About CollPlant Biotechnologies

CollPlant Biotechnologies Ltd. operates as a regenerative and aesthetic medicine company that focuses on 3D bioprinting of tissues and organs, and medical aesthetics. The company's products address indications for the diverse fields of tissue repair, aesthetics and organ manufacturing. The company's collaborations include among others, AbbVie, STEMCELL, Tel Aviv University, Sheba Medical Center, ARMI and ReMDO. The company's flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs. The company is developing 3D bioprinted breast implants for regeneration of breast tissue. In 2021, the company entered into a Development, Exclusivity and Option Products Agreement with AbbVie, pursuant to which it and AbbVie collaborates in the development and commercialization of dermal and soft tissue filler products for the medical aesthetics market, using its rhCollagen technology and AbbVie's technology. In 2022, the company launched Collink.3D 90, an rhCollagen-based bioink solution for use in a variety of 3D bioprinting applications, offering increased mechanical properties to address additional printing requirements of soft and hard tissues. Collink.3D 90 is complementary to its first commercial bioink, Collink.3D 50, which was launched in November 2021, for use in 3D bioprinting. Collink.3D 50, its first commercially available rhCollagen-based bioink product is designed to allow the scalable and reproduceable biofabrication of scaffolds, tissues and organ transplants. In 2022, the company entered into a license and research agreement with Tel Aviv University and Sheba Medical Center hospital, to co-develop a 'Gut-on-a-Chip' tissue model for drug discovery and high throughput screening of drugs. The model is intended to be used in personal medicine applications for the treatment of ulcerative colitis, an inflammatory bowel disease affecting millions of individuals worldwide. In January 2023, the company launched Collink.3D 50L in powder form, which is its first bioink available in powder form and provides enhanced operational flexibility to support a wide range of 3D bioprinting applications, including drug discovery, drug screening, tissue testing, as well as the development of transplantable tissues and organs. Previously, in December 2020, the company entered into a product manufacturing and supply agreement with STEMCELL. As part of the agreement, it is selling its proprietary recombinant human Type I collagen (rhCollagen) to STEMCELL, which incorporates its product into cell culture media kits. The company's rhCollagen has superior biological function when compared to any tissue-derived collagens, whether from animal or human tissues, according to data published in peer-reviewed scientific publications. The company's rhCollagen can be fabricated in different forms and shapes, including gels, pastes, sponges, sheets, membranes, fibers, and thin coats, all of which have been tested and proven superior to tissue-derived products. The company has demonstrated that, due to its homogeneity, rhCollagen can produce fibers and membranes with high molecular order, meaning there is high molecular alignment, which enables the formation of tissue repair products with distinctive physical properties. The company produces its rhCollagen from genetically engineered tobacco plants, assuring a relatively abundant supply of high-quality raw materials. The company focuses on the following two rhCollagen-based family products lines: CollPlant rhCollagen-based BioInk for use in the 3D printing of tissues and organs: The company's flagship BioInk product line provides an ideal building block for three dimensional bioprinting of tissues and organs. Its BioInk is being developed to be compatible with numerous 3D bioprinting technologies and with printed organ characteristics. The company is developing a bioprinted regenerative breast implants, which are designed to gradually degrade and be replaced by newly grown natural breast tissue. It is also developing a regenerative soft tissue matrix. Both the bioprinted breast implants and soft tissue matrix programs are in the pre-clinical phase, and it plans to initiate a second large animal study for the breast implant product in the second half of 2023. Aesthetic medicine product line, including a dermal filler and breast implants: The company's rhCollagen offers a portfolio of opportunities in the field of regenerative aesthetics, owing to its ideal structure and non-immunogenic properties. In addition, the company is developing a photocurable regenerative dermal filler combining its tissue regenerating rhCollagen and other technologies which is designed to address the need for more innovative aesthetic products to treat wrinkles. In addition, it is developing an injectable breast implant for regeneration of breast tissue consists of rhCollagen and additional materials. The company is also markets two of its products in Europe: VergenixSTR, a soft tissue matrix, intended to accelerate treatment of tendinopathy, and VergenixFG, a wound healing flowable gel, intended to enhance the quality and speed of closure of deep surgical incisions and wounds. The company's rhCollagen platform to develop products to address additional indications in these markets, as well as in new markets, including cardiovascular, orthobiologics, and ophthalmic markets. Strategy The key elements of the company's strategy include position its rhCollagen as the 'gold standard' platform technology for collagen-based products in a broad range of markets; utilize collaborative partners and distributors to develop and commercialize its technology and products; manufacturing capacity to support commercialization of rhCollagen-based end products; expand its pipeline through ongoing development of new products; and advance its leadership position in recombinant