Tendon

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ReaCT Trial at University of British Columbia Treating Patients with Autologous Cell
Therapy

VANCOUVER, BC – June 30, 2015 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that the first participant in its Phase 1/2 clinical trial of RCT-01, being tested for the treatment of chronic unilateral Achilles tendinosis, has been enrolled and their tissue biopsy sent for processing prior to intra-tendon ultrasound-guided injections. RCT-01 is comprised of non-bulbar dermal sheath (NBDS) cells isolated from hair follicles via a small biopsy taken from the back of the participant’s head. A total of 28 participants, male and female, will be included in this study, also known as the ‘ReaCT Trial’.

“The first participant enrollment and the subsequent booked patients are significant milestones in the development of RCT-01 and our NBDS fibroblast platform,” stated David Hall, CEO. “In parallel to the RCT-01 trial, we have a clinical trial application for a companion platform product, RCS-01, for aging and sun damaged skin currently under review by European regulators in Germany. Upon receiving approval to initiate the RCS-01 trial which is anticipated in the near future, we will have two active clinical trials based on our NBDS platform. Both of these clinical trials are designed to deliver safety, clinical, and biologic mechanistic data next year – approximately 6 months after participants receive their last injection.”

“Our RCT-01 treatment for chronic tendinosis represents a first step in developing a broad treatment platform for musculoskeletal injuries,” commented Lee Buckler, VP Business and Corporate Development. “We are looking to expand the application of our RCT-01 treatment into other indications and other markets, particularly in Japan, where we are actively seeking partners for RCT-01 to take advantage of the opportunity there for accelerated market access. RepliCel is committed to a business model of out-licensing and partnerships for the late-stage development and commercialization of all our products.”

About RepliCel’s NBDS Fibroblast Platform
RepliCel’s NBDS fibroblast platform has the potential to address numerous indications where impaired tissue healing has been stalled due to a deficit of active fibroblast cells required for tissue remodeling and repair. RepliCel’s proprietary NBDS fibroblast cells, isolated from healthy hair follicles, are a rich source of fibroblasts unique in their high-level expression of the necessary proteins, such as Type I collagen, required to jump-start the stalled healing cycle. The company is developing a series of products from this platform that have the potential to address large commercial markets in the areas of musculoskeletal and skin-related conditions. To learn more about RepliCel’s RCT-01 treatment for chronic tendinosis please watch our video.

About the ReaCT Trial
The ReaCT trial is a randomized, double-blind, placebo-controlled, single-centre study being conducted at the University of British Columbia. The study will include 28 participants, male and female between 18 and 50 years, in good health with chronic Achilles tendinosis symptoms for 6 months or more and who have completed at least three months of physiotherapy with no improvement. Study participants will receive ultrasound-guided injections of either RCT-01 or placebo (on a 3:1 treatment-to-placebo ratio) directly into areas of injury within the Achilles tendon. Participants’ overall health and tendinosis will be monitored over a six month period while they undergo post-treatment physiotherapy to help facilitate recovery from their Achilles tendinosis. To learn more about the trial and to determine if you qualify for participation please visit www.tendonstudy.com. More details on the trial design can be found on the www.clinicaltrials.gov website.

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. 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 anticipated to launch through Q1 2015 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.

For more information please contact:

CORPORATE/MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693
lee@replicel.com

This press release contains forward-looking information that involve various risks and uncertainties regarding future events, including statements regarding our approach and our technology, expected and planned upcoming milestones and events, and the timing of trials. 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. 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: approval to conduct clinical trials; approval from the University of British Columbia’s Clinical Ethics Review Board; delays enrolling clinical trial participants; 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. 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.

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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Conference program to include presentations on the clinical development of RepliCel’s skin rejuvenation, hair regeneration, and tendon repair technologies

VANCOUVER, BC – June 5, 2015 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that RepliCel’s technology founders and management will be attending the 23rd World Congress of Dermatology (“WCD”) 2015 held in Vancouver, British Columbia, Canada. This year’s congress will take place from June 8 – 13, 2015 at the Vancouver Trade and Convention Centre. The RepliCel team will be involved in multiple sessions spanning the length of this conference. Chief Scientific Officer, Dr. Kevin McElwee will be chairing a session entitled: “Hair Biology and its exploitation in health and disease” on Tuesday, June 9th from 8 – 10 AM PST in West 2015-107. Dr. McElwee will also be giving a poster presentation entitled: “Hair-follicle derived mesenchymal cells in cell therapy: multiple therapeutic applications” on Thursday, June 11th from 9 AM – 1PM PST. Chief Medical Officer, Dr. Rolf Hoffmann, will be coming from Germany to co-chair a session entitled: “Alopecia Areata” on Thursday June 11th from 2:30 – 4:30 PM PST in West 223-224. Also present at this conference will be RepliCel’s CEO David Hall, VP Business and Corporate Development Lee Buckler, and Director of Research and Development Dr. Hisae Nakamura.

“We are pleased Vancouver is host to this year’s World Congress of Dermatology and excited to be participating among the world’s leading experts advancing science and technology in dermatology. We congratulate the event organizers, and in particular Drs. Jerry Shapiro, Harvey Lui and David McLean, who were amongst the visionary founding group of our company, on putting together what promises to be an outstanding program and world-class event,” stated David Hall, CEO of RepliCel. “We look forward to the contributions of our Chief Scientific Officer, Dr. Kevin McElwee, and Chief Medical Officer, Dr. Rolf Hoffmann, the scientific co-discoverers of RepliCel’s technology, in the conference at sessions highlighting various aspects of RepliCel’s hair follicle-derived technologies.”

About World Congress of Dermatology
WCD is the world’s oldest and longest-running international dermatology meeting, with the first Congress in 1889. It is presented by the International League of Dermatological Societies and will feature over 200 scientific sessions featuring experts and companies in the medical, surgical and cosmetic dermatological fields. The WCD’s focus is to bring the interests and priorities of the dermatology industries to an international, professional focus. For more information about the congress, visit The World Congress of Dermatology website.

About RepliCel
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 aged skin, and pattern baldness. Shiseido 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 proprietary 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 anticipated to launch through Q1 2015 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.

For more information please contact:

MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696 / tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693 / lee@replicel.com

This press release contains forward-looking information. 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: approval to conduct clinical trials; 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. 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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Clinical trial at the University of British Columbia now recruiting patients

VANCOUVER, BC – May 21, 2015 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today an upcoming poster presentation at the International Society for Cellular Therapy (ISCT) on RepliCel’s autologous cell treatment for chronic Achilles tendinosis currently in a Phase 1/2 clinical trial. The presentation, taking place on May 29th from 5:30 PM to 7:00 PM local time, will review RepliCel’s RCT-01 product isolated from specific cells located in the outer sheath of the hair follicle which are highly expressive of type 1 collagen, critical to the regeneration of tendon tissue. Pre-clinical work showed a similar protein expression profile between non-bulbar dermal sheath (NBDS) cells which constitute RCT-01 and both tendon derived cells and dermal fibroblasts in terms of their ability to produce tendon-related proteins under ex vivo mechanical force (stretching). Other data to be presented includes safety data from animal studies demonstrating NBDS cells were well-tolerated, did not form tumors or migrate to secondary sites.

“Based on our animal studies and predicate clinical trials done by collaborators using dermal fibroblasts for tendinosis,” stated RepliCel’s Director of Research and Development and poster co-author, Dr. Hisae Nakamura, “we believe delivering collagen producing cells directly to the site of injury will address the underlying cause of tendinosis which will be superior to currently available treatments.”

RepliCel is now actively recruiting patients for this trial, to learn more visit www.tendonstudy.com.

Tendinosis is the most prevalent form of overuse tendon injuries, impairing 30 to 50 million people worldwide. Tendinosis results from degeneration of tendon cells and collagen fibres caused by repetitive tendon usage and aging. Currently available treatments for tendinosis are directed mainly towards pain management and facilitation of the healing process. They do not often mediate complete recovery and leave individuals immobilized for several months. Therefore, improved therapeutic strategies are needed.

The four day conference will take place May 27 – 30, at Caesars Palace in Las Vegas, Nevada. The ISCT is a global society of clinicians, regulators, technologists, and industry partners with a shared vision to translate cellular therapy into safe and effective treatments to improve patients’ lives. RepliCel supports the advancement of cell therapy not only through its breakthrough technologies, but also through active participation in industry organizations like ISCT that play a key role in shaping the future of the industry.

