What changed in this filing

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Item 4. Controls and Procedures

2026-08-28 compared with 2026-02-09 · 47 added, 18 removed, 2 unchanged (97% of the section changed)

CONTROLS AND PROCEDURES

Disclosure Controls and

We maintain disclosure controls

and procedures 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 management, our chief 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 principal financial

officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rule 13a-15(e) under

the Exchange Act, 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 principal financial officer concluded that our disclosure controls and procedures were effective as of December 31, 2025.

Changes in Internal

Control over Financial Reporting

During the quarter ended

December 31, 2025, there were no changes to our internal control over financial reporting identified in management’s evaluation

pursuant to Rules 13a 15(d) or 15d 15 (d) of the Exchange Act that materially affected, or are reasonably likely to materially affect,

our internal controls over financial reporting.

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.

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

· 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.

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