Overview

Organovo Holdings, Inc. (ONVO) is an early commercial stage company focused on developing and commercializing functional three-dimensional (“3D”) human tissues. Using its proprietary technologies and expertise in bioprinting, Organovo Holdings is building functional 3D human tissues that mimic key aspects of native biology, and can be used in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or diseased tissues and organs. Organovo Holdings is utilizing its proprietary bioprinting platform to create human tissue constructs in 3D that mimic native human tissue composition, architecture, and function. Organovo Holdings is leveraging its unique tissue models to improve the current industry standard cell-based and animal model testing approaches, and the company believe its foundational approach provides it with the opportunity to fill many critical gaps in commercially available preclinical human tissue models as well as in tissue transplantation. Specifically, Organovo Holdings is focused on developing the following offerings:1

  • A suite of standardized, 3D human tissues for the preclinical assessment of drug effects, including applications in predictive toxicology, absorption, distribution, metabolism, excretion (“ADME”), and drug metabolism and pharmacokinetics (“DMPK”);
  • Highly customized human tissues as living, dynamic models of human biology or disease, for use in drug discovery and development and disease modeling; and
  • Three-dimensional human tissues for clinical applications, such as its therapeutic liver tissue patch.

Organovo Holdings has developed and currently offer two commercial products. In November 2014, the company began offering contract research services for pharmaceutical companies using its proprietary ExVive™ Human Liver Tissue model. In September 2016, the company began commercial contracting for its second tissue service, the ExVive™ Human Kidney Tissue model. This kidney proximal tubule model is a natural expansion of its preclinical product and service portfolio, allowing customers to study the effects of drug exposure on a key portion of the human kidney relevant to drug discovery and development. Organovo Holdings has signed multiple commercial orders and are collaborating on toxicology panels and transporter studies with its customers.

In addition to its ExVive™ Human Liver Tissue and ExVive™ Human Kidney Tissue service offerings, Organovo Holdings has entered into collaborative research agreements with pharmaceutical companies and academic medical centers to develop new tissue models, including models of diseased tissues. Organovo Holdings has also secured federal grants, including Small Business Innovation Research grants, to support the development of its technology.

In October 2016, the company announced its plan to develop 3D bioprinted human liver tissue for direct transplantation to patients. Its decision to develop this therapeutic tissue is based on the achievement of promising results in early preclinical animal studies demonstrating engraftment, vascularization and sustained functionality of its bioprinter liver tissue, including stable detection of human liver-specific proteins and metabolic enzymes. The company chose to advance this therapeutic tissue program first due to technical feasibility, a strong commercial opportunity and favorable clinical, regulatory, and reimbursement factors. Organovo Holdings is continuing to pursue this opportunity with a formal preclinical development program.

Platform Technology

Our unique bioprinting platform is based on proprietary technologies for preparing bioinks, bioprinting functional 3D human tissues and maintaining the viability and functionality of the tissues for an extended period of time. Its foundational proprietary technology, grounded in over a decade of peer-reviewed scientific publications, derives from research led by Dr. Gabor Forgacs, the former George H. Vineyard Professor of Biological Physics at the University of Missouri-Columbia. Organovo Holdings has a broad portfolio of intellectual property rights covering the principles, enabling instrumentation, applications, and methods of cell-based printing, including exclusive licenses to certain patented and patent pending technologies from the University of Missouri-Columbia and Clemson University. Organovo Holdings has continued to develop its technology and grow its intellectual property portfolio. In addition to its in-licensed patents, the company own outright more than 90 additional patents and pending patent applications around the world. The company believe that its broad and exclusive commercial rights to patented and patent-pending 3D bioprinting technology, 3D tissues and applications provides it with a strong and defensible market position for the successful commercialization of 3D bioprinted human tissues serving a broad array of unmet preclinical and clinical needs.