About ISCT
ISCT is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. ISCT is the only group focused on pre-clinical and translational aspects of developing cell therapy products. As such, ISCT helps academic, government and biotech/pharma sectors transform research into practice and product. For further information visit ISCT 2015 website.

About RepliCel
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 aged skin, and pattern baldness. Shiseido 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 anticipated to launch through Q1 2015 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.

For more information please contact:

MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696 / tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693 / lee@replicel.com

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Clinical trials underway for chronic Achilles tendinosis

By: Tammey George

Being sidelined due to an injury puts a tremendous amount of pressure on an athlete or on a team to get them back in the game as quickly as possible. Returning too soon, before adequate healing or recovery has taken place, can put the athlete at risk for re-injury and possibly an even longer down time. If this injury turns into a chronic condition it can be career ending, as was the case for Major League Soccer (MLS) Vancouver Whitecap’s captain, Jay DeMerit.

For years, DeMerit struggled with Achilles tendinosis, and often played through his pain. His injuries took him out of play for most of the 2011 season. Looking for a solution, the Whitecaps brought in physiotherapist consultant Rick Celebrini hoping that his innovative methods would get DeMerit back on the field. His efforts paid off and DeMerit was able to play the entire 2012 season. As luck would have it, DeMerit tore his left Achilles tendon in 2013, missing six months of the major league soccer season. Finally, in July 2014, DeMerit was forced to announce his retirement after his Achilles tendon ruptured. Unfortunately, DeMerit isn’t the only athlete who’s been forced into retirement due to a chronic tendon injury.

RepliCel Life Sciences, a Vancouver-based company, is conducting a clinical trial at the University of British Columbia Hospital to address chronic Achilles tendinosis. RepliCel’s cell-based treatment could be a game-changer in sports medicine, offering athletes a way to permanently repair their tendon injury by introducing new collagen producing cells into the degenerated tendon to kick-start the stalled healing process.

When an athlete has chronic tendinosis, it has generally been caused by repetitive injuries and incomplete healing cycles which leads to a degenerative breakdown of the collagen tissue within a tendon causing pain, dysfunction and often rupture.

RepliCel’s technology utilizes a rich source of fibroblast cells isolated from the patient’s own hair follicle. These cells, known as non-bulbar dermal sheath (NBDS) cells, are prolific in their expression of type 1 collagen which is the key to creating a complete healing cycle within the damaged and degenerated tendon. These injected cells are able to accomplish what the resident fibroblasts are no longer able to do – regenerate tendon.

RepliCel’s Phase 1/2 clinical trial will enroll 28 patients who have all failed traditional tendon therapy and who are otherwise in good health. NBDS cells will be isolated from a small punch biopsy taken from the back of the patient’s scalp. These cells will be replicated and then reintroduced into the damaged areas within the tendon via ultrasound guided imaging. After injections are performed, patients will undergo regular physiotherapy and will return to the clinic for assessments of safety, function and pain, as well as changes in tendon thickness, echotexture, interstitial tears and neovascularity. Measurements will be made at 1, 2, 4 and 6 months. Based on data from previous clinical studies, it is anticipated this treatment will restore a responding patient’s chronic tendinosis to a completely healed state. To learn more about this trial, and to determine possible candidacy, one may visit www.tendonstudy.com. Further indications being explored by RepliCel will include Patellar and lateral elbow tendinosis.

RepliCel is building a diverse portfolio of patented products within the field of autologous cell therapy. This includes RCT-01, a treatment of chronic tendinosis, RCS-01, a treatment for UV-damaged and aged skin, RCH-01, a treatment for pattern baldness, and RCI-02, a proprietary injector device used for a variety of dermatological applications.

All of RepliCel’s products leverage the unique biological function of hair follicle cells.

For more information, or to set-up an interview, please contact Tammey George, Media Relations

T: (604) 248-8696 / E: tg@replicel.com

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Regenerative Medicine Promises New Cure for Chronic Tendon Injuries

By Dr. Jack Taunton

A Regerative Cell therapy is now being tested on people suffering from chronic Achilles tendinosis at the Sport Medicine Clinic at the University of British Columbia. ________________________________________________________________________

Clinical researchers are testing a treatment developed by RepliCel Life Sciences called RCT-01 which is manufactured personally for each patient using specialized cells isolated from their own hair follicles. Several weeks after the collection of a single-suture biopsy taken from the back of the patient’s scalp, the product, a suspension of their own cells, is injected, under ultrasound guidance, into the injured tendon to promote its repair, Capturerestore function and eliminate pain.

It is exciting that following nearly 20 years of tendinopathy research, the medical community, at last, may have an answer for patients with chronic tendinopathy which current treatments simply cannot address.

Achilles tendinosis is a painful overuse injury that affects the lower leg. Often caused by a cycle of injury, improper healing and re-injury, chronic tendinosis is an accumulation of micro-tears which leads to structural degeneration of the tendon associated with weakness, loss of function, chronic pain and susceptibility to re-tearing and further injury.

Physiotherapy and dextrose injections are the most common treatments, but often don’t heal all the micro-tears. Up to 30 per cent of patients don’t satisfactorily improve despite following the prescribed protocols.

This is where the injection under ultrasound guidance comes into play. RCT-01 is a cell therapy product made from fibroblast cells that express high levels of Type 1 collagen – the key and missing ingredient needed to permanently heal the micro-tears and fully repair the tendon. In an injured tendon, these fibroblasts (or tenocytes as they are called when resident in a tendon) are simply exhausted and incapable of the Type 1 collagen production needed, or lay down the weak Type 3 collagen highly susceptible to re-tearing. RCT-01 is an ultrasound guided injection of fresh fibroblasts highly expressive of the Type 1 collagen needed to permanently repair the tendon and return the patient to full function.

RepliCel plans to expand clinical testing of its product to other areas of tendinosis (e.g., knee, elbow, etc.) as well as investigating both the treatment’s long-term durability and its potential to treat the more acute and inflammatory tendinitis, which often precedes the chronic condition.

To learn more, visit www.tendonstudy.com
Find the full article in Impact Magazine on Pg. 78.

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University studying the injection of cultivated cells from one’s own body to speed the healing process

By Tony Gallagher, The Province May 9, 2015

Gallagher: UBC achilles research could be key to revolutionary treatment

Rob Lloyd-Smith is one of the principal investigators into a UBC Sports Medicine study into achilles tendon repair. Photograph by: Jenelle Schneider , PRV

If you have a sore, stiff Achilles tendon, and have been through at least three months of physiotherapy which has maybe helped a little but topped out, and you have not had surgery on that area, you have a chance to help both yourself and millions of people around the world.

And if these proposed UBC clinical trials work as quickly as many involved in the research think they might, you may also be helping the likes of Dan Hamhuis and Kevin Bieksa and many other athletes who have experienced abdominal wall-groin issues, to say nothing of the many other areas of application.

The outstanding doctors at UBC Sports Medicine are looking for 28 men and women with just such an ailment situation to participate in clinical trials for a new study which has the potential to help patients with all kinds of injuries — groin, knee and tennis elbow, just to name a few. Twenty-one will be given real injections and seven will be in a control group, but after the research is unblinded, those control-group patients will have the option to get the injections because their cells will already have been harvested. But let’s explain this fairly expensive study being funded by RepliCel.

Dr. Ross Davidson, the former Canucks orthopedic surgeon for 20 years, and Dr. Jack Taunton, the former chairman of the Allan McGavin UBC Sports Medicine Clinic, are the advisers on a study which will take the patient’s own cells, culture them to allow them to multiply and then inject them into the injured area, using ultrasound to pinpoint the exact locations for said injections, with the intent of stimulating cell growth and healing in the area.

Principal investigators Dr. Don McKenzie and Dr. Rob Lloyd-Smith will take a biopsy of several hair follicles from the back of the scalp and send the biopsies to Austria, where the fibroblasts will be isolated and then cultured over a four- to six-week period to several million cells. They will then be frozen and sent back to UBC and injected under ultrasound guidance into the damaged area of the tendon, to kick-start the healing process and the formation of type 1 collagen so essential for the healing process.

The fact that fibroblasts from the linings of hair follicles produce up to eight times more type 1 collagen than fibroblasts from other cells was originally discovered by dermatologists looking to stimulate hair growth. And the UBC Sports Centre guys were contacted to see what they could do with such a find, given they had already been doing groundbreaking work in fibroblast growth.

