1. WILMETTE, Ill., March 30, 2021 (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 the publication of a peer-reviewed study titled "Engineered Antibody Fragment against the Urokinase Plasminogen Activator for Fast Delineation of Triple-Negative Breast Cancer by Positron Emission Tomography." Urokinase plasminogen activator (uPA) is an established biomarker in current breast cancer clinical practice guidelines and its presence is used to select appropriate drug treatment. This study demonstrates the potential to identify breast cancers with uPA…

    WILMETTE, Ill., March 30, 2021 (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 the publication of a peer-reviewed study titled "Engineered Antibody Fragment against the Urokinase Plasminogen Activator for Fast Delineation of Triple-Negative Breast Cancer by Positron Emission Tomography." Urokinase plasminogen activator (uPA) is an established biomarker in current breast cancer clinical practice guidelines and its presence is used to select appropriate drug treatment. This study demonstrates the potential to identify breast cancers with uPA overexpression and monitor uPA activity during treatment using PET imaging and Monopar's uPA antibody fragment radiotracer. Monopar has a panel of proprietary antibodies and antibody fragments to uPA and its receptor uPAR (such as MNPR-101).

    uPA and its receptor uPAR work together to drive aggressive tumor invasion, leading to metastasis, morbidity, and mortality in breast and other cancers. However, uPA is difficult to measure and currently requires a substantial amount of fresh frozen tissue. Monopar's antibody fragment (ATN-291 F(ab')2) conjugated to a copper radiotracer enabled rapid PET visualization of tumors with uPA overexpression in a human breast cancer model in mice. PET imaging may expand the current application of uPA as a breast cancer biomarker and enable the monitoring of tumor uPA expression during treatment.

    "The publication demonstrates the potential utility of Monopar's uPA antibody fragments as imaging agents in a model of aggressive triple negative breast cancer," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar and a co-author of the study. "Same-day PET imaging may guide treatment decisions for breast cancer, and potentially other solid cancers, given the established role of uPA in this disease."

    "We are pleased with the results of this peer-reviewed study," said Chandler Robinson, MD, Chief Executive Officer of Monopar, "and we look forward to exploring the potential of our versatile panel of uPA/uPAR targeted monoclonal antibodies in cancer imaging, cancer treatment, and other possible applications."

    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 the potential for same-day PET imaging of breast cancer, including aggressive triple negative breast cancer, using Monopar's uPA-targeted antibody fragment (ATN-291 F(ab')2), whether PET imaging may expand the current application of uPA as a biomarker for breast cancer and enable the monitoring of tumor uPA expression during treatment, and the potential of Monopar's versatile panel of uPA/uPAR targeted monoclonal antibodies in cancer imaging, cancer treatment, and other possible applications. The forward-looking statements involve risks and uncertainties including, but not limited to: the lack of any clinical activities to date with respect to Monopar's uPA targeted antibody fragments; that Monopar's MNPR-101 and related compound preclinical development activities to date have been focused on the treatment of cancers and not imaging medical devices; the requirement for additional capital to complete preclinical and clinical development of a medical device utilizing Monopar's uPA antibody fragments, and if successful, commercialization; if funding is available, not being able to successfully develop Monopar's antibody fragments for use as uPA imaging agents in triple negative breast cancer detection, or any other uses or indications; not being able to ensure volumes of ATN-291 F(ab') 2) conjugates or its derivatives can be manufactured and scaled up to meet potential demand; uncertainties about levels of demand if and when a medical device is available for commercialization and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of medical devices. 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

    Kim R. Tsuchimoto

    Chief Financial Officer

    Follow Monopar on social media for updates:

    Twitter: @MonoparTx

    LinkedIn: Monopar Therapeutics



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  2. Validive® Phase 2b/3 VOICE Clinical Trial Commenced
    Camsirubicin Phase 2 Clinical Trial Anticipated to Start in Q2 2021
    MNPR-101-Conjugate Data Published in European Journal of Cancer

    WILMETTE, Ill., March 25, 2021 (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 fourth quarter and full-year 2020 financial results and recent business updates.

    Recent Business Updates

    Lead Product Candidate Validive

    • Monopar's Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention…

    Validive® Phase 2b/3 VOICE Clinical Trial Commenced

    Camsirubicin Phase 2 Clinical Trial Anticipated to Start in Q2 2021

    MNPR-101-Conjugate Data Published in European Journal of Cancer

    WILMETTE, Ill., March 25, 2021 (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 fourth quarter and full-year 2020 financial results and recent business updates.

    Recent Business Updates

    Lead Product Candidate Validive

    • Monopar's Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.

    • The U.S. Patent and Trademark Office (USPTO) allowed patent claims for Validive, covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy." This patent expands coverage on the potential use of Validive in cancer patients beyond earlier allowed claims specifically for the prevention of oral mucositis in patients receiving CRT.

    Camsirubicin

    • The Phase 2 clinical trial of camsirubicin is anticipated to commence enrollment in the second quarter of 2021. Monopar's clinical development collaborator, Grupo Español de Investigación en Sarcomas (GEIS), 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 an open-label 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.

    • The USPTO allowed patent claims covering compositions of matter (2-pyrrilino camsirubicin) for a novel family of camsirubicin analogs. This patent expires in 2038, not including any patent term extensions. The patent broadens Monopar's camsirubicin portfolio and covers a pipeline of compounds designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin along with the potent broad-spectrum antitumor activity of doxorubicin. Preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active against doxorubicin-resistant tumor cells which may enable use in cancer types beyond those treatable with camsirubicin.

    MNPR-101 and Related Compounds

    • Progress continues in the Monopar/NorthStar Medical Radioisotopes collaboration focused on developing a novel treatment for severe COVID-19 by partnering with (i) IsoTherapeutics Group, LLC to develop and manufacture humanized urokinase plasminogen activator receptor radioimmunotherapeutics (uPRITs), (ii) Aragen Bioscience, Inc. which performed studies to enable the selection of a lead candidate uPRIT along with back-up candidates to potentially advance into IND-enabling development, and (iii) The University of Texas Health Science Center at Tyler and its Texas Lung Injury Institute (TLII) to perform in vitro and in vivo studies and to participate in the clinical development of uPRITs.

    • The European Journal of Cancer published a peer-reviewed preclinical study which shows the potential utility of MNPR-101 conjugates as uPAR imaging agents to improve surgical outcomes in bladder cancer and for surveillance post-resection.

    Results for the Fourth Quarter and Year Ended December 31, 2020 Compared to the Fourth Quarter and Year Ended December 31, 2019

    Cash and Net Loss

    Cash and cash equivalents as of December 31, 2020 were $16.7 million. Monopar anticipates that its current cash and cash equivalents, which includes an additional $10.9 million of net proceeds raised in the first quarter of 2021 under the Company's Capital on Demand® Sales Agreement with JonesTrading Institutional Services, at an average gross price per share of $10.20, will fund the Company's planned operations at least through March 2022. Planned operations include funding and completing the Phase 2b portion of the Validive "VOICE" clinical trial and commencing of the Phase 3 portion; the funding of the run-in portion of the GEIS Phase 2 camsirubicin clinical trial; and continuation of the development of the COVID-19 uPRIT program along with other MNPR-101 related compounds. The Company plans to raise additional funds or engage a partner in the next 12 months to complete the VOICE clinical program and continue the GEIS camsirubicin clinical trial beyond the run-in phase. 

    Net loss for the fourth quarter of 2020 was $2.1 million or $0.19 per share compared to net loss of $1.2 million or $0.13 per share for the fourth quarter of 2019. Net loss for the year ended December 31, 2020 was $6.3 million or $0.58 per share compared to net loss of $4.2 million or $0.45 per share for the year ended December 31, 2019.

    Research and Development (R&D) Expenses

    R&D expenses for the fourth quarter of 2020 were $1.6 million compared to $0.6 million for the fourth quarter of 2019. This increase of $1.0 million is primarily attributed to increases in expenses of $0.5 million for the planning of the GEIS camsirubicin Phase 2 clinical trial including manufacturing, $0.2 million for the VOICE clinical trial planning and manufacturing costs, and $0.3 million for R&D personnel salary and benefits.

    R&D expenses for the year ended December 31, 2020 were $4.1 million compared to $2.0 million for the year ended December 31, 2019. This represents an increase of approximately $2.1 million primarily attributed to increases in expenses of $1.1 million for the planning of the GEIS camsirubicin Phase 2 clinical trial including manufacturing, $0.1 million for the VOICE clinical trial planning and manufacturing costs, and $0.9 million for R&D personnel salary and benefits.

    General and Administrative (G&A) Expenses

    G&A expenses for the fourth quarter of 2020 were $0.6 million, equal to $0.6 million for the fourth quarter of 2019.

