Glucotrack Inc
For the period ended Jun 30, 2024. Filed Aug 13, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 13, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-15.
0001493152-24-019999
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001493152-24-031610
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 45 previous paragraphs and 59 current paragraphs.
22 unchanged; 12 reworded; 21 added; 11 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (21)
Current report
On April 22, 2024, we entered into a private placement agreement under which we issued 79,366 shares of our common stock at a price of $6.3 per share for aggregate gross proceeds of $500,000 to certain members of our executive management, Board of Directors and existing shareholders.
Current report
On April 26, 2024, we held our Annual Meeting of Shareholders (the “Annual Meeting”) under which our stockholders approved, inter alia, the following proposals: (i) adoption of our 2024 Equity Incentive Plan; (ii) approved of an amendment to Article IV of our Certificate of Incorporation, as amended, to effect a reverse stock split of the Company’s Common Stock at a ratio of between one-for-five and one-for-thirty, with such ratio to be determined at the sole discretion of the Board of Directors. Following the Annual Meeting, on April 30, 2024, the Board of Directors approved a one-for-five reverse split of our issued and outstanding shares of Common Stock (the “Reverse Stock Split”). On May 17, 2024, we filed a Certificate of Amendment to the Company’s Certificate of Incorporation with the Secretary of State of the State of Delaware which effected the Reverse Stock Split.
Current report
On June 27, 2024, the Board of Directors approved us to enter into note and warrant purchase agreements with certain investors, providing for the private placement of unsecured promissory notes in the aggregate principal amount of $100,000 (the “Notes”) and warrants (the “Warrants”) to purchase up to an aggregate of 300,000 shares of our Common Stock. The closing of the private placement occurred on July 1, 2024. The Notes bear simple interest at the rate of 3% per annum and are due and payable in cash on the earlier of: (a) twelve months from the date of the Note; or (b) the date we raise third-party equity capital in an amount equal to or in excess of $1,000,000 (the “Maturity Date”). We may prepay the Notes at any time prior to the Maturity Date without penalty. If an event of default occurs, the then-outstanding principal amount of the Notes plus any unpaid accrued interest will accelerate and become immediately payable in cash. Each Warrant has an exercise price of $4.95 per share. The Warrants are immediately exercisable and have a five-year term.
Current report
On July 18, 2024, we entered into a series of convertible promissory notes with certain investors, providing for the private placement of unsecured convertible promissory notes in the aggregate principal amount of $360,000 (the “Notes” and each a “Note”). The Notes bear simple interest at the rate of 8% per annum and are due and payable in cash on the earlier of: (a) the twelve month anniversary of Note, or (b) the date of closing of a Qualified Financing (as defined above). Interest will be computed on the basis of a 365-day year.
Current report
On July 30, 2024, we entered into a convertible promissory note and three warrant agreements (the “Warrants”) with an existing investor (the “Holder”), providing for the private placement of a secured convertible promissory note in the aggregate principal amount of $4,000,000 (the “Note”). The Note is not convertible until and unless approved at a meeting of our stockholders. We have agreed to hold such a meeting to seek stockholder approval within 90 days. The Note bears simple interest at the rate of 8% per annum and is due and payable in cash on the earlier of: (i) 12 months anniversary of Note, or (ii) the date of closing of a Sale Transaction (as defined above) (the “Maturity Date”). The Note is secured by a first-priority security interest on all our assets. Each Warrant becomes exercisable 12 months after its issuance and has term of 10 years. The Warrants are exercisable for cash only and have no price-based antidilution. The first Warrant is for 2,133,334 shares at $1.875 per share. The second Warrant is for 1,523,810 shares at $2.625 per share. The third Warrant is for 1,185,186 shares at $3.375 per share.
Current report
As of June 30, 2024, the balance of cash and cash equivalents of approximately $159,000 is insufficient for the Company to realize its business plans for the twelve-month period subsequent to the reporting period.
Current report
Research and development expenses were approximately $3.6 million for the three-month period ended June 30, 2024, as compared to approximately $627,000 for the prior-year period. The increase is attributable to ramping up product development actives.
Current report
General and administrative expenses were approximately $802,000 for the three-month period ended June 30, 2024, as compared to approximately $552,000 for the prior-year period. The increase is attributable to professional fees we accrued during the period.
Current report
Financing income, net
Current report
Financing income, net was approximately $2,000 for the three-month period ended June 30, 2024, as compared to financing income of approximately $3,000 for the prior-year period. The change is immaterial.
