MNPR Monopar Therapeutics Inc.

4.8
-0.08  -2%
Previous Close 4.88
Open 4.86
52 Week Low 4.28
52 Week High 48
Market Cap $51,534,701
Shares 10,736,396
Float 2,942,460
Enterprise Value $92,541,107
Volume 6,939
Av. Daily Volume 18,005
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Drug Pipeline

Drug Stage Notes
Camsirubicin
Soft tissue sarcoma
Phase 2
Phase 2
Phase 2 enrolment to commence late 2020/early 2021.
Validive
Oral mucositis
Phase 2/3
Phase 2/3
Phase 2b/3 trial to be initiated before end of 2020.

Latest News

  1. Validive® Phase 2b/3 Clinical Trial on Track to Start Before Year-end
    Issuance of New Patents For Validive
    Camsirubicin Phase 2 Clinical Trial to Start Late 2020/Early 2021

    WILMETTE, Ill., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced third quarter 2020 financial results and business update.

    Third Quarter Business Update

    Lead Product Candidate Validive

    • Monopar's Phase 2b/3 clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing…

    Validive® Phase 2b/3 Clinical Trial on Track to Start Before Year-end

    Issuance of New Patents For Validive

    Camsirubicin Phase 2 Clinical Trial to Start Late 2020/Early 2021

    WILMETTE, Ill., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced third quarter 2020 financial results and business update.

    Third Quarter Business Update

    Lead Product Candidate Validive

    • Monopar's Phase 2b/3 clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy for oropharyngeal cancer (OPC) is on track to commence before year-end. There currently is no FDA-approved prevention or treatment for radiation-induced SOM.

    • The U.S. Patent and Trademark Office allowed patent claims for Monopar's lead product candidate, Validive, covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy." The recently issued patents would provide protection should Monopar determine in the future to conduct additional Validive development and commercialization activities related to adverse side effects of chemotherapy beyond OPC.

    Camsirubicin

    • The Phase 2 clinical trial of camsirubicin is anticipated to begin at the end of 2020 or in early 2021. Monopar has partnered with Grupo Español de Investigación en Sarcomas (GEIS), which will lead the multi-country, randomized, open-label Phase 2 clinical trial evaluating camsirubicin head-to-head against standard-of-care doxorubicin in patients with advanced soft tissue sarcoma (ASTS).

    • The trial will begin with a dose escalation "run-in" prior to the randomization portion of the trial. The primary endpoint of the trial will be progression-free survival, with secondary endpoints including overall survival, response rate, and incidence of treatment-emergent adverse events.

    MNPR-101

    • Forward progress was made on the Monopar/NorthStar collaboration focused on developing a novel treatment for severe COVID-19 by partnering with 1) IsoTherapeutics Group, LLC to develop and manufacture radioimmunotherapeutics targeting uPAR (uPRITs), 2) Aragen Bioscience, Inc. to perform studies aimed at selecting a lead candidate uPRIT to advance into IND-enabling development, and 3) The University of Texas Health Science Center at Tyler and its Texas Lung Injury Institute (TLII) to perform in vitro and in vivo studies through the TLII and to participate in the clinical development of uPRITs.

    Third Quarter Summary Financial Results

    Results for the Third Quarter Ended September 30, 2020 Compared to the Third Quarter Ended September 30, 2019

    Cash and Net Loss

    Cash and cash equivalents as of September 30, 2020 were $18.0 million, which includes $6.7 million of net proceeds raised in the third quarter of 2020 under the Company's Capital on Demand® Sales Agreement with JonesTrading Institutional Services, at an average gross price per share of $9.66. Monopar anticipates that its current cash and cash equivalents will fund the Company's planned operations through 2021, including the initiation and completion of the Phase 2b portion of its Validive clinical trial and the initiation of the Phase 3 portion, the funding of the initiation of the GEIS Phase 2 camsirubicin clinical trial, and continuation of the development of the COVID-19 uPRIT program. The Company will need to raise funds or engage a partner to complete the Validive Phase 3 clinical trial. Net loss for the third quarter of 2020 was $1.6 million or $0.15 per share compared to net loss of $0.7 million or $0.08 per share for the third quarter of 2019.

