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Histogen Welcomes Dr. Martin Latterich as Vice President of Technical Operations

SAN DIEGO, September 18, 2016 Histogen, Inc., a regenerative medicine company developing innovative products from cells grown under simulated embryonic conditions, today announced that Martin Latterich, Ph.D. has joined the Company as Vice President of Technical Operations.

Dr. Latterich brings a wealth of biotechnology experience from both the business and academic sectors to Histogen. In addition to ProterixBio, Inc., a company developing disease management solutions for which he currently serves as Chief Scientific Officer, Dr. Latterich’s past professional affiliations include the Salk Institute, Diversa, and Illumina. He has a track record of success in the establishment and growth of science-focused research organizations, team-building, corporate scientific leadership and external collaborations and partnerships. Dr. Latterich has authored 39 publications and one book, has served as Editor-in-Chief of Proteome Science since 2002, and has been the recipient of grant funding from organizations including the NIH, HFSP, March of Dimes, Pew Foundation, and Genome Canada.

“Dr. Latterich’s background and expertise in the development and management of research programs will be a tremendous asset as Histogen progresses its hair program through clinical trials,” said Dr. Gail Naughton, CEO and Chairman of the Board. “His guidance will also be very valuable to our joint venture programs in orthopedics and oncology, and we are excited to have him on board.”

Through Histogen’s proprietary technology process, hypoxia-induced multipotent cells naturally secrete an array of growth factors, proteins and peptides which have been shown to stimulate stem cells in the body. Histogen’s lead application, the Hair Stimulating Complex (HSC), utilizes these naturally-secreted proteins to stimulate hair growth. Safety and statistically significant hair growth have been seen in two Company-sponsored clinical trials to date, and Histogen is working towards the next stages of clinical development in the United States, and well as through partnerships in other regions.

“Histogen will transform the field of cosmetics and regenerative medicine with its innovative cell-free and cell therapeutic technologies,” said Dr. Latterich. “I am genuinely thrilled to join a team as accomplished as Histogen’s at this important juncture in the commercialization process. I look forward to contributing to the success of its commercial products as well as a plethora of future new product opportunities”.


Histogen and Huapont Life Sciences Affiliate Partner to Develop Hair Stimulating Complex in China

SAN DIEGO, September 27, 2016 Histogen, Inc., a regenerative medicine company developing innovative products from cells grown under simulated embryonic conditions, today announced a license agreement with Pineworld Capital, Ltd., for the development and commercialization of its proprietary Hair Stimulating Complex (HSC) in Mainland China. Pineworld Capital is an affiliate of China-based, publicly traded Huapont Life Sciences, which has a $3 billion market capitalization.

Through an exclusive license and supply agreement, Pineworld will focus on clinical development, registration, marketing and sales of the HSC injectable hair growth treatment in China. Under the terms of the license, Histogen will receive milestone payments, a transfer price on the product, and escalating royalties on future sales. Histogen will utilize its patented technology process to manufacture HSC for the China market.

“We are honored to align with Huapont Life Sciences to bring HSC into China,” said Dr. Gail Naughton, Histogen CEO and Chairman of the Board. “With its strong dermatology portfolio, Huapoint is an ideal partner for developing and commercializing Histogen’s unique hair growth product to the world’s most populous nation. Hair loss affects men and women around the world, and our goal is to find the best partners in each region to bring solutions to this global problem.”

HSC is an injection treatment that has shown excellent safety and statistically and cosmetically significant hair growth in two Company-sponsored and one investigator-initiated clinical trial. Through Histogen’s technology process, which mimics the embryonic environment including conditions of low oxygen and suspension, cells are triggered to become multipotent, and naturally produce proteins that are key in hair formation and the stimulation of hair follicles.

"Huapont Life Sciences is excited to partner with Histogen to bring its innovative product to the millions of men and women in China suffering from hair loss,” said Hayden Zhang, Head of Investments for Huapont and CEO of Pineworld Capital. “By working closely together, we are confident HSC will enjoy tremendous market success.”

About Histogen
Histogen is a regenerative medicine company developing innovative products from cells grown under simulated embryonic conditions, including low oxygen and suspension. Through this unique technology process, newborn cells are directed to naturally produce vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.

About Huapont Life Sciences
Huapont Life Sciences is a China-based company focused on the research and development of new and innovative healthcare products, and the manufacture, marketing and sale of leading pharmaceutical products, active pharmaceutical ingredients (known as APIs) and a portfolio of safe and effective agricultural herbicides (including NC16, NC34, NC36, NC125, NC201) serving the agricultural business throughout the US and South American markets. Huapont Life Sciences’ pharmaceutical business includes dermatology products, cardiovascular products, anti-tuberculosis agents, autoimmune-related products and oncology-related products. Huapont Life Sciences’ API business involves the production and sale of bulk pharmaceutical chemicals, pharmaceutical intermediates and preparations of Western medicines, with current annual revenues of approximately US $1.1 billion, and approximately 7,100 employees operating throughout Mainland China. Huapont Life Sciences is listed on the Shenzhen Stock Exchange (002004.SZ) and carries a current market capitalization of approximately US $3.0 billion.


