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 June 30, 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
As previously disclosed in a Current Report on Form 8-K, filed with the SEC
on May 6, 2026, on April 30, 2026, the Special Committee terminated the employment of our former CEO for Cause (as defined in the Employment
Agreement, dated as of June 27, 2013, between us and our former CEO, as amended and restated (the
“Former CEO Employment Agreement” ), effective immediately for, among other things, conduct that the Special Committee
believed was inconsistent with Company policy. That action removed the individual with whom the relevant regulatory, clinical and other
non-financial information had been concentrated.
During the quarter ended June 30, 2026, building on the leadership change initiated
by the Special Committee, we began implementing certain of the remediations and enhancements described in the 2025 Form 10-K/A filed with
the SEC on August 28, 2026 to our disclosure and information-communication processes. Specifically, these remediation and enhancements
included:
· We established a formal Disclosure Committee with defined responsibilities for reviewing significant information
relevant to our SEC disclosures; and
· We implemented additional procedures to reconcile significant regulatory, clinical and non-financial source
documents to matters contained in our SEC disclosures;
Except for the measures described above, there were
no changes in our internal control over financial reporting during the quarter ended June 30, 2026 that materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting. We regularly evaluate our controls and procedures and make
improvements in the design and effectiveness of established controls and procedures and the remediation of any deficiencies which may
be identified during this process.
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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.