UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | Common Stock | GCTK | NASDAQ Capital Market | Indicate by check mark whether the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 000-54785 GLUCOTRACK, INC. (Exact name of registrant as specified in its charter) | Delaware | 98 ...

Part I [Business](index=5&type=section&id=Item%201.%20Business.) GlucoTrack, Inc. is a medical device company developing non-invasive glucose monitoring devices, focusing on the advanced GlucoTrack 2.0 for global markets [Overview and Product Development](index=5&type=section&id=Overview%20and%20Product%20Development) The company focuses on developing GlucoTrack 2.0, an advanced wireless non-invasive glucose monitor, for European and U.S. markets - GlucoTrack has developed a non-invasive glucose monitor (GlucoTrack®) that uses a combination of ultrasound, electromagnetic, and thermal technologies to measure glucose levels from the earlobe without drawing blood[22](index=22&type=chunk) - The company is accelerating the development of GlucoTrack 2.0, a wireless and rechargeable ear-clip paired with a smartphone, offering increased accuracy, greater margins, and lower cost compared to the 1.0 model[35](index=35&type=chunk) - The company is now focusing on the U.S. market, planning for FDA clinical trials and building a U.S. go-to-market strategy[37](index=37&type=chunk) [Market Opportunity and Competition](index=8&type=section&id=Market%20Opportunity%20and%20Competition) The substantial global diabetes market presents opportunities, but the company faces intense competition from established and CGM device manufacturers - The International Diabetes Federation estimated that **463 million adults worldwide had diabetes in 2019**, with this number expected to grow to approximately **700 million by 2045**[51](index=51&type=chunk) - The company faces significant competition from four major companies that dominate the self-monitored glucose testing market: Roche, LifeScan (a division of Johnson & Johnson), Abbott Laboratories, and Ascensia[113](index=113&type=chunk) - Continuous Glucose Monitoring (CGM) devices from competitors like Medtronic plc, Abbott Laboratories, and Dexcom, Inc. represent another major competitive threat[115](index=115&type=chunk) [Regulatory and Reimbursement](index=14&type=section&id=Regulatory%20and%20Reimbursement) GlucoTrack 1.0 has EU approval, but U.S. market entry requires FDA approval and securing uncertain third-party reimbursement - GlucoTrack 1.0 received CE Mark approval, allowing it to be marketed and sold in EU member countries, and the company also holds ISO 13485:2016 certification[26](index=26&type=chunk)[28](index=28&type=chunk) - The product has not been approved for commercial sale in the United States, though the FDA confirmed U.S. clinical trials would be considered non-significant risk device studies, allowing them to proceed without an Investigational Device Exemption (IDE) application[86](index=86&type=chunk)[87](index=87&type=chunk) - Commercial success is highly dependent on obtaining reimbursement from third-party payors such as Medicare, Medicaid, and private insurance plans, which is an uncertain and lengthy process[94](index=94&type=chunk)[98](index=98&type=chunk) [Intellectual Property](index=21&type=section&id=Intellectual%20Property) The company proactively protects its technology with 59 issued patents and "GlucoTrack®" trademark registrations in 24 countries - The company holds **59 issued patents** in multiple jurisdictions, including the United States, Europe, China, and Japan, covering its core technology[108](index=108&type=chunk) - Trademark registrations for "GlucoTrack®" have been obtained in **24 countries**, including the US, Europe, and China[110](index=110&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors.) Significant risks include operating losses, GlucoTrack 2.0's success dependency, third-party reliance, and internal control weaknesses - The company has a history of operating losses, with a net loss of approximately **$4.0 million in 2021** and an accumulated deficit of **$97.5 million as of December 31, 2021**[127](index=127&type=chunk) - The business is highly dependent on the success of its next-generation product, GlucoTrack® 2.0, which has not yet received regulatory approval or been commercialized[135](index=135&type=chunk) - The company relies on third parties for manufacturing and distribution, which exposes it to risks related to production quality, supply chain disruptions, and sales performance[160](index=160&type=chunk)[164](index=164&type=chunk) - A material weakness was identified in the company's internal control over financial reporting as of December 31, 2021, related to insufficient accounting personnel, lack of segregation of duties, and inadequate internal controls[187](index=187&type=chunk) [Unresolved Staff Comments](index=40&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) The company reports no unresolved staff comments - There are no unresolved staff comments[199](index=199&type=chunk) [Properties](index=40&type=section&id=Item%202.%20Properties.) The company leases vehicles and flexible shared workspaces for its principal offices, owning no real estate - The company leases several vehicles with terms expiring between **2023 and 2024**[200](index=200&type=chunk) - Since March 2021, the company rents flexible shared workspaces in Or Yehuda, Israel, on short-term agreements (typically 6 months)[201](index=201&type=chunk) [Legal Proceedings](index=40&type=section&id=Item%203.