Current report
Consolidated Results of Operations for the Six Months Ended June 30, 2024 and 2023
Current report
Research and development expenses
Current report
Research and development expenses were approximately $5.7 million for the six-month period ended June 30, 2024, as compared to approximately $1.3 for the prior-year period. The increase is attributable to professional fees we accrued during the period.
Current report
Marketing expenses
Current report
General and administrative expenses
Current report
General and administrative expenses were approximately $1.5 million for the six-month period ended June 30, 2024, as compared to approximately $1.2 million for the prior-year period. The increase is attributable to professional fees we accrued during the period.
Current report
Financing income, net
Current report
Net Loss
Current report
Financing Activities
Current report
Net cash provided by financing activities was approximately $580,000 and $8.7 million for the six-month periods ended June 30, 2024 and 2023, respectively. Net cash provided by financing activities primarily reflects the proceeds received from private placement transaction in 2024 versus net proceeds received upon completion of public offering.
Current report
The development of the implantable continuous glucose sensor product is expected to require substantial further expenditures. We remain dependent upon external sources for financing our operations. Since inception, we have incurred substantial accumulated losses and negative operating cash flow and have a significant accumulated deficit. We do not have any committed external source of funds or other support for our development efforts, and we cannot be certain that additional funding will be available on acceptable terms, or at all. Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, government funding, strategic alliances, licensing arrangements, and other marketing or distribution arrangements, any of which may include terms that may adversely affect our stockholders’ rights. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may have to significantly delay, scale back or discontinue our development or commercialization initiatives. Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline. As of June 30, 2024, we believe that our cash on hand will not provide sufficient working capital to fund its current operations and animal trial program for the development of its Implantable CGM for a period of twelve-months subsequent to the reporting period.
Removed paragraphs (11)
Previous report
We are currently developing our own mobile companion application and a cloud-based solution platform to provide real time, data driven personalized tools to effectively help users manage their diabetes. In addition to being a critical and effective management tool for the end user, we believe that third parties such as insurers, pharmaceutical companies and advertisers would be willing to pay for the de-identified data that we will obtain through our platform, and that this is an opportunity for us to develop an additional revenue source.
Previous report
As previously reported, on May 26, 2023, the Company received a staff deficiency notice from The Nasdaq Stock Market (“Nasdaq”) indicating that the Company no longer complied with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Capital Market under Rule 5550(a)(2) of the Nasdaq Listing Rules (the “Bid Price Rule”). Pursuant to Nasdaq Marketplace Rule 5810(c)(3)(A), the Company was provided with a compliance period of 180 calendar days, or until November 22, 2023, to regain compliance with the Bid Price Rule.
Previous report
On November 24, 2023, the Company received a notice from Nasdaq stating that it has been granted an additional 180 calendar days, or until May 20, 2024, to regain compliance with the Bid Price Rule (the “Extended Compliance Period”). If at any time during the Extended Compliance Period, the closing bid price of our Common Stock is at least $1.00 per share for a minimum of 10 consecutive business days, the Nasdaq will provide written confirmation that we have regained compliance with the Bid Price Rule. If we cannot demonstrate compliance during the Extended Compliance Period, then Nasdaq will provide notice that our Common Stock will be subject to delisting. At that time, the Company may appeal the Staff’s determination to a hearings panel.
Previous report
At the Company’s annual meeting of stockholders held on April 26, 2024, the stockholders of the Company approved a proposal to authorize the Company’s Board of Directors (the “Board”) to file a Certificate of Amendment to the Company’s Certificate of Incorporation, as amended, to effect a reverse stock split of the Company’s common stock, par value $0.001 per share at a ratio between 1-for-5 and 1-for-30, to be effected at such time and date, if at all, as determined by the Board in its sole discretion (the “Reverse Stock Split”). On April 30, 2024, the Board approved the Reverse Stock Split. Among other considerations, the Company plans to implement the Reverse Stock Split to satisfy the Bid Price Rule for continued listing on Nasdaq. There can be no assurance that we will be able to regain and sustain compliance with all applicable requirements for continued listing on Nasdaq. In the event that we are unable to regain and sustain compliance with all applicable requirements for continued listing on the Nasdaq, our common stock may be delisted from Nasdaq.
Previous report
On February 13, 2024, the Company entered into an exchange agreement with certain shareholders (the “Holders”), pursuant to which the Company and the Holders agreed to exchange 4,381,953 of common stock purchase warrants owned by the Holders for 3,593,203 shares of the Company’s common stock, par value $0.001 per share.
Previous report
Research and development expenses were approximately $2.1 million for the three-month period ended March 31, 2024, as compared to approximately $642,000 for the prior-year period. The increase is attributable to consulting fees we accrued during the period.
