MNPR Monopar Therapeutics Inc.

7.18
+0.07  (+1%)
Previous Close 7.11
Open 7.47
52 Week Low 4.94
52 Week High 48
Market Cap $76,352,659
Shares 10,634,075
Float 2,942,460
Enterprise Value $92,541,107
Volume 4,015
Av. Daily Volume 14,022
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Upcoming Catalysts

Drug Stage Catalyst Date
Validive
Oral mucositis
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
Camsirubicin
Soft tissue sarcoma
Phase 2
Phase 2
Phase 2 enrolment to commence 2H 2020.

Latest News

  1. 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

     

    Primary Logo

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  2. 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

     

    Primary Logo

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  3. 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.

    Primary Logo

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  4. 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.

    Primary Logo

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  5. 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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