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Nov 06, 2012 ![](\"/Blog/2014/Seeking-Alpha-title.jpg\")
- RepliCel is a rare blend of upside potential and risk mitigation.
- The company has a multiple-product approach.
- Near-term catalysts should make the stock pop.
While it is rare to find companies that offer a truly disproportionate positive risk-return profile, RepliCel Life Sciences (OTCQB:REPCF, RP.V) is positioned to have significant upside that is well-justified by the associated risks. The opportunity exists largely because the company is small and essentially unknown – its small size and low daily trading volume represent the most serious risk factors for investors to consider. As the company stands on the cusp of several catalytic events, however, RepliCel is positioned for a meaningful move that will benefit investors.
Who is RepliCel?
RepliCel is in the business of “treating cellular deficiencies” through its proprietary cell reproduction technology, specifically cases of tendonitis, pattern baldness and skin damage. Beyond the technology the company has developed to rapidly reproduce cells for its various treatment protocols, it has developed a delivery injector with addition potential applications. I recently had the opportunity to participate in a meeting directly with company president and CEO David Hall, who emphasized the importance of the diversified product portfolio that his company offers. Because RepliCel is diversified across the fibroblast (collagen-producing), dermal sheath cup (hair producing) and injector lines of business, Hall sees investor risk to be reduced as different lines move ahead.
![](\"/Blog/2014/4311741-14114038831831753-Douglas-Ehrman.png\")
Source: RepliCel Corporate Presentation August 2013
The general basis of RepliCel’s products is that the company harvest specific cells from the patient, and then uses its proprietary technology to replicate them in sufficient numbers to address the specific deficit. In the case of the tendonitis treatments, this involves creating new collagen cells that allow the damaged area to see improved function and reduced pain by altering the tendon’s basic construction. In the case of baldness treatment, healthy dermal sheath cells allow hair to grow in the needed areas. In both cases, the company’s injector is used to properly introduce the cells into the affected region. RepliCel’s method allows it to produce these cells much faster than competitors.
In early clinical testing, patient safety has been a top concern. In all Phase 1 trials thus far conducted, results were achieved within the required safety parameters. RepliCel is not involved in tradition stem cell therapies, making it less clinically and commercially risky. Part of what makes RepliCel unique, and particularly attractive from an investment standpoint, is that because the company is not using adult stem cells in its protocols, the regulatory burden falls on the low-end of the spectrum. The primary thrust of RepliCel’s treatments are in cosmetic and non-critical areas. While these do not tend to be of huge medical significance – although they can be – the revenue generating potential is there. This is one of the hallmarks of its current mandate to prove up its products to attract a buyer.
The fibroblast protocols have had statistically significant early results in treating various types of tendonitis (See below). In the Phase 1 trial, cell growth increases while pain decreased. Similar tests and Phase 2 testing are moving ahead for tendonitis in the elbow as well. This same technology is moving to Phase 1 trials for treating skin damaged by aging, UV exposure and lifestyle factors. Ultimately, each of these conditions alone represent a significant advance against currently available options, and are in sizeable markets.
![](\"/Blog/2014/4311741-14114039028626666-Douglas-Ehrman_origin.png\")
Source: RepliCel Corporate Presentation August 2013
Improved Baldness Treatment
In terms of the company’s baldness treatment, Phase 1 showed positive results in less time than the currently available options. While micro-transplant surgery is the current gold standard – it is expensive and highly dependent on the surgeon – Rogaine and Propecia are the most commonly used options currently. Rogaine has shown 8%-16% density increases over 12 months with topical treatment, and Propecia has shown 7%-14% increases over 12 months with an oral regimen. The Phase 1 RepliCel treatment showed an average 11.3% density gain, with 70% achieving over a 10% gain, with the over 10% group averaging 14.3%. The most significant difference with the RepliCel protocol is the end point. Where Rogaine and Propecia require continued use to maintain gains, after the RepliCel injections, gains remain in place. This is a significant point of differentiation.
Catalysts
A highlight for RepliCel from the investment prospective is that the management team is keenly focused on building shareholder value. Hall is targeting and projecting a takeout scenario within 24 months, with major catalysts building value on that path. The biggest driving factor there is new results from the ongoing clinical trials. As each sets a small step-up for the company in terms of the development of a fully saleable product, share price should be significantly impacted.
Along this path, RepliCel already has a key partnership in place with Shiseido, the fourth-largest cosmetics company in the world. The agreement, inked in 2013, provided RepliCel with $35 million, with $4 million upfront and additional fundings at key sales targets. Beyond the capital, Shiseido has built a new cell processing facility that opened in May 2014. The company represents a key strategic partner in terms of both financial strength and reputation. Additionally, this allegiance will allow RepliCel to move quickly in the region as trials for U.S. sales continue. RepliCel continues to seek new partners for other products, each of which, when identified, can serve as a catalyst.
In the near term, there are three different clinical trials beginning in 2014 that should yield the type of data results needed to see the stock move dramatically higher. For example, the planned Phase 2 study on pattern baldness will use a larger test group to establish the lasting efficacy of the treatment, confirming both the safety and effective end date relative to other options. As each of these steps move ahead, RepliCel is well-positioned to move. Hall reports that the company has plenty of cash to complete the clinical trials that are currently planned. He believes that the positive results expected from these will be sufficient to generate the buying interest needed, placing a takeout target within the next 24 months.
The Stock
A definite risk factor of the stock is the very low average trading volume (ADV) of shares. Between shares listed in the U.S. and on the Canadian Venture Exchange, the stock trades less than 100,000 shares per day. This means that the liquidity of any position must be a consideration for any investor making a larger play in the stock. On the other side of things, however, shares are near the bottom of the 52-week trading range. This means that a retracement of even 50% back to that high would represent a dramatic return.
![](\"/Blog/2014/4311741-1411403930670178-Douglas-Ehrman.png\")
Given the price of shares relative to the potential upside, I believe RepliCel offer an attractive risk-adjusted opportunity to shareholders. There are several catalysts tied to near-term expected milestones that should make the stock move higher. If management can achieve its ultimate goal of a takeout opportunity, shareholders will be well-rewarded. The liquidity risk is real, but the potential here justifies taking some risk.
Editor’s Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
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VANCOUVER, BC – September 9, 2014 – RepliCel Life Sciences Inc.’s (TSXV: RP) (OTCQB: REPCF) CEO, David Hall, kicked-off his New York roadshow with a live appearance on Fox Business network’s Varney & Co. following his presentation at Rodman & Renshaw’s Annual Global Investment Conference. The two discussed the company’s revolutionary products using an individual’s own cells to treat sports and work related tendon injuries, sun damaged and aging skin and pattern baldness. The interview can be viewed online at http://www.foxbusiness.com/on-air/varney-co/index.html#/v/3775771951001.
In addition to the U.S. coverage, Canada’s Financial Post featured a full page editorial on RepliCel in today’s biotechnology section (see page FP12). The article titled, “Cutting-edge advancements – new technology puts your own cells to work to repair and rejuvenate your body” can be viewed online at http://business.financialpost.com/2014/09/09/new-technology-puts-your-own-cells-to-work-to-repair-and-rejuvenate-your-body/.
“We are happy to be called upon by the media and the investment community to discuss the advancements being made in regenerative medicine. Cell therapy products like RepliCel’s represent a new way to repair and rejuvenate patients effected by aging and injury. In the months ahead, RepliCel will be fully engaged with three clinical trials targeting chronic tendinosis, sun damaged and aging skin and hair loss in addition to a parallel trial anticipated to launch by its partner, Shiseido. Data from these trials will help pave the way for other RepliCel products targeting diseases and conditions associated with a deficit of healthy functioning cells,” commented David Hall, CEO of RepliCel.
Mr. Hall’s 20 minute presentation from the Rodman & Renshaw conference was webcast, and can be viewed at http://www.wsw.com/webcast/rrshq24/repcf/.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aging skin, and pattern baldness. Shiseido Company, Limited has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The company’s product pipeline is comprised of multiple clinical trials all anticipated to launch in late 2014 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.
CORPORATE CONTACT:
David M. Hall, Chief Executive Officer
Tammey George, Director of Communications
RepliCel Life Sciences
604-248-8696
tg@replicel.com
INVESTOR RELATIONS:
Christina Cameron, Investor Relations
christina@clcameron.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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![](\"/Blog/2014/finalfp.jpg\")
The following has been published in the Financial Post:
There is enormous interest in the worlds of medicine and esthetics in the promise of regenerative medicine. From cellular replacement techniques for treating Parkinson’s disease to collagen-producing cell injections for wound healing and rejuvenating aging skin, significant steps are being made towards the commercialization of cell therapies. These changes are going to attract major industry players who are constantly on the watch for the latest technologies in development.
