Spero Therapeutics Reports Q2 2024 Results and Business Update

Spero Therapeutics, Inc., a clinical-stage biopharmaceutical company based in Cambridge, Massachusetts, has announced its financial results for the second quarter ending June 30, 2024, and shared updates on its ongoing business and clinical developments. Spero focuses on pioneering new treatments for rare diseases and multi-drug resistant (MDR) bacterial infections.

Sath Shukla, Spero's President and CEO, highlighted the advancement of the company's clinical-stage programs. Notably, the enrollment for the Phase 2a proof-of-concept trial of SPR720, an oral treatment for non-tuberculous mycobacterial pulmonary disease (NTM-PD), has been concluded. This trial enrolled 25 patients who received their first dose in July 2024. Preliminary data on SPR720’s efficacy and safety are anticipated in the fourth quarter of 2024. The study measures the decline in NTM bacterial load over 56 days, with key endpoints including changes in bacterial colony forming units and time to positivity.

Moreover, Spero disclosed the completion of dosing in two Phase 1 clinical studies for SPR720 in healthy volunteers. These studies evaluated the drug’s pharmacokinetics when administered alone and in combination with azithromycin and ethambutol. The results are expected to be revealed by the end of 2024. Additionally, new data on SPR720’s in-vitro resistance will be presented at the IDWeek 2024 conference in October.

In another important update, Spero announced the ongoing global Phase 3 PIVOT-PO clinical trial of tebipenem HBr, an oral antibiotic aimed at treating complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). This randomized trial, involving approximately 2,648 patients, compares oral tebipenem HBr with intravenous imipenem cilastatin. The primary endpoint is the overall response at the Test-of-Cure visit. Enrollment for this trial is expected to conclude in the second half of 2025.

Spero's investigational drug SPR206, an intravenously administered next-generation polymyxin, has shown promising activity against MDR Gram-negative pathogens. The FDA has cleared the company to start a Phase 2 trial for SPR206 in patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), contingent on securing non-dilutive funding.

In corporate news, Chief Medical Officer Kamal Hamed, MD, MPH, MBA, will leave the company on August 29, 2024. John C. Pottage, Jr., M.D., a board member since 2018, has been appointed as Special Advisor to oversee the company's medical functions. Dr. Pottage has extensive experience in developing therapeutics for infectious diseases, including senior roles at ViiV Healthcare and GlaxoSmithKline.

CEO Shukla expressed gratitude for Dr. Hamed's contributions over the past two years and confidence in Dr. Pottage’s ability to guide the company’s clinical programs. The search for a new Chief Medical Officer is ongoing.

Financially, Spero reported a net loss of $17.9 million for the second quarter of 2024, compared to an $11.9 million loss in the same period of 2023. The total revenue rose to $10.2 million, up from $2.7 million in the previous year, primarily due to increased collaboration and grant revenue related to tebipenem HBr. Research and development expenses grew to $23.7 million, mainly due to the Phase 3 trial for tebipenem HBr and the Phase 2a trial for SPR720. General and administrative expenses decreased slightly to $5.5 million.

As of June 30, 2024, Spero’s cash and cash equivalents stood at $63.5 million. The company expects these funds, along with other non-dilutive financing, to support operations into late 2025.

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