    Research and Development (R&D) Expenses

    R&D expenses for the third quarter of 2020 were $1.2 million, compared to $0.2 million, for the third quarter of 2019. This increase of $1.0 million is primarily attributed to increases in expenses for the planning of the camsirubicin Phase 2 clinical trial and manufacturing expenses of $0.4 million, increases in the Validive clinical trial planning and manufacturing expenses of $0.3 million, and increases in R&D personnel salaries and benefits, including equity grants and salaries and benefits for three new R&D personnel of $0.3 million.

    General and Administrative (G&A) Expenses

    G&A expenses for the third quarter of 2020 were $0.4 million, compared to $0.5 million, for the third quarter of 2019.

    About Monopar Therapeutics

    Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. The Company's pipeline consists of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; and a preclinical stage uPAR targeted antibody, MNPR-101, for advanced cancers and severe COVID-19. For more information, and links to SEC filings that contain detailed financial information, visit: https://ir.monopartx.com/quarterly-reports.

    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 Monopar's ability to commence its Phase 2b/3 clinical trial of Validive before the end of 2020, whether the recently issued patents would provide protection for development and commercialization in potential future indications, GEIS's ability to begin the camsirubicin Phase 2 clinical trial at the end of 2020 or early 2021, whether the Monopar/NorthStar collaboration will be successful in developing a uPRIT to treat severe COVID-19 with its development partners and whether the Company's current cash and cash equivalents will fund the Company's planned operations through 2021. The forward-looking statements involve risks and uncertainties including, but not limited to, not commencing the Validive Phase 2b/3 clinical trial or the Phase 2 GEIS-sponsored camsirubicin clinical trial within expected timeframes, if at all, our ability to commence the Validive Phase 3 portion without additional fundraising or a development partnership, to raise sufficient funds or engage a partner to complete the Phase 3 clinical trial, and not successfully developing a COVID-19 uPRIT with the Company's development collaborators. 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

    Kim R. Tsuchimoto

    Chief Financial Officer

    Follow Monopar on social media for updates: 

    Twitter: @MonoparTx LinkedIn: Monopar Therapeutics

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  2. WILMETTE, Ill., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced a series of recently issued patents for its Phase 2b/3 clinical-stage lead product candidate, Validive (clonidine HCl mucobuccal tablet). These patents, including U.S. Patent No. 10,675,271, provide claims covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy".

    "These recently issued patents broaden the patent protection for the use of Validive in cancer patients," said Andrew Mazar…

    WILMETTE, Ill., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced a series of recently issued patents for its Phase 2b/3 clinical-stage lead product candidate, Validive (clonidine HCl mucobuccal tablet). These patents, including U.S. Patent No. 10,675,271, provide claims covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy".

    "These recently issued patents broaden the patent protection for the use of Validive in cancer patients," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "Specifically, they provide protection into 2035 for the potential ability of Validive to prevent or treat common chemotherapy-associated side effects such as gastrointestinal disorders, respiratory disorders, fatigue and headache."



    "According to the U.S. Centers for Disease Control and Prevention, about 650,000 cancer patients receive chemotherapy each year in the U.S., and most of these experience side-effects as a result of their treatment," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "These patents expand the potential use of Validive beyond the earlier allowed claims for the prevention of oral mucositis in patients receiving chemoradiotherapy. This in turn serves to advance Monopar's mission to develop treatments that improve quality of life in cancer patients undergoing treatment."



    Monopar is currently developing Validive for the prevention of chemoradiation-induced severe oral mucositis in oropharyngeal cancer patients (OPC), an indication which currently has no FDA approved treatment. Monopar's Phase 2b/3 clinical trial in OPC patients is on track to start before year-end. The recently issued patents would provide protection should Monopar determine in the future to conduct additional Validive development activities related to adverse side effects of chemotherapy beyond OPC.

    About Monopar Therapeutics Inc.

    Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. Monopar's pipeline consists of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; and a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19. 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 Monopar's ability to remain on track to start the Validive Phase 2b/3 clinical trial before year-end, the potential for Validive to prevent or treat common chemotherapy-associated side effects such as gastrointestinal disorders, respiratory disorders, fatigue and headache, the potential for Validive to prevent oral mucositis in patients receiving chemoradiotherapy, the advancement of Monopar's mission to develop treatments that improve quality of life in cancer patients undergoing treatment, and that Validive patents will strengthen and provide protection for Monopar's intellectual property portfolio. The forward-looking statements involve risks and uncertainties including, but not limited to the requirement for Monopar to raise additional capital or engage a partner in order to complete future clinical development of Validive as well as potential commercialization (including if Monopar determines to expand currently contemplated development activities to other adverse side effects of chemotherapy beyond OPC), and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of 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.

