MNPR files exhibits for ALXN1840 long-term neurological data at ANA meeting

Rhea-AI Filing Summary

Monopar Therapeutics reported that it presented new long-term neurological efficacy and safety data for its investigational therapy ALXN1840 (tiomolybdate choline) for Wilson disease at the 150th American Neurological Association Annual Meeting held on September 14-15, 2025. The company furnished a press release, a poster presentation, and an oral presentation as Exhibits 99.1, 99.2, and 99.3 to the report and incorporated them by reference. The filing announces the dissemination of these materials but does not include detailed efficacy or safety results within the 8-K text itself. The disclosure is intended to satisfy Regulation FD requirements by making the presentations and release publicly available.

Positive

• Long-term neurological data for ALXN1840 were publicly presented at a major neurology meeting
• Multiple disclosure formats furnished (press release, poster, oral presentation) as Exhibits 99.1-99.3
• Regulation FD-compliant dissemination of clinical information at the September 14-15, 2025 ANA meeting

Negative

• The 8-K text does not include specific efficacy or safety results, requiring review of exhibits for material details
• No patient numbers, endpoints, or adverse event rates are disclosed within the filing itself
• No commentary on next regulatory or development steps is provided in the filing

Insights

Clinical Development Expert

New long-term neurological data were presented publicly; results are in attached exhibits.

The company reported presentation of long-term neurological efficacy and safety data for ALXN1840 at the 150th ANA meeting on September 14-15, 2025. The filing notes a press release, poster, and oral presentation were furnished as exhibits, which is the primary channel for sharing clinical detail.

The 8-K text itself contains no numerical efficacy or safety endpoints, so assessment of clinical impact requires review of the attached exhibits. Near-term monitoring should focus on the exhibits for specific endpoints, patient numbers, and adverse event rates disclosed.

Equity/Investor Relations Analyst

Public presentation increases information flow but the filing provides no direct trial results.

Making long-term data publicly available at a major neurology meeting can influence investor perception and liquidity for MNPR. The filing confirms distribution of materials as Exhibits 99.1-99.3, which investors should review to quantify commercial and regulatory implications.

Because the 8-K omits concrete metrics, investors should examine the exhibits for patient counts, magnitude of neurological benefit, safety signals, and any language about next development steps or regulatory interactions in the coming months.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 15, 2025

MONOPAR THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

Delaware		001-39070		32-0463781
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

1000 Skokie Blvd., Suite 350, Wilmette, IL		60091
(Address of principal executive offices)		(Zip Code)

(847) 388-0349

Registrant’s telephone number, including area code

N/A

(Former name or former address, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		MNPR		The Nasdaq Stock Market LLC (Nasdaq Capital Market)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01  Regulation FD Disclosure. 

On September 14, 2025, Monopar Therapeutics Inc. ("Monopar") issued a press release announcing the presentation of new data on the long-term neurological efficacy and safety of its investigational therapy ALXN1840 (tiomolybdate choline) for Wilson disease at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025.

The press release, poster presentation and oral presentation are furnished as Exhibit 99.1, 99.2 and 99.3, respectively, and incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits

Exhibit No.		Description
99.1		Press Release Dated September 14, 2025
99.2		Poster Presentation on the Long-Term Neurological Efficacy and Safety Data for ALXN1840 in Wilson Disease
99.3		Oral Presentation on the Long-Term Neurological Efficacy and Safety Data for ALXN1840 in Wilson Disease
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Monopar Therapeutics Inc.
Date: September 15, 2025	By:	/s/ Quan Vu
	Name:	Quan Vu
	Title:	Chief Financial Officer

FAQ

What did Monopar (MNPR) announce in this 8-K?

Monopar announced it presented new long-term neurological efficacy and safety data for ALXN1840 at the 150th ANA Annual Meeting on September 14-15, 2025, and furnished a press release, poster, and oral presentation as Exhibits 99.1-99.3.

Does the 8-K include trial results or numerical data for ALXN1840?

No. The 8-K states that materials were furnished as exhibits but does not include specific efficacy endpoints, patient numbers, or safety statistics in the filing text.

Where can investors find the detailed data referenced in the filing?

The filing indicates the detailed information is included in Exhibits 99.1 (press release), 99.2 (poster), and 99.3 (oral presentation) which are incorporated by reference and should be reviewed for results.

When and where were the ALXN1840 results presented?

The long-term neurological efficacy and safety data were presented at the 150th American Neurological Association Annual Meeting on September 14-15, 2025.

Does this filing indicate any regulatory decisions or next clinical steps?

No. The 8-K does not disclose regulatory decisions, approvals, or specific next steps; it only states that presentations and a press release were furnished as exhibits.