Copyright 2015 NeuroInsights, LLC. All rights reserved. Reproduction is strictly prohibited. To subscribe to NEUROTECH INSIGHTS contact NeuroInsights at (415)229-3225 or visit www.neuroinsights.com

Visit our website for more information on this newsletter, other industry reports, and premier advisory services

June 1, 2015 NEUROTECH INSIGHTS Page 23 of 27

DELSIA: ENABLING A NEW GENERATION OF AUTISM THERAPIES

Delivering Scientific Innovation for Autism LLC (DELSIA) was established in 2012 as a not-for-profit venture philanthropy affiliate of Autism Speaks with the goal of improving outcomes for individuals with autism. NeuroInsights spoke with DELSIAs President Daniel Smith, who also serves as Vice President of Innovative Technologies at Autism Speaks.

Autism Speaks was founded ten years ago by Bob and

Suzanne Wright. Their grandson, Christian, was diagnosed with autism and, at that time, there were not a lot of resources to direct parents and grandparents for information and support. Bob and Suzanne brought together three organizations to form Autism Speaks and received a $25 million gift from Bernie Marcus to launch the organization. Over the past ten years, Autism Speaks has funded $500 million in research, advocacy and awareness efforts, including basic research, policy reform activities in Washington D.C., and broad international community awareness activities.

Although these efforts have been significant and have had a

broad impact, Autism Speaks research funding has been provided primarily to academic institutions in the style of NIH or NSF funding, which, although very important, has two limitations: a long time horizon and significant hurdles in terms of commercialization of novel technologies. The question became, what could they do to improve the near term picture? Their answer was to increase investment in translational research and to launch DELSIA, an innovative funding vehicle that would support commercial enterprises positioned to translate scientific breakthroughs and technological advances into marketed products. Smith explains, In the autism space, venture, angel and other investors are largely inactive, and even combined with significant research dollars coming from the NIH, there was an unmet need for novel funders to step-up and bring something with the potential to transform the space for entrepreneurs and small businesses. We recognized that the market opportunity to achieve the financial ROI that traditional funders require may not be apparent or developed yet, and that there is really a major gap.

The model of venture philanthropy spoke to the board of

Autism Speaks as there is nothing like it in neurodevelopment or neuropsychiatry areas in general, or in the autism space specifically, and could be used to fund specific projects that could deliver results in the near term. DELSIA focuses specifically on partnering with for-profit entities and complements the funding of basic research. Smith clarifies, We are working with for-profit entities that are positioned to translate breakthroughs in science

and technology into products that can improve healthcare and quality of life for people with autism.

DELSIA is not only funding projects, they are true partners to

the project along the way, providing not only money but also the intellectual capital and connections to the relevant patient, business and medical communities, which can in some cases be more valuable than dollars. In addition, they are open and willing to participate in conversations with FDA to help develop regulatory pathways and advance projects to the clinic.

DELSIA has a broad scope of interest, and will support

projects aimed at identifying medical products including diagnostics, therapeutics, medical devices assistive technologies, services and other tools (e.g., biomarkers and novel outcomes measures). Over the past two years, DELSIA has been actively learning what markets exist across these sectors and what do the opportunity landscapes look like.

In a first project, DELSIA partnered with Seaside

Therapeutics in a biomarkers discovery project focused on acquiring and analyzing samples from the only blinded randomized controlled trials available at that time for autism. The goal was to identify DNA, RNA or proteomic markers to identify subtypes of patients and treatment responders. In Phase II trials of their autism candidate, Seaside Therapeutics did not meet the primary outcome measure. The combination of this and another failed trial in fragile X syndrome, along with Roches rejection of an option to one of the companys drugs, left them financially weak and the company dissolved.

