Spero Therapeutics, Inc.

Investigation
05/03/2022

Initial Lawsuit
05/26/2022

Lawsuit Progression
07/25/2022

Investigation

Continous Holding
October 28, 2021 to May 2, 2022
Proposed Claim
Securities Violation

We have opened an investor investigation focused on determining whether Spero communicated the truth about the approval of the Tebipenem HBr New Drug Application (NDA) for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis in its form submitted on October 28, 2021. The U.S. Food and Drug Administration (FDA) recently identified deficiencies precluding discussion of labeling and post-marketing requirements/commitments.

Investors are invited to collaborate, participate and follow the development of the subsequently filed class action lawsuit.

Main Event

Changing Plans - FDA Separate Analysis

05/03/2022

SEC Filing

Spero discloses that it will “immediately defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting (LCM) with the U.S. Food and Drug Administration (FDA) regarding Spero’s New Drug Application (NDA) for tebipenem HBr.” The company also announced a 75% workforce reduction and a restructuring of its operations to focus on SPR720 and SPR206.

“In evaluating the efficacy of tebipenem HBr in the Phase 3 (ADAPT-PO) cUTI study, the FDA conducted a separate analysis of the microbiological intent-to-treat (micro-ITT) population, relative to the prespecified analysis as set forth in the previously submitted and reviewed protocol and statistical analysis plan for ADAPT-PO. The effect of this new analysis was to reduce the number of evaluable patients in the primary analysis population compared with those resulting from the trial’s pre-specified micro-ITT population as outlined in the statistical analysis plan. As a result, the FDA considers that the pre-specified non-inferiority (NI) margin of -12.5%, was not met. Spero is continuing its dialogue with the FDA, as the company seeks a pathway forward for potential approval of tebipenem HBr.”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close	Previous close	Price variation	Percentage variation
$1.85	$5.09	$-3.24	-63.65%

See more on Factual Timeline

Initial Lawsuit

A Spero Therapeutics, Inc. investor filed a federal securities class action lawsuit on behalf of a class consisting of all persons and entities other than defendants that purchased or otherwise acquired Spero securities between October 28, 2021 and May 2, 2022, both dates inclusive.

Filing Date
05/26/2022
Class Period
10/28/2021 to 05/02/2022
Transgression
Securities Violation
Filing Firms
Pomerantz LLP
Case Title
Germond v. Spero Therapeutics, Inc. et al
Docket Number
1:22-cv-03125
Court
New York Eastern District Court
Free File
Complaint

Allegations

According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors that:

(i) the data submitted in support of the Tebipenem HBr NDA were insufficient to obtain FDA approval;
(ii) accordingly, it was unlikely that the FDA would approve the Tebipenem HBr NDA in its current form;
(iii) the foregoing would necessitate a significant workforce reduction and restructuring of Spero’s operations; and
(iv) as a result, the company’s public statements were materially false and misleading at all relevant times.