Changing the game one dose at the time Presentation to Investors - - PowerPoint PPT Presentation

Changing the game – one dose at the time

Presentation to Investors RESI March 23d-25th 2020

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• 1. FASS (Farmaceutiska Specialiteter)
• 2. Vuswanathan et al, Ann Intern Med. 2012;157(11):785-795
• 3. Rosenbaum and Shrank, N Engl J Med 2013; 369:694-695
• 4. https://adhdstimulantawareness.com

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Critical for a multitude of diseases in psychiatry and neurology where several of dose strengths are needed1

50%

Healthcare costs associated to poor adherence are $100-290B early3 1 out 5 college students misuse ADHD stimulants; >150 000 exposures reported to US poison centres 2000-20144 Rx opioids lead to 17 000 deaths yearly in the US5 Tablets and capsules less suitable for children, especially for the <5 years old6 60% of patients 60 and 89 years experience difficulties in swallowing tablets7

“One size does NOT fit all”

1 in 5

Misuse and diversion of controlled substances is a growing concern 50% of medications for chronic disease are not taken as prescribed2 Dose optimization

• f tablets and capsules

is complex and time consuming Children and elderly often have issues accepting tablets and capsules

Individualization Adherence Misuse and abuse Swallowing difficulties

60%

• 5. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
• 6. Adopted from: European Medicines Agency. Committee for Medicinal products for Human use (CHMP) 2005: Reflection Paper: Formulations of Choice for the Paediatric Population.

EMEA/CHMP/PEG/194810/2005

• 7. Strachan I, Greener M. Medication-related swallowing difficulties may be more common than we realise. Pharm Pract. 2005;15:411–414

OnDosis addresses significant unmet needs related to todays usage of pills and capsules

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…and pushing the use of beads, a well-known formulation technology, to it’s full potential Addressing unmet needs by combining medicines and OnDosis handheld device…

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Misuse and abuse Swallowing difficulties Individualization Adherence

OnDosis technology platform; a 1st in category Dosage Manager

OnDosis01 Dosage Manager integrates oral medicines with proprietary intelligent dosing and health tech

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The device consists of a control unit lasting for 24 months programmed for the specific medicine and a disposable cartridge dispensing medicine formulated as granules Flexible dose adjustments for individualized treatments 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, dose adjustment for data collection Programmable dosing and titration schedules Connectivity enabled

OnDosis makes sure the patient is always on the right dose

Improved adherence Increased security Improved control Improved self-monitoring Increased simplicity

Superior dosing

Doctor More information and increased reassurance Payer Quality assurance and follow up

Better outcomes

OnDosis connects treatments and results for doctors and payers OnDosis links pharma and patients for faster and more insightful development

Faster drug development Paradigm shift to truly individualized medication Digitalization of the disease management loop Enabling agile drug development

The OnDosis solution supports both patients and HCPs to improve outcomes

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Decision support for HCPs Remote disease management

Dashboard and EMR integration

Tailored for the specific disease Reminders Patient reported symptoms Link dose to subjective outcomes

Patient app

For the specific disease Data collection Combinations Link dose to objective outcomes

Patient wearables, sensors or DTx

Prescribed by doctor, pre-filled at manufacturing, reimbursed/covered as a combination treatment

Drug/device combination

Contract manufacturing partners Digital health platform partners

Control Unit/ Cartridge API/Granules

ADHD IP Product development Regulatory Business development Data

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Epilepsy Immunos. Pain Oncology

In-house development of Device and granules for an OnDosis drug/device combination

Rare disease

Next wave opportunities; out-licensing on field-by-field basis

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

We will make it... …easier to find the right dose, for children to take medicine, possible to monitor adherence, and possible to prevent non- medical use

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ADHD Pain Immunosuppression post organ transplant

We will make it... …easier to taper ongoing treatment, find lowest effective dose, monitor adherence and possible to prevent abuse We will make it... …easier to individualize dose and possible to improve adherence to protect organ grafts Growing market valued at $8.5B Growing market valued at $8B Growing market valued at $6B

Epilepsy in children

We will make it... …easier to individualize dose and possible to improve adherence and create parent reassurance to avoid seizures Growing market valued at $1.6B by 2026

Four high potential opportunities as 1st wave

A promising pipeline of collaboration opportunities with big and small PharmaCo as well as strategic partners

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Ongoing discussions with collaboration partners Ongoing discussions with Big Pharma (out-licensing deal) Ongoing discussions with SME pharma (out-licensing deal)

Oncology Endocrinology Diabetes CNS (Dvlpmnt agreement) ADHD

Platform partner for chronic pain management (ongoing discussions)

Innovative EU based pharma Mid sized EU based pharma

Platform for development/ commercialization of ADHD and immunosuppression (draft agreement)

Technology platform partner

Mid sized EU based technology company (ongoing discussions)

CNS Rare disease Epilepsy/paediatrics Epilepsy/paediatrics Rare disease Hematology

High abuse & diversion risk 1 in 5 college students has misused or abused ADHD drugs. >150 000 exposures reported to US poison centres 2000-2014. Pill-swallowing difficulties 4/10 of individuals find tablets hard to swallow. Children can develop aversion to treatment. Delicate dose titration Multiple doses and titration over several weeks to manage severe adverse effects

