Results for announcement to market
Up / Down
Revenue from ordinary activities
Loss after tax from ordinary activities
attributable to members Down 213% (10,032,750) (3,207,577)
Loss attributable to members Down 213% (10,032,750) (3,207,577)
Amount per share
Franked Amount per share
Dividend - current reporting period Nil Nil
Dividend - previous reporting period Nil Nil
Net Tangible Asset Backing per Ordinary Share cents
Net tangible asset backing per ordinary share - current reporting
Net tangible asset backing per ordinary share - previous reporting
Commentary on the Results for the Period
During the year ended 30 June 2017, the Company increased its research and development activities. A large portion of the net loss for the current year is also made up of the valuation of options issued during the year.
The loss for the prior year is attributable to operating activities and research and development costs incurred following the acquisition of ResApp Diagnostics.
This Preliminary Final Report is based on the Annual Financial Report which is in the process of being audited.
Managing Director and Chief Executive Officer
Dated at Brisbane this 31st day of August 2017
During the year, the Company continued the development and commericalisation of the ResApp technology for the purpose of providing health care solutions for respiratory disease.
REVIEW OF OPERATIONS
US SMARTCOUGH-C Study
During the period, the Company commenced its SMARTCOUGH-C study in the United States (US). SMARTCOUGH-C is a multi-site, double blind, prospective clinical study to investigate ResAppDx for the diagnosis of respiratory disease in infants and children using cough sounds. The co-primary endpoints of the study are the diagnosis of pneumonia compared to clinical and radiologic diagnosis. Secondary endpoints are diagnosis of upper respiratory tract infection, lower respiratory involvement, croup, asthma/reactive airways disease and bronchiolitis compared with a clinical diagnosis.
On 21 October 2016, the Company announced that it is had received its first institutional review board (IRB) approval at the Cleveland Clinic for the SMARTCOUGH-C study. The Company subsequently announced that it had also received IRB approval at the Massachusetts General Hospital (MGH) on 11 November 2016 and at Baylor College of Medicine and Texas Children's Hospital on 16 November 2016.
On 9 December 2016, ResApp confirmed the initiation of its SMARTCOUGH-C study in the US.
On 10 January 2017, the Company announced that it had entered into a two-year expanded research collaboration with MGH alongside MGH's participation in ResApp's SMARTCOUGH-C study. Working together, ResApp and MGH will perform additional analysis of the SMARTCOUGH-C study data, use the SMARTCOUGH-C dataset to investigate the state of respiratory disease clinical practice today and evaluate the efficacy of ResApp's cough-based diagnostic test in additional respiratory disease indications.
On 15 March 2017, the Company provided an update on its SMARTCOUGH-C study confirming recruitment locations included multiple emergency departments, urgent care facilities and primary care offices at each of the three participating hospitals, with 478 participants having been enrolled as of 10 March 2017.
On 19 April 2017, the Company announced its intention to extend the SMARTCOUGH-C study through to the end of May and increase maximum recruitment to 1,500 patients. Enrolment in the study had progressed well across eleven recruitment locations maintained by the three participating hospitals, however the incidence of pneumonia and croup among study patients had been unseasonably low.
On 19 June 2017, the Company announced that it has completed enrolment in its SMARTCOUGH-C study with a total of 1,245 patients enrolled across the three participating hospitals, all located in the United States. With enrolment complete, the study entered the data verification phase, where clinical and radiologic adjudication were conducted for the remaining patients and final source data verification site visits performed.
Subsequent to the end of the period on 9 August 2017, the Company announced top-line data from its multi-site, double blind, prospective clinical study to investigate ResAppDx for the diagnosis of respiratory disease in infants and children using cough sounds. The predefined study endpoints were based on achieving greater than 75% for positive percent agreement (PPA) and negative percent agreement (NPA) for the diagnosis of pneumonia, croup, bronchiolitis, asthma/reactive airways disease (RAD), lower respiratory tract disease (LRTD) and upper respiratory tract infection (URTI).
In the final data review, prior to the un-blinding of the study data, ResApp identified at least two issues with the clinical data. Contrary to instructions and training, a high number of patients were treated before clinical research staff recorded their cough sounds. A high number of recordings were also found to contain a second person's cough sounds or an unacceptable amount of background noise and interference. These issues are known to affect cough sound analysis and their presence had skewed the preliminary results.
A preliminary analysis indicated that the study is unlikely to meet its predefined endpoints for diagnosis of childhood respiratory disease with the lower bound of the 95% confidence interval of both PPA and NPA with clinical diagnosis being below 75% of all diseases. The most promising result was for bronchiolitis, which achieved an 80% (95%CI 66%-91%) PPA and 95% (95%CI 94%-97%) NPA with clinical diagnosis, although due to the reduced number of bronchiolitis patients (caused by removing recordings with obvious issues) this result did not meet the predefined study endpoint.
The Company proposes completing a second US paediatric pivotal clinical study this US winter as well as continuing and completing its adult program, including its US adult pivotal study which is also set to begin this US winter.
