• Leap Therapeutics Reports Full Year 2016 Financial Results and Progression-Free Survival Data in Advanced Biliary Tract Cancers

    by on March 31st, 2017

    CAMBRIDGE, Mass., March 31, 2017 (GLOBE NEWSWIRE) — Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported financial results for the year ended December 31, 2016 and top-line progression-free survival (PFS) data.

    Preliminary median progression-free survival was 9.4 months in Leap’s clinical trial evaluating DKN-01 in combination with standard of care chemotherapy in patients with advanced biliary tract cancers. The median PFS for standard of care chemotherapy has been reported to be six to eight months. Data from the study has been submitted for presentation at an upcoming medical conference.

    “2016 was an important year for Leap. We became a public company and we generated exciting clinical data from our multiple ongoing clinical studies of two innovative cancer therapeutics,” said Christopher K. Mirabelli, Ph.D, Chief Executive Officer of Leap. “We are especially pleased with the PFS observed in patients with biliary cancers and the clinical data from our industry-leading GITR agonist program.”

    About the DKN-01 P103 Clinical Trial

    The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received two dose levels of DKN-01 in combination with gemcitabine and cisplatin. The primary objective of this study is to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin. The study has recently been expanded to enroll an additional 20 patients to enhance biomarker collection and analysis.

    2016 Accomplishments

    • Presented proof of concept clinical data of DKN-01 in advanced biliary tract and esophagogastric cancers with encouraging overall response and disease control rates at meetings of the European Society for Medical Oncology (ESMO), American Society for Clinical Oncology (ASCO), and the Cholangiocarcinoma Foundation.
    • Identified Wnt-pathway alterations as a potential genetically-defined population for DKN-01 development
    • Developed and presented first observed cases of human pharmacodynamic activity of GITR agonist TRX518 on immunosuppressive T cells.
    • Initiated two repeat-dose TRX518 studies in patients with refractory solid tumors.
    • Commenced trading on the Nasdaq Global Market in January 2017.

    Selected Year-End 2016 Financial Results

    Net loss was $25.6 million for the year ended December 31, 2016, compared to $12.1 million for the year ended December 31, 2015.

    Research and development expenses were $23.3 million for the full year 2016, compared to $10.4 million for the same period in 2015. This increase was primarily due to clinical development expenses and manufacturing costs of our clinical product candidates.

    General and administrative expenses were $4.2 million for the full year 2016, compared to $1.5 million for the same period in 2015. This increase was primarily due to increased personnel and legal expenses to support the company’s expanding operations, including our acquisition of Macrocure Ltd.

    The financial results presented for 2016 represent Leap Therapeutics as a private company, as the merger with Macrocure was completed on January 23, 2017.  The financial results presented also include an unaudited pro-forma calculation of Leap Therapeutics’ balance sheet to present the merger with Macrocure and the related transactions as if they had closed on December 31, 2016. The financial statements for the first quarter 2017 will reflect the actual transaction closing date and subsequent financial results as a public company.

    2017 Objectives and Upcoming Presentations

    DKN-01 Program Objectives

    • Extend biomarker clinical studies to include genetically-identified populations in gastric, liver, ovarian, and uterine cancers
    • Initiate immunotherapy combination study with PD-1 inhibitor
    • Present DKN-01 non-clinical and clinical biomarker data at the 2017 American Association for Cancer Research Annual Meeting
    • Present clinical data of DKN-01 in advanced biliary tract and esophagogastric cancers

    TRX518 Program Objectives

    • Complete enrollment of TRX518-003 repeat-dose monotherapy study in patients with refractory solid tumors
    • Present TRX518 clinical biomarker data at the 2017 American Association for Cancer Research Annual Meeting

    About Leap Therapeutics 
    Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response.  For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements relating to Leap’s expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the Securities and Exchange Commission (the “SEC”), including Leap Therapeutics’ Form 10-K that Leap filed with the SEC on March 31, 2017. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     
    Leap Therapeutics, Inc.
    Condensed Statement of Operations
     
            (Amount in thousands)
            Year Ended December 31,
             2016   2015 
               
    Operating expenses:    
     Research and development $23,292  $10,411 
     General and administrative  4,229   1,511 
       Total operating expenses  27,521   11,922 
    Loss from operations  (27,521)  (11,922)
    Interest income  2   1 
    Interest expense – related party  (1,233)  (129)
    Other income (expense), net  3,120    
    Net loss  (25,632)  (12,050)
               
    Other comprehensive loss:    
    Foreign currency translation adjustments  295   (1)
    Comprehensive loss $(25,337) $(12,051)
               

    Leap Therapeutics, Inc.
    Condensed Balance Sheet
     
            (Amount in thousands)
            December 31,
             2016   2015 
               
    Assets    
    Current assets:    
     Cash and cash equivalents $793  $405 
     Research and development incentive receivable  3,053    
     Prepaid expenses and other current assets  183   89 
         Total current assets  4,029   494 
               
     Property and equipment, net  119    
     Deferred offering costs  1,402    
     Other assets  907   766 
         Total assets $6,457  $1,260 
    Liabilities, Convertible Preferred Stock and Stockholders’ Deficiency    
    Current liabilities:    
     Accounts payable $3,225  $2,048 
     Accrued expenses  2,658   479 
     Notes payable and accrued interest – related party  30,274   3,141 
         Total current liabilities  36,157   5,668 
               
         Total stockholders’ equity  (29,700)  (4,408)
         Total liabilities and stockholders’ equity $6,457  $1,260 
               

    Leap Therapeutics, Inc.
    Condensed Statement of Cash Flows
     
            (Amount in thousands)
            Year Ended December 31,
             2016   2015 
               
    Cash flows from operating activities:  (25,337)  (8,102)
    Cash flows from investing activities:  (144)   
    Cash flows from financing activities:  25,618   8,270 
    Effect of exchange rate changes on cash and cash equivalents  251   (1)
    Net increase (decrease) in cash and cash equivalents  388   167 
    Cash and cash equivalents at beginning of period  405   238 
    Cash and cash equivalents at end of period $793  $405 
               

    CONTACT: CONTACT:
    
    Douglas E. Onsi
    Chief Financial Officer
    Leap Therapeutics, Inc.
    donsi@leaptx.com
    617-714-0360
    
    Argot Partners
    
    Susan Kim
    212-203-4433
    susan@argotpartners.com
    
    or
    
    Heather Savelle
    617-663-4863
    heather@argotpartners.com
  • Leap Therapeutics Reports Full Year 2016 Financial Results and Progression-Free Survival Data in Advanced Biliary Tract Cancers

    by on March 31st, 2017

    CAMBRIDGE, Mass., March 31, 2017 (GLOBE NEWSWIRE) — Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported financial results for the year ended December 31, 2016 and top-line progression-free survival (PFS) data.

    Preliminary median progression-free survival was 9.4 months in Leap’s clinical trial evaluating DKN-01 in combination with standard of care chemotherapy in patients with advanced biliary tract cancers. The median PFS for standard of care chemotherapy has been reported to be six to eight months. Data from the study has been submitted for presentation at an upcoming medical conference.

    “2016 was an important year for Leap. We became a public company and we generated exciting clinical data from our multiple ongoing clinical studies of two innovative cancer therapeutics,” said Christopher K. Mirabelli, Ph.D, Chief Executive Officer of Leap. “We are especially pleased with the PFS observed in patients with biliary cancers and the clinical data from our industry-leading GITR agonist program.”

    About the DKN-01 P103 Clinical Trial

    The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received two dose levels of DKN-01 in combination with gemcitabine and cisplatin. The primary objective of this study is to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin. The study has recently been expanded to enroll an additional 20 patients to enhance biomarker collection and analysis.

    2016 Accomplishments

    • Presented proof of concept clinical data of DKN-01 in advanced biliary tract and esophagogastric cancers with encouraging overall response and disease control rates at meetings of the European Society for Medical Oncology (ESMO), American Society for Clinical Oncology (ASCO), and the Cholangiocarcinoma Foundation.
    • Identified Wnt-pathway alterations as a potential genetically-defined population for DKN-01 development
    • Developed and presented first observed cases of human pharmacodynamic activity of GITR agonist TRX518 on immunosuppressive T cells.
    • Initiated two repeat-dose TRX518 studies in patients with refractory solid tumors.
    • Commenced trading on the Nasdaq Global Market in January 2017.

    Selected Year-End 2016 Financial Results

    Net loss was $25.6 million for the year ended December 31, 2016, compared to $12.1 million for the year ended December 31, 2015.

    Research and development expenses were $23.3 million for the full year 2016, compared to $10.4 million for the same period in 2015. This increase was primarily due to clinical development expenses and manufacturing costs of our clinical product candidates.

