Clopper Presents Foregen at World Stem Cell Summit 2015

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Scott Livingston:

All right. Why don't we get started so we can be on time? Thanks everyone for showing up today and I hope you had a nice morning session and breakfast and your networking's going well. My name's Scott Livingston. I'm the Chief Executive Officer of Livingston Securities. We're based in New York with offices in different cities around the country. And we're an investment bank and broker dealer that finances advanced technology companies in the public and private markets.

I’m happy to be invited to moderate this panel. I think this is my third year, maybe fourth year coming to the World Stem Cell Summit. And we have a great interest in regenerative medicine and stem cells and emerging life sciences technologies, and I consider this to be one of the must-attend events for enthusiasts, investors, entrepreneurs in these technologies. So I'm really happy to be here. And throughout the day I'll be kind of going in and out in different places and talking about different topics.

For me, in our business, the things that we're interested in are financing companies doing IPOs, secondaries, and venture capital financings. We've participated in over 120 IPOs and other public market transactions over the last three years, probably half of them in advanced life sciences. Questions that that are important to me include things like is the IPO window open anymore? What our investor attitudes towards stem cells and regenerative medicine, especially considering the significant correction that we've seen in the biotech index over the last six months or so? And where do entrepreneurs go to get financing at early stages? So during the Q&A, if people have questions about markets and finances and that sort of thing, I'll be happy to talk about that or talk with anybody afterwards. But I'm really happy to be moderating this panel today.

I know some of the speakers already and have gotten to know some of the others over the last week or two. And I think we have a really nice cross section of entrepreneurs and experiences and everything. So I'll be happy to have them share with you. Each presenter is going to take about 10 minutes to tell you a little bit about their companies and about what they're doing and about their plans. That's about 50 minutes, and then we'll have about half an hour or so for Q&A afterwards. So let's get started.

Eric Clopper:

So how's everyone doing today? Good. It's a better response than I expected. So I see some familiar faces in the audience today, but for those of you whom I have yet to meet, my name is Eric Clopper and I'm the spokesman of Foregen. Joining me here today is Foregen president and founder, Vincenzo Aiello, one of our senior researchers, Dr Valeria Purpura, and my colleague Eric Cunningham.

For the next 12 minutes, I'd ask of you to approach this presentation with an open mind. As a fellow scientist and entrepreneur, we’re here understand the importance of critical examination. We know that science, business, and medicine are fraught with misunderstandings and social biases that are only clear in hindsight. It's true that we don't have all the answers and we do the best with what we know. And once we know better, we do better.

How this relates to Foregen is we are dealing with an issue that has enormous cultural and psychological implications that are only obvious to outside observers but not easily discernible for those of us raised within the culture. In a sentence, what Foregen does is we are a seed stage regenerative medicine company seeking to adapt the latest advances in the field to regenerate the only body part that one in three Americans are missing. Over 100 million Americans and well over 600 million men worldwide, which is the male foreskin. To restore natural form, feeling, and sexual function of circumcised men. Which often begs the question, why address the condition of being circumcised?

Oh Wow. This is not working [PowerPoint breaks down] ... This is highly unfortunate. Give me one minute. Anyways.

Why address the condition of being circumcised? Well, let's use an analogy. Some of you here may have noticed that I'm wearing glasses. What happens when I take my glasses off? I could still see, I can see the general shapes of people. I can orient myself. I'm not going to fall off stage, but at the end of the day I only have partial vision.

However, when I put my glasses back on, I can see the entire room in vivid detail, down to the facial expressions of those of you in the back with my corrected entire vision.

Sounds obvious, right? Well, it wasn't for me.

See, when I was young, I was decent at sports, but one notable exception was baseball. To the despair of my little league team, I managed to bat a zero for two consecutive years. And they threw the ball pretty slow back then. I had no idea why I was so bad. The reason was, apparently I couldn't see the ball, and it was out of my realm of consciousness and I just unwittingly assumed that everyone saw the way I did.

It was out of my realm of consciousness that the eye could see with such range, depth, and clarity. Now, the point of the story is once I realized I had a sensory deficit, I corrected that sensory deficit and my quality of life improved drastically, along with my batting average.

