Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a
medical technology company focused on the design, development, and
commercialization of novel technologies for people with diabetes,
today reported financial results and recent corporate highlights
for the fourth quarter and full year ended December 31, 2024.
“2024 was transformative for Glucotrack as we
advanced the development of our CBGM technology and successfully
transitioned from a preclinical to a clinical stage company. As we
move into the next phase of growth, we have also strengthened our
leadership team with key additions to our senior leadership,
clinical and regulatory management team as well as our Medical
Advisory Board,” said Paul V. Goode, PhD, President and Chief
Executive Officer of Glucotrack. “We are confident that our
differentiated technology for blood glucose monitoring will change
the lives of those living with diabetes and improve patient
outcomes. This will be the first fully implantable CBGM technology
with a multi-year monitoring system and real-time measuring
capabilities, offering differentiated benefits of accuracy,
convenience and independence for patients.”
Dr. Goode continued, “As we look to 2025, I am
pleased with the progress we are making to advance our technology.
Moving towards these goals, we will continue to look for ways to
strengthen our capital structure. We recently secured multiple
funding rounds, demonstrating investors’ continued support of our
mission, vision, and strategy. We are committed to pursuing
additional financing strategies that align with our mission, create
value for our shareholders, and provide additional runway to enable
us to continue executing on our strategic priorities. We are
optimistic about 2025 and look forward to updating you on our
progress periodically.”
Fourth Quarter 2024 & Recent
Highlights
Advanced Product and Clinical Development
- Successfully completed the first
human clinical study of the continuous blood glucose monitor (CBGM)
clearly demonstrating the promise and performance of the
technology:
- The study met its primary endpoint
with no procedure- or device-related serious adverse events
reported from placement, use and through removal.
- The study confirmed the function
and placement of the CBGM sensor lead in the subclavian vein and
verified no additional tools or skillset beyond typical cardiac
pacemaker lead placement are needed.
- The study confirmed reliable
Bluetooth performance and demonstrated similar accuracy as seen in
animal studies.
- Received ISO 13485:2016
certification from the British Standards Institute (BSI)
demonstrating our commitment and ability to meet rigorous global
standards for design and manufacturing of high-quality medical
devices.
- Presented preclinical data at the
Diabetes Technology Meeting in October 2024, highlighting the
robust early performance of our CBGM.
- Successfully completed the
first-ever long-term preclinical study of glucose monitoring in the
epidural space, creating a pathway for strategic opportunities in
integrated chronic disease management.
Strengthened Financial Position
- Secured $16.3 million in proceeds
through multiple rounds of funding from November 2024 through March
2025. The proceeds provide runway for the Company to achieve
near-term product and clinical development milestones in 2025.
Strengthened Leadership and Board to Drive
Clinical Development
- Appointed Guillermo Umpierrez, MD,
CDCES, FACE, MACP to the Medical Advisory Board. As a former
president of the American Diabetes Association for Medicine and
Science, Dr. Umpierrez has extensive experience leading and
participating in clinical research that has significantly advanced
the understanding and treatment of diabetes.
- Appointed Peter Wulff as Chief
Financial Officer. Mr. Wulff is an industry veteran with over 35
years of financial management experience in both public and
privately held companies in the emerging growth life sciences
sector.
- Appointed Ted Williams as Vice
President of Regulatory Affairs. Mr. Williams is a seasoned
executive with a proven track record of successfully guiding highly
complex Class III medical devices through various regulatory
pathways.
- Appointed Sandra Martha as Vice
President Clinical Operations. Ms. Martha brings over 20 years of
clinical research experience in both medical technology and drug
development, leading all aspects of clinical trials and successful
delivery of clinical trials to quickly advance products through the
clinical lifecycle.
Anticipated Milestones in
2025
- Presenting clinical data
demonstrating the safety and accuracy of the CBGM at major medical
conferences
- Early Feasibility Study to Evaluate
an Intravascular Continuous Blood Glucose Monitor in Adults with
Diabetes Mellitus Poster Presentation at the recent 18th
International Conference on Advanced Technologies & Treatments
for Diabetes (ATTD 2025), March 19-22, 2025, Amsterdam, The
Netherlands.
- Further expanding our Advisory
Board with world-renowned experts in endocrinology and
cardiology.
- Commencing a long-term, multicenter
feasibility study of the fully implantable CBGM system in
Australia, anticipated in Q2 2025.
- Securing IDE approval from the U.S.
Food and Drug Administration for a long-term, multicenter Pilot
Study of the CBGM system, anticipated in Q4 2025, subject to
current agency response timelines.
Financial Results for the Year Ended
December 31, 2024
Research and Development
Expenses: Research and development expenses were $9.5
million for the full year 2024 compared to $4.7 million for the
full year 2023. The increase of $4.8 million was primarily
attributable to increased activities related to product design,
development and manufacturing activities and pre-clinical animal
studies.
