Ann: Quarterly Update and Appendix 4C, page-4

Update for the Quarter Ending 30 September 2019
Brisbane, Australia, 30 October 2019 – ResApp Health Limited (ASX:RAP), a leading digital health
company developing smartphone applications for the diagnosis and management of respiratory
disease, is pleased to provide an update on the company’s activities for the first quarter ended
September 30, 2019.
“We have made significant progress this quarter by securing important regulatory approvals for
ResAppDx-EU in Europe and Australia. These approvals result from years of hard work by the
team and they unlock the commercialisation of our first product in these regions,” said Tony
Keating, CEO and Managing Director of ResApp. “We also received excellent results from our athome
sleep apnoea study which demonstrated that our algorithms perform just as well in a
patient’s own home as they did in the sleep laboratory – allowing us to progress
commercialisation. We now look forward to a transition in the company as we build and validate
our global sales and marketing strategies for ResAppDx.”
Recent Highlights and Outlook
• Secured regulatory approvals for ResAppDx-EU in Europe and Australia. During the
quarter, ResApp received CE Mark certification for ResAppDx-EU, the world’s first
smartphone-based diagnostic test for respiratory disease in adults and children. CE Mark
certification indicates that ResAppDx-EU meets the essential requirements of all the
applicable European regulations as a class IIa medical device and allows for its sale
throughout the European Economic Area. ResAppDx-EU also received Australian Therapeutic
Goods Administration (TGA) approval for paediatric use and is now listed on the Australian
Register of Therapeutic Goods allowing for its sale in Australia. The company has submitted
an application to the TGA for adult use and a De Novo application for paediatric use is under
review by the US Food and Drug Administration (FDA).
• Positive results from prospective at-home sleep apnoea study. In September, ResApp
released positive results from its prospective, at-home sleep apnoea study demonstrating
that ResApp’s algorithms, which analyse a person’s breathing and snoring sounds recorded
using a smartphone placed on a bedside table, were able to accurately identify obstructive
sleep apnoea when compared to a simultaneous at-home sleep study. For the three AHI
thresholds under consideration (representing mild, moderate, and severe sleep apnoea) the
area under the receiver operating characteristic curve was greater than 0.91, sensitivity was
between 83-85%, and specificity was between 73-90%.
• Joined Startup Creasphere program. In October, ResApp announced that it had been
selected to join the Startup Creasphere digital health program in Munich. Startup Creasphere
is a twelve-week program in which ResApp will work with subject matter experts and mentors
from the consumer healthcare business unit of Sanofi to explore opportunities to co-create
ResApp Health Limited ABN 51 094 468 318
Level 12, 100 Creek St, Brisbane QLD 4000 Australia
T +61 7 3724 0035 E [email protected] W www.resapphealth.com.au
consumer health-focused respiratory disease products. The Kick-off and Orientation
sessions were held in October, with the first Deep Dive week to take place in mid-November.
• Progress on DARPA WASH program. ResApp received additional funding from Lockheed
Martin during the quarter and continues to collaborate on the Defense Advanced Research
Projects Agency (DARPA) Warfighter Analytics using Smartphones for Health (WASH)
program.
• Data from Australian adult clinical study presented. Results from ResApp’s Australian
adult clinical study were recently presented at the European Respiratory Society (ERS)
International Congress 2020 in Madrid, Spain. ERS is the largest respiratory-focused medical
conference in Europe, with over 20,000 delegates attending each year. Additional data from
the study will be presented at the 24th Congress of the Asian Pacific Society of Respirology in
Vietnam in November.
• Asthma severity research accepted for publication. A publication titled, “Stratifying
asthma severity in children using cough sound analytic technology” has been accepted for
publication in the peer-reviewed medical journal, The Journal of Asthma. The publication,
authored by our partners at The University of Queensland and Joondalup Health Campus,
investigates the use of cough sounds to measure asthma severity in children.
• Increased presence at healthcare industry events. In October, the company attended the
11th Annual Connected Health Conference in Boston where Tony Keating, CEO and Managing
Director participated in the panel discussion, Vocal Biomarkers: New Evidence and Market
Opportunities. The company also attended HLTH 2019 in Las Vegas, one of the largest
conferences for health innovation with over 6,000 attendees. At HLTH, Tony participated in
the panel discussion, Putting Consumers in the Driver’s Seat: New Models, High Speed Lanes and
Road Blocks Ahead organised by the American Telemedicine Association. ResApp will also
present in London at the Digihealth Leaders conference in November.
• Strong balance sheet to advance ResApp through commercialisation. The company held
cash of $3.8 million as of September 30, 2019. ResApp recently filed its FY2019 tax return
with the Australian Tax Office and expects to receive a $1.8 million R&D tax incentive cash
rebate. A significant proportion of ResApp’s R&D spend for the current (FY2020) financial year
will also be eligible for the R&D tax incentive.
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