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The groundbreaking and growing field of regenerative medicine offers many potential benefits
for current unmet therapeutic needs. Histogen, Inc. is a regenerative medicine company
developing solutions based on the products of cells grown under embryonic conditions. The
Company is developing a rich portfolio from a single core technology process, creating
innovative products that fulfill market needs, yet do not contain embryonic stem cells or animal
Through Histogen's proprietary technology process that mimics the embryonic environment,
including very low oxygen and low gravity conditions, newborn cells are encouraged to naturally
produce vital proteins and growth factors which are characteristic of young, rapidly developing
tissue. From this process, Histogen extracts two products - a soluble human extracellular matrix
(hECM) and a solid hECM material – with a variety of applications ranging from research tools
to biological products in various markets and segments of the life science industry.
In addition, the Company has successfully developed commercial-scale production processes
which are economically viable. Histogen offers a unique opportunity to investors to make an
early-stage investment in products and technology that have passed the “proof of principle”
stage, thus reducing risk and at the same time accelerating timelines to commercialization.
Histogen’s one technology, two products, numerous applications
model offers a continuum of
product introduction opportunities, from lead applications such as hair regrowth and skincare to
longer timeline therapeutic applications including oncology and wound care.
Histogen’s purpose and focus is on the research, development and manufacturing of the products
derived from its core technology. The Company will achieve profitability through research
partnerships, upfront licensing payments and post-commercialization royalty streams attached to
each of its product applications.
Two patents on Histogen’s soluble and insoluble extracellular matrix have been filed in the
United States and Europe: #61/024,854 Extracellular Matrix Compositions including Embryonic
and 61/114,966: Extracellular Matrix Compositions and Treatment of Cancer
The complex of embryonic-like proteins and growth factors produced from Histogen’s propriety
technology process holds potential for a wide range of therapeutic applications. While many of
these applications face long timelines to market due to regulatory requirements, Histogen’s
product pipeline was designed to include applications that do not require FDA approval and can
go from development to market quickly.
Beauty and cosmetics products make up one of the world’s largest consumer markets. The
worldwide anti-aging skincare market alone was approximately $15B in 2008, with the U.S.
market accounting for $1.6B. The benefits Histogen recognized in entering the skincare market
were twofold – the Company had an opportunity to fulfill a need that is not currently met by
other products on the market, and an opportunity to generate early revenue while regulated
products are in research and development stages.
Based upon the results of three clinical studies, Histogen launched the ReGenica line of skincare
products in March 2009. The system consists of the Facial Rejuvenation Complex, marketed to
dermatologists and plastic surgeons for use as a post-laser treatment, and the Advanced
Rejuvenation Day & Overnight Repair products for anti-aging, which are sold through
physician’s offices as well as direct-to-consumer. Histogen is currently seeking a licensing or
distribution partner for ReGenica.
Histogen’s lead product application is its Hair Stimulating Complex (HSC), which is a soluble
formulation developed as an injectable for hair regrowth. The hair loss market is both large and
underserved - hair loss affects over 40 million men and 21 million women in the United States
alone, however less than 7% of sufferers currently seek treatment. This is largely due to the
ineffectiveness of currently available options such as Rogaine and Propecia.
Worldwide revenues in 2008 were reported to be $1.3B for surgical treatments, predominantly
hair transplant procedures, $1B for non-prescription treatments such as Rogaine, and $700M for
prescription treatments such as Propecia. Histogen sees HSC as a potential category killer, as
efficacy results far surpass those seen with topical and prescription treatments, and the injectable
form holds many advantages over surgical treatments.
Histogen’s pilot clinical trial of HSC was the first time time that a single application of a therapy
produced an increase in new hair follicles, thickness of existing hairs, and number of hairs in pre-
existing follicles, in a human study. 84.6% of subjects treated with a single injection of HSC
showed an increase in terminal hair 12 weeks post-injection, with a statistically significant
increase in the number of terminal hairs, cumulative hair thickness density and hair thickness
mean. From this single injection at the baseline timepoint, hair growth continued to increase with
a statistically significant increase in hair count and density seen across subjects at one year.
Histogen is seeking $756 thousand to close its $10 million Series A financing round. Due to new
research findings and new market applications, the company plans on commencing a Series B in
Q3 of 2010 to aid in the funding of additional clinical trials and company expansion.
The Company will focus its direct resources in start up costs, introduction of the short term
products and completion of the animal toxicology studies required for an IND submission for
induction of hair growth. By focusing on short-term products that require no regulatory approval
and products that are regulated under the 510(k) process, the Company expects to achieve a
revenue stream that will support the development and clinical trials of other therapeutic products
which address larger, more lucrative markets. In addition, use of the ExCeltrix and ReGenica as
research tools in the global market may generate multiple publications by leading scientists that
will substantiate utilization of these materials in new therapeutic areas.
With successful Phase I and Phase II trials for hair growth, it is believed that the Company will
have the ability to do an IPO within the next 3-5 years. Histogen has had a successful 25 patient
pilot hair growth study and plans on starting a 50 patient Phase I/II study in Q4 2010. Positive
results will allow the company the potential to do an IPO earlier, within 2-3 years.
ACHIEVEMENTS TO DATE
Advanced embryonic stem cell kit research, 4 partners evaluating data
Completed 3 clinical studies of the ReGenica skincare products
Launched the ReGenica line of skincare products for anti-aging and post-resurfacing Completed pilot clinical trial of Hair Stimulating Complex Raised $6.27 million in Series A financing (addendum for final close at $10 million)
More than 20 key scientific presentations
2 scientific manuscript publications
Submission of 510k for Wound Healing
Advanced research with ExCeltrix and tumor suppression Advanced research in device coatings for surgical and cardiovascular applications
(currently being evaluated by potential partners)
Made significant progress towards securing new facility
Developed branding/ trademark strategy
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