Previous report
General and administrative expenses were approximately $733,000 for the three-month period ended March 31, 2024, as compared to approximately $642,000 for the prior-year period. The increase is attributable to professional fees we accrued during the period.
Previous report
Financing income (expenses), net
Previous report
Based on our operating plans, we do not expect that our current cash and cash equivalents as of March 31, 2024, will be sufficient to fund our operating, investing, and financing cash flow needs for at least the next twelve months, assuming our programs advance as currently contemplated. Based upon this review and our current financial condition, the Company has concluded that substantial doubt exists as to our ability to continue as a going concern. We have and believe we will continue to be able to raise additional capital through debt financing, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. However, there can be no assurances that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate our clinical trials or other operations. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors.” Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.
Previous report
As of December 31, 2023, cash on hand was $1,497,000. The development and commercialization of non-invasive glucose monitoring devices for use by people, are expected to require substantial further expenditures. We remain dependent upon external sources for financing our operations. Since inception, we have incurred substantial accumulated losses and negative operating cash flow and have a significant accumulated deficit. These factors raise substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. We plan to finance our operations through the sale of equity (including a shelf registration statement on Form S-3 that was declared effective on September 27, 2021 by the SEC which allows the Company to register up to $90,000 of certain equity and/or debt securities of the Company). There can be no assurance that we will succeed in obtaining the necessary financing to continue our operations.
Previous report
However, in April 2024, the Company raised net proceeds of $500,000 through the completion of a private placement transaction.
Reworded paragraphs (12)
Previous wording
The Company was founded with a mission to develop GlucoTrack®, a non-invasive glucose monitoring device designed to help people with diabetes and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive) spot finger stick devices. The first generation of GlucoTrack, which successfully received CE Mark approval, obtained glucose measurements via a small sensor clipped onto one’s earlobe. A limited release beta test in Europe and the Middle East demonstrated the need for an updated product with improved accuracy and human factors. As the glucose monitoring landscape rapidly moved away from point-in-time measurement to continuous measurement since then, the Company recently determined that it would focus its efforts on developing its Implantable CBGM. As such, we have since withdrawn our CE Mark for GlucoTrack and are no longer pursuing commercialization of this product or development of any further iterations.
Current wording
The Company was founded with a mission to develop Glucotrack®, a noninvasive glucose monitoring device designed to help people with diabetes and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive) spot finger stick devices. The first generation Glucotrack, which successfully received CE Mark approval, obtained glucose measurements via a small sensor clipped onto one’s earlobe. A limited release beta test in Europe and the Middle East demonstrated the need for an updated product with improved accuracy and human factors. As the glucose monitoring landscape rapidly moved away from point-in-time measurement to continuous measurement since then, the Company recently determined that it would focus its efforts on developing its Implantable CBGM. As such, we have since withdrawn our CE Mark for Glucotrack and are no longer pursuing commercialization of this product or development of any further iterations.
Previous wording
The Company is currently developing an implantable CBGM for use by Type 1 diabetes patients as well as insulin-dependent Type 2 patients. Implant longevity is key to the success of such a device. We have recently completed a feasibility study successfully demonstrating that a minimum two-year implant life is highly probable with the current sensor design. We have also initiated an animal study with an initial prototype system that has thus far demonstrated a simple implant procedure and good functionality. The Company will initiate a long-term animal trial in late Q4 2024 as well as initiate development of its commercial device, also in late Q4, in preparation of regulatory submission in late 2024 for a first in human study. We believe our technology, if successful, has the potential to be more accurate, more convenient and have a longer duration than other implantable glucose monitors that are either in the market or currently under development.
Current wording
The Company is currently developing an Implantable CBGM for use by Type 1 diabetes patients as well as insulin-dependent Type 2 patients. Implant longevity is key to the success of such a device. We have continued to evolve our sensor chemistry following our successful in-vitro feasibility study demonstrating that a minimum two-year implant life is highly probable with the current sensor design. Recently we announced a 3-year longevity is feasible leveraging both in-vitro and in-silico test results. We have also completed our animal study with an initial prototype system which demonstrated a simple implant procedure and good functionality. The results of both were recently presented in poster form at the American Diabetes Association annual conference. The Company has also initiated a longer-term animal trial (to support projected longevity studies) as well as development of its commercial device. A regulatory submission has been made for a first in human study, expected to initiate in Q3 2024. Further to the above progress on our CBGM product, we have also successfully demonstrated continuous glucose sensing in the epidural space. This latter approach is of importance for patients with painful diabetic neuropathy contemplating spinal cord stimulation therapy for their condition. We believe our technology, if successful, has the potential to be more accurate, more convenient and have a longer duration than other implantable glucose monitors that are either in the market or currently under development.