    CONTACTS:

    Monopar Therapeutics Inc.

    Investor Relations:

    Kim R. Tsuchimoto

    Chief Financial Officer

    Follow Monopar on social media for updates:

    Twitter - @MonoparTx   LinkedIn - Monopar Therapeutics  

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  3. WILMETTE, Ill., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) today announced that Chandler D. Robinson, MD, Chief Executive Officer, will present a corporate update at the H.C. Wainwright 22nd Annual Global Investment Conference, Healthcare & Biotech Track. The conference will be held virtually.

    Presentation Details:

    Date: Wednesday, September 16, 2020

    Time: 1:30 PM EDT

    Location: Virtual

    https://hcwevents.com/

    For more information, please contact investor relations at .

    About Monopar Therapeutics Inc. 
    Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer…

    WILMETTE, Ill., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) today announced that Chandler D. Robinson, MD, Chief Executive Officer, will present a corporate update at the H.C. Wainwright 22nd Annual Global Investment Conference, Healthcare & Biotech Track. The conference will be held virtually.

    Presentation Details:

    Date: Wednesday, September 16, 2020

    Time: 1:30 PM EDT

    Location: Virtual

    https://hcwevents.com/

    For more information, please contact investor relations at .

    About Monopar Therapeutics Inc. 

    Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. Monopar's pipeline consists of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; and a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19. For more information, visit: www.monopartx.com

    About H.C. Wainwright 22nd Annual Global Investment Conference

    The H.C. Wainwright 22nd Annual Global Investment Conference featuring a Healthcare & Biotech track, will be a virtual event which includes keynote speakers, presenting companies, investor one-on-one meetings, networking opportunities and an evening of virtual entertainment. The event will occur from September 14-16, 2020. For more information on the event, visit https://hcwevents.com/.

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  4. WILMETTE, Ill., BELOIT, Wis. and TYLER, Texas, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) and NorthStar Medical Radioisotopes, LLC, which are jointly developing urokinase plasminogen activator receptor targeted radio-immuno-therapeutics (uPRITs) for the potential treatment of patients with severe COVID-19, today announced a collaboration with The University of Texas Health Science Center at Tyler (UTHSCT) and its Texas Lung Injury Institute (TLII). UTHSCT is planning to perform in vitro and in vivo studies through the TLII and participate in the clinical development of uPRITs for the treatment of severe COVID-19 through its medical center.

    The University of Texas Health Science Center at Tyler has taken a leading…

    WILMETTE, Ill., BELOIT, Wis. and TYLER, Texas, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) and NorthStar Medical Radioisotopes, LLC, which are jointly developing urokinase plasminogen activator receptor targeted radio-immuno-therapeutics (uPRITs) for the potential treatment of patients with severe COVID-19, today announced a collaboration with The University of Texas Health Science Center at Tyler (UTHSCT) and its Texas Lung Injury Institute (TLII). UTHSCT is planning to perform in vitro and in vivo studies through the TLII and participate in the clinical development of uPRITs for the treatment of severe COVID-19 through its medical center.

    The University of Texas Health Science Center at Tyler has taken a leading role in the fight against COVID-19. UTHSCT was recently awarded a $2 million National Institutes of Health (NIH) grant to investigate the potential use of convalescent plasma from recovered COVID-19 patients to prevent worsening lung symptoms, or death, in hospitalized COVID-19 patients. Enrollment for this study has already started. UTHSCT is also home to one of the leading laboratories in the world studying the role of urokinase plasminogen activator receptor (uPAR) in acute lung injury and respiratory distress, led by renowned pulmonologist Steven Idell, MD, PhD.

    "Given their expertise in uPAR, acute lung injury, as well as the treatment of COVID-19 patients, UTHSCT and Dr. Steven Idell are the ideal partners for the preclinical and clinical development of uPRITs for severe COVID-19," said Andrew Mazar, PhD, chief scientific officer of Monopar.

    "Dr. Idell and UTHSCT have extensive experience with cell-based and animal models of respiratory distress, along with COVID-19 clinical trials. These resources and experiences should help accelerate the development of uPRITs," said James T. Harvey, PhD, senior vice president and chief science officer of NorthStar.