    G&A expenses for the year ended December 31, 2020 were $2.4 million, equal to $2.4 million for the year ended December 31, 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 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 in the second quarter of 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 March 2022. The forward-looking statements involve risks and uncertainties including, but not limited to, not successfully recruiting patients and initiating additional clinical trial sites for the VOICE clinical trial or the Phase 2 GEIS-sponsored camsirubicin clinical trial within expected timeframes, if at all; the Company's inability to raise sufficient funds or engage a partner to complete the Phase 3 portion of the VOICE clinical trial and continue the GEIS camsirubicin 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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  3. WILMETTE, Ill., March 02, 2021 (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 it has entered into an agreement with serial medtech entrepreneur, Andrew Cittadine, to explore over the next few months strategic and developmental options for MNPR-101 as an intraoperative imaging agent in bladder cancer surgery as well as other cancers.

    Mr. Cittadine is an experienced healthcare executive with a track record of building new businesses from concept through acquisition, including successful exits of Sensant Corp. to Siemens and American Biooptics…

    WILMETTE, Ill., March 02, 2021 (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 it has entered into an agreement with serial medtech entrepreneur, Andrew Cittadine, to explore over the next few months strategic and developmental options for MNPR-101 as an intraoperative imaging agent in bladder cancer surgery as well as other cancers.

    Mr. Cittadine is an experienced healthcare executive with a track record of building new businesses from concept through acquisition, including successful exits of Sensant Corp. to Siemens and American Biooptics to Olympus. Mr. Cittadine was the co-founder and Vice President of Marketing at Sensant Corp., and co-founder and CEO of American Biooptics. Sensant was an oncology imaging startup that developed 3D ultrasound imaging systems, and American Biooptics was a startup that developed an advanced oncology diagnostic test for gastrointestinal cancers. His most recent endeavors include serving as the CEO of Diagnostic Photonics, an imaging systems company for cancer surgeries.

    "It is a strong fit," said Chandler Robinson, MD, Chief Executive Officer of Monopar, speaking to Mr. Cittadine's expertise and the recent MNPR-101 bladder cancer imaging data published in a peer-reviewed article in the European Journal of Cancer.

    "Mr. Cittadine's extensive experience in the oncology diagnostics and surgical imaging space combined with his previous successes makes for an ideal collaboration on exploring the potential of MNPR-101," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.

    "The MNPR-101 based imaging agent has shown early promise in in vivo human bladder cancer models. I am excited to work with the Monopar team exploring ways to further the development of MNPR-101, be it through a spin-out, an out-licensing, a partnership, or developing it in-house," said Andrew Cittadine, MBA.

    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. 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 and that preclinical development activities to date have been focused on the treatment of cancers and not medical devices; the inability to successfully spin-out, out-license or develop a partnership, or if developed in-house, the requirement for additional capital to complete preclinical and clinical development of a medical device utilizing MNPR-101, and if successful, commercialization; if funding is available, not being able to develop MNPR-101 for use as a uPAR imaging agent in bladder cancer or any other indications; not being able to ensure volumes of MNPR-101 conjugates can be manufactured and scaled up to meet potential demand; uncertainties about levels of demand if and when a medical device is available for commercialization and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of medical devices. 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  

    Kim R. Tsuchimoto  

    Chief Financial Officer  

      

    Follow Monopar on social media for updates: 

    @MonoparTx   Monopar Therapeutics  



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  4. WILMETTE, Ill., Feb. 24, 2021 (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 that Chandler D. Robinson, MD, Chief Executive Officer, is planning to present a Company overview at the following investor conferences in March:

    H.C. Wainwright Global Life Sciences Conference
    The Company's presentation will be webcast on Tuesday, March 9, 2021 at 7:00 a.m. ET

    33rd Annual Roth Conference, Healthcare
    The Company's fireside chat will be webcast on Tuesday, March 16, 2021 at 12:00 p.m. ET

    Maxim's 2021 Emerging Growth Virtual Conference
    Presentation…

    WILMETTE, Ill., Feb. 24, 2021 (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 that Chandler D. Robinson, MD, Chief Executive Officer, is planning to present a Company overview at the following investor conferences in March:

    H.C. Wainwright Global Life Sciences Conference

    The Company's presentation will be webcast on Tuesday, March 9, 2021 at 7:00 a.m. ET

    33rd Annual Roth Conference, Healthcare

    The Company's fireside chat will be webcast on Tuesday, March 16, 2021 at 12:00 p.m. ET

    Maxim's 2021 Emerging Growth Virtual Conference

    Presentation time to be determined on Wednesday, March 17, 2021

    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.

    CONTACT:

    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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  5. WILMETTE, Ill., Feb. 18, 2021 (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 the appointment of Laura Kelly as Director of Clinical Operations. Ms. Kelly will be responsible for managing Monopar's clinical programs, including the recently launched Phase 2b/3 VOICE trial for the Company's lead drug candidate Validive®.

    Ms. Kelly brings a wealth of clinical research experience, including oncology and the execution of Phase 1 through Phase 4 clinical trials, to the Monopar team. Prior to Monopar, Ms. Kelly served in strategic and clinical…

    WILMETTE, Ill., Feb. 18, 2021 (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 the appointment of Laura Kelly as Director of Clinical Operations. Ms. Kelly will be responsible for managing Monopar's clinical programs, including the recently launched Phase 2b/3 VOICE trial for the Company's lead drug candidate Validive®.

    Ms. Kelly brings a wealth of clinical research experience, including oncology and the execution of Phase 1 through Phase 4 clinical trials, to the Monopar team. Prior to Monopar, Ms. Kelly served in strategic and clinical operation leadership roles at Merck/EMD Serono, AbbVie, Abbott Labs, and Amgen.



    "The addition of Laura to the team comes at an ideal time, given the rapid ramp-up in development efforts resulting from the positive progression of our clinical programs," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "She will be a valuable contributor not only to our Validive clinical trial, but also to our camsirubicin clinical program and MNPR-101 as it moves toward an IND."

    "We are very pleased to welcome Laura to the team," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "Her extensive experience in clinical operations combined with strong leadership skills should allow her to make an immediate impact on the timely enrollment and execution of our clinical trials."

    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: whether Ms. Kelly will be a valuable contributor and make an immediate impact on the timely enrollment and execution of Monopar's Validive clinical trial, camsirubicin clinical program and MNPR-101; and whether MNPR-101 will move toward an IND, if at all. The forward-looking statements involve risks and uncertainties including, but not limited to not successfully enrolling or completing the VOICE clinical trial, if at all; the camsirubicin clinical partner not successfully enrolling or completing its clinical trial, if at all; MNPR-101 not becoming a viable clinical program; the requirement for additional capital to complete future clinical development of Validive in 2022 and beyond; if successful, the potential for Validive commercialization, including uncertainties about levels of demand; and the significant and 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.  

    CONTACT:  

    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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  6. WILMETTE, Ill., Feb. 16, 2021 (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 it has dosed the first patient in its Phase 2b/3 VOICE trial of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE).

    Validive's mucoadhesive buccal tablet formulation allows for prolonged and enhanced local delivery of drug to the regions of mucosal radiation damage, and its easy application under the upper lip allows for convenient once-daily self-administration in the patient's home setting…

    WILMETTE, Ill., Feb. 16, 2021 (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 it has dosed the first patient in its Phase 2b/3 VOICE trial of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE).

    Validive's mucoadhesive buccal tablet formulation allows for prolonged and enhanced local delivery of drug to the regions of mucosal radiation damage, and its easy application under the upper lip allows for convenient once-daily self-administration in the patient's home setting.

    "With this important milestone accomplished we are excited to be one step closer to bringing Validive to the approximately 40,000 OPC patients per year in the US that have no effective options for preventing or treating their chemoradiotherapy-induced SOM," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "SOM is a painful and debilitating severe adverse effect of chemoradiotherapy (CRT) treatment and can have significant negative impacts on clinical outcomes as well as quality of life in both the short and long term."

    "The number of newly diagnosed individuals with oropharyngeal cancer is growing," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "CRT is the standard of care for OPC, but unfortunately 60-70% of OPC patients undergoing CRT will develop severe oral mucositis in the course of their treatment."

    The completed Validive Phase 2 trial showed that administering a single, once daily 100µg Validive tablet resulted in a 40% reduction in the incidence of SOM compared to placebo in OPC patients undergoing CRT treatment. Up to approximately 260 patients will be enrolled in the current multi-center, randomized, double-blind, placebo-controlled, adaptive design Phase 2b/3 VOICE trial.

    Further information about the Validive Phase 2b/3 VOICE trial is available at www.ClinicalTrials.gov under study identifier NCT 04648020.

    About Validive

    Validive (clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal tablet (MBT) formulation. The mucobuccal tablet provides for prolonged and enhanced local delivery of clonidine to the regions of oral mucosal radiation damage in OPC patients. The tablet is self-administered once daily in the patient's home setting with the patient placing it under the upper lip where it adheres to the gums and dissolves over several hours, continuously releasing clonidine into the saliva. Clonidine agonizes the alpha-2 adrenergic receptor on macrophages (white blood cells present in the immune tissues of the oropharynx), decreasing the macrophages' expression of the destructive cytokines they release in response to radiotherapy. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial of Validive showed reduced incidence compared to placebo (absolute decrease of 26%, relative decrease of 40%) in OPC patients treated with Validive 100 µg, a safety profile similar to placebo, and a high rate of treatment compliance (over 90%).