%20Legal%20Proceedings.) The company is not currently a party to any material litigation - The company reports no material litigation as of the filing date[202](index=202&type=chunk) [Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[203](index=203&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=41&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) As of March 2022, the company had 358 common stock holders and does not anticipate paying cash dividends - As of March 30, 2022, there were approximately **358 holders of record** of the company's Common Stock[206](index=206&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future[207](index=207&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=41&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Net loss increased in 2021 due to higher R&D and G&A expenses; cash balance is sufficient for 12 months Results of Operations (in thousands of US dollars) | Expense Category | 2021 | 2020 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $1,810 | $1,532 | +18.1% | Increase due to slow inventory write-off | | Selling & Marketing | $139 | $415 | -66.5% | Reduced business development expenses pending GlucoTrack® 2.0 | | General & Administrative | $2,091 | $1,185 | +76.4% | Hiring of new and augmented personnel | | **Net Loss** | **$4,067** | **$2,696** | **+50.8%** | Primarily due to increased G&A and R&D expenses | - As of December 31, 2021, the company had cash on hand of **$6,062 thousand** and believes this is sufficient to meet its capital needs for at least 12 months[226](index=226&type=chunk) Net Cash Flow Summary (in thousands of US dollars) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($3,769) | ($3,501) | | Net Cash Used in Investing Activities | ($1) | ($53) | | Net Cash Provided by Financing Activities | $0 | $13,009 | [Controls and Procedures](index=46&type=section&id=Item%209A.%20Controls%20and%20Procedures.) Disclosure controls were ineffective in 2021 due to material weaknesses in internal control, with remediation planned - Management concluded that disclosure controls and procedures were ineffective as of December 31, 2021[237](index=237&type=chunk) - Material weaknesses were identified related to a lack of sufficient internal accounting personnel, inadequate segregation of duties, and insufficient internal controls for complex and non-routine transactions[238](index=238&type=chunk) - Management has identified corrective actions, including hiring additional employees, and intends to implement remediation procedures during fiscal year 2022[239](index=239&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Compensation, and Related Transactions](index=46&type=section&id=Items%2010-14) Information for Items 10-14 is incorporated by reference from the company's definitive proxy statement - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the company's definitive Proxy Statement[245](index=245&type=chunk)[248](index=248&type=chunk)[249](index=249&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=48&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules.) This section lists financial statements, schedules, and exhibits filed with the Form 10-K report - This section provides a list of all exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and certifications[253](index=253&type=chunk)[255](index=255&type=chunk)[256](index=256&type=chunk) Financial Statements [Consolidated Financial Statements](index=52&type=section&id=Consolidated%20Financial%20Statements) 2021 financial statements show decreased assets, increased net loss, and an inventory write-down due to strategic shift Consolidated Balance Sheet Data (in thousands of US dollars) | Account | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $6,062 | $9,823 | | Total Assets | $6,265 | $10,606 | | Total Liabilities | $1,110 | $1,624 | | Total Stockholders' Equity | $5,155 | $8,982 | | Accumulated Deficit | ($97,466) | ($93,399) | Consolidated Statement of Operations Data (in thousands of US dollars) | Account | 2021 | 2020 | | :--- | :--- | :--- | | Total operating expenses | $4,040 | $3,132 | | Operating loss | ($4,040) | ($3,132) | | Loss for the year | ($4,067) | ($2,696) | | Loss per share (Basic and Diluted) | $0.26 | $0.19 | - In the fourth quarter of 2021, the company recorded an inventory write-down of approximately **$321 thousand** as the development of its second-generation device rendered the existing inventory obsolete[345](index=345&type=chunk) - The company has an outstanding contingent liability to the Israeli Innovation Authority (IIA) for royalties on future sales, amounting to approximately **$43 thousand plus interest**[356](index=356&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 000-54785 INTEGRITY APPLICATIONS, INC. (Exact name of registrant as specified in its charter) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 000-54785 INTEGRITY APPLICATIONS, INC. (Exact name of registrant as specified in its charter) | De ...