Organovo Holdings has developed a proprietary instrument platform, its NovoGen Bioprinters®, which enables it to create a wide array of tissue compositions and architectures , using purely cellular ‘bio-ink’ (building blocks comprised of only living cells), biocompatible hydrogels, or combinations of the two. A key distinguishing feature of its bioprinting platform is the ability to generate complex 3D tissues that have all or some of their components comprised entirely of cells. Prior to the invention of its NovoGen bioprinting platform, the most common fabrication method for 3D tissues was the use of biomaterial scaffolding into which cells were incorporated. While useful for some applications, scaffold-based engineered tissues lack features of native tissue that are critical to function such as dense cellularity where cells have intimate contact with neighboring cells, and an intricate architecture created by the spatial arrangement of specific cellular compartments relative to each other. Organovo’s 3D bioprinting platform can deliver tissues that are truly three-dimensional with a cellularity and architecture that closely resembles native tissue. Moreover, the company can generate tissues using human cells as inputs, yielding functional models of human tissue that can be used in vitro for drug discovery and development. In the future, complex bioprinted human tissues may also address unmet clinical needs by serving as tissue grafts for the augmentation or replacement of functional mass in tissues and organs that have sustained significant damage by trauma or disease.

Market Opportunity

The company believe that its proprietary 3D bioprinting platform enables it to deliver highly unique functional human tissues to the drug discovery and development market and to multiple clinical markets:

3D Human Tissues for Predictive Toxicology and Preclinical Testing: The company believe that its NovoGen MMX Bioprinter delivers differentiated 3D tissues for use in assays aimed at predicting human clinical outcomes. Its products in this area may replace or complement traditional two-dimensional (“2D”) cell culture based cell assays, or cellular co-culture systems. Because its 3D tissues are made of human cells and reproduce many aspects of in vivo tissue architecture and function, the company believe they may provide advantages over animal models with respect to prediction of in vivo human outcomes. The company market its tissue products as a compound screening service, for customers who provide their compounds to it. The company conduct short- or long-term tests involving the exposure of its bioprinted 3D human tissues to their compound(s) and provide them with results and samples. In the future, this compound screening service may also be conducted by one or more partners, such as contract research organizations (“CROs”). In addition, the company may provide its bioprinted 3D human tissue products to the market as kits that are sold by us, or distributed by a partner.

Our 3D tissue products have demonstrated compatibility with a broad range of in vitro preclinical tests, including some aspects of assessments of ADME, DMPK, and predictive toxicology. DMPK testing is a subset of ADME. Determining the DMPK properties of a drug helps the drug developer to better predict its safety and efficacy. The ADME and DMPK properties of a drug essentially determine the bioavailability of that drug, including how long and at what concentrations it is exposed to the target tissue(s). Toxicology testing is a further requirement to assess the potential for a particular drug to seriously damage one or more organs systems while it is present in the body. Many aspects of preclinical drug testing can be altered significantly by age, genetics, disease state, and the presence of other drugs or chemicals. Most companies perform preclinical ADME, DMPK, and toxicology tests using a combination of biochemical and cell-based assays and animal testing. 3D bioprinted tissue products may replace or complement traditional cell based assays that typically employ primary hepatocytes, intestinal cell lines, renal epithelial cells and cell lines grown in traditional two-dimensional formats. Because 3D bioprinted tissues share more features with native tissue in vivo than standard 2D cell cultures, and they persist for extended time periods in vitro (>40 days), the company believe they can provide differentiated and valuable outcomes and give clients “human preclinical data” with greater depth and accuracy than has previously been possible. Additional opportunities in this area include the testing of environmental toxins and cosmetic products on living human tissues. Due to ethical concerns and regulatory considerations, there is a growing market opportunity for the use of 3D human tissue models as alternatives to animal studies. In addition, many of the standard tissue models developed within this aspect of its business may be used to assess the potential human health impacts and toxicological properties of a large number of chemical products, environmental toxins, or biowarfare agents.