Histogen and a Huapont Life Sciences Affiliate Enter Equity Financing Agreement for Development of Hair Stimulating Complex

SAN DIEGO, August 15, 2016Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, today announced that Pineworld Capital Ltd, an affiliate of Huapont Life Sciences, has made a $6,000,000 private equity investment into the Company to continue development of Histogen’s Hair Stimulating Complex (HSC).

Through this investment, Huapont's affiliate will be the lead investor in Histogen's Series D financing round. The proceeds from the Series D financing will in part be utilized to advance Histogen’s hair growth product, HSC, in the United States, as well as to begin preparations for an Initial Public Offering (IPO).

"We are honored that the leading dermatology company in China has recognized the potential of Histogen's technology," said Dr. Gail Naughton, Histogen CEO and Chairman of the Board. "We are looking forward to a fruitful relationship, and to having Hayden Zhang as a valuable addition to Histogen's Board of Directors."

Huapont will have a right to name one director to the Histogen Board of Directors, and has certain participation rights to invest in future equity financings. Huapont and Histogen intend to enter a license and supply agreement for the development and commercialization of HSC in Mainland China, with terms and conditions to be announced.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.

About Huapont Life Sciences
Huapont Life Sciences is a China-based company focused on the research and development of new and innovative healthcare products, and the manufacture, marketing and sale of leading pharmaceutical products, active pharmaceutical ingredients (known as APIs) and a portfolio of safe and effective agricultural herbicides (including NC16, NC34, NC36, NC125, NC201) serving the agricultural business throughout the US and South American markets. Huapont Life Sciences’ pharmaceutical business includes dermatology products, cardiovascular products, anti-tuberculosis agents, autoimmune-related products and oncology-related products. Huapont Life Sciences’ API business involves the production and sale of bulk pharmaceutical chemicals, pharmaceutical intermediates and preparations of Western medicines, with current annual revenues of approximately US 1.1 billion, and approximately 7,100 employees operating throughout Mainland China. Huapont Life Sciences is listed on the Shenzhen Stock Exchange (002004.SZ) and carries a current market capitalization of approximately US $3.0 billion.


New Research Shows Promise of Human Extracellular Matrix in Cartilage Formation

IRVINE, July 29, 2016 PUR Biologics, LLC, a biotech company focused on biologics and devices for musculoskeletal conditions, today announced the publication of new findings on its human extracellular matrix material for stem cell proliferation and cartilage formation in the peer-reviewed journal Stem Cell Reviews and Reports.

Work led by Dr. Wan-Ju Li in the Department of Orthopedics and Rehabilitation and the University of Wisconsin-Madison for the first time demonstrated the ability of a naturally-secreted human extracellular matrix (hECM) to not only support the proliferation of mesenchymal stem cells (MSCs), but to also upregulate the genes associated with hyaline cartilage formation. Further, this work showed that MSCs treated with hECM had increased chondrogenic potential, or increased potential to form cartilage, than untreated MSCs.

MSC subpopulations composed of cells with specific cell surface markers, CD73+,CD90+,CD105+, and CD45-, are known to have a greater therapeutic capacity than the MSC population as a whole.

Importantly, this latest research has shown that by culturing MSCs with hECM the number of cells with these markers increases exponentially.

"The main limitation of MSC therapies is the inability to grow a sufficient number of cells without changing their characteristics,” said Dr. Li. “We have found that hECM both increases the proliferate of these cells and primes them to become chondrocytes, which has the potential to be hugely impactful in the treatment of various cartilage disorders."

In addition, MSCs treated with hECM were shown to produce more collagen type 2, the primary collagen in articular cartilage, and collagen type 10, the primary collagen in the calcified cartilage layer. At the same time, treatment with hECM reduced the production of collagen type 1 which is distributed in fibrocartilage. This suggests that hECM may be well suited in the induction of hyaline cartilage formation.

The results of this research support previous studies in full thickness osteochondral defects in rat, rabbit and goat models, where mature hyaline cartilage was formed after implantation of hECM.

Manufactured by PUR's joint venture partner Histogen, Inc., the extracellular matrix utilized in this research is produced through a proprietary novel technology process which triggers the de-differentiation of fibroblast cells into multipotent stem cells through low oxygen and special culture conditions. This results in a hECM that is embryonic-like without utilizing embryonic stem cells, and that has potential benefit in a number of orthopedic applications.