    About Severe Oral Mucositis

    Severe oral mucositis (SOM) is a painful and debilitating inflammation and ulceration of the mucous membranes lining the oral cavity and oropharynx in response to insults such as chemoradiation treatment (CRT). SOM is the most frequent major side effect experienced by oropharyngeal cancer patients, experienced by a majority of those undergoing CRT. SOM impacts both quality of life and clinical outcomes for these patients. SOM prevents patients from drinking and/or eating, and can lead to severe weight loss, opiate usage, and the use of feeding tubes as well as intravenous supplementation to keep alive. Patients who develop SOM can become hospitalized, and symptoms can force patients to prematurely stop cancer treatment, reducing treatment efficacy and long-term survival.

    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 whether Monopar will successfully continue to enroll its Validive Phase 2b/3 VOICE clinical trial; whether Validive will benefit OPC patients in the VOICE trial; whether the VOICE trial will yield results similar to the Phase 2 clinical trial in OPC patients; and whether the incidence of OPC will continue to grow and continue to be treated with CRT. The forward-looking statements involve risks and uncertainties for Monopar including, but not limited to, the requirement for additional capital to complete the VOICE trial beyond the interim analysis and for potential commercialization; the VOICE trial not yielding statistically significant results; if successful, not being able to ensure volumes of Validive 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 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

    Kim R. Tsuchimoto

    Chief Financial Officer

    Follow Monopar on social media for updates:

    Twitter @MonoparTx LinkedIn Monopar Therapeutics


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  7. WILMETTE, Ill., Feb. 11, 2021 (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 the publication of a peer-reviewed study in the European Journal of Cancer which shows the potential utility of MNPR-101 as a uPAR imaging agent to improve surgical outcomes in bladder cancer.

    Using Monopar's proprietary humanized uPAR antibody, MNPR-101, a multimodal imaging probe was developed and tested in vivo in human bladder cancer models. The publication reports that high expression of uPAR in bladder cancer is localized at the tumor periphery, suggesting…

    WILMETTE, Ill., Feb. 11, 2021 (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 the publication of a peer-reviewed study in the European Journal of Cancer which shows the potential utility of MNPR-101 as a uPAR imaging agent to improve surgical outcomes in bladder cancer.

    Using Monopar's proprietary humanized uPAR antibody, MNPR-101, a multimodal imaging probe was developed and tested in vivo in human bladder cancer models. The publication reports that high expression of uPAR in bladder cancer is localized at the tumor periphery, suggesting that using a fluorescent-conjugated MNPR-101 probe might allow surgeons to better visualize the borders of the tumor, potentially resulting in more complete tumor resection and thereby minimizing relapse. Similar approaches have been utilized successfully in the resection of other tumor types, such as breast cancer.

    Bladder cancer is often treated with transurethral resection to remove cancerous tissue; however, recurrence can occur in up to 78% of patients within 5 years. Up to 40% of recurrent cases develop muscle invasive disease, which has a poor prognosis and requires complete removal of the bladder. Many patients with muscle-invasive bladder cancer unfortunately go on to develop and succumb to metastatic disease.

    "This novel MNPR-101 based imaging agent has promising utility in allowing surgeons to easily identify tumor margins during surgery," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar and a co-author of the publication. "Given the specificity of uPAR expression in bladder cancer versus normal bladder tissue, and its high expression at the border of the tumor, we believe imaging uPAR using MNPR-101 targeting could improve surgical outcomes and potentially reduce recurrence of the disease."

    "If confirmed in a clinical setting, an imaging probe based on MNPR-101 could result in a paradigm shift, altering how urologists survey and treat bladder cancer," said Cornelis Sier, PhD, member of the Image-Guided Surgery group at Leiden University Medical Center (LUMC), and the principal investigator on the study.

    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 the potential utility of MNPR-101 as a uPAR imaging agent, whether a MNPR-101 based imaging agent could improve surgical outcomes in bladder cancer and related matters. 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 and that preclinical development activities to date have been focused on the treatment of cancers and not medical devices; the requirement for additional capital to complete preclinical and clinical development of a medical device utilizing MNPR-101, and if successful, commercialization; if funding is available, not being able to develop MNPR-101 for use as a uPAR imaging agent in bladder cancer or any other indications; not being able to ensure volumes of MNPR-101 conjugates can be manufactured and scaled up to meet potential demand; uncertainties about levels of demand if and when a medical device is available for commercialization and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of medical devices. 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

    Kim R. Tsuchimoto

    Chief Financial Officer

    Follow Monopar on social media for updates:

    Twitter: @MonoparTx

    LinkedIn: Monopar Therapeutics



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  8. WILMETTE, Ill., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life and improve the quality of life for cancer patients, today announced the issuance of a patent covering composition of matter for MNPR-101 in Canada, adding to its existing protection in key markets around the world including the US, Europe and Japan.

    "This is an important advancement in our efforts to broaden our global patent estate for MNPR-101," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "MNPR-101 is a novel, first-in-class humanized monoclonal antibody to the urokinase Plasminogen Activator Receptor (uPAR…

    WILMETTE, Ill., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life and improve the quality of life for cancer patients, today announced the issuance of a patent covering composition of matter for MNPR-101 in Canada, adding to its existing protection in key markets around the world including the US, Europe and Japan.

    "This is an important advancement in our efforts to broaden our global patent estate for MNPR-101," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "MNPR-101 is a novel, first-in-class humanized monoclonal antibody to the urokinase Plasminogen Activator Receptor (uPAR). uPAR is a well credentialed target that appears to be overexpressed in certain aberrantly activated cells, but does not appear much, if at all, in healthy tissue."

    In June 2020, Monopar entered into a collaboration with NorthStar Medical Radioisotopes, LLC to utilize MNPR-101 to create a radio-immuno-therapeutic (RIT) to potentially treat severe COVID-19 by targeting and eradicating the aberrantly activated immune cells causing cytokine storm. uPAR targeting by MNPR-101 has wide potential in treating other diseases as well, including cancers, as uPAR is over-expressed in multiple cancer types such as pancreatic and ovarian.

    "We are excited about the approval of this composition of matter patent in Canada as it further enables us to explore the potential of MNPR-101 on a global scale," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.

    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: whether Monopar's composition of matter patents (including in Canada) provide protection in key markets around the world; whether Monopar's collaboration with NorthStar Medical Radioisotopes, LLC utilizing MNPR-101 to create a radio-immuno-therapeutic (RIT) will result in a treatment for severe COVID-19 by targeting and eradicating the aberrantly activated immune cells causing cytokine storm; and whether MNPR-101 has wide potential in treating other diseases including cancers such as pancreatic and ovarian. The forward-looking statements involve risks and uncertainties including, but not limited to: Monopar's composition of matter patents (including in Canada) not providing protection in key markets around the world; Monopar and NorthStar are unable to develop a RIT to treat severe COVID-19; further development of MNPR-101 does not result in a treatment for cancers; the requirement for Monopar to raise additional capital to complete clinical development of MNPR-101 or a RIT, if at all; the potential for commercialization and uncertainties about levels of demand if and when a treatment is available for commercialization; and the significant and 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. 

    CONTACT: 

    Monopar Therapeutics Inc.: 

    Investor Relations: 

    Kim R. Tsuchimoto  

    Chief Financial Officer 

     

    Follow Monopar on social media for updates: 

    @MonoparTx

    Monopar Therapeutics  



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  9. -Issued patent expands and strengthens Monopar's existing camsirubicin IP portfolio
    -Phase 2 initiation for camsirubicin in advanced soft tissue sarcoma remains on track for early 2021 

    WILMETTE, Ill., Dec. 22, 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 the issuance of a U.S. patent (US 10,450,340) covering compositions of matter for a novel family of camsirubicin analogs. The patent, which expands the Company's camsirubicin intellectual property portfolio, is expected to expire in 2038 not including any patent term extensions.

    -Issued patent expands and strengthens Monopar's existing camsirubicin IP portfolio

    -Phase 2 initiation for camsirubicin in advanced soft tissue sarcoma remains on track for early 2021 

    WILMETTE, Ill., Dec. 22, 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 the issuance of a U.S. patent (US 10,450,340) covering compositions of matter for a novel family of camsirubicin analogs. The patent, which expands the Company's camsirubicin intellectual property portfolio, is expected to expire in 2038 not including any patent term extensions.

    "The analogs covered in this patent have been designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin and the potent broad-spectrum antitumor activity of doxorubicin; further, preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active in doxorubicin-resistant tumor cells. This may enable us to address additional cancer types beyond those possible with camsirubicin," said Andrew Mazar, PhD, Monopar's Chief Scientific Officer.

