Litigation | Note 13 – Litigation From time to time, the Company may be a party to litigation arising in the ordinary course of business. In addition, as Kain v. Ampio Pharmaceuticals, Inc., et al., 22-cv-2105 On August 17, 2022, a putative Ampio shareholder filed a securities fraud class action against the Company, its current CEO Michael A. Martino and two former executives, Michael Macaluso and Holli Cherevka, in the United States District Court for the District of Colorado, captioned Kain v. Ampio Pharmaceuticals, Inc., et al. The Complaint relied largely on Ampio’s announcement on May 16, 2022, that it had formed a special Board committee to investigate the statistical analysis of Ampio’s AP-013 clinical trial and the unauthorized provision of Ampion to various individuals who were not participating in clinical trials, and Ampio’s further announcement on August 3, 2022, that the investigation had revealed that various employees were aware that the AP-013 trial did not demonstrate efficacy for Ampion’s primary endpoints and did not fully and timely report the results of the trial and the timing of unblinding data from the trial. Based on the Company’s reports, the Complaint asserted that various statements made by the Company during the Class Period were false and misleading because they: (i) inflated Ampio’s ability to successfully obtain FDA approval for Ampion; (ii) inflated the results of the AP-013 clinical trial and failed to disclose the timing of unblinding the data from the study; and (iii) overstated the Company’s business, operations and prospects. The Complaint sought an unspecified amount of compensatory damages as well as attorneys’ fees and costs. On October 17, 2022, six putative shareholders filed motions seeking to be named lead plaintiff. On November 7, 2022, two of the movants filed oppositions to each other’s motions; the remaining movants either withdrew their motions or filed non-oppositions to another putative shareholder’s motion. On August 9, 2023, the Court ruled on the competing motions for appointment of lead plaintiff, and appointed Tao Wang and SynWorld Technologies Corporation as lead plaintiffs and approved the firm of Faruqi & Faruqi, LLP as lead counsel. The August 9, 2023, order also lifted the stay that had been in place and ordered the parties to jointly contact the magistrate judge to schedule a status conference or such other proceeding as the magistrate judge deemed appropriate to move the litigation forward. Pursuant to the Court’s order, on August 10, 2023, lead plaintiffs and defendants advised the magistrate judge that lead plaintiffs intended to file an amended complaint in the action and that the parties intended to submit a joint proposed scheduling order by August 18, 2023. On August 14, 2023, the Court entered a minute order setting a scheduling conference for August 30, 2023. On August 15, 2023, the parties filed a joint motion with a schedule for lead plaintiffs to file the amended complaint and a deadline for defendants to answer or file motions to dismiss, along with a briefing schedule for any potential motions to dismiss. On August 16, 2023, the Court entered an order granting in part and denying in part the parties’ joint motion. The order vacated the August 30, 2023 scheduling conference and any related deadlines and set lead plaintiffs’ deadline to file an amended complaint as October 16, 2023. It provided that defendants file answers or motions within sixty days of service of the amended complaint. It set a briefing schedule for any potential motions to dismiss. The order further provided that if defendants answer the amended complaint or any motion to dismiss does not fully resolve the case, the parties are required to contact the magistrate judge within 5 business days thereafter to schedule a scheduling conference. On September 19, 2023, defendant Michael Macaluso’s counsel filed a motion to withdraw due to Mr. Macaluso’s death and the lack of a personal representative to represent Mr. Macaluso’s interest. On September 20, 2023, the Court denied the motion without prejudice to refiling and ordered Mr. Macaluso’s counsel to file a Statement Noting the Death pursuant to Rule 25 of the Federal Rules of Civil Procedure and further noting that, if the claims are not extinguished against Mr. Macaluso by his death, any party may file a motion to substitute within 90 days of the filing of the Statement Noting the Death or Mr. Macaluso will be dismissed from the case. On September 20, 2023, Mr. Macaluso’s counsel filed a Suggestion of Death as directed by the Court and renewed his motion to withdraw adding additional information about his efforts to communicate with Mr. Macaluso’s family and the status of any probate proceedings. On September 27, 2023, the Court granted counsel’s renewed