This year, DELSIA partnered with Akili Interactive to support

a clinical trial of the Project: EVO platform in children and adolescents with autism and co-occurring attention deficits. Smith explains, We are very progressive in our thinking of where novel and impactful interventions may come from, and we focus a lot on opportunities in various technology business sectors. The Neurotechnology Industry Organization, the Neurotech Investing and Partnering Conference and Neurogaming Conference are incredibly important to us to draw in the companies that are working at the brain-technology interface and to potentially start working with us to improve the lives of people with autism. In addition, we launched our inaugural (and now annual) Autism Investment Conference in 2012 to bring together entrepreneurs and companies with great product concepts and investors looking to make a difference in autism. We invited Akili to present in 2012 and it started very productive conversations between us and them, resulting in a highly novel tech intervention clinical trial.

Akili was very attractive to DELSIA, as they have placed

significant effort on becoming differentiated as an FDA-approved or cleared medical device. Additionally, many people with autism have benefited from technology in many ways, for example speech learning apps and software programs for non-verbal

Company Spotlight

Copyright 2015 NeuroInsights, LLC. All rights reserved. Reproduction is strictly prohibited. To subscribe to NEUROTECH INSIGHTS contact NeuroInsights at (415)229-3225 or visit www.neuroinsights.com

Visit our website for more information on this newsletter, other industry reports, and premier advisory services

June 1, 2015 NEUROTECH INSIGHTS Page 24 of 27 individuals and tools for employers to work with people with autism, and Akilis software has a component that is very appealing and fun. A third aspect is that Akili is dedicated to developing a scientific evidence-basis and clear validation for the claims and uses of their products. DELSIA wants to support these types of projects that are rooted in a strong scientific foundation, and is looking specifically for those partners that are looking to differentiate themselves through science and controlled trials to demonstrated effectiveness. Finally, Smith points out, Signs and symptoms of ADHD are relatively common in people with autism, and current ADHD interventions are not addressing them well. We wanted to find novel and complementary interventions that may be safer; Akili brought that to the table.

In terms of future outlook, Smith points out that autism has

many known genetic risk factors and more are being uncovered every day, leading to identification of targets that are tractable. Hence, although the path is much longer than for technology-based interventions, there is great promise for pharma and biotech to deliver healthcare solutions that are based more closely on autism biology. He is optimistic and expects activity to pick up in these areas over the next five years. Also, medical devices, including those based on transcranial direct stimulation and transcranial magnetic stimulation, have presented a lot of anecdotal evidence of benefit for people with autism, and currently there is a critical need to rigorously test these innovations in true randomized trials to determine their real effects and to identify the subpopulations of people with autism that might benefit from them.

DELSIAs goal for 2015 is to make a few investments to build

their portfolio. They have already seen dozens of proposals but are always looking for more opportunities to diversify the portfolio and, more importantly, help bring novel technologies forward to address the diversity of unmet needs in the autism community. In that line, Smith comments, Among the many areas where we see opportunities, our priorities include assistive and medical technologies that can address core and major adjunct symptoms of autism, including social communication, anxiety, mood and sleep disorders. This may include a project focused on medical device assessment, where there is major gap in our knowledge and where the development of promising technologies is stalled. We are also prioritizing solutions to employment challenges (it is estimated that up to 90% of people with autism are unemployed or underemployed after finishing high school).

This year DELSIA co-sponsored the NeuroGaming

Hackathon that preceded the NeuroGaming conference, and they are looking to do more hackathons in the autism space to enable further development. In addition, they are working on shark tank-style business pitch competition events. This year, DELSIA awarded $50,000 in an Autism Speaks Google co-sponsored Pitch Playground to across three companies for a software/hardware combination (PuzzlePiece), an educational

app (Infinteach), and a video-remote diagnostic app (NODANow). Diagnostics are of special interest as autism is diagnosed in the US a few years after families report being aware of the first signs and symptoms. There is need to intervene as early as possible as a critical a critical window of time is being missed.

From his point of view, Smith feels confident that there is a lot

of activity in neuroscience and brain disease R&D at this time, and that some of the pullback from pharma and biotech and some investors may actually be stimulating the rapid rise in visibility and popularity of neurodevices, neurogaming, medical devices, and other technologies. He closes saying, This is a different sort of golden age in neuroscience and with tech so intimately involved, it is twice as golden as past decades of the brain.