3D Tissue Models for Drug Discovery and Development: Its NovoGen bioprinting platform, comprised of multicellular inputs (“bio-ink”) and a family of bioprinters with unique capabilities, can produce highly specialized human tissues that model physiology or disease. Organovo Holdings has used its bioprinting platform to create a wide array of human tissues, including blood vessels, liver tissues, skin tissues, kidney tissues, lung tissues, and tumor tissues. 3D bioprinted tissues possess unique features, including cell type-specific compartments, prevalent intercellular tight junctions, and microvascular structures. These features facilitate the development of complex, multicellular disease models for use in the development of targeted therapeutics for cardiovascular disease, lung disease, liver disease, kidney disease, and oncology. Market opportunities within this aspect of its business may include externally-partnered or internally-directed drug discovery and the clinical development and commercialization of new molecular entities using highly customized 3D tissue models.

Implantable 3D Tissues for Therapeutic Use: Cell- and tissue-based therapeutic products have advanced through research and development via multiple strategic approaches, with current clinical efforts in the field focused on systemic or localized delivery of cell suspensions or surgical installation of combination products that consist of a predominant biomaterial component and cellular component(s). The company believe the architectural precision and flexibility of its bioprinting platform facilitates the prototyping, optimization, development, and clinical use of three-dimensional tissue constructs. Importantly, its platform enables all or part of a three-dimensional tissue to be generated without dependence on scaffolding or biomaterial components, using only living cells as raw materials. The ultimate goal is to construct surgically implantable tissues that restore significant functional mass to a damaged tissue or organ after delivery. It is its belief that, in most cases, whole organ replacement will not be required to achieve meaningful clinical outcomes and address unmet medical needs. Three-dimensional tissues with tightly defined architecture and composition can create a new product category within cell and tissue therapies. Tissue products may include bioprinted tissues (patches, tubes, etc.) or hybrids comprised of bioprinted tissues and device component(s). The company may develop specific tissue targets with partners through technology licenses and royalty-bearing deals, and may self-fund the development of additional tissue targets through preclinical and clinical development.

Background on Bioprinting

The formation of ‘bio-ink’, the cell-based building blocks that can be dispensed by its suite of NovoGen Bioprinters®, relies on the demonstrated principle that groups of individual cells will self-assemble to generate aggregates, through the actions of cell surface proteins that bind to each other and form junctions between cells. Furthermore, if two or more compatible self-assembled aggregates are placed in close proximity, under the proper conditions they will merge to generate larger, more complex structures via physical properties analogous to those that drive fusion of liquid droplets. The concept of tissue liquidity originated in studies of developmental biology, where it was noted that developing tissues have liquid-like properties that enable individual cellular components to pattern each other, migrate, organize, and differentiate. As development progresses, tissues transition from a dynamic viscous liquid state to a more static semi-solid state, largely driven by the compartmentalized organization of cellular components and production within the organized tissue of extracellular matrix proteins that provide the mature tissue with the biomechanical properties required for tissue specific function.

Early publications describing scaffold-free bioprinting demonstrate self-assembly and tissue liquidity using cellular aggregates generated from developing chicken heart tissue, showing that adjacent aggregates will fuse over time and generate a larger cellular structure. This basic behavior can be leveraged to form more complex structures whereby aggregates are arranged in a specific geometry that can recapitulate shapes and architectures commonly found in tissues and organs, including tubes and multi-layered structures.

Additional published results demonstrated that the observed fusion of aggregates in embryonic tissue can be extended to adult-derived cultured mammalian cells, as demonstrated by the fusion of adult hamster ovary epithelial cell aggregates to form toroid (ring) structures when placed into that geometry and held for about 120 hours.

The NovoGen Bioprinter® Platform

HTG Molecular's NovoGen Bioprinters are automated devices that enable the fabrication of 3D living tissues comprised of mammalian cells. A custom graphic user interface (“GUI”) facilitates the 3D design and execution of scripts that direct precision movement of multiple dispensing heads to deposit defined cellular building blocks called bio-ink. Bio-ink can be formulated as a 100% cellular composition or as a mixture of cells and other matter (hydrogels, particles, etc.). Its NovoGen Bioprinters can also dispense pure hydrogel formulations provided the physical properties of the hydrogel are compatible with the dispensing parameters. Most typically, hydrogels are deployed to create void spaces within specific locations in a 3D tissue or to aid in the deposition of specific cell types. The company employ a wide variety of proprietary cell- and hydrogel-based bio-inks in the fabrication of tissues. Its NovoGen Bioprinters also serve as important components of its tissue prototyping and manufacturing platform, as they are able to rapidly and precisely fabricate intricate small-scale tissue models for in vitro use as well as larger-scale tissues suitable for in vivo use.