Vancouver-based RepliCel Life Sciences Inc. (TSX.V: RP) is a company that is already capturing industry attention. Its unique research into cells from hair follicles could play an integral part in accelerating the repair of tendons, damaged skin and pattern baldness.
David Hall, chief executive officer of RepliCel, describes the premise behind its research as being “elegant in its simplicity.” For example, to treat chronically injured tendons, a patient’s collagen-producing cells (fibroblasts) are isolated from a small biopsy taken from the nape of the patient’s neck, replicated and then injected directly into a damaged tendon to stimulate the stalled healing process leading to structural rehabilitation.
“These isolated fibroblast cells are prolific in their ability to produce Type 1 collagen, the key and missing cell in the stalled healing cycle of a tendon. This same principle holds for aged and sun-damaged skin where the collagen-producing fibroblasts have been damaged by ultraviolet light over time. Our focus is to address indications where there is a deficit of active fibroblasts,” Hall explains. “As injuries occur and people age, their ability to produce collagen and other critical proteins is depleted through repeated injury, sun damage, aging and other factors. Our technology, as it’s proposed, will jump-start the healing process.”
One focus for RepliCel is on clinical trials for chronic tendon injuries, an area of major concern for employers, compensation boards, athletes, active aging populations and the military. Early clinical work using cells isolated from the skin returned excellent results, and RepliCel believes that it has improved the technology even further by using healthier cells isolated from hair follicles. Trials planned for the fall of 2014 will return results in 2015.
The power of the RepliCel approach lies in the fact that treatment utilizes a person’s own cells, thereby reducing risk of complications, notes Lee Buckler, managing director for Cell Therapy Group, a Vancouver-based regenerative industry consulting company. “Taking a patient’s own cells, replicating them in a regulated facility and then returning them to the body minimizes safety risks.”
The markets RepliCel is addressing with their products are significant, he adds. “Their platform, built around two different hair follicle cell populations, could be instrumental in skin applications for burns, acne scarring or aging, in addition to the market for musculoskeletal injuries. It could also play a key role in disrupting the micro-transplant and hair rejuvenation business for pattern baldness.”
Regenerative medicine technologies are now solidly on the radar of big pharmaceutical, biotech and health care companies, Buckler says. “Most life science company executives now believe that cell-based products will represent a new way of delivering therapies to patients. As such, they’re now starting to invest in technologies to make sure they have a horse in the race.”
“Most of the top companies like Pfizer, Janssen, GSK, Novartis, Celgene now have internal and/or external cell therapy programs,” Buckler adds. “Other companies are investing in bringing manufacturing technologies to the sector and even companies not traditionally in health care, like Nestlé and L’Oreal, have established their own research institutes for these cell-based programs. If you look at the industry’s development pipeline, most every condition is being pursued as a target for a cell therapy.”
RepliCel’s current pipeline includes trials for tendinosis, pattern baldness and treatments for aging and sun-damaged skin in various stages of development. Hall estimates that data from the tendon and dermal programs will be available to support licensing discussions by 2015, and pattern baldness in 2016.
“Having this many trials is pretty impressive for a small company,” Hall says. “Our model has always been to develop products, demonstrate efficacy and then license to large pharma or cosmetics firms who can do the final commercialization. We want to be the research and development engine that creates revenues from licences and royalties. In fact, Shiseido Company of Japan has already partnered with us on our pattern baldness product. They acquired an exclusive geographic license for Asia.”
Having spent much of his career researching treatments for tendinosis, Dr. Jack Taunton, professor at the University of British Columbia faculty of medicine’s sports medicine division, says regenerative therapy holds great promise when dealing with chronic, long-term injuries. “We’ve dealt with a number of these types of injuries caused by overuse or repetitive strain in thousands of patients. Typically treatments have included physiotherapy, ice, anti-inflammatory’s, dextrose and PRP [platelet-rich plasma] injections. Yet, we still have a significant population of patients that do not get better.” He is hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”
Dr. Ross Davidson, an orthopedic surgeon and director of post-graduate sports medicine at the University of Auckland in New Zealand has treated countless athletes with chronic overuse injuries throughout his career. “I do see a huge potential for this. It has been a pleasant surprise to see the amount of collagen these fibroblasts produce for repairing tendons. It’s a big change from other treatments being released. If it works — and I believe it will — it will reduce the number of surgeries significantly.”
Beyond its clinical trials, the success of RepliCel’s products will be put in the hands of licensing partners which have the infrastructure to support commercialization, says Mark Landy, director of research for senior medical technology and regenerative medicine analyst for Summer Street Research in Boston. The good news is that the industry is not having to wait too long for the clinical trials to get proof of concept. “Having data coming in 2015 and 2016 enables the company to accelerate licensing.”
He believes RepliCel has a significant opportunity ahead given that its regenerative therapy approach addresses extremely large markets that are ready for solutions not provided by today`s treatments. “The industry as a whole has gone beyond the fears around regenerative and genetic engineering and is seeing its value. We now know we can take certain cells from the body and safely put them in certain areas. It’s a notion that goes back to bone marrow transplants and implants. The opportunities — and the markets — for regenerative medicine are very, very large.”
With results from clinical trials on the horizon, Hall is confident things are moving forward as they should. “We’ve been quietly building the fundamentals of this business – forging deals with major players, building up a diversified portfolio and strengthening our management team. Every step we take is incrementally adding value to the shareholders and furthering therapies for patients.”
hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”
Dr. Ross Davidson, an orthopedic surgeon and director of post-graduate sports medicine at the University of Auckland in New Zealand has treated countless athletes with chronic overuse injuries throughout his career. “I do see a huge potential for this. It has been a pleasant surprise to see the amount of collagen these fibroblasts produce for repairing tendons. It’s a big change from other treatments being released. If it works — and I believe it will — it will reduce the number of surgeries significantly.”
Beyond its clinical trials, the success of RepliCel’s products will be put in the hands of licensing partners which have the infrastructure to support commercialization, says Mark Landy, director of research for senior medical technology and regenerative medicine analyst for Summer Street Research in Boston. The good news is that the industry is not having to wait too long for the clinical trials to get proof of concept. “Having data coming in 2015 and 2016 enables the company to accelerate licensing.”
He believes RepliCel has a significant opportunity ahead given that its regenerative therapy approach addresses extremely large markets that are ready for solutions not provided by today`s treatments. “The industry as a whole has gone beyond the fears around regenerative and genetic engineering and is seeing its value. We now know we can take certain cells from the body and safely put them in certain areas. It’s a notion that goes back to bone marrow transplants and implants. The opportunities — and the markets — for regenerative medicine are very, very large.”
With results from clinical trials on the horizon, Hall is confident things are moving forward as they should. “We’ve been quietly building the fundamentals of this business – forging deals with major players, building up a diversified portfolio and strengthening our management team. Every step we take is incrementally adding value to the shareholders and furthering therapies for patients.”
This story was produced by Postmedia’s advertising department on behalf of Market One Media Group for commercial purposes. Postmedia’s editorial departments had no involvement in the creation of this content.
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The 20 minute presentation by Mr. David Hall, CEO, will include an update on the Company’s current programs for chronic Achilles tendinosis (RCT-A-01), sun damaged and aging skin (RCS-01) and pattern hair loss (RCH-01). All of RepliCel’s autologous cell product candidates address medical conditions caused by a deficit of healthy, functioning cells required for normal healing and function.
The presentation will be webcast and posted on Rodman & Renshaw’s website shortly after the live presentation at http://wsw.com/webcast/rrshq24/repcf and on RepliCel’s website under the Investor section at http://www.replicel.com/investors/corporate-publications/.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function such as chronic tendinosis, damaged skin and pattern baldness. The company’s RCT-01 and RCS-01 cell therapies are designed to treat chronic tendinosis and damaged or aging skin respectively, using fibroblasts isolated from the sheath of the hair follicle. Another of the company’s pipeline products, RCH-01 for the treatment of pattern baldness, is manufactured from cells derived from the hair follicle dermal cup. Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.
For more information please contact:
David M. Hall, Chief Executive Officer
Tammey George, Director of Communications
RepliCel Life Sciences
604-248-8696
tg@replicel.com
INVESTOR RELATIONS:
Christina Cameron, Investor Relations
christina@clcameron.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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![](\"/Blog/2014/Capture.png\")
The following is an excerpt from The Life Sciences Report, with Mark Landy’s comments on RepliCel:
“RepliCel Life Sciences Inc. is at the forefront of the utilization of stem cells to treat disorders and defects.”
TLSR: Your universe of coverage includes medical technology and regenerative
medicine. Would you talk about some names, please? Do you have a regenerative
medicine story you can share?