Marketing, General and Administrative
Expenses: Marketing, General and Administrative expenses
were $5.1 million for the full year 2024 compared to $2.4 million
for the full year 2023. The increase of $2.7 million was primarily
attributable to increased legal and professional fees, personnel
costs and placement agent fees.
Net Loss: Net loss for the full
year 2024 was $22.6 million compared to a net loss of $7.1 million
for the full year 2023. The increase in net loss is attributable
primarily to the operating expenses of $7.5 million discussed above
in addition to non-cash losses of $7.5 million related to the
settlement of debt and the issuance of warrants containing
derivative features.
Cash Position: Cash and cash
equivalents as of December 31, 2024, were $5.6 million, compared
with $4.5 million in cash and cash equivalents as of December 31,
2023. The net increase in cash and cash equivalents compared to
December 31, 2023 was attributable to the $13.7 million from
financing activities offset by cash used in operating and investing
activities of $12.6 million.
On a pro forma basis, cash and cash equivalents
as of December 31, 2024 was $11.9 million when adjusted for
proceeds from financing activities during the first quarter 2025 of
$6.3 million.
Based on current plans and assumptions, the
Company believes that its existing cash and cash equivalents will
be sufficient to fund its 2025 operating plan to initiate human
clinical trials and related milestones.
GLUCOTRACK
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
|
|
In thousands of US dollars(except stock
and per stock amounts) |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Research and development
expenses (Note 9) |
|
|
9,499 |
|
|
|
4,704 |
|
Marketing expenses |
|
|
393 |
|
|
|
122 |
|
General and administrative
expenses (Note 10) |
|
|
4,655 |
|
|
|
2,278 |
|
Total operating expenses |
|
|
14,547 |
|
|
|
7,104 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
14,547 |
|
|
|
7,104 |
|
|
|
|
|
|
|
|
|
|
Other (income) expense |
|
|
(14 |
) |
|
|
- |
|
Change in fair value of
derivative liability |
|
|
798 |
|
|
|
- |
|
Loss on equity issuance |
|
|
1,925 |
|
|
|
- |
|
Loss on settlement of
liabilities |
|
|
4,758 |
|
|
|
- |
|
Finance expense (income), net
(Note 7) |
|
|
583 |
|
|
|
(7 |
) |
Loss for the year |
|
|
22,597 |
|
|
|
7,097 |
|
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
Foreign currency translation
adjustment |
|
|
(24 |
) |
|
|
1 |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss for
the year |
|
|
22,573 |
|
|
|
7,098 |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share (Note 2O) |
|
|
68.44 |
|
|
|
34.18 |
|
|
|
|
|
|
|
|
|
|
Weighted average
number of Common Stock outstanding used in computing basic and
diluted net loss per share |
|
|
330,171 |
|
|
|
207,603 |
|
GLUCOTRACK
INC.CONSOLIDATED BALANCE SHEETS
|
|
In thousands of US dollars(except stock
data) |
|
|
|
December 31,2024 |
|
|
December 31,2023 |
|
|
|
|
|
|
|
|
Current
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents (Note 2D) |
|
|
5,617 |
|
|
|
4,492 |
|
Other current assets |
|
|
151 |
|
|
|
376 |
|
Total current assets |
|
|
5,768 |
|
|
|
4,868 |
|
|
|
|
|
|
|
|
|
|
Operating lease right-of-use
asset, net (Note 6) |
|
|
59 |
|
|
|
- |
|
Property and equipment,
net |
|
|
95 |
|
|
|
27 |
|
Restricted cash (Note 2D) |
|
|
10 |
|
|
|
10 |
|
TOTAL ASSETS |
|
|
5,932 |
|
|
|
4,905 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ (DEFICIT) EQUITY |
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
992 |
|
|
|
839 |
|
Operating lease liability, current (Note 6) |
|
|
26 |
|
|
|
- |
|
Convertible promissory notes (Note 4E) |
|
|
5 |
|
|
|
- |
|
Other current liabilities |
|
|
252 |
|
|
|
673 |
|
Total current liabilities |
|
|
1,275 |
|
|
|
1,512 |
|
|
|
|
|
|
|
|
|
|
Non-Current Liabilities |
|
|
|
|
|
|
|
|
Derivative financial liabilities (Note 4F, 4G and Note 4J) |
|
|
17,421 |
|
|
|
- |
|
Operating lease liability, non-current (Note 6) |
|
|
33 |
|
|
|
- |
|
Loans from stockholders (Note 3) |
|
|
203 |
|
|
|
196 |
|
Total liabilities |
|
|
18,932 |
|
|
|
1,708 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingent
liabilities (Note 5) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ (Deficit) Equity
(Note 8) |
|
|
|
|
|
|
|
|
Common Stock of $0.001
par value (“Common Stock”): |
|
|
|
|
|
|
|
|
100,000,000 shares authorized as of December 31, 2024 and 2023;
791,609 and 208,914 shares issued and outstanding as of December
31, 2024 and 2023, respectively |
|
|
1 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
119,229 |
|
|
|
112,986 |
|
Receipts on account of shares |
|
|
228 |
|
|
|
48 |
|
Accumulated other comprehensive income |
|
|
(8 |
) |
|
|
16 |
|
Accumulated deficit |
|
|
(132,450 |
) |
|
|
(109,853 |
) |
Total stockholders’ (deficit) equity |
|
|
(13,000 |
) |
|
|
3,197 |
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ (DEFICIT) EQUITY |
|
|
5,932 |
|
|
|
4,905 |
|
GLUCOTRACK INC.UNAUDITED
PRO FORMA BALANCE SHEET
The unaudited pro forma information gives effect
to the first quarter 2025 Offerings, the exchange of Series B
Warrants to common stock, and the revaluation of Series A
Warrants.