    Doxorubicin is FDA approved in 14 different types of cancers including soft tissue and bone sarcomas; metastatic stomach, ovarian, thyroid, lung, and breast cancer; acute myeloid and lymphoblastic leukemia; Hodgkin and non-Hodgkin lymphoma; and neuroblastoma. However, cumulative dose effects of doxorubicin can result in irreversible heart damage and death, which is why a restrictive lifetime cumulative dose limitation has been placed on its use.

    "If successful, camsirubicin and its analogs could overcome the restrictive dose limitation and be administered at higher doses and for longer periods of time than doxorubicin," said Chandler Robinson, MD, Monopar's Chief Executive Officer. "This could lead to improved efficacy and better patient outcomes."

    Monopar's clinical trial collaboration partner, Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcomas, is on track to initiate an open-label Phase 2 clinical study in early 2021 evaluating camsirubicin head-to-head against doxorubicin in advanced soft tissue sarcoma (ASTS), where doxorubicin is currently the first-line treatment.

    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: whether the issued patent expands and strengthens Monopar's existing camsirubicin IP portfolio; whether GEIS will initiate the Phase 2 camsirubicin clinical trial in early 2021, if at all; whether the analogs covered in the patent could retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin and the potent broad-spectrum antitumor activity of doxorubicin; whether this new family of 2-pyrrilino camsirubicin analogs could be active in doxorubicin-resistant tumor cells which may enable Monopar to address additional cancer types beyond those possible with camsirubicin; and whether camsirubicin and its analogs could overcome the restrictive dose limitation and be administered at higher doses and for longer periods of time than doxorubicin which could lead to improved efficacy and better patient outcomes. The forward-looking statements involve risks and uncertainties including, but not limited to the requirement for additional capital to complete future clinical development beyond the GEIS Phase 2 clinical trial; the safety and efficacy of camsirubicin in the Phase 2 and in future clinical development, if at all; if successful, the potential for commercialization, including uncertainties about levels of demand of camsirubicin; and the significant and 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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  10. WILMETTE, Ill. and BELOIT, Wis., Dec. 10, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) and NorthStar Medical Radioisotopes, LLC, which are jointly developing a urokinase plasminogen activator receptor targeted radio-immuno-therapeutic (uPRIT) for the potential treatment of severe COVID-19, today announced the selection of a uPRIT clinical candidate. Monopar and NorthStar partnered with IsoTherapeutics Group LLC to generate a panel of uPRIT leads, which were then screened by Aragen Bioscience Inc., resulting in the identification of a uPRIT clinical candidate plus several backup candidates.

    uPRITs are analogs of MNPR-101, Monopar's proprietary humanized urokinase plasminogen activator receptor (uPAR) targeted antibody…

    WILMETTE, Ill. and BELOIT, Wis., Dec. 10, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) and NorthStar Medical Radioisotopes, LLC, which are jointly developing a urokinase plasminogen activator receptor targeted radio-immuno-therapeutic (uPRIT) for the potential treatment of severe COVID-19, today announced the selection of a uPRIT clinical candidate. Monopar and NorthStar partnered with IsoTherapeutics Group LLC to generate a panel of uPRIT leads, which were then screened by Aragen Bioscience Inc., resulting in the identification of a uPRIT clinical candidate plus several backup candidates.

    uPRITs are analogs of MNPR-101, Monopar's proprietary humanized urokinase plasminogen activator receptor (uPAR) targeted antibody, that have been modified to enable attachment of a therapeutic radioisotope. uPRITs bind to uPAR with high affinity and are thought to selectively recognize the aberrantly activated, pro-inflammatory immune cells that express this target and also seem to be mediating the cytokine storm leading to respiratory failure and poor outcomes in severe COVID-19 patients.

    The cleaved, blood-circulating soluble form of uPAR, suPAR, has been gaining attention as a potentially important prognostic biomarker for severe COVID-19 in several recently published studies. Rovina et al. 2020 showed that patients with elevated levels of suPAR at the time of hospital admission are 17 times more likely to develop severe respiratory failure (p=0.0000000012); Arnold et al. 2020 showed suPAR to have the best performance in predicting outcome (such as intensive care unit admission and death) of all the biomarkers examined; and Eugen-Olsen et al. 2020 showed that low levels of suPAR are predictive of mild outcome in COVID-19 patients.

    The aim with uPRITs is to bind to and rapidly eliminate the aberrantly activated immune cells, quickly shutting down the cytokine storm. If uPRITs are effective in this setting, they may also be effective in treating other diseases characterized by rapid and severe systemic inflammatory responses, including certain pneumonias and sepsis.

    The uPRIT with the most attractive uPAR binding profile was selected to advance into IND-enabling studies. "Selection of a uPRIT candidate allows us to begin preclinical studies, and brings us one step closer to reaching human clinical trials," said Andrew Mazar, Ph.D., Chief Scientific Officer of Monopar. "Even when SARS-CoV2 vaccines are available, treatments will be needed for those who are not vaccinated, or for patients for whom the vaccine is not effective, and who thereby contract severe COVID-19. Successfully combatting COVID-19 over the long term will require a combination of preventive and treatment approaches."

    "This rapid advancement of our uPRIT program highlights the innovation and collaborative efforts of Monopar, NorthStar and our partners," stated James Harvey, Ph.D., Senior Vice President and Chief Scientific Officer of NorthStar. "Selecting a highly specific therapeutic candidate for the potential treatment of severe COVID-19 in short order is a significant achievement."

    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. Follow Monopar on LinkedIn and Twitter.

    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.

    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: the selected MNPR-101 derived uPRIT's ability to mediate the cytokine storm which leads to respiratory failure and poor outcomes in severe COVID-19 patients; whether biomarkers in published studies can be repeated in uPRIT preclinical and clinical studies; uPRIT's ability to be effective in treating other diseases characterized by rapid and severe systemic inflammatory responses, including certain pneumonias and sepsis; and whether uPRITs will be successful in preclinical studies or move forward into clinical trials in patients with severe COVID-19. 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 and for potential commercialization, the uPRIT not being able to kill aberrantly activated cytokine producing immune cells, the uPRIT 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 when vaccines are widely utilized or treatments are approved for marketing and 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 and NorthStar 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 and NorthStar'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



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  11. There are currently no FDA-approved drugs to prevent or treat chemoradiotherapy-induced SOM

    WILMETTE, Ill., Dec. 08, 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 that its Phase 2b/3 clinical trial of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE) is active and recruiting patients.

    "We are pleased to have multiple clinical sites activated," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar, "and are looking forward to dosing the first patients…

    There are currently no FDA-approved drugs to prevent or treat chemoradiotherapy-induced SOM

    WILMETTE, Ill., Dec. 08, 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 that its Phase 2b/3 clinical trial of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE) is active and recruiting patients.



    "We are pleased to have multiple clinical sites activated," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar, "and are looking forward to dosing the first patients shortly."



    "The commencement of our Phase 2b/3 VOICE trial is a significant milestone for Monopar and, it represents a key step in the development of a therapy that could benefit many OPC patients," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "This trial builds on the foundation of the completed Phase 2, and is designed to confirm Validive reduces the incidence of SOM in OPC patients undergoing chemoradiotherapy." The completed Phase 2 trial showed the incidence of SOM in OPC patients receiving Validive 100 µg to be 40% lower compared to those receiving placebo.

    It is estimated there will be greater than 40,000 new OPC patients in the U.S. alone in 2021, the majority of whom will be treated with chemoradiation and run substantial risk of developing SOM. Currently, there is no FDA approved preventive or treatment for SOM in these patients, emphasizing the clear unmet medical need in this patient population.

    Up to approximately 260 patients will be enrolled in this multi-center, randomized, double-blind, placebo-controlled, Phase 2b/3 clinical trial. The trial includes an interim analysis, which is anticipated to be reached approximately twelve months after the first patient is dosed.

    Further information about the Validive Phase 2b/3 VOICE trial is available at www.ClinicalTrials.gov under study identifier NCT 04648020.

    About Validive

    Validive (clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal tablet (MBT) formulation of clonidine which provides for prolonged and enhanced local delivery of clonidine to the regions of mucosal radiation damage in OPC patients. The tablet is self-administered once daily in the patient's home setting with the patient placing it under the upper lip where it adheres to the gums and dissolves over several hours, continuously releasing the clonidine into the saliva. Clonidine agonizes the alpha-2 adrenergic receptor on macrophages (white blood cells present in the immune tissues of the oropharynx), decreasing the macrophages' expression of destructive cytokines they tend to release in response to radiotherapy. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial of Validive showed reduced incidence (absolute decrease of 26%, relative decrease of 40%) in OPC patients treated with Validive 100 µg (a meaningful trend in the Phase 2, which the Phase 2b/3 is designed to confirm with a larger trial in OPC for potential statistical significance), a safety profile similar to the placebo, and a high rate of treatment compliance (over 90%).