protein production through its plant-based technology. Products and Product Candidates BioInk for 3D Printing of Tissues and Organs 3D bioprinting is being applied to the field of regenerative medicine to address the need for complex scaffolds, tissues, and organs that are suitable for transplantation. The company has developed rhCollagen-based BioInks that are optimized and provides an ideal building block for the three-dimensional bioprinting of tissues and organs. The company has initiated several research collaborations with biotechnology and medical device companies, as well as academic and research institutions. These collaborations include development of technology for 3D bioprinting of life-saving organs and different tissues, such as cornea, using its BioInk formulations. The company's collaborations are generally structured such that its partners provide research funding and purchasing of its BioInk to cover the scope of work, in part or in full. In 2022, the company launched Collink.3D 90, an rhCollagen-based bioink solution for use in a variety of 3D bioprinting applications, offering increased mechanical properties to address additional printing requirements of soft and hard tissues. Collink.3D 90 is complementary to its first commercial bioink, Collink.3D 50, which was launched in November 2021, for use in 3D bioprinting. Collink.3D 50, its first commercially available rhCollagen-based bioink product is designed to allow the scalable and reproduceable biofabrication of scaffolds, tissues and organ transplants. In January 2023, the company launched Collink.3D 50L in powder form, which is its first bioink available in powder form and provides enhanced operational flexibility to support a wide range of 3D bioprinting applications, including drug discovery, drug screening, tissue testing, as well as the development of transplantable tissues and organs. Medical Aesthetics Dermal Filler and Soft Tissue Fillers In 2021, the company entered into a Development, Exclusivity and Option Products Agreement, or the Development Agreement, with AbbVie, pursuant to which it and AbbVie will collaborate in the development and commercialization of dermal and soft tissue filler products for the medical aesthetics market, using its rhCollagen technology and AbbVie's technology. Pursuant to the Development Agreement, the company agreed to undertake projects for the development of an aseptic process for sterile rhCollagen that meets or exceeds certain specifications as set forth in the Development Agreement. Pursuant to the Development Agreement, the company granted to AbbVie and its affiliates, worldwide exclusive rights to use its rhCollagen in combination with AbbVie proprietary technologies, for the production and commercialization of dermal and soft tissue filler products, or the Exclusive Products. Further, pursuant to the Development Agreement, the company granted to AbbVie and its affiliates, a right of first negotiation to enter into a definitive agreement to obtain exclusive, worldwide rights to the use of its rhCollagen for the commercialization and sale of an injectable breast implant product and a right of first negotiation to enter into a definitive agreement to obtain exclusive, worldwide rights to the use of its rhCollagen for the commercialization and sale of a photocurable dermal filler product, each an 'Option Product' and together, the 'Option Products'. Products during the term of the Development Agreement or grant any third party any rights to its rhCollagen technology that would conflict with rights granted to AbbVie. The Development Agreement provides that later on the company and AbbVie will enter into a supply agreement whereby it will manufacture and supply AbbVie with rhCollagen, at a pre-agreed price, to be used solely for the development and manufacture of the Exclusive Products and Option Products. In addition, the company is developing a photocurable regenerative dermal filler, which is one of AbbVie's Option Products, and is designed to address the need for more innovative aesthetic products to treat wrinkles. In this regard, the company recently completed a 12-month preclinical study with its photocurable regenerative dermal filler, demonstrating superior tissue regeneration, lifting capacity and volume retention when compared to a commercial standard. A photocurable version of the company's tissue regenerating rhCollagen, serves as the basis for a new dermal filler product line in development. It is developing a photocurable regenerative filler consists of rhCollagen and other substances which is intended to provide several revolutionary effects: lifting, sculpturing ability, retention to the host tissue, and tissue regeneration. Breast Implants The company is developing 3D bioprinted breast implants and injectable breast implants for regeneration of breast tissue. In January 2023, the company successfully completed a large animal study for its 3D bioprinted regenerative breast implants with full achievement of study objectives, demonstrating tissue regeneration which included the formation of maturing connective tissue and neovascular networks. Injectable Implants Injectable implants composed of rhCollagen, additional materials and fat cells taken from the patient are intended to promote breast tissue regeneration. The specific compositions are designed to support the viability and function of the autologous fat cells, and to attract cells to promote tissue regeneration. The scaffold is designed to gradually degrade and be replaced by newly grown natural breast tissue that is free of any foreign material. The injectable breast implant is one of AbbVie's Option Product. 