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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): August 14, 2024
 
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 August 14, 2024, Monopar Therapeutics Inc. (Monopar) issued a press release announcing the successful dosing of the first patient in its open-label Phase 1 imaging and dosimetry clinical trial of its uPAR-targeted imaging radiopharmaceutical MNPR-101-Zr.
 
The press release is furnished as Exhibit 99.1 to this report and incorporated herein by reference.
 
Item 9.01 Financial Statements and Exhibits
 
Exhibit No.  
 
Description
99.1
 
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: August 14, 2024
By:
/s/ Karthik Radhakrishnan
 
 
Name:
Karthik Radhakrishnan
 
 
Title:
Chief Financial Officer and Director
 
 
 

Exhibit 99.1

 

monologo.jpg

 

 

 

 

Monopar Announces Initial Data for First Patient Dosed in Radiopharma Phase 1 Clinical Trial of MNPR-101-Zr

 

WILMETTE, Ill., August 14, 2024 — Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced the successful dosing of the first patient in its open-label Phase 1 imaging and dosimetry clinical trial of its uPAR-targeted imaging radiopharmaceutical MNPR-101-Zr.

 

MNPR-101-Zr was well-tolerated with no serious adverse reactions reported through the last imaging timepoint and the corresponding initial safety review. Preliminary analysis of MNPR-101-Zr’s pharmacokinetics and biodistribution suggests the low radiation dose to healthy tissue aligns with what was anticipated based on the previously presented MNPR-101-Zr preclinical biodistribution data. Dosimetry analysis showed absorbed organ doses were well below accepted safety limits; for example, the radiation dose to red bone marrow was about 14 mGy, which is around 150 times less than the generally accepted limit of 2-to-3 Gy. No unanticipated or excessive uptake of MNPR-101-Zr was observed in any critical organs through the end of the subject’s imaging period. The patient has metastatic disease from a cancer type not known for high uPAR expression. The study aims to include several patients with cancers known to express high levels of uPAR to gain insight into MNPR-101-Zr’s tumor uptake profile, in addition to patients with cancers of unknown uPAR expression.

 

“The safety profile observed thus far, along with the encouraging biodistribution data, gives us an increased confidence as we continue to advance our Phase 1 study and prepare to launch our therapeutic study,” said Andrew Cittadine, Monopar’s Chief Operating Officer.

 

Further information about the ongoing MNPR-101-Zr trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.

 

 

 

About Monopar Therapeutics Inc.

 

Monopar Therapeutics is a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, including Phase 1-stage MNPR-101-Zr for imaging advanced cancers and late preclinical-stage MNPR-101 radio-immuno-therapeutic (RIT) for the treatment of advanced cancers, as well as early development programs against solid cancers. For more information, visit: www.monopartx.com.

 

Forward-Looking Statements

 

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 study aims to enroll several patients with cancers known to express high levels of uPAR to gain insight into MNPR-101-Zr’s tumor uptake profile, in addition to patients with cancers of unknown uPAR expression; and that the safety profile observed thus far, along with the encouraging biodistribution data, gives Monopar an increased confidence as it continues to advance its Phase 1 study and launch its therapeutic study. The forward-looking statements involve risks and uncertainties including, but not limited to: the Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr may not yield satisfactory results, if at all; that future preclinical or clinical data will not be as promising as the data to date; that MNPR-101-Zr and/or MNPR-101 conjugated to a therapeutic radioisotope may cause unexpected serious adverse effects or fail to image or be effective against the cancer tumors in humans; that Monopar may not advance its Phase 1 study and launch its therapeutic study; that Monopar may not regain compliance with Nasdaq listing standards within any extended Nasdaq deadline; that Monopar may expend available funds sooner than anticipated or require additional funding due to change in circumstances or unanticipated events; 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.

 

 

CONTACT:  

 

Monopar Therapeutics Inc.

Investor Relations

  

Karthik Radhakrishnan  

Chief Financial Officer  

karthik@monopartx.com

 

Follow Monopar on social media for updates:

Twitter: @MonoparTx  LinkedIn: Monopar Therapeutics

 

 
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Document And Entity Information
Aug. 14, 2024
Document Information [Line Items]  
Entity, Registrant Name MONOPAR THERAPEUTICS INC.
Document, Type 8-K
Document, Period End Date Aug. 14, 2024
Entity, Incorporation, State or Country Code DE
Entity, File Number 001-39070
Entity, Tax Identification Number 32-0463781
Entity, Address, Address Line One 1000 Skokie Blvd.
Entity, Address, Address Line Two Suite 350
Entity, Address, City or Town Wilmette
Entity, Address, State or Province IL
Entity, Address, Postal Zip Code 60091
City Area Code 847
Local Phone Number 388-0349
Title of 12(b) Security Common Stock, $0.001 par value
Trading Symbol MNPR
Security Exchange Name NASDAQ
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity, Emerging Growth Company true
Entity, Ex Transition Period true
Amendment Flag false
Entity, Central Index Key 0001645469

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