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) This section presents the unaudited condensed consolidated financial statements for the three-month period ended March 31, 2021, including the balance sheet, statement of operations, statement of changes in stockholders' equity, and statement of cash flows, reporting a net loss of **$904 thousand** and **$8.9 million** in cash and cash equivalents [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$9.6 million** from **$10.6 million** at year-end 2020, primarily due to reduced cash and cash equivalents, with total liabilities falling to **$1.5 million** and stockholders' equity to **$8.1 million** Condensed Consolidated Balance Sheet Highlights (in thousands of US dollars) | Account | March 31, 2021 (Unaudited) | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 8,887 | 9,823 | | Total current assets | 9,280 | 10,229 | | **TOTAL ASSETS** | **9,628** | **10,606** | | **Liabilities & Equity** | | | | Total Current Liabilities | 1,248 | 1,345 | | Total Liabilities | 1,479 | 1,624 | | Total Stockholders' equity | 8,149 | 8,982 | | **TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY** | **9,628** | **10,606** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported no revenue and a net loss of **$904 thousand** for the three months ended March 31, 2021, an increase from **$734 thousand** in 2020, primarily due to higher general and administrative expenses Condensed Consolidated Statements of Operations (in thousands of US dollars) | Account | Three-month period ended March 31, 2021 | Three-month period ended March 31, 2020 | | :--- | :--- | :--- | | Research and development expenses | 309 | 413 | | Selling and Marketing | 23 | 91 | | General and administrative expenses | 564 | 252 | | **Total operating expenses** | **896** | **756** | | **Operating loss** | **896** | **756** | | **Loss for the period** | **904** | **734** | | **Comprehensive Loss for the period** | **882** | **715** | | Loss per share (Basic and Diluted) | (0.00) | (0.00) | [Condensed Consolidated Statement of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity decreased from **$9.0 million** to **$8.1 million** as of March 31, 2021, primarily due to the **$904 thousand** net loss incurred during the quarter, partially offset by other comprehensive income and stock-based compensation Changes in Stockholders' Equity for Q1 2021 (in thousands of US dollars) | Description | Amount | | :--- | :--- | | Balance as of January 1, 2021 | 8,982 | | Loss for the period | (904) | | Other comprehensive income | 22 | | Stock-based compensation | 49 | | **Balance as of March 31, 2021** | **8,149** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$933 thousand** for Q1 2021, with no investing or financing activities, contrasting with **$13.0 million** in financing cash inflow in Q1 2020, leading to a decrease in cash, cash equivalents, and restricted cash from **$9.9 million** to **$9.0 million** Condensed Consolidated Statements of Cash Flows (in thousands of US dollars) | Cash Flow Activity | Three-month period ended March 31, 2021 | Three-month period ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | (933) | (989) | | Net cash used in investing activities | - | (15) | | Net cash provided by financing activities | - | 13,009 | | **Change in cash, cash equivalents, and restricted cash** | **(932)** | **12,002** | | Cash, cash equivalents, and restricted cash at end of the period | 8,953 | 12,478 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes confirm the company's ability to operate as a going concern for at least 12 months with **$8.9 million** in cash, detail its focus on non-invasive glucose monitoring device development, and outline significant accounting policies and operating lease liabilities - The company expects its cash and cash equivalents of approximately **$8.9 million** as of March 31, 2021, to be sufficient to meet its capital needs for at least 12 months, allowing it to operate as a going concern[24](index=24&type=chunk) - The company's subsidiary, Integrity Israel, focuses on the design, development, and commercialization of non-invasive glucose monitoring devices for people with diabetes and prediabetes[25](index=25&type=chunk) - As of March 31, 2021, total future operating lease payments amount to **$163 thousand**, with a present value of **$149 thousand**[37](index=37&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=12&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses the company's non-invasive glucose monitor, GlucoTrack®, including CE Mark approval and self-calibration, reporting no revenue for Q1 2021, a net loss of **$904 thousand** (up from **$734 thousand**), and **$8.9 million** in cash, deemed sufficient for over a year [Overview](index=12&type=section&id=Overview) The company, a medical device firm, focuses on its non-invasive glucose monitor, GlucoTrack®, with CE Mark approval and recent self-calibration enhancements, while developing companion apps and a cloud-based platform for future data-driven revenue streams - The company's primary product is the GlucoTrack® model DF-F, a non-invasive blood glucose monitor that uses ultrasound, electromagnetic, and thermal technologies via an earlobe clip[40](index=40&type=chunk) - Key product enhancements have received CE Mark approval, simplifying the calibration process from 3 hours monthly to 30 minutes every six months, which can now be performed by the user at home[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) - Future strategy includes developing companion applications and a cloud-based solution to provide personalized diabetes management