“Fibroblasts form the lining of the tube that the hair fibre grows out of,” said Davidson. “And so what was happening was they were getting mixed in with the hair follicles in their cultures and those guys noticed these fibroblasts were also growing in that culture and they asked: ‘What’s different about these cells?’ And by doing some tests they found out these fibroblasts produced all this type 1 collagen and that’s the spinoff. That’s how this all got started.”

The UBC guys had been stimulating fibroblasts and doing dextrose as well as platelet-rich plasma injections for years, and that’s why they’re at the centre of this exciting new research.

The study is going to look at injecting these fibroblasts into a diseased Achilles where tendinosis has occurred and these micro-tears (which cause the damage) have been formed and where the healing process has run out of oomph. The cells will be injected in a patterned way (using ultrasound as a guide) to get to the right places and therefore stimulate continued healing.

“We’re starting small because immediately when you say you’re using cells, the alarm bells go off and you have to go through all kinds of regulatory approval,” said Taunton. “We’ve contacted all the necessary people and received the approval of all the appropriate bodies and we’re ready to go.”

It should be mentioned these are not stem cells but rather cellular-based regeneration. The cells have differentiated into fibroblasts and so are one step removed from stem cells and the attendant controversies.

Needless to say, if this is successful it opens up a whole new world of injury recovery applicable to all manner of athlete, to say nothing of the person on the street. To give you an example of how, take the knee sprain suffered by Ryan Miller in the later stages of this season. If he had been through this process whereby at the outset of the season he had his cells harvested and fibroblasts grown and then frozen until he needed them, those cells could have been injected into his knee after the injury and the expectation is that it would significantly shorten the time needed for full recovery. For instance, Hamhuis’s cells could be injected precisely into the groin area that needs help the most, using the same ultrasound techniques to target the right areas, thereby increasing the likelihood that increased healing would be kick-started, again improving his overall condition in the area. For all future injuries of anyone else, the cells could be immediately injected, thus speeding and increasing the entire healing process. It will be open season on all tendon injuries — and not just for athletes, for everyone.

“That’s why WorkSafe (B.C.) is and has been so interested and supportive of our work, because we have all kinds of people who are laid up by these injuries,” said Taunton. “They can’t work, their lives are significantly impacted. It has the potential to help a tremendous number of people.”

So if you fit the criteria or think you might and want to help, give UBC sports medicine a call at (604) 822-3614.

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RepliCel Targets Low-Risk, Near-Term Opportunities in Regenerative Medicine

By: Gail Dutton

The regenerative medicine company RepliCel Life Sciences is developing potential cures for chronic tendinosis, damaged or aging skin, and pattern baldness by reseeding affected areas with specific cell populations isolated from patients’ own healthy hair follicles.

RepliCel is picking the low-hanging fruit of regenerative medicine—low technological risk, underserved markets, clear clinical indications. Furthermore, commercial success is not dependent on successful reimbursement negotiations.

“On the technical level, we’re not asking these cells to do anything other than what they naturally do, or be anything more than they are,” CEO David Hall says. “These are adult, somatic cells derived from the patient which we simply isolate and grow. We’re not differentiating, genetically modifying, or manipulating these cells in any way.

At present, there is no therapy to treat the underlying causes of tendinosis, which include a deficit of collagen-producing tenocytes (fibroblasts). RepliCel’s approach to the treatment of tendinosis uses injections of cultured autologous, collagen-producing, nonbulbar dermal sheath cells into the injury site to stimulate tendon regeneration

From the scientific and manufacturing perspective, RepliCel is using the hair follicle as the cell source because the cells are simple to collect, grow well in culture, and are both relatively naive and highly functional. On a clinical level, the company is simply addressing a deficit of active cells in the patient by local delivery of cells shown to function in ways needed to solve a human condition such as tendinosis or pattern baldness.

“The cells are injected in ways and places that largely eliminate any concerns around in vivo cell migration,” explains Hall. “[This approach ensures] enough cells stay in situ and viable to affect a sustained effect.”

Indications

For tendinosis—a disrupted healing cycle of the tendon—nonbulbar dermal sheath (NBDS) fibroblast cells are isolated from a biopsy of hair follicles taken from the back of the scalp. After these cells are replicated, creating populations of millions of cells, they are injected into the wound site to jump-start the disrupted wound repair.

In early-stage trials, clinical advisory board member David Connell, M.D., used a similar approach with tendinosis patients who had been failed by other therapies. The NBDS approach returned these patients to painless, near-normal function.

In the next 18 months, Hall says he expects to conclude a Phase I/II study at the University of British Columbia involving 28 participants. As yet, there is no approved therapy that treats the underlying cause of this chronic condition.

This same NBDS platform technology also may be used to repair damaged and aging skin. RepliCel filed a clinical trial application for Germany in February.

Phase II trials to treat baldness—specifically, androgenetic alopecia—will begin this year. For this therapy, dermal sheath cup (DSC) cells are isolated from the base of the hair follicle, replicated into the millions, and injected to the area of thinning hair.

“DSC cells are responsible for maintaining the number of dermal papillae cells, which directly corresponds to the hair thickness,” Hall explains. “We are simply delivering a volume of androgen-insensitive DSC cells into an area where androgen-sensitive DSC cells have disappeared … to restore the normal hair follicle cycle.”

RepliCel’s autologous cell therapy utilizes dermal sheath cup (DSC) cells to treat androgenetic alopecia. DSC cells are responsible for the regulation of the volume of dermal papillae (DP) cells, which are responsible for the thickness and growth of a hair fiber. Another RepliCel technology uses nonbulbar dermal sheath (NBDS) fibroblast cells to treat tendinosis.

In animal studies, this approach grew hair on the feet of mice (which have no hair follicles there). When these cells were injected into their ears, the healthy cells migrated into resident hair follicles, making that hair thicker.

In humans, this approach could address existing hair follicle damage. “This is our longer-term program,” Hall stresses. RepliCel will begin a clinical trial in Germany this year involving 160 patients. Hall says results from RepliCel’s Phase I and Phase II clinical trials for chronic tendinosis and UV-damaged/aged skin are expected in 2016.

Manufacturing and Delivery

RepliCel currently uses industry-standard fetal calf serum in its manufacturing process, but is validating a serum-free process. “This is a distinguishing commercial step,” Hall asserts. “[It] adds value to our therapeutics program.” Hall notes that RepliCel anticipates licensing the process.

RepliCel is also investigating the potential of using its cells in an allogeneic setting. Hall says that a successful licensing effort could enhance both the business model and the value of company assets.
RepliCel also is developing a dermal injector to ensure controlled, consistent delivery of the cells to the skin and scalp. RepliCel expects that this device will control cell volume and delivery depth while minimizing shear force to the cells.

“We have also incorporated a Pelletier element into the tip, which reduces or removes the need for pre-injection anesthetics,” Hall informs. This second-generation injector is available for licensure. RepliCel plans to file for the CE mark in the latter half of 2015.

Partnerships

RepliCel already has a partnership with Shiseido in Japan to co-develop and commercialize RepliCel’s RCH-01 technology as a therapy for thinning hair in China, South Korea, and the ASEAN nations. RepliCel is actively pursuing similar geographically focused licensing and co-development partnerships for its other products.

It also is commercially active in Japan, where recent changes to Japanese regulations for regenerative medicine “have dramatically changed the pathway toward revenue generation,” Hall remarks. Those changes allow products that have demonstrated safety and potential efficacy in early-stage trials to gain conditional marketing approval. That lets them be sold and reimbursed up to seven years before being subjected to a final marketing approval review.

“In the current Japanese environment, we can generate data while simultaneously generating revenue and continuing to develop the same technology in the West,” Hall confides. He suggests that as a result of these regulatory changes, Japan will become important as a test bed for regenerative medicine.

RepliCel’s business model seems well-suited to Japan’s new regulatory stance for regenerative medicine. “We’re built to discover, validate, and license,” Hall states. “Commercialization is done with partners.”

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The University of British Columbia Clinical Research Ethics Board Clears Clinical Trial to Proceed with Site Initiation and Patient Recruitment

VANCOUVER, BC – April 15, 2015 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that it has received approval from the University of British Columbia (UBC) Clinical Research Ethics Board (CREB) to conduct a phase 1/2 clinical trial at the UBC Hospital.

The trial, entitled, “A randomized, double-blind, placebo-controlled, single-centre study to evaluate the efficacy and safety of RCT-01 in men and women with unilateral, chronic Achilles tendinosis” (also known as the “ReaCT study”), will investigate the potential of RepliCel’s tendon repair product, RCT-01, to treat chronic tendon injury. CREB approval clears the way for site initiation and patient recruitment into the clinical trial.

