RepliCel Life Sciences, Inc. – On Verge of Biotech Breakthrough (OTCQB: REPCF) (TSX.V: RP)

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Summary of Our Research Findings

  • We begin coverage of RepliCel Life Sciences, Inc. with an investment opportunities score of “Significant”, based on our belief the Company has unique therapies targeting significantly sized and growing markets, especially relating to pattern baldness, tendinosis, and skin rejuvenation.
  • While primarily a biotech play, the Company also has a unique, patented dermatological injection device that we think holds great promise to not only deliver the Company’s therapies, but also dermatological fillers produced by other companies.
  • RepliCel completed a substantial financial restructuring in late 2016, which included a healthy financial injection of capital. We believe this restructuring now positions the Company to accelerate and further clinical studies.
  • We also believe some compelling statistically significant data was produced via the Company’s aging and UV skin Stage I trial. We are eagerly awaiting additional data or advancement of the clinical trial process for this innovative therapy, which seems to have produced collagen biomarkers.
  • The Company is led by an experienced team that not only has medical and clinical experience, but also an entrepreneurial bent, which we believe could prove vital in moving these therapies from the drawing board to the marketplace.
  • We expect the remaining portion of 2017 to be news driven and encourage risk-averse small-cap investors to consider beginning to track this developing biotechnology play.

RepliCel Life Sciences, Inc. – Summary

RepliCel Life Sciences Inc. (“RepliCel”) is a pre-revenue biotech company with a unique direction. The company’s management and scientific team are well versed in various cell therapies, most particularly specific cells that are present within human hair follicles. The Company then utilizes these cells in order to produce its unique therapies. It appears that RepliCel is the only company using cells derived from human hair follicles in order to develop such products. This unique cell harvesting procedure is outlined in Exhibit One.

We believe 2017 could be a big year for RepliCel. In October, the Company completed a financial restructuring that included a $4.2 million financing. This financing will likely allow the Company to significantly accelerate clinical trials for pattern baldness, skin care and tendinosis. We are excited about both of these therapies as both are novel and address significantly sized markets. In particular, the early stage clinical results relative to pattern baldness not only showed no adverse effects, but also lead to non-statistically significant indications of efficacy. There have been few advances in the treatment of baldness in many years, and further clinical studies in the area, such as those being conducted by RepliCel, should attract considerable interest within both the medical and investor communities.

We think there was also encouraging data from the early clinical study for tendinosis. While the market for this condition receives less attention compared to pattern baldness, there is nevertheless considerable growth from this area as populations in the United States and other industrialized countries continue to age.

While the company is primarily known as a biotechnology play, we also point out the Company has a very interesting medical device, which is close to prototype status. As Botox, dermal fillers and other injectables increase in popularity, more and more physicians are attempting to cash in on the bonanza. Many of these physicians lack the experience of the highly-trained board-certified plastic surgeons and dermatologists who had been the primary administrators of these aesthetic therapies. The Company’s dermal injector will allow not only the experienced physician, but also the less-experienced injection specialists, to administer dermatological injectables in a more precise and controlled manner, which will likely lead to better aesthetic results and improved patient comfort. The Company was recently awarded a patent on this device, which we believe could prove valuable in the future. We will be watching closely as RepliCel reactivates its thermal injector product program and begins to produce working prototypes for physician trials and government certification.

We also believe the Company is run by a sound team that has not only extensive medical and biotechnology experience, but also an entrepreneurial bent that we believe is a necessity to bring a company from development to production stage.

We view this Company as an exciting one for small risk-averse investors. There is a story developing here and we can see a scenario developing where RepliCel develops a strong following among interested investors.

We expect considerable amounts of news for the remainder of 2017 and into 2018 relative to therapy development and clinical trials. Considering that the clinical trials are in some exciting areas, we believe investors will increasingly be attracted to the shares as the story develops.

Exhibit One – RepliCel Use Cells Derived From Human Hair Follicles

Source: RepliCel Life Sciences Inc.

