Item 2.05. Costs Associated with Exit or Disposal Activities.
On August 2, 2022, Ampio Pharmaceuticals, Inc. (the "Company" or "Ampio")
committed to a reduction in force that will result in the termination by August
31, 2022 of 10 of the Company's current 18 employees, or approximately 55.5%. As
part of this reduction, four non-terminated employees have been offered
conditional retention and severance arrangements with the Company pursuant to
which it is expected that they will continue to provide services for a period
ending December 31, 2022 in exchange for retention and severance payments should
the full term of service be completed, during which time the Company and its
Board of Directors (the "Board") will continue to actively evaluate and monitor
the Company's near-term personnel needs based in part on the Company's financial
status and the Board's review of strategic alternatives.
The Company's decision to engage in this reduction results from the Board's
determination not to pursue the continued development of Ampion as part of its
review of strategic alternatives. At this time, the Company is discontinuing
development of Ampion for all indications and discontinuing most other
development activities pending conclusion of the strategic alternatives process.
The reduction in force is a measure to manage costs and conserve cash resources
with the goal of maximizing the opportunities available to Ampio during the
Board's review of strategic alternatives.
The Company expects to record a charge of up to $425,000 in the third quarter of
2022 relating to the reduction in force for the employees being terminated by
August 31, 2022. These charges are primarily one-time severance and termination
benefits in cash. The Company also expects to record a charge of up to $355,000
beginning in the third quarter and continuing through the fourth quarter of 2022
relating to the retention and severance arrangements described above. The actual
severance, termination and retention benefits to be paid will depend on the
employees remaining employed at August 31, 2022 and December 31, 2022,
respectively. The foregoing estimated amounts do not include any non-cash
charges associated with stock-based compensation. The Company expects to
recognize a stock-based compensation expense related to vested awards and does
not anticipate modifying the affected employees' stock awards to accelerate the
vesting of such awards or to otherwise modify such awards in a manner that would
result in such additional charges.
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Item 7.01. Regulation FD Disclosure.
On August 3, 2022, Ampio issued a press release containing a letter to Ampio's
stockholders from Michael A. Martino, Chief Executive Officer, and Kevin Buchi,
Chair of the Board. Within the stockholder letter, the independent special
committee of the Board (the "Special Committee") summarized the results of its
previously announced internal investigations. A copy of the press release is
attached hereto as Exhibit 99.1 and is incorporated by reference herein.
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Item 8.01. Other Events.
As the Company announced on May 16, 2022, the Special Committee has been
conducting internal investigations focused primarily on (1) the statistical
analysis of Ampio's AP-013 clinical trial and (2) unauthorized provision of
Ampion, an investigational drug that is not approved by the Food and Drug
Administration ("FDA"), for use by individuals not participating in clinical
trials ("unauthorized use"). These investigations are now completed and the
investigations are summarized below.
Through outside counsel, the Special Committee has engaged in extensive fact
finding, including interviewing numerous individuals and reviewing documents and
emails relating to the AP-013 clinical trial. In connection with the
unauthorized use investigation, the Special Committee also reviewed documents,
conducted interviews, and reviewed other information regarding the provision and
unauthorized use of Ampion. The Special Committee committed significant
resources to these endeavors and did not impose material limitations on the
investigations' scope, timing, or access to information.
As it relates to the AP-013 clinical trial, the Special Committee's primary
findings include that certain former Ampio executive officers and senior staff
were aware, at the time of the per-protocol interim analysis in March 2020, that
the AP-013 trial did not demonstrate efficacy for Ampion on its co-primary
endpoints of pain and function; and that these former Ampio executive officers
and senior staff did not fully report the results of the AP-013 trial and the
timing of unblinding of data from the AP-013 trial. The Special Committee has
determined that the Company's current executive officers were not made aware of
the unblinding events in March 2020. Through counsel, the Company and the
Special Committee have informed the Securities and Exchange Commission of the
investigations. The Company and the Special Committee also have contacted the
FDA regarding this investigation.
As it relates to the unauthorized use of Ampion, the Special Committee's primary
finding is that certain Ampio personnel, including a former executive officer
and certain former directors, facilitated the provision of Ampion for
unauthorized use. Ampio has worked to resolve this issue, including through the
conduct of safety surveillance activities relating to the provision of Ampion
for unauthorized use, implementation of appropriate mitigation measures
(described below), and self-reporting to FDA. The results of the safety
surveillance activities have not changed the Company's view of the safety
profile of Ampion. The Special Committee has determined that the Company's
current executive officers were not involved in the provision of Ampion for
unauthorized use.
The Company has taken the following actions based in part upon the
investigations and the findings of the Special Committee:
? Terminated the employment of two executive officers;
? Restructured the Board of Directors through resignation of certain directors;
? Separated the role of Chair of the Board and Chief Executive Officer;
? Re-constituted the Company's Disclosure Committee with additional
subject-matter experts;
? Enhanced Company policies and procedures, including those related to inventory
management and distribution; and
? Conducted company-wide training regarding appropriate use of Ampion while in
the clinical trial stage.
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Item 9.01. Financial Statements and Exhibits.
Exhibit Description
99.1 Ampio Pharmaceuticals, Inc. press release, dated August 3, 2022
104 Cover Page Interactive Data File (formatted as Inline XBRL)
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