Item 1B. Unresolved Staff Comments
ITEM
1B. UNRESOLVED STAFF COMMENTS
None.
ITEM
1C. CYBERSECURITY
We
believe cybersecurity is critical to advancing our technological developments. As a biopharmaceutical company, we face a multitude of
cybersecurity threats that range from attacks common to most industries, such as ransomware and denial-of service. Our customers, suppliers,
subcontractors, and business partners face similar cybersecurity threats, and a cybersecurity incident impacting us or any of these entities
could materially adversely affect our business strategy, performance, and results of operations. These cybersecurity threats and related
risks make it imperative that we expend resources on cybersecurity.
Risk
Management
We
engage third-party services to conduct evaluations of our security controls, whether through penetration testing, independent audits,
or consulting on best practices to address new challenges. We have established cybersecurity security awareness training and ongoing
monitoring.
In
the event of an incident, we intend to follow our cybersecurity incident response plan, which outlines the steps to be followed from
incident detection to mitigation, and notification. We contract with external firms that have extensive information technology and program
management experience. We have implemented a governance structure and processes to assess, identify, manage, and report cybersecurity
risks. As a biopharmaceutical company, we must comply with extensive regulations, including requirements imposed by the Federal Drug
Administration related to adequately safeguarding patient information and reporting cybersecurity incidents to the SEC. We believe we
are positioned to meet the requirements of the SEC. In addition to following SEC guidance and implementing pre-existing third party frameworks,
we have developed our own practices and frameworks, which we believe enhance our ability to identify and manage cybersecurity risks.
Assessing, identifying, and managing cybersecurity related risks are factored into our overall business approach. We rely heavily on
our supply chain to deliver our products and services, and a cybersecurity incident at a clinical site, subcontractor, or business partner
could materially adversely impact us. We require that our subcontractors report cybersecurity incidents to us so that we can assess the
direct impact of the incident.
Governance
The
Audit Committee has oversight responsibility for risks and incidents relating to cybersecurity threats, including compliance with disclosure
requirements, cooperation with law enforcement, and related effects on financial and other risks, and it reports any findings and recommendations,
as appropriate, to the full Board for consideration. Senior management regularly discusses cyber risks and trends and, should they arise,
any material incidents with the Audit Committee.
While
we have not experienced any material cybersecurity threats or incidents in recent years, there can be no guarantee that we will not be
the subject of future threats or incidents. Notwithstanding the extensive approach we take to cybersecurity, we may not be successful
in preventing or mitigating a cybersecurity incident that could have a material adverse effect on us. While we maintain cybersecurity
insurance, the costs related to cybersecurity threats or disruptions may not be fully insured. See “Risk Factors” for a discussion
of cybersecurity risks.
ITEM
2. PROPERTIES
We
sublease a facility to support our clinical trial operations and research and development.
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