The Details

RepliCel, which trades on the over-the-counter in the United States Venture Marketplace under the symbol OTCQB: REPCF and in Canada with the symbol TSX.V: RP, is a pre-revenue biotechnology company concentrating on regenerative medicine.

For the past few hundred years, there have been significant developments in prolonging life and treating diseases and conditions that threaten human health. However, many of these advancements relate specifically to only managing the symptoms of the underlying injuries, diseases, or conditions. Simply put, modern medicine is very effective at treating us, but not necessarily in curing us. Many of the root causes of diseases and conditions are never addressed by modern medicine.

The field of regenerative medicine seeks to change this dynamic offering physicians for the first time new tools to not only manage the patient’s symptoms, but also to treat, and many cases, actually heal the underlying issue causing the illness or condition.

The field of regenerative medicine is concentrating in 3 main areas:

Cell or System Replacement – System replacement is the area which most ordinary investors have some familiarity. Heart, kidney, or liver transplants are examples. The diseased or damaged organ is removed and replaced with a healthy organ from either a living or deceased donor.

Rejuvenation – Most people are less familiar with rejuvenation, which is the area of regenerative medicine that involves boosting the human body’s own defensive or rejuvenation mechanisms. While the largest organ on the human body, the skin, is excellent at rejuvenating itself after a cut or burn, most other organs in the human body are far less capable. An entire field of study is advancing very rapidly toward finding such therapies and treatments.

Regeneration – In our opinion, the most exciting area of biotechnology and medicine is specific to the regeneration of diseased tissues or organisms via the process of delivering specific types of cells, or cell products, directly into, or on to, the target. The first bone marrow transplants are an excellent example of regeneration. Currently, many other regenerative therapies are now coming online offering the potential to significantly alleviate human suffering, retard aging (or the appearance of aging), and even to save human life.

Sizing the Market Opportunity

The field of regenerative medicine is growing rapidly and represents one of the most exciting investment opportunities in not only the biotech sector, but across all sectors of the economy. According to Transparency Market Research, the market value of regenerative medicine, which they define as stem cell therapy, tissue engineering, and biomaterials, is expected to reach $6.5 billion within the United States alone by 2019. As is outlined in Exhibit Three, Allied Market Research Group, which defines the market much more broadly, is forecasting the worldwide market to grow to nearly $67 billion by 2020. This forecast implies a 23% compounded annual growth rate.

Exhibit Two – A Huge and Growing Market

 

 
Source: Transparency Market Research

Whichever set of analyst statistics and forecasts are used, it really makes no difference, in our opinion. What is important is that regenerative medicine is likely one of the fastest growth sectors within the worldwide economy.

The growth being seen in this market and the estimates of future market size, are not being lost on companies in the biotech sector. As is outlined in Exhibit Two, above, and in Exhibit Three, below, investments in regenerative medicine companies more than doubled on an annual basis between 2013 and 2014. Analysts are estimating that the investments in the sector during 2015 and 2016 accelerated from these levels.

These investments have been put to good use by the biotech sector, yielding strong growth in clinical trials. As is further outlined in Exhibit Two above, the number of clinical trials has grown steadily, with additional acceleration seen during 2015 and 2016. Today, there are more than 700 companies involved in the sector and it is expected that more than 100 formal applications will be filed during 2017 for regenerative medicine clinical trials.

Exhibit Three – Worldwide Market Growth Ten Times Global GDP

Source: Allied Market Research Group

The RepliCel Approach

RepliCel is focusing on three very potentially lucrative areas within the field of regenerative medicine – Skin rejuvenation, tendon regeneration, and hair re-growth.

While most have known the Company is seeking biotech-oriented approaches within the field of regenerative medicine, the Company also has an interesting medical device, which it is introducing to the marketplace. The new device, which is a dermal injector, holds the promise to not only deliver the therapies developed by the company, but could also be sold into the widely expanding cosmetic-oriented injectable marketplaces.

