What changed in this filing

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Item 9A. Controls and Procedures

2026-03-31 compared with 2025-03-27 · 108 added, 126 removed, 113 unchanged (67% of the section changed)

Controls and Procedures

Disclosure Controls and Procedures

As of December 31, 2024, we conducted an evaluation

of the effectiveness of our “disclosure controls and procedures” (“Disclosure Controls”), as defined by Rules

13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

The Disclosure Controls

evaluation was done under the supervision and with the participation of management, including our chief executive officer and chief financial

There are inherent limitations to the effectiveness of any system of disclosure controls and procedures.

Accordingly, even effective

disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives.

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

Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2024.

Based on that

evaluation, our CEO and CFO concluded that our disclosure controls and procedures were not effective as of December 31, 2024, due to

material weaknesses in our internal control over financial reporting, which are described below in “Management’s Annual Report

on Internal Control over Financial Reporting”.

Controls and Procedures

of December 31, 2025, we conducted an evaluation of the effectiveness of our “disclosure controls and procedures” (“Disclosure

Controls”), as defined by Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange

The Disclosure Controls evaluation was done under the supervision and with the participation of management, including our

chief executive officer and chief financial officer.

There are inherent limitations to the effectiveness of any system of disclosure

controls and procedures.

Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving

their control objectives.

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

the effectiveness of our disclosure controls and procedures as of December 31, 2025.

Based on that evaluation, our CEO and CFO concluded

that our disclosure controls and procedures were not effective as of December 31, 2025, due to material weaknesses in our internal control

over financial reporting, which are described below in “Management’s Annual Report on Internal Control over Financial Reporting”.

Annual Report on Internal Control over Financial Reporting and Attestation Report of the Registered Accounting Firm

7 unchanged sentences

Based on that assessment, management

has concluded that its internal control over financial reporting was not effective as of December 31, 2024 to provide reasonable

assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with accounting

principles generally accepted in the United States of America due to the following:

(i) we have not designed controls to ensure all accounting

journals entries are reviewed and approved and (ii) we identified one individual in our accounting department who has “super user”

access and security administration rights to the financial reporting systems.

To remediate these material weaknesses, we are working

to do the following:

(i) implementing appropriate controls for accounting journal entry approvals, including the approval of our Chief

Financial Officer, and (ii) either actively monitoring any accounting user with elevated rights or assigning another employee outside

of an accounting and reporting role with elevated access.

Given we are neither an

accelerated filer nor a large accelerated filer, we are not required to include an attestation report regarding the effectiveness of

our internal controls over financial reporting of our independent registered public accounting firm in our Annual Report.

Financial Reporting Process

We have not designed controls to ensure the financial reporting process is operating effectively.

improper fair value adjustments to contingent consideration, failure to record adequate inventory reserves and various balance sheet accounts

not being properly reconciled.

We intend to design controls to ensure the financial information is accurate, complete, and recorded in

the correct period.

Change in Internal Control over Financial Reporting

There have been no changes in our internal control

over financial reporting during the fiscal year ended December 31, 2024 that have materially affected, or are reasonably likely to materially

affect, our internal control over financial reporting.

has concluded that its internal control over financial reporting was not effective as of December 31, 2025 to provide reasonable assurance

regarding the reliability of financial reporting and the preparation of financial statements in accordance with accounting principles

generally accepted in the United States of America.

Specifically, management has concluded that its internal control over financial reporting

was not effective as of December 31, 2025 to provide reasonable assurance regarding the reliability of financial reporting and the preparation

of financial statements in accordance with accounting principles generally accepted in the United States of America due to not maintaining

proper segregation of duties, including:

(i) we have not designed controls to ensure all accounting journals entries are reviewed and

approved and (ii) we have one individual in our accounting department who has “super user” access and security administration

rights to the financial reporting systems.

remediate these material weaknesses, we are working to do the following:

(i) implementing appropriate controls for accounting journal

entry approvals, including the approval of our chief financial officer, and (ii) either actively monitoring any accounting user with

elevated rights or assigning another employee outside of an accounting and reporting role with elevated access.

We will not be able to

fully remediate the material weakness until the actions discussed above have been implemented and operated effectively for a sufficient

period of time.

we are neither an accelerated filer nor a large accelerated filer, we are not required to include an attestation report regarding the

effectiveness of our internal controls over financial reporting of our independent registered public accounting firm in our Annual Report.

Reporting Process

have not designed controls to ensure the financial reporting process is operating effectively, as noted above.

We intend to design controls

to ensure the financial information is accurate, complete, and recorded in the correct period.

in Internal Control over Financial Reporting

have been no changes in our internal control over financial reporting during the fiscal year ended December 31, 2025 that have materially

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

Other Information

Rule 10b5-1 Trading Plans .

