Monopar Therapeutics: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 14 May 2026: press release. Guidance figures: 2 kept. The quarter’s numbers.

Key takeaways

Net loss rose year on year: Net loss was $3.9 million, or $0.46 per share, against $2.6 million, or $0.38 per share, in the first quarter of 2025. Source
R&D expense more than doubled: R&D expense was $3,487,247, against $1,643,375 a year earlier, an increase of $1,843,872. Source
Contractors and personnel drove R&D rise: Increase attributed to $825,972 in R&D contractor and consulting, $799,593 in R&D personnel including stock-based compensation, and $218,307 in other R&D. Source
FoCus data show neurologic benefit: Phase 3 FoCus analyses presented at AAN in April reported greater neurologic benefit versus standard of care in patients with neurologic symptoms at baseline. Source
ALXN1840 described as late-stage: Company describes ALXN1840 as its late-stage program for Wilson disease, alongside radiopharmaceutical programs. Source
Cash position at quarter end: Cash, cash equivalents and investments were $137.5 million at March 31, 2026. Source
Chief commercial officer leads readiness: Susan Rodriguez, Chief Commercial and Strategy Officer who joined in March 2026, leads commercial readiness for a potential launch. Source

“The Company remains on track with its plans to submit the New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in mid-2026.”
Monopar Therapeutics, press release

Guidance

Area	Period	Figure	Against last quarter
NDA submission for ALXN1840 Source	mid-2026	mid-2026	Kept
Cash runway Source	through December 31, 2027	at least through December 31, 2027	Kept

What changed from last quarter

New: Phase 3 FoCus analyses were presented at the AAN 2026 meeting in April, after the prior release listed them as upcoming. Source

Net loss and interest income

Net loss rose year on year: Net loss was $3.9 million, or $0.46 per share, against $2.6 million, or $0.38 per share, in the first quarter of 2025. Source
Interest income more than doubled: Interest income was $1,332,203 against $596,845. The release attributes the rise to Treasury securities, commercial paper and higher bank balances from the September 2025 raise. Source
Fourth-quarter 2025 loss was larger: The prior release reported a fourth-quarter 2025 net loss of $5.2 million, or $0.61 per share.

R&D and G&A spend

R&D expense more than doubled: R&D expense was $3,487,247, against $1,643,375 a year earlier, an increase of $1,843,872. Source
Contractors and personnel drove R&D rise: Increase attributed to $825,972 in R&D contractor and consulting, $799,593 in R&D personnel including stock-based compensation, and $218,307 in other R&D. Source
G&A rose on personnel costs: G&A was $1,738,006 against $1,578,442, up $159,564, mainly $134,599 in G&A personnel expenses including stock-based compensation. Source

“Monopar expects its current funds to support operations at least through December 31, 2027, including: (1) regulatory and potential commercial activities for ALXN1840;”
Monopar Therapeutics, press release

ALXN1840 Wilson disease program

FoCus data show neurologic benefit: Phase 3 FoCus analyses presented at AAN in April reported greater neurologic benefit versus standard of care in patients with neurologic symptoms at baseline. Source
EASL liver and quality-of-life presentation: The EASL 2026 presentation is titled on liver stabilization, neurological symptoms and quality of life in treatment-experienced patients. Source
Patient-focused FDA meeting in January: Patients and caregivers described disease burden and experience with current treatments at the meeting, per the prior release.

Program stages across pipeline

ALXN1840 described as late-stage: Company describes ALXN1840 as its late-stage program for Wilson disease, alongside radiopharmaceutical programs. Source
MNPR-101 stages by candidate: MNPR-101-Zr is in Phase 1 for imaging; MNPR-101-Lu is Phase 1a and MNPR-101-Ac is late preclinical, for treatment of advanced cancers. Source
Radiopharmaceuticals target uPAR: The three MNPR-101 agents, labeled with zirconium-89, lutetium-177 and actinium-225, target uPAR, which is expressed in several aggressive cancers.

Cash and capital position

Cash position at quarter end: Cash, cash equivalents and investments were $137.5 million at March 31, 2026. Source
Year-end 2025 cash balance: Cash, cash equivalents and short-term investments were $140.4 million at December 31, 2025, per the prior release.
2025 offering proceeds noted: The prior release says the 2025 underwritten offering generated about $91.9 million, after a concurrent repurchase of stock and before offering expenses.

