Monopar Therapeutics Inc. (MNPR) SEC Filings & Earnings Calls

Regulatory Approval Uncertainty

“There can be no assurance that, following completion of the rolling submission, the FDA will accept the NDA for filing or that the NDA will ultimately be approved.”

Funding Dependency

“We have incurred losses and cumulative negative cash flows from operations since we commenced operations, resulting in an accumulated deficit of approximately $98.7 million as of June 30, 2026.” · word for word

Net loss increased significantly; no revenue; pre-commercial stage.

“Net loss for the second quarter of 2026 was $5.3 million, compared to net loss of $2.5 million for the second quarter of 2025.” · word for word

Regulatory risk: NDA may not be accepted for filing or approved by FDA.

“whether the FDA will accept the NDA for filing and the outcome of any review thereof” · word for word

Clinical-stage biopharmaceutical company with no approved products; dependent on ALXN1840 success.

“Monopar Therapeutics is a clinical-stage biopharmaceutical company developing ALXN1840” · word for word

Regulatory and commercial risks for ALXN1840

“Forward-looking statements about NDA approval and PRV”

Clinical trial failure pressure mitigated by positive data, but regulatory and commercial risks remain.

“Drug-related serious adverse events occurred in 4.9% of patients, including neurologic SAEs in less than 1% and no treatment-related deaths.”

Clinical-stage biotech with no approved products; reliance on trial results

“Phase 2 study results presented; no mention of regulatory path or commercialization”

Clinical trial results are from a small Phase 2 study (9 patients) and may not be replicated in larger Phase 3 trials or real-world settings.

“The open-label, single-arm Phase 2 trial evaluated daily dosing of ALXN1840 in nine patients with Wilson disease across two centers.” · word for word

Net loss increased 50% YoY due to higher R&D spending; cash burn rate may accelerate.

“Net loss for the first quarter of 2026 was $3.9 million, compared to $2.6 million for the first quarter of 2025.” · word for word

Clinical-stage biopharmaceutical company with history of losses

“We are a clinical-stage biopharmaceutical company with a history of financial losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain cash self-sufficiency or profitability.” · word for word

Regulatory approval uncertainty for ALXN1840

“The regulatory approval process can be lengthy, expensive and uncertain. The U.S. Food and Drug Administration ("FDA") and other regulatory agencies around the world may require us to perform additional nonclinical and/or clinical studies to obtain ALXN1840 approval.” · word for word

Dependence on third-party manufacturers and suppliers

“We rely on qualified third parties to conduct our active pharmaceutical ingredient and biologic drug substance manufacturing, drug product manufacturing, non-clinical studies, and clinical trials.” · word for word

Radiopharmaceutical technology novelty

“Radiopharmaceutical technology is a relatively novel approach to cancer imaging and treatment, which may create significant and potentially unpredictable challenges for such technology, including the availability of radioisotopes, potential misconception about its safety, and low market uptake due to its novelty.” · word for word

Geopolitical and macroeconomic uncertainties

“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.” · word for word

Clinical and regulatory risk

“The Company's success depends on the successful development and regulatory approval of ALXN1840; any delays or failures could materially impact the business.”

Financing risk

“The Company has a history of net losses and may need additional capital to fund operations and commercialization.”

Related party transaction risk

“The Company engaged in a share repurchase from Tactic Pharma, a related party, which may raise governance concerns.”

Concentration of ownership

“Several institutional investors hold significant stakes, which could lead to influence over corporate actions.”

Regulatory approval risk for NDA

“planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in mid-2026” · word for word

Clinical-stage company with no approved products

“Monopar Therapeutics is a clinical-stage biopharmaceutical company” · word for word

No Revenue and Accumulated Losses

“The Company has incurred an accumulated deficit of approximately $89.5 million as of December 31, 2025, and since inception has not generated any revenue.” · word for word

Clinical Development Risk

“Many, if not most, biopharmaceutical companies never become profitable and are acquired, merged, or liquidated before successfully developing any product that generates revenue from commercial sales to enable profitability.” · word for word

Related Party Transaction Risk

“Chandler D. Robinson, Monopar’s Chief Executive Officer and a member of the Board of Directors, is a minority owner and non-controlling Managing Member of Tactic Pharma.” · word for word

Dilution Risk

“As of December 31, 2025, the Company had 6,692,140 shares of common stock issued and outstanding and 1,843,303 pre-funded warrants outstanding” · word for word

Regulatory approval uncertainty for ALXN1840

“The regulatory approval process can be lengthy, expensive and uncertain. The U.S. Food and Drug Administration ("FDA") and other regulatory agencies around the world may require us to perform additional nonclinical and/or clinical studies to obtain ALXN1840 approval.” · word for word

Dependence on third-party manufacturers

“We rely on third-party contract manufacturers for all our required raw materials, active pharmaceutical ingredients ("API") and biologic drug substances, and finished drug products for ALXN1840 and MNPR-101 radiopharmaceutical programs, exposing us to potential delays and compliance inadequacies.” · word for word

Financing risk

“We may need to raise additional funding or find one or more suitable pharmaceutical partners to continue to advance our clinical programs; finance our regulatory, pre-commercial and commercial activities; and support our preclinical studies.” · word for word

Patent expiration risk for MNPR-101

“The U.S. patent covering the composition of matter of MNPR-101 will expire in 2027 and the corresponding Japanese patent expired in 2025; the U.S. patent covering the MNPR-101 epitope will expire in 2029 with the corresponding Japanese patent expiring in 2027.” · word for word

Competition from existing Wilson disease therapies

“Existing chelation therapies are penicillamine-based products, which include Cuprimine (Bausch Health Companies Inc.) and Depen (Meda Pharmaceuticals Inc., a Viatris company), and trientine-based products, which include Syprine (Bausch Health Companies Inc.) and Cuvrior (Orphalan SA).” · word for word

Clinical-stage biotech with no approved products; reliance on ALXN1840 NDA success and radiopharmaceutical pipeline.

“Company is a clinical-stage biopharmaceutical company; net loss and negative operating cash flow.”

Execution risk in building commercial infrastructure for ALXN1840 launch.

“Company preparing for NDA submission in H1 2026; new executive role created.”

Clinical-stage biotech with no approved products; reliance on regulatory success

“NDA submission for ALXN1840 planned; clinical trials ongoing”

Pre-revenue and development stage risk

“We are a clinical-stage biopharmaceutical company with a history of financial losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain cash self-sufficiency or profitability” · word for word

Regulatory approval uncertainty

“The regulatory approval process can be lengthy, expensive and uncertain...we may be unable to raise sufficient capital to complete or the results of which may not meet clinical and/or statistical significance” · word for word

Dependence on ALXN1840 and radiopharmaceutical programs

“Our business is highly dependent upon receiving marketing approvals from the FDA and various international regulatory agencies and would be severely harmed if we are not granted approvals to manufacture and sell our product candidates.” · word for word

Early-stage clinical data, limited sample size.

“n=8 patients in copper balance study.”