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The parties moved to consolidate the two complaints on July 22, 2022, which were ordered consolidated on August 5, 2022 (“Consolidated Putative Class Action”).
−Removed: The parties filed an Amended Complaint on December 5, 2022, purported to be brought on behalf of stockholders who purchased the Company's common stock from September 8, 2020 through May 2, 2022.
−Removed: The Amended Complaint generally alleges that the Company and certain of its current and former officers violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the New Drug Application (“NDA”) for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
+Added: The parties filed an Amended Complaint on December 5, 2022, purported to be brought on behalf of stockholders who purchased our common stock from September 8, 2020 through May 2, 2022.
+Added: The Amended Complaint generally alleges that the Company and certain of its current and former officers violated Sections 10(b) and/or 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the NDA for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
Plaintiffs seek unspecified damages, interest, attorneys’ fees, and other costs.
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On March 20, 2025, the Second Derivative Complaint was voluntarily dismissed by the plaintiff.
−Removed: The Company denies any allegations of wrongdoing and intends to vigorously defend against these lawsuits.
−Removed: However, there is no assurance that the Company will be successful in its defense or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of these actions.
−Removed: Moreover, the Company is unable to predict the outcomes or reasonably estimate a range of possible loss at this time.
+Added: On March 31, 2025, the First Derivative Complaint was voluntarily dismissed by the plaintiff.
Additional lawsuits against the Company and certain of its officers or directors may be filed in the future.
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SEC Investigation and Wells Notice
−Removed: On January 9, 2025, the Company responded to a “Wells Notice” from the staff of the Boston Regional Office (“Staff”) of the SEC regarding its preliminary determination to recommend a civil enforcement action or administrative proceeding against the Company, its former Chief Executive Officer and Chairman of the Board of Directors, Ankit Mahadevia, M.D.
+Added: On January 9, 2025, the Company responded to a “Wells Notice” from the Staff of the SEC regarding its preliminary determination to recommend a civil enforcement action or administrative proceeding against the Company, its former Chief Executive Officer and a former member of its Board of Directors, Ankit Mahadevia, M.D.
Mahadevia”), and its former Chief Financial Officer and President and Chief Executive Officer, Satyavrat “Sath” Shukla (“Mr.
−Removed: Shukla”), relating to certain public disclosures by the Company from March 31, 2022 leading up to the Company’s announcement on May 3, 2022 that it had determined to cease commercialization of tebipenem HBr based on feedback from the FDA, and whether the Company’s disclosures may have violated the federal securities laws (the “Investigation”).
−Removed: Specifically, the contemplated civil enforcement action, if approved by the Commissioners, could include allegations that the Company violated Section 17(a) of the Securities Act and Sections 10(b) and 13(a) of the Exchange Act and Rules 10b-5, 12b-20, and 13a-1 thereunder;
−Removed: and could allege against Dr.
−Removed: Mahadevia and Mr.
−Removed: Shukla violations of Section 17(a) of the Securities Act and Section 10(b) of the Exchange Act and Rules 10b-5 and 13a-14 thereunder.
−Removed: The Company, Dr.
−Removed: Mahadevia and Mr.
−Removed: Shukla continue to cooperate with the SEC, they have engaged in further dialogue with the Staff and maintain that the Company’s disclosures were appropriate.
+Added: Shukla”), relating to certain public disclosures by the Company from March 31, 2022 leading up to the Company’s announcement on May 3, 2022 that it had determined to cease commercialization of tebipenem HBr based on feedback from the FDA, and whether the Company’s disclosures may have violated the federal securities laws.
A Wells Notice is neither a formal charge of wrongdoing nor a final determination that the recipient has violated any law, but is a preliminary determination by the Staff to recommend to the SEC Commissioners that a civil enforcement action or administrative proceeding be brought against the recipients.
It provides the recipients the opportunity to address in a non-public forum the issues raised by the Staff before a recommendation is made to the SEC regarding an enforcement action.
−Removed: If the SEC were to authorize an action against the Company and/or any of the identified individuals, it may seek an injunction or cease-and-desist order against future violations of provisions of the federal securities laws, the imposition of civil monetary penalties, disgorgement or other equitable relief within the SEC’s authority, or any combination of the foregoing.
−Removed: The SEC could also seek an order barring each identified individual from serving as an officer or director of a public company for a specified period of time.
−Removed: The results of the Investigation and the Wells Notice process and any corresponding enforcement action against the Company and/or any of the identified individuals, and the costs, timing and other potential consequences of responding and complying therewith are unknown at this time.
+Added: If the SEC were to authorize an action against the Company and/or any of the identified individuals, it may seek an injunction or cease-and-desist order against future violations of provisions of the federal securities laws, the imposition of civil monetary penalties, disgorgement or other equitable relief.
+Added: On January 16, 2026, acting pursuant to an offer of settlement submitted by each of Dr.
+Added: Mahadevia and Mr.
+Added: Shukla, the SEC issued an order instituting cease-and-desist proceedings, making findings, and imposing a cease-and-desist order pursuant to Section 8A of the 1933 Act, directing Dr.
+Added: Mahadevia and Mr.
+Added: Shukla to cease and desist from committing or causing any violations of Section 17(a)(2) of the 1933 Act, 15 U.S.C.
+Added: § 77q(a)(2) (the “SEC Order”).
+Added: In the SEC Order, the SEC made findings that, from March 31, 2022 to May 3, 2022, Dr.
+Added: Mahadevia and Mr.
+Added: Shukla, violated Section 17(a)(2) of 1933 Act, which provides that it is unlawful for any person, in the offer or sale of a security, to “obtain money or property by means of any untrue statement of material fact” or a material
+Added: omission necessary to make statements made not misleading.
+Added: A violation of this provision does not require scienter and may rest on a finding of negligence.
+Added: Mahadevia and Mr.
+Added: Shukla consented to entry of the SEC Order without admitting or denying the findings contained therein, except as to jurisdiction.
+Added: On January 20, 2026, the Company received a letter (the “Letter”) from the SEC advising the Company that the SEC has concluded its investigation into the Company and that, based on the information as of the date of the Letter, the SEC does not intend to recommend an enforcement action against the Company at this time.
+Added: The Letter was provided under the guidelines set out in the final paragraph of Securities Act Release No.
+Added: The Company and Mr.
+Added: Shukla mutually decided to separate, and Mr.
+Added: Shukla resigned from the Board of Directors, in each case effective as of May 2, 2025.
+Added: On January 30, 2026, Dr.
+Added: Mahadevia resigned from the Board of Directors, including from his service on the Development Committee of the Board and from all officer and director positions he then held with any and all subsidiaries of the Company, effective as of January 30, 2026.
Mine Saf ety Disclosures.
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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.