Genetic Technologies Limited (NASDAQ: GENE, “Company”, “GTG”), a
global leader in Genomics based tests in health, wellness and
serious disease, is pleased to provide its Quarterly Business
Update to the market.
Highlights
- Revenues from
customers of A$99k in the quarter (unaudited), up from A$6k in Q3,
including receipt of first month IBX sales
- Confirmed launch of
COVID-19 Risk Test by Infinity Biologix in the US
- Confirmed grant of
US Patent No 11,031,098 - ‘Computer Systems and Methods for Genomic
Analysis’ (ASX Announcement on 11 June 2021)
- Post quarter end
acquisition of EasyDNA for US$4 million; strategically, this
direct-to-consumer acquisition provides the foundation to grow the
portfolio of serious disease tests across well-established websites
in 40 countries
- Strong cash balance
of A$20.8 million as at 30 June 2021 provides runway to fund
commercialization opportunities and continued product
development
- Net cash used for
operations of A$2.12 million, an increase on the prior quarter (Q3
FY21: A$1.08 million) due mainly to the increase in R&D and
operating expense of A$353k and receipt in Q3 of the R&D tax
incentive receipt for A$763k
- Appointment of Carl
Stubbings as Chief Commercial Officer and commencement of Mike
Tonroe as Chief Financial Officer
Simon Morriss, CEO of Genetic Technologies,
stated, “Genetic Technologies is moving rapidly into the
commercialization of its products with the launch of its COVID-19
Risk Test in May and the post quarter end announcement of the
acquisition of EasyDNA.”
“This acquisition provides a direct-to-consumer
platform and strong alignment with GTG’s planned expansion into
health and wellness testing across well-established websites in 40
countries. This alignment was critical to our decision to acquire
the brand and assets of EasyDNA,” continued Morriss.
Commercialization Update
Launch of COVID-19 Serious Disease Risk Test
The three-year co-exclusive licence agreement
between IBX and GTG was announced on 3 March 2021 for the
production, distribution, sales and marketing of GTG’s COVID-19
Risk Test in the US with the product launch at the end of May 2021.
Revenues in the quarter from the IBX agreement were A$95k.
Commercialization Strategy for Broader
Product Portfolio
The Company has previously outlined its key
avenues for commercialization which currently include the
consumer-initiated online sales and marketing platform (CIT)
available in Australia and the US. With the recent inclusion of
EasyDNA the Company intends to leverage this direct-to-consumer
(DTC) platform to enhance the visibility and awareness of its
existing products globally.
Additionally, GTG is engaging in business to
business (B2B) sales via medical professionals and now has
distribution coverage of the Australian and US markets. The Company
is assessing the CE certification requirements for its products and
have identified Europe and the UK as the next regions the company
intends to enter.
Product Overview and Regulatory
Progress
GeneType Comprehensive Risk Assessment Test
(Multitest)
GTG’s Polygenic Risk Score (PRS) products under development will
ultimately be offered as part of the GeneType Multitest, which will
provide risk assessment for greater than 70% of all morbidities
including Breast Cancer, Colorectal Cancer, Cardiovascular Disease,
Type 2 Diabetes, Melanoma and Prostate Cancer. The Multitest will
leverage the foundational IP granted under US Patent 7,127,355 –
‘Methods for Genetic Analysis’. Recent advances in the Prostate
Cancer and Melanoma Tests have identified informative polygenic
risk scores that could enhance predictability with the Company
intending to release initial findings by the end of CY21.
The overall strategy for the Multitest is
focused on precise risk assessments for the most common preventable
diseases. Future iterations of the test will include the Company’s
germline hereditary cancer testing products which are currently
under development.
GeneType Breast Cancer and Colorectal Cancer
Screening and Germline Testing Platform
GTG continues to progress the development of its Germline
Testing division for hereditary testing. The initial BRCA and Lynch
Syndrome tests, that align with GTG’s GeneType products in market
for Breast Cancer and Colorectal Cancer respectively, are
anticipated to launch by the end of CY21. These hereditary tests
increase coverage from 85% under standalone polygenic risk up to
100%1 of known risk coverage when combined with GTG’s PRS testing.
BRCA and Lynch Syndrome tests also have existing reimbursement
codes, which provides a clear pathway to monetization and an
opportunity to bundle with their associated PRS tests.
The Company continues to engage in discussions
with Medicare to enable the Company to secure a rebate for PRS
tests conducted. This remains a longer-term objective and is
expected to support distribution through the B2B channel.
