6-K
Check-Cap Ltd (MBAI)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For August 2020
Commission File No. 001-36848
Check-Cap Ltd.
Check-Cap Building
Abba Hushi Avenue
P.O. Box 1271
Isfiya, 30090
Mount Carmel, Israel
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES.)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Other Information
On August 26, 2020, Check-Cap Ltd. updated its corporate presentation that it intends to use in conferences and meetings with investors. A copy of the presentation is furnished with this Report of Foreign Private Issuer on Form 6-K as Exhibit 99.1 and is incorporated herein by reference.
| Exhibit | |
|---|---|
| Exhibit No. | Description |
| 99.1 | Corporate<br> Presentation of Check-Cap Ltd., dated August 2020. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Check-Cap Ltd. | ||
|---|---|---|
| By: | /s/ Alex Ovadia | |
| Name: Alex Ovadia | ||
| Date: August 26, 2020 | Title: Chief Executive Officer |
Exhibit 99.1
Check-CapRedefining Colorectal Cancer Screening & Prevention CORPORATE PRESENTATION August 2020 check-cap.com NASDAQ : CHEK
Safe Harbor Statement Forward-Looking StatementsThis presentation contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our ongoing and planned product development and clinical trials; the timing of, and our ability to make, regulatory filings and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; the degree of clinical utility of our products, particularly in specific patient populations; our ability to develop commercial functions; expectations regarding product launch and revenue; our results of operations, cash needs; our financial condition, liquidity, prospects, growth and strategies; the industry in which we operate; and the trends that may affect the industry or us. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, this presentation, various filings made by us with the SEC, press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the factors summarized below. These factors include, but are not limited to, the following: our history of losses and needs for additional capital to fund our operations; our ability to continue as a going concern; our inability to obtain additional capital on acceptable terms, or at all; the impact of the recent outbreak of coronavirus; the initiation, timing, progress and results of our clinical trials and other product development efforts; our reliance on one product or product line; the clinical development, commercialization and market acceptance of C-scan; our ability to receive de novo classification and other regulatory approvals for C-Scan; our ability to successfully complete clinical trials; our reliance on single-source suppliers; our reliance on third parties such as for purposes of our clinical trials and clinical development and the manufacturing, marketing and distribution of C-Scan; our ability to establish and maintain strategic partnerships and other corporate collaborations; our ability to achieve reimbursement and coverage from government and private third-party payors; the implementation of our business model and strategic plans for our business; the scope of protection we are able to establish and maintain for intellectual property rights covering C-Scan and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; and statements as to the impact of the political and security situation in Israel on our business. More detailed information about the risks and uncertainties affecting Check-Cap is contained under the heading "Risk Factors" included in Check-Cap’s most recent Annual Report on Form 20-F filed with the SEC on March 6, 2020, and in other filings that Check-Cap has made and may make with the SEC in the future. These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf included in, but not limited to, this presentation speak only as of the date hereof and are expressly qualified in their entirety by the foregoing. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. The presentation contains information about an investigation-stage medical device product under development, which has not yet been approved by the FDA for commercial distribution in the United States. All representations in this presentation are based upon investigations in certain clinical and other research, but which accordingly should not be construed as general claims for the safety or efficacy of the products when used by patients. 2
3 The Check-Cap Mission Prevent Colorectal Cancer through Precancerous Polyp Detection
Check-Cap at a Glance Prep-free capsule-based screening option for the health-conscious population and those that currently avoid other screening procedures Target to improve global screening adherence and detection of polyps before they may turn into cancerDesigned to address unmet needs in a multibillion-dollar marketCE Mark granted, approved for sale in IsraelPositive clinical data from U.S. pilot study and post-CE approval study Global manufacturing footprintStrong IP profile 4
Source:1. Can Colorectal Polyps and Cancer Be Found Early? American Cancer Society.2. Pickhardt et al. Glin. Gatro. And Hep. 2010; 8; 610 Why wait for cancer? ~ 0.5% present cancerous polyps ~ 75%present No polyps ~ 25%present benign polyps Average risk population ages 50-75 0% 0.9% 6.1% Crucial Prevention Window1 <10mm 10 - 19mm ~10-15 years 20 - 29mm 5 38.1% ≥ 30mm Polyp Size Malignancy rate2