    General and administrative expenses were $4.2 million for the full year 2016, compared to $1.5 million for the same period in 2015. This increase was primarily due to increased personnel and legal expenses to support the company’s expanding operations, including our acquisition of Macrocure Ltd.

    The financial results presented for 2016 represent Leap Therapeutics as a private company, as the merger with Macrocure was completed on January 23, 2017.  The financial results presented also include an unaudited pro-forma calculation of Leap Therapeutics’ balance sheet to present the merger with Macrocure and the related transactions as if they had closed on December 31, 2016. The financial statements for the first quarter 2017 will reflect the actual transaction closing date and subsequent financial results as a public company.

    2017 Objectives and Upcoming Presentations

    DKN-01 Program Objectives

    • Extend biomarker clinical studies to include genetically-identified populations in gastric, liver, ovarian, and uterine cancers
    • Initiate immunotherapy combination study with PD-1 inhibitor
    • Present DKN-01 non-clinical and clinical biomarker data at the 2017 American Association for Cancer Research Annual Meeting
    • Present clinical data of DKN-01 in advanced biliary tract and esophagogastric cancers

    TRX518 Program Objectives

    • Complete enrollment of TRX518-003 repeat-dose monotherapy study in patients with refractory solid tumors
    • Present TRX518 clinical biomarker data at the 2017 American Association for Cancer Research Annual Meeting

    About Leap Therapeutics 
    Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response.  For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements relating to Leap’s expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the Securities and Exchange Commission (the “SEC”), including Leap Therapeutics’ Form 10-K that Leap filed with the SEC on March 31, 2017. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     
    Leap Therapeutics, Inc.
    Condensed Statement of Operations
     
            (Amount in thousands)
            Year Ended December 31,
             2016   2015 
               
    Operating expenses:    
     Research and development $23,292  $10,411 
     General and administrative  4,229   1,511 
       Total operating expenses  27,521   11,922 
    Loss from operations  (27,521)  (11,922)
    Interest income  2   1 
    Interest expense – related party  (1,233)  (129)
    Other income (expense), net  3,120    
    Net loss  (25,632)  (12,050)
               
    Other comprehensive loss:    
    Foreign currency translation adjustments  295   (1)
    Comprehensive loss $(25,337) $(12,051)
               

    Leap Therapeutics, Inc.
    Condensed Balance Sheet
     
            (Amount in thousands)
            December 31,
             2016   2015 
               
    Assets    
    Current assets:    
     Cash and cash equivalents $793  $405 
     Research and development incentive receivable  3,053    
     Prepaid expenses and other current assets  183   89 
         Total current assets  4,029   494 
               
     Property and equipment, net  119    
     Deferred offering costs  1,402    
     Other assets  907   766 
         Total assets $6,457  $1,260 
    Liabilities, Convertible Preferred Stock and Stockholders’ Deficiency    
    Current liabilities:    
     Accounts payable $3,225  $2,048 
     Accrued expenses  2,658   479 
     Notes payable and accrued interest – related party  30,274   3,141 
         Total current liabilities  36,157   5,668 
               
         Total stockholders’ equity  (29,700)  (4,408)
         Total liabilities and stockholders’ equity $6,457  $1,260 
               

    Leap Therapeutics, Inc.
    Condensed Statement of Cash Flows
     
            (Amount in thousands)
            Year Ended December 31,
             2016   2015 
               
    Cash flows from operating activities:  (25,337)  (8,102)
    Cash flows from investing activities:  (144)   
    Cash flows from financing activities:  25,618   8,270 
    Effect of exchange rate changes on cash and cash equivalents  251   (1)
    Net increase (decrease) in cash and cash equivalents  388   167 
    Cash and cash equivalents at beginning of period  405   238 
    Cash and cash equivalents at end of period $793  $405 
               

    CONTACT: CONTACT:
    
    Douglas E. Onsi
    Chief Financial Officer
    Leap Therapeutics, Inc.
    donsi@leaptx.com
    617-714-0360
    
    Argot Partners
    
    Susan Kim
    212-203-4433
    susan@argotpartners.com
    
    or
    
    Heather Savelle
    617-663-4863
    heather@argotpartners.com
  • Leap Therapeutics Reports Full Year 2016 Financial Results and Progression-Free Survival Data in Advanced Biliary Tract Cancers

    by on March 31st, 2017

    CAMBRIDGE, Mass., March 31, 2017 (GLOBE NEWSWIRE) — Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported financial results for the year ended December 31, 2016 and top-line progression-free survival (PFS) data.

    Preliminary median progression-free survival was 9.4 months in Leap’s clinical trial evaluating DKN-01 in combination with standard of care chemotherapy in patients with advanced biliary tract cancers. The median PFS for standard of care chemotherapy has been reported to be six to eight months. Data from the study has been submitted for presentation at an upcoming medical conference.

    “2016 was an important year for Leap. We became a public company and we generated exciting clinical data from our multiple ongoing clinical studies of two innovative cancer therapeutics,” said Christopher K. Mirabelli, Ph.D, Chief Executive Officer of Leap. “We are especially pleased with the PFS observed in patients with biliary cancers and the clinical data from our industry-leading GITR agonist program.”

    About the DKN-01 P103 Clinical Trial

    The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received two dose levels of DKN-01 in combination with gemcitabine and cisplatin. The primary objective of this study is to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin. The study has recently been expanded to enroll an additional 20 patients to enhance biomarker collection and analysis.

    2016 Accomplishments

    • Presented proof of concept clinical data of DKN-01 in advanced biliary tract and esophagogastric cancers with encouraging overall response and disease control rates at meetings of the European Society for Medical Oncology (ESMO), American Society for Clinical Oncology (ASCO), and the Cholangiocarcinoma Foundation.
    • Identified Wnt-pathway alterations as a potential genetically-defined population for DKN-01 development
    • Developed and presented first observed cases of human pharmacodynamic activity of GITR agonist TRX518 on immunosuppressive T cells.
    • Initiated two repeat-dose TRX518 studies in patients with refractory solid tumors.
    • Commenced trading on the Nasdaq Global Market in January 2017.

    Selected Year-End 2016 Financial Results

    Net loss was $25.6 million for the year ended December 31, 2016, compared to $12.1 million for the year ended December 31, 2015.

    Research and development expenses were $23.3 million for the full year 2016, compared to $10.4 million for the same period in 2015. This increase was primarily due to clinical development expenses and manufacturing costs of our clinical product candidates.

    General and administrative expenses were $4.2 million for the full year 2016, compared to $1.5 million for the same period in 2015. This increase was primarily due to increased personnel and legal expenses to support the company’s expanding operations, including our acquisition of Macrocure Ltd.

    The financial results presented for 2016 represent Leap Therapeutics as a private company, as the merger with Macrocure was completed on January 23, 2017.  The financial results presented also include an unaudited pro-forma calculation of Leap Therapeutics’ balance sheet to present the merger with Macrocure and the related transactions as if they had closed on December 31, 2016. The financial statements for the first quarter 2017 will reflect the actual transaction closing date and subsequent financial results as a public company.

    2017 Objectives and Upcoming Presentations

    DKN-01 Program Objectives

    • Extend biomarker clinical studies to include genetically-identified populations in gastric, liver, ovarian, and uterine cancers
    • Initiate immunotherapy combination study with PD-1 inhibitor
    • Present DKN-01 non-clinical and clinical biomarker data at the 2017 American Association for Cancer Research Annual Meeting
    • Present clinical data of DKN-01 in advanced biliary tract and esophagogastric cancers

    TRX518 Program Objectives

    • Complete enrollment of TRX518-003 repeat-dose monotherapy study in patients with refractory solid tumors
    • Present TRX518 clinical biomarker data at the 2017 American Association for Cancer Research Annual Meeting

    About Leap Therapeutics 
    Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response.  For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements relating to Leap’s expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the Securities and Exchange Commission (the “SEC”), including Leap Therapeutics’ Form 10-K that Leap filed with the SEC on March 31, 2017. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     
    Leap Therapeutics, Inc.
    Condensed Statement of Operations
     
            (Amount in thousands)
            Year Ended December 31,
             2016   2015 
               
    Operating expenses:    
     Research and development $23,292  $10,411 
     General and administrative  4,229   1,511 
       Total operating expenses  27,521   11,922 
    Loss from operations  (27,521)  (11,922)
    Interest income  2   1 
    Interest expense – related party  (1,233)  (129)
    Other income (expense), net  3,120    
    Net loss  (25,632)  (12,050)
               
    Other comprehensive loss:    
    Foreign currency translation adjustments  295   (1)
    Comprehensive loss $(25,337) $(12,051)
               

