Microsoft word viewer - histogen executive summary - december 2010.doc
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 components. Through Histogen's proprietary technology process that mimics the embryonic environment, including very low oxygen and suspension, 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 Proteins 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 that a single application of a treatment 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.
FINANCING Histogen opened its Series B financing round in December in which preferred shares are a $1 per share. The Company seeks to raise $23 million in this round, of which $7M has been committed. These funds will aid in funding additional clinical trials and company expansion as needed. The company believes several value inflection points will occur over the next year due to major partnerships as well as results from the HSC trial in Singapore. 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.
The Company will focus resources towards manufacturing of product, the development and completion of the Phase I /II study in Singapore, operations, and business development activities to garner and finalize licensing and corporate partnerships for company product applications.
ACHIEVEMENTS TO DATE
• Developed branding/ trademark strategy
• 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
• More than 25 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)
• Entered new facility with GMP manufacturing capabilities
• Raised $10 Million in Series A financing round
ST GEORGE’S RESPIRATORY QUESTIONNAIRE FOR COPD PATIENTS (SGRQ-C) Professor Paul Jones Division of Cardiac and Vascular Science St George’s, University of London London SW17 0RE Tel +44 (0) 208 725 5371Fax +44 (0) 208 725 5955 CONTENTS 1. THE SGRQ The SGRQ-C was developed from the SGRQ which was designed to measure healthimpairment in patients with asthma and COPD. The
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