CohBar Inc. (COB.U:CA) Q&A with CEO Simon Allen

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CohBar Inc. (COB.U:CA) is an innovative biotechnology company whose mission is to treat major diseases and extend healthy life spans through the discovery of novel Mitochondrial-Derived Peptides (“MDPs”) and the advancement of their development into clinically relevant and commercially successful therapeutics.

CohBar’s scientific leadership is centered on the expertise of our founders, Dr. Pinchas Cohen, Dean of the Davis School of Gerontology at the University of Southern California, and Dr. Nir Barzilai, Professor of Genetics and Director of the Institute for Aging Research at the Albert Einstein College of Medicine, and is supported by our co-founders, Dr. David Sinclair, Professor of Genetics at Harvard Medical School, and Dr. John Amatruda, former Senior Vice President and Franchise Head for Diabetes and Obesity at Merck Research Laboratories.

Read More about CohBar here

Below is a Q&A with CEO Simon Allen

Steve: Welcome everyone. This is Steve Kanaval, Director of Research at Equities.com. Glad to be with Simon Allen, CEO of CohBar. Simon, thank you so much for joining us.

Simon: It's my pleasure Steve, thank you.

Steve: I thought we'd talk about the phenomenon that is happening with your company.You guys have had tremendous success from what I’ve seen. We stumble on articles about your company all the time and we talked a little bit about addressing the phenomena that as our society ages and as we get older, our health declines and we become more susceptible to age related diseases. Some interesting stats there about once we reach the age of 50 the incidence of debilitating age related diseases increase dramatically.Simon can you talk about that and how CohBar fits into that?

Simon: Absolutely Steve. We are focused on the effective treatment of age related diseases. Before we get into our technology and products, let's remind ourselves of where we're headed as a society and what we're currently faced with. One of the greatest achievements of our time is extending life expectancy as a society. However, one of the consequences of growing older is our declining health. From the age of 50 years and onwards, the incidence of age related diseases such as diabetes, obesity, cardiovascular, cancer, and neurodegenerative diseases increase dramatically. Our healthcare system is already burdened with these diseases and it will become increasingly burdened as we grow older as a society.

Through the work of our founders we know that age related diseases are connected to metabolism and declining mitochondrial function - This is the basis of our technology.While the primary role of the mitochondria is to provide our body with energy, they are also essential in regulating our metabolism via peptides encoded within their genome. As we get older mitochondrial function declines and their ability to regulate metabolism becomes compromised. At CohBar, we are focused on the biological function of mitochondria derived peptides and how they may be optimized to treat a wide range of age related diseases.

Steve: Simon, tell us about your background. I saw that you were a healthcare analyst and you've come across the field. Tell us about that.

Simon: I always knew I wanted to focus on science out of high school and went on to complete a bachelor’s degree in science. That was back in Australia. Biotech really interested me, and more specifically human therapeutics. I took the opportunity to come over to the States and work for a company called Gilead Sciences which was a small company when I joined in the early 90's. It has now gone on to be one of the premier pharmaceutical companies in our industry.

At that point I had a decision to continue along a science path or transition to a business path within the biotech sector. I went on to complete my MBA back in Australia. One of my first roles after receiving my MBA was working as an analyst covering the healthcare and biotech sector in Australia. I then went back to my roots of working with emerging biotech companies by working within the business development groups at several biotech’s in the Bay Area, New York City and San Diego. This is where I got an understanding of how to form partnerships and how to bring emerging biotech’s together with larger pharmaceutical companies. A primary objective was to match a biotech’s innovation, intellectual property and assets with the substantial resources, disease specific expertise, clinical, regulatory and commercial talents of a large pharma company.

I’ve been fortunate enough to work with many talented teams and formed multiple collaborations with pharma as well as completed M&As. The same opportunity exists for CohBar which,I think, has tremendous potential to develop multiple first-in-class products and expand our knowledge of mitochondria based therapeutics.

Steve: Simon, let's talk about the product pipeline and shift back into the innovative technology of CohBar.