The unaudited pro forma financial information is
presented for informational purposes only and does not purport to
represent what the results of operations or financial position of
the Company would have been had the transactions described above
actually occurred on the dates indicated, nor do they purport to
project the financial condition of the Company for any future
period or as of any future date. The unaudited pro forma financial
information should be read in conjunction with the Company’s
financial statements and notes thereto included elsewhere in this
Annual Report.
UNAUDITED PRO FORMA CONDENSED BALANCE
SHEET
|
|
Year Ended December 31, 2024 |
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
As Reported |
|
|
Series B Warrant Exercise |
|
|
2025 Offerings |
|
|
Revaluation of Series A Warrants |
|
|
Pro Forma as Adjusted |
|
Current
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
5,617 |
|
|
|
|
|
|
|
6,300 |
|
|
|
|
|
|
|
11,917 |
|
Total assets |
|
|
5,932 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,232 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ (DEFICIT)
EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Current Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative financial
liabilities |
|
|
17,421 |
|
|
|
(14,877 |
) |
|
|
|
|
|
|
(2,452 |
) |
|
|
92 |
|
Total liabilities |
|
|
18,932 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,603 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ (Deficit) Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid-in
capital |
|
|
119,229 |
|
|
|
14,877 |
|
|
|
6,300 |
|
|
|
2,452 |
|
|
|
142,858 |
|
Total stockholders’ (deficit)
equity |
|
|
(13,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,629 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY |
|
|
5,932 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,232 |
|
About Glucotrack, Inc.
Glucotrack, Inc. (NASDAQ: GCTK) is focused on
the design, development, and commercialization of novel
technologies for people with diabetes. The Company is currently
developing a long-term implantable continuous blood glucose
monitoring system for people living with diabetes.
Glucotrack’s CBGM is a long-term, implantable
system that continually measures blood glucose levels with a sensor
longevity of 3 years, no on-body wearable component and with
minimal calibration. For more information, please
visit http://www.glucotrack.com.
Forward-Looking Statements
This news release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Statements contained in this news release that
are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the generality of the
foregoing, words such as “believe”, “expect”, “plan” and “will” are
intended to identify forward-looking statements. Such
forward-looking statements are based on the beliefs of management,
as well as assumptions made by, and information currently available
to, management. These statements relate only to events as of the
date on which the statements are made, and Glucotrack undertakes no
obligation to publicly update any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law. All of the forward-looking statements
made in this press release are qualified by these cautionary
statements, and there can be no assurance that the actual results
anticipated by Glucotrack will be realized or, even if
substantially realized, that they will have the expected
consequences to or effects on us or our business or operations.
Readers are cautioned that certain important factors may affect
Glucotrack’s actual results and could cause such results to differ
materially from any forward-looking statements that may be made in
this news release. Factors that may affect Glucotrack’s results
include, but are not limited to, the ability of Glucotrack to raise
additional capital to finance its operations (whether through
public or private equity offerings, debt financings, strategic
collaborations or otherwise); risks relating to the receipt (and
timing) of regulatory approvals (including U.S. Food and Drug
Administration approval); risks relating to enrollment of patients
in, and the conduct of, clinical trials; risks relating to
Glucotrack’s future distribution agreements; risks relating to its
ability to hire and retain qualified personnel, including sales and
distribution personnel; and the additional risk factors described
in Glucotrack’s filings with the U.S. Securities and Exchange
Commission (the “SEC”), including its Annual Report on Form 10-K
for the year ended December 31, 2024 as filed with the SEC on March
31, 2025.
Contacts:
Investor Relations:investors@glucotrack.com
Media:GlucotrackPR@icrinc.com
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