During its 10 years of existence, Brain+ has built an extensive understanding of brain functionalities and a broad platform of software technologies that can effectively assess and address the cognitive symptoms of dementia. Based on this platform, the company has developed a number of DTx dementia product candidates, of which the first, Cognitive Stimulation Therapy (CST), is in preparation for commercial launch in Germany and Denmark in 2023 in collaboration with RoX Health, a subsidiary of Roche. This partnership was signed in December 2021 as the first milestone in the strategy of Brain+ to go to market and commercially scale its digital dementia therapeutics via partnerships. The Rox Health partnership has put Brain+ firmly on the map as a core player in the DTx field.

The pharma industry is increasingly interested in DTx within Central Nervous System (CNS) diseases, and in particular within dementia and Alzheimer's Disease, and based on its growing portfolio of DTx product candidates, Brain+ has begun to more actively present its value propositions at life science partnering conferences to attract big pharma interest.

On 27-28 June, Brain+ appeared on stage and participated in multiple panel debates at the premier Digital Therapeutics (DTx) conference, DTx Europe, held in London. This event has spurred additional interest in the company's technologies and products, and following the conference, Brain+ is in exploratory dialogues with several pharma companies focused on dementia and AD.

Watch Kim (CEO) and Paula (CTO) of Brain+ discuss the growing interest here: https://vimeo.com/734368691/e58ce3abcf (https://vimeo.com/729092696) (5 minutes)

Kim Baden-Kristensen, CEO & Co-founder, Brain+:

" I am very pleased with the growing interest that we are being met with from big pharma companies in our software solutions and DTx products for dementia. It is key for us to get access to the right resources and competencies to ensure a fast route to commercialization for our products. We are convinced that our DTx solutions offer considerable value for people living with dementia, their relatives, and the healthcare communities around them - and the interest from core pharma players in this field is also an important validation of our business potential."

Pharma sees Digital Therapeutics as new revenue generators

One of the major changes from pharmaceutical companies in 2022 from the last DTx Europe conference in 2019 (pre-Covid) is that more pharma companies are beginning to think of and treat Digital Therapeutics (DTx) as a profit center in its own right, believing that DTx will be a substantial part of the industry in the future. They are thus looking for DTx solutions to be part of their product portfolio, either as a product on its own or as companion products to a pharmaceutical product. See DTx Europe participants here: https://www.dtxeurope.com.

Examples of major DTx Pharma-deals

• Description: BehaVR and Sumitomo signed a deal to create virtual reality (VR) therapies to treat social anxiety disorder, generalized anxiety disorder, and major depressive disorder.
• Amount: The deal is estimated at a potential $163 million.
• Stage: Pre-commercial, product launch expected later in 2022.
• Source: https://pharmaphorum.com/digital/partnering-to-advance-digital-therapeutics-offerings/

• Description: AptarGroup, Inc. (NYSE: ATR), a global leader in drug delivery, consumer product dispensing, and active material science solutions, completed an acquisition of a majority stake in Voluntis (ENXTPA: ALVTX)
• Amount: Approximately €51 million.
• Stage: Commercial
• Source: https://www.businesswire.com/news/home/20210902005790/en/Aptar-Announces-the-Completion-of-the-Acquisition-of-a-Majority-Stake-in-Voluntis

• Description: In exchange for the exclusive global rights to the novel treatment, Boehringer Ingelheim agreed to provide Click with an upfront payment for R&D followed by additional payments for clinical, regulatory, and commercial milestones. 
• Amount: Total deal value in excess of $500 million, not counting royalties on worldwide annual net sales that Click will also be receiving.
• Stage: Before Pivotal trial.
• Source: https://www.boehringer-ingelheim.us/press-release/boehringer-ingelheim-and-click-therapeutics-enter-collaboration-develop

About BRAIN+ [BRAINP]

Brain+ is a pioneer of Digital Therapeutics for dementia and Alzheimer's disease, including disease stages of prodromal/mild cognitive impairment, and pre-clinical/subjective cognitive impairments.

PROBLEM:

Dementia is a terrible condition, crippling a person's independence and putting a heavy burden also on the family. This puts an enormous emotional burden on the patients and their loved ones. As cognitive abilities deteriorate, behaviors change, and independence is lost. The complexity of the underlying pathology of dementia has so far made it hard for traditional pharmaceutical companies to deliver effective treatments, and there is an increasing focus on new non-drug therapies that can pave the way to help relieve the heavy burden of dementia - for people living with the disease, their relatives and healthcare systems. With an aging population, dementia - and in particular Alzheimer's dementia - is a growing problem, threatening to overwhelm the health care systems of the world.

