• Cash and Cash Equivalents: $52.9 million as of December 31, 2024.
• Fourth Quarter Revenue: $15 million, down from $73.5 million in Q4 2023.
• Full-Year Revenue: $48 million for 2024, compared to $103.8 million in 2023.
• R&D Expenses: $28.8 million for Q4 2024, up from $16.6 million in Q4 2023; $97 million for the full year 2024, up from $51.4 million in 2023.
• G&A Expenses: $7.1 million for Q4 2024, compared to $6.4 million in Q4 2023; $23.7 million for the full year 2024, down from $25.6 million in 2023.
• Net Loss: $20.7 million for Q4 2024 and $68.4 million for the full year 2024.
• Diluted Net Loss Per Share: $0.38 for Q4 2024 and $1.27 for the full year 2024.
• Net Income (Previous Year): $51.2 million for Q4 2023 and $22.8 million for the full year 2023.
• Net Income Per Share (Previous Year): $0.96 for Q4 2023 and $0.43 for the full year 2023.

• Warning! GuruFocus has detected 4 Warning Signs with SPRO.

Release Date: March 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Spero Therapeutics Inc (NASDAQ:SPRO) is advancing its lead product candidate, tebipenem HBr, in a Phase 3 trial, which could become the first broad-spectrum oral carbapenem for complicated urinary tract infections.
• The company has a partnership with GSK for the co-development of tebipenem HBr, which could lead to significant milestone payments if regulatory and commercialization efforts are successful.
• Spero Therapeutics Inc (NASDAQ:SPRO) has sufficient cash and cash equivalents to fund operations into Q2 2026, providing financial stability for ongoing projects.
• The Phase 3 PIVOT-PO trial for tebipenem HBr is designed to address a significant unmet need in the treatment of complicated UTIs, potentially reducing hospital stays by offering an oral alternative to IV therapy.
• The company is conducting a pre-specified interim analysis for the Phase 3 trial of tebipenem HBr, with results expected in the second quarter of 2025, which could accelerate the development timeline if successful.

Negative Points

• Spero Therapeutics Inc (NASDAQ:SPRO) reported a decrease in total revenue for 2024 compared to 2023, primarily due to reduced collaboration revenue from agreements with GSK and Pfizer.
• The company experienced a significant increase in R&D expenses year-over-year, driven by increased clinical trial activity, which contributed to a net loss for the year.
• The Phase 2A trial for SPR720 did not meet its primary endpoint, and there were dose-limiting safety signals, including cases of reversible Grade 3 hepatotoxicity.
• Spero Therapeutics Inc (NASDAQ:SPRO) decided to discontinue development of SPR206, an IV-administered antibiotic, following a pipeline review and reprioritization.
• The company reported a net loss of $68.4 million for the year ended December 31, 2024, compared to a net income in the previous year, indicating financial challenges.

Q & A Highlights

Q: Does the trial get unblinded if the interim analysis for tebipenem is successful? A: Yes, if the interim analysis is successful, the trial will be unblinded. The process is managed by an independent data monitoring committee, and if they recommend stopping the trial, the management team will be unblinded at that time. - Esther Rajavelu, Interim CEO & CFO

Q: Is there any reason to continue the trial longer even if it's positive early on, particularly for subgroup analyses like the ESBL-positive population? A: We cannot speculate on that at the moment as we are currently blinded and preparing for the interim analysis. We will be able to respond once we receive the recommendation from the IDMC. - Esther Rajavelu, Interim CEO & CFO

Q: What is the alpha spend on the interim analysis? A: A small amount of alpha will be spent for the pre-specified interim analysis, and this has been accounted for in determining the overall sample size for the study. - Esther Rajavelu, Interim CEO & CFO

Q: Can you comment on the bar for success for the interim analysis and when it is conducted? A: There are three likely scenarios: the trial meets the primary endpoint with the pre-specified interim, fails, or continues enrolling. The primary endpoint is a 10% non-inferiority margin. - Esther Rajavelu, Interim CEO & CFO

Q: What are the potential paths forward for SPR720, and when can we expect an update? A: The first step is to complete the data analysis of all 25 patients dosed in the trial. Once we have the full data, we will decide on the best path forward, which may include a reformulation strategy. An oral path for NTMPD is unlikely due to dose-limiting Grade 3 toxicity at the 1,000 mg dose. - Esther Rajavelu, Interim CEO & CFO

For the complete transcript of the earnings call, please refer to the full earnings call transcript.