The ReaCT study will be led by an affiliated researcher, Dr. Rob Lloyd-Smith, with the Vancouver Coastal Health Research Institute (VCHRI). “VCHRI is very pleased to be supporting biotechnology in British Columbia and play a role in the development of a potential technology in cell therapy,” says Dr. Robert McMaster, Executive Director of VCHRI and Vice-President of Research with Vancouver Coastal Health.

The study will include 28 participants with chronic Achilles tendinosis. Study participants will receive ultrasound-guided injections of either RCT-01 or placebo (on a 3:1 treatment-to-placebo ratio) directly into areas of injury within the Achilles tendon. Participants’ overall health and tendinosis will be monitored over a six month period while they undergo post-treatment physiotherapy to help facilitate recovery from their Achilles tendinosis.

“I am very excited to be involved in this world-class study investigating the use of RepliCel’s autologous cell therapy for the treatment of chronic tendinosis,” stated Jack Taunton, MD, Professor Emeritus Faculty of Medicine, Division of Sports Medicine at the University of British Columbia and Director Sports Medicine at Fortius Sport & Health, acting in the capacity of clinical trial medical monitor. “For several decades, I have been proud to be part of a group of clinicians in Vancouver conducting cutting-edge research looking for better ways to treat patients with various tendinopathies. We believe cell therapy – and in particular hair-derived fibroblasts which are highly expressive of type 1 collagen – represents a promising approach to treating these patients and generating better, quicker, and longer-lasting outcomes than current treatment options. While patients will be followed-up for longer periods, by early 2016 we expect to have data giving us a clear indication of the potential for this treatment to regenerate tendon in ways currently not possible.”

“With UBC CREB approval, we can immediately take the steps needed to open this trial to patient recruitment and treatment. This is an important milestone in management’s plan to create significant value in the company through mid-2016,” stated Darrell Panich, Vice President of Clinical Affairs for RepliCel.

RCT-01 is the first of two products from RepliCel’s non-bulbar dermal sheath (NBDS) fibroblast platform currently slated to be tested in clinical trials in 2015. Subject to regulatory clearance, the second product, RCS-01, will be evaluated as a potential treatment for aged and UV-damaged skin. The company filed an application to conduct a phase 1 clinical trial of RCS-01 with the German competent regulatory authority on February 23, 2015 and is now awaiting clearance. RepliCel’s NBDS fibroblast program is a broad platform that has the potential to extend into other indications characterized by impaired tissue healing and a deficit of type 1 collagen.

RepliCel is actively targeting commercialization partners for both of these products, particularly in Asian markets at this time. The company owns all rights to these product candidates and is in active prosecution of a full spectrum of intellectual property protection around key aspects of the cell source, manufacturing, use and composition of matter.

About Chronic Achilles Tendinosis
Chronic Achilles tendinosis is a degenerative disease of the tendon. It is caused by a cycle of injury, improper healing and re-injury. It can result in ongoing pain and loss of function. Tendinosis is often caused by sports related injuries, occupational overuse, aging and poor general health. Chronic Achilles tendinosis affects both physically active and inactive individuals accounting for 30 to 50% of all sports injuries and 50% of occupation-related disorders in the United States.

Healthy functioning tendon is comprised largely of highly structured type 1 collagen supported by the repair and maintenance functions of resident fibroblasts. In chronic tendinosis, it is believed that the resident fibroblast population is insufficient to complete the required healing. The basis of the RCT-01 treatment is to augment the resident fibroblast population in the damaged tendon with fibroblasts which are easily isolated (from the hair follicle), readily expanded, and highly expressive of the type 1 collagen and other extracellular proteins needed to reignite the healing process and support the regeneration of tendon.

About the UBC Clinical Research Ethics Board (CREB)
The UBC CREB reviews clinical research conducted at UBC’s Vancouver campus and at Vancouver Coastal Health Authority sites including UBC Hospital, Vancouver General Hospital and GF Strong. Activities that fall under UBC CREB review include: the administration or testing of drugs, medical devices, medical imaging or diagnostic techniques; and the taking of blood or other specimens. It also includes the analysis of laboratory, physiological, kinesiological or biological data obtained from physical interventions, medical records or clinical studies involving the linkage of data from existing databases.

About Vancouver Coastal Health Research Institute (VCHRI)
VCHRI, a world leader in translational health research, is the research body of Vancouver Coastal Health Authority. VCHRI includes three of BC’s largest academic and teaching health sciences centres — Vancouver General Hospital, UBC Hospital, and GF Strong Rehabilitation Centre — as well as many other hospitals and public health agencies across Vancouver Coastal Health. VCHRI is academically affiliated with UBC Faculty of Medicine and is one of Canada’s top funded research centres receiving between $80-100 million in research funding annually. Over 1500 personnel are engaged in a variety of research centres, programs and evolving research areas. www.vchri.ca

For more information please contact:

CORPORATE/MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693
lee@replicel.com

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New Treatment for NFL Players and Pro Athletes Offers New Hope

Story by: Jo-Carolyn

New York, NY, January 26, 2014 – Reversing career-ending injuries like chronic tendinosis, a common medical condition caused by a cycle of incomplete healing and re-injury that leads to a painful degenerative state, is the focus for RepliCel Life Sciences Inc., a clinical stage regenerative medicine company. Tendinosis is often caused by sports related injuries, occupational overuse, aging and poor general health. Chronic Achilles tendinosis can affect both physically active and inactive individuals, accounting for 30 to 50% of all sports injuries and 50% of occupation-related disorders in the United States.

Replicel is proud to announce they recently received a No Objection Letter from Health Canada that will allow them to proceed with a clinical trial investigating the use of RCT-01 to treat patients suffering from chronic Achilles tendinosis. “The trial will include 28 patients who have this condition and have undergone physiotherapy with no improvement. We will be giving them a single injection, directly into the Achilles tendon using ultrasound guided imaging, of replicated collagen producing fibroblast cells isolated from the dermal sheath of their own hair follicles,” said CEO David Hall.

The injected fibroblasts should promote the healing process by producing proteins that are necessary for restoring tissue’s structural integrity as well as type I collagen fibers which orientate themselves along the direction of the stretch of the tendon. “The anticipated long-term outcome is the return of normal tendon structure, improved function and zero pain,” adds Hall.

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. They appointed respected leaders in the field of treating tendinopathies to support the clinical development of its RCT-01 autologous cell therapy. Their newest Clinical Advisory Board Member is Jack E. Taunton, M.D. A visionary and leader in the field of sport medicine, Taunton is a Professor in the Faculty of Medicine, Division of Sports Medicine at the University of British Columbia and has a clinical practice in sports medicine. He served as Chief Medical Officer at Vancouver’s 2010 Winter Games. A marathon runner himself, Taunton became interested in medicine after surviving polio as a child and a severe car crash as a teen.

An approach using autologous cell therapy has never been tried before but Hall and Taunton are eagerly looking forward to results from the clinical trials. RepliCel successfully pioneered regenerative cell therapy as a non-invasive cure for hair loss; that work launched this innovative treatment. To learn more about the study please visit www.tendonstudy.com, or for information on regenerative cell therapy for tendons, please visit: http://www.replicel.com/product-pipeline/rct-01-tendon-repair/.

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To listen to the full interview, click here or view the file below.

CEO & President Mr. Hall was interviewed on ESPN New York Radio – the Worldwide Leader in Sports News, discussing how RepliCel’s cell therapy treatment could help professional athletes resolve their chronic tendon injuries.

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Meetings focused on investors, analysts, and potential partners for RCS-01 and RCT-01 cell therapies

VANCOUVER, BC – January 7, 2015 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies announced today that CEO and President, David Hall, and Vice-President of Business and Corporate Development, Lee Buckler, will be representing RepliCel Life Sciences Inc. at the Biotech Showcase 2015, January 12-14th in San Francisco, CA at the Parc 55 Wyndham in Union Square.

Hall will be presenting Monday, January 12th at 2:30 PM (ET) at C – Mission II on the 4th floor, providing updates on RepliCel’s clinical programs for chronic Achilles tendinosis (RCT-01), sun damaged and aging skin (RCS-01), and pattern hair loss (RCH-01) in addition to the development of its own proprietary injection device.

“The Biotech Showcase has become a central hub for the regenerative medicine industry during this healthcare investment week in San Francisco,” stated RepliCel CEO, David Hall. “It begins with the Alliance for Regenerative Medicine Industry Briefing on Monday morning and is followed by a series of public and private company presentations over the course of the conference including RepliCel Life Sciences.”

