Organovo Holdings Stock

Organovo Holdings, Inc. operates as an early-stage biotechnology company that focuses on developing 3D tissues that recapitulate key aspects of human disease.

The company uses these models to identify gene targets capable of modulating the disease phenotype across multiple patients and intends to initiate drug discovery programs around these validated targets. It is initially targeting the intestine and has ongoing 3D tissue development efforts in Ulcerative colitis and Crohn’s disease. It intends to add additional tissues/diseases/targets to its portfolio.

Platform Technology

The company’s 3D human tissue platform is multifaceted. It approaches each tissue agnostic to specific technologies and intends to apply the major 3D technology to a given disease. The company is developing novel disease models using high throughput systems, bioprinted and flow/stretch capable 3D systems as appropriate. It has a 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 (MU) and Clemson University. The company owns or exclusively licenses approximately 90 patents and pending applications worldwide covering specific tissue designs, uses, and methods of manufacture.

The NovoGen Bioprinter Platform

The company’s NovoGen Bioprinters are automated devices that enable the fabrication of 3D living tissues comprised of mammalian cells. A custom graphic user interface 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 could be formulated as a 100% cellular composition or as a mixture of cells and other matter (hydrogels, particles). The company’s NovoGen Bioprinters could also dispense pure hydrogel formulations, provided the physical properties of the hydrogel are compatible with the dispensing parameters. The company employs various proprietary cell- and hydrogel-based bio-inks in the fabrication of tissues. Its NovoGen Bioprinters also serve a major component of its tissue prototyping and manufacturing platform, as they fabricate intricate small-scale tissue models for in vitro use, as well as larger-scale tissues suitable for in vivo use.

Research Collaborations

The company continues to collaborate with various academic institutions by providing them with access to its NovoGen Bioprinters for research purposes, including Yale School of Medicine, University of California, San Francisco, Knight Cancer Institute at Oregon Health & Science University, and the University of Virginia. Its academic research collaborations involve both parties contributing resources directly to projects.

Research and Development

For the year ended March 31, 2021, the company’s research and development expenses were $1.1 million.

Intellectual Property

The company owns or holds exclusive licenses to 30 issued U.S. patents and approximately 40 issued international patents in foreign jurisdictions, including Australia, Canada, China, Denmark, France, Great Britain, Germany, Ireland, Japan, South Korea, Sweden, the Netherlands and Switzerland. It solely or jointly owns or holds exclusive licenses to 8 pending U.S. patent applications and approximately 14 pending international applications in foreign jurisdictions, including Australia, Canada, China, the European Patent Office, Japan and South Korea. These patent families relate to the company’s 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 Intellectual Property

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 includes 6 issued U.S. patents, 2 pending U.S. applications and 11 issued international patents. The Forgacs Intellectual Property provides the company 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 the company to utilize its NovoGen 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. This intellectual property has been returned to UniQuest Pty Limited.

Company Owned Intellectual Property

With respect to its bioprinting platform, the company has 8 issued U.S. patents and 9 issued foreign patents directed to its NovoGen Bioprinter and methods of bioprinting: U.S. Patent Nos. 8,931,880; 9,149,952; 9,227,339; 9,315,043; 9,499,779; 9,855,369; 10,174,276 and 10,967,560; Australia Patent Nos. 2011318437, 2015202836, 2016253591, and 2013249569; China Patent Nos. ZL201180050831.4 and ZL201480054148.1; European Patent No. 2838985; Japan Patent Nos. 6333231 and 6566426. These issued patents and pending patent applications carry remaining patent terms ranging from approximately 12 years to 6 years. It has additional U.S. continuation applications pending in these families, as well foreign counterpart applications in multiple countries.

The company’s ExVive Human Liver Tissue is protected by U.S. Patent Nos. 9,222,932, 9,442,105 and 10,400,219; Australia Patent Nos. 2014236780 and 2017200691; and Canada Patent No. 2,903,844, and its ExVive Human Kidney Tissue is protected by U.S. Patent Nos. 9,481,868, 10,094,821 and 10,962,526; and European Patent No. 3204488. These issued patents and pending patent applications carry remaining patent terms ranging from approximately 14 years to 11 years. It has additional U.S. patent applications pending in these families, as well as foreign counterpart applications in multiple countries. The company has pending various patent applications in the U.S. and internationally that are directed to additional tissue types, their methods of fabrication, and specific applications.

The company’s U.S. Pat. Nos. 9,855,369 and 9,149,952, which relate to its bioprinter technology, are the subject of IPR proceedings filed by Cellink AB, one of its competitors. In addition, U.S. Patent Nos. 9,149,952, 9,855,369, 8,931,880, 9,227,339 and 9,315,043 (all assigned to Organovo, Inc.) and U.S. Patent Nos. 7,051,654 and 9,752,116 (assigned to Clemson University and the University of Missouri, respectively) are implicated in a declaratory judgment complaint filed against Organovo, Inc., the company’s wholly owned subsidiary, by Cellink AB and certain of its subsidiaries in the United States District Court for the District of Delaware.

History

Organovo Holdings, Inc. was founded in 2007 in Delaware. The company was incorporated in 2007.