ML: While I don’t formally cover RepliCel Life Sciences Inc. (RP:TSX.V;
REPCF:OTCQB), I do find it an interesting and exciting story. I have been doing
diligence on the company to learn more about its technology and opportunities. It
falls into a new category of medicine that is very intriguing to me: regenerative
medicine and gene therapy. RepliCel and another company I follow, Harvard
Apparatus Regenerative Technology Inc. (HART:NASDAQ), are at the forefront of
the utilization of stem cells to treat disorders and defects, which is definitely the
future of medicine.
TLSR: RepliCel has two proposed Phase 2 trials with its RCT-01 (non-bulbar
dermal sheath fibroblasts) cells, which should be initiated before the end of this
year. One trial will be for the Achilles tendinosis indication. I realize that as a Phase
2, this is not designed to be a pivotal trial. But will 82 patients, 41 of whom will
receive RCT-01, be enough to get an indication of efficacy?
ML: To me, the real questions are: What could go wrong and is it safe? My
hypothesis is: Not a whole lot can go wrong and the therapy will be safe, as the
company is using autologous cells. Autologous cells are taken from an individual
and returned to the body. They are a perfect immunological match, and if handled in
a safe and appropriate manner, should not cause the patient any harm. At this
stage, I think what we are all interested in is the safety of RepliCel’s therapy, and I
do not see a lot of risk.
With that said, you are right: The numbers in this study may be too small to determine scientific evidence of efficacy. However, companies like to get some understanding
or signal indicating that there could be efficacy, and they like to learn how to power
larger studies. Also, and more important, in some countries, the pathway to
approval and commercialization for stem cell therapy is being altered so that
companies only need to generate safety data in trials. Then, within a specified
amount of time, they must provide data on efficacy to maintain the therapies on the
market. This is an opportunity that RepliCel can take advantage of, shortening the
cost and time to market in some countries.
TLSR: The other proposed Phase 2 study will be in androgenic alopecia (male
pattern baldness). This study will be with a total of 160 male patients—two
experimental arms, one with 66 single injections and one with 66 repeat injections,
with a 28-patient control arm. What could this trial tell us?
ML: RepliCel could get an indication of efficacy, and could also use this study to
solidify a commercial partner with the financial resources to take the product to
market. This is RepliCel’s strategy: to develop new products and therapies, and
then license the commercial rights to companies with deep pockets and strong
distribution networks.
Cell therapies for curing alopecia are early in their clinical development. These must still show evidence of durable and robust efficacy. Nevertheless, it bears watching. Regenerative cell therapies are making swift, genuine strides in treating specific human organs such as the hart. We expect these gains to extend towards rejuvenating hair follicles.
Among cell therapy companies in the alopecia space, tiny RepliCel Life Sciences in Vancouver, BC, is furthest into human testing. RepliCel originally started trading on the OTC bulletin board (OTCQB: REPCF) and was recently added to the Toronto Stock Exchange (TSXV: RP)
Replicel Life Sciences is developing its proprietary cell therapy approach designed RCH-01. It aims to rejuvenate damaged, miniaturized hair follicles in balding scalp skin. It focuses on correcting a deficit of healthy dermal sheath cup cells (DSCs) in the follicle.
To read the full excerpt covering RepliCel click here! For more information visit BioWatch News’ website.
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life-scineces-report
Read below for an excerpt from Street Wise Reports on Alan Leong’s comments about RepliCel:
TLSR: You mentioned RepliCel in regenerative medicine. Tell me your growth theory for this company.
AL: RepliCel came onto our radar when we were at the Biotech Showcase and JP Morgan Healthcare Conference back in January. The company is very early in development and caught our eye for a couple of reasons.
One, the cells are derived from cells in the hair follicle. Two, the company is competing in less crowded niches—baldness or alopecia, and tendinosis. It’s very interesting that these hair follicle-derived cells appear to have advantageous properties when applied to healing tennis elbow, Achilles tendinosis and similar complaints. The early results are interesting and positive.
“The day is coming in which we will be able to pick a very specific niche or cluster and provide very effective treatments for more defined diseases.”
RepliCel is going to launch two Phase 2 trials this year. For those thinking of investing, the company is in a low-cash position, and is risky. RepliCel behaves like a private company in a lot of ways, because it is raising money to fund some of the next trials. One of the scientists involved with the technology, Kevin McElwee from the University of British Columbia, has an excellent reputation, not just among scientists but also among clinicians who are into hair restoration. Usually, companies joining the regenerative medicine space target major organs and systems. RepliCel, on the other hand, is going after niche indications that give it a much clearer playing field. There was one direct cell therapy competitor, the Aderans Research Institute, out there in the baldness space, but it abandoned the field a few months ago.
TLSR: RepliCel’s technology is autologous. The cells are harvested from the back of the patient’s scalp, and are expanded and processed ex vivo. The harvest and readministration of these cells by injection for alopecia, given that it is a two-step procedure, is about even in clinical complexity to hair plug therapy. Will this therapy for baldness be superior to hair plug therapy, which we know can be painful for the patient?
AL: All things being otherwise equal, patients will be more sold on RepliCel’s therapy than on the hair transplant procedure. With a hair transplant, the physician typically has to implant thousands of units from one part of the head to another. That requires incredible dexterity and takes several hours. In fact, that is why robotics are getting involved—the physician endures incredible repetitive strain. In addition, physicians are digging out not just follicles but a little bit of muscle, too, and placing that into the patient.
Another thing that makes RepliCel’s therapy attractive is that, if you look at surveys or talk to people who are losing hair, the concept of having these injections is very palatable. This possibly could expand the market. Finally, if you look at surveys, the percentage of men who say they would give up a significant portion of their wealth to have their hair restored is astounding.
TLSR: Back on May 20, the company said its licensing partner, Shiseido Company Ltd., was opening a new cell processing facility at the Kobe Biomedical Innovation Cluster in Japan. Does it make sense to process and expand those cells so far away?
AL: Shiseido, a major cosmetics company, is licensing RepliCel’s hair regeneration technology in the largest parts of Asia. It has more than $7B in revenue. In Japan, companies that get involved in pharmaceuticals aren’t like the ones here. For instance, you have major pharmaceutical companies that also make beer, and cosmetic companies doing major research. Shiseido’s new facility is not just a tiny laboratory. It represents a major cell therapy investment. Shiseido’s investment into the collaboration is a form of validation for RepliCel.
TLSR: In mid-June, RepliCel announced it had closed on the third and final tranche of a nonbrokered capital raising that it originally announced at the end of March. Each unit sold for $0.75, and that includes one warrant that could be exercised for $1/share in the first year and $1.25 in year two. The total of these tranches was only about $3.9M, which is not a lot of money. How much dilution are RepliCel investors in for in the future?
AL: It’s a good question, because the dilution could be serious. RepliCel is trying to raise cash in fits and gulps to get it through the next set of trials and raise the company’s valuation. I think that’s part of the rationale behind why the Phase 2 trials are confined in terms of geography. The company wants to put out strong proof of concept and raise the valuation while still making progress on the commercial side. There’s no doubt about it: There’s a balancing act going on here. RepliCel is also trying to raise money through unconventional sources, including governmental sources of funding. We shall see.
TLSR: Alan, I have read that 11 of 12 patients in the Phase 1 Achilles tendinosis trial had what the company calls “satisfactory outcomes,” but those were with adipose-derived cells and not with cells derived from the patient’s hair follicles, which will be used in Phase 2.
AL: That’s correct. The tendinosis indication has had the Phase 1 proof-of-concept study performed, but the Phase 2 study will incorporate some tweaks to the procedure.
TLSR: Is the lead indication at RepliCel Achilles tendinosis or alopecia?
AL: If you asked the company’s CEO, David Hall, I think he would say he’s looking at both of them. Right now, you would have to pick alopecia as positioned to be RepliCel’s lead indication, because a) it has the Phase 2 data, and b) it has the alliance with Shiseido, which also will be advancing work in its labs back in Japan.
", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - As Seen In" ], "ItemCategoryIdList": [ 2395 ], "ItemTags": [ "Hair", "Media", "Partnerships", "Skin", "Tendon" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Item_Rating": 0, "Image": "/Blog/2017/RP-recent-coverage.jpg", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.0, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 992450, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "Hair", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 2115, "Name": "RepliCel Life Sciences’ Licensing Partner, Shiseido, Opens Cell Processing and Expansion Facility in Japan to Advance RCH-01, a Treatment for Pattern Baldness", "Url": "/news/replicel-life-sciences-licensing-partner-shiseido-opens-cell-processing-and-expansion-facility-in-japan-to-advance-rch-01-a-treatment-for-pattern-baldness", "Url_List": [ "/news/replicel-life-sciences-licensing-partner-shiseido-opens-cell-processing-and-expansion-facility-in-japan-to-advance-rch-01-a-treatment-for-pattern-baldness" ], "UrlSlug": "replicel-life-sciences-licensing-partner-shiseido-opens-cell-processing-and-expansion-facility-in-japan-to-advance-rch-01-a-treatment-for-pattern-baldness", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "News Template", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2014-05-19T17:00:00", "ExpiryDate": "2099-12-11T17:00:00", "SiteSearchKeywords": [], "Description": "VANCOUVER, BC – May 20, 2014 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) a clinical stage regenerative medicine company focused on the development of autologous cell therapies, is pleased to announce that its RCH-01 licensing partner, Shiseido, celebrated the opening of its new cell-processing facility at the Kobe Biomedical Innovation Cluster (KBIC) located on Port Island, Japan on May 18, 2014. Dignitaries, physicians, partner companies, and government representatives were in attendance at this important event. Shiseido’s state-of-the-art facility will focus on the continued research and development, and the commercialization of RepliCel’s RCH-01 hair regeneration technology.
“Shiseido has been working diligently on the construction of their facility and we congratulate them on their efficiency and commitment to building a world-class cell research and development centre capable of handling all aspects of the RCH-01 technology from hair follicle biopsy through to cell replication and patient treatment,” commented David M. Hall, CEO of RepliCel Life Sciences. “We continue to support Shiseido with its highly focused development towards commercialization of RCH-01 as a treatment for pattern baldness.”
The KBIC is a complex of medical-related industries located on the 833-hectare man-made island of Port Island in Kobe, Japan. Working in cooperation with academic research institutions, government organisations, and industry, the island has been developed as a focal point for research and development of highly advanced medical technologies with the goal of streamlining processes from research to clinical application and commercialization.
Regenerative medicine in Japan is an emerging industry which the government has designated as an important part of its economic reform. Legislative support has come from the introduction of new laws to expedite otherwise lengthy clinical research and trial application processes to promote competitive advantage in the international market. In November 2013, as one of the new economic reform strategies, the Japanese government passed the Regenerative Medicine Law, which ensures safety of regenerative medicine, and approved revisions to its existing Pharmaceutical Affairs Law to improve the timelines for the development of regenerative medicine and to promote commercialization. Shiseido has entered into this field via its licensing agreement with RepliCel and is committed to its advancement and success.
Licensing Agreement
On July 11, 2013, RepliCel and Shiseido announced the completion of a Collaboration and Technology Transfer Agreement, giving Shiseido an exclusive geographic license to use RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries Shiseido and RepliCel will collaborate on the continued improvement of the technology and will conduct human clinical trials in each of their territories with the goal of commercializing a safe and effective hair regenerative treatment to help those suffering from pattern baldness and thinning hair.
RCH-01 has been developed over 10 years of scientific research, and safe application in humans was validated during RepliCel’s phase 1 clinical trial. RepliCel has patents issued for hair follicle mesenchymal stem cells and their usage in Japan, the United States, Australia and the EU. RCH-01 is an autologous cell-based hair regenerative technology whereby specific hair follicle cells are isolated from a scalp biopsy, expanded in culture at a cell processing facility and injected back into patients.
About the Kobe Biomedical Innovation Cluster and Shiseido’s Facility
More than 260 domestic and international companies have built R&D facilities focusing on regenerative medicine, pharmaceuticals, medical equipment and devices in the research park, taking advantage of the opportunities for collaboration and synergy that the KBIC fosters. Centralised support services facilitate clinical research, commercialisation, consultations on pharmaceutical development issues and financing, and the establishment of comprehensive platforms for biomedical research and development. The Business Support Centre for Biomedical Research Activities has been built to support and to provide space for research and commercialization of regenerative medicine. This facility is divided into two sections, research and cell-processing. Shiseido’s Cell-Processing and Expansion Centre (SPEC) is located in the cell processing section, Room 620, 1-5-5 Minamimachi, Minatojima, Chuoku, Kobe, 650-0047, Japan.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that treat functional cellular deficits including chronic tendinosis, pattern baldness and skin aging. Initiation of Phase 2 trials are planned for 2014 on RepliCel’s RCT-01 treatment for Achilles tendinosis and RCH-01 treatment for pattern baldness. Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. These products are built on the company’s proprietary manufacturing platforms. For additional information please visit www.replicel.com.
CORPORATE CONTACTS:
David M. Hall, Chief Executive Officer
Tammey George, Director of Communications
RepliCel Life Sciences
604-248-8696
tg@replicel.com
INVESTOR CONTACT:
Westwicke Partners, LLC
Robert H. Uhl
Managing Director
858-356-5932
robert.uhl@westwicke.com
Neither the TSX Venture Exchange Inc. nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture Exchange Inc.) accepts responsibility for the adequacy or accuracy of this press release.
This press release contains forward-looking information that involve various risks and uncertainties regarding future events. Such forward-looking information can include without limitation statements based on current expectations involving a number of risks and uncertainties and are not guarantees of future performance of RepliCel, such as the statement that RepliCel is seeking additional financing. There are numerous risks and uncertainties that could cause actual results and RepliCel’s plans and objectives to differ materially from those expressed in the forward-looking information, including: (i) adverse market conditions; (ii) the inability of RepliCel to complete the private placement at all or on the terms announced; or (iii) the TSX Venture Exchange not approving further private placements. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, RepliCel does not intend to update these forward-looking statements.
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The Congress of the Japanese Society for Regenerative Medicine Conference aims to promote the exchange of leading scientific knowledge and technologies of cell therapy and to expedite its integration into regenerative medicine. The multi-disciplinary approach of this meeting will bring together experts from various fields to generate a better understanding of human cells and to provide potential tools to utilize, control and apply the regenerative abilities of the cells to clinical therapy. Another aspect of this meeting is to create an opportunity for industry, academia and regulatory agents to work together to create a setting in which regenerative medicine is best supported and promoted.
About RepliCel Life Sciences
RepliCel is a clinical stage biopharmaceutical company focused on developing autologous cell therapies that treat functional cellular deficits. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.
CORPORATE CONTACTS:
David M. Hall, Chief Executive Officer
Tammey George, Director of Communications
(604) 248-8696
tg@replicel.com
INVESTOR CONTACT:
Westwicke Partners, LLC
Robert H. Uhl, Managing Director
(858) 356-5932
robert.uhl@westwicke.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
FINANCIAL POST ARTICLE PUBLISHED ON FEBRUARY 25, 2014
Imagine using healthy cells from your body to heal areas in which other cells are damaged or deficient. That’s what RepliCel Life Sciences Inc. (TSXV: RP) expects to do by developing a new cell-based treatment for chronic tendinosis, in which a patient’s own fibroblast cells from their hair follicles are harvested, replicated, and then reintroduced into the damaged areas within the tendon via ultrasound, which “jump starts” the wound-healing cycle. These cells are replicated but are not altered in any way, so there is no safety issue involved in the re-introduction of a patient’s own cells.
Tendinosis is the result of repetitive injuries and incomplete healing cycles that lead to a degenerative breakdown of the collagen tissue within a tendon, which inevitably leads to pain, dysfunction, and often rupture. The company estimates the potential market for the treatment of tendinosis is in excess of $3 billion per year.
RepliCel’s fibroblast technology uses nonbulbar dermal sheath (NBDS) cells, which are prolific in their expression of type I collagen and are key to creating a complete healing cycle within the damaged and degenerated tendon. These cells are taken from the back of the patient’s scalp with the use of a small punch biopsy. The NBDS cells are unique in that they are capable of dividing and renewing for long periods. In a laboratory, this process can yield millions of cells. These cells, which make up the sheath of a hair follicle, are healthy throughout a person’s life as they are in a continued state of renewal.
“It takes us about five to six weeks to replicate the cells and the cells are returned to the patient via a minimally invasive ultrasound guided injection directly to the area of damage and it takes about six months to return the patient to full functionality,” said RepliCel President and CEO David Hall in a recent interview. Mr. Hall has more than 20 years of biotech experience and is the former Chief Financial Officer at Angiotech Pharmaceuticals Inc.
The Company’s phase 2 tendinosis fibroblast program is being followed into human clinical trials with a treatment for UV damaged and aging skin using the same technology platform. RepliCel has also developed unique injector devices to support the delivery of its treatments. The company expects to complete the development of its injector device, which is programmable to depth and dose and has built-in cooling that replaces the need for an anesthetic. This device could also find a market in the delivery of other cosmetic dermal injectors. The device is expected to be commercialized in the next year, providing additional licensing opportunities for the company and asset value accretion.
