Item 1B. Unresolved Staff Comments
ITEM
1B. UNRESOLVED STAFF COMMENTS
Not
applicable.
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ITEM
1C. CYBERSECURITY
Cybersecurity
Risk Management and Strategy
The
Company does not have its own cybersecurity policy but relies on the policies and procedures of its Contract Research Organizations (CROs)
and Software as a Service (SaaS) contractors that handle its data and software. We are committed to protecting the confidentiality, integrity,
and availability of our information assets and complying with applicable laws and regulations regarding cybersecurity.
Cybersecurity
Risks and Incidents
The
Company faces various cybersecurity risks and threats that could potentially affect its operations, reputation, financial condition,
and competitive position. These risks and threats include, but are not limited to, unauthorized access, use, disclosure, modification,
or destruction of our data, systems, or networks; denial of service attacks; malware infections; phishing or social engineering attacks;
ransomware attacks; loss or theft of devices or media containing our data; human error or negligence; natural disasters; power outages;
or sabotage. Our data and systems may also be subject to cybersecurity breaches or incidents at its CROs, vendors, partners, or other
third parties that we interact with or rely on.
We
have not experienced any material cybersecurity breaches or incidents to date, but we cannot guarantee that we will not suffer any such
breaches or incidents in the future. We may not be able to detect, prevent, or respond to all cybersecurity risks and threats in a timely
or effective manner. We may also incur significant costs and liabilities as a result of any cybersecurity breaches or incidents, such
as legal claims, regulatory fines, remediation expenses, reputational damage, loss of business opportunities, or competitive disadvantage.
We may also face litigation, investigations, or enforcement actions by governmental authorities, customers, shareholders, or other parties
arising from any cybersecurity breaches or incidents.
Cybersecurity
Policies and Procedures
The Company does not have its own cybersecurity policy,
but it contracts with CROs that handle all of its data and software. Our CRO’s data systems are 21 CFR 11 (Part 11) compliant,
which means that they have implemented controls to ensure the reliability and integrity of electronic records and signatures. Our CRO
also runs industry standard antivirus and antimalware software on their networks and has written procedures for cybersecurity management,
incident response, backup and recovery, and employee training. We have reviewed the cybersecurity policies and procedures of our CRO
and require them to report any cybersecurity breaches or incidents that may affect our data or systems.
All
of the software that we use is Commercial Off the Shelf Software (COTS) and Microsoft, Dropbox, and Google cloud services. We do not
develop, modify, or customize any software for our own use. We rely on the cybersecurity measures and practices of our software and cloud
service providers and update our software and systems regularly to address any known vulnerabilities or issues. We also limit the access
and use of our software and cloud services to authorized personnel and encourage them to use strong passwords and multifactor authentication.
We do not store any sensitive or confidential data on our own devices or media but use password-protected cloud storage.
Cybersecurity
Oversight and Governance
The
Company’s management is responsible for overseeing and managing our cybersecurity risks and activities as part of its overall risk
assessment portfolio. Our management regularly evaluates and reviews the Company’s cybersecurity posture and performance and reports
to the board of directors on any material cybersecurity matters or developments. Our management also coordinates with our CROs, vendors,
partners, and other third parties to ensure that they comply with our cybersecurity expectations and requirements and to address any
cybersecurity issues or concerns that may arise.
The
Company’s board of directors is responsible for overseeing and approving our cybersecurity strategy and policies. Our board of
directors receives updates from management on the Company’s cybersecurity status and initiatives and provides guidance and feedback
on the cybersecurity goals and objectives. Our board of directors also monitors the Company’s cybersecurity risks and exposures
and ensures that the company has adequate cybersecurity resources and capabilities to protect its data and systems.
ITEM
2. PROPERTIES
The
Company leases office space in Vero Beach, Florida for its headquarters operation at less than $100 per month.
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