"PUR is closer than ever to putting together the pieces of quality cartilage repair in the human body," said Ryan Fernan, CEO at PUR Biologics. "Dr. Li's work demonstrates how PUR's materials maintain the perfect environment for your body's own cells to naturally and effectively heal itself, potentially providing a vitally needed solution to the millions suffering from cartilage complications."

The paper entitled "Effects of Human Fibroblast-Derived Extracellular Matrix on Mesenchymal Stem Cells" is currently published in the online edition of Stem Cell Reviews and Reports, available at http://link.springer.com/journal/12015/onlineFirst/page/1.

About PUR Biologics
PUR Biologics is dedicated to providing regenerative biologic and device solutions to address musculoskeletal surgical needs, including orthopedic, spine, dental, and medical device coating applications. In addition to distribution of approved allograft and biologic products, PUR is focused on development of next-generation orthopedic products based upon human protein and growth factor materials for bone and tissue regeneration. For more information visit www.purbiologics.com.


Multipotent Cell-Secreted Extracellular Matrix Supports Cartilage Formation
Histogen to present at International Cartilage Repair Society 2015

CHICAGO, May 8, 2015 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, will present new research on its human extracellular matrix (hECM) material in the promotion of cartilage regeneration during the International Cartilage Repair Society (ICRS) 2015 Meeting, taking place May 8-11, 2015 in Chicago, IL. The orthobiologic applications of all of Histogen's products are being developed by its worldwide joint venture, PUR Biologics LLC.

Histogen has previously shown that hypoxia-induced multipotent cells produce soluble and insoluble materials that contain components associated with stem cell niches in the body and with scarless healing. These proteins include a variety of laminins, osteonectin, decorin, hyaluronic acid, collagen type IV, SPARC, CXCL12, NID1, NID2, NOTCH2, tenascin, thrombospondin, fibronectin, versican, and fibrillin-2. In vitro studies further demonstrated that the CCM and ECM promote the adhesion, proliferation and migration of bone marrow-derived human mesenchymal stem cells (MSCs).

In this latest research, in vivo studies with the hECM were undertaken to determine their potential as orthobiologics. Rabbit studies demonstrated the potential of the hECM to promote regeneration and repair of full-thickness articular cartilage defects. Eight weeks following hECM treatment of femoral osteochondral defects, mature bone and hyaline cartilage formation was seen, exemplified by the presence of a tide mark and integration into the adjacent cartilage. This work is currently being repeated in a goat cartilage defect model, with similar results to date.

"The efficacy we have seen with the multipotent cell-secreted ECM in bone and cartilage regeneration is unprecedented," said Ryan Fernan, CEO of PUR Biologics. "The preclinical work overwhelmingly supports use of the material as an orthobiologic to reduce inflammation and promote cartilage regeneration in the articulating joint and intervertebral spinal disc. We look forward to entering human trials for these indications, as well as to continuing our research on utilizing the product for soft tissue repair in a variety of sports injuries."

Histogen's cell conditioned media (CCM) and hECM were also evaluated in an ex vivo rabbit intervertebral spinal disc model to study the effects of these materials in an environment where an extensive inflammatory response was induced by thrombin injection. Compared to untreated controls, both the CCM and ECM treatment significantly down regulated the expression of the inflammatory cytokine genes IL-1, IL-6, TNF-alpha, as well as the genes encoding the extracellular matrix degrading enzymes MMP3, and ADAMTS4, while upregulating aggrecan expression in the annulus fibrosus and nucleus pulposus tissue.

Dr. Gail Naughton, CEO of Histogen, will present "Human Cell Conditioned Media and Extracellular Matrix Reduce Inflammation and Support Hyaline Cartilage Formation" at the ICRS 2015 meeting in Chicago on May 9, 2015. Following the event, the presentation will be available upon request.

About PUR Biologics
PUR Biologics is dedicated to providing regenerative biologic solutions to address musculoskeletal surgical needs, including spine, dental, ligament and medical device coating applications. In addition to distribution of approved allograft and biologic products, PUR is focused on development of next-generation orthopedic products based upon human protein and growth factor materials for bone and tissue regeneration. For more information visit www.purbiologics.com.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.


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Histogen's proprietary tissue-engineering process is utilized for manufacturing all of Histogen's products. Newborn cells are placed into a bioreactor and conditioned with a liquid media.
  • HSC's components have recently been shown to be critical for new hair follicle formation
  • The field of stem cell research is rapidly expanding
  • Histogen scientists have developed regenerative medical technologies without the use of stem cells or animal serum
© Histogen Inc., CA 92121