Changing the game – one dose at the time Presentation to Investors RESI March 23 d -25 th 2020 1
OnDosis addresses significant unmet needs related to todays usage of pills and capsules Individualization Adherence Misuse and abuse Swallowing difficulties Dose optimization 50% of Misuse and Children and of tablets and capsules medications for diversion of controlled elderly often have issues is complex and time chronic disease are substances is a growing accepting tablets and consuming not taken as prescribed 2 concern capsules “One size does 50% 1 in 5 60% NOT fit all” Critical for a multitude of diseases Healthcare costs associated to 1 out 5 college students misuse Tablets and capsules less suitable in psychiatry and neurology where poor adherence are ADHD stimulants; >150 000 for children, especially for the <5 several of dose strengths are $100-290B early 3 exposures reported to US poison years old 6 needed 1 centres 2000-2014 4 60% of patients 60 and 89 years Rx opioids lead to 17 000 experience difficulties in deaths yearly in the US 5 swallowing tablets 7 1. FASS (Farmaceutiska Specialiteter) 5. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates 2. Vuswanathan et al, Ann Intern Med. 2012;157(11):785-795 6. Adopted from: European Medicines Agency. Committee for Medicinal products for Human use (CHMP) 2005: Reflection Paper: Formulations of Choice for the Paediatric Population. 3. Rosenbaum and Shrank, N Engl J Med 2013; 369:694-695 EMEA/CHMP/PEG/194810/2005 2 4. https://adhdstimulantawareness.com 7. Strachan I, Greener M. Medication-related swallowing difficulties may be more common than we realise. Pharm Pract. 2005;15:411–414
OnDosis technology platform; a 1 st in category Dosage Manager Addressing unmet needs by combining medicines and OnDosis handheld device… Individualization Adherence Misuse and abuse Swallowing difficulties …and pushing the use of beads, a well-known formulation technology, to it’s full potential 3 3
OnDosis01 Dosage Manager integrates oral medicines with proprietary intelligent dosing and health tech Flexible dose adjustments for individualized treatments Programmable dosing and titration schedules Dose timing lock for overdose protection PIN code or biometric lock for personalized use and keeping medicines safe Dispensing locked when cartridge not docked Event logging such as docking, undocking, dose taken, The device consists of a control unit lasting for 24 months dose adjustment for data collection programmed for the specific medicine and a disposable cartridge dispensing medicine formulated as granules Connectivity enabled 4
Digitalization of the Paradigm shift to truly Enabling agile disease management loop individualized medication drug development OnDosis makes sure the patient OnDosis connects treatments and is always on the right dose results for doctors and payers Doctor Improved adherence More information and increased Increased security reassurance Improved control OnDosis links pharma and patients for Improved self-monitoring Payer faster and more insightful development Increased simplicity Quality assurance and follow up Faster drug development Superior dosing Better outcomes
The OnDosis solution supports both patients and HCPs to improve outcomes Drug/device combination Prescribed by doctor, pre-filled at manufacturing, reimbursed/covered as a combination treatment Patient app Patient wearables, 7 sensors or DTx Tailored for the specific disease Reminders For the specific disease Patient reported symptoms Data collection Link dose to subjective outcomes Combinations Link dose to objective outcomes Dashboard and EMR integration Decision support for HCPs Remote disease management 6
OnDosis business model is based on out-licensing to PharmaCos on a field by field basis; ADHD the beachhead case to drive path to market Contract manufacturing Digital health partners platform partners Control Unit/ Cartridge Product Business API/Granules Data IP Regulatory development development In-house development of Device and granules for an OnDosis drug/device combination ADHD Pain Epilepsy Oncology Immunos. Rare disease Next wave opportunities; out-licensing on field-by-field basis 7
Four high potential opportunities as 1 st wave Pain Immunosuppression Epilepsy in children ADHD post organ transplant We will make it... We will make it... We will make it... We will make it... …easier to find the right dose, …easier to taper ongoing …easier to individualize …easier to individualize for children to take medicine, treatment, find lowest dose and possible to dose and possible to possible to monitor adherence, effective dose, monitor improve adherence to improve adherence and and possible to prevent non- adherence and possible to protect organ grafts create parent reassurance medical use prevent abuse to avoid seizures Growing market valued Growing market valued Growing market valued Growing market valued at $6B at $1.6B by 2026 at $8.5B at $8B 8