    About Severe Oral Mucositis

    Severe oral mucositis (SOM) is a painful and debilitating inflammation and ulceration of the mucous membranes lining the oral cavity and oropharynx in response to insult such as chemoradiation treatment (CRT). SOM is the most frequent major side effect experienced by oropharyngeal cancer patients, experienced by a majority of those undergoing CRT. SOM impacts both quality of life and clinical outcomes for these patients. SOM prevents patients from drinking and/or eating, and can lead to severe weight loss, opiate usage, and the use of feeding tubes as well as intravenous supplementation to keep alive. Patients who develop SOM can become hospitalized, and symptoms can force patients to prematurely stop cancer treatment, reducing treatment efficacy and long-term survival.

    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 whether Monopar will successfully enroll its Validive Phase 2b/3 VOICE clinical trial, if at all; whether Validive will benefit OPC patients in the VOICE trial; whether the VOICE trial will yield results similar to the Phase 2 clinical trial in OPC patients and that are statistically significant; and whether the VOICE trial will reach the interim analysis approximately twelve months from the first patient dosed, if at all. The forward-looking statements involve risks and uncertainties for Monopar including, but not limited to, the requirement for additional capital to complete the VOICE trial beyond the interim analysis and for potential commercialization; not being able to ensure volumes of Validive 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 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 

    Kim R. Tsuchimoto 

    Chief Financial Officer 

     

    Follow Monopar on social media for updates:

    Twitter @MonoparTx  LinkedIn Monopar Therapeutics



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  12. 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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  13. 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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  14. 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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  15. 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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  16. 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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  17. WILMETTE, Ill., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) today announced its plan to develop a test to potentially triage COVID-19 patients into those likely versus unlikely to progress to severe respiratory failure. The test would use Monopar's proprietary monoclonal antibody, ATN-658, to detect soluble urokinase plasminogen activator receptor (suPAR) in COVID-19 patient plasma. A suPAR test for COVID-19 patients, if successful, could identify those at high risk for severe respiratory failure, facilitating earlier therapeutic interventions or allowing for the staging of patients to an optimal treatment based on their disease characteristics.

    A prototype enzyme-linked immunosorbent assay (ELISA) for measuring…

    WILMETTE, Ill., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) today announced its plan to develop a test to potentially triage COVID-19 patients into those likely versus unlikely to progress to severe respiratory failure. The test would use Monopar's proprietary monoclonal antibody, ATN-658, to detect soluble urokinase plasminogen activator receptor (suPAR) in COVID-19 patient plasma. A suPAR test for COVID-19 patients, if successful, could identify those at high risk for severe respiratory failure, facilitating earlier therapeutic interventions or allowing for the staging of patients to an optimal treatment based on their disease characteristics.

    A prototype enzyme-linked immunosorbent assay (ELISA) for measuring blood suPAR levels using ATN-658 has been developed, and Monopar is currently in discussions with several parties to further develop and commercialize either an ELISA or other suPAR-based test using ATN-658. The aim is to clinically validate the suPAR-based test in COVID-19 patients.

    The use of suPAR for triaging COVID-19 patients is supported by a growing body of recent studies. Rovina et al. 2020 showed that patients with elevated levels of suPAR at the time of hospital admission are 17 times more likely to develop severe respiratory failure (p=.0000000012). Arnold et al. 2020 showed suPAR to have the best performance in predicting outcome (such as intensive care unit admission and death) of all the biomarkers examined; and Eugen-Olsen et al. 2020 showed that low levels of suPAR are predictive of mild outcome in COVID-19 patients.

    "suPAR is emerging as an important biomarker that predicts outcome in diseases characterized by rapid and severe systemic inflammatory responses including COVID-19, certain pneumonias, and sepsis," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "This suPAR test may enable the early identification of patients who will rapidly deteriorate, and thereby could greatly improve the treatment of COVID-19 patients."

    suPAR is the cleaved, blood-circulating form of the cell-surface anchored protein called urokinase plasminogen activator receptor (uPAR). Monopar recently entered into a collaboration with NorthStar Medical Radioisotopes, LLC to develop a precision Radio-Immuno-Therapeutic (RIT) based on the same antibody scaffold that is used in the prototype ELISA to detect suPAR.

    The aim of the NorthStar collaboration is to develop a uPAR-targeted RIT (uPRIT) to selectively target and eradicate the aberrantly activated ("rogue") immune cells that cause the cytokine storm and subsequent severe respiratory failure and death in COVID-19 patients. These rogue immune cells seem to be making uPAR and shedding it into the blood as suPAR. Fortunately, uPAR is a protein that is not found much, if at all, on normal healthy tissue, so there is an opportunity to potentially use a uPRIT to quickly shut down the cytokine storm by selectively killing the rogue immune cells while sparing healthy cells.

    "If successful, the suPAR test could serve as a companion diagnostic to Monopar's uPRIT. Specifically, the test could identify those patients who are most appropriate for the potential uPRIT treatment," said Chandler Robinson, MD, Chief Executive Officer of Monopar.

    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 develop a test to triage COVID-19 patients into those likely versus unlikely to progress to severe respiratory failure; ATN-658's ability to detect soluble urokinase plasminogen activator receptor (suPAR) in COVID-19 patient plasma; the suPAR test's ability to enable the early identification of COVID-19 patients who will rapidly deteriorate and thereby greatly improve the treatment of COVID-19 patients; that identification of such high risk for respiratory failure could facilitate therapeutic interventions earlier or allow for the staging of patients to an optimal treatment based on their disease characteristics; the success, if any, of Monopar's discussions with several parties to further develop either an ELISA or other suPAR-based test for COVID-19 patients; Monopar's or a future collaborator's ability to clinically validate the suPAR-based test in COVID-19 patients; Monopar's ability to replicate results of earlier third-party studies of suPAR; that suPAR as a novel biomarker could predict outcome in diseases; that Monopar's collaboration with NorthStar will successfully result in a uPRIT for the treatment of COVID-19; that a uPRIT could quickly shut down the cytokine storm through selectively killing the rogue immune cells while sparing healthy cells; and that the suPAR test could serve as a companion diagnostic to Monopar's uPRIT. The forward-looking statements involve risks and uncertainties including, but not limited to, the lack of any clinical activities to date with respect to ATN-658 or MNPR-101; the requirement for additional capital to complete preclinical and clinical development, and if successful, commercialization of the suPAR test and/or the uPRIT; the uPRIT not being able to kill aberrantly activated cytokine-producing immune cells; the uPRIT not being able to use uPAR to gain entry into these cells and deliver cytotoxic payload to kill these cells while sparing normal tissue; not being able to ensure volumes of chosen radioisotope can be manufactured and scaled up to meet potential demand; the suPAR test being unable to detect suPAR with sufficient precision, sensitivity and/or accuracy; uncertainties about levels of demand if and when a treatment and/or test is available for commercialization and the significant general risks and uncertainties surrounding the research, development, regulatory approval and commercialization of therapeutics and diagnostics. 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

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  18. WILMETTE, Ill. and BELOIT, Wis. and ANGLETON, Texas, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) (Wilmette, IL) and NorthStar Medical Radioisotopes, LLC (Beloit, WI), who are collaborating on the development of Radio-Immuno-Therapeutics (RITs) to treat patients with severe COVID-19, today announced a partnership with IsoTherapeutics Group, LLC (Angleton, TX), to develop and manufacture a RIT for the potential treatment of severe COVID-19.

    IsoTherapeutics will modify Monopar's proprietary urokinase plasminogen activator receptor (uPAR) targeted antibody, MNPR-101, by making conjugates that will allow the attachment of therapeutic radioisotopes supplied by NorthStar, creating a platform of uPAR-targeted RIT (uPRIT…

    WILMETTE, Ill. and BELOIT, Wis. and ANGLETON, Texas, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) (Wilmette, IL) and NorthStar Medical Radioisotopes, LLC (Beloit, WI), who are collaborating on the development of Radio-Immuno-Therapeutics (RITs) to treat patients with severe COVID-19, today announced a partnership with IsoTherapeutics Group, LLC (Angleton, TX), to develop and manufacture a RIT for the potential treatment of severe COVID-19.

    IsoTherapeutics will modify Monopar's proprietary urokinase plasminogen activator receptor (uPAR) targeted antibody, MNPR-101, by making conjugates that will allow the attachment of therapeutic radioisotopes supplied by NorthStar, creating a platform of uPAR-targeted RIT (uPRIT) candidates to be evaluated as treatments for severe COVID-19.  The plan is for IsoTherapeutics to then advance a clinical candidate identified from this platform through GMP manufacturing for Monopar and NorthStar to take into its first in human trials.

    Recent publications have implicated uPAR-expressing immune cells in the development of severe lung injury, multiple organ failure, and death in severe COVID-19 patients. "A treatment that specifically targets and eradicates these over-activated immune cells could significantly improve patient outcomes in severe COVID-19," said Andrew Mazar, Ph.D., Chief Scientific Officer of Monopar.

