Spero Therapeutics Reports Q1 2024 Results and Business Update

Spero Therapeutics Inc., a clinical-stage biopharmaceutical company, announced its financial and operational output for the quarter ending March 31, 2024. The company, which specializes in developing treatments for rare diseases and multi-drug resistant bacterial infections, has outlined several key milestones and financial results for the period.

Sath Shukla, the President and CEO of Spero, highlighted the company's progress in its clinical pipeline. Notably, top-line data from the Phase 2a clinical trial of SPR720 is expected in the second half of 2024. This trial focuses on treatment-naive and treatment-experienced non-refractory NTM-PD patients and aims to redefine the standard care in nontuberculous mycobacterial pulmonary disease.

In other clinical developments, Spero's pivotal Phase 3 clinical trial of oral tebipenem HBr in complicated urinary tract infections (cUTI) continues to enroll patients globally. Named PIVOT-PO, this trial compares the oral antibiotic to the intravenous imipenem cilastatin. The enrollment is expected to complete by the second half of 2025. Tebipenem HBr has also been granted an exclusive license by GSK for commercialization in various territories, except certain Asian regions.

SPR206, another promising candidate, has received FDA Fast Track designation for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABc) and carbapenem-resistant Pseudomonas aeruginosa (CRPA). The company plans to initiate a Phase 2 trial, pending non-dilutive funding.

Financially, Spero reported a net loss of $12.7 million for Q1 2024, slightly improved from the $13.3 million loss in Q1 2023. Total revenue increased significantly to $9.3 million in Q1 2024, up from $2.1 million in the same period the previous year. This growth was primarily driven by increased collaboration revenue from the agreement with GSK for tebipenem HBr and grant revenue related to a BARDA contract for the same drug.

Research and development expenses rose to $17.3 million in Q1 2024, compared with $9.0 million in Q1 2023. This increase is attributed to heightened clinical activities, particularly the ongoing Phase 2a trial of SPR720 and the Phase 3 trial of tebipenem HBr. General and administrative expenses, however, decreased to $5.9 million from $7.3 million, primarily due to reduced personnel-related costs and professional fees.

As of March 31, 2024, Spero had a cash balance of $82.3 million, up from $76.3 million at the end of 2023. This increase is largely due to a $23.8 million milestone payment from GSK, related to the first patient enrollment in the tebipenem HBr Phase 3 PIVOT-PO trial. The company expects its cash and equivalents, along with other non-dilutive funding, to sustain operations into late 2025.

In summary, Spero Therapeutics has made significant strides in its clinical programs and financial health. With promising developments in SPR720, tebipenem HBr, and SPR206, and a robust financial position, the company is well-positioned to advance its mission of addressing rare diseases and MDR bacterial infections.