tools and monetize de-identified user data[41](index=41&type=chunk) [Results of Operations](index=15&type=section&id=Results%20of%20Operations) For Q1 2021, the company reported no revenue, with total operating expenses increasing to **$896 thousand** from **$756 thousand** due to a rise in general and administrative expenses from **$252 thousand** to **$564 thousand**, resulting in a widened net loss of **$904 thousand** from **$734 thousand** year-over-year Comparison of Operating Results (in thousands of US dollars) | Account | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Revenues | 0 | 0 | | Research and development expenses | 309 | 413 | | Selling and marketing expenses | 23 | 91 | | General and administrative expenses | 564 | 252 | | **Net Loss** | **904** | **734** | - The increase in general and administrative expenses is primarily attributable to the hiring of new and augmented personnel to advance the company's business agenda[58](index=58&type=chunk) [Liquidity and Capital Resources](index=16&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2021, the company held approximately **$8.9 million** in cash from a **$15 million** private placement, which management deems sufficient for over one year of operations, with net cash used in operating activities at **$933 thousand** for the quarter - The company had cash on hand of approximately **$8.9 million** as of March 31, 2021[62](index=62&type=chunk) - Management believes current cash and cash equivalents will enable operations for a period exceeding one year from the report date[62](index=62&type=chunk) Net Cash Flow Summary (in thousands of US dollars) | Cash Flow Activity | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (933) | (989) | | Net Cash Used in Investing Activities | 0 | (15) | | Net Cash Provided by Financing Activities | 0 | 13,009 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=17&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk - Disclosure is not required for smaller reporting companies[67](index=67&type=chunk) [Item 4. Controls and Procedures](index=17&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2021, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2021, the President and Interim CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[68](index=68&type=chunk) - No changes occurred in the company's internal control over financial reporting during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, these controls[69](index=69&type=chunk) [PART II - OTHER INFORMATION](index=18&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=18&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section discloses a private placement on February 14, 2020, involving the sale of **37,500,000 shares** for **$15 million** in gross proceeds, with the placement agent receiving **$1.95 million** in fees and a warrant to purchase **3,750,000 shares** - On February 14, 2020, the company entered into a Securities Purchase Agreement with an accredited investor, selling **37,500,000 shares** for a gross purchase price of **$15,000 thousand**[71](index=71&type=chunk) - In Q1 2020, the placement agent, Andrew Garrett, was paid **$1,950 thousand** in fees and issued a warrant to purchase **3,750,000 shares**[72](index=72&type=chunk) [Item 6. Exhibits](index=18&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q report, including certifications from the Principal Executive Officer and Financial Officer under Sarbanes-Oxley Act Sections 302 and 906, and various XBRL data files - The report includes certifications from the Principal Executive and Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[73](index=73&type=chunk) - XBRL Instance, Schema, Calculation, Label, Presentation, and Definition documents are included as exhibits[73](index=73&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________________ to _________________________ Commission file number 000-54785 INTEGRITY APPLICATIONS, INC. (Exact name of registrant as specified in its ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | None. | | | Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Ac ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended June 30, 2020 or For the transition period from ________________ to ________________ Commission File Number: 000-54785 INTEGRITY APPLICATIONS, INC. (Exact name of registrant as specified in its charter) Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...

PART I - FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements, management's discussion, and controls [Item 1. Financial Statements.](index=4&type=section&id=Item%201.%20Financial%20Statements.) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity (deficit), and statements of cash flows, along with their accompanying notes for the period ended March 31, 2020 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section details the company's financial position, including assets, liabilities, and equity, at specific reporting dates Condensed Consolidated Balance Sheets (March 31, 2020 vs. December 31, 2019) | Item | March 31, 2020 (unaudited) | December 31, 2019 | | :-------------------------------- | :------------------- | :------------------ | | Cash and cash equivalents | $12,422,578 | $418,621 | | Total current assets | $12,814,674 | $718,042 | | Total assets | $13,333,082 | $1,282,461 | | Total current liabilities | $1,983,739 | $2,272,255 | | Total liabilities | $2,385,757 | $2,964,063 | | Total stockholders' equity (deficit) | $10,947,325 | $(1,411,602) | - The company's cash and cash equivalents significantly increased from **$418,621** at December 31, 2019, to **$12,422,578** at March 31, 2020[9](index=9&type=chunk) - Total stockholders' equity shifted from a deficit of **$(1,411,602)** at December 31, 2019, to a positive equity of **$10,947,325** at March 31, 2020[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance, including revenues, expenses, and net loss, over specific periods Condensed Consolidated Statements of Operations and Comprehensive Loss (Three-month period ended March 31) | Item | 2020 (unaudited) | 2019 (unaudited) | | :------------------------------------------ | :--------------- | :--------------- | | Revenues | $2,174 | $25,562 | | Research and development expenses | $415,039 | $425,117 | | Selling and marketing expenses | $90,756 | $125,343 | | General and administrative expenses | $251,869 | $500,155 | | Total operating expenses | $757,664 | $1,050,615 | | Operating loss | $755,490 | $1,025,053 | | Financing income, net | $21,721 | $3,400 | | Loss for the period | $(733,769) | $(1,021,653) | | Comprehensive loss for the period | $(714,478) | $(1,054,801) | | Loss per share (Basic and Diluted) | $(0.00) | $(0.01) | - Revenues decreased significantly from **$25,562** in Q1 2019 to **$2,174** in Q1 2020[11](index=11&type=chunk) - Loss for the period decreased from **$(1,021,653)** in Q1 2019 to **$(733,769)** in Q1 2020, primarily due to reduced operating expenses[11](index=11&type=chunk) [Condensed Consolidated Statement of Changes in Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Stockholders%27%20Equity%20(Deficit)) This section tracks the changes in the company's stockholders' equity or deficit over the reporting period Condensed Consolidated Statement of Changes in Stockholders' Equity (Deficit) (Three-month period ended March 31, 2020) | Item | Balance as of Jan 1, 2020 | Loss for the period | Issuance of Common Stock net of cash issuance costs | Issuance of shares as settlement of financial liabilities | Warrants issued as consideration for placement services | Stock-based compensation | Balance as of Mar 31, 2020 | | :------------------------------------------ | :------------------------ | :------------------ | :-------------------------------------------------- | :-------------------------------------------------------- | :------------------------------------------------------ | :----------------------- | :------------------------- | | Common Stock (Amount) | $161,858 | - | $37,500 | - | - | - | $199,358 | | Additional paid in capital | $89,005,407 | - | $12,215,682 | - | $756,087 | $843 | $101,978,019 | | Receipts on account of shares | - | - | - | $63,293 | - | - | $63,293 | | Accumulated other comprehensive income | $124,062 | - | - | - | - | - | $143,353 | | Accumulated deficit | $(90,702,929) | $(733,769) | - | - | - | - | $(91,436,698) | | Total Stockholders' Equity (Deficit) | $(1,411,602) | $(733,769) | $12,253,182 | $63,293 | $756,087 | $843 | $10,947,325 | - Total Stockholders' Equity (Deficit) increased from **$(1,411,602)** at January 1, 2020, to **$10,947,325** at March 31, 2020, primarily driven by the issuance of common stock[14](index=14&type=chunk) - Issuance of Common Stock net of cash issuance costs contributed **$12,253,182** to equity during Q1 2020[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the cash inflows and outflows from operating, investing, and financing activities for the period Condensed Consolidated Statements of Cash Flows (Three-month period ended March 31) | Item | 2020 (unaudited) | 2019 (unaudited) | | :------------------------------------------ | :--------------- | :--------------- | | Net cash used in operating activities | $(989,105) | $(821,023) | | Net cash used in investing activities | $(14,615) | $(6,378) | | Net cash provided by financing activities | $13,009,269 | $756,111 | | Change in cash, cash equivalents, and restricted cash | $12,002,304 | $(64,823) | | Cash, cash equivalents, and restricted cash at end of the period | $12,478,017 | $84,861 | - Net cash provided by financing activities increased substantially from **$756,111** in Q1 2019 to **$13,009,269** in Q1 2020[16](index=16&type=chunk) - Cash, cash equivalents, and restricted cash at the end of the period increased significantly to **$12,478,017** in Q1 2020 from **$84,861** in Q1 2019[16](index=16&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [NOTE 1 – GENERAL](index=8&type=section&id=NOTE%201%20%E2%80%93%20GENERAL) This note describes the company's primary operations, financial condition, and going concern assessment - The Company's primary operations are carried out by its Israeli subsidiary, Integrity Israel, which focuses on non-invasive glucose monitoring devices[23](index=23&type=chunk) - As of March 31, 2020, the Company had an accumulated deficit of **$91,436,698** and has reported losses and negative cash flows from operations since inception[23](index=23&type=chunk) - A **$15 million** private placement (net cash over **$13,009,269**) closed on February 14, 2020, is expected to provide sufficient capital for at least 12 months, supporting the going concern assumption[22](index=22&type=chunk) [NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=NOTE%202%20%E2%80%93%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the