RepliCel’s technologies carry issued and filed patent applications. Furthermore, the Company’s cell manufacturing technology is protected by trade secrets and is unique in its ability to quickly replicate fibroblast cells versus other replication technologies. RepliCel is also entering into a Phase 2 clinical trial for the treatment of pattern baldness using another cell isolated from the hair follicle. The technology was the subject of a Q2, 2013 Collaboration and Technology Development Transfer Agreement with Shiseido Company, Limited of Japan, the third-largest cosmetic company in world, in which Shiseido paid RepliCel an upfront fee of $4,120,400 for a geographic license including Japan, China and the ASEAN countries. Shiseido will initiate its own clinical program in Japan, providing two parallel clinical trials. RepliCel plans to initiate a Phase 2 trial for chronic tendinosis and a Phase 1 trial for aging and damaged skin in 2014 with results expected in 2015.
“I expect we can get an approval for treating chronic tendinosis within three years,” Mr. Hall added. RepliCel had $3.2 million in cash and equivalents as of September 30, 2013, and has a cash burn rate of approximately $200,000 per month. The company has 48,118,609 issued and outstanding common shares as of February 1, 2014, and after its listing on the TSX-V in February of this year its stock has surged 50% to its recent price of 90 cents a share.
About RepliCel Life Sciences:
RepliCel Life Sciences Inc. (TSXV: RP) is a clinical stage biopharmaceutical company focused on developing autologous cell therapies that treat functional cellular deficits. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.
Disclosure
RepliCel Life Sciences is a featured sponsored company and has paid SmallCapPower.com a fee for coverage.
VANCOUVER, BC – January 13, 2014 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) today announced that it has been granted a patent by Japan’s Ministry of International Trade and Industry for hair follicle mesenchymal stem cells and their use thereof. These cells are used in RepliCel’s RCH-01 treatment for androgenetic alopecia, also known as pattern hair loss. With the issuance of this patent, RepliCel now has patents issued in Japan, the United States, Australia and the European Union protecting its technology with other jurisdictions still pending.
This patent approval is an important milestone as RepliCel’s licensing partner, Shiseido Company, prepares to conduct human clinical trials using RCH-01. Shiseido has an exclusive license to use RCH-01 in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people. According to the International Society of Hair Restoration (ISHR), the leading authority on hair loss treatment and restoration, almost one million patients sought treatment for hair loss in 2012. Of this number, 41% of the patients were from Asia, representing the largest single region, surpassing the United States by 15%.
David Hall, CEO of RepliCel stated, “The allowance of our first patent in Japan is significant as it protects RepliCel’s licensing partner, Shiseido Company, as they move forward with their clinical trial program in Japan. In addition, recently adopted legislation in Japan governing regenerative medicine underlines the country’s commitment to accelerate R&D and clinical pathways which could be beneficial to our Japanese partner.”
About RepliCel Life Sciences
RepliCel is a clinical stage biopharmaceutical company focused on developing autologous cell therapies that treat functional cellular deficits. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.
About Shiseido Company, Limited
Shiseido was established in 1872 as Japan’s first Western-style pharmacy. Since then, the company has led the cosmetic technology and culture in Japan over more than 100 years. The company now aspires to become a “global player to represent Asia with origins in Japan” and operate businesses all over the world, including Europe, the U.S. and Asia. Its representative global brand, “SHISEIDO” is now sold in 89 countries and regions as of April 2013.
CORPORATE CONTACT:
Tammey George
Director of Communications
RepliCel Life Sciences Inc.
604-248-8696
tg@replicel.com
INVESTOR CONTACTS:
Westwicke Partners, LLC
Stefan Loren, Ph.D.
Managing Director
(443) 213-0507
sloren@westwicke.com
Robert H. Uhl
Managing Director
(858) 356-5932
robert.uhl@westwicke.com
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements and include the following: (i) that the Company will conduct further human clinical trials; (ii) that ongoing research collaboration will be conducted by the Company and Shiseido for the continued improvement of the technology; (iii) that a commercial, safe and effective hair regenerative treatment will be developed and commercialized; (iv) that the Company and Shiseido will develop further improvements to the technology; (v) that the Company will undertake and enter into development and collaboration agreements for the development of its technologies; and (vi) and that the Company’s technology will rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: that negative results from the Company’s clinical trials may impact further clinical trials, development, approval and commercialization of the technology; the effects of government regulation on the Company’s business, including the future development of the technology; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; that the Company may not be able to find other parties will to participate in the development and collaboration of its technologies, and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2012 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
![](\"/Blog/2014/bilde1.jpg\")
BUSINESS IN VANCOUVER ARTICLE PUBLISHED ON JANUARY 13, 2014
Vancouver-based RepliCel Life Sciences Inc., a clinical stage biopharmaceutical company, has been granted a patent by Japan’s Ministry of International Trade and Industry for the applied use of hair follicle mesenchymal stem cells, the company announced January 13.
These cells are used in RepliCel’s treatment for androgenetic alopecia, also known as pattern hair loss.
RepliCel now has patents issued in Japan, the United States, Australia and the European Union, with other jurisdictions still pending.
RepliCel said the patent approval is an important milestone as its licensing partner, Shiseido Company, prepares to conduct human clinical trials using RCH-01. Shiseido has an exclusive license to use RCH-01 in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people.
According to the International Society of Hair Restoration, almost one million patients sought treatment for hair loss in 2012. Of this number, 41% of the patients were from Asia, representing the largest single region, surpassing the United States by 15%.
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About the Biotech Showcase
The Biotech Showcase is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives.
About RepliCel Life Sciences
RepliCel is a clinical stage biopharmaceutical company focused on developing autologous cell therapies. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.
CORPORATE CONTACT:
Tammey George, Director of Communications
RepliCel Life Sciences
604-248-8696
tg@replicel.com
INVESTOR CONTACTS:
Westwicke Partners, LLC
Stefan Loren, Ph.D., Managing Director
(443) 213-0507
sloren@westwicke.com
Robert H. Uhl, Managing Director
(858) 356-5932
robert.uhl@westwicke.com
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements and include the following: (i) that the Company will conduct further human clinical trials; (ii) that ongoing research collaboration will be conducted by the Company and Shiseido for the continued improvement of the technology; (iii) that a commercial, safe and effective hair regenerative treatment will be developed and commercialized; (iv) that the Company and Shiseido will develop further improvements to the technology; (v) that the Company will undertake and enter into development and collaboration agreements for the development of its technologies; and (vi) and that the Company’s technology will rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: that negative results from the Company’s clinical trials may impact further clinical trials, development, approval and commercialization of the technology; the effects of government regulation on the Company’s business, including the future development of the technology; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; that the Company may not be able to find other parties will to participate in the development and collaboration of its technologies, and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2012 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
VANCOUVER, BC – December 19, 2013 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (CNSX: RP) today reported on the progress of its technology transfer agreement with its partner, Shiseido Company, Limited.
Recently, a group from Shiseido met with RepliCel management and advisors in Vancouver, BC to continue the technology transfer between the two companies as outlined in the July 9, 2013 licensing agreement. The Shiseido team spent three weeks in the lab with RepliCel’s Chief Scientific Officer, Dr. Kevin McElwee and Director, Research and Development, Dr. Hisae Nakamura learning techniques of specific hair follicle cell isolation and replication methods for RCH-01. Furthermore, RepliCel’s Vice-President of Clinical Affairs, Darrell Panich reviewed progress to date in the clinical development program of RCH-01 and discussed the plans for future development in the companies’ respective regions.
During this past quarter, Dr. Nakamura and representatives from the Shiseido team visited RepliCel’s contract Good Manufacturing Practice compliant facility in Innsbruck, Austria. It was during this visit that the transfer of RCH-01 manufacturing technology between the two companies and its contract manufacturer was initiated.
“These meetings have done much to foster the collaborative relationship between RepliCel and Shiseido and both companies are committed to working very closely on the successful development of RCH-01,” said Chief Scientific Officer, Dr. Kevin McElwee. “Both teams will continue in-depth research and development in the laboratory and clinical trials with the goal of commercializing a safe and effective hair regenerative treatment to help those suffering from pattern baldness and thinning hair.” In this regard, RepliCel expects to initiate a Phase 2 clinical trial for RCH-01 in the EU in the first half of 2014. In addition, both companies will work towards establishing a clinical research program in Asia with the goal of increasing the available human clinical data on RCH-01. Collaborative technology transfer will continue between the companies as any new improvements to the RCH-01 technology are developed by either party.
As per the agreement, Shiseido will have an exclusive geographic license to use RepliCel’s RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people.
