Read the title, where’s the news?
» Read the title, where’s the news?
This is very distressing. Either there is something wrong, or they are playing games with us.
» » Read the title, where’s the news?
»
» This is very distressing. Either there is something wrong, or they are
» playing games with us.
The fact that their stock has been pumped by NTB et al and that they’ve uploaded a couple of the videos from their home page onto youtube this week doesn’t help, either. It’s hard to ignore the possibility that they may be trying to raise capital before releasing disappointing results. If the results truly inspired confidence, they wouldn’t need to pull this monkeying-around kind of b.s.
it is 1130pm at vancouver now 
» Read the title, where’s the news?
Maybe they’ve been so busy counting new hairs that they’ve forgotten what day it is.
LOL
» it is 1130pm at vancouver now
as i posted previously… they reconfirmed on twitter that they will be releasing their phase I info in late - april just two days ago. Let’s be patient.
» » Read the title, where’s the news?
»
» Maybe they’ve been so busy counting new hairs that they’ve forgotten what
» day it is.
»
» LOL
Oh, they know what day it is and they are timing the release perfectly. I think they will release the results later today or early Monday Morning. They may even do it over the weekend. So, be watchful and you’ll see what happens.
» Oh, they know what day it is and they are timing the release perfectly.
Wow, you know a lot about what they are doing.
on the bright side stock is up.
which one of you mofos been responsible for this runup?
» » Oh, they know what day it is and they are timing the release perfectly.
»
» Wow, you know a lot about what they are doing.
Ironass, I know a lot more about this company than I care to share with you.
» » » Read the title, where’s the news?
» »
» » This is very distressing. Either there is something wrong, or they are
» » playing games with us.
»
» The fact that their stock has been pumped by NTB et al and that they’ve
» uploaded a couple of the videos from their home page onto youtube this week
» doesn’t help, either. It’s hard to ignore the possibility that they may be
» trying to raise capital before releasing disappointing results. If the
» results truly inspired confidence, they wouldn’t need to pull this
» monkeying-around kind of b.s.
The did just raise capital remember? The private placement on APril 18?
» Ironass, I know a lot more about this company than I care to share with
» you.
I have no doubts.
» on the bright side stock is up.
»
» which one of you mofos been responsible for this runup?
Not ! Did you skip a heartbeat?
Anyways, KO. I predicted the stock will go to 2.7 before the announcement a week ago.
» » on the bright side stock is up.
» »
» » which one of you mofos been responsible for this runup?
»
» Not ! Did you skip a heartbeat?
»
» Anyways, KO. I predicted the stock will go to 2.7 before the announcement a
» week ago.
Right on MOFO! You have any other predictions?
» » » on the bright side stock is up.
» » »
» » » which one of you mofos been responsible for this runup?
» »
» » Not ! Did you skip a heartbeat?
» »
» » Anyways, KO. I predicted the stock will go to 2.7 before the announcement
» a
» » week ago.
»
» Right on MOFO! You have any other predictions?
Yes, I already stated my predictions on their results.
» 1. All Women will show results. Thickening of follicles , 50% increased
» density
» 2. NW3s will show some results. some vellus hair here and there, no
» terminal hair (yet)
» 3. NW4s will show no results. Nothing at all.
If my predictions are true, consider the cure for baldness true combining replicel with Gho.
» » » » Read the title, where’s the news?
» » »
» » » This is very distressing. Either there is something wrong, or they
» are
» » » playing games with us.
» »
» » The fact that their stock has been pumped by NTB et al and that they’ve
» » uploaded a couple of the videos from their home page onto youtube this
» week
» » doesn’t help, either. It’s hard to ignore the possibility that they may
» be
» » trying to raise capital before releasing disappointing results. If the
» » results truly inspired confidence, they wouldn’t need to pull this
» » monkeying-around kind of b.s.
»
» The did just raise capital remember? The private placement on APril 18?
Sure, but what other explanation for the cryptic behavior concerning the apparent “pimping of the stock” and youtube postings all this week, right before supposedly releasing Phase I results? Is this supposed attract investors who’ve never heard about these guys? 'cause it’s giving me second thoughts…
Their annual report is out, they just haven’t announced it yet. At first glance, there is no juicy information in it regarding efficacy.