Simon: Our lead program is based on MOTS-c, a peptide encoded within the mitochondrial genome. To recap, mitochondria have their own genetic material distinct from our nuclear genome. MOTS-c comes from the mitochondrial genome. Our founders and scientific team have worked hard to understand the biological function of MOTS-c. We are currently optimizing MOTS-c to improve its drug like qualities and are seeing encouraging pre-clinical data in cell based assays and animal models that lead us to believe it has potential utility for the treatment of Type 2 diabetes, obesity as well as fatty liver disease.

Once we identify our clinical candidate we will start IND-enabling studies and initiate Phase 1 clinical trials. We anticipate starting clinical trials in the next two years.

Steve: Anything that we should add to that before we transition into some of Myron's questions?

Simon: We’re the first company, we believe, that is discovering mitochondrial-derived peptides, identifying their biological functions and optimizing them into therapeutics for age related disease. We are developing novel products with new mechanisms of action that represent first-in-class opportunities. They have clear potential to be groundbreaking and disruptive.

In the field of type 2 diabetes you have several well-established therapies but there remains significant unmet medical need for new treatments. We are developing products with novel mechanisms with the potential to show superiority over,or synergy with,entrenched therapies such as metformin and GLP-1 agonists. The top 10 therapies for type 2 diabetes are each selling for billions and billions of dollars annually. What we bring to the table is not just an improvement or an off shoot of these current therapies. Our products are novel first-in-class opportunities that may become blockbuster products.

Myron: You indicated in your 10K that the company has enough cash and investments to meet operating expenses into the second quarter of 2017. You just indicated that the MOTS-cprogram may not enter Phase 1 trials until two years from now which puts us past that quarter. What do you expect to do in terms of getting the cash to finish this off?

Simon: As you noted, we have cash in hand to get into the second quarter of 2017. That puts us somewhere within our IND-enabling studies. We continually assess opportunities for dilutive and non-dilutive funding. For example, we have a partnering process underway where we are putting our MOTS-c program and other pipeline opportunities in front of large pharmaceutical companies. From a financial perspective, if we're successful in securing such a partnership, we could receive upfront cash, milestones and royalties. It could also include a direct investment in CohBar.

Lastly, which is often overlooked, our partner may pay for the ongoing development of the program so that we could use the non-dilutive partnership capital to ramp up activities on our second, third and subsequent programs within our pipeline.

In summary, we could go back to the market for dilutive capital, secure non-dilutive partnership funding or a combination. That will be a strategic decision. Particular to CohBar, we also have a number of outstanding warrants associated with our initial public offering that may be exercised. This could generate an additional $14 million of funding. If these warrants are exercised, and we are successful in our partnering activities, we may never have to go back to the market for funding. Without setting expectations, these are things that we will assess over time and make the appropriate decision.

Myron: For my own sense of clarification, you have MOTS-c, you have the SHLP-6, SHLP-2 and there were a couple of others. At this stage you're focused solely on the MOTS-c as the one that you're going to be putting all your resources behind?

Simon: Our primary objective and focus for the near term is to get MOTS-c prepared for Phase 1 clinical trials. However, we do have two other important activities underway at CohBar. We continue to develop our other products in our pipeline and continue our discovery efforts to identify new mitochondrial derived peptides. For now, the majority of our resources and focus is directed toward MOTS-c and Phase 1 clinical trials.

However, I mentioned the other activities because it is important to note that CohBar is not a single product company. We are taking a strategic approach to a multi-product pipeline by sequencing our development timelines and continuing to discover additional MDPs. This will help maintain our leadership position in this field.

Myron: Talking about potential partnerships assuming all things go well and it successful goes through the trials and it gets approved. You need to manufacture it and you’re going to need to distribute it so are you looking at the partnerships as bonding up with a pharmaceutical company to actually manufacture the drug when it gets to that point as well as someone to sell and distribute the drug, how the stuff goes to areas is not something that you will be doing in house.