HTG Molecular's first-generation NovoGen MMX Bioprinter™ went from in-licensing and initial design to commercial production in less than two years. Its efforts in systems engineering are focused on ensuring the continuous improvement and evolution of its NovoGen Bioprinters to meet the needs of internally driven and externally partnered tissue programs. To date, several generations of NovoGen Bioprinters have been designed, developed, and are being used for tissue production. Generation of bio-ink building blocks is the first step in bioprinting. A wide variety of cells can serve as the raw materials for bio-ink, including cell lines, primary cells, stromal cells, epithelial cells, endothelial cells, and progenitor cells. The majority of tissue designs employ two or more distinct varieties of bio-ink, usually comprised of cells that represent distinct compartments within a target tissue. For example, a 3D tumor might consist of both stromal and epithelial bio-inks, a vascular tube may consist of both fibroblast and smooth muscle bio-inks, and a liver tissue may consist of four bio-inks made from distinct liver cell types. Its NovoGen Bioprinters dispense two or more bio-inks layer by layer in the geometry specified by the user, with bio-inert hydrogels serving as an optional physical support for the bioprinted tissue as well as occupying any negative space included in the design.

HTG Molecular's NovoGen MMX BioprinterTM is a powerful enabling tool for the design, optimization, and fabrication of viable functional human tissues, based on its internal product discovery and development efforts as well as through collaboration with its partners and customers. Use of NovoGen Bioprinters in the pursuit of multiple in vitro and in vivo applications provides key insights that drive design features and specifications for next-generation instrumentation.

The company currently collaborate with the following institutions, providing access to its NovoGen Bioprinters for research purposes: Yale School of Medicine, University of California, San Francisco (“UCSF”), Knight Cancer Institute at Oregon Health & Science University (“OHSU”), the National Center for Advancing Translational Sciences (“NCATS”), the National Eye Institute (“NEI”), Murdoch Childrens Research Institute (“MCRI”), and the University of Virginia (“UVA”). The company believe that the use of its bioprinting platform by major research institutions will help to advance the basic capabilities of the platform and generate new applications for bioprinted tissues, ultimately creating future opportunities for its commercial products and intellectual property licensing.

Products and Product Candidates

Organovo Holdings has utilized and intend to utilize its bioprinting technology to develop functional human tissues that can be employed in drug discovery and development, biological research and as therapeutic implants. The first tissue that the company launched commercially, ExVive™ Human Liver Tissue, is designed to be used for predictive preclinical testing of drug compounds. In April 2014, the company announced that the company had begun to sign contracts with pharmaceutical and biotechnology companies for toxicity research services using its 3D Human Liver Tissue. In November 2014, the company began to offer 3D Human Liver services more broadly. The company currently focus on contract research services, though the company also intend to offer its ExVive™ Human Liver Tissue directly to end user customers as a product in a kit for toxicological and other testing over time. The company launched its second commercial product, the ExVive™ Human Kidney Tissue, in September 2016. Similar to its ExVive™ Human Liver Tissue, the company designed its ExVive™ Human Kidney Tissue to be used for predictive preclinical testing of drug compounds.

Research Collaborations

The company currently have research collaborations with pharmaceutical, biotechnology and cosmetic companies, and academic and research institutions. These collaborations are focused on a variety of research projects, including: developing tissue-based drug discovery assays and tissues, developing more clinically predictive in vitro three-dimensional cancer models, exploring the use of its 3D liver tissues in toxicology, and exploring the use of 3D skin for testing skin care products. Its collaborations with pharmaceutical and biotechnology companies generally involve the partner providing research funding to cover, in part or in full, the scope of work. This funding is typically reflected as collaboration revenues in its financial statements. Upon entering into a collaboration, the company disclose the financial details only to the extent that they are material to its business and not subject to confidentiality agreements with its partners. Its research collaborations typically involve both it and the academic partner contributing resources directly to projects, but also may involve sponsored research agreements where the company fund specific research programs. The company may also contribute a bioprinter and technical support or a bioprinter and research headcount, depending on the project scope.

