Promising results support the potential of epidural glucose monitoring for simplified disease management for patients with painful diabetic neuropathy Rutherford, NJ, May 16, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that its implantable continuous glucose monitor has successfully completed 30 days of a 60-day long-t ...

PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) Glucotrack Inc. reported a **$2.93 million** net loss for Q1 2024, driven by increased R&D expenses, significantly weakening its cash position and raising going concern doubts [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$2.1 million** as of March 31, 2024, primarily due to a reduction in cash and cash equivalents, while stockholders' equity fell sharply to **$376,000** Condensed Consolidated Balance Sheet Highlights (in thousands of US dollars) | Account | March 31, 2024 (Unaudited) | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $1,497 | $4,492 | | Total current assets | $1,937 | $4,868 | | **TOTAL ASSETS** | **$2,106** | **$4,905** | | **Liabilities & Equity** | | | | Total current liabilities | $1,482 | $1,512 | | Total liabilities | $1,730 | $1,708 | | Total stockholders' equity | $376 | $3,197 | | **TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY** | **$2,106** | **$4,905** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for Q1 2024 more than doubled to **$2.93 million**, driven by a substantial rise in operating expenses, particularly R&D, worsening loss per share to **$0.12** Statement of Operations Summary (in thousands of US dollars) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $2,148 | $642 | | General and administrative | $733 | $642 | | Selling and marketing expenses | $70 | $0 | | **Total operating expenses** | **$2,951** | **$1,284** | | **Operating loss** | **($2,951)** | **($1,284)** | | **Net Loss** | **($2,927)** | **($1,286)** | | **Basic and diluted net loss per share** | **($0.12)** | **($0.08)** | [Condensed Consolidated Statement of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity declined from **$3.2 million** to **$376,000** by March 31, 2024, primarily due to the **$2.93 million** net loss, while outstanding shares increased Changes in Stockholders' Equity (in thousands of US dollars) | Description | Amount | | :--- | :--- | | Balance as of January 1, 2024 | $3,197 | | Net Loss for the period | ($2,927) | | Other comprehensive income | $6 | | Stock-based compensation & other | $100 | | **Balance as of March 31, 2024** | **$376** | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$2.94 million** in Q1 2024, leading to a nearly **$3.0 million** decrease in cash and cash equivalents, ending at **$1.5 million** Cash Flow Summary (in thousands of US dollars) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,942) | ($1,313) | | Net cash used in investing activities | ($59) | $0 | | Change in cash and cash equivalents | ($2,995) | ($1,318) | | **Cash and cash equivalents, end of period** | **$1,507** | **$1,013** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight substantial doubt about going concern due to insufficient cash, warrant exchanges for common stock, and subsequent private placement and reverse stock split approval - The company's cash and cash equivalents of **$1,497,000** as of March 31, 2024, are insufficient to fund its business plans for the next twelve months, which raises substantial doubt about its ability to continue as a going concern[24](index=24&type=chunk)[25](index=25&type=chunk) - On February 13, 2024, the company exchanged **4,381,953** warrants for an aggregate of **3,593,203** shares of common stock[43](index=43&type=chunk)[44](index=44&type=chunk) - Subsequent to the quarter, on April 22, 2024, the company raised gross proceeds of **$500,000** through a private placement of common stock[63](index=63&type=chunk) - On April 26, 2024, stockholders approved a proposal to authorize a reverse stock split at a ratio between **1-for-5** and **1-for-30**[65](index=65&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses the strategic pivot to an implantable CBGM, noting a **$2.93 million** net loss in Q1 2024 due to increased R&D, and expresses substantial doubt about going concern due to insufficient cash - The company has shifted its focus from the original non-invasive GlucoTrack device to the development of an implantable Continuous Blood Glucose Monitor (CBGM)[70](index=70&type=chunk)[71](index=71&type=chunk) - A long-term animal trial for the CBGM is planned for late Q4 2024, with a first-in-human study submission also targeted for late 2024[73](index=73&type=chunk) - Management concluded that substantial doubt exists about the company's ability to continue as a going concern, as current cash is not sufficient to fund operations for at least the next twelve months[98](index=98&type=chunk)[99](index=99&type=chunk) Comparison of Operating Results (in thousands of US dollars) | Expense Category | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $2,100 | $642 | +$1,458 | | General and administrative | $733 | $642 | +$91 | | Marketing | $70 | $0 | +$70 | | **Net Loss** | **$2,930** | **$1,310** | **+$1,620** | [Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Glucotrack is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Glucotrack is not required to provide quantitative and qualitative disclosures about market risk[101](index=101&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2024, due to material weaknesses, with remediation plans including hiring additional personnel - Management concluded that disclosure controls and procedures were ineffective as of March 31, 2024[102](index=102&type=chunk) - Material weaknesses were identified related to a lack of sufficient internal accounting personnel, inadequate segregation of duties, and insufficient internal controls[102](index=102&type=chunk) - Management plans to remediate these weaknesses during fiscal year 2024 by hiring additional employees and engaging external financial reporting consultants[103](index=103&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not party to any material legal proceedings[107](index=107&type=chunk) [Risk Factors](index=23&type=page&id=Item%201A%20Risk%20Factors) Significant risks include potential failure of the new implantable CBGM technology and ongoing Nasdaq delisting risk due to minimum bid price non-compliance, addressed by a planned reverse stock split - A key risk is the potential failure to capitalize on the strategic shift to implantable CBGM technology, which could lead to the company's dissolution[109](index=109&type=chunk) - The company is not in compliance with Nasdaq's minimum bid price rule and faces delisting, with an extension granted until May 20, 2024, to regain compliance[111](index=111&type=chunk)[112](index=112&type=chunk) - To address the Nasdaq compliance issue, stockholders approved a reverse stock split on April 26, 2024[113](index=113&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during Q1 2024 that were not previously reported on a Form 8-K - There were no unregistered sales of securities during Q1 2024 that were not previously reported on a Form 8-K[116](index=116&type=chunk) [Defaults Upon Senior Securities](index=24&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None reported[119](index=119&type=chunk) [Mine Safety Disclosures](index=24&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[120](index=120&type=chunk) [Other Information](index=24&type=section&id=Item%205.%20Other%20Information) The company reports no information for this item - None[121](index=121&type=chunk) [Exhibits](index=24&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents and required CEO/CFO certifications - The report includes various exhibits, such as corporate governance documents, the Form of Exchange Agreement from February 2024, and required CEO/CFO certifications[122](index=122&type=chunk)

