Spero Therapeutics, Inc. Q2 FY2023 earnings call

• Tebipenem HBr: Partnered with GSK, received FDA SPA on Phase 3 trial design, expect Q4 enrollment in PIVOT-PO, entitled to up to $150 million in milestones including first $30 million received in current quarter.
• SPR720: Phase 2a proof-of-concept trial ongoing, working on toxicology, CMC, FDA engagement, Japan expansion, initiated Phase 1 studies.
• SPR206: On track for Phase 2 IND in Q4 2023, funded by grant.
• Organizational changes: Sath Shukla became CEO, Ankit Mahadevia is Chairman, search for permanent CFO, Steve Dipalma as Interim CFO.

In the second quarter of 2023, Spero Therapeutics reported total revenues of $2.7 million, an increase from $2 million in the same period of 2022 due to revenue recognition from the GSK transaction. Research and development expenses were $9.5 million in 2023 compared to $8.2 million in 2022, primarily driven by higher costs for SPR720, Tebipenem HBr, and SPR206 programs, offset by lower R&D head count expenses from strategic restructuring. General and administrative expenses were $6.1 million in 2023, down from $8.1 million in 2022. The net loss for the second quarter of 2023 was $11.9 million, or $0.23 per share, compared to a net loss of $28.7 million, or $0.87 per share, in the same period of 2022.

• Tebipenem HBr: Expect Q4 enrollment in PIVOT-PO, GSK target commercialization in 2026.
• SPR720: Top line results expected in second half of 2024.
• SPR206: On track for Phase 2 IND in Q4 2023.

Forward-looking statements may not materialize; actual results could differ due to factors detailed in Spero Therapeutics’ SEC filings, including Risk Factors section of Form 10-Q.

Q: What else in addition to SPR720 and SPR206 might you explore in terms of pipeline? Do you plan to expand beyond these two?

A: Spero has flexibility and balance sheet strength to evaluate business development opportunities that fit high unmet need and strong economic/commercial opportunity criteria.

Q: How swiftly might the confirmatory pivotal trial of tebipenem could reach full enrollment?

A: Timing not disclosed, but GSK targets commercialization in 2026; trial expected to be larger than ADAPT-PO, taking longer than previous trial.

Q: How is tebipenem performing commercially in Japan?

A: Not tracked actively as it's in different indication (pediatric pneumonia) since 2009, but drug has performed well with millions dosed.

Q: Can you talk to how including some subsection of refractory patients in the Phase 2 of SPR720 may impact top line data?

A: SPR720 study enrolls patients who do not have refractory disease; strategy is to pursue first-line treatment first, and no refractory patients are enrolled in this Phase 2a trial.