What changed in this filing

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Item 1B. Unresolved Staff Comments

2026-04-15 compared with 2025-03-31 · 56 added, 51 removed, 13 unchanged (89% of the section changed)

UNRESOLVED STAFF COMMENTS

CYBERSECURITY

Cybersecurity

Risk Management and Strategy

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.

Not applicable.

CYBERSECURITY

Risks and Incidents

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;

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;

2 unchanged sentences

ransomware attacks;

loss or theft of devices or media containing our data;

loss or theft of devices or

media containing our data;

human error or negligence;

1 unchanged sentence

power outages;

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.

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 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.

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,

2 unchanged sentences

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.

of the software that we use is Commercial Off the Shelf Software (COTS) and Microsoft, Dropbox, and Google cloud services.

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

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.

Company’s board of directors is responsible for overseeing and approving our cybersecurity strategy and policies.

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.

Company leases office space in Vero Beach, Florida for its headquarters operation at less than $100 per month.

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.

The Company leases office space in Vero Beach,

Florida for its headquarters operation at less than $100 per month.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1B. Unresolved Staff Comments