Item 4. Controls and Procedures
Item 4.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures and
Changes in Internal Control over Financial Reporting
We maintain a set of disclosure controls and procedures
designed to ensure that material information required to be disclosed in our filings under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified in the SEC’s rules and forms and that material information is accumulated and communicated
to our management, including our chief executive officer, who serves as our principal executive officer, and our chief financial officer,
who serves as our principal financial officer, as appropriate, to allow timely decisions regarding required disclosures.
Under
the supervision, and with the participation of our management, including our chief executive officer and our chief financial officer,
we conducted an evaluation of the effectiveness, as of June 30, 2026, of our disclosure controls and procedures, as defined in Rules 13a-15(e)
and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer
in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including
its principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely
decisions regarding required disclosure.
Based upon such evaluation, our chief executive
officer and our chief financial officer have concluded that, as of June 30, 2026, our disclosure controls and procedures were, and
continue to be, ineffective because of the material weaknesses in our internal control over financial reporting due to 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 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 a reasonable possibility 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 fiscal 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.