Now, how does this relate to the problem that Foregen is addressing? Well, I'm sure many of us have had pretty mundane conversations about eyesight and corrective lenses, but how many of us, and you can raise your hands if you'd like, have had in-depth conversations about how much pleasure we receive and where in our penises?

Probably none of us is my guess.

However, in a 2007 study in the British Journal of Urology, they did just that. They studied the sensitivity differences of the circumcised versus the intact penis. Now if we take a look at the sensitivity diagrams with purple and red being the most sensitive, what we see is the most sensitive part of the circumcised penis is along the circumcision scar line. However, if we observe the uncircumcised or more appropriately named intact penis, what we see is the most sensitive part of the intact penis is the entirety of the foreskin.

So in other words, the most sensitive part of the circumcised penis is the scar line of where the foreskin was removed, which when I talk to some of my adult friends who were circumcised in adulthood, they said the difference is between night and day, black and white and color, which makes sense because most of their nerve endings were in their foreskin.

So if you are circumcised, you are like me before I got glasses. You can see just fine to function. And you may even unwittingly believe that's what everyone sees or feels. But you have no idea what your penis is truly capable of because you've never had the sensory tissue necessary to feel the sensations you're supposed to.

So instead of thinking of Foregen as glasses for your penis, think of it as regenerative medicine. I mean, think of it as LASIK eye surgery, but with regenerative medicine.

I mean, let's be honest, putting lasers in your eyes doesn't sound too appealing either, but it works beautifully. Think of Foregen along the same lines. But Foregen is more than just restoring natural levels of sexual sensation of circumcised men. They're actually functions of human sexuality that are in the foreskin which is why it has evolved to be part of our reproductive organ.

Which brings me to my next question. You saw the sensitivity diagrams, which are great, but what actually is the foreskin?

Now, this is a valid question. Most Americans have no idea. I myself didn't know for two decades, and by no stretch of the imagination are medical professionals exempt from this gap in knowledge. And the reason is medical professionals, especially older ones, grew up in the age of mass circumcision in the US with rates as high as 90%. Meaning they never had a foreskin, never saw foreskin growing up, and study from medical textbooks that omitted the foreskin as if it's not part of the penis.

Now this is truly mind blowing! I need you to grasp this reality to understand this presentation. It's a reality that would make Orwell himself shudder! We have censored a human body part, a human body part of great value, out of the public's consciousness. Now this is a direct result of growing up in a genital-cutting culture.

Reality can often be quite discomforting, and this is a prime example. So let me clear up the misconceptions. The average male foreskin is 12 to 15 square inches of the penis. As shown on stage, it's composed of four major parts.

I actually have one with me. Don't worry, it's just a model. But as you can see the four major parts, we have the outer for skin, which is just a continuation of the shaft skin, which covers the glans and the internal organ, keeping it sensitive throughout life.

We have the inner foreskin, much like the inner mucosa of your mouth.

We have the frenulum, a highly sensitive tethering structure, and then we have the ridged band of the foreskin, also known as the lips or the foreskin. Because like the lips of the face, the lips of the foreskin provide transition from skin to inner mucosa. And also like the lips of the face, the lips of the foreskin are densely innervated with approximately 10 to 20,000 fine touch nerve endings. Also making this known as the male G-spot.

Ever wonder why ribbed condoms exist? They're trying to recreate the ridges that every man comes with standard issue.

The foreskin is also responsible for all the natural mobility, lubrication, and sensitivity preserving functions that the penis evolved to have. So once it's removed, not only is the quantity, quality, and range of sexual sensations sharply reduced, but the mechanics are permanently and drastically altered, which can manifest itself in sexual pain and or discomfort for both partners, the effects of which are pronounced as a circumcised male ages.

Now I realize it's not immediately obvious how this butterfly shape is a foreskin. Very few people actually guess when I show them. So if you take a look at this composite, it shows how the foreskin is a bi-layer tissue that wraps around the head of a circumcised penis. Now this is a rough visual representation of an existing surgery that has poor clinical outcomes. And the reason is you can't simply graft skin and expect it to act like a foreskin, which you now know is an extremely confusing misnomer, because it's actually highly specialized mucosa.

