What changed in this filing

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Item 4. Controls and Procedures

2023-05-12 compared with 2022-11-14 · 10 added, 42 removed, 5 unchanged (91% of the section changed)

1 unchanged sentence

of Disclosure Controls and Procedures

management, with the participation of our Chief Executive Officer and Chief Financial Officer , evaluated,

as of the end of the period covered by this Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in

Rules 13a-15(e) and 15d-15(e) under the Exchange Act).

Based on that evaluation, and as a result of the material weakness described

below, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2022, our disclosure controls and

procedures were not effective at the reasonable assurance level.

Weaknesses in Internal Control Over Financial Reporting

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

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

on a timely basis.

connection with the audits of our financial statements as of and for the years ended December 31, 2021 and December 31, 2020, we identified

a material weakness in our internal control over financial reporting.

The previously identified material weakness pertains to our oversight

of work being performed for the Company by third-party service providers;

as the Company’s management review control over information

produced by third-party service providers was not sufficiently precise to identify errors.

Specifically, as part of the valuation of

an intangible asset in connection with the acquisition of Cutanea, we failed to identify a computational error within the valuation model

for the Xepi ® intangible asset.

In addition, in 2021 an error in the valuation of the same intangible asset was identified

relating to insufficient information being provided to the third-party consultant in connection with an impairment assessment.

to the previously identified deficiency pertaining to management’s review of work performed by specialists, management has implemented

measures designed to improve our internal control over financial reporting including formalized reviews of transactions handled by the

However, in light of the prior year control deficiency, the remediation is still considered to be in process.

We will monitor

the effectiveness of our remediation plan and will continue to make changes we determine to be appropriate.

As a result, management has

concluded that the material weakness was not fully remediated as of September 30, 2022.

will continue its remediation work by adding steps to the engagement of third-party specialists for assistance with complex or judgmental

accounting areas, including checks and balances over the proper flow of information to the specialist to allow for an adequate understanding

of the transaction.

previously noted, we are still in process of remediating this material weakness as of September 30, 2022.

If we are unable to remediate

this material weakness, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system

of internal control, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely

affect investor confidence in us and, as a result, our stock price.

management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated, as of the end of the period

covered by this Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under

the Exchange Act).

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of March 31,

2023, our disclosure controls and procedures were effective at the reasonable assurance level.

in Internal Control Over Financial Reporting

were no changes in our internal control over financial reporting during the most recent fiscal quarter ended September 30, 2022 that

materially affected, or is reasonably likely to materially affect, our internal control over financial reporting (as defined in Rule

13a-15(f) under the Exchange Act).

were no changes in our internal control over financial reporting during the most recent fiscal quarter ended March 31, 2023 that materially

affected, or is reasonably likely to materially affect, our internal control over financial reporting (as defined in Rule 13a-15(f) under

the Exchange Act).

OTHER INFORMATION

Legal Proceedings

information regarding legal proceedings in which we are involved, see Note 23 - Commitments and Contingencies under the subsection

titled “Legal Proceedings” in our Notes to Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report

on Form 10-Q.

information regarding legal proceedings in which we are involved, see Note 21 - Commitments and Contingencies under the subsection titled

“Legal Proceedings” in our Notes to Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form

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