Samsara Sciences

In January 2016, the company announced that its wholly-owned subsidiary, Samsara Sciences, Inc. (“Samsara”), commenced commercial operations. The company formed Samsara to serve as a key source of certain of the primary human cells the company utilize in its products and services and in the development of therapeutic products. The company believe Samsara can help it optimize its supply chain and reduce operating expenses related to cell sourcing and procurement and ensure that the cellular raw materials the company use are of the highest quality and are derived from tissues that are ethically sourced in full compliance with state and federal guidelines. Samsara has begun providing it with qualified liver cells for use in its 3D Human Liver Tissue manufacturing, and certain other human cells for use in its preclinical research and development programs. In addition to serving as one of its key suppliers, Samsara offers human cells for use by life science customers, both directly or through distribution partners.

Competition

Organovo Holdings is subject to significant competition from pharmaceutical, biotechnology, and diagnostic companies; academic and research institutions; and government or other publicly-funded agencies that are pursuing the development of tissue models and therapeutic products that otherwise address the needs of its potential customers. The company believe its future success will depend, in large part, on its ability to maintain a first mover advantage and competitive lead in its industry. Biopharmaceutical technologies have undergone and are expected to continue to undergo rapid and significant change. We, or its competitors, may make rapid technological developments which may cause its research tools or therapeutic products to become obsolete before the company recover the development expenses Organovo Holdings has incurred. The introduction of less expensive or more effective therapeutic discovery and development technologies, including technologies that may be unrelated to its field, may also make its technology or products less valuable or obsolete. The company may not be able to make the necessary enhancements to its technologies or products to compete successfully with newly emerging technologies. The failure to maintain a competitive position in the biopharmaceutical field may result in decreased revenues.

Organovo Holdings is a platform technology and tissue development company dedicated to the development and production of functional human tissues that service the drug discovery and development, biological research, and cell- and tissue-based therapy industries.

Set forth below is a discussion of competitive factors for each of the broad markets in which the company intend to utilize its technology:

3D Tissues for in vitro Preclinical Testing: The company intend to employ its technology to provide an array of broadly applicable 3D tissue models for use in preclinical assessments of safety and efficacy as an adjunct or alternative to animal studies. Examples of products in this segment of the business include cell-based models for ADME/TOX/DMPK markets.

The company believe that Organovo Holdings is the first and only company to leverage a bioprinting system in the commercial production of 3D tissue products. Importantly, its fabrication platform remains highly unique in its ability to fabricate 3D tissues from human cells without reliance on biomaterial scaffolding. Consequently, the tissues that the company produce have unique features that to date have not been attainable in 3D tissues generated by alternative strategies. Specifically, the company believe the dense cellularity, compartmentalized 3D geometry, and microarchitectural features of its bioprinted tissues offer unparalleled in vitro modeling of native tissues. Current competition in this area, and predominant market share, arises mainly from two sources, traditional cell-based in vitro culture approaches and traditional in vivo animal models and testing. Additional competition exists from non-bioprinted cell-based assays offered by such companies as InSphero AG, Ascendance Biotechnology, Inc., RegeneMed Inc., and Hurel Corporation, some of which have a three-dimensional aspect. Although assays from these companies have limited market share today, they may improve market share and competitive position in the future. Future competition may also exist from companies developing cellular models “on a chip”, such as Emulate, or developing tissues with alternative biofabrication methods, such as Cyfuse.

Models for Drug Discovery and Development: This aspect of its business is driven by leveraging its technology as a high-end partnered service that designs and delivers highly complex, custom tissue models of normal or diseased tissue for use in drug discovery and development. Each model is designed to enable a customer to discover or optimally formulate a pharmacologic product that delivers a specific therapeutic effect, or avoids a particular side effect. In addition to revenue generated from the tissue production work, additional revenues are possible in the form of up-front license fees, milestone payments, know-how payments, and royalties. The company can provide the customer access to tissues as a service or can produce and supply the tissues to customers with both options designed to generate continuing revenue. Competition in this area arises mainly from two sources, traditional cell-based in vitro culture approaches and traditional in vivo animal models and testing. The company may also face future competition from companies like Cyfuse Biomedical (including service companies using their instrument platform) and Aspect Biosystems.