Australian Clinical Studies
During the period, the Company continued its Australian paediatric clinical studies at Joondalup Health Campus (JHC) and Princess Margaret Hospital in Perth and its Australian adult studies at JHC and Wesley Hospital in Brisbane.
On 3 October 2016, ResApp announced further positive results from its Australian adult study. ResApp's cough sound-based algorithms achieved between 91% and 100% accuracy for distinguishing adult patients with chronic obstructive pulmonary disease (COPD), asthma or pneumonia from subjects with no discernible respiratory disease. In addition, the new analysis demonstrated accuracy of 100% for distinguishing patients with an upper respiratory tract infection (URTI) from the no respiratory disease group (not previously reported). The differential diagnosis of asthma versus COPD, pneumonia versus asthma and pneumonia versus COPD (not previously reported) was achieved at an accuracy in the range of 88% and 94%. As was found in the paediatric study, the algorithms were able to correctly detect lower respiratory tract disease in 84% of adult patients who were initially diagnosed as clear by experienced clinicians using stethoscopes but were finally diagnosed as having a lower respiratory tract disease after additional clinical testing.
On 18 August 2016, the Company announced preliminary clinical results that demonstrated the potential for measuring the severity of asthma or viral wheeze in children using cough sounds. The Company also announced that it had begun working with two lung function test laboratories, one at Joondalup Health Campus in Perth and one at the Wesley Hospital in Brisbane to record adult asthma and chronic obstructive pulmonary disease (COPD) patients' breathing and cough sounds alongside comprehensive lung function tests.
On 28 April 2017, ResApp announced that it had signed an exclusive worldwide license agreement with UniQuest for an additional diagnostic tool that complements ResApp's existing cough-based diagnostic technology. The tool is a set of machine learning algorithms that use a combination of clinical features to screen for childhood pneumonia. Unlike ResAppDx, it does not use cough sound analysis, but relies on commonly-taken measurements such as heart rate, temperature, presence of chest in-drawing or oxygen saturation.
On 22 June 2017, the Company provided an update on its Australian paediatric clinical study. A total of 1,127 children had been enrolled, and for most disease groups patient numbers had more than doubled since previous results. The dataset and machine learning algorithms were optimised to match the design of the SMARTCOUGH- C study as closely as possible. ResAppDx achieved between 90% and 100% PPA and between 89% and 96% NPA with clinical diagnosis of primary upper respiratory tract infection (i.e. with no comorbidities), croup, lower respiratory tract involvement, asthma/reactive airways disease (RAD) and bronchiolitis. For pneumonia, ResAppDx demonstrated 89% PPA and 79% NPA with clinical diagnosis. The lower NPA reflects the higher uncertainty in the current method of clinical diagnosis of pneumonia and in particular the clinical overlap between pneumonia, bronchiolitis and asthma/RAD, which can occur at the same time.
Doctors Without Borders / Médecins San Frontières (MSF)
On 15 September 2016, the Company, in partnership with UniQuest (the main commercialisation company of The University of Queensland), announced it had shipped smartphones to a leading global humanitarian organisation under the terms of a non-binding memorandum of understanding to field-test ResApp's smartphone-based respiratory disease diagnostic tool in the developing world. The Company subsequently named this humanitarian organisation partner as Doctors Without Borders/Médecins San Frontières (MSF), who are moving towards starting a clinical study of ResAppDx in a lower income rural context setting.
On 9 November 2016, the Company confirmed the appointment of new auditors Grant Thornton Audit Pty Ltd replacing Greenwich & Co Audit Pty Ltd.
Subsequent to the end of the period, on 23 August 2017 the Company announced the appointed of Dr Philip Currie to its Scientific Advisory Board. Dr Currie is a cardiologist with more than 35 years in cardiology both in the US and in Australia with extensive experience in medical research, clinical cardiology and business.
As noted above, subsequent to the end of the period on 9 August 2017, the Company announced top-line data from its multi-site, double blind, prospective clinical study to investigate ResAppDx for the diagnosis of respiratory disease in infants and children using cough sounds. In the final data review, prior to the un-blinding of the study data, ResApp identified at least two issues with the clinical data. Contrary to instructions and training, a high number of patients were treated before clinical research staff recorded their cough sounds. A high number of recordings were also found to contain a second person's cough sounds or an unacceptable amount of background noise and interference. These issues are known to affect cough sound analysis and their presence had skewed the preliminary results. Preliminary analysis indicated that the SMARTCOUGH-C study is unlikely to meet its predefined endpoints for diagnosis of childhood respiratory disease with the lower bound of the 95% confidence interval of both PPA and NPA with clinical diagnosis being below 75% of all diseases.
The Company indicated that it proposes completing a second US paediatric pivotal clinical study this US winter as well as continuing and completing its adult program, including its US adult pivotal study which is also set to begin this US winter.
Except for the events noted above, no material events have occurred subsequent to the reporting date.
ResApp Health Limited published this content on 31 August 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 31 August 2017 06:32:07 UTC.