    Leap Therapeutics, Inc.
    Condensed Balance Sheet
     
            (Amount in thousands)
            December 31,
             2016   2015 
               
    Assets    
    Current assets:    
     Cash and cash equivalents $793  $405 
     Research and development incentive receivable  3,053    
     Prepaid expenses and other current assets  183   89 
         Total current assets  4,029   494 
               
     Property and equipment, net  119    
     Deferred offering costs  1,402    
     Other assets  907   766 
         Total assets $6,457  $1,260 
    Liabilities, Convertible Preferred Stock and Stockholders’ Deficiency    
    Current liabilities:    
     Accounts payable $3,225  $2,048 
     Accrued expenses  2,658   479 
     Notes payable and accrued interest – related party  30,274   3,141 
         Total current liabilities  36,157   5,668 
               
         Total stockholders’ equity  (29,700)  (4,408)
         Total liabilities and stockholders’ equity $6,457  $1,260 
               

    Leap Therapeutics, Inc.
    Condensed Statement of Cash Flows
     
            (Amount in thousands)
            Year Ended December 31,
             2016   2015 
               
    Cash flows from operating activities:  (25,337)  (8,102)
    Cash flows from investing activities:  (144)   
    Cash flows from financing activities:  25,618   8,270 
    Effect of exchange rate changes on cash and cash equivalents  251   (1)
    Net increase (decrease) in cash and cash equivalents  388   167 
    Cash and cash equivalents at beginning of period  405   238 
    Cash and cash equivalents at end of period $793  $405 
               

    CONTACT: CONTACT:
    
    Douglas E. Onsi
    Chief Financial Officer
    Leap Therapeutics, Inc.
    donsi@leaptx.com
    617-714-0360
    
    Argot Partners
    
    Susan Kim
    212-203-4433
    susan@argotpartners.com
    
    or
    
    Heather Savelle
    617-663-4863
    heather@argotpartners.com
  • Leap Therapeutics Reports Full Year 2016 Financial Results and Progression-Free Survival Data in Advanced Biliary Tract Cancers

    by on March 31st, 2017

    CAMBRIDGE, Mass., March 31, 2017 (GLOBE NEWSWIRE) — Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported financial results for the year ended December 31, 2016 and top-line progression-free survival (PFS) data.

    Preliminary median progression-free survival was 9.4 months in Leap’s clinical trial evaluating DKN-01 in combination with standard of care chemotherapy in patients with advanced biliary tract cancers. The median PFS for standard of care chemotherapy has been reported to be six to eight months. Data from the study has been submitted for presentation at an upcoming medical conference.

    “2016 was an important year for Leap. We became a public company and we generated exciting clinical data from our multiple ongoing clinical studies of two innovative cancer therapeutics,” said Christopher K. Mirabelli, Ph.D, Chief Executive Officer of Leap. “We are especially pleased with the PFS observed in patients with biliary cancers and the clinical data from our industry-leading GITR agonist program.”

    About the DKN-01 P103 Clinical Trial

    The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received two dose levels of DKN-01 in combination with gemcitabine and cisplatin. The primary objective of this study is to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin. The study has recently been expanded to enroll an additional 20 patients to enhance biomarker collection and analysis.

    2016 Accomplishments

    • Presented proof of concept clinical data of DKN-01 in advanced biliary tract and esophagogastric cancers with encouraging overall response and disease control rates at meetings of the European Society for Medical Oncology (ESMO), American Society for Clinical Oncology (ASCO), and the Cholangiocarcinoma Foundation.
    • Identified Wnt-pathway alterations as a potential genetically-defined population for DKN-01 development
    • Developed and presented first observed cases of human pharmacodynamic activity of GITR agonist TRX518 on immunosuppressive T cells.
    • Initiated two repeat-dose TRX518 studies in patients with refractory solid tumors.
    • Commenced trading on the Nasdaq Global Market in January 2017.

    Selected Year-End 2016 Financial Results

    Net loss was $25.6 million for the year ended December 31, 2016, compared to $12.1 million for the year ended December 31, 2015.

    Research and development expenses were $23.3 million for the full year 2016, compared to $10.4 million for the same period in 2015. This increase was primarily due to clinical development expenses and manufacturing costs of our clinical product candidates.

    General and administrative expenses were $4.2 million for the full year 2016, compared to $1.5 million for the same period in 2015. This increase was primarily due to increased personnel and legal expenses to support the company’s expanding operations, including our acquisition of Macrocure Ltd.

    The financial results presented for 2016 represent Leap Therapeutics as a private company, as the merger with Macrocure was completed on January 23, 2017.  The financial results presented also include an unaudited pro-forma calculation of Leap Therapeutics’ balance sheet to present the merger with Macrocure and the related transactions as if they had closed on December 31, 2016. The financial statements for the first quarter 2017 will reflect the actual transaction closing date and subsequent financial results as a public company.

    2017 Objectives and Upcoming Presentations

    DKN-01 Program Objectives

    • Extend biomarker clinical studies to include genetically-identified populations in gastric, liver, ovarian, and uterine cancers
    • Initiate immunotherapy combination study with PD-1 inhibitor
    • Present DKN-01 non-clinical and clinical biomarker data at the 2017 American Association for Cancer Research Annual Meeting
    • Present clinical data of DKN-01 in advanced biliary tract and esophagogastric cancers

    TRX518 Program Objectives

    • Complete enrollment of TRX518-003 repeat-dose monotherapy study in patients with refractory solid tumors
    • Present TRX518 clinical biomarker data at the 2017 American Association for Cancer Research Annual Meeting

    About Leap Therapeutics 
    Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response.  For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements relating to Leap’s expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the Securities and Exchange Commission (the “SEC”), including Leap Therapeutics’ Form 10-K that Leap filed with the SEC on March 31, 2017. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     
    Leap Therapeutics, Inc.
    Condensed Statement of Operations
     
            (Amount in thousands)
            Year Ended December 31,
             2016   2015 
               
    Operating expenses:    
     Research and development $23,292  $10,411 
     General and administrative  4,229   1,511 
       Total operating expenses  27,521   11,922 
    Loss from operations  (27,521)  (11,922)
    Interest income  2   1 
    Interest expense – related party  (1,233)  (129)
    Other income (expense), net  3,120    
    Net loss  (25,632)  (12,050)
               
    Other comprehensive loss:    
    Foreign currency translation adjustments  295   (1)
    Comprehensive loss $(25,337) $(12,051)
               

    Leap Therapeutics, Inc.
    Condensed Balance Sheet
     
            (Amount in thousands)
            December 31,
             2016   2015 
               
    Assets    
    Current assets:    
     Cash and cash equivalents $793  $405 
     Research and development incentive receivable  3,053    
     Prepaid expenses and other current assets  183   89 
         Total current assets  4,029   494 
               
     Property and equipment, net  119    
     Deferred offering costs  1,402    
     Other assets  907   766 
         Total assets $6,457  $1,260 
    Liabilities, Convertible Preferred Stock and Stockholders’ Deficiency    
    Current liabilities:    
     Accounts payable $3,225  $2,048 
     Accrued expenses  2,658   479 
     Notes payable and accrued interest – related party  30,274   3,141 
         Total current liabilities  36,157   5,668 
               
         Total stockholders’ equity  (29,700)  (4,408)
         Total liabilities and stockholders’ equity $6,457  $1,260 
               

    Leap Therapeutics, Inc.
    Condensed Statement of Cash Flows
     
            (Amount in thousands)
            Year Ended December 31,
             2016   2015 
               
    Cash flows from operating activities:  (25,337)  (8,102)
    Cash flows from investing activities:  (144)   
    Cash flows from financing activities:  25,618   8,270 
    Effect of exchange rate changes on cash and cash equivalents  251   (1)
    Net increase (decrease) in cash and cash equivalents  388   167 
    Cash and cash equivalents at beginning of period  405   238 
    Cash and cash equivalents at end of period $793  $405 
               

    CONTACT: CONTACT:
    
    Douglas E. Onsi
    Chief Financial Officer
    Leap Therapeutics, Inc.
    donsi@leaptx.com
    617-714-0360
    
    Argot Partners
    
    Susan Kim
    212-203-4433
    susan@argotpartners.com
    
    or
    
    Heather Savelle
    617-663-4863
    heather@argotpartners.com
  • Loxo Oncology Announces Proof of Concept Clinical Data for Larotrectinib in TRK Fusion Glioblastoma Presented at the AACR Annual Meeting 2017

    by on March 31st, 2017

    STAMFORD, Conn., March 31, 2017 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that larotrectinib (LOXO-101) data will be presented at the American Association for Cancer Research (AACR) 2017 Annual Meeting taking place April 1 – 5, 2017, in Washington, DC.