    "We are excited to partner with Monopar and NorthStar," said Jim Simón, Ph.D., Chief Scientific Officer of IsoTherapeutics. "A uPAR-targeted RIT has great therapeutic potential, and we are proud to contribute our expertise in radiopharmaceutical research and manufacturing to ensure its rapid and effective development."

    James T. Harvey, Ph.D., Senior Vice President and Chief Science Officer of NorthStar, said "We have successfully worked with IsoTherapeutics on a previous project that led to an FDA approval, and we value their expertise. This is a crucial step in the development of a uPRIT for severe COVID-19."

    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 IsoTherapeutics Group, LLC

    IsoTherapeutics Group is a radiopharmaceutical company that provides research and development services, including animal studies and early stage manufacturing for the purpose of aiding customers and collaborators in the development of radionuclide-based drug and device products. IsoTherapeutics scientists hold over 100 patents for novel chemistry and radiopharmaceutical formulations. For more information, visit: http://isotherapeutics.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 IsoTherapeutics' ability to create a platform of uPAR-targeted RIT (uPRIT) candidates based upon MNPR-101 and  a therapeutic radioisotope from NorthStar; IsoTherapeutics' ability to advance a clinical candidate identified from this platform through GMP manufacturing for Monopar and NorthStar to take into its first in human trials; that a treatment that specifically targets and eradicates these over-activated immune cells could significantly improve patient outcomes in severe COVID-19; that a uPAR-targeted RIT has great therapeutic potential; and that IsoTherapeutics' expertise in radiopharmaceutical research and manufacturing will ensure rapid and effective development of uPRIT candidates. 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 and that preclinical development activities to date have been focused on the treatment of cancers, the requirement for additional capital to complete preclinical and clinical development, and if successful, commercialization, IsoTherapeutics 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 deliver 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 IsoTherapeutics 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 IsoTherapeutics' 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 IsoTherapeutics Group, LLC.:

    Lance Cooper

    Director of Business Development

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  19. CHICAGO, Aug. 06, 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 second quarter 2020 financial results and business updates.

    Second Quarter and Recent Highlights

    Collaboration with NorthStar Medical Radioisotopes to Develop Potential Therapeutic for Severe COVID-19 and Other Respiratory Diseases

    • Monopar and NorthStar entered into a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19.
       
    • Monopar will provide its pre-IND stage humanized uPAR targeted monoclonal…

    CHICAGO, Aug. 06, 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 second quarter 2020 financial results and business updates.

    Second Quarter and Recent Highlights

    Collaboration with NorthStar Medical Radioisotopes to Develop Potential Therapeutic for Severe COVID-19 and Other Respiratory Diseases

    • Monopar and NorthStar entered into a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19.

       
    • Monopar will provide its pre-IND stage humanized uPAR targeted monoclonal antibody, known as MNPR-101, and NorthStar will supply a cytotoxic radioisotope. The aim is to create a highly selective agent that has the potential to kill aberrantly activated cytokine-producing immune cells thought to be largely responsible for the severe lung injury that contributes to poor outcomes and death in patients with severe COVID-19.

       
    • Provisional patent has been filed that covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radio-immuno-therapeutics (uPRITs) for the treatment of severe COVID-19 and other respiratory diseases.            

    Validive Phase 2b/3 Clinical Trial and Camsirubicin Phase 2 Clinical Trial Continue on Schedule           

    • Monopar's two clinical-stage programs both continue to be on schedule for first patient dosing in the second half of 2020.

    Second Quarter Summary Financial Results

    Results for the Quarter Ended June 30, 2020 Compared to the Quarter Ended June 30, 2019

    Cash and cash equivalents as of June 30, 2020 were $12.5 million. Net loss for the three months ended June 30, 2020 was $1.4 million or $0.14 per share compared to net loss of $0.9 million or $0.10 per share for the three months ended June 30, 2019.

    Research and Development (R&D) Expenses

    R&D expenses for the three months ended June 30, 2020 were $0.8 million, compared to $0.3 million, for the three months ended June 30, 2019. This represents an increase of $0.5 million primarily attributed to increases in camsirubicin and Validive clinical trial planning and materials manufacturing costs and increases in personnel expenses for three new R&D employees and higher salary and stock-based (non-cash) compensation for 2020.

    General and Administrative (G&A) Expenses

    G&A expenses for the three months ended June 30, 2020 were $0.6 million, compared to $0.6 million, for the three months ended June 30, 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 the potential for NorthStar Medical Radioisotopes' development collaboration to develop a COVID-19 uPRIT and the Company's ability to dose first patients in the Validive and camsirubicin clinical trials in the second half of 2020. The forward-looking statements involve risks and uncertainties including, but not limited to, not successfully developing a COVID-19 uPRIT with the Company's development collaborator, and not commencing the Validive Phase 2b/3 clinical trial and Phase 2 GEIS-sponsored camsirubicin clinical trial in the second half of 2020, if at all, and not commencing the Validive Phase 3 portion subject to fundraising and partnership efforts, if at all. 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

     

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  20. CHICAGO and BELOIT, Wis., June 30, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) (Chicago, IL) and NorthStar Medical Radioisotopes, LLC (Beloit, WI) announced today that a provisional patent application entitled "Precision Radioimmunotherapeutic Targeting of the Urokinase Plasminogen Activator Receptor (uPAR) for Treatment of Severe COVID-19 Disease" has been filed with the U.S. Patent and Trademark Office (USPTO).

    This application covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radiotherapeutics (uPRITs) for the treatment of severe COVID-19 and other respiratory diseases. Advanced COVID-19 patients frequently develop severe, life-threatening…

    CHICAGO and BELOIT, Wis., June 30, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) (Chicago, IL) and NorthStar Medical Radioisotopes, LLC (Beloit, WI) announced today that a provisional patent application entitled "Precision Radioimmunotherapeutic Targeting of the Urokinase Plasminogen Activator Receptor (uPAR) for Treatment of Severe COVID-19 Disease" has been filed with the U.S. Patent and Trademark Office (USPTO).

    This application covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radiotherapeutics (uPRITs) for the treatment of severe COVID-19 and other respiratory diseases. Advanced COVID-19 patients frequently develop severe, life-threatening, pulmonary inflammation as a result of a viral induced cytokine storm. The development of this cytokine storm is associated with a high rate of mortality in severe COVID-19 patients, even with oxygen support and mechanical ventilation. uPRITs have been designed with the goal of selectively destroying the aberrantly activated white blood cells responsible for causing the cytokine storm. If successful, healthy tissue would be spared in the process as the uPAR target is primarily only present on this unique class of white blood cells and not in healthy tissue. The co-inventors of the provisional patent application are James Harvey, Chief Scientific Officer of NorthStar, and Andrew P. Mazar, Chief Scientific Officer of Monopar.

    If granted, the patent would offer exclusivity to Monopar and NorthStar for the development and potential use of uPRITs in the treatment of severe COVID-19 and other respiratory diseases. This provisional patent application leverages the therapeutic radioisotope expertise of NorthStar and the translational expertise of Monopar to create a novel, targeted radioimmunotherapeutic. On June 16, 2020, Monopar and NorthStar announced a 50/50 collaboration to couple Monopar's MNPR-101 uPAR targeting monoclonal antibody to a therapeutic radioisotope provided by NorthStar.

    About Monopar Therapeutics Inc. (Monopar)

    Monopar Therapeutics is a clinical-stage biopharmaceutical company 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 preclinical stage uPAR targeted antibody MNPR-101 for advanced cancers and severe COVID-19. For more information, visit: www.monopartx.com.

    About NorthStar Medical Radioisotopes, LLC (NorthStar)

    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.

    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 the collaboration's ability to create precision targeted radiotherapeutics (uPRITs) for the treatment of severe COVID-19 and other respiratory diseases; and that the patent may be granted. The forward-looking statements involve risks and uncertainties including, but not limited to, whether or not the patent will be granted, the lack of any clinical activities to date with respect to MNPR-101 and that pre-clinical development activities to date have been focused on the treatment of cancers, the requirement for additional capital to complete preclinical and clinical development, and if successful, commercialization, not being able to couple MNPR-101 to a therapeutic radioisotope, the uPRITs may not selectively destroy the aberrantly activated white blood cells responsible for causing the cytokine storm while sparing healthy 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. Monopar and NorthStar are not making any express or implied claims that uPRITs have the ability to eliminate or mitigate severe COVID-19 at this time. 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 and NorthStar 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 and NorthStar'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

    Corporate:

    Lisa Holst

    Vice President Sales and Marketing

    678-471-9027

    Media:

    Priscilla Harlan

    781-799-7917

     

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  21. CHICAGO and BELOIT, Wis., June 16, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) (Chicago, IL) and NorthStar Medical Radioisotopes, LLC (Beloit, WI) announced today a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19 (patients with SARS-CoV-2 infection). Monopar is a clinical-stage biopharmaceutical company and NorthStar is a commercial producer and supplier of medical radioisotopes. This collaboration combines NorthStar's expertise in the innovative production, supply, and distribution of important medical radioisotopes with Monopar's expertise in therapeutic drug development and its pre-IND stage humanized urokinase plasminogen activator receptor (uPAR) targeted monoclonal…

    CHICAGO and BELOIT, Wis., June 16, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) (Chicago, IL) and NorthStar Medical Radioisotopes, LLC (Beloit, WI) announced today a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19 (patients with SARS-CoV-2 infection). Monopar is a clinical-stage biopharmaceutical company and NorthStar is a commercial producer and supplier of medical radioisotopes. This collaboration combines NorthStar's expertise in the innovative production, supply, and distribution of important medical radioisotopes with Monopar's expertise in therapeutic drug development and its pre-IND stage humanized urokinase plasminogen activator receptor (uPAR) targeted monoclonal antibody known as MNPR-101, along with a proprietary portfolio of related monoclonal antibodies that target uPAR or its ligand uPA.