Here is an excerpt from the MD&A portion of the recently released (but the company strangely hasn’t released a press release yet) that I found interesting. Most of it is rehashed information that we already know, but a few nuggets I believe are new info.
The Company has developed RepliCel™, a natural hair cell replication technology that has the potential to
become the world’s first, minimally invasive solution for androgenetic alopecia (pattern baldness) and general
hair loss in men and women. RepliCel™ is based on autologous cell implantation technology that replicates a
patient’s hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, the
Company hopes to initiate natural hair regeneration. Patents for the technology have been issued by the
European Union and Australia and are pending in other major international jurisdictions. The RepliCel™
procedure has been developed over the past nine years by the Company’s recognized research scientists and
medical experts – specialists in the fields of hair growth, hair biology and dermatology. The address of the
Company’s corporate office and principal place of business is Suite 1225 – 888 Dunsmuir Street, Vancouver, BC,
V6C 3K4.
Our technology has been developed over nine years of research, experimentation and trials. The mechanics of
our technology involve the extraction of as few as 20 hair follicles from the back of a patient’s scalp where
healthy cycling hair follicles reside. Specific cells are isolated from the hair follicles and are then replicated in a
current Good Manufacturing Practice (“cGMP”) compliant facility through our proprietary cellular replication
process and then reintroduced back into balding areas on a patient’s scalp. The implanted cells are expected to
induce the formation and growth of new hair follicles and are expected to also help rejuvenate damaged hair
follicles. Our anticipated long term result is the restoration of a full head of hair that has been seeded by the
patient’s own natural hair cells.
The product development path of our technology effectively began in 2000/03 when Drs. McElwee and
Hoffmann began focusing on specific groups of cells in the hair follicle described as dermal sheath cup cells
(“DSCs”). Together they hypothesized that these DSCs were a reservoir of cells that were responsible for the
continued cycling of the hair follicle, as well as neogenesis of new hair follicles. Multiple experiments on
purpose‐bred mice demonstrated that hair follicle DSCs could induce successful hair growth. The scientists’
landmark study was published in the peer‐reviewed Journal of Investigative Dermatology in ©2003. Together,
the scientists filed patent applications. To date, patents have been issued in Europe and Australia, and are now
pending in the US, Canada and Japan.
These results have led us to believe in the effectiveness of the procedure and its potential to become a solution
to hair loss for the hair restoration market. From 2004 to 2007, the developers of our technology planned for
human clinical trials and cell culture laboratories, and sourced initial funding. In 2007, the developers of the
technology assigned the technology, including the intellectual property, to TrichoScience Innovations Inc.
(“TrichoScience”), all of the shares of which we acquired, in stages, between December 2010 and April 2011.
We believe our technology will offer several advantages over current hair loss solutions. Traditional hair
transplantation surgery requires the surgical removal of a prominent band of hair‐bearing scalp from the back
of the head, dissection of individual hair follicles and then implantation of these follicles into the balding region
of the scalp. Often, a number of similar surgical procedures are required to achieve the desired result. In effect,
surgical hair transplantation removes and redistributes a patient’s own hair follicles to cover sections of bald
scalp, leaving a longitudinal scar across the back of a patient’s scalp where the strip of skin tissue carrying the
hair follicles was removed. In follicular unit extraction (“FUE”) transplants, the back of the scalp is left with
multiple small round wound marks where the micro extractions have occurred.
In contrast, our technology is designed to replicate a patient’s hair cells and rejuvenate miniaturized hair
follicles, as well as induce entirely new follicles to grow from the balding scalp with only a minor single suture
closure from the tissue extraction site. We believe there will be minimal pain involved and a short recovery
period. Our technology is designed to provide the ability to grow a patient’s own hair back, rather than to
redistribute hair from the back of the scalp to the front.
3
In addition, hair transplantation surgery requires a team of six or more people, including up to four technicians
trained in micro‐dissection. The surgical procedure takes up to eight hours to complete. Our technology is
designed to be fully performed by a single clinician who requires minimal additional training. We expect the
time involved in the clinic to be less than thirty minutes for tissue collection and less than one hour for cell
injection.