A promising pipeline of collaboration opportunities with big and small PharmaCo as well as strategic partners Ongoing discussions with Ongoing discussions with Big Ongoing discussions with SME collaboration partners Pharma (out-licensing deal) pharma (out-licensing deal) Mid sized EU based pharma Hematology Rare disease Platform for development/ commercialization of ADHD and Rare disease immunosuppression (draft agreement) Endocrinology Epilepsy/paediatrics Technology platform partner Oncology Mid sized EU based technology Epilepsy/paediatrics company (ongoing discussions) Diabetes CNS Innovative EU based pharma CNS (Dvlpmnt agreement) ADHD Platform partner for chronic pain management (ongoing discussions) 9
OnDosis addresses significant challenges in today’s ADHD treatment Major unmet needs in ADHD treatment: OnDosis 01 approach: Delicate dose titration Flexible and individualized dosing, and Multiple doses and titration over several weeks ability to easily respond to patient symptoms to manage severe adverse effects User ID, tamper resistant device and max dose High abuse & diversion risk limitations, against abuse and accidental overdose 1 in 5 college students has misused or abused ADHD drugs. >150 000 exposures reported to US poison centres 2000-2014. Drug formulated as granules, increasing treatment acceptance in children Pill-swallowing difficulties 4/10 of individuals find tablets hard to swallow. Companion app for patient smartphone, supporting compliance, Children can develop aversion to treatment. reminders and self-monitoring Compromised compliance Dashboard for physicians to remotely monitor and track patient The characteristics of ADHD implies risk of poor treatments adherence and high discontinuation rates 10
OnDosis potential in ADHD confirmed by research across key stakeholders in the US; forecast $300M for 1 st product • 88% of ADHD patients were positive to using OnDosis • This was further confirmed during usability testing where over 90% found the Patients device intuitive and easy to use; zero critical errors and 14 out of 17 able to operate the device without instructions • In a quantitative study, 87% of physicians would prescribe an OnDosis mixed Physicians amphetamine device, with stated use at over 30% across all patients • Four target patient types were identified, representing 48% of total • Positive reaction in executive exchanges with 15 payer and pharmacy Payers executives, confirming potential for competitive coverage It is the combination of benefits that drive Physicians perceived high value of OnDosis in ADHD; 5.3 on a scale from 1 (low) to 7 (high) 11
OnDosis01 have the potential to be 1 st in category with a unique value proposition Patient acceptance Tamper resistance and convenience Flexible and tailored dosing Health tech and evidence connectivity Company/ 4 1 2 3 Product Description Device for individualized dosing via micro tablets; Adherence monitoring ZipDose tech. for orodispersibe high-dose delivery. 3D printing tech; Taste masking Take As Directed device for dispensing pills; Connected App/portal; Fingerprint ID Locked dispenser device prefilled per prescription; Personal log-in via web/phone Ingestible sensor swallowed with drug; Patch/sensor for tracking; connected portal/App Intelligent clinical packaging & analytics platform with adherence support & monitoring Digital therapeutic for abuse disorders Dose-time reminder device to increase adherence; Bluetooth tech monitoring Devices for pill dispensing; Multi-dosing; Bluetooth remote connection; Adh. monitoring Tamper resistant, block chain controlled dispenser for opioids Pill package sending real-time info on drug intake to IT system; Phone reminders; API Smart pillbox with embedded sensors; connected App/web Carousel pill organizer providing medication reminders; Connected web Capsule with sensor for true adherence monitoring PillDrill medication tracking system; Reminders, tracking, instant notifications; App App "Florence" providing reminders; Patient can own make notes on mode, pain, etc. NerveLabs Smart appliance to store & dispense pills; Multi-dosing; Alerts; Pw protection 1. Incl. NIH, National Institute on Drug Abuse; CHA, Cambridge Health Alliance, Source: Desktop research
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