    The uPA system (comprised of the serine protease enzyme uPA and its receptor uPAR) has been demonstrated to be selectively expressed on aberrantly activated immune cells. In response to coronavirus infection, these rogue immune cells produce pro-inflammatory cytokines that can cause runaway inflammation throughout the body, commonly referred to as a cytokine storm. It is this systemic hyper-inflammatory state that is thought to be largely responsible for the severe lung injury and further multiple organ damage that contributes to poor outcomes and death in patients with severe COVID-19.

    In this collaboration, Monopar and NorthStar plan to couple MNPR-101 to a therapeutic radioisotope supplied by NorthStar in order to create a highly selective agent that has the potential to kill aberrantly activated cytokine-producing immune cells. By eradicating these cells with a targeted RIT, the goal is to spare healthy cells while quickly reducing the cytokine storm and its harmful systemic effects.

    "This collaboration is a powerful combination of unique scientific and technical expertise to help combat severe COVID-19," said Chandler Robinson, MD, CEO of Monopar Therapeutics. "The companies will be conducting a development program to determine if Monopar's uPA/uPAR monoclonal antibodies can be transformed into RITs that are effective as treatments against severe COVID-19, as well as other corona viruses."

    "We are pleased to work together with Monopar in the battle against COVID-19," said Stephen Merrick, CEO of NorthStar Medical Radioisotopes." Our hope is that, by joining forces, we can develop a targeted radiopharmaceutical treatment that has the ability to prevent patients with severe COVID-19 from being placed on ventilators and from dying."

     "To help mitigate the cytokine storm and reduce deaths associated with COVID-19, our goal is to develop an RIT that selectively eliminates the rogue aberrantly activated immune cells that produce these cytokines," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "uPAR is selectively expressed on these rogue immune cells but not on healthy cells. An antibody carrying a therapeutic radioisotope could gain entry into these cells through uPAR and deliver its cytotoxic payload to kill these cells while sparing normal tissue."

    "NorthStar will apply its expertise to identify and supply the optimal therapeutic radioisotope to couple with Monopar's uPAR monoclonal antibodies," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. "We will deploy the most appropriate development approaches and production technology to ensure that both development and, if successful, commercial-scale volumes of this radioisotope can be supplied in order to meet potential demand."

    This targeted therapeutic approach to treating severe COVID-19 is supported by a recently published study (Rovina et al. 2020) demonstrating that soluble urokinase plasminogen activator receptor (suPAR), which is shed by aberrantly activated immune cells that make uPAR, is an early predictor of severe respiratory failure in COVID-19 and its presence increases as patients develop severe COVID-19.

    About Monopar Therapeutics Inc. (Monopar)

    Monopar Therapeutics is a clinical-stage biopharmaceutical company 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 more information, visit: https://www.monopartx.com.

    About NorthStar Medical Radioisotopes, LLC (NorthStar)

    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: https://www.northstarnm.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 the collaboration's ability to develop a targeted radiopharmaceutical treatment that has the ability to prevent patients with severe COVID-19 from being placed on ventilators and from dying. 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 and that pre-clinical development activities to date have been focused on the treatment of cancers, the requirement for additional capital to complete preclinical and clinical development, and if successful, 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 and NorthStar 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 and NorthStar'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

    Corporate:

    Lisa Holst

    Vice President Sales and Marketing

    678-471-9027                  

    Media:

    Priscilla Harlan

    781-799-7917

     

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  22. CHICAGO, May 07, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (NASDAQ:MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced first quarter 2020 financial results and business updates.

    First Quarter and Recent Highlights

    Validive Phase 2b/3 Clinical Trial

    • Monopar, in response to the current COVID-19 pandemic and its effects on clinical trials, has modified the original adaptive design Phase 3 clinical trial to be a Phase 2b/3 clinical trial to better fit the types of trials which can enroll patients in the current environment.
       
    • The primary endpoint, absolute incidence of severe…

    CHICAGO, May 07, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (NASDAQ:MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced first quarter 2020 financial results and business updates.

    First Quarter and Recent Highlights

    Validive Phase 2b/3 Clinical Trial

    • Monopar, in response to the current COVID-19 pandemic and its effects on clinical trials, has modified the original adaptive design Phase 3 clinical trial to be a Phase 2b/3 clinical trial to better fit the types of trials which can enroll patients in the current environment.
       
    • The primary endpoint, absolute incidence of severe oral mucositis, remains the same, but the touch points with the healthcare system have been minimized.
       
    • The Validive program will now consist of a randomized Phase 2b/3 clinical trial anticipated to start in the second half of 2020, which will have an unblinded data readout after the Phase 2b portion (estimated to be in the second half of 2021), and shortly thereafter the Phase 3 portion will commence subject to the Company's ability to raise additional funding or find a suitable pharmaceutical partner.

    Camsirubicin Phase 2 Clinical Trial

    • Camsirubicin clinical program continues to make progress with its collaboration with Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcoma cancers, which is sponsoring the approximately 170-patient camsirubicin Phase 2 clinical trial for the treatment of advanced soft tissue sarcoma, anticipated to begin in the second half of 2020.

    "We are excited to move our clinical development programs forward, especially in light of the challenges that the COVID-19 pandemic has created for many biopharmaceutical companies. Addressing the needs of oncology patients is our highest priority and we look forward to entering the clinic in the second half of this year," said Andrew Mazar, Ph.D., Monopar's Chief Scientific Officer.

    First Quarter Summary Financial Results

    Results for the Quarter Ended March 31, 2020 Compared to the Quarter Ended March 31, 2019

    Cash and cash equivalents as of March 31, 2020 were $12.6 million. Net loss for the three months ended March 31, 2020 was $1.1 million or $0.10 per share compared to net loss of $1.4 million or $0.15 per share in the comparable period in 2019.

    Research and Development (R&D) Expenses

    R&D expenses for the three months ended March 31, 2020 were $0.3 million, compared to $0.8 million, for the three months ended March 31, 2019. This represents a decrease of $0.5 million primarily attributed to a decrease in Validive clinical trial planning and accrued material costs.

    General and Administrative (G&A) Expenses

    G&A expenses for the three months ended March 31, 2020 were $0.8 million, compared to $0.6 million, for the three months ended March 31, 2019. This represents an increase of $0.2 million primarily attributed to increases in professional fees and G&A cash and stock-based (non-cash) compensation.

    About Monopar Therapeutics

    Monopar Therapeutics is a clinical-stage biopharmaceutical company 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 late-stage preclinical antibody MNPR-101. For more information, and links to SEC filings that contain detailed financial 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 the clinical development timing of Validive and the potential of camsirubicin and the timing of the GEIS clinical trial. The forward-looking statements involve risks and uncertainties including, but not limited to, not commencing the Validive Phase 2b/3 clinical trial and Phase 2 GEIS-sponsored camsirubicin clinical trial in the second half of 2020, if at all, not obtaining the Validive Phase 2b unblinded data readout in the second half of 2021, if at all, and not commencing the Validive Phase 3 portion subject to fundraising and partnership efforts, if at all. 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

    Chandler D. Robinson, M.D., MBA, M.Sc.
    Chief Executive Officer, Monopar Therapeutics Inc.

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  23. Initial public offering on Nasdaq Capital Market in December 2019

    Orphan Drug Designation from the European Commission for camsirubicin for the treatment of soft tissue sarcoma

    CHICAGO, March 27, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (NASDAQ:MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced fourth quarter and full-year 2019 financial results and business updates.

    Fourth Quarter and Recent Highlights

    Initial Public Offering

    • In December 2019, the Company completed its initial public offering of 1,277,778 shares of common stock, including the underwriters' exercise of…

    Initial public offering on Nasdaq Capital Market in December 2019

    Orphan Drug Designation from the European Commission for camsirubicin for the treatment of soft tissue sarcoma

    CHICAGO, March 27, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (NASDAQ:MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced fourth quarter and full-year 2019 financial results and business updates.

