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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act 1934
Date of Report (Date of earliest event
reported): July 14, 2023
NEMAURA MEDICAL INC.
(Exact name of registrant as specified in charter)
Nevada
(State or other jurisdiction of incorporation)
001-38355 |
|
46-5027260 |
(Commission File Number) |
|
(IRS Employer Identification No.) |
57 West 57th Street
Manhattan, NY |
10019 |
(Address of principal executive offices) |
(Zip Code) |
|
|
|
Registrant’s telephone number, including area code: |
+1 (646) 416-8000 |
N/A
(Former name or former
address, if changed since last report) |
|
|
|
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12(b) under the Exchange
Act (17 CFR 240.14a-12(b))
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock |
NMRD |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR
§240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of
Operations and Financial Condition.
On July 14, 2023,
Nemaura Medical, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal year ended
March 31, 2023. A copy of this press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information contained in the website is not a part of this current report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
SIGNATURE
Pursuant to the requirements of
the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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NEMAURA MEDICAL INC. |
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|
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By: |
/s/ Dewan F. H. Chowdhury |
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|
Dewan F. H. Chowdhury Chief Executive Officer |
Date:
July 14, 2023
Exhibit 99.1
Nemaura
Medical Reports Financial Results and Provides Business Update for the Fiscal Year Ended March 31, 2023
Loughborough,
England, July 14, 2023 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (Nasdaq: NMRD) (“Nemaura” or the “Company”),
a medical technology company focused on developing and commercializing a daily disposable, wearable glucose sensor and supporting personalized
lifestyle coaching programs, today provides a business update and financial results for the fiscal year ended March 31, 2023.
Corporate Highlights:
- Entered
into a Registered Direct Offering and concurrent Private Placement for gross proceeds of approximately $8.4 million (before expenses).
- Signed
a preliminary agreement with Eversana to support a planned commercial launch of its Diabetes and Metabolic Health programs in the USA.
- Announced
initial patient data from UK NHS (National Health Service) Miboko Study that thus far demonstrated weight loss in 100% of participants,
with further studies ongoing. The data is expected to support reimbursement applications and product marketing in various territories.
- Continued
to work with Benchmark Electronics Inc as a contract manufacturing partner (CMO) to facilitate future volume scale-up manufacture of
the electronic transmitter at its FDA approved facility in Thailand, in anticipation of commercial-sales ramp-up.
- Completed
phased delivery of transmitters against the purchase order received from MSW in December 2021.
- Received
a provisional purchase order for 1.7 million sensors from its licensee TPMENA in anticipation of product registration in the KSA.
“We
continue to build momentum on both manufacturing activities and consumer feedback through pilot trials, in preparation for scaling up
commercial sales activities. The trials with the NHS in the UK have demonstrated the commercial potential for our sensors and digital
health and wellbeing programs and has allowed us to undertake continuous refinements prior to commercial scale-up initiatives. Similarly,
we believe working with world-class contract manufacturers and advancing our manufacture scale-up, and ensuring a well-managed supply
chain through forward planning will support our planned commercial endeavours”, commented Dr Faz Chowdhury, CEO of Nemaura medical.
“During the new fiscal year our focus is on global partnerships and revenue ramp-up, leveraging off the progress we have made on
the product refinement and feedback, and product manufacture”.
FY2022 Financial Summary:
- Research
and development expenses were consistent with the prior year at approximately $1.5 million.
- General
and administrative expenses were $6,590,227 and $6,173,049 for the fiscal years ended March 31, 2023 and 2022, respectively. These expenses
consisted of fees for legal, professional, consultancy, audit services, investor relations, insurance, advertising, and general and operational
wages. The year-over-year increase in expenses were driven predominantly by increased wages, as the Company has increased headcount to
support the operational scale-up process across both its UK and U.S. teams.
- Cash
and cash equivalents at 31st March 2023 were approximately $10.1m
About
Nemaura Medical, Inc.
Nemaura
Medical, Inc. is a medical technology company developing and commercializing non-invasive wearable diagnostic devices. The company is
currently commercializing sugarBEAT®and proBEAT™. sugarBEAT®, a CE mark approved Class
IIb medical device, is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time
glucose measurements and daily glucose trend data, which may help people with diabetes and pre-diabetes to better manage, reverse, and
prevent the onset of diabetes. Nemaura has submitted a PMA (Premarket Approval Application) for sugarBEAT® to the
U.S. FDA. proBEAT™ combines non-invasive glucose data processed using artificial intelligence and a digital healthcare
subscription service and has been launched in the U.S. as a general wellness product as part of its BEAT®diabetes program
that is currently undergoing pilot studies.
Additionally,
Nemaura has launched a beta trial of Miboko, a metabolic health and well-being program using a non-invasive glucose sensor along with
an AI mobile application that helps a user understand how certain foods and lifestyle habits can impact one’s overall metabolic
health and well-being. Nemaura believes that up to half the population could benefit from a sensor and program that monitors metabolic
health and well-being.
The Company
sits at the intersection of the global Type 2 diabetes market that is expected to reach nearly $59 billion by 2025, the $50+ billion
pre-diabetic market, and the wearable health-tech sector for weight loss and wellness applications that is estimated to reach $60 billion
by 2023.
For more
information, please visit www.NemauraMedical.com.
Cautionary
Statement Regarding Forward-Looking Statements:
The
statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations
and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied
by such statements. Those risks and uncertainties include, but are not limited to, the launch of proBEAT™ in the
U.S., risks related to regulatory status and the failure of future development and preliminary marketing efforts, Nemaura Medical’s
ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical and its partners’
ability to develop, market and sell proBEAT™, the availability of substantial additional equity or debt capital to support
its research, development and product commercialization activities, and the success of its research, development, regulatory approval,
marketing and distribution plans and strategies, including those plans and strategies related to both proBEAT™ digital
health, and sugarBEAT®. There can be no assurance that the company will be able to reach a part of or any of the global
market for CGM with its products/services. The U.S. Food and Drug Administration (the “FDA”) reserves the right to re-evaluate
its decision that proBEAT™ qualifies as a general wellness product should it become aware of any issues such as
skin irritation or other adverse events from the device, as well as any misuse impacting patient safety, and any other reason as the
FDA may see fit at its discretion to determine the product does not fit the definition of a general wellness product. These and other
risks and uncertainties are identified and described in more detail in Nemaura Medical’s filings with the United States Securities
and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the most recently completed fiscal year, its
Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura Medical undertakes no obligation to publicly update or revise
any forward-looking statements.
Investor
Relations Contact:
IR@NemauraMedical.com
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