Release Date: August 05, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Spero Therapeutics Inc (SPRO, Financial) reported a significant increase in total revenue for Q2 2024, reaching $10.2 million compared to $2.7 million in Q2 2023.
- The company has a strong cash position with $63.5 million in cash and cash equivalents, along with anticipated milestone payments from GSK totaling $24 million every six months.
- Enrollment for the Phase 3 PIVOT-PO clinical trial for tebipenem HBr is on track, with completion expected in the second half of 2025.
- SPR720 shows promise as a first-line oral agent for nontuberculous mycobacterial pulmonary disease (NTMPD), with comprehensive data expected in Q4 2024.
- SPR206 received FDA clearance to advance into a Phase 2 clinical trial and was awarded fast-track designation, indicating strong regulatory support.
Negative Points
- The departure of Chief Medical Officer Dr. Kamal Hamed could indicate potential instability or challenges within the executive team.
- Research and development expenses increased significantly to $23.7 million in Q2 2024 from $9.5 million in Q2 2023, impacting overall financial performance.
- The company reported a net loss of $17.9 million for Q2 2024, higher than the $11.9 million loss in Q2 2023.
- There is uncertainty regarding the mix of treatment-naive and treatment-experienced patients in the SPR720 trial, which could impact the interpretation of results.
- The success of SPR720 and tebipenem HBr is contingent on future data readouts and regulatory approvals, which carry inherent risks and uncertainties.
Q & A Highlights
Q: What's the significance of the IDWeek data that you're going to present, and what should we learn from it? Also, can you provide more details on Kamal's departure?
A: Kamal's departure is unrelated to the data or programs. We look forward to the unblinding and reporting of the top-line data for SPR720 in Q4 and for tebipenem next year. Regarding IDWeek, we are excited to present resistance data, which will build on the value proposition of SPR720's novel mechanism of action showing a low propensity for resistance and no evidence of cross-resistance.
Q: For the PK substudy, what duration of MIC90 coverage do you believe SPR720 has at both doses, specifically at the site of infection?
A: We have not disclosed that data yet. This information will be part of our future reports.
Q: Can you clarify if the 25 patients enrolled in the Phase 2A trial were all treatment-naive or included treatment-experienced patients?
A: The trial includes both treatment-naive and non-refractory treatment-experienced patients. However, the specific mix of these patients is currently blinded to us.
Q: Can you elaborate on the secondary endpoint of time to positivity?
A: Time to positivity measures the time it takes for bacterial growth to be detected in a liquid media inoculated with a sputum sample. The longer the time to positivity, the better the efficacy of the treatment. This metric is well established in TB and is a key secondary endpoint for our study.
Q: Can you provide more details on the tebipenem Phase 3 program, including the number of clinical sites and factors impacting enrollment?
A: The trial involves multiple countries and is expected to have sites in the triple digits. Enrollment is on track, and we have not faced significant headwinds like those experienced during the ADAPT trial. We expect to complete enrollment in the second half of next year.
Q: How is the pro-drug SPR720 converted into its active moiety SPR719? Also, what additional combinations might you assess for plasma PK variability?
A: SPR720 rapidly converts to SPR719. We will provide detailed publications on this. Currently, we are evaluating co-administration with azithromycin and ethambutol. Future evaluations will depend on the evolving landscape and discussions with the FDA.
Q: What is the financial outlook for Spero Therapeutics?
A: Spero ended Q2 with $63.5 million in cash and cash equivalents. We anticipate additional milestone payments from GSK, totaling approximately $24 million every six months. Our cash and funding commitments are expected to cover operating expenses and capital requirements into late 2025.
Q: Can you summarize the financial results for the second quarter of 2024?
A: Total revenue was $10.2 million, up from $2.7 million in Q2 2023, primarily due to increased collaboration and grant revenue. R&D expenses were $23.7 million, up from $9.5 million, mainly due to higher costs for the Phase 3 trial for tebipenem HBr and the Phase 2A trial for SPR720. G&A expenses decreased to $5.5 million from $6.1 million. The net loss was $17.9 million, or $0.33 per share.
Q: What are the next steps for SPR720 and tebipenem HBr?
A: For SPR720, we expect to share a comprehensive data set from ongoing and completed clinical studies in Q4. For tebipenem HBr, we aim to complete enrollment in the Phase 3 trial by the second half of 2025.
Q: What is the status of SPR206?
A: SPR206 is an investigational intravenous polymyxin partnered with Pfizer for European markets. The FDA has cleared the IND for a Phase 2 trial in patients with hospital-acquired or ventilator-associated bacterial pneumonia and awarded it fast-track designation. The Phase 2 study initiation is contingent on non-dilutive funding.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
