What changed in this filing

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Item 4. Controls and Procedures

2026-08-28 compared with 2026-08-28 · 21 added, 34 removed, 15 unchanged (79% of the section changed)

2 unchanged sentences

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.

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”).

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.

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.

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

9 unchanged sentences

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

· We established a formal Disclosure Committee with defined responsibilities for reviewing significant information

relevant to our SEC disclosures;

· 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.

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

Following the identification of the material weakness, management began developing a remediation plan, as described in the 2025

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.

PART II – OTHER INFORMATION

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-Q

Item 4. Controls and Procedures