New Regenerative Medicine Legislation Passed in Japan
On November 20, 2013 the Japanese Legislature approved new legislation targeted at improving the development and regulatory processes for regenerative medicine therapies. The Regenerative Medicine Law directs the Ministry of Health, Labour and Welfare to adopt new procedures and rules that will accelerate the clinical development of regenerative medicine and cell therapies. The Japanese Pharmaceutical Affairs Law will now become the Pharmaceuticals and Medical Devices Act that will include a new branch specifically for Regenerative Medicine Products, which will be regulated on a fast track process that focuses primarily on product safety. Under the law, the government is responsible for mapping out and implementing measures to safely accelerate research and development projects and make regenerative medicine widely available in the country. The law specifically stipulates that the government must make basic plans for the promotion of regenerative medicine and change such plans if necessary by reviewing them at least every three years in light of any changes in external conditions that may occur. This news positively impacts RepliCel and its licensing partner, Shiseido, as it looks to conduct human clinical trials on RCH-01.
About RepliCel Life Sciences
RepliCel is a clinical stage biopharmaceutical company focused on developing autologous cell therapies. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.
About Shiseido Company, Limited
Shiseido was established in 1872 as Japan’s first Western-style pharmacy. Since then, the company has led the cosmetic technology and culture in Japan over more than 100 years. The company now aspires to become a “global player to represent Asia with origins in Japan” and operate businesses all over the world, including Europe, the U.S. and Asia. Its representative global brand, “SHISEIDO” is now sold in 89 countries and regions as of April 2013.
CORPORATE CONTACT:
Tammey George, Director of Communications
RepliCel Life Sciences<
604-248-8696
tg@replicel.com
INVESTOR CONTACTS:
Westwicke Partners, LLC
Stefan Loren, Ph.D., Managing Director
(443) 213-0507
sloren@westwicke.com
Robert H. Uhl, Managing Director
(858) 356-5932
robert.uhl@westwicke.com
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements and include the following: (i) that the Company will conduct further human clinical trials; (ii) that ongoing research collaboration will be conducted by the Company and Shiseido for the continued improvement of the technology; (iii) that a commercial, safe and effective hair regenerative treatment will be developed and commercialized; (iv) that the Company and Shiseido will develop further improvements to the technology; (v) that the Company will undertake and enter into development and collaboration agreements for the development of its technologies; and (vi) and that the Company’s technology will rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: that negative results from the Company’s clinical trials may impact further clinical trials, development, approval and commercialization of the technology; the effects of government regulation on the Company’s business, including the future development of the technology; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; that the Company may not be able to find other parties will to participate in the development and collaboration of its technologies, and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2012 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
![](\"/Blog/2013/National-Post-Cover1-300x225.jpg\")
The cure for baldness? It could be closer than you think — i.e. among the baldness-proof follicles that usually reside at the bottom back of the head, stem cell researchers claim.
Erin Ellis, Postmedia News Files
NATIONAL POST ARTICLE PUBLISHED ON OCTOBER 30, 2013
The cure for baldness? It could be closer than you think — i.e. among the baldness-proof follicles that usually reside at the bottom back of the head, stem cell researchers claim.
A cure for baldness doesn’t leap to mind when one ponders the next advance in stem-cell research, but whoever manages to do it could become very rich.
Scientists have already grown liver and brain cells in the laboratory using cell samples from humans. Others are trying to find a way to nurture new hair growth on shiny heads.
A new analysis of existing studies linking hair loss and cardiac health suggests men who experience premature balding before the age of 50 may have an increased risk of developing heart disease.
In the meta-analysis (a critical examination of previous observational studies), conducted at the University of Tokyo, researchers analyzed data from six previous studies that investigated the link between male hair loss, congenital traits and cardiovascular disease. All together, the studies tracked the hair patterns of over 40,000 men ranging from middle age to those over age 60.
“It’s a market where people spend a tonne of money,” says David Hall, CEO of RepliCel Life Sciences Inc., a Vancouver-based biotech firm that has attracted the attention of Japan’s Shiseido Co. The cosmetic giant paid $4.2 million in July to share RepliCel’s research on highly speculative technology for treating hair loss.
Hair transplants are still the “gold standard” for hair restoration, Hall says, but their success relies on the skill of the surgeon and a supply of healthy follicles from elsewhere on the scalp.
The RepliCel technique was pioneered by company co-founders Rolf Hoffmann, a German dermatologist, and Vancouver researcher Kevin McElwee. Hair follicles are harvested from the back of a person’s scalp, where hair is typically resistant to the hormone that causes baldness. That tissue is transferred to the lab, where researchers isolate dermal sheath cup cells from the base of the follicle. Those cells are replicated by the millions over a period of three months, later to be injected into bald areas at the top of the scalp.
“What initially attracted me to this concept is it’s not a drug,” says Hall. “The treatment uses the patient’s own cells to replace hormone-compromised hair-follicle cells in the bald areas. The concept of treating cellular deficits with your own cells is elegant.”
The company hopes to have a clinical trial with 120 men in Germany in the coming months as it works its way through regulatory requirements that could lead to licensing in Europe, the U.S. and Japan. It has already completed an initial trial of 19 subjects that found no serious adverse reactions six months after injections.
But RepliCel’s plan isn’t to bring its cell cloning all the way to market, Hall says. Rather, it wants to prove the effectiveness of the technology in the hopes it will be purchased by another company.
Companies are chasing the estimated $3 billion annually spent on hair-restoration treatments worldwide.The market could be even larger if women — who are turning to hair-replacement surgery in greater numbers — also buy into newer procedures.
‘You feel bad because you’re losing your hair. Then you feel guilty for feeling bad because it’s only hair. So the psychological hit isn’t just once, it’s twice’
Christine Janus, executive director of Ottawa-based Canadian Skin Patient Alliance, says hair loss is a becoming more common for women.
“For women, when you’re starting to lose your hair — no matter what age you are — it really packs an emotional wallop. You can feel less attractive, you can feel less sexy. It turns out a lot of our identity is tied up in our hair,” she said. “It’s how we present ourselves to the outside world.”
Androgenetic alopecia is the medical name for male pattern baldness (thinning hair and eventual baldness starting at the temples, moving to the crown and top of the head) and female-pattern baldness (general thinning.) They’re both caused by a combination of genetic predisposition and hormonal changes that are not particularly well understood in women. Once hair loss starts, says Janus, both women and men are launched on a conflicted emotional journey.
“There’s a real dichotomy. You feel bad because you’re losing your hair, losing who you were. Then you feel guilty for feeling bad because it’s only hair. So the psychological hit isn’t just once, it’s twice. Society tells you you shouldn’t care, but you know you look weird.
Another reason for a jaundiced view of the search for a cure to baldness is that it’s been dominated by snake-oil salesmen for decades. These schemes have played on the emotions of people worried about losing their sex appeal or even their edge in the professional world.
Janus says anyone who can make an effective product will find a world of grateful buyers.
“If they’re selling stuff that really doesn’t work, then I think they’re taking advantage,” she says. “If they actually have a product that works very well, like Rogaine or implants or wigs. … If they’re selling something that is going to give a person — male or female — that sense of self back, then they provide a service. And it’s a good thing.”
‘How do you get the public to understand that this is really backed by science’?
Jeff Donovan, a Toronto dermatologist specializing in hair transplants, agrees the hair-restoration industry has a dismal reputation because it’s short on hard research and long on hard sells.
“It makes it a lot more difficult for people doing good work to get their data seen,” he says. “How do you get the public to understand that this is really backed by science — which is what is so desperately needed — vs. someone who just brings a product to market and licenses it under nutritional supplements, let’s say, and with strong marketing the public can be convinced that both of those are equally promising.”
Donovan advises consumers to wait for clinical evidence before buying into anything.
And like the U.S. Food and Drug Administration-approved treatments already on the market — such as minoxidil cream and finasteride pills — anything new will probably work to some extent on some people, he predicts. Donovan has heard RepliCel’s Hoffman present early findings at a European dermatology conference and says he’s intrigued by the possibility that it could one day be added to the mix.
“These treatments don’t work in everyone and don’t work in advanced hair loss. Minoxidil works differently than Propecia; one’s a topical treatment and one’s a pill, and the two combined work even better. So here we have a third treatment (RepliCel’s) that works even differently. It’s going to be exciting to see if it does anything and, if it does, even a little bit, then it can be combined with minoxidil as a treatment. Because anything you can do to help hair is going to be good.”
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Hisae Nakamura, director of research and development for RepliCel, with a device used to inject cells into the scalp to stimulate hair growth. The company’s process replicates cells from hair follicles on the back of the scalp, which are typically resistant to the hormone that causes baldness, and injects them into bald areas.
Photograph by: Nick Procaylo, PNG
VANCOUVER SUN ARTICLE PUBLISHED ON OCTOBER 26, 2013
A cure for baldness doesn’t leap to mind when one ponders the next advance in stem cell research, but whoever manages to do it stands to become very rich.