3D Bioprinted Regenerative Soft Tissue Matrix The company is developing a 3D bioprinted regenerative soft tissue matrix for use in breast reconstruction procedures in combination with an implant. In June 2021, the company signed a co-development agreement with 3D Systems for the development of the product candidate. The agreement was terminated in March 2023, and it is using printers of other companies for the development of its product candidates. The in-vitro intestine-on-chip platform combines its rhCollagen with other proprietary biomaterials and human cells. Orthopedic and Wound Healing VergenixSTR-Tendinopathy Treatment VergenixSTR is a soft tissue repair matrix that combines cross-linked rhCollagen with PRP, a concentrated blood plasma that contains high levels of platelets, a critical component of the healing process. VergenixSTR serves as a scaffold to support cell proliferation and the release of growth factors. The product is injected into the affected area and forms a viscous gel matrix which serves as a temporary reservoir for PRP in the vicinity of a tendon injury site, holding the platelet concentrate in place at the injured area. The matrix formed has the capabilities to activate the platelets in PRP, thereby releasing growth factors in a controlled manner and controlled biodegradation time, enabling optimal healing. In the European Union, VergenixSTR is intended for the treatment of tendinopathy by promoting healing and repair of tendon injuries in a variety of tendons, including the elbow tendon, rotator cuffs, patellar tendons, Achilles tendon, and hand tendon. The company completed a 40 patient open label, single arm, and multi-center clinical trial of VergenixSTR at hospitals in Israel, which demonstrated the safety and evaluated the performance of VergenixSTR in patients suffering from tennis elbow or lateral epicondylitis. In 2016, the company received CE marking certification for VergenixSTR. In 2016, the company entered into an exclusive distribution agreement with Arthrex GmbH, for VergenixSTR covering Europe, the Middle East, India, and certain African countries. In 2018, Arthrex GmbH (Arthrex) announced results of ACP Tendo, a product for the treatment of tendinopathy combining its VergenixSTR and Arthrex's platelet plasma extraction kit, in a European case series. The safety and performance of ACP Tendo was evaluated for the treatment of tendinopathy in 24 patients in 9 different European locations. The indications included injuries in rotator cuff, Achilles tendon, peroneal tendon, tibialis tendon and common extensor tendon. In all treatment groups, patient-recorded-pain decreased after 2 weeks and continued along this trend up to the last follow-up at 6 months. Specifically for rotator cuff and common extensor tendon groups, the functionality was increased over the study period, almost achieving pre-symptom levels after 6 months. VergenixFG-Wound Filler VergenixFG is an advanced wound care product based on the company's rhCollagen. In the European Union, VergenixFG is intended for the treatment of deep surgical incisions and deep wounds, including diabetic ulcers, venous and pressure ulcers, burns, bedsores, and other chronic wounds that are difficult to heal. VergenixFG is designed to be easy to use and to be administrated through a cannula by a doctor or nurse. The VergenixFG formulation provides a scaffold of pure human collagen, an important characteristic in promoting the closure of wounds, that fills the wound bed and is engineered to create maximal contact with the surrounding tissue. VergenixFG provides complete coverage of the wound site, facilitates wound closure through an engineered synchronization between scaffold degradation and growth of new tissue, and offers a non-allergenic and pathogen-free scaffold for safe and efficacious wound care therapy. The company's initial market for VergenixFG in Europe is chronic wounds, which includes diabetic foot ulcers, venous ulcers, and pressure ulcers. The company has completed an open label, single arm, and multi-center registration trial of VergenixFG of 20 patients in Israel to demonstrate safety and to evaluate the performance of VergenixFG in patients with hard-to-heal chronic wounds of the lower limbs. Patients enrolled in the trial, received a single treatment of VergenixFG followed by a four-week follow up. In 2016, the company received CE marketing certification for VergenixFG. Since then, the company has entered into distribution agreements for the distribution of VergenixFG in several countries in Europe and Asia. Sales, Marketing, and Distribution The company sells its BioInk and rhCollagen directly to its business partners, collaborators and selective customers. The company sells its rhCollagen in the research market mostly to selective customers, including business collaborators and potential collaborators. The company is marketing and distributing VergenixSTR and VergenixFG in the European market with business partners. It distributes VergenixFG in European and other countries with local distributors and distributed VergenixSTR with Arthrex GmbH mainly in Europe. The company terminated the agreement with Arthrex effective as of December 31, 2020. It continues exploring opportunities to distribute its Vergenix products in additional countries. In 2020, the company announced that it signed an agreement for distribution of VergenixFG with a Swiss-headquartered pharmaceutical group in six Commonwealth of Independent States (CIS) countries: Belarus, Kazakhstan, Georgia, Azerbaijan, Armenia and Uzbekistan. In July 2021, the agreement was extended to additional territories: Hong Kong, Denmark, Switzerland, Estonia, Latvia, and Lithuania. The company's proprietary end products are marketed, and will be marketed, to physicians, hospitals, and clinics. It plans to expand the awareness of rhCollagen and its rhCollagen-based products to the end users through the publication of clinical trial data, as well as marketing studies it may conduct, along