key accounting principles, estimates, and assumptions used in preparing the financial statements - The unaudited condensed consolidated financial statements are prepared in accordance with SEC rules for interim financial statements and U.S. GAAP, with certain information condensed or omitted[25](index=25&type=chunk) - Significant estimates and assumptions include the measurement of benefits to warrants with down-round protection, going concern assumptions, stock-based compensation, and inventory valuation[30](index=30&type=chunk) - Diluted net loss per share calculation excluded **82,442,314** and **76,597,357** outstanding stock options and warrants for Q1 2020 and Q1 2019, respectively, as their effect was anti-dilutive[29](index=29&type=chunk) [NOTE 3 – RECENT EVENTS](index=10&type=section&id=NOTE%203%20%E2%80%93%20RECENT%20EVENTS) This note highlights significant events, including product approvals, financing activities, and potential risks - On January 21, 2020, the Company received CE Mark approval for a major enhancement to GlucoTrack, enabling user self-calibration, reducing calibration time to 30 minutes, and frequency to once every six months[34](index=34&type=chunk) - On February 14, 2020, the Company closed a **$15,000,000** private placement of common stock, receiving net proceeds of **$13,009,269**[34](index=34&type=chunk) - The Company identified potential risks to its business due to the current COVID-19 pandemic, including impacts on product demand and global economies[33](index=33&type=chunk) [NOTE 4 – INVENTORIES](index=11&type=section&id=NOTE%204%20%E2%80%93%20INVENTORIES) This note provides a breakdown of the company's inventory components and valuation Inventories (March 31, 2020 vs. December 31, 2019) | Item | March 31, 2020 (unaudited) | December 31, 2019 | | :-------------------------------- | :------------------- | :------------------ | | Raw materials | $14,848 | $18,381 | | Work in process | $1,618,178 | $1,541,932 | | Finished products | $48,833 | $80,886 | | Total | $1,681,859 | $1,641,199 | | Less – provision for slow moving inventory | $(1,456,597) | $(1,456,597) | | Net Inventory | $225,262 | $184,602 | - Net inventory increased from **$184,602** at December 31, 2019, to **$225,262** at March 31, 2020[36](index=36&type=chunk) [NOTE 5 – LEASES](index=11&type=section&id=NOTE%205%20%E2%80%93%20LEASES) This note details the company's operating lease agreements, associated costs, and liabilities Operating Lease Costs (Three Months Ended March 31, 2020) | Item | Amount (unaudited) | | :---------- | :----------------- | | Office space | $30,000 | | Vehicles | $9,666 | | Total | $39,666 | - Remaining lease terms are **0.67 years** for office space and **2.14 years** for vehicles, with a weighted average discount rate of **10%** for both[38](index=38&type=chunk) - Total operating lease payments as of March 31, 2020, are **$162,462**, with a present value of lease liabilities of **$149,411**[41](index=41&type=chunk) [NOTE 6 – FINANCING INCOME, NET](index=12&type=section&id=NOTE%206%20%E2%80%93%20FINANCING%20INCOME%2C%20NET) This note presents the components of the company's financing income and expenses Financing Income, Net (Three-month period ended March 31) | Item | 2020 (unaudited) | 2019 (unaudited) | | :------------------------------------------------ | :--------------- | :--------------- | | Israeli CPI linkage difference on principal of loans from stockholders | $(186) | $(523) | | Exchange rate differences | $(121) | $8,063 | | Interest Income (expenses) on credit from banks and others | $22,028 | $(4,140) | | Total Financing income, net | $21,721 | $3,400 | - Net financing income increased from **$3,400** in Q1 2019 to **$21,721** in Q1 2020, primarily due to interest income[42](index=42&type=chunk) [NOTE 7 – SUBSEQUENT EVENTS](index=12&type=section&id=NOTE%207%20%E2%80%93%20SUBSEQUENT%20EVENTS) This note reports significant events that occurred after the balance sheet date - On April 23, 2020, the Company increased its authorized shares of common stock from **200,000,000** to **500,000,000**[43](index=43&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=13&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides management's perspective on the company's financial condition and results of operations, including an overview of its business, critical accounting policies, detailed analysis of revenue and expenses, liquidity, and capital resources. It also includes cautionary notes regarding forward-looking statements and risks [Overview](index=13&type=section&id=Overview) This section introduces the company's business, core product, and strategic commercialization efforts - The Company is a medical device company focused on non-invasive glucose monitoring devices (GlucoTrack® model DF-F) for people with diabetes and prediabetes[47](index=47&type=chunk) - GlucoTrack® utilizes a patented combination of ultrasound, electromagnetic, and thermal technologies to obtain blood glucose measurements in less than one minute[47](index=47&type=chunk) - Recent CE Mark approval (January 21, 2020) allows for user self-calibration, reducing calibration time to **30 minutes** and frequency to once every six months, enhancing commercial viability[51](index=51&type=chunk)[52](index=52&type=chunk) - Strategic commercialization efforts