Predictix by Taliaz
GTG highlighted the Predictix by Taliaz product
at the General Practice Conference and Exhibition (GPCE) in Sydney
in mid-May 2021 with solid feedback and are progressing discussions
on partnerships to advance the distribution and sales of the
product in Australia and New Zealand. In addition, the Taliaz
product will be incorporated into GTG’s Multitest.
Research and Publications
GTG continues to focus on publications of
relevant content for submission to peer-reviewed journals.
The Company confirms the below article, authored
by GTG employees, was made available online by Cambridge University
Press on 2 July 2021.
‘Development and validation of a
clinical and genetic model for predicting risk of severe COVID-19’
authored by Dite, Murphy and Allman;
The Dite, Murphy and Allman article outlines the
outcomes from the analysis of an updated dataset of 2,205 cases and
5,416 control patients. The increased sample numbers have enabled
separation into test and validation datasets, a key requirement for
commercialization.
Post quarter end acquisition of EasyDNA
GTG signed an agreement to acquire the brand and
distribution rights for EasyDNA from BelHealth for US$4 million.
The EasyDNA acquisition will provide GTG the platform to build its
direct-to-consumer offerings and wellness division. This
acquisition provides an established revenue stream with US$4.63
million in unaudited revenue for CY20 and the ability to leverage
existing direct-to-consumer marketing avenues.
The agreement provides for the acquisition of
all brands, websites and reseller agreements associated with
EasyDNA. This includes over 70 websites in 40 countries and six
brand identities. EasyDNA revenue contributions are strongly
weighted to five countries: Australia, UK, France, Canada and the
US, where it received 68% of its CY20 revenue, with the UK as the
largest market contributing 20% of total revenue. EasyDNA has
current agreements with 12 NATA and associated international
certified laboratories.
Morriss commented, “We look forward to
integrating the EasyDNA team into our business and working closely
with them to continue to build upon their existing product
portfolio and the brand recognition they have already achieved.
EasyDNA is a leader in paternity testing and animal genomics, and
their breadth of available products also extends into the important
wellness category, providing multiple highly attractive growth
opportunities for GTG moving forward.”
GTG will be onboarding EasyDNA’s existing team,
retaining the skills and expertise of its employees based in Malta
and Australia. This includes the retention of Kevin Camilleri,
founder and CEO of EasyDNA, who will be heading up GTG’s Direct to
Consumer Division following the completion of the acquisition
expected to occur by 31 July 2021.
Corporate Update
The Company has recently appointed Carl
Stubbings to the role of Chief Commercial Officer. Carl rounds out
the leadership team for GTG with considerable experience
commercialising diagnostic products. Based in the USA for 13 years,
he served as Senior Vice President for Panbio USA Ltd and
Vice-President of Sales and Marketing for Focus Diagnostics, a
subsidiary of Quest Diagnostics, one of the world’s largest
pathology laboratories. More recently he was Chief Operating
Officer of ASX listed BARD1 Life Sciences having successfully
facilitated the merger with Sienna Cancer Diagnostics as its CEO
and Managing Director.
Investor Webinar
The Company will provide an update on its
results and recent acquisition and hold an investor webinar on
Tuesday 27 July 2021 at 7:30pm EDT.
To participate on the quarterly investor
webinar, please register at:
https://us02web.zoom.us/webinar/register/WN_ntdVwrJPQkeM0XszdzUvXQ
After registering, you will receive a
confirmation email containing information about joining the
webinar.
Investor Relations (AUS) |
Investor Relations and Media (US) |
Stephanie Ottens |
Dave Gentry |
Market Eye |
1 800 RED CHIP (733 2447) |
M: +61 434 405 400 |
Cell: 407 491 4498 |
E: stephanie.ottens@marketeye.com.au |
E: dave@redchip.com |
|
|
About Genetic Technologies Limited
Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a
diversified molecular diagnostics company. GTG offers cancer
predictive testing and assessment tools to help physicians
proactively manage patient health. The Company’s lead products
GeneType for Breast Cancer for non-hereditary breast cancer and
GeneType for Colorectal Cancer are clinically validated risk
assessment tests and are first in class. Genetic Technologies is
developing a pipeline of risk assessment products.
For more information, please visit www.gtglabs.com
_________________________1 Source: “An integrated clinical and
genetic model for predicting risk of severe COVID-19” available at:
https://www.medrxiv.org/content/10.1101/2020.09.30.20204453v1.full.pdf
Genetic Technologies (NASDAQ:GENE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Genetic Technologies (NASDAQ:GENE)
Historical Stock Chart
From Apr 2023 to Apr 2024