PURPOSE:

Making effective dementia treatment and prevention available to everyone in need, as digital therapeutics (also called as `Software-as-medicine').

CLINICAL TARGETS

To slow cognitive decline, maintain functional abilities, preserve independence, and add more healthy years for people living with dementia; additionally, to prevent progression into dementia for people at risk of dementia.

SOLUTION:

Together with world-leading experts and institutions, we are digitizing the best-in-class, non-drug dementia therapies, making them available on regular digital devices - both in people's homes and at clinics. A therapy here, simply means a person having to actively do something, interacting with a software program or another person, which is stimulating to the brain, or which results in changes in behavior that brings measurable health benefits. Our digital therapeutic solutions also benefit the patient caregivers in their work and can help ease the pressure on the health care systems.

DIGITAL & DRUGS:

Software-as-medical treatments can be used on their own or be combined with traditional drug treatments. We believe the future will combine the best of both the digital and the pharmacological world for mutually enhancing benefits, including synergies in compliance, patient engagement, and mechanisms of action for better health outcomes.

PERSONALIZED, DATA-DRIVEN MEDICINE:

We believe a key benefit of digital medicine is also to proactively collect and use data to create tailored and more effective personalized therapy experiences, and to help improve clinical and scientific practice, while always adhering to strict ethical standards of personal data protection.

OUR DNA:

We are a digital biotech company. Our technologies and products are being built on a deep understanding of the challenges and needs associated with dementia, rigorously tested, scientifically and clinically validated, and regulated as software-as-medical-devices (software-as-treatments). These treatments will be prescribed by health care professionals and paid for by health insurance or state health care.

PRODUCTS & TECH:

• Cognitive Stimulation Therapy is a dementia therapy that treats the main symptoms of dementia. This technology is the basis of the first dementia treatment product, `Cognitive Stimulation Therapy - Therapist Companion, which will be launched in Denmark and Germany in 2023. A second product, called `Cognitive Stimulation Therapy - Home Extension, is planned next.
• Computerized Cognitive Training is essentially like fitness exercises for the brain. A 2[nd] generation of this technology is currently being developed for use in the pre-stages of dementia, like mild cognitive impairment, or in people who are in high-risk groups for developing dementia.
• Starry Night Test is a special memory test, which was originally developed by Professor Masud Husain at Oxford University, and then further co-developed, gamified, and made scalable with Brain+, with the aim of doing early detection of Alzheimer's disease and monitoring of disease progression.

CLINICAL PIPELINE:

Brain+ is expecting results from 5 Pilot and Proof of Concept (PoC) studies in H2 2022 on the 3 core technologies, and 1 additional study in 2023. 4 trials (1 Pilot, 3 PoC) have been successfully concluded as of February 2022, with positive results for all three technologies.

POTENTIAL:

Currently, 50 million people are diagnosed with dementia globally, and this number is expected to triple to more than 150 million people by 2050. In the US, 1 in 3 seniors dies with or of dementia.

 In 2030, the global costs of dementia are expected to be $2 trillion (or equal to 2/3rds of the entire health care budget of the USA), prospectively 1 in 3 people will die from dementia, and the estimated market potential for digital dementia treatments approximately $2-5 billion. Tapping into this market with effective digital solutions has the potential to generate revenue of hundreds of millions $. Brain+ aims to commercialize its products based on licensing deals with strategic commercial partners for faster market penetration and global scaling.

TEAM:

We have built our knowledge base, know-how, and network of global expert collaborators over 10 years, and our technology portfolio is the results of R&D investments of over €10 million, which puts us in a unique position to become a global market leader in digital therapeutic solutions for dementia and Alzheimer's. We have a senior management team with a combined 100 years of track record, with backgrounds from companies such as Coloplast, Lundbeck, Novartis, and GN Hearing. This provides us the solid backbone needed, to change the way we treat and deal with dementia on a global scale.

PARTNERS & COLLABORATORS:

We believe collaborations give the best outcomes, and so we partner with the best minds and hearts in our eco-system; pharmaceutical leaders in Alzheimer's, such as Biogen and Rox Health, a subsidiary of Roche Germany; academic & clinical partners, such as universities of Oxford, Nottingham, Aarhus, Gothenburg; patient organizations and NGOs, such as Alzheimer Europe, Alzheimer's disease international, and the European Brain Council.