The company believe that an important factor distinguishing its approach from that of its competitors is its ability to build models that are composed of human cells and have a 3D tissue-like configuration (i.e., able to generate results that are not subject to inherent limitations of 2D monolayer culture). The company acknowledge, however, that there are some areas of research for which the existing methods (2D cell culture and/or animal studies) are adequate and 3D in vitro human tissues are not sufficiently advantageous on a cost basis.

Implantable 3D Tissues for Clinical Use: This aspect of its business involves application of its 3D bioprinting technology to generate human tissues suitable for implantation in vivo to augment or replace damaged or degenerating tissues. These efforts will be undertaken by it alone, or as partnered projects with leading therapeutic companies seeking to develop a therapeutic tissue product for a specific application. Near-term revenues would come from the funding of development work and, in some cases, licensing fees for access to its platform technologies. The company expect longer-term revenues may arise from shared profits and royalties or other forms of income from successful clinical and commercial development of the tissue products. There are many companies pursuing the discovery, development, and commercialization of tissue-based products for a variety of applications, including but not limited to Organogenesis and Cyfuse. These companies uniquely represent potential competition for it while also being partner candidates. Its platform has the ability to enable the generation and optimization of unique, scaffold-free or hybrid tissue prototypes and ultimately support production of the tissue.

Research and Development

The company continuously engage in research and development to enhance its platform technology, to develop new products and service offerings and to pursue its therapeutic initiatives. Its research and development efforts include internal initiatives as well as collaborative development opportunities with third parties. Its research and development expenses were $19.5 million, $18.0 million and $12.9 million for the fiscal years ended March 31, 2017, March 31, 2016, and March 31, 2015, respectively. The company focus its research and development activities in areas where Organovo Holdings has technological expertise and where the company believe a significant market opportunity exists for its technology and the products and services the company develop. The company intend to continue its focus on research and development as a key strategy for the growth of its business.

Intellectual Property

HTG Molecular's success depends in large part on its ability to establish and protect its proprietary bioprinting technologies and its engineered tissue products and services. The company rely on a combination of patents, trademarks, trade secrets, confidential know-how, copyrights and a variety of contractual mechanisms such as confidentiality, material transfer, licenses, research collaboration, limited technology access, and invention assignment agreements, to protect its intellectual property. Its intellectual property portfolio for its core technology was initially built through licenses from the University of Missouri-Columbia (“MU”) and the Medical University of South Carolina. Organovo Holdings has subsequently expanded its intellectual property portfolio by filing patent and trademark applications worldwide and negotiating additional licenses and purchases.

The company solely own or hold exclusive licenses to 16 issued U.S. patents and 32 issued international patent applications. The company solely or jointly own, or hold exclusive licenses to more than 20 pending U.S. patent applications and over 100 pending international applications. These patent families relate to its bioprinting technology and its engineered tissue products and services, including its various uses in areas of tissue creation, in vitro testing, utilization in drug discovery, and in vivo therapeutics.

In-Licensed IP

In 2009 and 2010, the company obtained world-wide exclusive licenses to intellectual property owned by MU and the Medical University of South Carolina, which now includes 6 issued U.S. patents, 6 pending U.S. applications, 15 issued international patents and 5 pending international applications. Dr. Gabor Forgacs, one of its founders and a former George H. Vineyard Professor of Biophysics at MU, was one of the co-inventors of all of these works (collectively, the “Forgacs Intellectual Property”). The Forgacs Intellectual Property provides it with intellectual property rights relating to cellular aggregates, the use of cellular aggregates to create engineered tissues, and the use of cellular aggregates to create engineered tissue with no scaffold present. The intellectual property rights derived from the Forgacs Intellectual Property also enables it to utilize its NovoGen MMX Bioprinter to create engineered tissues.

