Spero Therapeutics Q2 2025 Earnings Call Transcript

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August 12, 2025

Key Takeaways

  • Positive Sentiment: The Phase 3 PIVOT PO trial of tebipenem HBr met its primary endpoint of clinical cure and microbiological eradication in complicated UTIs and was stopped early for efficacy after a positive interim analysis.
  • Neutral Sentiment: The Independent Data Monitoring Committee identified no new safety concerns beyond previously reported diarrhea and headache adverse events in the tebipenem HBr program.
  • Positive Sentiment: GSK plans to include PIVOT PO data in a U.S. regulatory filing by year-end 2025 under a Special Protocol Assessment, with FDA action expected in 2026.
  • Positive Sentiment: Spero’s cash and equivalents of $31.2 M plus $23.8 M in upcoming GSK milestone payments and meaningful trial cost savings are projected to extend the company’s runway into 2028.
  • Negative Sentiment: The SPR720 Phase 2A proof-of-concept study for nontuberculous mycobacterial pulmonary disease failed to meet its primary endpoint and showed dose-limiting hepatotoxicity, prompting a reassessment of the program.
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Earnings Conference Call
Spero Therapeutics Q2 2025
00:00 / 00:00

There are 5 speakers on the call.

Operator

Good afternoon, and welcome to Spero Therapeutics second quarter twenty twenty five earnings conference call. At this time, all participants are in a listen only mode. Following the company's formal remark, we will open up the call for questions. Please be advised that this call is being recorded, and a replay will be available. You can find the in the replay and further information related to today's announcement on the Spero Therapeutics website at ww.sperotherapeutics.com.

Operator

At this time, I would like to turn the call over to Shai Viran, senior director, investor relations. Mister Biran, please go ahead.

Speaker 1

Thank you, operator, and thank you all for participating in today's conference call. This afternoon, Spero Therapeutics released financial results and provided a business update for the 2025. The press release is available on the investor page of the Spero Therapeutics website. Before we begin, I would like to remind you that some of the information presented on this conference call contains forward looking statements under the Private Securities Litigation Reform Act of 1995, as amended. These forward looking statements are based on management's current expectations and beliefs and are subject to risks, uncertainties, and other factors that may cause actual results to differ materially from those indicated by such forward looking statements.

Speaker 1

These risks, uncertainties, and other factors are described in detail in Spero Therapeutics' filings with the SEC, including in the risk factors set forth in the periodic report on Form 10 Q for the second quarter ended 06/30/2025, filed with the SEC today. Leading our call today will be Esther Rajavelu, our Chief Executive Officer and Chief Financial Officer. She will be joined by our Chief Operating Officer, Tim Koytsfer. Esther will provide an update on our lead clinical program, tebipenem HBr, for complicated urinary tract infections, or CUTIs. Then Tim will provide an overview of the CUTI therapeutic landscape and the unmet need we believe tebipenem HBr could fill, followed by a brief update on SPR720.

Speaker 1

Esther will then conclude with a review of our financials before opening the call for questions. I will now turn the call over to Esther.

Speaker 2

Thank you, Shay. Good afternoon, everyone, and thank you for joining our second quarter twenty twenty five earnings and business update call. I'm very pleased to share that in May, together with our development partner GSK, we announced that the Phase three PIVOT PO trial evaluating tebipenem HVR in patients with CUTI, including pyelonephritis successfully met its primary endpoint and was stopped early for efficacy. This decision follows a recommendation from the Independent Data Monitoring Committee or IDMC, which reviewed data from a pre specified interim analysis based on sixteen ninety patients enrolled in the trial. The primary endpoint was overall response at the test of cure visit, a composite of clinical cure plus microbiological eradication.

Speaker 2

Tevipenem HBr demonstrated non inferiority to intravenous imipenem celestatin in hospitalized adult patients with CUTI, including pyelonephritis. The positive outcome from the PIVOT PO trial further supports our thesis that tebipenem HBr and oral carbapenem can deliver comparable treatment outcomes to standard of care IV carbapenem therapy. The IDMC review did not identify any new safety concerns beyond what had been reported in prior tabipenem studies. Diarrhea and headache were the two most reported adverse events. We and GSK plan to submit the full results from PIVOT PO for presentation at an upcoming scientific conference and for publication in a peer reviewed journal.