Below we take a quick look at the four major market initiatives for the company.

Hair Re-Growth

The fact of the matter is that current hair re-growth treatments are relatively ineffective. Minoxidil (Rogaine®), is a topical treatment that dilates the small blood vessels of the scalp to promote hair re-growth. While there is evidence that Minoxidil is moderately effective, it is far from a cure as treatment time is long and there are some side effects. Finasteride (Propecia®) is an oral medication approved for use for men only. Again, it is far from an optimal solution, as treatment time is lengthy and side effects significant.

With an aging population within most industrialized countries, the overall market size for hair loss and restoration products is expected to grow significantly over the coming years. As is outlined in Exhibit Four, the North American hair loss and rejuvenation related markets are valued at more than $2.5 billion annually as of year-end 2016 with significant growth forecasted.

While most think the target market of the hair loss market is men, further research reveals this is not the actual case. While it is estimated that more than 35 million men within the United States are excellent candidates for hair loss treatments and therapies, there are also nearly 25 million women who are candidates. Many who analyze this sector of the medical industry believe that there will be more revenue growth to be gained in the female part of the market than in the male part of the market.

RepliCel is developing a hair loss therapy utilizing cells taken directly from healthy hair follicles at the back of the scalp. After a population of a specific type of cells (dermal sheath cup or DSC cells) are removed, the cells are replicated and re-introduced into the balding areas of the subject’s scalp. Therapy is now under clinical investigation in Japan under the supervision of one of its partners, Shiseido, the fourth largest cosmetics company in the world.

In mid-March of 2017, the Company announced the successful completion of its first human clinical study of this therapy with the trial successfully meeting its end points. Management indicates that one of the main objectives of the study was to confirm the safety profile of a high dose of the therapy into patients. There were no serious adverse effects reported over the more than 60-month follow-up period of the trial.

 Exhibit Four – Hair Loss Market Continues to Boom with More Growth to Come

Source: Standish Analysis, LLC

While it is clearly important that the trial produced no adverse effects, in our opinion, it is even more significant that there were indications of potential efficacy. While there was, by the Company’s own admission, no statistical significance for any data relating to efficacy, management believes there was circumstantial evidence from the data collected from the 19 patients in the study with several trial participants seeing increased hair density at 6 months post injection, with one participant observed at a 20% increase by 24 months.

While officially the study merely establishes a sound safety profile for the therapy, it clearly provides information to defend additional clinical studies that could further evidence of efficacy. We believe this in itself is very exciting for the Company’s stakeholders and its investors.

Tendon Regeneration

RepliCel’s treatment for tendinosis is called RCT-01. Work on the therapy dates back to 2008 when one of the Company’s collaborators was conducting research on tendinosis. Dr. David Connell theorized that one of the underlying causes of tendinosis is a deficit of a certain type of cell in the tendon. These cells, called tenocytes, produce a specific type of collagen and it is the lack of this collagen that is the cause of tendinosis. He further theorized that the augmentation of these tenocytes into the tendon could be an effective treatment for the condition.

Three Phase I clinical studies have been conducted based on Dr. Connell’s research with each providing evidence that his initial theory was on target. The Company began collaborating with Dr. Connell in 2011 to further develop the therapy.

RepliCel reported recently some compelling clinical data from its early clinical study on tendon repair using RCT-01. Just as in the hair growth initial study, the RCT-01 therapy study showed a strong safety profile with no serious adverse events reported. More importantly, however, each of the participants, all of whom suffered chronic tendon pain, showed important improvements.

There are hundreds of thousands of individuals within the United States alone who suffer from chronic tendon-related conditions, especially Achilles tendinosis, which is a growing problem as Americans continue to age and gain weight. This therapy clearly, while needing additional clinical study, offers one of the few hopes for long-term recovery to members of this growing community.

Skin Rejuvenation

Relative to cosmetic treatments in the United States, cutting is out! Injectables are in!