Commercial readiness and leadership

Chief commercial officer leads readiness: Susan Rodriguez, Chief Commercial and Strategy Officer who joined in March 2026, leads commercial readiness for a potential launch. Source
Launch preparation tied to hire: Chandler Robinson, CEO, said the leadership addition came as the company prepares for the potential launch of ALXN1840.
CFO named as investor contact: Quan Vu, Chief Financial Officer, is listed as the investor relations contact. Source

Coming up, as management said on 14 May 2026

EASL presentation on May 29: Dr. Valentina Medici is scheduled to present at EASL Congress 2026 in Barcelona on May 29 at 08:45 CEST. Source
FoCus poster in Geneva: FoCus results are to be shown in a poster at the European Academy of Neurology congress in Geneva, June 27-30, 2026. Source
Poujois presentation on June 28: The release names Dr. Aurélia Poujois, a leading Wilson disease authority, to present on June 28 at 12:50 CEST; the venue is not named in that sentence. Source

Figures management reported

Figure	Reported
R&D expenses Source	$3,487,247 in Q1 2026 vs $1,643,375 in Q1 2025
Phase 3 trial readout Source	FoCus analyses presented at AAN 2026, April 2026

Earlier plans management reported on

On track: Company says it remains on track with its NDA submission plans from the prior release. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Monopar Therapeutics Reports First Quarter 2026

Financial Results and Provides Business Updates

Wilmette, IL, May 14, 2026 - Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced first quarter 2026 financial results and provided business updates.

Recent Program Developments

ALXN1840 for Wilson Disease - NDA Submission on Track for Mid-2026

In April 2026, Monopar presented new analyses from the randomized controlled Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline, TMC) at the American Academy of Neurology (AAN) Annual Meeting 2026. The late-breaker oral and poster presentation, titled “Greater clinical benefit with tiomolibdate choline versus standard-of-care in neurologic Wilson disease patients in the Phase 3 FoCus Trial,” demonstrated greater neurologic benefit of ALXN1840 versus standard of care (“SoC”) in Wilson disease patients with neurologic symptoms at baseline.

These results from the FoCus trial will also be presented in a poster at the 12th Congress of the European Academy of Neurology (EAN) in Geneva, Switzerland, June 27-30, 2026. Dr. Aurélia Poujois, MD, PhD, of the Adolphe de Rothschild Foundation Hospital, a leading authority in Wilson disease, will present on June 28 at 12:50 CEST.

Monopar will also present at the European Association for the Study of the Liver (EASL) Congress 2026, a leading global forum for liver disease research. The presentation, titled “Tiomolibdate choline stabilizes liver disease and improves neurological symptoms as well as quality-of-life in treatment-experienced Wilson disease patients,” will be presented by UC Davis Professor Dr. Valentina Medici, MD, MAS, FAASLD. EASL Congress 2026 will take place in Barcelona, Spain, from May 27-30, 2026, with Dr. Medici presenting on May 29 at 08:45 CEST.

The Company remains on track with its plans to submit the New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in mid-2026. Susan Rodriguez, the Company’s Chief Commercial and Strategy Officer who joined in March 2026, is leading commercial readiness activities in preparation for a potential launch.

Financial Results for the First Quarter Ended March 31, 2026, Compared to the First Quarter Ended March 31, 2025

Cash and Net Loss

Cash, cash equivalents and investments as of March 31, 2026, were $137.5 million. Monopar expects its current funds to support operations at least through December 31, 2027, including: (1) regulatory and potential commercial activities for ALXN1840; (2) continued development of MNPR-101 programs; and (3) internal research and development.

Net loss for the first quarter of 2026 was $3.9 million, or $0.46 per share, compared to net loss of $2.6 million, or $0.38 per share, for the first quarter of 2025.

Research and Development (“R&D”) Expenses

R&D expenses for the first quarter of 2026 were $3,487,247 compared to $1,643,375 for the first quarter of 2025. This represents an increase of $1,843,872 primarily attributed to (1) an $825,972 increase in R&D contractor and consulting expenses, (2) a $799,593 increase in R&D personnel expenses including stock-based compensation and (3) a net increase of $218,307 in other R&D expenses.

General and Administrative (“G&A”) Expenses

G&A expenses for the first quarter of 2026 were $1,738,006 compared to $1,578,442 for the first quarter of 2025. This represents an increase of $159,564 primarily attributed to (1) a $134,599 increase in G&A personnel expenses including stock-based compensation and (2) a net increase of $24,965 in other G&A expenses.

Interest Income

Interest income for the first quarter of 2026 was $1,332,203 compared to $596,845 for the first quarter of 2025. The increase is attributed to interest earned on U.S. Treasury securities and commercial paper, and higher bank balances in 2026, due to the net proceeds of approximately $91.9 million from the September 2025 capital raise.

About Monopar Therapeutics Inc.

Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including MNPR-101-Zr (Phase 1) for imaging advanced cancers along with MNPR-101-Lu (Phase 1a) and MNPR-101-Ac (late preclinical) for the treatment of advanced cancers. For more information, and links to SEC filings that contain detailed financial information, visit: https://ir.monopartx.com/quarterly-reports.

Forward-Looking Statements

Forward-looking statements notice

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: that the Company remains on track with its plans to submit the New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in mid-2026; that Susan Rodriguez is leading commercial readiness activities in preparation for a potential launch; and that Monopar expects its current funds to support operations at least through December 31, 2027. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840, including the submission of the NDA to the FDA, and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar’s ability to raise sufficient funds in order for the Company to support continued preclinical, clinical, regulatory, pre-commercial and commercial development of its programs and to make contractual milestone payments, as well as its ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Monopar Therapeutics Inc. Investor Relations Quan Vu Chief Financial Officer vu@monopartx.com

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