Scientists around the world have already grown liver and brain cells in the laboratory using cell samples from humans. Others — including some working for a Vancouver-based company — are hard at work trying to find a way to nurture new hair growth on shiny heads.
“It’s a market where people spend a ton of money,” says David Hall, CEO of RepliCel Life Sciences Inc., a biotech firm with offices in downtown Vancouver that has attracted the attention of Japan’s Shisheido Co. The cosmetic giant paid $4.2 million in July to share RepliCel’s research on a highly speculative technology for treating hair loss.
Hall, who says his own flowing locks have no high-tech enhancement, acknowledges that plenty of people think hair cloning research is frivolous. But those usually aren’t people who are losing their hair, particularly at a young age.
“It’s just not perceived as a medical need, but I think there are a lot of people who would say it’s important to them,” Hall says. “There’s definitely a mental health aspect for young men and for women in their 30s and 40s. It can be very devastating to their self-esteem.”
Hair transplants are still the “gold standard” for hair restoration, he says, but their success relies on the skill of the surgeon and a supply of healthy follicles from elsewhere on the scalp. The RepliCel technique was pioneered by company co-founders Dr. Rolf Hoffmann, a German dermatologist, and Vancouver researcher Kevin McElwee. Hair follicles are harvested from the back of a person’s scalp, where hair is typically resistant to the hormone that causes baldness. That tissue is transferred to the lab, where researchers isolate dermal sheath cup cells from the base of the follicle. Those cells are replicated by the millions over a period of three months, later to be injected into bald areas at the top of the scalp using a specially designed device.
“What initially attracted me to this concept is it’s not a drug,” says Hall. “The treatment uses the patient’s own cells to replace hormone-compromised hair follicle cells in the bald areas. The concept of treating cellular deficits with your own cells is elegant. It’s the same concept we’re using in our other treatment in development for chronic tendinosis.”
The company hopes to have a clinical trial with 120 men test the procedure in Germany in coming months as it works its way through regulatory requirements that could ultimately lead to licensing in Europe, the U.S. and Japan. It has already completed an initial trial of 19 subjects that found no serious adverse reactions six months after injections.
But RepliCel’s game plan isn’t to bring its cell cloning all the way to market, Hall says. Rather it wants to prove the effectiveness of the technology in the hopes it will be purchased by a much larger company.
(Hall was formerly the chief financial officer of Angiotech Pharmaceuticals Inc., a Vancouver biotech darling that rode high during a boom early last decade after it developed a drug-coated cardiac stent. U.S. medtech firm Boston Scientific became a partner on that technology and still sells the stents, but Angiotech faltered in the 2008 financial crisis and filed for bankruptcy protection in 2011.)
Until recently, RepliCel’s main direct competitor in this area was a biotech start-up called Aderans Research Institute based in Atlanta, Ga. It ran clinical trials on a process described as “hair multiplication or hair cloning,” although it targeted different cell from the hair follicle than RepliCel. The work was initially bankrolled by Japan-based Aderans, a multinational company that started as a wig-maker in the ’60s, eventually buying Bosley, a chain of hair transplant clinics. In 2012, Aderans bought Hair Club, formerly known as Hair Club for Men, the U.S. company that spawned a generation of testimonial-style late-night TV commercials.
Vern Liebmann, CEO of Aderans Research Institute, said in a recent telephone interview that his company is now “in hibernation” since Aderans pulled its funding. “It’s perceived as high-risk and in the current climate — going back to 2007-2008 — funds for pioneering-type efforts are hard to come by.”
Liebmann said investors are interested in hair treatments because of the immense market they could potentially tap, but bringing a biological treatment to fruition means following the same strict regulatory process required by pharmaceutical companies before a drug can be sold. That takes deep pockets.
“If RepliCel didn’t have Shisheido, they’d be in a world of hurt,” he said. “They got lucky. We didn’t.”
The companies are all chasing the estimated $3-billion per year spent on hair restoration treatments around the world. The market could be even larger if women — who are turning to hair replacement surgery in greater numbers — also buy into newer procedures.
Christine Janus, executive director of the Ottawa-based Canadian Skin Patient Alliance, says hair loss is a serious condition for women and it’s becoming more common.
“For women, when you’re starting to lose your hair — no matter what age you are — it really packs an emotional wallop. You can feel less attractive, you can feel less sexy. It turns out a lot of our identity is tied up in our hair, ” she said in a telephone interview. “It’s how we present ourselves to the outside world.”
Androgenetic alopecia is the medical name for male pattern baldness (thinning hair and eventual baldness starting at the temples, moving to the crown and top of the head) and female-pattern baldness (general thinning.) They’re both caused by a combination of genetic predisposition and hormonal changes that are not particularly well understood in women. In men, testosterone is converted to dihydrotestosterone (DHT), which causes follicles to slow and eventually stop producing hair.
Once it starts, says Janus, both women and men are launched on a conflicted emotional journey.
“There’s a real dichotomy. You feel bad because you’re losing your hair, losing who you were. Then you feel guilty for feeling bad because it’s only hair. So the psychological hit isn’t just once, it’s twice. Society tells you you shouldn’t care, but you know you look weird.”
Another reason for a jaundiced view of the search for a cure to baldness — the holy grail of hair treatments — is that it’s been dominated by snake-oil salesmen for decades. These schemes have played on the emotions of men and women worried about losing their sex appeal or even their edge in the business and professional world.
But Janus says anyone who can make an effective product will find a world of grateful buyers.
“Are they playing on insecurities and are they making money?” asks Janus. “If they’re selling stuff that really doesn’t work, then I think they’re taking advantage. If they actually have a product that works very well, like Rogaine or implants or wigs … If they’re selling something that is going to give a person — male or female — that sense of self back, then they provide a service. And it’s a good thing.”
Dr. Jeff Donovan, a Toronto dermatologist who specializes in hair transplants, agrees the hair-restoration industry has a dismal reputation because it’s short on hard research and long on hard sells.
“It makes it a lot more difficult for people doing good work to get their data seen … How do you get the public to understand that this is really backed by science — which is what is so desperately needed — versus someone who just brings a product to market and licenses it under nutritional supplements, let’s say, and with strong marketing the public can be convinced that both of those are equally promising.”
Donovan advises consumers to wait for evidence from objective clinical trials before buying into anything.
And like the U.S. Food and Drug Administration-approved treatments already on the market — such as minoxidil cream and finasteride pills — anything new will probably work to some extent on some people, he predicts. Donovan has heard RepliCel’s Hoffman present early findings at a European dermatology conference and says he’s intrigued by the possibility that it could one day be added to the mix.
“These treatments don’t work in everyone and don’t work in advanced hair loss. Minoxidil works differently than Propecia (finasteride), one’s a topical treatment and one’s a pill, and the two combined work even better. So here we have a third treatment (RepliCel’s) that works even differently. It’s going to be exciting to see if it does anything and, if it does, even a little bit, then it can be combined with minoxidil as a treatment. Because anything you can do to help hair is going to be good.”
Not just for Nobel Prizes anymore A team from the Tokyo University of Science made headlines in 2012 by implanting laboratory-made human hair follicle germs on the necks and heads of bald mice which later grew tiny mohawks of straight black hair.
That work builds on the groundbreaking discoveries of 2012 Nobel Prize co-winner Shinya Yamanaka of Kyoto University, who found a way to turn mature cells from mice into immature stem cells that can then be programmed to grow into any type of cell in the body. Until then researchers had concentrated on embryonic stem cells — harvested from animal and human embryos a few days after fertilization — which are known as undifferentiated cells, capable of multiplying into all of the body’s specialized tissues.
Now labs can create induced pluripotent stem cells, meaning they are capable of becoming any type of cell, from mature human cells. That’s the basis upon which other scientists have grown liver tissue and more recently brain tissue in a laboratory setting.
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By Emma Crawford, Thu Apr 18, 2013 10:53am PST
Vancouver biotech RepliCel Life Sciences Inc. (OTCQB:REPCF)(CNSX:RP) has received a United States patent for its technology related to hair regeneration, the company announced this morning.
The company’s hair restoration procedure involves taking a small biopsy from the back of a patient’s scalp and preparing populations of “dermal sheath cup cells” that are then used to treat patients with pattern hair loss.
“The allowance of our first U.S. patent is a major achievement for our business as the United States represents the largest current market for hair restoration procedures, conservatively estimated at over $1.3 billion annually,” said David Hall, CEO of RepliCel. “The market for a permanent, non-invasive procedure like RepliCel’s is clearly significant.
“If you factor in the still-untouched market of hair loss in women, the total patients for RepliCel’s treatment would expand even further.”