    The abstract and poster describe initial clinical data across the larotrectinib program for all patients with TRK fusion primary CNS cancers. The cases include three patients with glioblastoma: one patient treated under an expanded access protocol and two patients treated in the ongoing Phase 2 NAVIGATE trial. In the cases described, larotrectinib showed preliminary evidence of anti-tumor activity. The expanded access patient, described in detail in the abstract, had progressed through prior radiation, temozolomide and bevacizumab and demonstrated a brief mixed radiographic response on larotrectinib in the context of a molecularly complex tumor (select regions of the tumor harbored a TRK fusion, while others did not). The two patients treated in NAVIGATE, described in the poster, were enrolled following progression on chemoradiation and temozolomide (both cases) and bevacizumab (one case).  The NAVIGATE patients remain on therapy at four months with radiographic evidence of treatment effect, as of a March 13, 2017 data cut-off date. Glioblastomas are highly aggressive CNS tumors, particularly in the post-bevacizumab setting where median overall survival is typically three to six months. Global regulatory discussions have established that primary CNS tumors, including glioblastoma, will not be included in the primary efficacy analysis dataset intended to support initial drug approval, though they are being enrolled in a dedicated treatment arm of NAVIGATE.  

    “Glioblastomas have historically defied rational targeted therapy approaches, so we are encouraged that larotrectinib may have a role in treating TRK fusion presentations of this devastating disease.  We hope these early data lead to increased molecular profiling and referrals to appropriate clinical trials,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology.  “We knew it would be necessary to evaluate these patients separately from our primary efficacy dataset, which relies on a RECIST overall response rate primary endpoint.  Given the limitations around response assessment in neuro-oncology, randomized survival trials remain the gold standard for evaluating new drugs in primary CNS cancers. However, patients with systemic tumors that have metastasized to the brain are included in our primary efficacy dataset, though they have been exceedingly uncommon.  As illustrated in our adult Phase 1 dataset and this AACR poster, we are pleased with larotrectinib’s ability to enter the CNS in a tolerated fashion and address TRK fusion tumors.”

    Abstracts from the AACR Annual Meeting 2017 are available online on the conference website.

    The details of the poster presentation are as follows:

    Date: April 5, 2017, 8:00am – 12:00pm ET
    Title: Potential role of larotrectinib (LOXO-101), a selective pan-TRK inhibitor, in NTRK fusion-positive recurrent glioblastoma
    Session: Late-Breaking Research: Experimental and Molecular Therapeutics II
    Abstract Code: LB-302
    Poster Board Number: 10
    Session Location: Poster Section 34

    About Larotrectinib (LOXO-101)
    Larotrectinib (LOXO-101) is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, larotrectinib has demonstrated encouraging preliminary efficacy. Larotrectinib is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and the SCOUT Phase 1/2 trial in pediatric patients, including patients with advanced cancer, TRK gene fusions and infantile fibrosarcoma. Larotrectinib has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

    About Loxo Oncology
    Loxo Oncology is a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers. Our pipeline focuses on cancers that are uniquely dependent on single gene abnormalities, such that a single drug has the potential to treat the cancer with dramatic effect. We believe that the most selective, purpose-built medicines have the highest probability of maximally inhibiting the intended target, thereby delivering best-in-class disease control and safety. Our management team seeks out experienced industry partners, world-class scientific advisors and innovative clinical-regulatory approaches to deliver new cancer therapies to patients as quickly and efficiently as possible. For more information, please visit the company’s website at www.loxooncology.com.

    Forward Looking Statements
    This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, the availability of funding, timing and success of our clinical trials, success in our collaborations and the potential therapeutic benefits of our lead product candidate or other product candidates. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Annual Report on Form 10-K, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

    Contacts for Loxo Oncology, Inc.
    Company:
    Jacob S. Van Naarden
    Chief Business Officer
    jake@loxooncology.com 

    Investors:
    Peter Rahmer
    The Trout Group, LLC
    646-378-2973
    prahmer@troutgroup.com 

    Media:
    Dan Budwick
    Pure Communications, Inc.
    973-271-6085
    dan@purecommunicationsinc.com 
    Loxo Oncology, Inc. 

  • Loxo Oncology Announces Proof of Concept Clinical Data for Larotrectinib in TRK Fusion Glioblastoma Presented at the AACR Annual Meeting 2017

    by on March 31st, 2017

    STAMFORD, Conn., March 31, 2017 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that larotrectinib (LOXO-101) data will be presented at the American Association for Cancer Research (AACR) 2017 Annual Meeting taking place April 1 – 5, 2017, in Washington, DC.

    The abstract and poster describe initial clinical data across the larotrectinib program for all patients with TRK fusion primary CNS cancers. The cases include three patients with glioblastoma: one patient treated under an expanded access protocol and two patients treated in the ongoing Phase 2 NAVIGATE trial. In the cases described, larotrectinib showed preliminary evidence of anti-tumor activity. The expanded access patient, described in detail in the abstract, had progressed through prior radiation, temozolomide and bevacizumab and demonstrated a brief mixed radiographic response on larotrectinib in the context of a molecularly complex tumor (select regions of the tumor harbored a TRK fusion, while others did not). The two patients treated in NAVIGATE, described in the poster, were enrolled following progression on chemoradiation and temozolomide (both cases) and bevacizumab (one case).  The NAVIGATE patients remain on therapy at four months with radiographic evidence of treatment effect, as of a March 13, 2017 data cut-off date. Glioblastomas are highly aggressive CNS tumors, particularly in the post-bevacizumab setting where median overall survival is typically three to six months. Global regulatory discussions have established that primary CNS tumors, including glioblastoma, will not be included in the primary efficacy analysis dataset intended to support initial drug approval, though they are being enrolled in a dedicated treatment arm of NAVIGATE.  

    “Glioblastomas have historically defied rational targeted therapy approaches, so we are encouraged that larotrectinib may have a role in treating TRK fusion presentations of this devastating disease.  We hope these early data lead to increased molecular profiling and referrals to appropriate clinical trials,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology.  “We knew it would be necessary to evaluate these patients separately from our primary efficacy dataset, which relies on a RECIST overall response rate primary endpoint.  Given the limitations around response assessment in neuro-oncology, randomized survival trials remain the gold standard for evaluating new drugs in primary CNS cancers. However, patients with systemic tumors that have metastasized to the brain are included in our primary efficacy dataset, though they have been exceedingly uncommon.  As illustrated in our adult Phase 1 dataset and this AACR poster, we are pleased with larotrectinib’s ability to enter the CNS in a tolerated fashion and address TRK fusion tumors.”

    Abstracts from the AACR Annual Meeting 2017 are available online on the conference website.

    The details of the poster presentation are as follows:

    Date: April 5, 2017, 8:00am – 12:00pm ET
    Title: Potential role of larotrectinib (LOXO-101), a selective pan-TRK inhibitor, in NTRK fusion-positive recurrent glioblastoma
    Session: Late-Breaking Research: Experimental and Molecular Therapeutics II
    Abstract Code: LB-302
    Poster Board Number: 10
    Session Location: Poster Section 34

    About Larotrectinib (LOXO-101)
    Larotrectinib (LOXO-101) is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, larotrectinib has demonstrated encouraging preliminary efficacy. Larotrectinib is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and the SCOUT Phase 1/2 trial in pediatric patients, including patients with advanced cancer, TRK gene fusions and infantile fibrosarcoma. Larotrectinib has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

    About Loxo Oncology
    Loxo Oncology is a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers. Our pipeline focuses on cancers that are uniquely dependent on single gene abnormalities, such that a single drug has the potential to treat the cancer with dramatic effect. We believe that the most selective, purpose-built medicines have the highest probability of maximally inhibiting the intended target, thereby delivering best-in-class disease control and safety. Our management team seeks out experienced industry partners, world-class scientific advisors and innovative clinical-regulatory approaches to deliver new cancer therapies to patients as quickly and efficiently as possible. For more information, please visit the company’s website at www.loxooncology.com.

    Forward Looking Statements
    This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, the availability of funding, timing and success of our clinical trials, success in our collaborations and the potential therapeutic benefits of our lead product candidate or other product candidates. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Annual Report on Form 10-K, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

    Contacts for Loxo Oncology, Inc.
    Company:
    Jacob S. Van Naarden
    Chief Business Officer
    jake@loxooncology.com 

    Investors:
    Peter Rahmer
    The Trout Group, LLC
    646-378-2973
    prahmer@troutgroup.com 

    Media:
    Dan Budwick
    Pure Communications, Inc.
    973-271-6085
    dan@purecommunicationsinc.com 
    Loxo Oncology, Inc. 

