Wael Fayad, the Chairman, President and CEO of Enumeral Biomedical Holdings, is a veteran in the pharmaceutical industry with over two decades of experience.
Prior to joining Enumeral in September 2016, Wael has held senior positions at Novartis, Schering-Plough and most recently was Corporate Vice President, Global Business Development of Forest Laboratories. He holds a B.S. in biology from the American University of Beirut, and an M.B.A. from Concordia University.
Why did you decide to join Enumeral (ENUM)?
I joined Enumeral because I was attracted to the company’s science, powered by its proprietary platform, and the promise it holds to create significant value to shareholders and patients. Further, I joined Enumeral because I felt there was a very good fit with my skill set and background with what Enumeral needs to advance its business.
I have been in the industry for more than 23 years and I spent most of this time assessing risk and finding value in pharma and biotech so I know an underappreciated asset when I see one. Previously I spent 14 years at Forest Laboratories Inc. where I was most recently head of business development and alliance management. As you may know, Forest was acquired for $28 billion dollars in large part due to the pipeline we built through business development, so I have intimate knowledge of how to value assets and create value.
Based on my experience, I believe Enumeral has a platform that provides the opportunity for the company to unlock value across a host of applications. During my career, I have built an extensive network in the life science industry that I intend to leverage at Enumeral.
What have you focused on since you joined ENUM?
Enumeral is a promising company undergoing a transitional phase. During my diligence before I joined the company, it became clear to me that Enumeral has validated its platform as a discovery engine for new and potentially differentiated therapeutics but needed strong leadership to articulate a clear vision for the company and execute a strategy focused on creating value in the near and long term.
Working with colleagues at the company, we have put in place a plan that has four main components: 1) create near term value by advancing our pipeline to near term value inflection points, 2) prioritize partnering with pharma and biotech companies to support further funding of our business and validate our science, 3) secure funding to execute the plan, 4) put the company on strong footing for future capital raises or strategic options.
What assets or pipeline does Enumeral have?
Enumeral has a powerful platform for discovering potential best in class therapeutics and a promising pre-clinical pipeline in immuno oncology, one of the fastest growing markets in life sciences.
Visualize our platform as a precision tool focused on finding the proverbial needles in the haystack. These needles have the potential to represent breakthoughs or best in class therapeutics. The Enumeral platform has application in immuno oncology and other diseases mediated by the immune system. Crohn’s disease, psoriasis, rheumatoid arthritis and multiple sclerosis are among the auto-immune diseases that we could target going forward in addition to infectious diseases.
Enumeral has the potential to create value at the foundational level of the commercial life cycle. The building block for value creation in pharma and biotech is finding the right development candidate to justify the cost and time associated with the rigorous development process required for regulatory approval and commercialization. Enumeral has the potential to excel and distinguish itself at this foundational stage of drug development.
The core technology behind our platform is exclusively licensed to us from the Massachusetts Institute of Technology. Our immune profiling platform enables us to extensively interrogate the immune microenvironment, including from human disease tissue, to identify and validate potential drug candidates and understand disease processes to guide development. This puts us in a position to be at the center of the race in pharma and biotech to identify the next breakthroughs and this is a core element of our growth plan going forward.
Enumeral has 2 programs in the pre-clinical stage and several programs in discovery. Our lead program is ENUM244C8, which we refer to as C8, a monoclonal antibody against PD-1, a checkpoint inhibitor in the field of immuno oncology, which is one of the fastest growing markets in the industry.
C8 has distinct characteristics compared to other PD-1 inhibitors and therefore has the potential for differentiation in a very large and growing market. In contrast to other PD-1 inhibitors, C8 does not inhibit the binding of PDL-1 to PD-1, but renders the binding of PDL-1 ineffective in suppressing the immune response. While we don’t fully understand the implications of this, we are trying to further elucidate the profile of the drug in relevant pre-clinical models and we expect to have data before end of the year. We believe C8’s distinct binding profile provides a strong basis to investigate C8 in cancer patients.