    "We are excited to be working with Monopar and NorthStar on developing a uPRIT, an innovative and clinically promising treatment for severe COVID-19 patients," said Dr. Steven Idell, senior vice president for research and dean of the School of Medical Biological Sciences at UTHSCT.

    The aim of this partnership is to evaluate uPRIT candidates in in vitro and in vivo models to facilitate the selection and IND-enabling development of a clinical candidate that could then move into first-in-human trials in patients with severe COVID-19 at UTHSCT.

    About Monopar Therapeutics Inc.

    Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. Monopar's pipeline consists of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; and a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19. For more information, visit: www.monopartx.com.

    About NorthStar Medical Radioisotopes, LLC

    NorthStar Medical Radioisotopes is a global innovator in the production and distribution of radioisotopes used for medical imaging and therapeutic purposes. NorthStar is a company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company's first product is the RadioGenix® System (technetium Tc 99m generator), an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in February 2018. For more information, visit: www.northstarnm.com.

    About The University of Texas Health Science Center at Tyler

    As part of the world-renowned University of Texas System, The University of Texas Health Science Center at Tyler (UTHSCT) is a graduate school providing programs for those seeking careers in the medical field. UTHSCT offers Master of Science in Biotechnology, Master of Public Health and Master of Health Administration degrees, as well as residency programs for medical school graduates in family medicine, general surgery, internal medicine, occupational medicine, rural family medicine, general psychiatry and rural psychiatry. Psychology internships and fellowships are also available. Graduate students, medical residents and other medical professionals-in-training develop marketable skills and qualifications to excel in the medical field as they learn alongside innovative scientists, physicians and other healthcare experts at UTHSCT and UT Health East Texas, a 10-hospital health system throughout East Texas. Led by Kirk A. Calhoun, MD, FACP, the university will soon become the home to the first medical school in East Texas, pending regulatory and accreditation approval. For more information, visit www.uthct.edu.

    About the TLII

    Housed within UTHSCT, the Texas Lung Injury Institute (TLII) was created in 2004 to provide state-of-the-art research that advances our understanding about the pathogenesis of lung disease and its treatment. For more information, visit: https://www.uthct.edu/texas-lung-injury-institute.

    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 Monopar's and NorthStar's ability to develop uPRITs for the potential treatment of patients with severe COVID-19; UTHSCT's ability to perform in vitro and in vivo studies through the TLII and participate in the clinical development of uPRITs for the treatment of severe COVID-19 through its medical center; UTHSCT's ability to accelerate the development of uPRITs; uPRITs ability to be an innovative and clinically promising treatment for severe COVID-19 patients; and that uPRIT candidates in in vitro and in vivo models can facilitate the selection and IND-enabling development of a clinical candidate that could then move into first-in-human trials in patients with severe COVID-19 at UTHSCT. The forward-looking statements involve risks and uncertainties including, but not limited to, the lack of any clinical activities to date with respect to MNPR-101, the requirement for additional capital to complete preclinical and clinical development, potential for commercialization, not being able to couple MNPR-101 to a therapeutic radioisotope, the conjugate not being able to kill aberrantly activated cytokine-producing immune cells, the conjugate not being able to use uPAR to gain entry into these cells and release this cytotoxic payload to kill these cells while sparing normal tissue, not being able to ensure volumes of this radioisotope can be manufactured and scaled up to meet potential demand, uncertainties about levels of demand if and when a treatment is available for commercialization and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of 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, NorthStar and TLII undertake 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, NorthStar's and TLII's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

    CONTACTS:

    For Monopar Therapeutics Inc.

    Investor Relations:

    Kim R. Tsuchimoto

    Chief Financial Officer

    For NorthStar Medical Radioisotopes, LLC

    Investor Relations:

    Paul Estrem

    Senior Vice President and Chief Financial Officer

    For The University of Texas Health Science Center at Tyler

    Media Contact:

    Janet Ragland

    Senior Media Specialist



    (903) 241-5109

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  5. WILMETTE, Ill. and BELOIT, Wis. and MORGAN HILL, Calif., Aug. 19, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) (Wilmette, IL) and NorthStar Medical Radioisotopes, LLC (Beloit, WI), who are collaborating on the development of urokinase plasminogen activator receptor targeted radio-immuno-therapeutics (uPRITs) for the potential treatment of patients with severe COVID-19, today announced a partnership with Aragen Bioscience, Inc. (Morgan Hill, CA),  a leading contract research organization focused on accelerating preclinical biologics product development. Aragen will perform studies aimed at selecting a lead candidate uPRIT to advance into IND-enabling development for severe COVID-19.