“We are pleased to use the opportunity next week presents us to drive our partnering discussions forward,” stated RepliCel VP, Lee Buckler. “2015 will be a busy year in terms of our clinical programs and data read outs and this week provides an opportunity to advance our company’s programs with analysts, bankers and potential development partners.”

The Biotech Showcase is one of the largest annual healthcare investor conferences and partnering meetings, dedicated to providing both public and private life sciences and biotechnology companies the opportunity to meet and present to investors and executives in the pharmaceutical industries. In its seventh year, Biotech Showcase is expected to attract upwards of 1,700 attendees and over 1,100 companies engaged in one-on-one meetings, plenary sessions, workshops and networking.

About RepliCel
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 aged skin, and pattern baldness. Shiseido 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 anticipated to launch through Q1 2015 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.

For more information please contact:

MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693
lee@replicel.com

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Written By: James West

Listen to the full interview here.

RepliCel’s VP Lee Buckler explains the excitement among company stakeholders surrounding upcoming trials of RepliCel’s autologous cell therapy approach to chronic Achilles tendinosis, and other catalysts in 2015. RepliCel received Health Canada approval for the clinical trial to go forward on December 1st, 2014.

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Using Your Own Cells to Heal Tendon Injuries

RepliCel is developing an autologous cell-based product for the treatment of chronic Achilles tendinosis. This treatment has the potential to restore a patient’s chronic tendinosis to a completely healed state. To learn more watch our two minute video.

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Health Canada Issues “No Objection Letter” for RepliCel’s Phase 1/2 Clinical Trial of RCT-01

VANCOUVER, BC – December 1, 2014 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, today announced that it has received a No Objection Letter from Health Canada providing its clearance to proceed with the Company’s proposed phase 1/2 clinical trial investigating the use of RCT-01 to treat patients suffering from chronic Achilles tendinosis. The study entitled, “A randomized, double-blind, placebo-controlled, single-centre study to evaluate the efficacy and safety of RCT-01 in men and women with unilateral, chronic Achilles tendinosis” (known as the “ReaCT” study), investigates the potential of RCT-01 to treat chronic tendon injury. The ReaCT study has been submitted to the University of British Columbia (UBC) Clinical Ethics Review Board (CREB) for its review and required approval prior to study initiation at the University of British Columbia Hospital.

The ReaCT study is anticipated to include 28 participants who will receive either an injection of RCT-01 or placebo (on a 3:1 treatment-to-placebo ratio) directly into the Achilles tendon using ultrasound guided imaging. Participants’ overall health and tendinosis will be monitored over a six month period while they undergo post-treatment therapy to help facilitate recovery from their Achilles tendinosis. Depending on the time required to enrol the study participants, the Company anticipates this treatment follow-up period could be complete as early as the latter part of 2015. To learn more about the study please visit www.tendonstudy.com.

“Health Canada’s No Objection Letter for RepliCel’s ReaCT trial within 30 days of the Company’s first clinical trial application not only supports the technology, but evidences the great work done by the clinical team in terms of the trial design,” commented Dr. Ross Davidson, Chair of RepliCel’s RCT-01 Clinical Advisory Board and retired Clinical Professor, Department of Orthopaedics, UBC. “I have seen first-hand the limitations of the current standard of care for a significant percentage of chronic tendinosis patients whom remain refractory to any available treatment. The ReaCT trial marks a milestone in the advancement of regenerative medicine for the treatment of tendinosis and offers the very distinct possibility of a new treatment paradigm for this difficult and often debilitating condition. I expect this trial focused on chronic Achilles tendinosis to be the first step in addressing other debilitating tendon injuries in the future,” concluded Dr. Davidson.

“The design of this trial has benefited from contributions from an outstanding group of key opinion leaders, including our clinical advisors and principal investigators, who provided expertise on the trial’s design, implementation, and several other critical parameters,” stated David Hall, President and CEO of RepliCel. “The ReaCT trial represents an important step in the development of a series of products based on our non-bulbar dermal sheath (NBDS) fibroblast technology platform with the potential to address large commercial markets in the areas of musculoskeletal injury and disease. In conclusion, the initiation of the ReaCT trial triggers a significant series of asset-building steps over the next 18 months covering clinical and business milestones.”

RCT-01 is the first of two products from RepliCel’s NBDS fibroblast platform currently slated to be tested in clinical trials in 2015. Subject to regulatory clearance, the second product, RCS-01, will be evaluated as a potential treatment for aged and sun-damaged skin. The Company anticipates filing this clinical trial application with the German competent regulatory authority in the near future. RepliCel’s NBDS fibroblast program is a broad platform that has the potential to extend into other indications characterized by impaired tissue healing and a deficit of type 1 collagen.

RepliCel is actively targeting commercialization partners for both of these products, particularly in Asian markets. The Company owns all rights to these product candidates and is in active prosecution of a full spectrum of intellectual property protection around key aspects of the cell source, manufacturing, use and composition of matter.

The RCT-01 and RCS-01 trials are in addition to the Company’s proposed phase 2 clinical trial evaluating RCH-01 for the treatment of pattern baldness; a trial the Company anticipates will involve over 160 patients and launch early next year in conjunction with Shiseido’s clinical trial of the same product in Japan under the terms of its co-development and licensing agreement with RepliCel.

Healthy functioning tendon is comprised largely of highly structured type 1 collagen supported by the repair and maintenance functions of resident fibroblasts. In chronic tendinosis, it is believed that the resident fibroblast population is insufficient to complete the required healing. The basis of the RCT-01 treatment is to augment the resident fibroblast population in the damaged tendon with fibroblasts derived from the patient’s own hair follicle. These particular fibroblasts are easily isolated and expanded in addition to being highly expressive of the type 1 collagen and other extracellular proteins needed to reignite the healing process and support the regeneration of tendon for patients suffering from chronic tendinosis.

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. 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 anticipated to launch through Q1 2015 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.
For more information please contact:

CORPORATE/MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693
lee@replicel.com

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To read the full report, click here: R. Lee Bucker on RepliCel Life Sciences

Regenerative medicine and cell therapies hold possibilities for achieving near miracles in a multitude of indications, from life-saving treatments to aesthetic applications. RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB) is tackling a mix of medical and cosmetic issues that include hair regeneration, repair of painful and debilitating tendon injuries and rejuvenation of damaged skin. In this interview with The Life Sciences Report, R. Lee Buckler, the company’s new vice president of business and corporate development, discusses his firm’s innovative technology platform and the upcoming milestones that could affect its shares.

The Life Sciences Report: Lee, you’ve made a recent career change and are now an executive at RepliCel. Tell us about that.

R. Lee Buckler: As of Oct. 7, I have been appointed vice president of business and corporate development for RepliCel Life Sciences Inc., which is engaged in development of cell-based regenerative medicine therapeutics in Canada, Europe and Japan through our licensing partner, Shiseido Company Ltd. (4911:TSE). I found RepliCel to be a very interesting company poised to go on an exciting run, and that enticed me to join the team.

TLSR: Prior to your work with RepliCel, what experience had you had in the cell therapy industry?

RLB: In 2000, I left the practice of law to join Allen Eaves in the Stem Cell Technologies group of companies, where I ran a company called Malachite Management Inc. In 2006, I was recruited by Progenitor Cell Therapy to run its business development, marketing, communication and sales before the NeoStem acquisition.

In 2008, I founded my own consulting firm, called the Cell Therapy Group (CTG), which focused exclusively on the cell therapy industry. In the early days, we did some communications work for clients, but for the bulk of my tenure with CTG, we were involved in a wide range of planning and business development work. Some of it was transactional, but other aspects included market and competitive intelligence, building strategies, identifying partners, targeting partners, engaging in partnership discussions on behalf of clients and the like. I also worked with fund managers and investors through education, namely technology and platform explanations.

“RepliCel is a very interesting company poised to go on an exciting run, and that enticed me to join the team.”

Over the past year, I worked as a consultant and on the board of directors positioning TheraVitae Inc. (private) for a merger with a company listed on the Toronto Venture Exchange. The merger is expected to complete in early November, and the company will be renamed Hemostemix Inc. I helped TheraVitae raise several million dollars as part of that process. Being on the road giving presentations to prospective investors is a new skill set for me, but I’ve found I really enjoy this side of the business.

TLSR: You are an attorney by training, but I see from your curriculum vitae that you did a couple of stints as a medical laboratory technician while you were still in law school. Is that what led you to the life sciences field?