We also have another program in preclinical research directed against TIM-3, another checkpoint inhibitor that has the potential for mono and combination therapy including with PD-1. We have identified a diverse series of antibodies and we are in the process of selecting a lead candidate for further development. Again, what we have been able to do here is identify a diverse library of TIM-3 antibodies that tells us that our platform is an excellent tool for discovering potential best in class therapeutics.
In addition, we have other programs in earlier stages of development.
What is Enumeral’s strategy to further develop its pipeline?
We want to develop our pipeline in a capital-efficient manner. The applications of Enumeral’s platform are too broad for us to exploit on our own. Therefore, partnerships and collaborations with other pharma and biotech companies are a core element of our growth strategy. This is an area that Enumeral can execute better in and this is why I am here.
We believe we will be successful in securing transformative deals for three main reasons: 1) new management has the right experience and a broad network of relationships among potential collaborators, 2) new R&D strategy is focused on value creation to make our pipeline more attractive to potential partners, and 3) prioritized partnering strategy that is broader in scope. In addition to partnering our development programs, we will also be seeking strategic research collaborations for discovering potential breakthrough or differentiated therapeutics through the utilization of our proprietary platform. Considering the broad applications of our platform, this significantly expands the potential universe of collaborations we can enter into in the near term.
Why should investors be interested in ENUM now?
I believe Enumeral is underappreciated and we are working very hard to change this picture. The company has advanced its pipeline and validated its platform but has not yet been successful in using this progress to enhance value for its shareholders by securing more corporate partnerships or further capitalizing the company. Investing in biotech is risky but the upside is enormous and all successful biotech companies became successful by pairing their science with a winning strategy and focused execution. We believe Enumeral has the ingredients for success and we are working on securing a financing plan to extend our runway and allow us to execute a turnaround plan to create value and position us for more strategic options in the future.
Some people ask me how you are going to create value without having products in the clinic. We don’t need to be in the clinic to create value. We know there is a big market for early stage biotech assets as evidenced by recent deals in several therapeutic areas including immuno oncology. Due to the race in pharma and biotech to find the next breakthrough or differentiated therapy, pre-clinical programs of interest are commanding significant upfront payments in many cases. We also see early stage biotech companies with market caps much larger than ours. So we see examples of how early stage companies can create value, and we believe that we have the platform, the pipeline and the right management team now in place to capitalize on this opportunity.
What are your three biggest hurdles as the CEO and how do you plan on addressing them to ensure return of value for ENUM investors?
Time is our best friend and our worst enemy. We are confident that with time we have the opportunity to move the business forward and create value for our stockholders, but we need to first inject cash into the company to enable us to execute our turnaround plan. As a new CEO, I needed to get up to speed quickly and put a plan in place that would help fund the company to create near term value and position us for further capitalization or other strategic options later. I feel good about the plan we have in place and believe we have the right team to execute it.
We also needed to improve awareness and credibility of the company with key stakeholders since the company has basically been flying under the radar screen. Having new, experienced, and well-networked management in place paired with a clear plan, makes us confident that we will succeed in this regard.
In addition, we believe that in order to realize our growth potential, we need to grow our institutional investor base. We feel confident that if we can execute our turnaround plan, we will be able to secure the institutional support we need for our longer term prospects.
What are the larger risks involved in investing in ENUM?
Like almost all emerging biotech companies, Enumeral is dependent on funding to execute its business plan. We have previously reported that we have cash to fund operations through November. Our number one priority is to secure funding to enable us to execute our turnaround plan. We are continuing to explore a range of potential transactions, which may include public or private equity offerings, debt financings, collaboration and licensing arrangements, and/or other strategic alternatives.
Also like other emerging biotech companies, we are dependent on generating positive data from our R&D pipeline to build value.
Our business risks are outlined in our SEC filings and investors should refer to these filings for full disclosure.