During the three months ended December 31, 2024,

no director or officer of the Company adopted , modified or terminated a “Rule 10b5-1 trading arrangement”

or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Disclosure Regarding Foreign Jurisdictions

that Prevent Inspections

Not applicable.

Directors, Executive Officers and Corporate

The information required

by this Item is set forth under the headings “Directors, Executive Officers and Corporate Governance” and “Section

16(a) Beneficial Ownership Reporting Compliance” in the Company’s 2025 Proxy Statement to be filed with the SEC within 120

days after December 31, 2024 in connection with the solicitation of proxies for the Company’s 2025 annual meeting of shareholders

and is incorporated herein by reference.

The Company has adopted an insider trading policy which governs transactions in our

securities by the Company and its directors, officers, employees, any applicable consultants and contractors (as determined by the Company),

and each of their respective family members, and is designed to promote compliance with insider trading laws, rules and regulations applicable

to the Company.

10b5-1 Trading Plans .

the three months ended December 31, 2025, no director or officer of the Company adopted

, modified or terminated a “Rule

10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Directors, Executive Officers and Corporate Governance.

information required by this Item is set forth under the headings “Directors, Executive Officers and Corporate Governance”

and “Section 16(a) Beneficial Ownership Reporting Compliance” in the Company’s 2026 Proxy Statement to be filed with

the SEC within 120 days after December 31, 2025 in connection with the solicitation of proxies for the Company’s 2025 annual meeting

of shareholders and is incorporated herein by reference.

The Company has adopted an insider trading policy which governs transactions

in our securities by the Company and its directors, officers, employees, any applicable consultants and contractors (as determined by

the Company), and each of their respective family members, and is designed to promote compliance with insider trading laws, rules and

regulations applicable to the Company.

A copy of our insider trading policy is filed with this Annual Report on Form 10-K as Exhibit

The Company has adopted

a Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available on the Company’s

website (https://ir.nexgel.com/corporate-governance/governance-documents) under “Governance Documents.” The Company intends

to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of its Code

of Conduct by posting such information on the website address and location specified above.

Company has adopted a Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available on

the Company’s website (https://ir.nexgel.com/corporate-governance/governance-documents) under “Governance Documents.”

The Company intends to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a

provision of its Code of Conduct by posting such information on the website address and location specified above.

Executive Compensation

The information required by this

Item is set forth under the heading “Executive Compensation” and under the subheadings “Board Oversight of Risk Management,”

“Compensation of Directors,” “Director Compensation-2024” and “Compensation Committee Interlocks and Insider

Participation” under the heading “Directors, Executive Officers and Corporate Governance” in the Company’s 2025

Proxy Statement to be filed with the SEC within 120 days after December 31, 2024 and is incorporated herein by reference.

Security Ownership of Certain Beneficial

Owners and Management and Related Stockholder Matters

The information required by this

Item is set forth under the headings “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation

Plan Information” in the Company’s 2025 Proxy Statement to be filed with the SEC within 120 days after December 31, 2024

and is incorporated herein by reference.

Certain Relationships and Related Transactions

and Director Independence

The information required by this

Item is set forth under the heading “Review, Approval or Ratification of Transactions with Related Persons” and under the

subheading “Board Committees” under the heading “Directors, Executive Officers and Corporate Governance” in the

Company’s 2025 Proxy Statement to be filed with the SEC within 120 days after December 31, 2024 and is incorporated herein by reference.

information required by this Item is set forth under the heading “Executive Compensation” and under the subheadings “Board

Oversight of Risk Management,” “Compensation of Directors,” “Director Compensation-2025” and “Compensation

Committee Interlocks and Insider Participation” under the heading “Directors, Executive Officers and Corporate Governance”

in the Company’s 2026 Proxy Statement to be filed with the SEC within 120 days after December 31, 2025 and is incorporated herein

by reference.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

information required by this Item is set forth under the headings “Security Ownership of Certain Beneficial Owners and Management”

and “Equity Compensation Plan Information” in the Company’s 2026 Proxy Statement to be filed with the SEC within 120

days after December 31, 2025 and is incorporated herein by reference.

Certain Relationships and Related Transactions and Director Independence

information required by this Item is set forth under the heading “Review, Approval or Ratification of Transactions with Related

Persons” and under the subheading “Board Committees” under the heading “Directors, Executive Officers and Corporate

Governance” in the Company’s 2026 Proxy Statement to be filed with the SEC within 120 days after December 31, 2025 and is

incorporated herein by reference.

