A Message From the President and CEO – Six Months of Growth

It has been six months since I took the reins as President and CEO of OncoCell, and my teammates and I are extremely excited about what we are building here. We are working hard to manifest the potential of this immunogenomics platform company, and we are committed to making a global impact on the patients and physicians we serve while delivering excellent returns to our investors. In the last six months, we’ve made significant progress in advancing our team, our platform, and our data as we scale the organization. I wanted to share some of our wins and our upcoming plans:

  1. We put a great team in place.

When I started at OncoCell, I endeavored to build a team of dedicated, engaged people organized around a bold purpose and transformative technology. Chris Thibodeau joined as Chief Operating Officer, Dr. Kirk Wojno joined as Chief Medical Officer, and next week, Leander Van Neste, PhD will join as Chief Scientific Officer. We also added Jessica DeHart to the team as Director of Research/Clinical Affairs and Geff Erickson, PhD, and Amin Kassis, PhD, both founding team members, have remained onboard and are key contributors. Finally, Marc Stapley, CEO of Helix, joined our Board of Directors.

  1. We met major funding and development milestones.

This summer, we raised $22.2 million in a series B financing led by Savitr Capital, with participation from existing investors. With this new funding, we have raised a total of $30 million to date. These funds will support ongoing development of our immunogenomics platform and preparations for commercialization of our suite of novel noninvasive blood-based tests, including our first product in 2020 – a blood test to detect and grade prostate cancer. We have already completed discovery studies on the prostate diagnostic test and are now in the process of validation and verification studies. We’re also leveraging the platform to develop new assays for other cancers and disease. And we’re building on a broad IP portfolio, including rights from Harvard to 45 issued patents and more than 100 pending applications in the United States and internationally. These issued and pending patents cover various aspects of our technology in numerous clinical indications including cancer, cardiovascular, infectious, and neurodegenerative disease, and immune and kidney-related diseases.

  1. We continue to advance our platform for earlier signal detection, real-time surveillance and personalized assessment.

What sets us apart from other liquid biopsy companies is our platform’s potential in both pan-disease and individual assays, and how it approaches disease. The platform leverages the immune system, NGS RNA-SEQ and Machine Learning to assess the incremental effort expended by the immune system to contain the disease, measured by specific gene expression signatures, to identify and characterize it, at the time the tumor evades the defense system. Leveraging the internal amplification structure inherent in the immune system allows earlier signal detection than other techniques such as looking for circulating free DNA from apoptotic circulating tumor cells, which are more likely to be present in more advanced disease. Our prostate cancer test addresses a significant need to improve patient selection for active surveillance and to provide a noninvasive method for annual monitoring. Our goal is to help patients get the right therapy for the right target at the right time to optimize the chance for cure. We also have the potential to stratify risk and thus reduce over treatment of indolent disease.  To date we’ve amassed a patient database of over 2,100 patients with RNA-SEQ data and identified unique immunogenomic signatures that distinguish healthy patients from those with indolent or aggressive disease along with a large sample biorepository of over 5,000 samples with well annotated blood samples that can aid in drug discovery or test development.

So what’s next?

The liquid biopsy market is growing. In fact, it’s estimated to reach as much as $30 billion in the next five years. Our company is well positioned to grow with and into that market. In the coming months, we plan to announce a name change that better captures the breadth and opportunity for our company. And in addition to publishing and validating our data, we’ll also explore additional financing to bring the prostate test to market, advance R&D in new indications to include pan disease, and advance clinical studies.

Our goal is to help patients get the right therapy for the right target at the right time. We are concurrently focused on reducing the frequency of – and eventually replace – invasive, expensive and imprecise diagnostic procedures. We endeavor to help physicians make better and more timely decisions about who and how to treat, preclude over treatment, potentially reduce deaths related to under treatment, thus enhancing the effectiveness of treatment. In so doing, we aim to give patients their lives back.

I look forward to keeping you apprised of our progress.

Mark

Mark McDonough