include selecting appropriate distribution partners, targeting key customer segments, revising cost structures, and seeking reimbursement approval, with a pilot program underway in the Netherlands[54](index=54&type=chunk)[55](index=55&type=chunk) - The company is developing companion applications and a cloud-based solution, aiming to create an additional revenue source by monetizing de-identified data[48](index=48&type=chunk) [Critical Accounting Policies](index=15&type=section&id=Critical%20Accounting%20Policies) This section highlights the accounting policies requiring significant management judgment and estimation - The most significant estimates and assumptions relate to the measurement of the benefit to warrants with down-round protection and the going concern assumption[57](index=57&type=chunk) - Due to the early stage of operations, management considers the going concern assessment as the primary critical accounting policy[58](index=58&type=chunk) [Results of Operations](index=16&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance by examining revenue and expense categories [Revenues](index=16&type=section&id=Revenues) This section details the company's revenue performance and contributing factors Revenues (Three-month period ended March 31) | Period | Amount | | :----- | :----- | | 2020 | $2,174 | | 2019 | $25,562 | - Revenues decreased significantly in Q1 2020 compared to Q1 2019 due to a decrease in orders for GlucoTrack® and PEC products[60](index=60&type=chunk) [Research and development expenses](index=16&type=section&id=Research%20and%20development%20expenses) This section analyzes the company's research and development expenditures and future expectations Research and Development Expenses (Three-month period ended March 31) | Period | Amount | | :----- | :----- | | 2020 | $415,039 | | 2019 | $425,117 | - R&D expenses decreased slightly in Q1 2020, primarily due to lower salary and personnel-related expenses, including stock-based compensation[62](index=62&type=chunk) - R&D expenses are expected to increase in 2020 and beyond due to hiring additional personnel, product line development, and GlucoTrack® improvements[63](index=63&type=chunk) [Selling and marketing expenses](index=16&type=section&id=Selling%20and%20marketing%20expenses) This section analyzes the company's selling and marketing expenditures and future strategic focus Selling and Marketing Expenses (Three-month period ended March 31) | Period | Amount | | :----- | :----- | | 2020 | $90,756 | | 2019 | $125,343 | - Selling and marketing expenses decreased in Q1 2020, mainly due to a strategic decision to reduce business development personnel in the European market[64](index=64&type=chunk) - These expenses are expected to increase in 2020 and beyond as the company focuses on marketing and sales of GlucoTrack® and potential FDA clinical trials[65](index=65&type=chunk) [General and administrative expenses](index=16&type=section&id=General%20and%20administrative%20expenses) This section analyzes the company's general and administrative expenditures and their drivers General and Administrative Expenses (Three-month period ended March 31) | Period | Amount | | :----- | :----- | | 2020 | $251,869 | | 2019 | $500,155 | - G&A expenses decreased significantly in Q1 2020, primarily due to the departure of former executives, reduced professional fees, and lower stock-based compensation[66](index=66&type=chunk) [Financing income, net](index=17&type=section&id=Financing%20income%2C%20net) This section analyzes the company's net financing income and its components Financing Income, Net (Three-month period ended March 31) | Period | Amount | | :----- | :----- | | 2020 | $21,721 | | 2019 | $3,400 | - Net financing income increased to **$21,721** in Q1 2020 from **$3,400** in Q1 2019[68](index=68&type=chunk) [Net Loss](index=17&type=section&id=Net%20Loss) This section analyzes the company's net loss and its primary drivers Net Loss (Three-month period ended March 31) | Period | Amount | | :----- | :----- | | 2020 | $(733,769) | | 2019 | $(1,021,653) | - Net loss decreased in Q1 2020, primarily due to the reduction in operating expenses[69](index=69&type=chunk) [Liquidity and Capital Resources](index=17&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its financial obligations and manage its capital - As of March 31, 2020, cash on hand was approximately **$12.4 million**, primarily from a **$15 million** private placement (net cash of **$13 million**) in February 2020[70](index=70&type=chunk) - The current cash and cash equivalents are expected to enable operations for over one year from the report date[70](index=70&type=chunk) - The company has outstanding loans from stockholders (totaling **$143,662** as of March 31, 2020) that are not required to be repaid until the first year of accounting profit[71](index=71&type=chunk) - A contingent liability for royalty payments to the Office of the Chief Scientist of the Ministry of Industry, Trade and Labor of the State of Israel was approximately **$34,000** as of March 31, 2020[72](index=72&type=chunk) [Net Cash Used in Operating Activities](index=17&type=section&id=Net%20Cash%20Used%20in%20Operating%20Activities) This section analyzes the cash flows generated or used by the company's core business operations Net Cash Used in Operating Activities (Three-month period ended March 31) | Period | Amount | | :----- | :----- | | 2020 | $(989,105) | | 2019 | $(821,023) | - Net cash used in operating activities increased in Q1 2020, primarily reflecting the net loss for the period[73](index=73&type=chunk) [Net Cash Used in Investing Activities](index=18&type=section&id=Net%20Cash%20Used%20in%20Investing%20Activities) This section analyzes the cash flows related to the company's investment activities Net Cash Used in Investing Activities (Three-month period ended March 31) | Period | Amount | | :----- | :----- | | 2020 | $(14,615) | | 2019 | $(6,378) | - Cash used in investing activities was primarily for the purchase of equipment[75](index=75&type=chunk) [Net Cash Provided by Financing Activities](index=18&type=section&id=Net%20Cash%20Provided%20by%20Financing%20Activities) This section analyzes the cash flows resulting from the company's financing activities Net Cash Provided by Financing Activities (Three-month period ended March 31) | Period | Amount | | :----- | :----- | | 2020 | $13,009,269 | | 2019 | $756,111 | - Net cash provided by financing activities significantly increased in Q1 2020 due to net capital raised from the February 2020 private placement and common stock issuance[76](index=76&type=chunk) [Off-Balance Sheet Arrangements](index=18&type=section&id=Off-Balance%20Sheet%20Arrangements) This section discloses any material off-balance sheet commitments or obligations of the company - As of March 31, 2020, the Company did not have any off-balance sheet arrangements[77](index=77&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk.](index=18&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) This item is not required for smaller reporting companies - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[78](index=78&type=chunk) [Item 4. Controls and Procedures.](index=18&type=section&id=Item%204.%20Controls%20and%20Procedures.) This section discusses the evaluation of the company's disclosure controls and procedures and reports no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=18&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section assesses the effectiveness of controls for financial reporting - Management, including the President and Interim Chief Financial Officer, evaluated the effectiveness of disclosure controls and procedures as of March 31, 2020[79](index=79&type=chunk) - It was concluded that the disclosure controls and procedures were effective at the reasonable assurance level[79](index=79&type=chunk) [Changes in Internal Control over Financial Reporting](index=18&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports any changes in internal controls - There were no changes in internal control over financial reporting during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[80](index=80&type=chunk) PART II - OTHER INFORMATION This section includes additional information not covered in the financial statements, such as equity sales and exhibits [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=18&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the company's unregistered sales of equity securities, including the Series D Units offering in 2019 and a significant private placement of common stock in February 2020, along with associated placement agent compensation [Offering of Series D Units](index=18&type=section&id=Offering%20of%20Series%20D%20Units) This section describes the company's private placement of Series D Units and common stock - During 2019, the Company received aggregate gross proceeds of **$4,873,520** from the private placement of Series D Units to accredited investors[82](index=82&type=chunk) - On February 14, 2020, the Company sold **37,500,000** shares of common stock to an accredited investor for an aggregate gross purchase price of **$15,000,000**[86](index=86&type=chunk) [Placement Agent Compensation](index=20&type=section&id=Placement%20Agent%20Compensation) This section outlines the compensation, including cash and warrants, provided to placement agents - For the Series D Units offering, the placement agent received a cash commission of **10%** of the aggregate sales price, a **3%** non-accountable expense allowance, and warrants to purchase up to **10%** of the shares and warrants issued[87](index=87&type=chunk) - In Q1 2020, Andrew Garrett was paid **$1,950,000** in fees and issued a warrant to purchase **3,750,000** shares for placement agent services related to the February 2020 private placement[87](index=87&type=chunk) [Item 6. Exhibits.](index=20&type=section&id=Item%206.%20Exhibits.) This section lists the exhibits filed as part of the Form 10-Q, including organizational documents, agreements, and certifications - Exhibits include the Merger Agreement, Certificate of Incorporation, Bylaws, Form of Securities Purchase Agreement, and various certifications (e.g., Section 302 and 906 of Sarbanes-Oxley Act)[88](index=88&type=chunk) - XBRL Instance, Schema, Calculation, Label, Presentation, and Definition Linkbase Documents are also included[88](index=88&type=chunk) [SIGNATURES](index=21&type=section&id=SIGNATURES) This section contains the required signatures of the company's authorized officers, certifying the filing of the report - The report was signed on May 19, 2020, by David Malka, President (Principal Executive Officer), and Jolie Kahn, Interim Chief Financial Officer (Principal Financial Officer)[91](index=91&type=chunk)