Marketing Strategy Overview
We have launched a branded corporate website which can be viewed at www.replicel.com to provide
corporate information and information about our technology and the progress of our clinical trials. In the
future, this site will act as our principal marketing and communications tool and, in time, we will add sections
appropriate to our targeted key audiences – medical professionals, hair restoration clinics and appropriate
professional associations. All marketing and communications efforts will feature a constant internet based
strategy which we anticipate will allow us to leverage our technology advantages and brand to generate license
sales.
We expect that, eventually, a highly targeted marketing effort will supplement the broad communications
tactics and website with a focused direct sales campaign to primary licensee markets. We have identified the
primary licensee market as more than 800 hair restoration physicians.
Business Model
The RepliCel™ procedure will be marketed directly to those medical professionals currently engaged in hair
transplant procedures, as well as established hair loss and dermatology clinics. Access to, and application of the
procedure will be offered to these establishments under a licensing arrangement. Clinicians will be charged a
license fee by the company on an annual basis. We will then train and educate the clinicians in the RepliCel™
procedure. Clinicians will extract the patient’s tissues through a punch biopsy which will then be shipped to our
cGMP facilities where cells will be isolated and proprietary cellular replication will take place. We will be able to
maintain full control over the cellular replication process through the use of our own contracted facilities and
our own trained technicians. We will charge the clinic a per‐patient replication fee, while the clinic will be free
to set the price it charges the patient, based on what the market will bear. Therefore, we will have two revenue
streams: patient fees and annual license fees.
Regulatory Environment
The process of obtaining marketing authorization for the RepliCel™ procedure requires the collection of a
thorough body of information that satisfies requirements set forth by regulators that oversee the safety and
efficacy of products sold to the public. Each jurisdiction has specific regulatory requirements, many of which
differ from region to region.
We are developing a clinical and regulatory strategy that will ensure adherence to regulations that will advance
the marketing approval of our technology worldwide. As part of this strategy, plans for the following projects
are in development:
- Completion of a Phase I/IIa human clinical trial in Europe; TS001‐2009 trial commenced in December,
2010; - Ongoing research and pre‐clinical development to enhance knowledge base of our technology; and
- Initiation of Phase IIb human dosing clinical trials in Europe and/or North America.
4
Phase I/IIa: TS001‐2009
The protocol for the TS001‐2009, Phase I/IIa study was developed with advice from European Union regulatory
authorities responsible for advanced therapy medicinal products (ATMPs) of which our product is one. The
clinical trial is designed to test the safety and efficacy of our technology in men and women with AGA through
the assessment of the following endpoints: - Primary Endpoint: local safety profile of our technology at the 6‐month time point as defined by the
incidence, relationship, severity and seriousness of adverse events at the injection sites and local tolerance
(as judged by the investigator and patient); - Secondary safety endpoints:
a. the local safety profile (as defined above) of our technology at the 12 and 24 month time points,
b. systemic adverse events over the 24‐month study,
c. analysis of macroscopic images of injection sites, and
d. analysis of histopathological biopsies taken at the 6, 12 and 24 month time points; and
3. Secondary efficacy endpoint:
a. difference in hair thickness and hair density between 6 months (Visit 7) and baseline will be
calculated using the TrichoScan® procedure.
The protocol, designed in compliance with International Conference on Harmonisation guidelines for Good
Clinical Practice (ICH GCP), underwent thorough scientific and ethical review by the Georgian National Council
of Bioethics and approval to conduct the study was granted on October 27, 2010.
Subjects with mild to moderate AGA categorized on the Ludwig Scale (female) or the Norwood scale (male)
were enrolled in the study over a 4‐month period starting in December 2010. These subjects provided blood
samples to confirm their health status and scalp biopsies which were sent to a cGMP‐compliant facility with the
specific license to manufacture our product in Austria.