    Fourth Quarter and Recent Highlights

    Initial Public Offering

    • In December 2019, the Company completed its initial public offering of 1,277,778 shares of common stock, including the underwriters' exercise of their over-allotment option, at a public offering price of $8.00 per share before underwriting discounts and commissions. 

    • The shares began trading on the Nasdaq Capital Market on December 19, 2019 under the symbol "MNPR."

    Orphan Drug Designation

    • On February 18, 2020, the Company announced that the European Commission has granted Orphan Drug Designation for the Company's Phase 2 clinical-stage drug candidate, camsirubicin, for the treatment of soft tissue sarcomas. Camsirubicin is being developed under a clinical trial partnership with Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcoma cancers. The approximately 170-patient GEIS-sponsored camsirubicin Phase 2 clinical trial for the treatment of advanced soft tissue sarcoma is anticipated to begin in the second half of 2020.
       
    • European Orphan Drug Designation benefits include protocol assistance, reduced EU regulatory filing fees and 10 years of market exclusivity. Designated orphan medicines are also eligible for conditional marketing authorization. Camsirubicin has already received Orphan Drug Designation in the U.S. by the Food and Drug Administration (FDA), which provides for similar benefits such as fee reductions and 7 years of market exclusivity.

    Fourth Quarter and Full Year Summary Financial Results

    Results for the Quarter and Year Ended December 31, 2019 Compared to the Quarter and Year Ended December 31, 2018

    Cash and cash equivalents as of December 31, 2019 were approximately $13.2 million, compared to approximately $6.9 million as of December 31, 2018. The increase in cash and cash equivalents was driven primarily by the approximately $9.4 million net cash proceeds from the Company's initial public offering offset by approximately $3.0 million of cash used in operating activities.

    Research and Development (R&D) Expenses

    R&D expenses for the quarter ended December 31, 2019 were approximately $0.6 million, compared to approximately $0.5 million for the quarter ended December 31, 2018, an increase of approximately $0.1 million.

    R&D expenses for the year ended December 31, 2019 were approximately $2.0 million, compared to approximately $1.8 million for the year ended December 31, 2018, an increase of approximately $0.2 million.

    General and Administrative (G&A) Expenses

    G&A expenses for the quarter ended December 31, 2019 were approximately $0.6 million, compared to approximately $0.4 million for the quarter ended December 31, 2018, an increase of approximately $0.2 million.

    G&A expenses for the year ended December 31, 2019 were approximately $2.4 million, compared to approximately $1.6 million for the year ended December 31, 2018, an increase of approximately $0.8 million.

    Net loss was $0.13 per share for the fourth quarter of 2019, compared to $0.10 per share in the comparable period in 2018. For the year ended December 31, 2019, net loss was $0.45 per share compared to $0.35 per share in the same period in 2018.

    About Monopar Therapeutics

    Monopar Therapeutics is a clinical-stage biopharmaceutical company 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 late-stage preclinical antibody MNPR-101. 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 the potential of camsirubicin and the timing of the GEIS clinical trial. The forward-looking statements involve risks and uncertainties including, but not limited to, that enrollment of the camsirubicin clinical trial will not begin in the second half of 2020, if at all. 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

    Chandler D. Robinson, M.D., MBA, M.Sc.

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  24. CHICAGO, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) today announced it has been granted Orphan Drug Designation from the European Commission for its drug candidate camsirubicin in the treatment of soft tissue sarcoma (STS), and the European Medicines Agency's Committee for Orphan Medicinal Products has issued its public summary of opinion for the designation, which can be found on the Company's website: https://www.monopartx.com/pipeline/Camsirubicin/development-strategy.

    Orphan Drug Designation: is given to medicinal products that represent a significant benefit over existing treatments; are intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating…

    CHICAGO, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (NASDAQ:MNPR) today announced it has been granted Orphan Drug Designation from the European Commission for its drug candidate camsirubicin in the treatment of soft tissue sarcoma (STS), and the European Medicines Agency's Committee for Orphan Medicinal Products has issued its public summary of opinion for the designation, which can be found on the Company's website: https://www.monopartx.com/pipeline/Camsirubicin/development-strategy.

    Orphan Drug Designation: is given to medicinal products that represent a significant benefit over existing treatments; are intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; and where prevalence of the condition in the European Union (EU) is less than 5 in 10,000 persons. Orphan Drug Designation benefits include protocol assistance, reduced EU regulatory filing fees and 10 years of market exclusivity. Designated orphan medicines are also eligible for conditional marketing authorization. Camsirubicin has already received orphan drug designation in the U.S. by the Food and Drug Administration (FDA), which provides for similar benefits such as fee reductions and 7 years of market exclusivity.

    "We are pleased to receive Orphan Drug Designation from the European Commission as it is another important acknowledgement of the potential benefits of camsirubicin in the treatment of advanced soft tissue sarcoma (ASTS)," said Chandler Robinson, M.D., Chief Executive Officer of Monopar. "This designation complements our U.S. orphan drug designation already granted by the FDA. We look forward to initiating our previously announced Phase 2 clinical trial in ASTS in collaboration with our partner, Grupo Español de Investigación en Sarcomas (GEIS), in the first half of 2020."

    Andrew Mazar, Ph.D., Chief Scientific Officer of Monopar added, "We are encouraged by camsirubicin's potential demonstrated in its early clinical data to date. As a novel analog of doxorubicin, camsirubicin has been designed to reduce the irreversible heart damage generated by doxorubicin while retaining anti-cancer activity." Dr. Mazar continued, "Doxorubicin's efficacy is highly dose dependent; however, higher cumulative doses have historically led to increased rates of irreversible heart damage. As a result, responding patients are pulled off treatment once a maximum lifetime cumulative dose has been reached. Disease progression and poor clinical outcomes in many patients is the unfortunate consequence of the maximum lifetime dose limitation. Camsirubicin offers the potential to administer drug without the risk of irreversible heart damage, thereby potentially improving efficacy by maintaining treatment in these patients as long as they demonstrate clinical benefit."

    About Camsirubicin

    Camsirubicin is a proprietary doxorubicin analog that is selective for topoisomerase-IIa. It has been investigated in ASTS patients in a Phase 1 and a single arm Phase 2 clinical trial. In these studies, no camsirubicin-treated patients developed the irreversible cardiotoxicity common to doxorubicin. The most common adverse event observed in the Phase 1 study was neutropenia, which was mitigated in the Phase 2 study through the use of prophylactic G-CSF.  Based on encouraging clinical results to date, Monopar has entered into a clinical trial partnership with Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcoma cancers. GEIS will be conducting a multi-country, randomized, open-label Phase 2 clinical trial in the 1st line setting evaluating camsirubicin head-to-head against doxorubicin in patients with ASTS. Enrollment for the trial is expected to begin in the first half of 2020 and will include approximately 170 ASTS patients. The primary endpoint of the trial will be progression-free survival, with secondary endpoints that include overall survival.

    About Monopar Therapeutics

    Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to improve clinical outcomes for cancer patients. The Company's pipeline consists of Validive® for the potential prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicin for the potential treatment of advanced soft tissue sarcoma; and a late-stage preclinical antibody MNPR-101. 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 the potential of camsirubicin and the timing of the GEIS clinical trial. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that camsirubicin will not replace doxorubicin as 1st line therapy for ASTS, and that enrollment of the trial will not begin in the first half of 2020, if at all. 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
    
    Chandler D. Robinson, M.D., MBA, M.Sc.
    

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  25. CHICAGO, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. today announced the closing of its initial public offering of 1,277,778 shares of common stock, including the underwriters' exercise of its over-allotment option, at a public offering price of $8.00 per share before underwriting discounts and commissions.

    Total gross proceeds were approximately $10.2 million.  Total net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, are approximately $9.3 million from the initial public offering.

    The shares began trading on the Nasdaq Capital Market on December 19, 2019 under the symbol "MNPR." 

    JonesTrading Institutional Services LLC acted as Lead Bookrunning Manager and Brookline Capital…

    CHICAGO, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. today announced the closing of its initial public offering of 1,277,778 shares of common stock, including the underwriters' exercise of its over-allotment option, at a public offering price of $8.00 per share before underwriting discounts and commissions.

    Total gross proceeds were approximately $10.2 million.  Total net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, are approximately $9.3 million from the initial public offering.

    The shares began trading on the Nasdaq Capital Market on December 19, 2019 under the symbol "MNPR." 

    JonesTrading Institutional Services LLC acted as Lead Bookrunning Manager and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as Co-Manager for the offering.

    The offering of these securities was made only by means of a prospectus. Copies of the final prospectus may be obtained from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing .

    A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission.  This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these shares in any state in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any state.

    About Monopar Therapeutics Inc.

    Monopar Therapeutics is a clinical stage biopharmaceutical company focused on developing proprietary therapeutics designed to improve clinical outcomes 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 advanced soft tissue sarcoma; and a late-stage preclinical antibody MNPR-101.

    CONTACT:

    Kim R. Tsuchimoto
    Chief Financial Officer

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