Simon: There are two aspects of manufacturing that you touched on. Our current manufacturing and what we will need to manufacture for human clinical trials and beyond. While our technology and products are novel, their building blocks are readily available. Our products fall within a therapeutic class whose raw materials and manufacturing processes are standard and well established.

Right now we in the preclinical setting and require research grade materials. As we move closer to human clinical trials we will initiate GMP manufacturing activities. As these activities are well established, we will use third parties to manufacture our products. It does not make sense for CohBar to invest in its own manufacturing equipment when third parties have already made that investment and operate on a service basis within a very competitive market. We’re in the enviable position where our technology is unique but it does not rely on esoteric or unproven manufacturing processes and equipment.

Myron: Let's stay on manufacturing. Would you then license with royalties associated with the product to a manufacturer or would you just, I’m just trying to understand how much of the revenue potential of the MOTS-c potential drug would be retained by CohBar?

Simon: Our therapeutics are directed towards large indications that have attractive reimbursement. Our projected cost of goods is competitive in that we do not require novel or proprietary manufacturing processes. This would all be done under a standard third party manufacturing agreement.

Myron: Milestone payments required to the California Regents. Do you need to make those payments prior to commercialization or post commercialization?

Simon: As you may imagine,our founders have done considerable work in this area over a 15-year period and have accessed over $30 million in grants to progress this technology. We entered into a license agreement with UCLA that gives us exclusive rights to these discoveries. For example, our licenses provide us with freedom to operate and patent protection when developing MOTS-c and its analogs. In return, we would pay UCLA milestones and royalties on any product covered by the patent. These terms are typical for what you would expect between an academic institution and a biotech company like CohBar. I believe we may pay UCLA a total of $765,000 in development milestones and a 2% royalty on net sales for the MOTS-c program.

Myron: When you relocated the company why did you pick the Menlo Park area? Is it closer to doing some work with Stanford and Berkeley?You just mentioned that the original one came out of UCLA and you were in Pasadena. I’m a little bit curious why you chose the Bay Area.

Simon: We do not physically conduct all of our research activities at academic institutions, it is a collaboration, so geography is not a limitation or constraint in that regard. We were fortunate enough to attract the talent of Dr. Ken Cundy, our Chief Scientific Officer, in November of 2014. Ken has spent much of his career in the Bay Area and has worked with very talented individuals which,I’m happy to say, chose to work with him again at CohBar.

So, we’re very familiar with the Bay Area. We found ourselves in a situation where the Bay Area is the number one biotech arena in the United States and has a deep talent pool which we've already tapped into. It really made a lot of sense for us to be where the action is.

Myron: Thank you very much. At this time,I have no further questions.

Steve: Thank you Myron. Thank you Simon. Simon, in closing how would you like to wrap up? We look forward to introducing you to the Equities readers and all of our followers. We love following CohBar. It a great story and it's really interesting for us to follow. Is there anything else you would like to add in closing Simon?

Simon: I would say our enthusiasm and dedication to developing Mitochondria Based Therapeutics to treat age related disease is probably the most exciting thing I’ve had the opportunity to work on. As much as 80% of the healthcare costs incurred today are related to the treatment of age related diseases. As our society gets older, it's very clear that if we don’t effectively treat age related diseases, it will continue to be a substantial burden on our economy. This relates to the lost productivity when people suffer from diabetes, obesity, cancer, cardiovascular and neurodegenerative disease. It's very expensive to treat these individuals and while pharmaceutical companies are doing a good job in providing therapies, it is placing a tremendous burden on our healthcare system and overall economy.

We are focused on providing new and effective treatments for age related diseases that can help to reduce the burden on our healthcare system, allow ourselves to be more productive in our older years and boost our impact on society. Living longer is not a benefit if we are to become sick and debilitated by these diseases. Adding another 10 years onto our life span, only to have those years plagued with cancer, diabetes, cardiovascular complications and Alzheimer's, is not an attractive proposition.

We’re looking to effectively treat these age diseases and increase our healthy lifespan.

Steve: Simon Allen, CEO at CohBar, thank you so much for taking your time with us today. This is Steve Kanaval at Equities.com.

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