A similar trend is also being seen in major Asian countries and within the European Union market.

With changing lifestyles, an aging population, rising disposable incomes in many countries, and an ever-increasing focus on physical appearance, the market for facial injectables is booming. Transparency Market Research (TMR) estimates in their April of 2019 report, that the market for facial injectables in North America was valued at approximately $2.6 billion. Remarkably, the market is expected to exceed $6 billion by the end of 2024, constituting a compound annual growth rate in excess of 12%.

There have been significant advances in injectables over the past few years with these products providing results that are more realistic in look and longer in effectiveness.

As is outlined in Exhibit 5, North America leads in total dollars forecasted, with Europe, Asia, and the rest of world following.

Exhibit Five – Continued North American Market Strength

Source: CGI Group, LLC, New York

RepliCel’s therapy for skin rejuvenation has been named RCS-01, and an initial Phase I clinical trial in Germany was conducted in August of 2015. The purpose of the study was to treat patients suffering from aged and UV damaged skin with the patients being both male and female and 50 to 65 years old.

The Company recently announced an interim analysis of the study. While the primary objective of the study was to establish the safety profile of the therapy, RepliCel received very surprising news reporting statistically and clinically significant positive data resulted from the interim analysis of the German Phase I clinical.

Specifically, there was a twofold increase in collagen related biomarkers after only a single injection of the therapy. The results were so dramatic that even after a single injection, a statistically significant result was validated. We also believe it is interesting to point out that the lead scientist conducting the study indicated that the type of positive gene expression that was realized is rarely observed. We believe this could be important and future announcements could be exciting.

The above developments are relatively new (early April 2017) and it will likely be some time before the Company is able to more fully analyze the data received. We suspect the results are significant enough to convince everyone involved to move toward a full-scale larger trial.

This therapy is certainly one worth watching as it moves into further clinical trials. The market for dermal fillers and Botox has boomed over the past 10 years. These therapies, however, are far less than perfect with many potential adverse side effects. In particular, Botox, produces far more injury to patients than most people realize. There is clearly a market for alternatives.

Dermal Injector Product

We are very excited about the Company’s dermal injector device.

Here’s why:

When Botox hit the market years ago, it was mainly board-certified plastic surgeons and specially trained dermatologists who injected patients with the wrinkle reducer. As more and more physicians realized that the business of Botox injections was a profitable one, a host of different types of physicians joined the fray. Today, there are many physicians who have only limited plastic surgery and dermatological experience who are now injecting Botox into patients. Additionally, these less experienced physicians are also attempting to augment their businesses by injecting dermatological fillers that reduce wrinkles, lines, and sagging skin. While these physicians have received some limited training, it is generally accepted that their results are inferior compared to those achieved by the more experienced specialized dermatologists and board-certified plastic surgeons.

The limited amount of training the average physician receives before injecting patients with Botox and fillers prepares him or her only to a relatively modest degree. There are many ins and outs to injectables and Botox that are learned only through extensive experience. Simply put, many of the physicians who are injecting patients with Botox and fillers need a lot more training. That’s why we are so excited about the Company’s dermal injector device.

The new device, which is depicted in Exhibit Seven, provides both the highly experienced and the novice physician with improved levels of control and precision for injectables and Botox.

Exhibit Seven – RepliCel’s Dermal Injector – Could it Eclipse the Other Products?

Source: RepliCel Life Sciences, Inc.

The device removes much of the guesswork around specific depths for any particular injectable and also allows for better tracking of specific volumes of materials to be injected. While it appears this device was mainly designed to support the company’s specific therapies, we believe there are much broader applications.

Here’s an example:

A highly experienced plastic surgeon or dermatologist will have little problem with shallow injections for very small and fine wrinkles. Most of them have done this hundreds of times during their career and they do it with precision and a certain degree of artistry that produces a pleasing aesthetic result. The average internist, or other non-dermatology related physician, may have attempted the procedure only a few times. For such a physician, a delicate injection like this can be problematic. The Company’s injector device could be highly useful as it will provide specific depth and volume controls in order to target these fine wrinkles with very shallow injections. Simply put, it can make an average doctor a better doctor.

