Item 4. Controls and Procedures
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure
Controls and Procedures
We maintain disclosure controls
and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934 (the
“Exchange Act”) that are designed to provide reasonable assurance that material information required to be disclosed in our
periodic reports filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the
SEC’s rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our Principal
Executive Officer and our Principal Financial Officer to allow timely decisions regarding required disclosure.
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We carried out an evaluation, under the supervision and with the participation
of our management, including our Principal Executive Officer and our Principal Financial Officer, of the effectiveness of the design and
operation of our disclosure controls and procedures, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based
on this evaluation, our Principal Executive Officer and our Principal Financial Officer concluded that our disclosure controls and procedures
were not effective as of March 31, 2026 due to the material weakness in internal control over financial reporting as described in our
Form 10-K/A for the fiscal year ended September 30, 2025, filed with the SEC on August 28, 2026
(the “2025 Form 10-K/A”).
As described in the 2025 Form 10-K/A, the material weakness that was identified
related to deficiencies in our Control Environment and Information and Communication, including a historical failure to set an appropriate
tone at the top and the historical process for identifying, escalating and communicating regulatory, clinical and other non-financial
information to our principal financial officer, the Audit Committee and the Board. During the affected period, regulatory, clinical and
non-financial information was concentrated with our former CEO, and we did not maintain sufficiently formal and precise controls to provide
reasonable assurance that such information would be identified, accumulated and communicated completely and timely to all appropriate
financial reporting and disclosure-process participants. See Item 9A of the 2025 Form 10-K/A for additional information, including regarding
our remediation plans.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over
financial reporting during the quarter ended March 31, 2026 that materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
The material weakness described in the 2025 Form 10-K/A
was identified subsequent to the end of the quarter, and therefore no remediation activities had been designed or implemented as of March
31, 2026. Following the identification of the material weakness, management began developing a remediation plan, as described in the 2025
Form 10-K/A. These remediation activities were initiated after the quarter ended and accordingly are not reflected as changes in internal
control over financial reporting for the quarter ended March 31, 2026.
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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.