Item 4. Controls and Procedures
Item 4.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures and
Changes in Internal Control over Financial Reporting
Our chief executive officer and our chief financial
officer are responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in
Exchange Act Rules 13a-15(f). Management conducted an assessment of the effectiveness of our internal control over financial reporting
as of March 31, 2026. In making this assessment, management used the criteria described in Internal Control-Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Our management concluded that
our internal control over financial reporting were, and continue to be ineffective, as of March 31, 2026 due to a lack of segregation
of duties (resulting from the limited number of personnel available), limited access to timely and complete information regarding the
status of costs incurred in the activation of investigational sites and costs from treating patients in our study which is a result of
the use of a third-party Contract Research Organization (“CRO”) to manage the study, and the lack of formal documentation
of our control environment. Management is commencing actions to address the lack of formal documentation of our control environment, although
this will not address the lack of segregation of duties. Management is also working with the CRO to improve the timeliness and completeness
of the data reported to the Company to address this material weakness, as well as conducting increased analytical analysis of such data
to be performed by the Company.
A material weakness is a control deficiency (within
the meaning of the Public Company Accounting Oversight Board (“PCAOB”) Auditing Standard 1305) or combination of control deficiencies
that result in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented
or detected.
It should be noted that any system of controls,
however well designed and operated, can provide only reasonable and not absolute assurance that the objectives of the system are met.
In addition, the design of any control system is based in part upon certain assumptions about the likelihood of certain events. Because
of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving its stated
goals under all potential future conditions, regardless of how remote.
In light of the material weakness described above,
we performed additional analysis and other post-closing procedures to ensure our financial statements were prepared in accordance with
generally accepted accounting principles. Accordingly, we believe that the financial statements included in this report fairly present,
in all material respects, our financial condition, results of operations and cash flows for the periods presented.
Other than as described above, there has been no
change in our internal control over financial reporting during our most recent calendar quarter that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.