So what we're doing at Foregen is using existing surgical techniques, but with the proper structure to restore natural form, feeling, and function of circumcised men.

Finally to recap because that was a lot of information, probably the most that anyone has heard about foreskins in their life, is the foreskin is responsible for most of the sensation during intercourse, all the natural mobility, lubrication, and sensitivity preserving functions, and unless we forget, to help stimulate the female as well. And the problems Foregen as addressing is, one, a major sensory deficit.

Now, just as you can never fully appreciate a kiss if you have your lips amputated, you can’t fully appreciate sexual intercourse if you have your foreskin amputated. Meaning if you do not have your foreskin, you will live your entire life without ever having a natural sexual experience, because you physically lack the anatomy to do so.

Now this extremely unfortunate reality explains why some men vehemently defend their circumcision, because they are not psychologically prepared to deal with this loss. Other problems we're addressing are any sexual and/or erectile dysfunction that results from circumcision.

For example, it's a common observation that circumcised men often rely on lubricant for intercourse and or masturbation, which is imposed sexual handicap. And the reason is the part of their body that deals with natural lubrication has been cut off. So they have to replace that function with a synthetic chemical lubricant.

There have also been numerous studies that link circumcision with higher incidences of erectile dysfunction and/or sexual dissatisfaction for both partners, making this a very promising market to address.

And finally, pain is a woman's number one complaint in intercourse in this country. And the reason is women are engaging in intercourse with men in this country with men who do not have the penises they were born with. The female evolved to be stimulated by the nonabrasive pressure of the males erectile body sliding in and out of the foreskin, not the friction of an immobile circumcised penis.

To remove a massive amount of form from the penis and expect not to affect its function is simply naive and exhibits fundamental misunderstandings in biology 101, evolution, and the history of circumcision, 99% of which has been an outspoken attempt to control and repress male sexuality, which is radically opposed to our current cultural values.

The US is one of the only countries in the world who does this for supposed medical reasons. It's also the only country in the world that has multiple billion-dollar industries that rely on the continuation of circumcision, with companies whose sole products are derived from foreskins harvested either from infants today or likely yourself if you're under 30 years old and circumcised in this country. But I digress.

The point is, circumcision is a big problem in this country. So what are we going to do about it? We are going to regenerate the foreskin.

Now, this is a somewhat unusual pitch for a number of reasons, but one is, I spent most of my allotted time talking about the problem, I'm going to briefly outline the business plan, our team, and our value added milestones to bring this technology to market.

As we all know, regenerative medicine works by taking a 3D mold, seeding it with cells, and then you get that regenerated body part. Now, there's two ways to get that mold. Either the cadaveric or the manufactured method. Now the benefit of the cadaveric method is nature makes the vascular networks, but it's harder to mass manufacturer because it requires a donor. However, with the manufactured method, it takes years of R&D to develop, but it's easier to mass manufacturer. Therefore, we're going to develop and commercialize the cadaveric method first and then move on to the manufactured method.

The business model is actually quite simple. There's three phases: Tissue supply, tissue prep, and tissue application phase. And how it works is we take our adult tissue from a European tissue source and then decellularize that tissue to get a foreskin mold and then apply that to the patient to receive that mold and have that regenerated foreskin.

We already have our adult tissue source lined up. As you can see, Foregen would comfortably occupy the tissue preparation phase. We already have our adult tissue source lined up, our incubators, initial researchers, and surgeons. In terms of publicity and marketing, circumcised men have been wondering literally for millennia while their penises look and function differently than most men’s in the world. As a result, we've been covered by these major news organizations this year alone, just when they got wind of our proof of principle research on animals.

We're also working on a feature-length documentary with Hollywood A-list after Alan Cumming as a protagonist, along with myself and prominent physicians, ethicists, and human rights attorneys. And it's called Pigs Without Blankets. We thought it was kind of funny. We don't have to be deadly serious about everything.