RLB: Yes. I always joke with people that I didn’t get to the cell therapy/regenerative medicine industry through education—I got here more by osmosis. I was not a silver spoon kid; I had to work my way through school. So while I was studying to be an attorney, I ended up working in the lab of a leading cardiovascular investigator, who was involved in some clinical trials at the time. I was mainly doing grunt work, but it exposed me to an environment where people were extremely dedicated to their sciences and to doing something novel. I was exposed to the excitement that builds when people truly believe what they’re doing could revolutionize the way people are treated.

I’ve always felt a little bit like an outsider in an industry of people who belong here. While that may feel uncomfortable from time to time, it also affords me a unique perspective that others don’t have. While others in the industry tend to focus on vertical specialties, I’ve come to specialize in a macro view of this industry. My focus has been very horizontal, which gives me a perspective of the industry that not many people are able to see.

TLSR: What kind of work has RepliCel been doing in the cell therapy field?

RLB: When CEO and President David Hall took over the company in 2011, it was built around hair regeneration. That is still an important part of our portfolio; however, he had a vision for broadening the technology and building a platform, which the company has now executed.

We are preparing to launch a very significant Phase 2 trial using our RCH-01 (dermal sheath cup [DSC] cells) for hair regeneration. This is a cellular injection—a cell transplant rather than a hair transplant—and is an important evolution because hair transplant is limited by three very significant factors. First, when transplanting hair follicles from one location on your scalp to another, there are only so many follicles available to harvest. With a cell transplant, there is no limit to the number of cells we can grow to use in regenerating poorly functioning hair follicles. Second, hair transplantation only achieves a satisfactory result when performed by a gifted surgeon, of which there are few. A simple cell injection takes the art out of the procedure—particularly when combined with our proprietary injection device designed to optimally deliver the cells into the scalp. Finally, hair transplantation is not an option women find attractive for a number of reasons, and a significant population of women suffer from hair loss.

TLSR: How is RepliCel working to ensure this therapy will be effective in both the short and long term? What prevents the dermal sheath cells from ceasing to grow hair once they are in the locale where the original follicles quit producing hair?

RLB: The cells we are using to address pattern baldness (androgenetic alopecia) are taken from a cell population found at the base of the hair follicle. These DSC cells are used to produce our RCH-01 product. Research has demonstrated that these cells are responsible for the reorganization of the hair follicle, which is a mini-organ that organizes upon an unknown signal. Our research leads us to believe this cell population is responsible for hair regeneration.

We source our particular cells from hair follicles isolated from the back of the scalp, between the ears, because most balding people retain this area of hair. This hair is insensitive to the androgen hormone (DHT), which causes hair loss, making these hair follicles prime candidates for our hair regeneration product.

“We are preparing to launch a very significant Phase 2 trial using our RCH-01 (dermal sheath cup [DSC] cells) for hair regeneration.”

As to the question of whether this will be a durable response—how long the hair will last—this is one of several questions both we and Shiseido are targeting in our respective upcoming pattern baldness trials. We’re designing this next phase to look at dosing. We’re also looking at frequency of treatment: One cohort of the study gets a single treatment, another gets a second treatment at day 91.

But we’ll also be following these patients for a considerable length of time, to see whether the intended effects are maintained or whether they diminish over time. Even though there are only a proposed 160 participants, utilizing different dosing and different injection points throughout the scalp, there will be 396 treatment sites, or data points, that we will be able to gather from those 160 patients, in addition to the data to be gleaned and shared from the trial Shiseido is funding in Japan. These questions are great—effectiveness and duration of effect—and we have an obligation to answer them, which is why the trials are designed the way they are.

TLSR: What else is RepliCel working on at the moment?

RLB: We have another population of cells derived from the hair follicle (the non-bulbar dermal sheath cells [NBDS cells]) that we believe is a platform capable of generating multiple products for various indications. These cells can be readily expanded, and it turns out they are highly expressive of type 1 collagen. Our first trial with these cells will be using our RCT-01 product for the treatment of chronic Achilles tendinosis.

Up to 90% of healthy tendon is comprised of well-constructed type 1 collagen, and a number of indications manifest in patients due to the loss of type 1 collagen production in the endogenous cells, one of which is Achilles tendinosis. Tendons often are not well vascularized, and after a series of injuries and as a patient ages, the endogenous fibroblasts are exhausted of their ability to continue to produce the type 1 collagen necessary to support healthy tendons. RepliCel’s predicate science is built around the injection of autologous (harvested and administered back to the same patient) fibroblasts capable of producing the kind of collagen needed to restore the patient to healthier function and better pain scores.

TLSR: Do you have evidence of actual tendon regeneration?

RLB: In three tendinosis-related clinical trials performed using a similar cell type, which has now been licensed into the company, MRI imaging shows that tendon treated with this cell type was much more akin to healthy, young, functioning tendon than what the patients had prior to injection of cells. This is an exciting platform, and the company is about to launch a Phase 1/2 trial in chronic Achilles tendinosis. We believe the cells could also have application in other indications, including jumper’s knee, golfer’s elbow, tennis elbow and torn rotator cuffs, as well as in a number of dermatological applications. Late this year, we will launch a Phase 1 study in healthy volunteers to look at the ability to regenerate the underlying tissue of skin in patients who have aging or sun-damaged skin.

TLSR: Achilles tendinosis and androgenic alopecia are very different indications. Androgenic alopecia is a hormone-dependent condition, while Achilles tendinosis is trauma-related.

RLB: That’s a great point. Even though both of these studies—tendon repair and hair regeneration—use cells derived from the hair follicle, we’re working with two very different cell populations. As a result, they have the ability to elicit very different, targeted responses.

TLSR: RepliCel’s shares have suffered considerably over the past six months. What caused the dip and what is the company doing to fix the issue?

RLB: The fact of the matter is the company was delayed in progressing to its Phase 2 trial for RCH-01 in hair regeneration because of an issue with the supply of a critical growth media. The new media wasn’t producing the same results, so we had to go back to the drawing board and discover what the problem was. The comparability data is now coming in to support our belief that we’ve solved that problem. We have four trials expected to launch in the next few months (three of ours and one of Shiseido’s). Two of these are expected to give clinical readouts late next year. Until we are a company executing clinical trials, we are a company talking about executing clinical trials, and certain investors grow understandably impatient.

“We have another population of cells derived from the hair follicle that we believe is a platform capable of generating multiple products for various indications.”

I’m very pleased that in October we submitted an application to Health Canada for the proposed Phase 1/2 clinical trial for chronic Achilles tendinosis. This triggers a 30-day window during which Health Canada can provide a No Objection Letter allowing us to proceed with the trial. This event is the initial trigger for a cascade of catalysts anticipated over the following months related to this trial, as well as our proposed Phase 1 clinical trial in Germany for aging and sun-damaged skin, our proposed Phase 2 trial for pattern baldness (androgenetic alopecia) in Germany, and Shiseido’s upcoming trial for pattern baldness in Japan. We’ve been on the road for several weeks, crisscrossing the U.S., Canada and Japan, talking to investors, analysts and potential partners. We are pleased with the level of interest being generated, and believe that once we demonstrate we are executing on schedule, we will generate increased support.

TLSR: Is it possible that all these milestones will be met by the end of 2014?

RLB: We are working very hard to make that happen. I believe we’re on target to have our three clinical trial application filings submitted by year-end. We expect Shiseido to file its clinical trial application early in Q1/15.

We are, of course, dependent on regulatory clearance to initiate any trial, but we have had very active dialogues with the regulators overseeing all our proposed trials, and are submitting precisely what has been discussed. As mentioned, we have now filed the first of our three applications. The second trial application proposes to use a product (RCS-01) developed from the same platform technology, so the clinical-regulatory team can leverage much of the work already done to get the second application filed.

One thing to note is that the dermatology and tendinosis trials are relatively quick studies to enroll. We’ve been in constant dialogue with the principal investigators of the RCT-01 trial in chronic Achilles tendinosis, and they assure us there’s a pipeline of patients waiting to enroll in the study. The RCT-01 tendon trial is going to be a 28-participant study, and the RCS-01 in skin rejuvenation is a proposed 28-participant study design as well, but using healthy volunteers. The RCH-01 hair regeneration study is going to extend over a longer period of time, because it targets 160 participants. But the RCT-01 and RCS-01 studies will be relatively quick to enroll and to follow up on, and we expect data in 2015 for both of those.