Previous wording
Our Senior Management team includes; CEO and President, Paul V. Goode PhD, who has a decorated career developing innovative medical technologies, including at Dexcom and MiniMed, CFO, James Cardwell, CPA who has over 16 years of experience as a Chief Financial Officer and Chief Operating Officer with a concentration in both SEC financial reporting and tax compliance, James P. Thrower PhD, Vice President of Engineering, a seasoned executive formerly of Sterling Medical Devices, Mindray DS USA and Dexcom, Inc., Mark Tapsak PhD, Vice President of Sensor Technology, a medical research scientist who brings over 25 years of experience in the diabetes industry, including previous senior roles at Dexcom and Medtronic, and Drinda Benjamin, Vice President of Marketing, a medical device professional with over 20 years of experience in the medical device and diabetes industry with senior roles at Intuity Medical, Senseionics, Abbott Diabetes, and Medtronic Diabetes. Several highly talented and accomplished executives joined the Company as senior advisors to the Board. These include Daniel McCaffrey MBA MA, a world-renowned behavioral scientist and digital health expert formerly at Samsung Health and Dexcom, Inc., Dr. Alexander Raykhman PhD, a measurement and artificial intelligence expert and Dr. David C. Klonoff, world renowned endocrinologist and diabetes technology thought leader. We intend to continue to invest in our talent and to expand and strengthen all areas within the Company.
Current wording
Our Senior Management team includes; CEO and President, Paul V. Goode PhD, who has a decorated career developing innovative medical technologies, including at Dexcom and MiniMed, CFO, James Cardwell, CPA who has over 16 years of experience as a Chief Financial Officer and Chief Operating Officer with a concentration in both SEC financial reporting and tax compliance, James P. Thrower PhD, Vice President of Engineering, a seasoned executive formerly of Sterling Medical Devices, Mindray DS USA and Dexcom, Inc., Mark Tapsak PhD, Vice President of Sensor Technology, a medical research scientist who brings over 25 years of experience in the diabetes industry, including previous senior roles at Dexcom and Medtronic, and Drinda Benjamin, Vice President of Marketing, a medical device professional with over 20 years of experience in the medical device and diabetes industry with senior roles at Intuity Medical, Senseonics, Abbott Diabetes, and Medtronic Diabetes. Erin Carter, formerly of Medtronic and Boston Scientific, has joined as an independent board member. Several highly talented and accomplished executives joined the Company as senior advisors to the Board. These include Daniel McCaffrey MBA MA, a world-renowned behavioral scientist and digital health expert formerly at Samsung Health and Dexcom, Inc., and Dr. David C. Klonoff, world renowned endocrinologist and diabetes technology thought leader. We intend to continue to invest in our talent and to expand and strengthen all areas within the Company.
Previous wording
Since our incorporation, we have devoted substantially all our resources to research and product development and to providing general and administrative support for these activities. Since our incorporation, we have incurred significant losses and negative cash flows from operations. During the three months ended March 31, 2024, we incurred a net loss of approximately $3.0 million and used $2.9 million of cash in our operations. As of March 31, 2024, we had an accumulated deficit of approximately $112.8 million. We expect to continue to incur significant and increasing losses and do not expect positive cash flows from operations for the foreseeable future, and our net losses may fluctuate significantly from period to period depending on the timing of and expenditures on our research and development activities.
Current wording
Since our incorporation, we have devoted substantially all our resources to research and product development and providing general and administrative support for these activities. Since our incorporation, we have incurred significant losses and negative cash flows from operations. During the six months ended June 30, 2024, we incurred a net loss of approximately $7.5 million and used $4.8 million of cash in our operations. As of June 30, 2024, we had an accumulated deficit of approximately $117.3 million. We expect to continue to incur significant and increasing losses and do not expect positive cash flows from operations for the foreseeable future, and our net losses may fluctuate significantly from period to period depending on the timing of and expenditures on our research and development activities.
Previous wording
The following discussion of our operating results explains material changes in our results of operations for the three-months ended March 31, 2024 compared with the same periods ended March 31, 2023. The discussion should be read in conjunction with the financial statements and related notes included elsewhere in this report.
Current wording
The following discussion of our operating results explains material changes in our results of operations for the three and six months ended June 30, 2024 compared with the same periods ended June 30, 2023. The discussion should be read in conjunction with the financial statements and related notes included elsewhere in this report.
