Spero Therapeuti Stock Price, News & Analysis

Spero Therapeutics, Inc. (Nasdaq: SPRO) is hosting a virtual R&D event on October 6, 2022, at 11:30 a.m. ET. Key opinion leader Kevin L. Winthrop, MD, MPH, will discuss the treatment landscape for non-tuberculous mycobacteria (NTM) pulmonary disease, alongside presentations from Spero's management about SPR720, a potential novel oral therapy for NTM infections. A live Q&A session will follow the presentations. Interested participants can register for the event here.

Spero Therapeutics and GSK have entered an exclusive license agreement for the late-stage antibiotic tebipenem HBr, aimed at treating complicated urinary tract infections (cUTI). Spero will receive an upfront payment of $66 million and potential milestone payments totaling up to $225 million, along with tiered royalties. GSK will invest $9 million in Spero's common stock and is set to develop and commercialize tebipenem HBr globally, except in Japan. The partnership is expected to enhance Spero's financial position and facilitate a new Phase 3 clinical trial in 2023.

Spero Therapeutics has appointed Kamal Hamed as Chief Medical Officer, bringing over 20 years of expertise in anti-infective development. Previously, Dr. Hamed held senior roles at Lysovant Sciences and Basilea Pharmaceutica, where he led the successful global approval of various anti-infective products. Dr. Hamed aims to advance Spero’s pipeline, including the promising SPR720 for nontuberculous mycobacterial infection and SPR206 for resistant Gram-negative infections. His leadership is expected to strengthen Spero’s position in the biopharmaceutical sector focused on urgent healthcare needs.

Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company, announced that Ankit Mahadevia, M.D., will present at the 24th Annual H.C. Wainwright Global Investment Conference from September 12-14, 2022. The presentation is scheduled for September 12 at 3:30 PM ET at Lotte New York Palace Hotel. Spero focuses on treatments for rare diseases and multi-drug resistant infections, with key products including SPR720 for rare pulmonary disease and SPR206 for Gram-negative infections. Webcasts of the presentation will be available on their website after the event.

Spero Therapeutics (Nasdaq: SPRO) announced alignment with the FDA regarding the regulatory path for tebipenem HBr, targeting complicated urinary tract infections (cUTI). A recent Type A meeting revealed that positive results from an additional Phase 3 trial could support its NDA resubmission. This pivotal trial is designed to demonstrate tebipenem HBr as a viable oral alternative to intravenous therapies. If approved, it would be the first oral carbapenem antibiotic in the U.S. The company aims to advance development through external partnerships.

Spero Therapeutics (Nasdaq: SPRO) reported Q2 2022 results, highlighting a net loss of $28.7 million, down from $18.6 million a year earlier. Total revenues decreased to $2.0 million, reflecting reduced BARDA and DoD funding. The company plans to initiate a Phase 2 trial for SPR720 in Nontuberculous Mycobacterial Pulmonary Disease in Q4 2022, with interim results expected in mid-2023. Additionally, a Phase 2 trial for SPR206 is set for Q3 2023. Despite setbacks with tebipenem HBr's NDA and restructuring costs of $11.8 million, Spero maintains sufficient cash reserves of $45.4 million until late 2023.

Spero Therapeutics (Nasdaq: SPRO) has announced a conference call on August 10, 2022, at 4:30 p.m. ET to discuss its Q2 2022 financial results and update its business operations and pipeline. Investors can access the call via phone or through a live audio webcast available on Spero's website. The archived webcast will be available for 30 days post-call. Spero is focused on developing treatments for bacterial infections, including multi-drug resistant strains, with pipeline candidates including SPR720, SPR206, and investigational drug Tebipenem HBr.

Spero Therapeutics (Nasdaq: SPRO) has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for tebipenem HBr oral tablets, intended for treating complicated urinary tract infections (cUTI). The FDA's action, announced on June 27, 2022, indicates that the NDA cannot be approved in its current form, citing insufficient data from Spero's Phase 3 clinical trial. The company plans to request a Type A meeting with the FDA to discuss next steps and address the agency's concerns, aiming for a clearer pathway to regulatory approval.

Spero Therapeutics (Nasdaq: SPRO) reported its Q1 2022 financial results, revealing a net loss of $32.8 million, up from $19.4 million in Q1 2021. Total revenues plummeted to $2.1 million from $7.3 million due to decreased funding under previous contracts. The company announced plans to initiate a Phase 2 trial for SPR720 in Nontuberculous Mycobacterial-Pulmonary Disease in H2 2022, while SPR206 shows promise for treating multi-drug resistant infections. With a cash position of $122 million, Spero aims to sustain its operations through late 2023 amid a strategic focus on clinical milestones.