The company already has patents in Australia and the European Union.
Link to article: http://www.biv.com/replicel-us-patent-issue-notification
Email: ecrawford@biv.com
Twitter: @EmmaCrawfordBIV
VANCOUVER, BC – April 18, 2013 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) (CNSX:RP) is pleased to announce that it has received issue notification from the United States Patent and Trademark Office with respect to RepliCel’s technology for preparing populations of dermal sheath cup cells for its hair regeneration procedure. These cells are used to treat patients suffering from androgenetic alopecia, also known as pattern hair loss. With the issuance of this patent, RepliCel will now have patents issued in the United States, Australia and the European Union. Additional patent applications, further protecting and expanding on our technology, are pending in the European Union, Canada, Japan, the United States, as well as other countries.
A minimally invasive treatment like RepliCel’s, that only requires a small biopsy from the back of a patient’s scalp to isolate and replicate dermal sheath cup cells, would be a highly desirable solution for male’s and female’s suffering from hair loss. According to the International Society of Hair Restoration (ISHR), the leading authority on hair loss treatment and restoration, 923,599 patients sought out treatment for hair loss in 2010, a 66 percent increase from 2004. Of this number, only 279,381 surgical hair restoration procedures were actually performed due to the highly-invasive nature of the procedure or the lack of viable hair follicles that could be harvested. Although the majority of hair restoration patients have traditionally been men, over the years more women are seeking help for hair loss. Since 2004, the number of female surgical hair restoration patients worldwide increased 24 percent.
David Hall, CEO of RepliCel states, “The allowance of our first U.S. patent is a major achievement for our business as the United States represents the largest current market for hair restoration procedures, conservatively estimated at over $1.3 billion annually. The market for a permanent, non-invasive procedure like RepliCel’s is clearly significant.” Mr. Hall goes on to say, “If you factor in the still untouched market of hair loss in women, the total patients for RepliCel’s treatment would expand even further. This patent allowance is one more critical step achieved in building value for our shareholders.”
Dr. Rolf Hoffmann, Chief Medical Officer of RepliCel comments, “This is a very significant milestone for the Company, representing the first patent allowed from our family of filed patents in the United States relating to RepliCel’s dermal sheath cup hair follicle therapy named RCH-01. This is important, as the Company will look to initiate a pivotal trial in the United States, following the completion of our Phase II dosing trial targeted to start later this year in Germany.”
About RepliCel Life Sciences
The Company has developed RepliCel™, a natural hair cell replication technology that has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. RepliCel™ is based on autologous cell implantation technology that replicates a patient’s hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, the Company hopes to initiate natural hair regeneration. The RepliCel™ procedure has been developed over the past ten years by the Company’s recognized research scientists and medical experts – specialists in the fields of hair growth, hair biology and dermatology. Additional information on RepliCel is available at www.replicel.com.
For more information please contact:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements that relate to the approval and the commercialization of the Company’s hair restoration process and the Company’s expected timeline regarding the expected commencement of the Company’s Phase II clinical trial. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2011 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on Sedar at www.sedar.com.
Phase II Dose Ranging Trial Planned for 2013
VANCOUVER, BC – February 4, 2013 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) is pleased to report that it will be meeting with the German Competent Authority responsible for cellular therapies (the Paul Ehrlich Institute (PEI)) to discuss plans for its upcoming Phase II clinical trial for its autologous hair cell product, RCH-01, on February 5, 2013.
In November, RepliCel’s scientific team had its first meeting with experts from the PEI to discuss important improvements to its current Good Manufacturing Practice (cGMP)-compliant manufacturing process for RCH-01. Tomorrow’s meeting will address updates made to the manufacturing process that were recommended at the last PEI meeting, as well as plans the Company has to conduct a Phase II clinical trial in Germany. This study is designed to confirm the efficacy of injections of RCH-01 in over 100 male participants. In addition to augmenting the Company’s information on the safety of injections of RCH-01, the trial will also provide insight into the optimal treatment regimen to increase hair growth.
“We are happy with the progress made with the design of our upcoming Phase II trial and are quite eager to get input from the PEI that will allow us to conduct the best clinical trial for the development of our product,” stated Darrell Panich, Vice-President of Clinical Affairs. “Designing a trial in consultation with the PEI will facilitate the completion of the formal clinical trial application for our upcoming trial.” The Company anticipates initiation of the Phase II study this year.
“The Company has made significant advancements in its manufacturing procedures and these improvements are expected to have a meaningful impact on our RCH-01 program,” commented David Hall, CEO. “We are committed to receiving guidance and implementing the recommendations provided by the regulatory authorities to ensure we have a well-constructed Phase II trial that will lead to the optimum dose to treat pattern baldness. Our proposed Phase II dosing trial will provide us with 288 data points as compared to 16 in our Phase I safety trial. This should allow us to isolate an effective treatment regime,” concluded Mr. Hall.
About RepliCel Life Sciences
The Company has developed RepliCel™, a natural hair cell replication technology that has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. RepliCel™ is based on autologous cell implantation technology that replicates a patient’s hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, the Company hopes to initiate natural hair regeneration. Patents for the technology have been issued by the European Union and Australia and are pending in other major international jurisdictions. The RepliCel™ procedure has been developed over the past ten years by the Company’s recognized research scientists and medical experts – specialists in the fields of hair growth, hair biology and dermatology. Additional information on RepliCel is available at www.replicel.com.
For more information please contact:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements include that RepliCel™ has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2011 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
Phase II Dose Ranging Trial on its Hair Cell Replication Technology Expected to Commence Mid-2013
VANCOUVER, BC – November 7, 2012 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) is pleased to report on its pre-filing scientific meeting with the German Competent Authority responsible for cellular therapies – the Paul Ehrlich Institute (PEI).
During the latter part of 2012, the Company has been making enhancements to the RepliCel™ procedure to improve the quality, characterization, and shelf-life of its autologous hair cell product which has been named RCH-01. RepliCel’s scientific team met with experts from the PEI on November 2, 2012 to discuss these important revisions and to receive guidance on its proposed current Good Manufacturing Practice (cGMP)-compliant manufacturing process and product specifications that will be used in the conduct of RepliCel’s upcoming Phase II, dose-ranging clinical trial. The PEI experts agreed that the proposed manufacturing process for RCH-01 is acceptable for the conduct of a Phase II study and recommended some additional validation work on the manufacturing process be included in the investigational medicinal product dossier (IMPD) that forms part of the clinical trial application.
The results achieved at this meeting have laid the groundwork for the next pre-filing meeting with PEI experts during which time RepliCel’s scientific team will discuss the design and methodology of its Phase II clinical trial to be implemented in Germany. This trial is designed to confirm the efficacy of injections of RCH-01 in over 100 male participants. In addition to augmenting the Company’s information on the safety of injections of RCH-01, the trial will also provide insight into the optimal treatment regimen for hair growth. The meeting with the PEI, and subsequent confirmation of the design of the Phase II clinical trial, will be completed prior to the end of 2012.
RepliCel’s scientific team anticipates the non-binding recommendations received at these meetings, in advance of submitting the formal clinical trial application, will help ensure that all regulatory requirements are met in order to facilitate a smooth review, approval, and implementation of future clinical research. The Company anticipates initiation of the Phase II study by mid-2013.
“We are pleased with the direction and counsel offered by the experts at the PEI,” stated Darrell Panich, RepliCel’s VP Clinical Affairs. “Our next step is to reappear before a different panel of experts at the PEI next month to obtain counsel that will assist us in finalizing the clinical design which will allow us to complete our application. We are delighted to be one step closer to the initiation of our Phase II trial.”
About RepliCel Life Sciences
The Company has developed RepliCel™, a natural hair cell replication technology that has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. RepliCel™ is based on autologous cell implantation technology that replicates a patient’s hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, the Company hopes to initiate natural hair regeneration. Patents for the technology have been issued by the European Union and Australia and are pending in other major international jurisdictions. The RepliCel™ procedure has been developed over the past ten years by the Company’s recognized research scientists and medical experts – specialists in the fields of hair growth, hair biology and dermatology. Additional information on RepliCel is available at www.replicel.com.
For more information please contact:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements and include that RepliCel™ has the potential to become the world’s first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women and that RepliCel will initiate the Phase II study by mid-2013. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: negative results from the Company’s clinical trials; the inability to meet the proposed timeline for clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statements speak only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2011 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
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DISCLAIMER:
The information in these press releases is historical in nature, has not been updated, and is current only to the date indicated in the particular press release. This information may no longer be accurate and therefore you should not rely on the information contained in these press releases. To the extent permitted by law, RepliCel Life Sciences Inc. and its employees, agents and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission.
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