with participation in academic and industry conferences. Intellectual Property Patents As of March 15, 2023, the company had a global patent portfolio that included twelve patent families. More than three dozen of its patent applications have issued as patents or will issue soon, having been allowed by the relevant patent office. The company has exclusive ownership of 21 issued patents in its patent family that cover the methods of creating collagen-producing plants and three issued patents that cover the methods of processing recombinant collagen. These issued patents and others that may issue in the future in these patent families, assuming timely payment of annual fees, are expected to expire in 2025-2028. The company has ongoing patent application covering the specific collagen producing plants based on their genetic arrangement. If granted, it could provide patent protection for the collagen producing plants until 2039. The company's patent portfolio also includes patent families that cover different uses of collagen, including 3D Bioprinting, dermal fillers and soft tissue fillers which, if granted, could provide patent protection for particular formulations and the uses of its rhCollagen until 2038-2040. In addition, the company's patent portfolio includes pending applications, some of which are jointly owned with Yissum Research Development Company of the Hebrew University of Jerusalem Ltd. (Yissum). Research and Development The company's total research and development expenses were $10.3 million for the year ended December 31, 2022. Government Regulation In order to obtain marketing authorization in the United States, the company and/or its partners would be subject to extensive regulation by the FDA and other federal, state, and local regulatory agencies. The Federal Food, Drug, and Cosmetic Act; the Public Health Service Act; and their implementing regulations set forth, among others, requirements for the research, testing, development, manufacture, quality control, safety, effectiveness, approval, labelling, storage, record keeping, reporting, distribution, import, export, advertising, and promotion of the company's products. In Israel, the company's operations are subject to permits from the Ministry of Health. Its international operations, as well as being an Israeli company, subject the company to laws regarding sanctioned countries, entities, and persons; customs, import-export, and laws regarding transactions in foreign countries; and the United States of America Foreign Corrupt Practices Act and local anti-bribery and other laws regarding interactions with healthcare providers. As a public company whose securities are registered pursuant to the Securities Act of 1933, as amended, the company is subject to U.S. securities laws and regulations, including the Sarbanes-Oxley Act. The company holds a valid permit from the Plant Protection and Inspection Services Administration, or PPIS, for growing tobacco plants in greenhouses in its site at Yessod Hama'ala, Israel, as well as in all of its subcontractors' facilities. Under the Israeli Licensing of Businesses Law, to which the company's production sites and laboratories are subject, operating a business without a license or temporary permit is a criminal offense. In September and November 2020, the company had obtained a business license for its sites in Rehovot, Israel. In addition, it has a business license for its production site at Yessod Hama'ala, in effect until July 18, 2025. The company's production sites and laboratories are subject to the Israeli Planning and Zoning Law, which sets provisions and obligations, inter alia, regarding the licensing process for a new building, including building permits, non-conforming use and easements, the supervision over its construction, and the required occupancy permits. Environmental, Health, and Safety Matters The company's activities require permits from various governmental authorities, including local municipal authorities, the Ministry of Environmental Protection, and the Ministry of Health. It has received all the necessary permits from the Ministry of Environmental Protection regarding its operations in Yessod Hama'ala; and it has obtained a business license for its facilities in Rehovot. Competition The primary competitors to the company's BioInk are potential bio-material inks for 3D biological printing, based on tissue-derived collagens. Manufacturers of these products include, among others, BICO, Allevi (now part of 3D systems) and Humabiologics. The main competitors to the company's 3D bioprinted regenerative breast implants that are in development include the commercially available breast implants by Allergan, Inc., an AbbVie company, and Mentor Worldwide LLC, Johnson & Johnson company. The competitors to the company's photocurable dermal fillers that are in development include the main commercially available hyaluronic acid dermal filler brands by Galderma, Sinclair and Merz. The competitors to the company's 3D bioprinted regenerative soft tissue matrix that is in development include the main commercially available acellular dermal matrices by AbbVie, MTF biologics, Bard, and Stryker. The company's VergenixSTR product competes with companies that sell steroid injections and PRP kits, including, among others, Zimmer Biomet., Harvest Technologies Corporation, and Arteriocyte Medical Systems Inc. The primary competitors to the company's VergenixFG products are product based on tissue-derived collagens. Manufacturers of these products include, among others, Integra Lifesciences Corporation, Organogenesis, Wright Medical Technology Inc., Smith & Nephew, Molnlycke, Convatec, Coloplast, and Urgo. History The company was founded in 2004. It was formerly known as CollPlant Holdings Ltd. and changed its name to CollPlant Biotechnologies Ltd. in 2019.