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    IQX   AU000000IQX4

IQX LIMITED

(IQX)
End-of-day quote. End-of-day quote NATIONAL STOCK EXCHANGE OF AUSTRALIA LIMITED - 08/10
0.13 AUD   +85.71%
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iQX : Filed a Pre-Submission package with the United States (US) Food and Drug Administration (FDA).

10/18/2021 | 06:42pm EST

19th October 2021

Announcements

National Stock Exchange of Australia

1 Bligh St

Sydney NSW 2000

Market announcement - LSBD Update on Biosensor FDA Pre-Submission

iQX Limited (NSX: IQX); on behalf of Life Science Biosensor Diagnostics Pty Ltd (LSBD), in which IQX holds 19% equity position, is

pleased to announce that LSBD's subsidiary GBS Inc. (Nasdaq: GBS); a life sciences company operating in the Asia Pacific region, under license from LSBD to commercialize its non-invasive,real-time Glucose Salivary test; has filed a Pre-Submission package with the United States (US) Food and Drug Administration (FDA).

The purpose of this Pre-Submission is to confirm with the FDA the clinical trial design, including trial objectives. This interaction will allow the FDA to review the Company's clinical trial plans and protocols while also providing a forum for feedback on these clinical studies as it pursues regulatory approval.

The primary objectives of the proposed clinical plan are as follows:

  • Correlate saliva glucose to plasma glucose
  • Develop and confirm the Biosensor algorithm
  • Validate, in accordance with FDA specifications, the Saliva Glucose Biosensor system

As per the license agreement between LSBD and GBS, it is foreseen that any Biosensor IP generated by GBS Inc.-funded Biosensor research and development will flow on to LSBD. LSBD is the IP owner and beneficial owner of all Biosensor IP generated by GBS biosensor programs. LSBD has also licensed its Biosensor IP to its fully owned subsidiary BioSensX Global Inc., which is the worldwide licensee, with exception of the GBS APAC region. It has also been agreed between LSBD and GBS that LSBD will be receiving royalties from their APAC sales revenue.

The IQ Group Global, through LSBD and its commercial subsidiary BioSensX Global Inc., is developing a suite of 148 different diagnostic point-of-care tests, including allergen panels and the saliva-based glucose test on the Biosensor platform to be used by patients living with diabetes. The Company intends to provide people living with diabetes a non-invasive solution to the current finger- prick glucose testing.

"GBS anticipates securing strategic partnership opportunities for sales and distribution in the APAC region by the end of the Financial Year 2022, and with this FDA Pre-Submission, LSBD expects to receive its first royalties (minimum 13%) in near term," CEO and Chairman of The iQ Group Global, Dr. George Syrmalis, said.

"This is an exciting time for LSBD and its parent companies, IQG and IQX, as the APAC market enumerates approximately 164 million people suffering from diabetes."

About iQX Limited (NSX:IQX)

iQX Limited is an NSX listed investment funds management company specialising in the bioscience sector that is committed to eradicating disease through capital investment. IQX Limited is a core member of The iQ Group Global.

About The iQ Group Global

The iQ Group Global is a group of companies that find, fund and develop bioscience discoveries to create life-changing medical innovations. Recognised by The Australian Financial Review for the second consecutive year as one of the country's Most Innovative Companies in 2020, The iQ Group Global's flagship innovations include the Biosensor Platform and TEX Core, a first-in-class oncology drug platform with the ability to develop a pipeline of novel oncology compounds. Visit our website: theiqgroupglobal.com

About GBS Inc.

GBS Inc. is a biosensor diagnostic technology company operating under license from LSBD Pty Ltd and is focused on commercialising the Saliva Glucose Biosensor in the Asia Pacific Region.

Disclaimer

IQX Ltd. published this content on 19 October 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 October 2021 22:41:06 UTC.


ę Publicnow 2021
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Financials
Sales 2021 3,83 M 2,68 M 2,68 M
Net income 2021 -23,1 M -16,2 M -16,2 M
Net Debt 2021 5,98 M 4,19 M 4,19 M
P/E ratio 2021 -1,31x
Yield 2021 -
Capitalization 56,2 M 39,4 M 39,3 M
EV / Sales 2020 13,5x
EV / Sales 2021 9,45x
Nbr of Employees -
Free-Float -
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Income Statement Evolution
Managers and Directors
George Syrmalis Chief Executive Officer & Executive Director
Kosmas Dimitriou Chairman
John Stratilas Independent Non-Executive Director
Peter Buchanan Simpson Non-Executive Director
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