  • CORRECTING and REPLACING — FLX Bio to Present Poster at the American Association of Cancer Research (AACR) Conference on its Lead Immuno-Oncology Program Targeting CCR4

    by on March 31st, 2017

    In a release issued under the same headline earlier today by FLX Bio, Inc., please note that the link to the abstract title under the Abstract information section was incorrect and has now been updated to the correct link. The corrected release follows: 

    SOUTH SAN FRANCISCO, Calif., March 31, 2017 (GLOBE NEWSWIRE) — FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of novel immuno-oncology (IO) agents and molecularly-targeted therapies, announced today that it will present a poster with preclinical data for its C-C Chemokine Receptor 4 (CCR4) antagonist compounds, at the American Association of Cancer Research (AACR) Conference to be held April 1-5, 2017, in Washington, D.C.

    CCR4 is a non-redundant mechanism for selectively recruiting regulatory T cells (Treg) to the tumor microenvironment. Treg dampen anti-tumor immune responses and worsen outcomes by suppressing effector T cells and dendritic cells. FLX Bio has developed best-in-class, orally-administered potent and selective CCR4 antagonists that reduce tumor Treg and inhibit tumor growth in murine models when combined with other IO agents. In contrast to the non-selective approach using anti-CCR4 depleting antibodies, FLX Bio’s CCR4 antagonists reduce Treg in the tumor, but not in peripheral tissues and represent a potentially safer approach. FLX Bio’s CCR4 antagonists are currently in preclinical development, and its lead CCR4 antagonist compound is expected to enter the clinic in 2017.

    Alexander Rudensky, Chairman of FLX Bio’s Scientific Advisory Board and Chair of the Immunology Program at the Sloan Kettering Institute, Director of the Ludwig Center for Cancer Immunotherapy at Memorial Sloan Kettering Cancer Center and Member, National Academy of Sciences said, “CCR4 is a highly promising target to selectively block Treg recruitment into the tumor microenvironment. FLX Bio has developed a novel series of small molecule CCR4 antagonists that have demonstrated excellent preclinical efficacy data, with potentially broad utility in combination with checkpoint inhibitors, immune agonists, CAR-T and cancer vaccine approaches.”

    Abstract information:

    Title: Potent and selective C-C chemokine receptor (CCR4) antagonists potentiate anti-tumor responses by inhibitory regulatory T cells (Treg)
    Number: 4600
    Presenter: Oezcan Talay
    Session: Poster Section 25. Immunology. Checkpoints 1
    Time and Location:
    Sunday, April 2, 2017: 1 pm – 5 pm
    Exhibition Hall, Section 25
    Walter E. Washington Convention Center
    Washington, D.C.

    About FLX Bio
    Founded in 2015 following the acquisition of its predecessor company, Flexus Biosciences, Inc., by Bristol-Myers Squibb, FLX Bio, Inc. is a privately-held biopharmaceutical company focused on the discovery, development and commercialization of novel immuno-oncology agents. The company leverages its unique insights in cancer biology and the immune system to discover and develop novel oral medicines that activate immune responses to eliminate cancer cells.

    Located in South San Francisco, Calif., and funded by leading investors, including Kleiner Perkins Caufield & Byers (KPCB), The Column Group (TCG), Topspin Partners and Celgene, FLX Bio has assembled a leadership team and advisory group with a proven track record of success and team of scientists with substantial knowledge and expertise in drug discovery and translational areas essential to execute on this approach. For more information, please visit www.flxbio.com.

    CONTACT: Contact: inquiries@flxbio.com
    Media Contact: Stephanie@ashecommunications.com
  • CORRECTING and REPLACING — FLX Bio to Present Poster at the American Association of Cancer Research (AACR) Conference on its Lead Immuno-Oncology Program Targeting CCR4

    by on March 31st, 2017

    In a release issued under the same headline earlier today by FLX Bio, Inc., please note that the link to the abstract title under the Abstract information section was incorrect and has now been updated to the correct link. The corrected release follows: 

    SOUTH SAN FRANCISCO, Calif., March 31, 2017 (GLOBE NEWSWIRE) — FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of novel immuno-oncology (IO) agents and molecularly-targeted therapies, announced today that it will present a poster with preclinical data for its C-C Chemokine Receptor 4 (CCR4) antagonist compounds, at the American Association of Cancer Research (AACR) Conference to be held April 1-5, 2017, in Washington, D.C.

    CCR4 is a non-redundant mechanism for selectively recruiting regulatory T cells (Treg) to the tumor microenvironment. Treg dampen anti-tumor immune responses and worsen outcomes by suppressing effector T cells and dendritic cells. FLX Bio has developed best-in-class, orally-administered potent and selective CCR4 antagonists that reduce tumor Treg and inhibit tumor growth in murine models when combined with other IO agents. In contrast to the non-selective approach using anti-CCR4 depleting antibodies, FLX Bio’s CCR4 antagonists reduce Treg in the tumor, but not in peripheral tissues and represent a potentially safer approach. FLX Bio’s CCR4 antagonists are currently in preclinical development, and its lead CCR4 antagonist compound is expected to enter the clinic in 2017.

    Alexander Rudensky, Chairman of FLX Bio’s Scientific Advisory Board and Chair of the Immunology Program at the Sloan Kettering Institute, Director of the Ludwig Center for Cancer Immunotherapy at Memorial Sloan Kettering Cancer Center and Member, National Academy of Sciences said, “CCR4 is a highly promising target to selectively block Treg recruitment into the tumor microenvironment. FLX Bio has developed a novel series of small molecule CCR4 antagonists that have demonstrated excellent preclinical efficacy data, with potentially broad utility in combination with checkpoint inhibitors, immune agonists, CAR-T and cancer vaccine approaches.”

    Abstract information:

    Title: Potent and selective C-C chemokine receptor (CCR4) antagonists potentiate anti-tumor responses by inhibitory regulatory T cells (Treg)
    Number: 4600
    Presenter: Oezcan Talay
    Session: Poster Section 25. Immunology. Checkpoints 1
    Time and Location:
    Sunday, April 2, 2017: 1 pm – 5 pm
    Exhibition Hall, Section 25
    Walter E. Washington Convention Center
    Washington, D.C.

    About FLX Bio
    Founded in 2015 following the acquisition of its predecessor company, Flexus Biosciences, Inc., by Bristol-Myers Squibb, FLX Bio, Inc. is a privately-held biopharmaceutical company focused on the discovery, development and commercialization of novel immuno-oncology agents. The company leverages its unique insights in cancer biology and the immune system to discover and develop novel oral medicines that activate immune responses to eliminate cancer cells.

    Located in South San Francisco, Calif., and funded by leading investors, including Kleiner Perkins Caufield & Byers (KPCB), The Column Group (TCG), Topspin Partners and Celgene, FLX Bio has assembled a leadership team and advisory group with a proven track record of success and team of scientists with substantial knowledge and expertise in drug discovery and translational areas essential to execute on this approach. For more information, please visit www.flxbio.com.

    CONTACT: Contact: inquiries@flxbio.com
    Media Contact: Stephanie@ashecommunications.com
  • MPI publishes Annual Report for 2016

    by on March 31st, 2017

    Medical Prognosis Institute A/S (“MPI”) publishes the Annual Report for 2016. For the complete report, see the following link Annual Report 2016. A summary of the Annual Report is presented below.