Both of these studies are randomized, placebo-controlled and specifically designed to provide measurable and material biologic and mechanistic data that we will use to drive partner discussions. Remember that the company’s business model is to codevelop assets with partners who understand the markets and have proven commercialization capabilities.

We are excited about being in the position we are now in, poised to imminently execute on three clinical trials, finalize the development and validation of our propriety injection device (which has licensable applications for acellular injectables), capitalize on our partnership with Shiseido and the innovative regulatory pathway for regenerative medicines in Japan, which provides a window to early-market access for our pattern baldness treatment, and to execute on one or more additional licenses with codevelopment partners in the near term.

TLSR: Thank you very much for your insight, Lee.

RLB: Thank you.

R. Lee Buckler is vice president of business and corporate development with RepliCel Life Sciences Inc. Prior to working with RepliCel, he was the managing director of Cell Therapy Group, a firm he formed in 2008, where he did business development consulting for companies and organizations in or interested in the cell therapy sector. Buckler served six years as executive director of the International Society for Cellular Therapy, and just over two years as director of business development for Progenitor Cell Therapy. He is on the editorial advisory boards of the journal Regenerative Medicine and the BioProcess International magazine, as well as the co-chair of the Alliance for Regenerative Medicine’s Communications and Education Committee. Buckler cofounded Cell Therapy News, founded Cell Therapy Blog, cofounded Regenerative Medicine Jobs, founded and continues to manage the LinkedIn Cell Therapy Industry Group, and is an active industry commentator in publications and in social media. He serves on numerous industry conference advisory boards, is an advisory board member for BioCision and RoosterBio, and is on the board of directors for Hemostemix. He has a bachelor’s degree in education and a law degree.

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DISCLOSURE: 1) George S. Mack conducted this interview for Streetwise Reports LLC, publisher of The Gold Report, The Energy Report, The Life Sciences Report and The Mining Report, and provides services to Streetwise Reports as an independent contractor. He owns, or his family owns, shares of the company mentioned in this interview: None. 2) RepliCel Life Sciences Inc. paid Streetwise Reports to conduct, produce and distribute the interview 3) R. Lee Buckler had final approval of the content and is wholly responsible for the validity of the statements. Opinions expressed are the opinions of R. Lee Buckler and not of Streetwise Reports or its officers. 4) The interview does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. 5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their families are prohibited from making purchases and/or sales of those securities in the open market or otherwise during the up-to-four-week interval from the time of the interview until after it publishes.

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Autologous cell therapy, RCT-01, to be investigated for treatment of tendinopathies refractory to other treatments

VANCOUVER, BC – October 29, 2014 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, today announced the submission of a Clinical Trial Application to Health Canada requesting clearance to initiate a Phase 1/2 clinical trial investigating the use of RCT-01 to treat patients suffering from chronic Achilles tendinosis.

The study entitled, “A randomized, double-blind, multi-centre dose-finding study to evaluate the efficacy and safety of RCT-01 in men and women with unilateral, chronic Achilles tendinosis” addresses the inherent deficit of active fibroblasts required to regenerate healthy functioning tendon after injury. The trial, to be conducted at the University of British Columbia (Canada), will measure several safety and efficacy endpoints following a single injection of RCT-01.

“We believe that RCT-01 has the potential to complete the disrupted healing process in patients with chronic tendinosis resulting in a normally functioning tendon with higher tensile strength – ultimately returning the patient to full normal tendon use,” commented Dr. Rolf Hoffmann, Chief Medical Officer. “Successfully treating chronic Achilles tendinosis will lead to therapies for a number of other indications including patellar tendinosis, or ‘jumper’s knee’, and both lateral and medial elbow tendinosis.”

Chronic Achilles tendinosis is a degenerative disease of the tendon caused by a cycle of injury, improper healing and re-injury resulting in ongoing pain and loss of function.

Healthy functioning tendon is comprised largely of highly structured type 1 collagen wherein resident fibroblasts play a significant role in repair and maintenance. In chronic tendinosis, it is believed that the resident fibroblast population is insufficient to complete the healing cycle. RCT-01 is based on fibroblasts derived from the patient’s hair follicle. These particular fibroblasts are easily isolated and expanded and are highly expressive of type 1 collagen and other extracellular proteins which are needed to reignite the healing process and support the regeneration of tendon for patients suffering from chronic tendinosis.

“Our RCT-01 trial represents the start of our fibroblast clinical program and it will soon be followed by RCS-01, a trial for aging and sun damaged skin. This fibroblast-based program should be viewed as a broad platform upon which we can move into other indications where impaired tissue healing is the underlying condition,” stated David Hall, CEO. “These trials, designed to measure safety and various clinical outcomes at 6 months post injection, will reveal data next year leading toward the establishment of the broad commercial value of our fibroblast platform.”

Final details of the clinical program evaluating the safety and efficacy of intra-tendon injections of RCT-01 for treating chronic Achilles tendinosis will be disclosed after it has been cleared by Health Canada.

A recent study published in the British Journal of Sports Medicine estimated the incidence rates of Achilles tendinopathy to be .235% of the general adult population (21-60 years) in the Netherlands. If applied to the North American population this would translate into approximately 530,000 people suffering from this condition at any given time.

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 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.

For more information please contact:

CORPORATE/MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

INVESTOR RELATIONS:
Christina Cameron, Investor Relations
Telephone: 604-248-8730
christina@clcameron.com

This press release contains forward-looking information that involve various risks and uncertainties regarding future events, including statements regarding our approach and our technology, expected and planned upcoming milestones and events, and the timing of trials. 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. 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: approval to conduct clinical trials; 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. 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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To listen to the full interview podcast and read the transcript click here: Midas Letter Interviews David Hall

Full Transcript:

James West: Let’s start off with an overview of exactly what the value proposition is for investors in RepliCel?

David Hall: RepliCel Life Sciences is an autologous cell therapy company that is developing treatments for aging and sun-damaged skin, chronic tendinosis…so any kind of tendon injury that people can imagine, and pattern baldness for males and females. I suppose the near-term catalytic investment proposition is that we’re within days of filing a clinical trial for chronic tendinosis in Canada, and that will be followed in a few weeks with a filing for a clinical trial in Europe for aging and sun-damaged skin, and then later on this year we’ll get into our Phase II trial for pattern baldness. So a lot of things happening.

James West: Yeah. That’s quite a broad mix of applications for one product. What is the essential technology? What is it all centered around?

David Hall: The technology comes from isolating specific cells from the human hair follicle. In the case of treating chronic tendinosis or sun-damaged skin, it all relates to a cell called a fibroblast, which we isolate from the sheath of a hair follicle, and these particular fibroblasts – which can also be isolated from other parts of the body – these particular fibroblasts are particularly proficient at producing type I collagen, which is the major substance structure of a tendon – it’s about 90% of the tendon – and of the skin itself. So in the case of a tendon, we’re healing that chronic wound, in the case of sun-damaged skin, we’re actually re-establishing the volume of fibroblasts in the dermis that produce the required proteins and type I collagen to give skin texture. So kind of like turning the clock back, if you will, for our aging and sun-damaged skin program.

James West: Interesting. Okay so how does RepliCel monetize this technology?

David Hall: It’s very straight forward. The company is designed to produce data on safety and efficacy, and take that data and go out and partner it. It is a platform technology where we can take our cells into other indications. Really if you demonstrate safety and efficacy in one fibroblast indication, for example, you’ll be able to take it into a bunch of other things like all of the different tendons, all of the different skin issues including scarring and acne, and burns and all sorts of issues with the skin, as well as things like periodontal disease which is a growing concern for health populations and health payers these days. And of course in terms of pattern baldness, we’ve already monetized it in the sense that we’ve licensed to Shiseido Corporation for Japan and Southeast Asia our cell treatment for pattern baldness, and they themselves are starting their own clinical trials in the not-to-distant future, so there’ll be two clinical trials developing dosing and frequency for that treatment. And once you get that kind of data, you can turn around and sell it for up-front payments for ongoing royalty payments, various sales milestones payments – so there’s lots of ways to monetize it. What we’re not doing is going out and building big factories and trying to build sales forces ourselves. The greatest value for the shareholder is actually to license this technology out at that sort of Phase II data point, of which we’ll get two sets of data next year that will be in that area.

James West: Okay so are you – is there substantial revenue at this point?

