Public benefit corporations are a relatively new class of corporations that are intended to produce a public benefit and to operate in a responsible and sustainable manner. Under Delaware law, public benefit corporations are required to identify in their certificate of incorporation the public benefit or benefits they will promote and their directors have a duty to manage the affairs of the corporation in a manner that balances the pecuniary interests of the stockholders, the best interests of those materially affected by the corporation’s conduct, and the specific public benefit or public benefits identified in the public benefit corporation’s certificate of incorporation. Public benefit corporations organized in Delaware are also required to assess their benefit performance internally and to disclose publicly at least biennially a report detailing their success in meeting their benefit objectives.
Our Manager’s public benefit, as provided in its certificate of incorporation, is to create and maintain a community-owned genomic and phenotypic database that is designed to solve humankind’s most important medical challenges.
Given the large number of rare, chronic, and overlooked diseases, and the huge volume of genomics data being generated, it is critical that genomics data be made available to researchers to support the public good. Traditionally, this has been the domain of government institutions such as the National Institutes of Health and various non-profit foundations. However, foundations, while supportive of data sharing, are often not in the position to build the required technology to create the searchable container, or database, nor are they in a position to be responsible for sustaining the data and safeguarding the privacy and security of the data.
First Class Team in the Epicenter of Genomics
Our Manager’s executive team is comprised of experienced leaders in science and genomics, engineering, economics, and large-scale consumer engagement platforms. See “Directors, Officers and Significant Employees” beginning on page 40.
Commercial Partnerships
Agreement with pharmaceutical company
In December 2019, the Manager signed a master services agreement and statement of work with a pharmaceutical company to create a virtual patient community around a specific disease indication to establish a better understanding of the disease through longitudinal collection and analysis of self- reported, longitudinal health information DNA and electronic health record data. The formation of this community has the broader goal of inviting community members to enroll in a clinical trial. The agreement has an initial term of five years unless earlier terminated.
The Manager, with support from Genetic Alliance (see the following paragraphs), has managed the program, developed a marketing & experience program, provided multilingual support, managed clinical lab and data integration, developed communications to assist with community formation and patient recruitment, enrolled patients in the Database for the study, managed patient requests and study updates, and established a private data analysis space where the study data can be stored and integrated with private data provided by the pharmaceutical company with the ability to perform queries and analysis. The agreement called for a minimum number of patients to be enrolled in the Database for the study and our Manager exceeded that minimum.
Genomics Opportunity
In January 2019, the Manager entered into a Master Agreement (the “GA Agreement”), with Genetic Alliance (“GA”), a 501(c)(3) non-profit organization, in order to provide an upgrade path for GA participants to manage their health data contained in GA’s Platform for Engaging Everyone Responsibly (“PEER”). PEER participants are invited to join the LunaDNA platform and be eligible to receive shares when contributing their Member Data to the Database, subject to local regulations or laws, such as those governing securities, data rights, or data privacy.
The initial term of the GA Agreement ends in June 2025. Thereafter, the agreement will be automatically renewed annually unless previously terminated for convenience or terminated for breach.
The communities started transitioning from PEER in the second quarter of 2020 and continued to transition their participants and recruit new participants to the LunaDNA platform. Any data previously shared by a participant in PEER remains bound to the permissions the participant defined in PEER and has not been/will not be transitioned to the Member accounts in the Database.
Certain expenses of hosting the PEER data became the responsibility of the Company after March 31, 2020 under the Management Agreement. These expenses were $18,165 for the nine months ended December 31, 2020. PEER has been obsolesced since December 2020 and the Company is no longer accruing hosting expenses for it.
In March 25, 2022, Genetic Alliance announced that its program, iHope Genetic Health, had been selected for a new global program from Amazon Web Services (“AWS”) supporting organizations that are developing solutions to advance health equity. A novel and critical part of the iHope Genetic Health program is the requirement that the data generated be given to the individuals and their families. The platform for these and other clinical data will be the Company’s platform.
Partnership with Takeda Pharmaceutical Company Limited
On December 14, 2021, our Manager announced the launch of a digital drug discovery community in partnership with Takeda Pharmaceutical Company Limited to advance the understanding of and develop therapeutic interventions for patients with Mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The program leverages whole-genome sequencing to create a rich, longitudinal data stream that can be viewed across different lenses between industry and the patient community. The comprehensive study – inclusive of input from patients and families, patient advocates, and patient-centric data stewardship – is designed to ensure that the most relevant clinical and behavioral features and key endpoints are incorporated in the drug discovery process. Access to these data streams, including medical history and patient-generated health data, will form the basis for discovery and development. Genetic Alliance is providing the partners with engagement and protocol expertise for this program to ensure study enrollment goals and support for study participants. The Database serves as the data visualization and analytics environment for this program.
On February 3, 2022, our Manager announced a program to assemble a patient-led drug discovery community studying the disease etiology of a rare neurodevelopmental disorder known as Aicardi-Goutières syndrome and support development of therapeutic treatments for this devastating disease. The program is being launched in collaboration with Biogen, Inc. The program will engage patients and their families, patient advocates, and pharmaceutical partners to create a patient-driven trial design—with patients and their parents as the stewards of their data with the goal of incorporating the optimal clinical and behavioral features and the most desired trial endpoints in the drug discovery process. Luna’s proprietary Community-Driven Innovation technology will align families and researchers on their key priorities and needs. The Database serves as the data visualization and analytics environment for this program.
Government Regulation
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
We are not subject to the Health Insurance Portability and Accountability Act of 1996, as amended, commonly known as HIPPA, because we are not a “covered entity” for purposes of that law. Accordingly, the privacy and other protections afforded to patients by HIPAA do not apply to us.
CCPA
In the United States, the California Consumer Privacy Act of 2018 (CCPA) became effective on January 1, 2020. The CCPA contains new obligations for businesses that collect personal information (which is broadly defined) about California residents. CCPA affords consumers expanded privacy protections and control over the collection, use and sharing of their personal information. For example, the CCPA gives California consumers (as defined by the law) expanded rights to access and delete their personal information, opt out of certain personal information sharing and receive detailed information about how their personal information is used. The CCPA provides for civil penalties for violations (up to $7,500), as well as a private right of action for data breaches that is expected to increase data breach litigation. The laws relating to privacy and data security are evolving. Other states are considering laws like the CCPA.
European General Data Protection Regulation (GDPR)
The European General Data Protection Regulation, commonly referred to as the GDPR, went into effect in May 2018. The GDPR increases privacy rights for individuals in Europe, extends the scope of responsibilities for data controllers and data processors and imposes increased requirements and potential penalties on companies offering goods or services to individuals who are located in Europe or monitoring the behavior of such individuals (including by companies based outside of Europe). Noncompliance can result in penalties of up to the greater of €20 million, or 4% of global company revenues. We are currently accepting only members who reside in the United States, and hence we do not believe we are currently subject to the requirements of the GDPR.
Employees
We have no full time employees. We are managed by our Manager. Currently, our Manager has thirteen full-time employees.
Legal Proceedings
We know of no existing or pending legal proceedings against us or our Manager, nor are we or our Manager involved as a plaintiff in any proceeding or pending litigation.
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