Ann: Annual General Meeting Presentation, page-18

I attended the AGM today. I was very impressed with the way Tony handled himself and what he is doing with the company.

Below are some rough notes i took during the Q&A. Hope they are useful for those that weren't able to attend. Standard disclaimer applies... DYOR

Q&A:

• DAPRA – Programme looking at US military personnel readiness deploy (passively monitoring health) – measuring lung health specifically, wearable devices and smartphones.
• Key differences to current ResApp programmes– 24/7 monitoring and passive monitoring
• Addressable market: 24/7 monitoring is Resapp’s long term end game
• DAPRA – using mobile phones not wearables atm…

• MSF partnership / humanitarian organisations
• Defocussed over last few years… haven’t reached out to developing world in the last 2 yrs
• Current - Refocussed some team members on emerging markets

• Sleep ap
• CE mark only – can be based off aus data
• FDA – there is a risk taking aus data to FDA
• Still evaluating risk as to whether to rely on aus data exclusively – noting that the study in this case at least was based off the same gold standard - AASM … but the FDA might state that there are differences in patient pop etc… As such, FDA might require a small scale US based trial. TBC

• Safe and effective language
• Relevant to regulatory requirements
• Safety – false results in resapp’s case (safety and efficacy closely linked for us)

• Screening tool in China?
• Sanofi agreement is limited to direct to consumer (scope deliberately limited by Tony)
• Sanofi have global presence (including china)
• Re telehealth etc – ResApp is actively talking to potential Chinese partners… china is a difficult market to enter though (will continue to have a number of discussions, until likely entering a strategic partnership)

• Has ResApp been approached by any of Sanofi competitors approaching even before or after the agreement was put in place
• Tony – “Cant comment”
• Working hard with European providers to lock in deals / MOU within next month

• Competitors?
• Haven’t seen too many players in space
• There are a few that Tony is aware of… however they are operating in slightly separate space
• Most looking at specialist hardware devices, monitoring devices …”we have carved a very strong niche”… big players so far have focussed on cardiovascular disease and diabetes (the easier wins), inevitably they will turn there focus to respiratory disease, but we have a strong competitive advantage (both tech and clinical data)
• Drowzle (re sleep apnoea)
• Tony pointed out there submission was not a de novo application but rather 510(k)
• Their approval could potentially make it easier for us re reg approval
• In their 510(K) approval – there approval related to not only algos for sound + also required the accompaniment of a standard questionaries (the imposition of a questionnaire was a requirement of their approval)
• Our results have been based off not including an accompanying questionnaire
• Tony believes we have a competitive advantage re our tech, as well of business wise we are taking different approach. Their approach seems to focus on health and wellness. Our focus is clinical and medical – medical device company
• Our strategy = get clinical buy in before release product to the world

• ResApp Staff mix:
• All staff currently based in Brisbane
• Small team doing algo work
• Small team re app development
• Clinical team and reg –
• 3 people doing BD and sales – Tony, BD development manager, emerging markets leader
• Currently hiring – shortlist for head of sales & marketing in UK (ee growth will come on sales side going forward).. but don’t expect large scale ee base given that the focus in Europe and other markets atm is B2B (e.g. 5 NHS hospitals in London)
• Note: Small = less than 5 people for each team
• Total headcount today = 16

• Feedback on FDA
• Experian – Reg person spoke to Experien 2 days ago.
• “there is no delay”
• Not in the middle but not at the end just yet
• Conservative estimate
• India and china market possibilities
• China
• Reg process is “extremely complex, more complex than FDA”.. company has a roadmap in place. Requires a local study in China. FDA doesn’t remove requirement to run local study in China. All Class 2 devices in China must have a local study
• As such, ResApp looking for strategic partners
• India
• Slightly different approach re reg

• Ramsay health care partnership – would we look to leverage their network in other countries e.g. France?
• Have already been working with them in in Perth. Having a number of discussions at different levels. A lot of influence comes from the clinicians themselves (i.e. whilst you might have hospital management on board it is equally or more important to get clinicians to buy in)
• Over last 12mths key focus has been getting clinicians on board through research journals and presentations
• Presentations and papers to date – have been “exceptional well received”
• Costing of devices
• $5-$10 per use still holds – this price point has held up well with telehealth ($50-$60 for telehealth atm)… and reasonably well for hospitals
• Sleep ap – still looking at strategy – e.g. partnerships, to consumer, to sleep ap labs
• Goal = allow broad use at cheap priceNote – test in their own homes for sleep apnoea – whether class 1 or class 2 unclear atm. EU regs changing, which is pushing a lot of previous class 1 classifications into class 2… class 2 requires formal review of the company’s technical file

• Wearable devices
• Multiple avenues
• Near term op – chronic asthma or COPD
• Longer term – gives ability to collect data… 24/7 monitoring of healthy people

• TGA adults approval
• Lack of TGA adults approval not an issue in regards to commercialisation efforts
• Unfortunately little snag with adults… why? Due to change of company address. Had to wait for BSI to update information which meant TGA paused application\
• Expect to be resolved in days or maybe weeks

• IP protection and status of tech
• Generation 1 now
• Generation 2 – R&D taem currently working on a number of things. Tony is excited about the improvements… which makes some “pretty material improvements”!
• Primary IP of computer source code + clinical data… a lot of security processes in place to protect these (i.e. ResApp does not provide source code to any partner atm and don’t expect to going forward…)

• R&D
• Expect $1.8m for 2019 and to receive before end of the quarter
• Similar for 2020

• US adult study
• o At best would commence this US winter. Adults expect quicker recruitment + enrolment also less seasonal in nature vs kid