    Selected announcements and News 2016

    • December 30th – MPI announced that the company and Oncology Venture have entered into agreements about: an exchange of exclusivity for warrants, an agreement regarding 2X Oncology Inc. with three anticancer products in pipeline and finally establishment of new OV-SPV2 – project Tyrosine Kinase inhibitor.
    • October 28th – MPI announces that an article has been accepted for publication in the Danish Journal Best Practice on the Drug Response Prediction (DRP(TM)) for Oncology Ventures immuno-oncology product APO010 for Multiple Myeloma.
    • October 10th – MPI announces that the poster #134P: APO010 sensitivity in relapsed Multiple Myeloma patients is presented at ESMO Annual Congress 2016 in Copenhagen, Denmark.
    • October 8th – MPI announces that the poster #1187P on DRP prediction “Multigene expression profile for predicting efficacy of cisplatin and vinorelbine in non-small cell lung cancer” is presented at ESMO Annual Congress 2016 in Copenhagen, Denmark.
    • September 27th – MPI is granted patent on the Drug Response Predictor technology in China.
    • September 20th – MPI’s spinout Oncology Venture signs partnership deal with Cadila Pharmaceuticals on LiPlaCis using MPI’s DRP technology.
    • September 14th – MPI announced that its Personalized Response Predictor PRP(TM) is to be studied in collaboration with Breast Cancer Experts at Danish oncology departments.
    • September 9th – MPIs spinout Oncology Venture incorporates 2X Oncology Inc., a Women’s Cancer Company in the United States.
    • August 23rd – MPI announces that the first patient with metastatic Breast Cancer included in the extension – proof of concept part of the LiPlaCis trial, has obtained a confirmed Partial Remission (ie >30% reduction of her tumor).
    • July 5th – MPI and Oncology Venture enhances the collaboration by entering another agreement on DRP’s.
    • June 21st – MPI announces that the company has been approved for listing on Nasdaq Stockholm First North and has received formal approval from the marketplace. First day of trading is June 27th 2016.
    • May 31st – MPI announces that the first patient has been dosed in the first prospective study using the DRP(TM). The DRP(TM) will be used in the LiPlaCis proof of concept extension phase study conducted by Oncology Venture.
    • May 12th – MPI announces that positive data on their Drug Response Predictor (DRP), has been published in the journal PLOS ONE.
    • April 27th – MPI and Oncology Venture enters three new agreements on DRP’s.
    • March 10th – MPI announced that the first patient has been included in the APO010 Screening Protocol for Multiple Myeloma by MPI’s spinout Oncology Venture.
    • March 4th – MPI and Oncology Venture announces that data from phase 1 dose-escalating PoC study to evaluate the safety and tolerability of LiPlaCis in patients with advanced refractory tumors will be presented at the AACR (American Association for Cancer Research) Annual Meeting.
    • February 19th – MPI raises DKK 8,686,575 in a private placement.
    • February 17th – MPI publishes positive results with DRPTM tool in gastroesophageal cancer.
    • January 28th – MPI is issued patent in Australia.

    Income statement
    Revenue amounted to DKK 4,990,407 in 2016 (DKK 5,837,783 for the corresponding period in 2015). Revenue for the 2nd half of 2016 amounted to DKK 3,141,203 (DKK 5,156,703) for the corresponding period in 2015). Gross loss amounted to DKK -8,452,816 (DKK -8,216,885 for the corresponding period in 2015). The development in gross profit margin amounted to -169 % (last year -141 %). Gross loss for the 2nd half of 2016 amounted to DKK -4,692,004 (DKK -1,866,659 for the corresponding period in 2015). The development in gross profit margin for the 2nd half of 2016 amounted to -148 % (last year -44 %). Staff expenses amounted to DKK 2,575,203 (last year DKK 2,501,562). Staff expenses for the 2nd half of 2016 amounted to DKK -1,360,102 (DKK -1,199,601 for the corresponding period in 2015). Profit/loss before financial income and expenses showed a loss of DKK 11,522,564 (last year a loss of DKK 11,036,202). This loss was in line with the guidance in the half year interim report. Profit/loss from ordinary activities before tax to a loss of DKK 11,473,192 (last year a loss of DKK 11,149,476). Tax income amounted to DKK 2,743,808 (last year DKK 2,783,774) and relates to tax refund of the tax losses from research and development costs. The Company realized a net loss of DKK 8,729,384 (last year a net loss of DKK 8,365,702). Net loss for the 2nd half of 2016 amounted to DKK -4,649,591 (DKK -2,280,160 for the corresponding period in 2015).

    Balance sheet
    Total assets amounted to DKK 53,622,958 (last year DKK 29,183,331) and primarily consist of investments in associates. Total liabilities amounted to DKK 53,622,958 (last year DKK 29,183,331) and primarily consist of the Company’s equity, DKK 50,234,430 (last year DKK 25,611,896).

    Cash flows
    The Company’s cash flows from operating activities were a negative DKK 8,748,714 (last year a negative DKK 9,752,262).

    Outlook for 2017
    The Company expects a result in the same range in 2017 as in 2016 and that the positive development continues.

    Subsequent events
    No events materially affecting the assessment of the Annual Report have occurred after the balance sheet date.

    Distribution of profit
    The Board of Directors proposes that the loss for the year be transferred to retained earnings.

    Annual General Meeting and availability of the Annual Report
    The Annual General Meeting 2017 is to be held on April 25th, 2017. The annual report is available for downloading on the company’s website (http://www.medical-prognosis.com/investor-and-media/).

    For further information, please contact:
    CEO, Peter Buhl Jensen, Adjunct Professor, MD, Ph.D.                              Ulla Hald Buhl, IR & Communication
    E-mail: pbj@medical-prognosis.com                                                            E-mail: uhb@medical-prognosis.com
    Telephone: +45 21 60 89 22                                                                         Telephone +45 21 70 10 49

    About MPI’s multiple biomarker called Drug Response Predictor – DRP(TM)
    MPI’s DRP(TM) is a tool for developing tumor-derived genetic signatures to predict which cancer patients are high likely to respond to a given anti-cancer product. The DRP(TM) has been tested in 37 trials, where 29 trials showed that drug-specific DRP(TM) Biomarkers could predict which patients responded well to the treatment. The DRP(TM) platform has amongst others been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP(TM) method can be used to design the Clinical Development Plan, i.e. to select which indications are relevant for a given anti-cancer drug. In addition to this, the individual genetic patterns of patients can be analyzed as part of a screening procedure for a clinical trial to ensure inclusion of patients with a high likelihood of response to the drug. DRP(TM) builds on comparison between sensitive and resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. The DRP(TM) is a Big Data tool based on messenger RNA. The DRP(TM) platform can be used in all cancer types, and has been patented for more than 70 anti-cancer drugs in the US.

    About MPI
    Medical Prognosis Institute is a publicly traded international company specialized in improving cancer patients’ lives by developing Personalized Medicine using its unique DRP(TM) technology. MPI’s exceptional opportunity to personalize cancer treatment begins with Breast Cancer moving on to Multiple Myeloma and Prostate Cancer as the first steps. MPI’s DRP(TM) tool has shown its ability to separate patients who benefit and who do not benefit from a specific cancer treatment. This has been shown in as many as 29 out of 37 trials, and covers more than 80 anti-cancer treatments in a wide range of cancer indications. MPI has built a significant large database with over 1,000 screened breast cancer patients and is building up a database in Multiple Myeloma to be followed by Prostate cancer in collaboration with oncologists and hematologists throughout Denmark. MPI has ownership of Oncology Venture (Publ) a spinout with three anti-cancer drugs in pipeline entered and of the privately hold Special Purpose Vehicles, 2X Oncology Inc. and OV-SPV2 Aps with four products in pipeline.

    This information is information that Medical Prognosis Institute A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on March 31st, 2017.

    Certified Adviser: Sedermera Fondkommission, Norra Vallgatan 64, 211 22, Malmö, Sweden

    Attachments:

    http://www.globenewswire.com/NewsRoom/AttachmentNg/8ebbfe8e-dbb8-4f60-a80a-80c2c1955021

    Attachments:

    http://www.globenewswire.com/NewsRoom/AttachmentNg/a5130f00-41f1-4f82-b194-ec8a86a1946a

  • MPI publishes Annual Report for 2016

    by on March 31st, 2017

    Medical Prognosis Institute A/S (“MPI”) publishes the Annual Report for 2016. For the complete report, see the following link Annual Report 2016. A summary of the Annual Report is presented below.

    Selected announcements and News 2016

    • December 30th – MPI announced that the company and Oncology Venture have entered into agreements about: an exchange of exclusivity for warrants, an agreement regarding 2X Oncology Inc. with three anticancer products in pipeline and finally establishment of new OV-SPV2 – project Tyrosine Kinase inhibitor.
    • October 28th – MPI announces that an article has been accepted for publication in the Danish Journal Best Practice on the Drug Response Prediction (DRP(TM)) for Oncology Ventures immuno-oncology product APO010 for Multiple Myeloma.
    • October 10th – MPI announces that the poster #134P: APO010 sensitivity in relapsed Multiple Myeloma patients is presented at ESMO Annual Congress 2016 in Copenhagen, Denmark.
    • October 8th – MPI announces that the poster #1187P on DRP prediction “Multigene expression profile for predicting efficacy of cisplatin and vinorelbine in non-small cell lung cancer” is presented at ESMO Annual Congress 2016 in Copenhagen, Denmark.
    • September 27th – MPI is granted patent on the Drug Response Predictor technology in China.
    • September 20th – MPI’s spinout Oncology Venture signs partnership deal with Cadila Pharmaceuticals on LiPlaCis using MPI’s DRP technology.
    • September 14th – MPI announced that its Personalized Response Predictor PRP(TM) is to be studied in collaboration with Breast Cancer Experts at Danish oncology departments.
    • September 9th – MPIs spinout Oncology Venture incorporates 2X Oncology Inc., a Women’s Cancer Company in the United States.
    • August 23rd – MPI announces that the first patient with metastatic Breast Cancer included in the extension – proof of concept part of the LiPlaCis trial, has obtained a confirmed Partial Remission (ie >30% reduction of her tumor).
    • July 5th – MPI and Oncology Venture enhances the collaboration by entering another agreement on DRP’s.
    • June 21st – MPI announces that the company has been approved for listing on Nasdaq Stockholm First North and has received formal approval from the marketplace. First day of trading is June 27th 2016.
    • May 31st – MPI announces that the first patient has been dosed in the first prospective study using the DRP(TM). The DRP(TM) will be used in the LiPlaCis proof of concept extension phase study conducted by Oncology Venture.
    • May 12th – MPI announces that positive data on their Drug Response Predictor (DRP), has been published in the journal PLOS ONE.
    • April 27th – MPI and Oncology Venture enters three new agreements on DRP’s.
    • March 10th – MPI announced that the first patient has been included in the APO010 Screening Protocol for Multiple Myeloma by MPI’s spinout Oncology Venture.
    • March 4th – MPI and Oncology Venture announces that data from phase 1 dose-escalating PoC study to evaluate the safety and tolerability of LiPlaCis in patients with advanced refractory tumors will be presented at the AACR (American Association for Cancer Research) Annual Meeting.
    • February 19th – MPI raises DKK 8,686,575 in a private placement.
    • February 17th – MPI publishes positive results with DRPTM tool in gastroesophageal cancer.
    • January 28th – MPI is issued patent in Australia.