In 2011, the company obtained an exclusive license to a U.S. patent (U.S. Pat. No. 7,051,654) owned by the Clemson University Research Foundation that provides it with intellectual property rights relating to methods of using ink-jet printer technology to dispense cells, and relating to the creation of matrices of bioprinted cells on gel materials.

In 2015, the company obtained world-wide exclusive licenses to intellectual property owned by The University of Queensland (collectively, “UniQuest Intellectual Property”) relating to technologies for producing kidney cells and kidney organoids from induced pluripotent stem cells (iPSCs). At the time, Professor Melissa Little and her team at The University of Queensland developed a method of growing kidney tissue from iPSCs for potential use in drug screening, disease modelling and cell therapy. Professor Little’s research was eventually published in 2015 in the prestigious scientific journal Nature. Currently, the UniQuest Intellectual Property includes 1 pending U.S. patent application and 12 pending international patent applications. The company hope to develop and secure additional intellectual property with the support of Professor Little for commercial applications such as kidney disease modelling, nephrotoxicity screening and discovery of compounds which may improve renal function for patients with genetic kidney disease.

The patent rights the company obtained through these exclusive licenses are not only foundational within the field of 3D Bioprinting, but provide it with favorable priority dates. Organovo Holdings is required to make ongoing royalty payments under these exclusive licenses based on net sales of products and services that rely on the intellectual property the company in-licensed. For additional information regarding its royalty obligations see Note 7 to Consolidated Financial Statements “Licensing Agreements and Research Contracts” in its audited financial statements that are included in this Annual Report.

Company Owned IP

In addition to the IP Organovo Holdings has in-licensed, Organovo Holdings has continued to innovate and grow its IP portfolio.

With respect to its bioprinting platform, Organovo Holdings has 5 issued U.S. patents and 4 issued foreign patents directed to its NovoGen MMX Bioprinter and methods of bioprinting: U.S. Patent Nos. 8,931,880; 9,149,952; 9,227,339, 9,499,779, and 9,315,043; Australia Patent Nos. 2,011,318,437 and 2,015,202,836; China Patent No. ZL201180050831.4; and Russia Patent No. 2,560,393. Organovo Holdings has additional U.S. continuation applications pending in these families as well foreign counterpart applications in multiple countries. The company intend to continue pursuing patent protection as the company continue to innovate in relation to the design, features, and functionality of its bioprinter platform and bioprinting methods.

Organovo Holdings is also pursuing U.S. and foreign patents covering its 3D bioprinted tissues and methods of fabricating such tissues. Its ExVive™ Human Liver Tissue is protected by U.S. Patent No. 9,222,932, U.S. Patent No. 9,442,105, Singapore Patent No. 1,120,157,202Y, and Israel Patent No. 241,055. Its ExVive™ Human Kidney Tissue is protected by U.S. Patent No. 9,481,868. Organovo Holdings has additional U.S. patent applications pending in these families, as well as foreign counterpart applications in multiple countries. The company currently have pending numerous patent applications in the U.S. and globally that are directed to additional types of tissues, their methods of fabrication, and specific applications. The company intend to continue filing additional patent applications as the company continue to innovate in this area.

Additionally, in 2013, the company purchased the exclusive rights to “Perfusion Bioreactors for Culturing Cells” (U.S. Patent No. 7,767,446, Japan Patent No. 4,914,835, and Australia Patent No. 2,005,287,162) from Becton Dickinson and Company. This patent represents the acquisition of bioreactor technology for the support of its 3D tissues for use in drug discovery and development.

The company believe that protection of the proprietary nature of its bioprinting technologies and products and services is essential to its business. Accordingly, Organovo Holdings has adopted and will continue a vigorous program to secure and maintain protection of its intellectual property. Under this program, the company intend to continue to file patent applications with respect to novel technology, and improvements thereof, that are important to its business. This program may also feature out-bound patent licensing of some or all of its IP portfolio. The company also will continue to rely upon trade secret and confidential know-how protection of its methods and technology, including its proprietary in-house manufacturing methods and in vitro testing methods. As with other areas of biotechnology, this provides a critical adjunct to the protection offered by patents. As always, the company continue to pursue its internal technological innovation and external licensing opportunities to develop and maintain its competitive position. There can be no assurance, however, that others will not independently develop substantially equivalent proprietary technology or that the company can meaningfully protect its proprietary position.

