Item 1B. Unresolved Staff Comments
Item 1B. Unresolved Staff Comments.
None.
Item 1C. Cybersecurity.
Cybersecurity Risk Management Strategy
We have implemented and recently
enhanced various information security processes designed to identify, assess, and manage material risks from cybersecurity threats to
our critical computer systems, third-party hosted services, communications systems, hardware and software, and our critical data, including
intellectual property, confidential information that is proprietary, strategic or competitive in nature, and data related to our clinical
studies, manufacturing, and employees. We engage an external entity to employ processes for assessing, identifying, and managing material
risks from cybersecurity threats that are incorporated into our overall risk management system. These items are designed to help protect
our information assets from internal and external threats and protect the integrity and confidentiality of our data. Our system includes
procedural and technical safeguards, response plans, and reviews of our policies.
In addition, our recently enhanced
information security process includes cybersecurity and prevention training for all employees and key consultants, including timely and
relevant topics covering social engineering, phishing, mobile security, and data protection and the need for reporting incidents and suspicious
events immediately.
Although we develop and maintain
systems and controls designed to prevent cybersecurity threats from occurring, and we have a process to identify and mitigate threats,
the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies
change and efforts to overcome security measures become increasingly sophisticated. Moreover, despite our efforts, the possibility of
these events occurring cannot be eliminated entirely. As we outsource more of our information systems to vendors, engage in more electronic
transactions with service providers, and rely more on cloud-based information systems, the related security risks will increase and we
will need to expend additional resources to protect our technology and information systems. In addition, there can be no assurance that
our internal information technology systems or those of our third-party contractors, or our consultants’ efforts to implement adequate
security and control measures, will be sufficient to protect us against breakdowns, service disruption, data deterioration or loss in
the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, industrial
espionage attacks or insider threat attacks which could result in financial, legal, business or reputational harm.
As of the date of this Report,
we are not aware of any risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, that have materially
affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition.
Cybersecurity Governance
Our senior management team conducts
the regular assessment and management of material risks from cybersecurity threats, including review with our third-party service provider.
All employees and consultants are directed to report to our senior management any irregular or suspicious activity that could indicate
a cybersecurity threat or incident. The Audit Committee of our Board of Directors periodically reviews our cybersecurity assessment and
management policies, as appropriate.
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