CRC: Third Most Diagnosed, Yet Least Prevented Cancer 6 Source:1. World Health Organization GLOBOCAN database. Accessed in January 20202. Arnold M, et al. Gut 2017;66:683–691. 3. American Society of Cancer. Cancer Facts and Figures 20204. National Cancer Institute. Cancer Trends Progress Report. Accessed in January 2020 5. Cancer Has Greater Economic Impact Than All Other Diseases. Zosia Chustecka. Medscape. August 2010 Annual CRC Incidence (Worldwide) 1.8M New cases1 881,000 Deaths1 Economic Burden Annual CRC Incidence (U.S.) 150K New cases3 55,000 Deaths3 Economic Burden ~ $99B Worldwide5 ~ $16B U.S alone (2018)4 Worldwide estimated figuresin millions, 20181 * 60% increase expected by 20302
Screening Rates - Global Unmet Need Source:1. Relates to ages 50 years and older, as of 2015. For colonoscopy, this includes adults that had a colonoscopy in the past 10 years or sigmoidoscopy in the past 5 years. For FIT this includes adults that had FIT or FOBT in the past year. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2017-2019.pdf2. For FIT this relates to 50-54 years old testing for fecal blood in 2014. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5341111/ , http://www.cancer-days.eu/res/file/presentations/2017/04-state-of-the-art-04b-seufferlein.pdf3. Schreuders EH, Ruco A, Rabeneck L, et al. Colorectal cancer screening: a global overview of existing programmes. Gut 2015;64:1637-1649. 7 BARRIERS TO COMPLIANCE ColonoscopyLaxative bowel preparationInvasiveSedationFIT or FOBTStool Handling US1 Germany2 China3 1 in 3 people are not getting screened as recommended > 50% not getting screened as recommended 38% 55% High Ages ≥50 Colonoscopy Not Screened Fecal Immunochemical Test (FIT) or Fecal Occult Blood Test (FOBT) Colonoscopy or Stool based test
Multi-Billion Dollar Market Opportunity Revised ACS guidelines recommending average risk population to begin screening earlier, at age of 45 95M ~$9B 231M ~$23B 419M ~$41B UNITED STATES EUROPE CHINA 8 Potential Population For Screening* Market Opportunity** Source:*Population age groups 50-74. United Nations DESA/ Population Division – World Population Prospects 2019 (U.S, China and Europe). https://population.un.org/wpp/Download/Standard/Population/ **For average risk patients, aged 50-75, screened once every 10 years according to ACS’ guidelines, at average estimated C-Scan test cost of $1K.
C-Scan® is not available for sale or clinical use in the U.S. Our Solution: Prep-Free Polyp Detection 9 First and only patient-friendly preparation-free test to detect polyps before they may transform into cancerPotential to help millions of busy, active people stay healthy through preventive polyp screening with less life disruptionPotential to motivate the younger, health-conscious patient population with increasingly higher CRC risk, to undergo screening earlier
C-Scan® View C-Scan® Track C-Scan® Cap C-Scan® is not available for sale or clinical use in the U.S. Capsule Based C-Scan® system 10 Natural passageUltra-low dose X-ray scanning technology Autonomous control positioning and recording Cloud based analysis suiteMaps of colon’s inner surface
Polyp Presence Confirmed by Colonoscopy Slice profiles 3D map of colon inner surface 11 Sessile polyps C-Scan polyp presence detection analysis tools Colonoscopy findings + images Height map of colon inner surface Single sessile polyp Single polyp Polyp size measured by Colonoscopy 5-10mm 10-20 mm 20 mm
C-Scan: A Prep-Free Patient-Friendly Test Capsule ingestionC-Scan® Track attached to patient’s back No special dietContrast agent + fiber with each mealTest takes 2-3 daysPatient is notified once capsule is excreted naturally Clinical data downloaded from Track to C-Scan® View cloudPre - Analysis and bookmarking of findings by Check-Cap’s expert technicianCloud based Physician Suite – review of bookmarks, analysis and report (~30 min) 12 Normal Daily Routine 1 Physician Analysis At the clinic 2 3
PhysicianPotential for improved adherence - alternative for patients refusing or unable to undergo colonoscopyPotential for increased treatment volumesCloud-based analysis toolNO operating room required to perform the screening C-Scan® Advantages 13 PatientOpportunity for preventive polyp screening Patient-friendly testNO bowel preparationNO sedation, pain or discomfortNO interruption of daily routine PayerPotential for reduced CRC incidence and mortality through prevention and reduced overall cost associated with CRC treatment Payer Physician Patient
Clinical Evidence of C-Scan ® Performance 14 Post CE approval study* results1 for precancerous polyp detection 76% Sensitivity** 82% Specificity *90 patients evaluated of 142 enrolled, evaluation was obtained implementing a gender-based motility analysis. Results of both C-Scan and FIT were compared to colonoscopy.** For polyps ≥10 mm Source:http://ir.check-cap.com/2019-07-09-Check-Cap-Announces-Positive-Final-Results-from-Its-Post-CE-Approval-Study-of-the-C-Scan-R-SystemPickhardt at al. Clin. Gastro. And Hep. 2010; 8:610 (≥30mm Polyps – 38.1% malignancy rate2) FIT Detection Rate 66% 76% 100%