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Compromised compliance The characteristics of ADHD implies risk of poor adherence and high discontinuation rates Major unmet needs in ADHD treatment: OnDosis 01 approach: Flexible and individualized dosing, and ability to easily respond to patient symptoms User ID, tamper resistant device and max dose limitations, against abuse and accidental overdose Drug formulated as granules, increasing treatment acceptance in children Companion app for patient smartphone, supporting compliance, reminders and self-monitoring Dashboard for physicians to remotely monitor and track patient treatments

OnDosis addresses significant challenges in today’s ADHD treatment

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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)

• Positive reaction in executive exchanges with 15 payer and pharmacy

executives, confirming potential for competitive coverage

• In a quantitative study, 87% of physicians would prescribe an OnDosis mixed

amphetamine device, with stated use at over 30% across all patients

• Four target patient types were identified, representing 48% of total
• 88% of ADHD patients were positive to using OnDosis
• This was further confirmed during usability testing where over 90% found the

device intuitive and easy to use; zero critical errors and 14 out of 17 able to

• perate the device without instructions

Payers Physicians Patients

OnDosis potential in ADHD confirmed by research across key stakeholders in the US; forecast $300M for 1st product

Company/ 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. 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

Flexible and tailored dosing Patient acceptance and convenience Health tech connectivity Tamper resistance and evidence

NerveLabs

1 2 3 4

OnDosis01 have the potential to be 1st in category with a unique value proposition

We are aiming for a $7.5M injection in the next financing round to build capabilities, scale-up and bring an ADHD drug/device to market

ü Capabilities build-out ü Upscaling of manufacturing ü Bioequivalence studies (in partnership) ü FDA filing of a drug device combination product (in partnership) ü Establishment of critical business functions and US presence

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Injection will take us into 2022, achieving the following:

IP strategy and patent attorney Strategic support: Formulation/ clinical/device/digital health Device design & development Health tech strategy & platform Pellet formulation & development Start-up and innovation incubator Strategic support

Located at AstraZeneca BioVenture hub in Gothenburg, Sweden Operating through a network of strategic partners

OnDosis was founded in 2017 as a spin-out from AstraZeneca

Go to Market Broaden offering and partnerships

2021-2022 2023-2024 2019 - 2020

Build & deliver the core

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Phase 1

2017 - 2018

Proof of Concept Seed 1st Patent

Foundation Phase 2

Verification and validation Regulatory filing; platform Formulation work ADHD Supply chain Series A Regulatory & launch ADHD Next wave indications Series B

Phase 3 Phase 4

AI & Algorithms Disease management IPO

We are here

We are targeting a US launch for ADHD drug/device in 2022 as 1st proof

• f concept for the platform

$7M raised 2017-2019 Expand

IP strategy and patent attorney Strategic support: Formulation/ clinical/device/digital health Device design & development Health tech strategy & platform Pellet formulation & development Start-up and innovation incubator Strategic support

Located at AstraZeneca BioVenture hub in Gothenburg, Sweden Operating through a network of strategic partners

OnDosis was founded in 2017 as a spin-out from AstraZeneca

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Johan Öberg, Senior partner, BCG Sweden Staffan Ternström, CEO Handicare Chairman of the Board Kay Brickmann, Business Development Director, AstraZeneca Jan Pilebjer, Business Intelligence Officer GU Ventures Adina Symreng, Director Corporate Strategy, Elekta Martin Olovsson, CEO & Co-founder Stéphane Baronnet, Head of Product Development Stina Wigren, COO Jonas Bäck, Head of Business Development

Leadership team Board

Klementina Österberg, CEO GU Ventures

The OnDosis leadership team

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Ou Our Vis isio ion

OnDosis will be a renowned game-changer in oral medicines, integrating medicines with proprietary dosing technology & Health Tech to improve patient outcomes across a multitude of diseases

Ou Our Ambit itio ion

• Build a new Drug/Device Health Tech company, Swedish born with Global reach
• Establish 20 partnerships with PharmaCo’s
• Deliver a first product launch in US by 2022

DISCLAIMER

This Investor Presentation has been prepared by OnDosis, (“Company”) for investors, solely for informational purposes. The information contained herein has been prepared to assist prospective investors in making their own evaluation of the Company and does not purport to be all-inclusive or to contain all of the information a prospective or existing investor may desire. In all cases, interested parties should conduct their own investigation and analysis of the Company and the data set forth in this information. OnDosis makes no representation or warranty as to the accuracy or completeness of this information and shall not have any liability for any representations (expressed or implied) regarding information contained in, or for any omissions from, this information or any other written or oral communications transmitted to the recipient in the course of its evaluation of the Company. This Information includes certain statements and estimates provided by the Company with respect to the projected future performance of the Company. Such statements, estimates and projections reflect various assumptions by management concerning possible anticipated results, which assumptions may or may not be correct. No representations are made as to the accuracy of such statements, estimates or projections. Prospective investors will be expected to have conducted their own due diligence investigation regarding these and all other matters pertinent to investment in the Company. This presentation may contain statements that are not historical facts, referred to as “forward looking statements.” The corporation’s actual future results may differ materially from those suggested by such statements, depending on various factors.