Principal Accountant Fees and Services.

Our independent public accounting

firm is Turner Stone & Company, L.L.P., Dallas, Texas, PCAOB Auditor ID 76.

The information required by this

Item is set forth under the subheadings “Fees Paid to Auditors” and “Policy on Audit Committee Pre-Approval of Audit

and Non-Audit Services Performed by the Independent Registered Public Accounting Firm” under the proposal “Ratification of

Appointment of Independent Registered Public Accounting Firm” in the Company’s 2025 Proxy Statement to be filed with the

SEC within 120 days after December 31, 2024 and is incorporated herein by reference.

independent public accounting firm is Turner Stone & Company, L.L.P., Dallas, Texas, PCAOB Auditor ID 76.

information required by this Item is set forth under the subheadings “Fees Paid to Auditors” and “Policy on Audit Committee

Pre-Approval of Audit and Non-Audit Services Performed by the Independent Registered Public Accounting Firm” under the proposal

“Ratification of Appointment of Independent Registered Public Accounting Firm” in the Company’s 2026 Proxy Statement

to be filed with the SEC within 120 days after December 31, 2025 and is incorporated herein by reference.

Exhibits and Financial Statement Schedules

The following documents are filed as part of this

following documents are filed as part of this report:

Financial Statements

The following financial statements are included herein:

Report of Independent Registered Public Accounting Firm (PCAOB

following financial statements are included herein:

Report of Independent Registered Public Accounting Firm (PCAOB ID:

Consolidated Balance Sheets as of December 31, 2025 and 2024

4 unchanged sentences

Financial Statement Schedules

Certificate of Incorporation of AquaMed Technologies, Inc.

of Incorporation of AquaMed Technologies, Inc.

(incorporated by reference to Exhibit 3.1 to Form S-1, filed with the SEC on January

28 unchanged sentences

of February 2024 Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on February

Form of August 2024 Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on August 13, 2024).

Form of November 2024 Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on November 12, 2024).

of August 2024 Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on August 13,

of November 2024 Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on November

and Amended and Restated Lease, dated as of January 25, 2002, by and between 2150 Cabot LLC, Embryo Development Corporation and Hydrogel

28 unchanged sentences

by and between NexGel.

and Auctus Fund, LLC (incorporated by reference to Exhibit 10.1 to the Quarterly Report on

Form 10-Q filed with the SEC on August 16, 2021).

and Auctus Fund, LLC (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q

filed with the SEC on August 16, 2021).

of Securities Purchase Agreement, dated September 2, 2021 (incorporated by reference to Exhibit 10.1 to the Current Report on Form

18 unchanged sentences

and Joseph F.

McGuire (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC on January 6, 2025).

McGuire (incorporated by reference to Exhibit

10.2 to the Current Report on Form 8-K filed with the SEC on January 6, 2025).

Executive Employment Agreement dated December 30, 2024 between NexGel, Inc.

and Adam Levy (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on January 6, 2025).

and Adam Levy (incorporated by reference to Exhibit 10.1

to the Current Report on Form 8-K filed with the SEC on January 6, 2025).

NexGel, Inc.’s Insider Trading Policy

4 unchanged sentences

Section 1350 Certification of Principal Financial Officer

Policy for the Recovery of Erroneously Awarded Compensation (incorporated by reference to Exhibit 97 to the Annual Report on Form 10-K filed with the SEC on April 10, 2024).

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Policy for the Recovery of Erroneously Awarded Compensation (incorporated by reference to Exhibit 97 to the Annual Report on

Form 10-K filed with the SEC on April 10, 2024).

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Filed herewith.

Furnished herewith.

Pursuant to the requirements

of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf

by the undersigned, thereunto duly authorized.

March 27, 2025

/s/ Adam Levy

Chief Executive Officer and President

Pursuant to the requirements

of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in

the capacities indicated as of the dates set forth below.

/s/ Adam Levy

March 27, 2025

Chief Executive Officer and President (Principal Executive Officer)

/s/ Joseph F.

March 27, 2025

Chief Financial Officer (Principal Accounting and Financial Officer)

/s/ Steven Glassman

to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed

on its behalf by the undersigned, thereunto duly authorized.

March 31, 2026

Executive Officer and President

to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the

Registrant and in the capacities indicated as of the dates set forth below.

Executive Officer and President (Principal Executive Officer) and Director

Adam Drapczuk

Financial Officer (Principal Accounting and Financial Officer)

Steven Glassman

/s/ Scott Henry

March 27, 2025

/s/ Nachum Stein

March 27, 2025

/s/ Jerome B.

March 27, 2025

Steven Ciardiello

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-K

Item 9A. Controls and Procedures