    Income statement
    Revenue amounted to DKK 4,990,407 in 2016 (DKK 5,837,783 for the corresponding period in 2015). Revenue for the 2nd half of 2016 amounted to DKK 3,141,203 (DKK 5,156,703) for the corresponding period in 2015). Gross loss amounted to DKK -8,452,816 (DKK -8,216,885 for the corresponding period in 2015). The development in gross profit margin amounted to -169 % (last year -141 %). Gross loss for the 2nd half of 2016 amounted to DKK -4,692,004 (DKK -1,866,659 for the corresponding period in 2015). The development in gross profit margin for the 2nd half of 2016 amounted to -148 % (last year -44 %). Staff expenses amounted to DKK 2,575,203 (last year DKK 2,501,562). Staff expenses for the 2nd half of 2016 amounted to DKK -1,360,102 (DKK -1,199,601 for the corresponding period in 2015). Profit/loss before financial income and expenses showed a loss of DKK 11,522,564 (last year a loss of DKK 11,036,202). This loss was in line with the guidance in the half year interim report. Profit/loss from ordinary activities before tax to a loss of DKK 11,473,192 (last year a loss of DKK 11,149,476). Tax income amounted to DKK 2,743,808 (last year DKK 2,783,774) and relates to tax refund of the tax losses from research and development costs. The Company realized a net loss of DKK 8,729,384 (last year a net loss of DKK 8,365,702). Net loss for the 2nd half of 2016 amounted to DKK -4,649,591 (DKK -2,280,160 for the corresponding period in 2015).

    Balance sheet
    Total assets amounted to DKK 53,622,958 (last year DKK 29,183,331) and primarily consist of investments in associates. Total liabilities amounted to DKK 53,622,958 (last year DKK 29,183,331) and primarily consist of the Company’s equity, DKK 50,234,430 (last year DKK 25,611,896).

    Cash flows
    The Company’s cash flows from operating activities were a negative DKK 8,748,714 (last year a negative DKK 9,752,262).

    Outlook for 2017
    The Company expects a result in the same range in 2017 as in 2016 and that the positive development continues.

    Subsequent events
    No events materially affecting the assessment of the Annual Report have occurred after the balance sheet date.

    Distribution of profit
    The Board of Directors proposes that the loss for the year be transferred to retained earnings.

    Annual General Meeting and availability of the Annual Report
    The Annual General Meeting 2017 is to be held on April 25th, 2017. The annual report is available for downloading on the company’s website (http://www.medical-prognosis.com/investor-and-media/).

    For further information, please contact:
    CEO, Peter Buhl Jensen, Adjunct Professor, MD, Ph.D.                              Ulla Hald Buhl, IR & Communication
    E-mail: pbj@medical-prognosis.com                                                            E-mail: uhb@medical-prognosis.com
    Telephone: +45 21 60 89 22                                                                         Telephone +45 21 70 10 49

    About MPI’s multiple biomarker called Drug Response Predictor – DRP(TM)
    MPI’s DRP(TM) is a tool for developing tumor-derived genetic signatures to predict which cancer patients are high likely to respond to a given anti-cancer product. The DRP(TM) has been tested in 37 trials, where 29 trials showed that drug-specific DRP(TM) Biomarkers could predict which patients responded well to the treatment. The DRP(TM) platform has amongst others been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP(TM) method can be used to design the Clinical Development Plan, i.e. to select which indications are relevant for a given anti-cancer drug. In addition to this, the individual genetic patterns of patients can be analyzed as part of a screening procedure for a clinical trial to ensure inclusion of patients with a high likelihood of response to the drug. DRP(TM) builds on comparison between sensitive and resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. The DRP(TM) is a Big Data tool based on messenger RNA. The DRP(TM) platform can be used in all cancer types, and has been patented for more than 70 anti-cancer drugs in the US.

    About MPI
    Medical Prognosis Institute is a publicly traded international company specialized in improving cancer patients’ lives by developing Personalized Medicine using its unique DRP(TM) technology. MPI’s exceptional opportunity to personalize cancer treatment begins with Breast Cancer moving on to Multiple Myeloma and Prostate Cancer as the first steps. MPI’s DRP(TM) tool has shown its ability to separate patients who benefit and who do not benefit from a specific cancer treatment. This has been shown in as many as 29 out of 37 trials, and covers more than 80 anti-cancer treatments in a wide range of cancer indications. MPI has built a significant large database with over 1,000 screened breast cancer patients and is building up a database in Multiple Myeloma to be followed by Prostate cancer in collaboration with oncologists and hematologists throughout Denmark. MPI has ownership of Oncology Venture (Publ) a spinout with three anti-cancer drugs in pipeline entered and of the privately hold Special Purpose Vehicles, 2X Oncology Inc. and OV-SPV2 Aps with four products in pipeline.

    This information is information that Medical Prognosis Institute A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on March 31st, 2017.

    Certified Adviser: Sedermera Fondkommission, Norra Vallgatan 64, 211 22, Malmö, Sweden

    Attachments:

    http://www.globenewswire.com/NewsRoom/AttachmentNg/8ebbfe8e-dbb8-4f60-a80a-80c2c1955021

    Attachments:

    http://www.globenewswire.com/NewsRoom/AttachmentNg/a5130f00-41f1-4f82-b194-ec8a86a1946a

  • HalioDx: New data on Halioseek(TM) PD-L1/CD8 presented at AACR 2017

    by on March 31st, 2017

    New data on Halioseek(TM) PD-L1/CD8 presented at AACR 2017

    • HalioDx has developed an assay based on the dual staining of PD-L1 + and CD8+ cells enabled by  advanced image analysis tool
    • The assay shows excellent concordance with approved PD-L1 methods
    • Combined analysis of PD-L1+ cells and CD8+ cells is expected to improve predictive performance to identify immune checkpoint inhibitors resistant NSCLC patients
    • Data presented support the potential benefit of using of Halioseek(TM) PD-L1/CD8 in routine practice and development of a CE-IVD version is ongoing

    Marseille, France, March 31, 2017 – HalioDx SAS, an immuno-oncology diagnostic company, will present a new set of data confirming the good performance of Halioseek(TM) PD-L1/CD8 at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington D.C., USA, on Sunday, April 2, 2017 (1:00 – 5:00 PM EST).

    PD1/PD-L1 pathway blockade results in a durable clinical response in a fraction of the non-small cell lung cancer (NSCLC) patients. Today, the expression of PD-L1, detected by immunohistochemistry (IHC) at the surface of tumor or tumor-infiltrating immune cells, is used to select patients that may respond to immune checkpoint inhibitors (ICI). However the predictive value of PD-L1 biomarker alone is questioned. In order to better stratify NSCLC patients, HalioDx has developed Halioseek(TM) PD-L1/CD8[*], a new dual-staining IHC assay of PD-L1+ and CD8+ cells (TILs) present in the tumor microenvironment on a single slide prepared from FFPE tissue.

    The Halioseek(TM) assay, powered by advanced image analysis tool, extracts a full set of information such as CD8+ cell density (cells/mm²), proximity between CD8+ and PD-L1+ cells and finally cluster indexes for CD8+ cells and PD-L1+ cells. Cell-to-cell distances were validated with an independent Digital Pathology (DP) tool. Variability and accuracy were assessed for all parameters using adjacent dual-stained slides on complete tissue sections. The concordance with main IVD approved PD-L1 methods was established on a representative set of 55 NSCLC tumors.

