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RepliCel Life Sciences Inc. (TSXV: RP) President and CEO David Hall explains the process by which his company is working on treatments for chronic tendinosis, sun-damaged skin, and male pattern baldness with the safe use of a patient’s own cells. He also describes how RepliCel is creating value for its shareholders by advancing its products through clinical trials as well as with a licensing agreement with the world’s third-largest cosmetic company.
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Video transcription
Narrator: The SmallCapPower CEO interview.
Interviewer: Can you tell our viewers a little about your company?
David Hall: I’m most pleased to do so. RepliCel is a life science company in the regenerative medicine business, listed on the Toronto Venture Exchange with the symbol RP. And we’re in the business of developing autologous cell therapies for the treatment of active cellular deficits in various conditions, such as chronic tendinosis or sun-damaged skin, which is all the result of either injury, aging or genetic predisposition.
Interviewer: What are the various products the company is developing?
David Hall: The lead product candidate is for the treatment of chronic tendinosis, which is a significant unmet medical need and the sort of the stage of injury that is past a tendinosis stage where a patient doesn’t resolve through traditional physiotherapy means. In this case, we are isolating the fibroblast from the hair follicle and directly replicating them and directly putting them under imaging, ultrasonic imaging, into the area of injury to jump start the healing process. And in Phase 1 clinical trials, we were very successful. The fibroblast is a complete platform, so we are moving into a secondary indication in the fibroblast therapy, which relates to sun-damaged and aging skin. And then a third platform or third indication is RCH-01, which is the treatment of pattern baldness.
And then the company has an underlying innovative manufacturing technology that supports the production and the replication of those cells. And finally, each of those indications needs a specific delivery device. In the case of our dermal delivery device, we’ve created something that can be used in other dermal products, which includes a pelchae element which freezes the skin and obviates the need for any lidocaine or anesthetic injection.
Interviewer: Biotech companies create value by continuously advancing products through phases of clinical trials. Can you walk our viewers through those process?
David Hall: Our lead product is RCT-01, which is the fibroblast-based product for treating chronic tendinosis, which will be in clinical trials this year. And that’s followed on the same fibroblast platform by RCS-01, which is our derm-related and damaged skin-related program which will start a Phase 1 trial this year and with data in 2015. And then that is followed by RCH-01, which is our treatment for pattern baldness, going into a Phase 2 in Europe with data owed in 2016. And supporting that is the novel injector device being used for the derm and as well as for the scalp.
Interviewer: What is the market size for your various treatments?
David Hall: Each of these indications are billion dollar-plus indications. For example, take chronic tendinosis. Fifteen percent of military recruits don’t get through boot camp because of patellar tendinosis, which is jumper’s knee. Four to seven people in 1000 people suffer from lateral epicondylitis, which is otherwise known as tennis elbow. There are significant long-term disability and even short-term disability issues for working with compensation boards, etc., trying to get people back to work who have chronic tendinosis.
And of course, the derm market is a multibillion dollar market. Just look at the success of BOTOX and dermal fillers, hyaluronic acid dermal fillers. And of course, pattern baldness that we all know if you, long term, were able to resolve that issue which is really just addressing a cellular deficit that is a massive market.
Interviewer: Are you planning to partner with anyone or license your technology?
David Hall: We’ve already began licensing our technology. We’ve licensed our CH-01 treatment for pattern baldness to Shiseido Corporation in Japan for geographic license, only to that technology for China, Japan and the ASEAN countries. Shiseido will begin, in parallel, doing their own clinical trial in addition to our own clinical trial in the west. The programs on the fibroblast side, we will start to initiate discussions and either do geographic licenses or worldwide licenses for these technologies.
Interviewer: What are the key risks and challenges facing the company?
David Hall: There’s always funding risk, although I’m comfortable that in this particular funding cycle that our clinical programs and our fundraising needs are aligned with the current marketplace that has quite attracted to biotech at this point in time. And similarly, I guess the other side is execution risk, and we’re quite comfortable in the execution risk of our programs. One of the things that needs to be mentioned is that we have an inherent safety benefit in the sense that this is a patient’s own cells, and those cells do not have the adverse events or the adverse reactions that you might otherwise have with a new chemical entity, like a drug or something like that. So it is an inherently safer treatment than normal drugs or biologics.
Interviewer: What are the major investment catalysts for the company in the next 12 months?
David Hall: Those are pretty clear, the start of clinical trials and clinical evidence being delivered next year and of course, potential licensing.
Interviewer: Thank you for taking the time for the interview, David.
David Hall: You’re most welcome. Thank you.
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