Item 1B. Unresolved Staff Comments
ITEM
1B. UNRESOLVED STAFF COMMENTS
None.
23
ITEM
1C. CYBERSECURITY
We
understand the importance of preventing, identifying, assessing and managing material risks associated with cybersecurity threats. Cybersecurity
processes to identify, assess and manage risks from cybersecurity threats have been incorporated as a part of our overall risk assessment
process and are designed to help protect our information assets and operations from internal and external cyber threats and protect employee
and customer information from unauthorized access or attack, as well as secure our network and systems. The Company’s cybersecurity
policies, standards, processes, and practices are based on recognized frameworks established by the National Institute of Standards and
Technology (“NIST”) and are included in the Company’s overall risk management system and processes. We have implemented
into our operations these cybersecurity processes, technologies and controls to identify, assess and manage material risks. Specifically,
we engage a third-party cybersecurity firm to assist with network and endpoint monitoring, cloud system monitoring and assessment of
our incident response procedures. Further, we employ periodic internal and external penetration testing by an independent cybersecurity
firm to inform our risk identification and assessment of critical, high, medium and minor material cybersecurity threats.
To
manage our material risks from cybersecurity threats and to protect against, detect, and prepare to respond to cybersecurity incidents,
we undertake the below listed activities:
●
Monitor
evolving cybersecurity standards and emerging data protection laws and implement changes to our processes to comply;
●
risk
assessments designed to help identify material cybersecurity risks to our critical systems, information, products, services, and
our broader enterprise IT environment;
●
The
Company leverages third-party vendors to house critical clinical trial data. These vendors are required to be GxP compliant which
entails strong cybersecurity controls that are validated by a third-party auditor. Furthermore, the Company has begun performing
security risk assessments prior to on-boarding new significant vendors.
●
The
Company provides regular, mandatory training for all levels of employees regarding cybersecurity threats as a means to equip the
Company’s employees with effective tools to address cybersecurity threats, and to communicate the Company’s evolving
information security policies, standards, processes, and practices.
●
Employ
multifactor authentication on internal and external systems;
●
Conduct
regular phishing email simulations for all employees; and
●
Carry
cybersecurity risk insurance that provides protection against the potential losses arising from a cybersecurity incident.
Our
incident response plan coordinates the activities that we and our third-party cybersecurity providers take to prepare to respond and
recover from cybersecurity incidents, which include processes to triage, assess severity, investigate, escalate, contain, and remediate
an incident, as well as to comply with potentially applicable legal obligations and mitigate brand and reputational damage.
As
part of the above processes, we engage with subject matter expert consultants to review our cybersecurity program to help identify areas
for continued focus, improvement, and compliance.
Our
processes also include assessing cybersecurity threat risks associated with our use of third-party services providers in normal course
of business use, including those in our supply chain or who have access to patient and employee data or our systems. Third-party risks
are included within our risk management process discussed above. In addition, we assess cybersecurity considerations in the selection
and oversight of our third-party services providers, including due diligence on the third parties that have access to our systems and
facilities that house systems and data.
We
do not believe that there are currently any known risks from cybersecurity threats that are reasonably likely to materially affect our
business strategy, results of operations or financial condition. However, cybersecurity threats may affect our business. See “ Cyber
security risks and the failure to maintain the integrity of company, employee or guest data could expose us to data loss, litigation
and liability, and our reputation could be significantly harmed. ” in “Item 1A. Risk Factors” of this Annual
Report on Form 10-K.
The
Audit Committee of the Board of Directors is responsible for oversight of our cybersecurity risk assessment, risk management, incident
response procedures and cybersecurity risks and provides updates to the Board of Directors regarding such oversight. Periodically during
each year, the Audit Committee receives an overview from our Vice President, Head of Technology of our cybersecurity threat risk management
and strategy processes, including potential impact on us, the efforts of management to manage the risks that are identified and our incident
response preparations.
Our
cybersecurity risk assessment, management and strategy processes are led by our Chief Technology Officer. Our Chief Technology Officer
has over 15 years of experience in various roles involving managing information security, managing privacy and data protection, developing
cybersecurity strategy, and implementing cybersecurity programs. The Chief Technology Officer was recently promoted and is training to
be a Certified Information Security Manager (CISM), is informed about and monitors the prevention, mitigation, detection, and remediation
of cybersecurity incidents through management of the cybersecurity risk management and strategy processes described above, including
our incident response plan.
24
ITEM
2. PROPERTIES
Our
headquarters are located at 2401 S. Foothill Drive, Salt Lake City, Utah. Our current facilities have approximately 54,000 square feet
of laboratory, manufacturing, storage and office space under leases that expire in 2026 through 2028. We believe the facilities we lease
are sufficient to meet our needs for the foreseeable future.