In terms of our scientific team, it's led by Dr. Elena Bondioli, who has over 10 years in decellularizing and regenerating tissues in a clinical setting, with dozens of publications and numerous patents. As well as her lead biotechnologist joining us here today, Dr. Valeria Purpura, who has her PHD in the modulation of cell growth factors and as well a wealth of clinical experience.

In terms of our management team, Foregen was started as an idea five years ago by former Vatican mosaic artist, Vincenzo Aiello. He's assisted by his, VP Carlo Cirioni, myself, the spokesman, Eric Clopper, our head of visual assets and head of IT, Peter Benson and Benjamin Morrison, respectively, joined the board, and Eric Cunningham, who's joining us here today, who helps direct social media with seven other social media moguls. On our scientific advisory board and we have two consulting plastic surgeons, a pathologist who specializes in the harm of genital cutting and a senior research technologist.

We're very receptive to the idea of bringing on an experienced life science CEO to decrease the time needed and increase the likelihood of a successful exit.

Now for the last slide, I promise, we have a five year, five phase plan to bring this technology to market. The first phase is to raise $1 million using the new provision of the Jobs Act to develop and validate a method to decellularize a foreskin and ensure that it can hold cells ex-vivo regeneration. And this is going to be done through an equity-based crowdfunding.

The next round is to conduct a preclinical animal trial and make sure there are no adverse effects from our therapy as well as make sure that the scaffolds are properly re-seeded in an animal model, and then continue on to a prospective clinical trial. The final stage would be to build a large-scale processing plant to decellularize these foreskins, make these molds, as well as secure our adult tissue sources, get FDA approval, and secure intellectual property on all of our processes.

By 2021, we expect a revenue positive and expanding company ready to IPO.

And I know I've got about a minute left, so I really want to communicate that Foregen is more than just a regenerative medicine company focused on a body part that has been grossly misunderstood for millennia. We represent an evolution in our species' consciousness, moving away from the cutting of our children's genitalia while simultaneously ushering in a new era of health care, one dominated by regenerative medicine by introducing an application to the mainstream that makes sex better.

To do this, though, we have to, as Bernie said last night, re-define the status quo, not do what is popular, but rather do what is intelligent. Now, if you believe in this project morally, scientifically, or economically, I encourage you to join us in our equity-based crowdfunding campaign in 2016 to make genital integrity a reality for either yourself, a loved one, or the hundreds of millions of men in the world who have lost it, as well as make a sizable return on your early investment in this revolutionary company.

Thank you so much for your time. I really do appreciate your attention with such a touchy topic. Myself, Vincenzo, Dr. Purpura, and Eric Cunningham will be around for the rest of the World Stem Cell Summit to answer any questions. I promise you we're very nice people, and on stage for a few minutes to answer some questions. Thank you.

[rousing applause]

Scott Livingston:

So I have lots of questions on that one. Let's see … What's the strategy for the crowdfunding? What are people going to get for their million bucks?

Eric Clopper:

So in terms of crowdfunding, the new law in the Provision Act allows you to invest in stock, but you don't have to be an accredited investor. And what that does is it democratizes investment in early companies, which I think for this unique issue that intimately affects 200 million Americans is particularly symbolic.

Scott:

Right? But what is someone going to get? So a million bucks gets you, I mean, maybe it's a question that you don't even know yet or what have you, but you know, 10% of the company? 5%? Have you figured out kind of what the valuation ...

Eric:

In terms of valuation, we're working with some attorneys now to incorporate, so we're not, I don't want to say something and then have to retrace my steps.

Scott:

The main question is have you figured it out yet?

Eric:

We're working on the valuation now. As you know, it's difficult to value a company without IP and both the entrepreneur and investor has to agree. And since this is a new method of raising money, it's yet to be fully defined.

Scott:

Yeah. Okay. And then do you have intellectual property yet?

Eric:

We’ve done some initial proof of principle research just to make sure that decellularization techniques on animal tissue, animal foreskin works, and it's worked well, but it wasn't novel enough to get IP, so we have not yet secured IP.