motion to withdraw. On October 16, 2023, lead plaintiffs filed an Amended Complaint, asserting the same claims against the Company and adding several additional defendants (namely the Company’s current CFO, Dan Stokely, and former directors David Bar-Or, Philip Coelho and Richard Giles), in addition to the previously named individual defendants Michael Martino, Michael Macaluso and Holli Cherevka. Pursuant to the Court’s order, Defendants had until December 15, 2023 to file answers or motions to dismiss in response to the Amended Complaint. On November 17, 2023, the parties (other than deceased defendant Macaluso) filed a Joint Stipulated Unopposed Motion to Extend Deadlines advising the Court that the parties had agreed to engage in a mediation to be conducted by January 5, 2024, and requesting that the Court vacate the time for all defendants to answer, move or otherwise respond to the Amended Complaint. The motion further requested that the parties be permitted to file a status report advising the Court within five As reported above, at the mediation, the parties reached a settlement in principle, subject to lead plaintiffs completing confirmatory discovery, to the negotiation and execution of final settlement papers, and to the Court approving the settlement. On January 9, 2024, the parties filed a status report with the Court advising it that they had reached agreement in principle and intended to file a motion for court approval within one hundred twenty (120) days. On January 12, 2024, the Court entered a minute order vacating all deadlines and providing, among other things, “The Parties shall submit to the Court a stipulation and agreement of settlement and a motion for preliminary approval of the settlement (including a plan of allocation and procedures for class notice) pursuant to Fed. R. Civ. P. 23(e) on or before May 13, 2024.” The parties are currently engaged in confirmatory discovery and are endeavoring to finalize and file the required settlement documents with the Court by May 14, 2024. Maresca v. Martino, et al., 22-cv-2646-KLM On October 7, 2022, putative Ampio shareholder Robert Maresca filed a Verified Shareholder Derivative Complaint in the United States District Court for the District of Colorado, captioned Maresca v. Martino, et al. Based largely on the same allegations as the Kain The Complaint asserts six causes of action on behalf of the Company and against the individual defendants: (1) violations of Section 14(a) of the Exchange Act based on purportedly false and misleading statements in the Company’s proxy statements; (2) violations of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder; (3) control person liability under Section 20(a) of the Exchange Act; (4) breach of fiduciary duty; (5) unjust enrichment; and (6) waste of corporate assets. The Complaint seeks an unspecified amount of compensatory and restitution damages to be paid to Ampio, together with pre- and post-judgment interest, as well as injunctive relief imposing certain corporate governance reforms and attorneys’ fees and costs. On November 2, 2022, the Company and plaintiff (together with plaintiff in a second derivative action -- the Marquis On January 10, 2023, after the Company received additional extensions of time to respond, the Court granted consolidation of the Maresca Marquis On January 17, 2023, the parties filed a joint stipulated motion seeking a temporary stay of the consolidated derivative actions, subject to various conditions, until the earlier of: (1) the dismissal of the Kain Kain As reported above, on January 4, 2024, the parties to the Consolidated Derivative Actions participated in a mediation at which they reached agreement in principle. The settlement is subject to various conditions, including the negotiation and execution of the full settlement agreements and obtaining court approval. On January 9, 2024, the parties filed a status report in the Consolidated Derivative Actions, advising the Court of the status of the settlement in principle and that the parties intended to file settlement documents within thirty days. Since then, the parties have filed several further status reports updating the Court on the parties’ continued negotiations and efforts to finalize the settlement documents. Marquis v. Martino, et al., 22-cv-2803-KLM On October 25, 2022, putative shareholder Samantha Marquis filed a derivative complaint in the United States District Court for the District of Colorado, captioned Marquis v. Martino, et al., 22-cv-2803-KLM. The Complaint, filed on behalf of Ampio, asserts that various current and former officers and directors of Ampio – namely, Michael Martino, Michael Macaluso, Holli Cherevka, David Bar-Or, David Stevens, Kevin Buchi, Philip Coelho, and Richard Giles, breached their fiduciary duties as directors