Check-Cap Reports Fourth Quarter and Full Year 2017 Financial Results

  • Initiated an EU post approval study using C-Scan system Version 3 (formerly referred to as Advanced C-Scan system), which incorporates the latest algorithms and system optimization and tailors scanning of the colon to the patient's natural colonic movements to maximize the amount of the colon that is tracked and imaged, and has demonstrated significant development in average colon imaging coverage compared with the C-Scan version used in the multi-center clinical study that supported the Company's CE Mark approval received in January 2018.
  • Reported interim clinical study of C-Scan Version 3 in March 2018 with evaluable results of 21 patients showing average colon imaging coverage of 64%, a 40% development over 46% average colon imaging coverage in the CE Mark study. As demonstrated in the CE Mark study, sensitivity (ability to correctly identify polyps) is strongly correlated (R-squared = 0.98) to the percentage of colon imaging coverage. Sensitivity was 78% (p<0.05) for subjects with greater than 50% colon imaging coverage and 100% (p<0.05) for subjects with greater than 70% colon imaging coverage. Specificity (ability to correctly recognize lack of polyps) was consistent at around 89%.
  • Entered the next phase of manufacturing collaboration with GE Healthcare ("GE"). The new phase involves GE final assembly, packaging and shipping of C-Scan capsules initially to support the Company's U.S. pilot trial. Check-Cap will supply GE with supporting calibration and final assembly methodology and equipment.
  • Late breaking, oral presentation of clinical safety and performance study abstract, "Clinical Performance of a Novel X-ray Based Imaging Capsule for Colonic Screening", and presentation of "A novel capsule technology platform for exact localized colon drug delivery" poster, acknowledged as one of "Posters of Excellence" at the United European Gastroenterology (UEG) Week 2017 in Barcelona, Spain.
  • In November and June 2017, the Company consummated two registered direct offerings of ordinary shares and concurrent private placements of warrants, with gross proceeds of $2.5 million and $2.69 million, respectively.
  • Submitted an application in February 2018, to register the C-Scan system for marketing and sale in Israel.
  • Appointed Alex Ovadia as Chief Executive Officer actual February 26, 2018. Prior to this appointment, Mr. Ovadia served as Check-Cap's Chief Operating Officer, Vice President of Research and Development and Israeli site manager since 2013.

In addition, the Company declared a 1-for-12 reverse share split of its ordinary shares, actual as of April 4, 2018. Beginning on April 4, 2018, the Company's ordinary shares will trade on the NASDAQ Capital Market on a post-reverse share split adjusted basis. At Check-Cap's extraordinary general meeting of shareholders held on April 2, 2018, the Company's shareholders accepted a reverse share split at a ratio in the range of 1-for-8 to 1-for-12, the exact ratio to be determined by further action of the Company's Board of Directors ("Board"), to be actual on a date to be determined by the Board. On April 2, 2018, the Board approved a reverse split at a ratio of 1-for-12, actual as of April 4, 2018. All share and per share amounts in this announcement have been adjusted to reflect the reverse share split. Further, at the extraordinary general meeting of shareholders, the Company's shareholders approved an growth in the Company's authorized and registered share capital by NIS 12,500,000 and to amend the Company's Articles of Association accordingly.

Alex Ovadia, CEO of Check-Cap, stated: "We believe that 2017 was a productive year for Check-Cap, with EU regulatory submissions in September yielding a key validation of our C-Scan system and with receipt of our CE Mark approval in January 2018. We were also very pleased to initiate our EU post authorization study in March 2018, using C-Scan system Version 3, which incorporates the latest algorithms and system optimization and demonstrated a significant enhancement in average colon imaging coverage in an interim study." Mr. Ovadia continued, "As we enter 2018 and look beyond, we plan to continue our EU post approval study, and anticipate that we will achieve clinical performance consistent with that seen in the CE study with majority of colon imaging coverage. We intend to continue to hold productive discussions with regulatory agencies in support of the C-Scan system Version 3 as we move toward initiation of our U.S. pilot study, which we expect to commence during the second half of 2018. We believe that successful completion of both the U.S. pilot and EU post approval studies, supported with appropriate capital, will become the key drivers in our efforts to commence the U.S. pivotal study during 2019. In parallel to our program's execution, we intend to continue to leverage our CE Mark and ISO 13485 certification through submitting an application to register the C-Scan system for marketing and sale in Israel. We are also continuing our work to develop our marketing and commercial pathways throughout 2018, while initiating discussions with potential partners, for both Israel and Europe markets."

 

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