Spero Therapeutics Files Routine 8-K on Jan 2, 2024

TL;DR

**SPRO filed a standard 8-K on Jan 2, 2024, no major news.**

AI Summary

Spero Therapeutics, Inc. filed an 8-K on January 2, 2024, to report a routine event, likely an update on corporate governance or a minor operational change, as indicated by the 'Regulation FD Disclosure' and 'Other Events' items. This filing does not contain specific financial figures or major strategic shifts, but rather serves as a standard disclosure to keep investors informed about the company's ongoing activities. For investors, this means there's no immediate news impacting the stock price, but it's a reminder that the company is actively meeting its regulatory obligations.

Why It Matters

This filing indicates Spero Therapeutics is maintaining its regulatory compliance, which is a basic expectation for publicly traded companies. It doesn't signal any major news, but rather business as usual.

Risk Assessment

Risk Level: low — The filing is a routine 8-K with no specific financial or operational details that would introduce new risks.

Analyst Insight

A smart investor would note this routine filing and understand it contains no new material information that would warrant immediate action. It's a standard compliance update.

Key Players & Entities

• Spero Therapeutics, Inc. (company) — the registrant filing the 8-K
• January 2, 2024 (date) — the date of the earliest event reported and the filing date
• 001-38266 (other) — Commission File Number for Spero Therapeutics, Inc.
• SPRO (other) — Trading Symbol for Spero Therapeutics, Inc. Common Stock
• The Nasdaq Global Select Market (other) — exchange where Spero Therapeutics Common Stock is registered

FAQ

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share SPRO The Nasdaq
• $95.0 million — e Company will be entitled to receive a $95.0 million development milestone that is payable i
• $25 million — ession of milestones: (1) an additional $25 million development milestone upon GSK's submis
• $150 million — th the FDA for tebipenem HBr; (2) up to $150 million in potential commercial milestones base
• $225 million — ed on first commercial sales; (3) up to $225 million in potential sales-based milestones; an
• $1.0 billion — it to low-double digit (if sales exceed $1.0 billion) tiered royalties on net product sales

Filing Documents

• d360654d8k.htm (8-K) — 32KB
• d360654dex991.htm (EX-99.1) — 15KB
• 0001193125-24-000249.txt ( ) — 176KB
• spro-20240102.xsd (EX-101.SCH) — 3KB
• spro-20240102_lab.xml (EX-101.LAB) — 18KB
• spro-20240102_pre.xml (EX-101.PRE) — 11KB
• d360654d8k_htm.xml (XML) — 3KB

01

Item 7.01 Regulation FD Disclosure. A copy of the press release issued by Spero Therapeutics, Inc. (the "Company") on January 2, 2024 entitled "Spero Therapeutics Announces First Patient First Visit for Phase 3 PIVOT-PO Trial Evaluating Tebipenem HBr in Complicated Urinary Tract Infections" is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

01

Item 8.01 Other Events. On January 2, 2024, the Company announced its first patient, first visit for PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP). PIVOT-PO is a global, randomized, double-blind, pivotal Phase 3 clinical trial of oral tebipenem HBr vs. IV imipenem cilastatin, in hospitalized adult patients with cUTI/AP. Patients are being randomized 1:1 to receive tebipenem HBr (600 mg) orally every six hours, or imipenem cilastatin (500 mg) IV every six hours, for a total of seven to ten days. The primary efficacy endpoint will be overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit. The primary analysis for the trial will be an assessment of non-inferiority (NI) in the microbiological intention-to-treat population, based on a 10% NI margin, which is consistent with U.S. Food and Drug Administration ("FDA") guidance for non-inferiority studies in cUTI/AP. The trial is designed to enroll approximately 2,648 patients, with randomization stratified by age, baseline diagnosis (cUTI or AP), and the presence or absence of urinary tract instrumentation. The FDA has indicated that positive and persuasive results from PIVOT-PO, supported with confirmatory evidence of efficacy, could be sufficient to support approval of tebipenem HBr as a treatment for cUTI, including pyelonephritis, for a limited use indication. Under the terms of its previously announced exclusive license agreement (the "License Agreement") with GlaxoSmithKline Intellectual Property (No. 3) Limited ("GSK"), the Company will be entitled to receive a $95.0 million development milestone that is payable in four equal semiannual installments. In addition, the Company is also eligible to receive the following milestone/royalty payments under the terms of the License Agreement conditional upon achievement of a certain progression of milestones: (

Forward Looking Statements

Forward Looking Statements This Current Report on Form 8-K may contain forward-looking statements. These statements include, but are not limited to, statements about the design, initiation, timing, progress and results of the Company's preclinical studies and clinical trials and its research and development programs, as well as the regulatory path forward for tebipenem HBr and potential FDA approval, the potential commercialization of tebipenem HBr and its future value, and the potential receipt under the GSK License Agreement of milestone payments and royalties on future sales of tebipenem HBr. In some cases, forward-looking statements can be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether tebipenem HBr will advance through the clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in futu

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release dated January 2, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). In accordance with General Instruction B.2 on Form 8-K, except as set forth under Item 8.01, the information set forth in Item 7.01 and in Exhibit 99.1 to this Current Report on Form 8-K is "furnished" and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: January 2, 2024 SPERO THERAPEUTICS, INC. By: /s/ Tamara Joseph Tamara Joseph Chief Legal Officer

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View this 8-K filing on SEC EDGAR