We think there is also a strong possibility use of the device could provide a better patient experience in that the device will offer better control of injection depth, which could result in less pain and bruising and an overall improved consistency of results.

The Company has recently been awarded a patent on the injection technology. Intellectual property protection relates to the technologies designed to enable control and repeatable consistency of needle action and product deposition.

We think this device has broad applications across a host of dermatological procedures and we believe it will make the average physician a better injector of cosmetic therapies.

Management team

RepliCel’s management team is loaded with highly experienced industry professionals. Not only is the team seasoned in the field of medicine, there are also several with strong entrepreneurial backgrounds and extensive business management experience.

The team includes:

Lee Buckler, B. Ed, LLB

President, CEO & Director

Mr. Buckler has been an executive in the cell therapy sector since 2000 beginning with Malachite Management in the Stem Cell Technologies group of companies.  Most recently he was the Managing Director of Cell Therapy Group, a firm he formed in 2008 where he did business development consulting for companies and organizations in or interested in the cell therapy sector.  His work included deal-targeting, transactions, market intelligence, competitive analyses, strategic assessments, and market profile planning for companies ranging from top-tier multinationals to start-ups. Mr. Buckler has a Bachelor’s Degree in Education and a Law Degree.  After law school, he did a one year judicial clerkship with the B.C. Supreme Court and was a practicing attorney for three years at Edwards, Kenny & Bray.  Mr. Buckler served six years as the Executive Director of the International Society for Cellular Therapy and just over two years as Director of Business Development for Progenitor Cell Therapy.  He is on the editorial advisory boards of the journal Regenerative Medicine and BioProcess International magazine as well as the Alliance for Regenerative Medicine’s Communications and Education Committee. He co-founded Cell Therapy News, founded Cell Therapy Blog, founded and continues to manage the LinkedIn Cell Therapy Industry Group, co-founded Regenerative Medicine Jobs, and is an active industry commentator in publications and on social media.  Mr. Buckler serves on numerous industry conference advisory boards and is an advisory board member for MedCision, Phacilitate Cell & Gene Therapy and RoosterBio.

Dr. Rolf Hoffmann, MD
Chief Medical Officer 

Dr. Hoffmann is a European-based clinical researcher who has spent decades researching the fields of pattern hair loss, alopecia areata, endocrinology of the hair follicle and hair follicle morphogenesis. Together with Dr. McElwee, he is the applicant of a landmark patent on the use of hair follicle cup cells and their use in hair diseases. He is working clinically in his private practice, as a teaching professor in the Department of Dermatology for Marburg University, as well as a researcher on histopathology on hair diseases, where he has published chapters in text books. Dr. Hoffmann has participated in dozens of clinical hair studies and consulted for a variety of large companies on hair matters. He is the inventor of TrichoScan®, a computerized technique to measure hair growth. Since then, he has run a successful privately owned company to market the device for dermatologists and to offer it as a service for clinical trials.

Dr. Kevin McElwee, PhD
Chief Scientific Officer

Dr. McElwee, co-discoverer of the Company’s technology, is an Associate Professor in the Department of Dermatology and Skin Health at the University of British Columbia, and Director of the Hair Research Laboratory in the Vancouver Coastal Health Research Institute at Vancouver General Hospital (VGH). His research is funded by competitive grants awarded by multiple organizations including the Canadian Institutes for Health Research (the equivalent of the National Institutes for Health in the USA). Dr. McElwee is one of only a small group of research scientists worldwide who studies hair biology and associated diseases. He has worked as a hair research scientist for 12 years and has published over 70 medical journal articles, research abstracts and academic book chapters on hair loss research. Dr. McElwee received his Bachelor of Science degree from the University of Aberdeen, Scotland and his PhD from the University of Dundee, Scotland. Postdoctoral training included three years at the Jackson Laboratory in Maine and four years at the University of Marburg, Germany, studying various hair loss diseases.