    "Aragen's expertise in this specific…

    WILMETTE, Ill. and BELOIT, Wis. and MORGAN HILL, Calif., Aug. 19, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) (Wilmette, IL) and NorthStar Medical Radioisotopes, LLC (Beloit, WI), who are collaborating on the development of urokinase plasminogen activator receptor targeted radio-immuno-therapeutics (uPRITs) for the potential treatment of patients with severe COVID-19, today announced a partnership with Aragen Bioscience, Inc. (Morgan Hill, CA),  a leading contract research organization focused on accelerating preclinical biologics product development. Aragen will perform studies aimed at selecting a lead candidate uPRIT to advance into IND-enabling development for severe COVID-19.

    "Aragen's expertise in this specific area of preclinical research should accelerate selection of a lead uPRIT based on the MNPR-101 antibody scaffold to advance toward the clinic," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.

    "We are pleased to partner with Aragen on this important phase of the uPRIT program," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. "Using rigorous criteria to select the uPRIT candidate to advance into IND-enabling studies is a crucial part of our COVID-19 program."

    "uPRIT has great therapeutic potential for severe COVID-19 patients," said Axel Schleyer, PhD, MBA, Chief Executive Officer of Aragen. "We are excited to partner with Monopar and NorthStar on this important endeavor."

    The aim of this partnership is to identify the uPRIT with the optimal urokinase plasminogen activator receptor binding profile, enabling selective delivery of a cytotoxic radioisotope to just those aberrantly activated immune cells that produce the "cytokine storm" that causes severe lung injury, multiple organ damage, and death in severe COVID-19 patients.

    About Monopar Therapeutics Inc.

    Monopar Therapeutics is a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients. Monopar's pipeline consists of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the treatment of advanced soft tissue sarcoma; and a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19. For more information, visit: www.monopartx.com.

    About NorthStar Medical Radioisotopes, LLC

    NorthStar Medical Radioisotopes is a global innovator in the production and distribution of radioisotopes used for medical imaging and therapeutic purposes. NorthStar is a company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company's first product is the RadioGenix® System (technetium Tc 99m generator), an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in February 2018. For more information, visit: www.northstarnm.com.

    About Aragen Bioscience, Inc.

    Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of in vitro and in vivo services for the discovery, cell line development, production, characterization, activity and efficacy assessment and development of biologic and diagnostic products. For more information, visit: www.aragenbio.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 Aragen's ability to select a lead candidate uPRIT, based on the MNPR-101 antibody scaffold, into IND-enabling development and toward the clinic for severe COVID-19, that uPRIT has great therapeutic potential for severe COVID-19 patients, and the partnership's ability to identify the uPRIT with the optimal binding profile that enables selective delivery of a cytotoxic radioisotope to just those aberrantly activated immune cells that produce the "cytokine storm" that causes severe lung injury, multiple organ damage, and death in severe COVID-19 patients. The forward-looking statements involve risks and uncertainties including, but not limited to, the lack of any clinical activities to date with respect to MNPR-101, the requirement for additional capital to complete preclinical and clinical development, potential for commercialization, not being able to couple MNPR-101 to a therapeutic radioisotope, the conjugate not being able to kill aberrantly activated cytokine-producing immune cells, the conjugate not being able to use uPAR to gain entry into these cells and release this cytotoxic payload to kill these cells while sparing normal tissue, not being able to ensure volumes of this radioisotope can be manufactured and scaled up to meet potential demand, uncertainties about levels of demand if and when a treatment is available for commercialization and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of 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, NorthStar and Aragen undertake 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, NorthStar's, and Aragen's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

    CONTACTS:

    For Monopar Therapeutics Inc.:

    Investor Relations:

    Kim R. Tsuchimoto

    Chief Financial Officer

    For NorthStar Medical Radioisotopes, LLC.:

    Investor Relations:

    Paul Estrem

    Senior Vice President and Chief Financial Officer

    For Aragen Bioscience, Inc.:

    David Lustig

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