Intec Pharma Reports Second Quarter 2018 Financial Results and Corporate Update

Enrolled more than 95% of patients in pivotal Phase 3 ACCORDANCE trial and more than 85% of eligible patients entered the open label extension study

JERUSALEM, Aug. 15, 2018 /PRNewswire/ -- Intec Pharma Ltd. (NTEC) ("Intec" or "the Company") today announces financial results for the three and six months ended June 30, 2018 and provides a corporate update. 

Highlights of the second quarter 2018 and recent weeks include:

• Global enrollment reached more than 400 of the projected 420 patients into the Phase 3 ACCORDANCE clinical trial of Accordion Pill Carbidopa/Levodopa (AP-CD/LD) for the treatment of advanced Parkinson's disease patients;
• Completed enrollment at the European and Israeli sites in the ACCORDANCE clinical trial with the balance of the study's patients to be recruited from the trial's U.S. clinical sites;
• More than 85% of eligible patients from the ACCORDANCE clinical trial are opting to participate in the Open Label Extension (OLE) study;
• Created a Scientific Advisory Board (SAB) comprised of internationally renowned scientists, whose mission will be to provide scientific and clinical advice on the advancement of AP-cannabinoids in various indications;
• Multiple poster presentations accepted at the upcoming International Parkinson and Movement Disorder Society (MDS) bi-annual meeting taking place October 5-9, 2018;
• Appointed Brad Hayes, former Executive Vice President, Chief Financial Officer and Treasurer of Laboratory Corporation of America (LabCorp), to the Company's Board of Directors;
• Voluntarily filed for and completed de-listing from the Tel Aviv Stock Exchange, with NASDAQ Capital Market now the sole trading exchange; and
• Raised gross proceeds of approximately $37.5 million in an underwritten public offering of 6.75 million ordinary shares and 400,000 ordinary shares following the partial exercise of the underwriters' over-allotment option.

Management Commentary

"We continue to be pleased with the progress Intec has made during the first half of 2018, as we made significant advances that position us to achieve a number of important clinical, commercial and corporate milestones throughout the balance of the year and beyond," stated Jeffery A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. 

"We are particularly excited about the progress we've made with our Phase 3 program for AP-CD/LD as a new backbone therapy for advanced Parkinson's disease patients.  As we near completion of global enrollment, we have completed planned enrollment at our sites located in Europe and Israel, leaving the balance of enrollment to our U.S. sites.  We remain on track to report topline data in mid-2019.  The strong interest in participating in the OLE study is encouraging and gives us confidence that these extended safety data will be available in the second half of 2019.  We look forward to the results from our pharmacokinetic (PK) study of the 50/500 mg AP-CD/LD dosed three times a day (TID), as we believe these PK data will be important to potential partners and for physician education at commercial launch. In addition, we are pleased to be presenting multiple posters from our Parkinson's therapy development program at the upcoming MDS meeting. 

"The scale-up and commercial manufacturing project with our partner, LTS Lohmann Therapie-Systeme AG (LTS), is well underway.  Fabrication of the commercial scale manufacturing systems is complete, initial system testing is being conducted in preparation for delivery to LTS, and ongoing technology transfer and process development work advances.  We are making plans for our validation, bridging and stability studies and expect to have greater clarity on these timelines around the end of the year.  Our market assessment and payor access work continue and the findings strongly support a significant market opportunity in Parkinson's disease where a more effective backbone therapy is greatly needed. 

"We continue to advance our pipeline opportunities for the Accordion platform and are moving forward with PK studies to individually evaluate CBD and THC, two key components of cannabis.  We plan to initiate the AP-THC study in the second half of 2018 and the AP-CBD study in early 2019.  Based on earlier Phase 1 work, we are very encouraged by the potential for the Accordion technology to enhance the bioavailability of these cannabinoids and improve their therapeutic potential.  We have established an advisory board of global leaders to assist us in planning our development program utilizing the AP-cannabinoids.

"We are building a blue-chip Board of seasoned leaders who have relevant experience to guide Intec to its next level of achievement. Toward that end, we were delighted to welcome Brad Hayes, former CFO of LabCorp, as our newest director and Chairman of our Audit Committee.

"We continue to advance our strategic initiatives and are committed to maximizing our current near-term opportunity in Parkinson's disease and to pursuing new growth initiatives to create both near- and long-term value for shareholders," concluded Mr. Meckler. 

Financial Highlights for the Three and Six Months Ended June 30, 2017

Research and development expenses, net, for the three-month period ended June 30, 2018 amounted to approximately $8.4 million, an increase of $2.8 million, or approximately 50%, compared with approximately $5.6 million in the three-month period ended June 30, 2017. Research and development expenses, net, for the six-month period ended June 30, 2018 amounted to approximately $17.3 million, an increase of $7.8 million, or approximately 82%, compared with approximately $9.5 million in the six-month period ended June 30, 2017. The increase in both periods was primarily due to an increase in expenses related to the progression of our Phase 3 ACCORDANCE clinical trial for AP-CD/LD, expenses related to the establishment of the commercial scale production capabilities for AP-CD/LD, share based compensation to employees and payroll and related expenses, mostly due to an increase in headcount.

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