Agreement between C-Scan and colonoscopy in detection of polyps for evaluable patients was consistent with data from the post-CE approval study2,3 U.S. Pilot Study Demonstrating Safety and Patient Satisfaction 15 Source:1. Prepless Colon Capsule Technology: New Research Examines This Less Invasive Approach to Colorectal Cancer Screening. Mayo Clinic Digestive Diseases Update. Gastroenterology and Hepatology. Vol 8, No.1, 2020. 2: http://ir.check-cap.com/2019-07-09-Check-Cap-Announces-Positive-Final-Results-from-Its-Post-CE-Approval-Study-of-the-C-Scan-R-System3. Due to sample size, the study was not designed to be powered for statistical significance. All patients who underwent the study complied with the procedure and completed a questionnaire after the test, reporting higher satisfaction with C-Scan compared to colonoscopy 28 evaluable study subjects (out of 40 who completed the study) in two sites, NYU Grossman School of Medicine and Mayo Clinic, Rochester1 Primary endpoint achieved; no device or test related serious adverse events (SAEs) were reported
Operations Ramp Up 16 Enhancing infrastructure including investments in manufacturing equipment and personnelBuilding out global supply chainHot line assembly of C-Scan for U.S. pivotal trial being conducted in collaboration with GE HealthcareOngoing evaluation of post-pivotal trial manufacturing scalability
Global Regulatory Pathway 17 Pivotal study initiation planned in 2021* *Assuming the COVID-19 pandemic does not cause further interruptions in the Company's operations Israeli Ministry of Health (“AMAR”) approval obtainedOngoing additional clinical data collection Israel EU CE Mark granted United States
Strong
Global Intellectual Property Franchise 18 42Granted 3Allowed 15Pending Core patents granted in major jurisdictions C-Scan Core Patents X-ray capsule medical imaging3D Real-time tracking3D Recon algorithms Future potential
applications Drug delivery capsuleMicrobiome sampling capsuleCatheter-based X-ray imaging
Management Team 19 Boaz Shpigelman Chief Executive Officer Alex Ovadia VP of Operations Joshua Belkar Founder & CTO Yoav Kimchy, Ph.D. Chief Financial Officer Mira Rosenzweig VP of Clinical Affairs Vardit Segal, Ph.D. VP of Research & Development VP QA&RA Israel Hershko Director of Human Resources Noa Reshef
Board of Directors Extensive Experience in Medical Technology Development and Commercialization XQ Lin Clara Ezed Steve Hanley Chairman Dr. Mary Jo Gorman Yuval Yanai
Strategic Path Forward IDE submission Initiation of U.S. Pivotal Study1,2,3 Completion of U.S. Pivotal Study1,2,3File with FDA1,2,3FDA Approval1,2,3 2021E 2022E-2023E 21 Pending sufficient capitalAssuming de novo classification, no PMA and no additional clinical studies requiredPending successful results of additional clinical data collection Q4/2020E Collection of additional clinical data in preparation for pivotal study* Operations ramp up, reimbursement strategy advancement and continued exploration of strategic partnerships * Includes larger-scale study in Israel in subjects considered to be average risk Disclaimer: This timeline assumes that the COVID-19 pandemic does not cause further interruptions in the Company's operations
Significant Market Potential ~881,000 CRC deaths ~1.8M new cases of CRC globally in 2018Multibillion-dollar addressable market C-Scan® Value Proposition Preparation-free test to detect polyps before they may transform into cancerOpportunity for patients to take control of their health through preventive screeningPositive clinical data Global Regulatory Pathway Collaboration with GE HealthcareU.S. pivotal study planned in 2021*CE marking in EU; AMAR approval in Israel Strong Worldwide IP 42 patents granted; 3 allowed; 15 pending Experienced Leadership Team Management experienced in navigating regulatory pathways and product launch/commercialization General Information HQ: Isfiya, Israel NASDAQ: CHEKNumber of employees: 63Cash and equivalents: $16.4M as of June 30, 2020 (excludes $8.7 million net proceeds received in July 27, 2020 from warrant exercise financing) Investment Summary 22 * Assuming the COVID-19 pandemic does not cause further interruptions in the Company's operations
APPENDIX
United States Colonoscopy Out of pocket private sector $1,2121 ($2,100 – $3,7642) Cologuard(Stool DNA, Exact) $5093 Reimbursement for Screening Methods Source:1. Relates to estimated average cost with biopsies in 2015 https://link.springer.com/article/10.1007/s00261-015-0538-1 2. https://aspe.hhs.gov/system/files/pdf/255906/DHNAdditionalInfor.pdf, https://www.bankrate.com/finance/smart-spending/how-much-does-colonoscopy-cost.aspx3. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-Summary-Data.pdf4. http://mayafiles.tase.co.il/rpdf/854001-855000/p854945-00.pdf Japan Capsule Endoscopy (Medtronic) $785*4 *83,100 JPY in 2019 or $785USD (based on August 2019 rates). 24
X-Ray Exposure Control 25 mSv Comparison of approximate effective radiation dose in adults for several radiology procedures Very Low Radiation ExposureProximity of the capsule to the scanning target allows for the use of an ultra-low dose radiation Low Environmental ImpactSource half lifetime 15.4 daysAlmost undetectable radiation after disposal Source: https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray 6 8 10 0.1 0.05
C-Scan®: Preparation-Free Colon Screening 26 Compton Back-scattering X-Ray Fluorescence Capsule scanning over a polyp Disruptive Imaging TechnologyAs the capsule moves naturally, it scans the inner lining of the colon in a 360-degree arc, scanning only when in motion Exclusive Motility AnalysisCapsule motility is continuously tracked and recorded