure that the proposed product meets the eligibility requirements for the assessed listed medicines pathway. Applicants can arrange a free optional pre-submission meeting with the TGA prior to submitting the application for a new assessed listed medicine;

	●	Application submission: applications are created and lodged through TGA Business services;

	●	Preliminary assessment: The TGA will conduct a preliminary assessment of the application to determine whether it meets the administrative requirements and basic technical eligibility requirements to proceed to evaluation;

	●	The decision: When making the decision under section 26AE of the Therapeutics Goods Act (1989) on whether to list the medicine in the ARTG, the decision maker (the delegate of the Secretary of the Department of Health) will review all documentation associated with the application, including the dossier, evaluation reports, responses to requests for information, and advice from expert advisory committees;

	●	Finalization: Sponsors need to provide a patent certificate under subsection 26B(1) of the act, or notification that this is not required before the medicine can be listed in the ARTG;

	●	Conduct post-marketing requirements, if any: a drug may be selected for a post-market compliance review at any time. The TGA will check the assessed listed medicine's compliance against the regulatory requirements that are self-certified by the sponsor.

	●	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;

	●	FDA review and approval of the NDA; and

	●	Fulfillment of FDA post-marketing requirements, if any.

	●	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, radioisotopes, and our product candidates;

	●	higher than expected costs for preclinical testing;

	●	the cost and availability of radioisotopes such as Ac-225 or Zr-89, or any other medical isotope we may incorporate into our product candidates;

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

	●	slower than expected progress in developing our MNPR-101 radiopharmaceutical program, camsirubicin, and 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.

	●	sourcing clinical and, if approved for commercialization, commercial supplies for the materials, such as radioisotopes, used to manufacture our product candidates;

	●	sourcing or establishing manufacturing capabilities to produce adequate amounts of our product candidates;

	●	securing reliable supply chain for our product candidates given that isotope half-life times are limited;

	●	utilizing imaging agents to visualize tumor uptake in advance of administering our therapeutic candidates, which may increase the risk of adverse side effects;

	●	facilitating patient access to the limited number of facilities able to administer our product candidates;

	●	using medicines to manage adverse side effects of our drug candidates that may not adequately control the side effects or that may have detrimental impacts on the efficacy of the treatment; and

	●	establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of the Company's novel radiopharmaceutical imaging and therapeutics.

	●	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.

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

	●	coordination with any 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 being studied;

	●	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;

	●	logistical challenges posed by the time-limited shelf-life of our current or future drug candidates;

	●	patient referral practices of physicians; and

	●	potential long-term effects of COVID-19, any resurgences thereof or any future pandemics.

	●	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.

	●	Continue the development of MNPR-101 for radiopharmaceutical use as a therapeutic as well as a diagnostic imaging agent. Based on promising preclinical results utilizing radiolabeled MNPR-101, we have been cleared to conduct a Phase 1 dosimetry clinical trial of MNPR-101-Zr in patients with advanced cancers in Australia.

	●	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-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, potentially addressing camsirubicin- and doxorubicin-resistant cancers.

	●	Expand our drug development pipeline through in-licensing and acquisition of product candidates. We plan to continue the expansion of our drug development pipeline through acquiring or in-licensing additional 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 Therapeutics), 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).

	Year Ended December 31,
(in thousands)	2023			2022			Variance
Research and development expenses	$	5,600		$	7,592		$	(1,992	)
General and administrative expenses		3,231			2,945			286
Total operating expenses		8,831			10,537			(1,706	)
Operating loss		(8,831	)		(10,537	)		1,706
Interest income		429			21			408
Net loss	$	(8,402	)	$	(10,516	)	$	2,114

	●	continue the clinical and preclinical activities of MNPR-101-Zr and MNPR-101-RIT to image and treat cancer;

	●	advance the clinical development for camsirubicin;

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

	●	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 our MNPR-101 radiopharma program;

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

	●	the costs, timing and outcomes of seeking, obtaining, and maintaining FDA, TGA and other international regulatory approvals;

	●	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 and regulatory requirements for future drug product candidates;

	●	the costs associated with manufacturing/quality requirements, establishing a reliable supply chain, 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 management, operational, record keeping and other 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 license, milestone or royalty payments under these arrangements.

	●	development of our MNPR-101 radiopharma program to image and treat various advanced cancers;

	●	Development of our camsirubicin program if data support development beyond Phase 1b;

	●	development of potential new in-licensed product candidates;

	●	employee compensation and consulting fees to support the increased scope of activities required for the progress of our product candidate programs including MNPR-101 for radiopharmaceutical use, camsirubicin, and MNPR-202 (and related analogs)

Name	Age	Positions	Director Since
Christopher M. Starr, PhD	71	Executive Chairman, Director, Member of the Plan Administrator Committee	December 2014
Chandler D. Robinson, MD MBA MSc	40	Chief Executive Officer, Director	December 2014
Raymond W. Anderson, MBA	82	Director, Chair of the Audit Committee, Chair of the Compensation Committee and Member of the Corporate Governance and Nominating Committee, Member of the Plan Administrator Committee	April 2017
Michael J. Brown, MSc	67	Director, Member of the Audit Committee, Member of the Compensation Committee, Member of the Corporate Governance and Nominating Committee, Member of the Plan Administrator Committee	December 2014
Arthur J. Klausner, MBA	63	Director, Chair of the Corporate Governance and Nominating Committee, Member of the Audit Committee, Member of the Compensation Committee	August 2017
Kim R. Tsuchimoto	61	Chief Financial Officer, Director	March 2023

*Name*	*Age*	*Positions*
Chandler D. Robinson, MD MBA MSc	40	Chief Executive Officer, Director
Kim R. Tsuchimoto	61	Chief Financial Officer, Secretary, Treasurer, Director
Andrew J. Cittadine	52	Chief Operating Officer
Patrice Rioux, MD, Ph.D.	73	Acting Chief Medical Officer