What changed in this filing

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Item 4. Controls and Procedures

2024-11-12 compared with 2024-08-16 · 45 added, 33 removed, 6 unchanged (93% of the section changed)

1 unchanged sentence

of disclosure controls and procedures.

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 principal executive officer and our principal financial officer, to allow timely decisions regarding required disclosure.

Our management,

with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure

controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act, as amended) as of the end of the period covered by this report.

In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter

how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.

In addition, the design

of disclosure controls and procedures must reflect the fact that there are resource constraints, and that management is required to apply

its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Based on that evaluation, our Chief

Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered

by this report were not effective as of June 30, 2024 due to the material weakness described below.

weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable

possibility that a material misstatement of the annual or interim consolidated financial statements will not be prevented or detected

on a timely basis.

not maintain an effective control environment over the internal control activities to ensure the proper recognition and measurement

related to the accounting for complex and non-routine transactions.

We did not have adequate supervision and review controls over

the complex accounting related to the non-cash impairment of intangibles, non-cash equity transactions and the recoverability of

As a result, management review of asset impairment calculations did not identify errors in the associated cash flow

projections which lead to an error in the conclusion of the initial impairment assessment.

We also did not properly assess the

realizability of inventory based upon the projections utilized and our assessment of an amendment to existing warrants that were

reclassified into equity in the same period did not include a quantitative evaluation of the potential materiality of revaluation

of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any

evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions,

or that the degree of compliance with the policies or procedures may deteriorate.

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 Securities Exchange Act of 1934, as amended, 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 principal executive officer and our principal financial officer, to allow timely

decisions regarding required disclosure.

Our management, with the participation of our Chief Executive Officer and our Chief

Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the

Exchange Act, as amended) as of the end of the period covered by this report.

In designing and evaluating the disclosure controls

and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only

reasonable assurance of achieving the desired control objectives.

In addition, the design of disclosure controls and procedures must

reflect the fact that there are resource constraints, and that management is required to apply its judgment in evaluating the

benefits of possible controls and procedures relative to their costs.

Based on that evaluation, our Chief Executive Officer and our

Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report

were effective as of September 30, 2024, as the material weakness described below has been remediated.

Previously Reported Material Weakness

in Internal Control Over Financial Reporting

were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2024 that have materially

affected, or are reasonably likely to materially affect, our internal control over financial reporting.

In the 2024 Form 10-Q,

filed with the SEC on August 16, 2024, management concluded that our internal control over financial reporting was not effective

as of June 30, 2024.

In the evaluation, we did not maintain an effective control environment over the internal control activities

to ensure the proper recognition and measurement related to the accounting for complex and non-routine transactions.

have adequate supervision and review controls over the complex accounting related to the non-cash impairment of intangibles, non-cash

equity transactions and the recoverability of inventory.

As a result, management review of asset impairment calculations did not

identify errors in the associated cash flow projections which led to an error in the conclusion of the initial impairment assessment.

We also did not properly assess the realizability of inventory based upon the projections utilized and our assessment of an amendment

to existing warrants that were reclassified into equity in the same period did not include a quantitative evaluation of the potential

materiality of revaluation adjustments.

In connection with

the material weakness as it relates to the accounting for complex and non-routine transactions related to the non-cash impairment

of intangibles, non-cash equity transactions and the recoverability of inventory, management re-evaluated the effectiveness of

such controls as of September 30, 2024, and concluded that such controls were operating effectively as of September 30, 2024.

remediation of the material weakness over the complex accounting related to the non-cash impairment of intangibles, non-cash equity

transactions was as a result of no material balances related to these financial statement captions as of September 30, 2024, and

consequently there was no risk of material misstatements for these financial statement captions.

In relation to the realizability

of inventory, the remediation of this material weakness constituted expanded review processes including but not limited to the

assessment of additional data points for the assessment and additional personnel included to evaluate our ability to realize inventory

in internal control over financial reporting.

Other than as described

above, there were no changes in our internal control over financial reporting that occurred during the quarter ended September

30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

II - OTHER INFORMATION

2 unchanged sentences

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