Regulatory Considerations

Organovo Holdings is not aware of any current U.S. Food and Drug Administration (FDA) regulatory requirements for sale or use of 3D tissue models in research applications, and Organovo Holdings is not currently conducting research services pursuant to Good Laboratory Practice (“GLP”). GLP data is required in the development of any human therapeutic, and its technology platform has been designed to support compliance with GLP, although no independent certification has been performed to date to confirm this compliance. As its therapeutic tissue constructs move into clinical and commercial settings, full compliance with the FDA’s cGTP (current Good Tissue Practices) and cGMP (current Good Manufacturing Practices) guidelines will be required. Suitable design and documentation for clinical use of the bioprinter will be a part of future phases of its NovoGen Bioprinter® design programs.

Therapeutic tissues and other regenerative medicine products are subject to an extensive, lengthy and uncertain regulatory approval process by the FDA and comparable agencies in other countries. The regulation of new products is extensive, and the required process of laboratory testing and human studies is lengthy and expensive. The resource investment necessary to meet the requirements of these regulations will fall on its collaborating partners, or may be shared with us, to the extent that Organovo Holdings is developing proprietary products that are the result of a collaboration effort. The resource investment of time, staff and expense to satisfy these regulations will fall on it for the proprietary products Organovo Holdings is developing on its own. The company may not be able to obtain FDA approvals for those products in a timely manner, or at all. The company may encounter significant delays or excessive costs in its efforts to secure necessary approvals or licenses. Even if the company obtain FDA regulatory approvals, the FDA extensively regulates manufacturing, labeling, distributing, marketing, promotion and advertising after product approval. Moreover, several of its product development areas may involve relatively new technology and have not been the subject of extensive product testing in humans. The regulatory requirements governing these products and related clinical procedures remain uncertain and the products themselves may be subject to substantial review by the FDA and/or foreign governmental regulatory authorities that could prevent or delay approval of these products and procedures. Regulatory requirements ultimately imposed on its products could limit its ability to test, manufacture and, ultimately, commercialize its products and thereby could adversely affect its financial condition and results of operations.

Raw Materials

The company use live human cells to produce its 3D tissues. The company source cells only from suppliers who have provided assurances that their cells come from tissues that were (1) collected in compliance with applicable laws, and (2) provided based on informed consent by the donors. The company formed its wholly-owned subsidiary, Samsara Sciences, Inc. (“Samsara”), to serve as a key source of the primary human cells the company utilize in its products and services and in the development of therapeutic products. Samsara is currently supplying it with qualified human liver and kidney cells for use in manufacturing its ExVive™ Human Liver Tissue and ExVive™ Human Kidney Tissue, as well as certain cells for research and development activities. The company believe that Samsara can help it optimize its supply chain and reduce operating expenses and ensure that the human cells the company utilize for its services, products and research and development programs are of the highest quality and are derived from tissues that are ethically sourced in full compliance with state and federal guidelines. In addition to Samsara, the company also purchase human cells from selected third-party suppliers based on quality assurance, cost effectiveness, and regulatory requirements. The company work closely with Samsara and its third-party suppliers to assure continuity of supply while maintaining high quality and reliability. Although the company believe Organovo Holdings has adequate available sources of raw materials, there can be no guarantee that the company will be able to access the quantity of raw material needed to meet its demands on a timely basis or at a cost effective price.

Employees

As June 1, 2017, Organovo Holdings has 113 full-time employees. The company also engage consultants and temporary employees from time to time to provide services that relate to its bioprinting business and technology as well as for general administrative services.

References

  1. ^ https://fintel.io/doc/sec-onvo-organovo-holdings-10k-annual-report-2018-may-31-17978
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Created by Asif F on 2019/12/09 07:32
     
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