Once the manufacturing process was completed, the 19 subjects returned to the clinic to receive blinded
injections of their own (autologous) replicated cells in a carrier medium on one part of the scalp, and another
injection of carrier medium without replicated cells (placebo) on the other side of the scalp to allow for better
assessment of the safety and efficacy of our technology. The final study participant received injections of hair
follicle cells in late August 2011, thus marking the end of the treatment phase of TS001‐2009.
In the next stage of the TS001‐2009 trial, the post‐injection follow‐up period, subjects return to the clinic for
ten follow‐up visits over a 24‐month period to have their health closely monitored to ensure that there have
been no adverse effects associated with receiving the injections and to determine the efficacy of hair follicle
cell injections at stimulating hair growth. Furthermore, at 6, 12 and 24 months post‐injection, four subjects at
each time point will provide biopsies of the injection sites for histopathological analysis. The post‐injection
follow‐up period will be completed for all patients by the end of August 2013. The total duration of subject
participation in the study is approximately 27 months.
An interim analysis of data is scheduled to take place in the first quarter of 2012 once all patients have had a 6‐
month follow‐up visit. The results of this analysis will be released in late April 2012. This data will allow for
analysis of the primary endpoint of the study; assessment of the local (at treatment sites) safety profile of our
product compared to placebo as defined by adverse events with respect to their causality, incidence, severity
and seriousness. Secondary outcome measures of systemic (overall) safety (through review of adverse events
5
in a similar fashion as described above) and efficacy (hair growth at treatment sites) will also be performed at
this time. Analysis of efficacy will also be studied at 9, 12 and 24 months.
Final analysis of safety data from the entire 24‐month post‐injection follow‐up period should be available in
late 2013. To date, no serious adverse events have been reported post‐injection.
Pre‐Clinical Research
Even though our product has already started testing in human subjects; we continue to perform pre‐clinical
research to improve the production and delivery of our product. Currently we are conducting such research
with our partners in Guangzhou, China; Innsbruck, Austria; and Vancouver, Canada in conjunction with the
guidance we have received from regulators in the European Union and Canada.
Phase IIb Dosing Clinical Trials
Results from the pre‐clinical work will be included along with the study results from TS001‐2009 in making the
application to perform Phase IIb dosing clinical trials in Europe and North America. The process of making this
application will allow regulators to provide feedback on our product and the methodology used to research its
effects in humans. Such feedback will allow us to streamline our research efforts to ensure we can bring our
product to those in need as quickly and safely as possible.
Intellectual Property
The success of RepliCel will be highly dependent on the protection of our intellectual property. We are
developing a diverse portfolio of intellectual property for the use of stem cells in the treatment of hair loss, as
well as other medical conditions. For example, RepliCel inventors filed an early patent application on the use of
hair follicle derived stem cells (see EP 1 509 597 B1) entitled “Method for isolating hair follicle mesenchymal
stem cells”. This family of patents describes methods for isolating stem cells from hair follicles, and the growth
and use of these stem cells for the treatment of a variety of medical conditions (including hair loss). Within this
portfolio, there are granted patents in Australia (AU 2003246521) and Europe (EP1 509 597 B1), which were
issued unopposed. Related patent applications are also pending in the United States, Canada and Japan.
Plan of Operations
The sections above contain a broad overview of our plan of operations on a go‐forward basis. We intend to
specifically focus on continuing our human trials in Europe and preparing for human trials in Canada. During
this time, we will attempt to seek regulatory approval in those areas for our technology. We also intend to
continue to focus on obtaining patents for our technology in various international jurisdictions. At the same
time, we will be taking steps to implement our branding and marketing strategies discussed above under the
heading, “Marketing Strategy”.
The Company currently has four full time employees, as well as five contractors. These employees have
expertise in biotechnology management, clinical trials, financial management and communications.
Marketing
On April 12, 2012, the Company entered into an arrangement with a private US company to perform
professional services related to the dissemination of corporate marketing materials. In return for these
services, the Company has paid US $338,000. [THIS IS THE PAID PENNY STOCK PROMOTIONS WE HAVE SEEN THE LAST WEEK] There is no formal agreement with respect to this arrangement.
“Impressive!” [-Darth Vader voice]
Does that mean they approved this headline:
This Public Company is DAYS Away From The $Billion Cure for Baldness