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WILMETTE, Ill., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR) (“Monopar” or the “Company”), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the pricing of an underwritten registered offering of 798,655 shares of its common stock at an offering price of $23.79 per share. In addition to the shares sold in the registered offering, Monopar announced the concurrent pricing of a private placement of pre-funded warrants to purchase 882,761 shares of common stock at a purchase price of $23.789 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. The gross proceeds to Monopar from the registered offering and private placement, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be $40 million. The offering is expected to close on or about December 23, 2024, subject to customary closing conditions. Monopar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital. RA Capital Management, Janus Henderson Investors, Adage Capital Partners LP and ADAR1 Capital Management participated in the offering. Piper Sandler & Co. is acting as the sole book-running manager for the offering. The securities in the registered offering are being offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-268935), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 21, 2022, and declared effective on January 4, 2023. A prospectus supplement and accompanying prospectus describing the terms of the registered offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the registered offering, when available, may also be obtained by contacting Piper Sandler & Co. by mail at Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at prospectus@psc.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Monopar Therapeutics Inc. Monopar Therapeutics is a clinical-stage biotechnology company with late-stage ALXN-1840 for Wilson disease, and radiopharma programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced 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: statements regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering and the anticipated use of proceeds therefrom. The forward-looking statements involve risks and uncertainties including, but not limited to: our ability to raise sufficient funds in order for us to support continued clinical, regulatory and commercial development of our programs and to make contractual future milestone payments, as well as our 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; uncertainties related to the regulatory discussions we intend to initiate related to ALXN-1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which we receive marketing approval, and our ability to competitively market any such products as compared to larger pharmaceutical firms; 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 Released December 20, 2024

WILMETTE, Ill., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the first patient ever dosed with MNPR-101-Lu. This novel therapeutic radiopharmaceutical combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR), with the therapeutic radioisotope lutetium-177. uPAR is involved in tumor growth and metastasis, and is found in some of the most aggressive, deadly cancers, including pancreatic, ovarian, triple negative breast, and colorectal cancers. The MNPR-101-Lu intravenous infusion was well-tolerated with no serious adverse reactions reported. This patient, dosed under a compassionate use protocol in the US, has metastatic pancreatic cancer, and prior to dosing, the cancer was imaged using MNPR-101-Zr (a zirconium-89 imaging radioisotope conjugated to MNPR-101) with a PET/CT scanner and showed uPAR expression.“As a result of encouraging biodistribution and dosimetry clinical data we recently reported (link) with our radiodiagnostic, MNPR-101-Zr, we have been eagerly looking forward to initiating treatment of patients with MNPR-101-Lu, hopeful it may provide an important therapeutic benefit to a group of cancer patients very much in need,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.“We are thrilled to have dosed this patient with MNPR-101-Lu, and believe this may be the world’s first dosing of a patient with a uPAR-targeted therapeutic radiopharmaceutical,” said Andrew Cittadine, Monopar’s Chief Operating Officer. Monopar is actively enrolling participants in two Phase 1 clinical studies in Australia, evaluating MNPR-101-Zr for imaging and MNPR-101-Lu for treatment of advanced solid tumors. Further information about the MNPR-101-Lu Phase 1a trial is available at www.ClinicalTrials.gov under study identifier NCT06617169. Further information about the MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial is available at www.ClinicalTrials.gov under study identifier NCT06337084. About Monopar Therapeutics Inc.Monopar Therapeutics is a clinical-stage biotechnology company with ALXN-1840 for Wilson disease which has completed a Phase 3 trial, and radiopharma programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, visit: www.monopartx.com. Forward-Looking StatementsStatements 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: the MNPR-101-Lu intravenous infusion was well-tolerated with no serious adverse reactions reported; that as a result of recently reported encouraging biodistribution and dosimetry clinical data with Monopar’s radiodiagnostic, MNPR-101-Zr, the Company has been eagerly looking forward to initiating treatment and to seeing if the Company can bring an important therapeutic benefit to a group of cancer patients very much in need; and the Company believes this may be the world’s first dosing of a patient with a uPAR-targeted therapeutic radiopharmaceutical. The forward-looking statements involve risks and uncertainties including, but not limited to: that the patient may develop a serious adverse event in the future to MNPR-101-Lu; that radiation dosimetry analytics in the future may not be consistent with the estimated data generated thus far; that Monopar may not find enough patients to successfully enroll its MNPR-101-Lu therapeutic study; that the Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr may not yield consistently satisfactory results; that future preclinical or clinical data may not be as promising as the data to date; that MNPR-101-Zr and/or MNPR-101-Lu may cause unexpected serious adverse effects or fail to be effective against the cancer tumors in humans; that the trials could result in a clinical hold should there be a Serious Adverse Event; Monopar’s ability to raise sufficient funds in order for the Company to support continued clinical, regulatory and commercial development of its programs and to make contractual future milestone payments, as well as its ability to further raise additional funds in the future to support any future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; uncertainties related to the regulatory discussions that Monopar intends to initiate related to ALXN-1840 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; 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