and/or officers and violated Section 14(a) of the Exchange Act by causing the Company to file false and misleading proxy statements. The Complaint focuses on the Company’s alleged failure to timely report that the results of the AP-013 trial for Ampion were unfavorable, failing to show efficacy on the co-primary endpoints of pain and function, and the Company’s alleged failure to disclose the results of and timing of unblinding the study data. The Complaint asserts that the individual defendants breached their fiduciary duties by making or causing the Company to make materially false and misleading statements regarding Ampio’s business, operations and prospects and by failing to maintain adequate internal controls. Based on these allegations, the Complaint asserts two causes of action on behalf of the Company: (1) violations of Section 14(a) of the Exchange Act against all defendants other than Cherevka; and (2) breach of fiduciary duty against all defendants. Based on these claims, the Complaint seeks judgment in favor of the Company and against the individual defendants in an unspecified amount of compensatory and restitution damages, together with pre- and post-judgment interest and costs of the action including reasonable attorneys’ and experts’ fees as well as a mandatory injunction requiring Ampio and the defendants to reform and improve the corporate governance and internal controls of the Company. On November 2, 2022, the Company and plaintiff (together with plaintiff in the previously filed Maresca On January 10, 2023, the Court granted consolidation of the Maresca Marquis co-lead counsel. On January 12, 2023, the Court granted the renewed motion and appointed co-lead counsel for plaintiffs. On January 17, 2023, the parties filed a joint stipulated motion seeking a temporary stay of the consolidated derivative actions, subject to various conditions, until the earlier of: (1) the dismissal of the Kain Kain As reported above, on January 4, 2024, the parties to the Consolidated Derivative Actions participated in a mediation at which they reached agreement in principle. The settlement is subject to various conditions, including the negotiation and execution of the full settlement agreements and obtaining court approval. On January 9, 2024, the parties filed a status report in the Consolidated Derivative Actions, advising the Court of the status of the settlement in principle and that the parties intended to file settlement documents within thirty days. Since then, the parties have filed several further status reports updating the Court on the parties’ continued negotiations and efforts to finalize the settlement documents. McCann v. Martino, et al On January 27, 2023, putative shareholder John McCann filed a derivative complaint in the District Court, City & County of Denver, State of Colorado, captioned McCann v. Martino et al Defendant Cherevka was served and by order dated February 9, 2023, obtained an extension of time to respond to the Complaint through March 31, 2023. On March 2, 2023, the parties filed a joint stipulated motion seeking a temporary stay of the action, subject to various conditions, until the earlier of: (1) the dismissal of the Kain Kain As reported above, on January 4, 2024, the parties to the McCann derivative action participated in the mediation at which the parties to the Consolidated Derivative Actions reached agreement in principle. The settlement of the Consolidated Derivative Action is subject to various conditions, including the negotiation and execution of the full settlement agreements and obtaining court approval. The plaintiffs in the McCann action have indicated their assent to the settlement of the Consolidated Derivative Actions and would seek dismissal of the McCann action if and when the Court finally approves the settlement of the Consolidated Derivative Actions. In accordance with ASC 450, Contingencies relieving the Company of any liability. It is reasonably possible that the estimated amount of the loss will change in the near term as the formal settlement(s) are finalized and approved by the court(s); however, the Company expects that payment would continue to be paid directly by the insurance carrier to the parties involved in the Shareholder Class Action and Consolidated Derivative Actions. SEC Investigation On October 12, 2022, the Securities and Exchange Commission, or SEC, entered an order directing private investigation and designating officers to take testimony to determine whether we or any other entities or persons have engaged in, or are about to engage in, any violations of the securities laws. The SEC has since issued subpoenas to the Company and numerous current and former officers, directors, employees and consultants of the Company. We intend to cooperate fully with the SEC. |