Previous wording
Marketing expenses were approximately$70,000 for the three-month period ended March 31, 2024, as compared to $0 for the prior-year period. This increase is primarily attributable to business development personnel and professional marketing services.
Current wording
Marketing expenses were approximately $100,000 for the three-month period ended June 30, 2024, as compared to$0 for the prior-year period. This increase is primarily attributable to business development personnel and professional marketing services.
Previous wording
Net loss was approximately $2.93 million for the three-month period ended March 31, 2024, as compared to approximately $1.31 million for the prior-year period. The increase in net loss is attributable primarily to the increase in our research and development operating expenses, as described above.
Current wording
Net loss was approximately $4.5 million for the three-month period ended June 30, 2024, as compared to approximately $1.2 million for the prior-year period. The increase in net loss is attributable primarily to the increase in our operating expenses, as described above.
Previous wording
Research and development expenses consist primarily of salaries and other personnel-related expenses, materials, animal trials and other expenses. We expect research and development expenses to increase in 2024 and beyond, primarily due to hiring additional personnel, as well the development of Glucotrack CBGM; however, we may adjust or allocate the level of our research and development expenses based on available financial resources and based on our commercial needs, including the FDA registration process, specific requirements from customers, development of new Glucotrack CBGM models and others.
Current wording
Research and development expenses consist primarily of salaries and other personnel-related expenses, materials, animal trials and other expenses. We expect research and development expenses to marginally increase in 2025 and beyond, primarily due to hiring additional personnel, as clinical trials for the Glucotrack CBGM; however, we may adjust or allocate the level of our research and development expenses based on available financial resources and based on our commercial needs, including the FDA registration process, specific requirements from customers, development of new Glucotrack CBGM models and others.
Previous wording
Financing income, net was approximately $24,000 for the three-month period ended March 31, 2024, as compared to financing expense of approximately $2,000 for the prior-year period. The increase is attributable to interest income received during the period.
Current wording
Financing income, net was approximately $26,000 for the six-month period ended June 30, 2024, as compared to financing income of approximately $1,000 for the prior-year period. The increase is attributable to interest income received during the period.
Previous wording
Cash Flows for the Nine Months Ended March 31, 2024 and 2023
Current wording
Cash Flows for the Six Months Ended June 30, 2024 and 2023
Previous wording
Net cash used in operating activities was approximately $2.94 million and approximately $1.31 million for the three-month periods ended March 31, 2024 and 2023, respectively. Net cash used in operating activities primarily reflects the net loss for those periods of approximately $2.93 million and approximately $1.29 million, respectively.
Current wording
Net cash used in operating activities was approximately $4.8 million and approximately $2.3 million for the six-month periods ended June 30, 2024 and 2023, respectively. Net cash used in operating activities primarily reflects the net loss for those periods of approximately $7.4 million and approximately $2.5 million, respectively.
Previous wording
Net cash used in investing activities was $59,000 and $0 for the three-month periods ended March 31, 2024 and 2023, respectively. Net cash used in investing activities primarily reflects the purchasing of fixed assets.
Current wording
Net cash used in investing activities was $71,000 and $0 for the six-month periods ended June 30, 2024 and 2023, respectively. Net cash used in investing activities primarily reflects the purchasing of fixed assets.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
Research and development expenses consist primarily of salaries and other personnel-related expenses, materials, animal trials, production labor and other expenses. We expect research and development expenses to marginally increase in 2025 and beyond, primarily due to hiring additional personnel, as well clinical trials for the Glucotrack CBGM; however, we may adjust or allocate the level of our research and development expenses based on available financial resources and based on our commercial needs, including the FDA registration process, specific requirements from customers, development of new Glucotrack CBGM models and others.
Current report — wording carried from elsewhere
Marketing expenses were approximately $170,000 for the six-month period ended June 30, 2024, as compared to$0 for the prior-year period. This increase is primarily attributable to business development personnel and professional marketing services.
Current report — wording carried from elsewhere
General and administrative expenses consist primarily of professional services, salaries, consulting fees, insurance, travel expenses and other related expenses for executive, finance and administrative personnel, including stock-based compensation expenses. Other general and administrative costs and expenses include facility-related costs not otherwise included in research and development costs and expenses, and professional fees for legal and accounting services.
Current report — wording carried from elsewhere
Net loss was approximately $7.4 million for the six-month period ended June 30, 2024, as compared to approximately $2.5 million for the prior-year period. The increase in net loss is attributable primarily to the increase in our operating expenses, as described above.