Tom Kordyback, CA
Chief Financial Officer

Tom Kordyback is a Chartered Accountant and a member of the British Columbia Institute of Chartered Accountants with over 25 years of experience in corporate finance and management for emerging growth companies.  From 1984 to 1994, he held senior financial positions with Glenayre Electronics Inc. and Telelink Communications Inc. and worked as a consultant to other Vancouver area companies. In 1995, he began working for Creo, now part of Eastman Kodak Company as their Chief Financial Officer.  In this role he oversaw private financings totaling over $80 million, and in 1999 he led the company’s Initial Public Offering on NASDAQ.  He remained at Creo until 2000; at which time, the company had over 4000 employees worldwide. In 2004, Mr. Kordyback joined Extreme CCTV Inc., a developer and manufacturer of state-of-the-art surveillance systems listed on the TSX.  He worked for them for three years as a director and member of its Audit, Compensation and Merger and Acquisitions Committees. In 2008 the company was sold to Bosch Security Systems, Inc. for CDN $93 million. Mr. Kordyback currently serves as a director of Silver Sun Resources Corp., a public Canadian-based resource company.

Darrell Panich, MSc, PMP, CPM
Clinical Consultant

An experienced clinical trial management specialist, Mr. Panich has managed multinational clinical research studies in more than 15 different countries for over 20 different pharmaceutical and biotechnology companies. He obtained his Master of Science degree from the University of Alberta while conducting clinical research in neuroscience. Mr. Panich has obtained certifications in project management from the Project Management Institute (Project Management Professional; PMP) and Project Management Leadership Group (Certified Project Manager; CPM).

Financials

RepliCel reports as a Canadian company and files financials with the U.S. Securities & Exchange Commission on form 20-F. The most recent filing of financials provides year-end 2016 results. Considering this is a pre-revenue biotech company, there is not a significant amount of analysis possible on the financial statements. The Company has a relatively small amount of cash, but does have approximately $1.8 million in current assets. Liabilities are modest at $622,000.

As of May 1, 2017 there were 18,626,703 shares outstanding.  Cash used in operations during full year 2016 was approximately $3.5 million, which was down from $4.4 million for full year 2015.

During October of 2016, the Company completed a major financial restructuring, which included a $4.2 million financing. With this capital investment, the Company plans to further clinical studies for it tendon injury and pattern baldness therapies.

Additionally, with the financing completed, the Company plans to reactivate and prioritize the dermal injector product program with the aim of manufacturing prototypes. RepliCel also plans to initiate a program to receive the European Union CE certification.

Certainly, this is a speculative story worth monitoring moving forward and we without a doubt will be watching for positive news over the coming weeks and months.

Disclosures

We do not own these shares and have no plans to acquire, purchase, sell, trade or transfer these shares in any manner.

We have no association with anyone, or any group, with any plan to acquire, purchase, sell, trade or transfer these shares.

Any opinions we may offer about the Company are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice. Such information and the opinions expressed are subject to change without notice. Separate from the factual content of our articles about the Company, we may from time to time include our own opinions about the Company, its business, markets and opportunities.

The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. We did not make an independent investigation or inquiry as to the accuracy of any information published by the Company, or other firms. The author relied solely upon information published by the Company through its filings, press releases, presentations, and through its own internal due diligence for accuracy and completeness. Statements herein may contain forward-looking statements and are subject to significant risks and uncertainties affecting results.

This report or article is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed. This publication does not take into account the investment objectives, financial situation, or particular needs of any particular person. This publication does not provide all information material to an investor’s decision about whether or not to make any investment. Any discussion of risks in this presentation is not a disclosure of all risks or a complete discussion of the risks mentioned. We are not registered as a securities broker-dealer or an investment adviser with FINRA, the U.S. Securities and Exchange Commission or with any state securities regulatory authority.

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