    Vincent FERT, CEO of HalioDx comments: “Because it measures the two key components of the immune microenvironment with respect to the known ICI mechanism of action, Halioseek(TM) PD-L1/CD8 has the potential to become the reference assay for precision Immunotherapy. The assay has proven today its accuracy and concordance with main IVD approved PD-L1 methods.” He adds: “This assay is already available to provide our pharmaceutical partners a unique solution for companion diagnostic development and registration. A CE-IVD version is under development to assist clinicians in defining immunotherapy treatment strategy for NSCLC patients in combination with other tumor and patient biological and clinical features.”

    Poster details:
    Session Title: Checkpoints 1
    Session Date and Time: Sunday, April 2, 2017 1:00 – 5:00 PM EST
    Location: Poster Section 25 / Poster Board Number: 24
    The poster will be downloadable on HalioDx website when the session will start.

    About HalioDx
    The Immune Response to Cancer Diagnostics

    HalioDx is an immuno-oncology diagnostic company providing oncologists with first in- class Immune-based diagnostic products and services to guide cancer care and contribute to precision medicine in the era of immuno-oncology and combination therapies.
    HalioDx Immunoscore® technology integrates immunohistochemistry combined with advanced imaging analysis enabling extraction of spatially-organized tissue molecular information.
    Immunoscore® is a platform for many cancers, as immune response to tumor is a key hallmark of disease progression.
    Pioneered by Jérôme Galon at the Cordeliers Research Center, Paris, France, Immunoscore® Colon is the flagship assay of HalioDx, positioned to be a future diagnostic standard for delivering prognostic and predictive information. HalioDx develops also assays such as Halioseek(TM) and Immunosign® to help stratifying patients for immunotherapies.
    HalioDx collaborates with an increasing number of renowned international clinical groups and biopharmaceutical companies to support clinical utility and ensure rigorous performance validation of its assays in a large number of cancer indications.
    HalioDx has an experienced team of more than 100 employees, a CLIA-certified laboratory (H1 2017) and compliant facilities to develop, manufacture, register and market in vitro diagnostic (IVD) products.
    HalioDx executes biomarker studies and companion diagnostic assay development in conformity with regulations and in partnership with biopharmaceutical companies.
    The company co-founded the European immunology cluster Marseille Immunopole (MI).

    For more information, please visit our website www.haliodx.com and follow the company on Twitter @HalioDx.

    Contacts

    HalioDx SAS
    Vincent Fert
    President and CEO
    + 33 (0)4 91 29 30 90
    vincent.fert@haliodx.com

     

    ATCG Press
    Marie Puvieux (France)
    Mob: +33 (0)6 10 54 36 72
    Jean-Mehdi Grangeon (ROW)
    Mob: +33 (0)6 62 22 00 24
    haliodx@atcg-partners.com

     

    [*] For Research Use Only. Not for Use in Diagnostic Procedures.

    Attachments:

    http://www.globenewswire.com/NewsRoom/AttachmentNg/8b579767-d003-4787-b9c3-88c4276b0534

  • HalioDx: New data on Halioseek(TM) PD-L1/CD8 presented at AACR 2017

    by on March 31st, 2017

    New data on Halioseek(TM) PD-L1/CD8 presented at AACR 2017

    • HalioDx has developed an assay based on the dual staining of PD-L1 + and CD8+ cells enabled by  advanced image analysis tool
    • The assay shows excellent concordance with approved PD-L1 methods
    • Combined analysis of PD-L1+ cells and CD8+ cells is expected to improve predictive performance to identify immune checkpoint inhibitors resistant NSCLC patients
    • Data presented support the potential benefit of using of Halioseek(TM) PD-L1/CD8 in routine practice and development of a CE-IVD version is ongoing

    Marseille, France, March 31, 2017 – HalioDx SAS, an immuno-oncology diagnostic company, will present a new set of data confirming the good performance of Halioseek(TM) PD-L1/CD8 at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington D.C., USA, on Sunday, April 2, 2017 (1:00 – 5:00 PM EST).

    PD1/PD-L1 pathway blockade results in a durable clinical response in a fraction of the non-small cell lung cancer (NSCLC) patients. Today, the expression of PD-L1, detected by immunohistochemistry (IHC) at the surface of tumor or tumor-infiltrating immune cells, is used to select patients that may respond to immune checkpoint inhibitors (ICI). However the predictive value of PD-L1 biomarker alone is questioned. In order to better stratify NSCLC patients, HalioDx has developed Halioseek(TM) PD-L1/CD8[*], a new dual-staining IHC assay of PD-L1+ and CD8+ cells (TILs) present in the tumor microenvironment on a single slide prepared from FFPE tissue.

    The Halioseek(TM) assay, powered by advanced image analysis tool, extracts a full set of information such as CD8+ cell density (cells/mm²), proximity between CD8+ and PD-L1+ cells and finally cluster indexes for CD8+ cells and PD-L1+ cells. Cell-to-cell distances were validated with an independent Digital Pathology (DP) tool. Variability and accuracy were assessed for all parameters using adjacent dual-stained slides on complete tissue sections. The concordance with main IVD approved PD-L1 methods was established on a representative set of 55 NSCLC tumors.

    Vincent FERT, CEO of HalioDx comments: “Because it measures the two key components of the immune microenvironment with respect to the known ICI mechanism of action, Halioseek(TM) PD-L1/CD8 has the potential to become the reference assay for precision Immunotherapy. The assay has proven today its accuracy and concordance with main IVD approved PD-L1 methods.” He adds: “This assay is already available to provide our pharmaceutical partners a unique solution for companion diagnostic development and registration. A CE-IVD version is under development to assist clinicians in defining immunotherapy treatment strategy for NSCLC patients in combination with other tumor and patient biological and clinical features.”

    Poster details:
    Session Title: Checkpoints 1
    Session Date and Time: Sunday, April 2, 2017 1:00 – 5:00 PM EST
    Location: Poster Section 25 / Poster Board Number: 24
    The poster will be downloadable on HalioDx website when the session will start.

    About HalioDx
    The Immune Response to Cancer Diagnostics

    HalioDx is an immuno-oncology diagnostic company providing oncologists with first in- class Immune-based diagnostic products and services to guide cancer care and contribute to precision medicine in the era of immuno-oncology and combination therapies.
    HalioDx Immunoscore® technology integrates immunohistochemistry combined with advanced imaging analysis enabling extraction of spatially-organized tissue molecular information.
    Immunoscore® is a platform for many cancers, as immune response to tumor is a key hallmark of disease progression.
    Pioneered by Jérôme Galon at the Cordeliers Research Center, Paris, France, Immunoscore® Colon is the flagship assay of HalioDx, positioned to be a future diagnostic standard for delivering prognostic and predictive information. HalioDx develops also assays such as Halioseek(TM) and Immunosign® to help stratifying patients for immunotherapies.
    HalioDx collaborates with an increasing number of renowned international clinical groups and biopharmaceutical companies to support clinical utility and ensure rigorous performance validation of its assays in a large number of cancer indications.
    HalioDx has an experienced team of more than 100 employees, a CLIA-certified laboratory (H1 2017) and compliant facilities to develop, manufacture, register and market in vitro diagnostic (IVD) products.
    HalioDx executes biomarker studies and companion diagnostic assay development in conformity with regulations and in partnership with biopharmaceutical companies.
    The company co-founded the European immunology cluster Marseille Immunopole (MI).

    For more information, please visit our website www.haliodx.com and follow the company on Twitter @HalioDx.

    Contacts

    HalioDx SAS
    Vincent Fert
    President and CEO
    + 33 (0)4 91 29 30 90
    vincent.fert@haliodx.com

     

    ATCG Press
    Marie Puvieux (France)
    Mob: +33 (0)6 10 54 36 72
    Jean-Mehdi Grangeon (ROW)
    Mob: +33 (0)6 62 22 00 24
    haliodx@atcg-partners.com

     

    [*] For Research Use Only. Not for Use in Diagnostic Procedures.

    Attachments:

    http://www.globenewswire.com/NewsRoom/AttachmentNg/8b579767-d003-4787-b9c3-88c4276b0534

  • Latest weekly flu data show no decline in visits

    by on March 31st, 2017

    Outpatient visits for influenza-like illness (ILI) held steady for the week ending March 25, but the number of states at the “high” range of activity dropped from 12 from 10 the previous week, according to the Centers for Disease Prevention and Control. The proportion of outpatient visits for ILI was 3.2% for the second consecutive […]

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