Continuous blood glucose monitor's preclinical data and sensor longevity modeling to be presented at major diabetes conference Rutherford, NJ, May 02, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced two abstracts have been accepted for poster presentation at the American Diabetes Association (ADA) 84th Scientific Sessions ...

Rutherford, NJ, April 22, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that the Company has closed a private placement of securities. The Offering included participation by CEO Paul V. Goode, PhD, as well as other members of the Company's executive management, Board of Directors, and existing shareholders. In a transact ...

Expansion offers the potential for continuous, discreet and simplified epidural glucose monitoring solutions for patients with Painful Diabetic Neuropathy Rutherford, NJ, April 16, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced that it is expanding its glucose monitoring technology to include measuring glucose in the epidural s ...

Computational modeling with The Technology Partnership shows sensor longevity beyond 3 years; 1 year longer than previously announced Implantable Continuous Blood Glucose Monitor technology could transform lives of patients with diabetes Rutherford, NJ & Cambridge, UK, April 02, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, and The Tec ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 Delaware 98-0668934 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 301 Route 17 North, Suite 800 Rutherford, NJ 07070 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (201) 842-7715 ...

Rutherford, NJ, March 12, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced today that Vincent Wong has joined the Company as Vice President of Quality. Mr. Wong has extensive experience in life sciences and medical device manufacturing, with expertise in establishing Quality Management functions, managing FDA inspections, and dri ...

Rutherford, NJ & Brooklyn Park, MN, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (NASDAQ:GCTK), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced the selection of Cirtec Medical Corp, the leading medical device solutions provider of implantable therapies, as manufacturer for the implantable Continuous Blood Glucose Monitor (CBGM). The two companies have signed a development agreement for clinical and comme ...

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, 2023 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: 001-41141 Indicate by check mark whether the registrant has submitted electronically and post ...