David Hall: Ah, no it’s a capital consumer like most biotech’s, although we did take a $4 million up-front payment from Shiseido, but that’s the nature of this game. You consume capital to a certain point in time, and then you produce data that says, well, this is now worth $100 million, $200 million, $300 million, $400 million – those are the kinds of metrics that you get in a biotech company. We know that for example on the derm side of the world, there’s already been one program approved for a company called Fibrocell (NASDAQ:FCSC) with respect to the smile lines in the face. So we know we can get approved through the FDA – that’s not a problem. And we think we have a much more prolific cell in terms of the fibroblast that we’re using. There are partnerships – lots of partnerships – that are coming into the regenerative medicine space. There’s market cap companies like Mesoblast Ltd. (ASX:MSB) (OTCMKTS:MBLTY) that’s over $1 billion, so there’s a vast array of market caps, but all of those examples as you get larger, all relate to delivering data, getting into clinics where there’s anticipation of data. It’s not unlike the junior oil and gas business, or a mining property, where there’s drilling, and you get that early evidence of an asset, and then you have to drill it out, and so we’re in the process of drilling it out, because we have that early asset. That’s probably a good analogy.

James West: Mm-hmm. Okay so let’s talk about that a bit. So analogous to what major market cap companies did you say that RepliCel is similar to?

David Hall: As I said, Fibrocell has a market cap around $100 million. They have a fibroblast treatment for the face – that’s one of our indications that we think we can improve on. There’s companies like Mesoblast Limited (ASX:MSB; USOTC:MBLTY) that are over $1 billion and they’re much more sophisticated – well not necessarily more sophisticated – they’re using bone marrow derived mesenchymal stem cells. We’re actually just using a target cell and we’re just making more of them. So we have a lower safety hurdle, but that’s an example of a company that is a leading one. And then there’s, other companies in between, like the Israeli company called Pluristem Therapeutics Inc. (NASDAQ:PSTI) – Nasdaq-listed, $200 million market cap, and they’re basically using placenta-derived stem cells. What we’re doing in contrast to all these other companies, is just simply taking a specific cell from the patient, and making more of them, and then moving them into the area where they’re required. So in the case of tendinosis, there’s a lack of these fibroblasts, and we can isolate really prolific fibroblasts, and replicate them and stick them directly into the wound.

The same concept as with the skin, or with a burn or with scarring acne. And with the case of pattern baldness, there is a specific cell that is missing in those people who are affected by androgen – it’s called a ‘dermal sheath cup cell’. We take androgen insensitive dermal sheath cup cells from the back of the head, replicate them and then inject them into the top to replenish a population of unhealthy dermal sheath cup cells to rejuvenate the hair follicle that’s been losing the thickness and the size of the fiber growth that comes from that hair follicle. So it’s really elegantly simple science, and it’s just a matter of us executing now, and that’s what we’re doing. We’re going into two clinical trials, our Japanese partner will start one later this year, so a lot of activity.

James West: Okay so let’s focus for a moment on the pattern baldness concept. I mean I would just think that if you came up with a cure, I mean a real cure, for pattern baldness that you would have yourself a very valuable company on your hands. Now has your strategy or your approach to pattern baldness been tested on human beings at this point?

David Hall:Yes. We actually did a 16 patient Phase 1 study, which is the basis of the data that we’re using for our Phase 2 study, as well as the data that’s being used by Shiseido Company in Japan to file for their trials. So in that safety trial that was 16 patients – only 16 data points – we had an average density growth in 6 months, which is all the trial went for in terms of the safety measurements – of 11.8%. Now, by contrast, the very best you get with the current drug therapies of Minoxidil or Rogaine – is about 16% and Finisteride, which is for Alapecia, is only about 14%. And those are over 12 months. So we know that we’re going in the right direction in terms of the density, and indeed about 70% of the responders were above 10%. And they averaged around almost 15%.

So we know we’re going in the right direction, and that was only with 16 patients. Now, the next step for us, is a 160-patient trial that will measure frequency and dosage. We need to determine if you have to give more than one injection to get a serial conversion of healthy hair follicles? And the other aspect is determining the best dosage so we will be testing three different doses. And that’s going to give us 390 data points versus the 16 that we had before, so we know we’ll have far greater data that will tell us what is the dose and what is the frequency, in order to treat somebody and get their hair follicles basically converted over to a population of androgen-insensitive cells. And androgen is the problem. No one knows why, but in some people androgen causes pattern baldness, and in some cases androgen causes people to have undesirable growth on different parts of their body. You know, it’s just how humans are. But we do know that the cells at the back of the head are completely androgen insensitive, and if you take those cells, replicate them, and put them up into the area of the pattern baldness, the goal is to let that population recruite into every hair follicle fiber cycle, and basically rejuvenate the population of cells that have been previously compromised by androgen. Again, very simple concept – now we just have to execute and figure out what dose, and what frequency.

James West: Yeah okay so is it looking to you like a complete cure? I mean so is a guy who’s bald as a cue ball going to be able to grow hair down to his butt? Is that what we’re talking about here?

David Hall: Yeah I mean that’s the point…based on the 16 patients that we tested, we were able to do a $35 million deal with Shiseido Corporation; $4 million up front, and $31 million in milestones and then ongoing royalties for Japan alone, and South Asia. So we really attracted a big company – they are the fourth biggest cosmetic company in the world – to the elegance of the science. And the outcome is yes – to simply change the outcome of pattern baldness. So if you think of yourself…the back of your head has hair follicles that produce fiber. The problem is that on the top of the head, over the years, your hair follicles, the cells called dermal sheath cups at the bottom of those hair follicles in the top of your head – they have been compromised by androgen. But the back of your head has hair follicles that are completely androgen insensitive, so we’re taking those cells – the cells from those follicles, it’s a single maybe two suture punch biopsy, and isolating those androgen-insensitive cells, and making them into millions, and then injecting them back up into the scalp. And every hair fibre cycle that you have causes the cells to turn over, and now we’re integrating these cells that are insensitive to androgen. So if we get the right dose, which is what we’re doing right now, and you have to get the right frequency, in other words do you have to take more than one injection – then the logical conclusion is that you get a complete serial conversion to a healthy hair follicle which you had when you were younger. And that’s kind of the goal. And it makes sense scientifically, but the challenge is you’ve got to figure out the dose and frequency, and that’s just a matter of trying.

James West: So the short answer to the original question then is ‘maybe’. Maybe this is a complete cure?

David Hall: Well if it works, then it’s a cure. I mean you no longer have cells that are affected by androgen running in your hair follicle on top of your head. So that is a permanent solution. It’s not like you’re taking a drug, which basically juices the performance of what cells are left, but it doesn’t actually change the inevitable outcome. We’re changing, we’re going to reverse and change the inevitable outcome, so those hair follicles no longer are compromised by androgen. That is the goal, and as I said it’s a matter of dose, and frequency that we’re trying to figure out between ourselves and Shiseido.

James West: Well that’s great…that’s a perfect first interview. We’re going to catch up with you in about another quarter and see how you’re making out. Thank you for joining us today.

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VANCOUVER, BC – October 2, 2014 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), clinical stage regenerative medicine company focused on the development of autologous cell therapies will be presenting at the Stem Cell Meeting on the Mesa Partnering Forum on Tuesday, October 7, 2014 at 11:45 a.m. local time in La Jolla Ballroom 2 at the Estancia La Jolla Hotel.

The presentation by Mr. David Hall, CEO, will include an update on RepliCel’s pending clinical trials for chronic Achilles tendinosis (RCT-A-01) and sun-damaged and aging skin (RCS-01) as well as its program for pattern hair loss (RCH-01). It will be webcast and posted on the conference website at http://stemcellmeetingonthemesa.com/webcast/, on RepliCel’s website at http://www.replicel.com/investors/corporate-publications/ and on the Alliance for Regenerative Medicine website, after the event, at http://alliancerm.org/ bringing tremendous exposure to the company.

“The Stem Cell meeting does an excellent job of bring together leading researchers, clinical experts, senior executives, health care investors and top decision-makers in the regenerative medicine industry. With nearly 800 attendees from around the globe, it is a great environment for discussions around partnerships, collaborations and investment,” commented David Hall, CEO of RepliCel.

Please visit http://stemcellmeetingonthemesa.com/ for full information on the conference including registration. Complimentary attendance at this event is available for credentialed investors and members of the media only.

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.

For more information please contact:

Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

INVESTOR RELATIONS:
Christina Cameron, Investor Relations
christina@clcameron.com

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To view the article as it appears on Seeking Alpha, click here.

Summary

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.

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.

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.

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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RepliCel’s Innovative Technology Converts Your Own Cells into Products to Repair and Rejuvenate the Body

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

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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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