Speaker 2

GSK responsible for regulatory filings and has communicated that they plan to work with the FDA to include the PIVOT PO data as part of an FDA filing at year end 2025. We currently believe that FDA action is likely in the 2026. Sparrow will support GSK in the preparation of the filing and any potential pre approval communications with the FDA. The PIVOT PO study is covered by the Special Protocol Assessment Agreement entered into with the FDA in 2023. The FDA has indicated that positive and persuasive results from the PIVOT PO together with results from previously completed studies could be sufficient to support approval of tebipenem HBr as a treatment for TUTI, including pyelonephritis for a limited use indication.

Speaker 2

As a reminder, our agreement with GSK grants them an exclusive license to develop and commercialize tebipenem HVR in all territories except for Japan and certain other Asian countries that are covered by our partnership with Meiji Seika Pharmaco. While Sparrow is responsible for the execution and cost of the PIVOT PO trial, GSK is responsible for the execution and cost of the planned regulatory filings and commercialization activities, as well as any future clinical development activities. Assuming these activities are successfully pursued, SPARO could qualify for up to $351,000,000 in contingent milestones, including $25,000,000 when GSK submits The U. S. Regulatory filing and subsequent milestones based on commercialization and sales ramp, as well as tiered royalties on net sales.

Speaker 2

Our press release and 10 Q filed this evening include additional details on these contingent payments. Importantly,

Speaker 3

with

Speaker 2

the trial stopping early for efficacy, we have achieved meaningful cost savings in the near term, which we anticipate will extend our cash runway into 2028 based on our current operating plan. I will now turn the call over to Tim, who will provide additional details on the TEVY program and SPR720.

Speaker 3

Thank you, Esther, and hello, everyone. We estimate that there are approximately two point nine million episodes of complicated urinary tract infections each year in The United States alone. These infections typically occur in patients with structural or functional abnormalities of the urinary tract, in patients requiring catheters, or in patients with comorbidities such as kidney infections. They are also more likely to involve multi drug resistant or MDR pathogens. If not properly treated, complicated UTIs can recur repeatedly or escalate into more severe conditions, including sepsis and septic shock.

Speaker 3

They are a leading cause of hospitalization and contribute to over $6,000,000,000 per year in US healthcare costs. Currently, the standard of care for many infections caused by MDR gram negative bacteria, including CUTIs, is carbapenem antibiotics. However, carbapenems are currently only available in IV form. This means patients often require inpatient admission or prolonged outpatient IV therapy, adding significant complexity and cost to their treatment. The lack of an effective, well tolerated oral alternative has left a major gap in care.

Speaker 3

If approved, we believe tebipenem hydrobromide is well positioned to change the treatment landscape for patients with CUTIs, offering an oral option where currently IV therapy is the standard of care. We believe the product would represent a major clinical advance for patients and has the potential to create significant economic benefits for the healthcare system. Next on to SPR720, our novel gyrase B inhibitor that was in a phase 2A proof of concept study as an oral treatment for patients with nontuberculous mycobacterial pulmonary disease or NTMPD. In October 2024, we completed a planned interim analysis of the trial, results from which showed that the study did not meet its primary endpoint. While there was some evidence of antimicrobial activity, the treated arm did not show sufficient separation from placebo.

Speaker 3

In addition, we saw potential dose limiting safety signals, including three cases of reversible grade three hepatotoxicity in the high dose cohort receiving one thousand milligrams once daily. The assessment of the full data set of all 25 patients dosed in the trial is now complete, and we're currently determining the next steps for the program. I will now hand the call back to Esther for a review of our financials. Thank you for your attention.

Speaker 2

Thank you, Tim. As of June 30, Spero had cash and cash equivalents of $31,200,000 We estimate that our existing cash and cash equivalents, together with the remaining $23,800,000 in earned and non contingent development milestone payments received from GSK in August 2025 will be sufficient to fund the company's current operating and capital expenditures into 2028. As I mentioned during the first part of the call, we achieved meaningful cost savings as the PIVOT PO trial met the primary endpoint following the pre specified interim analysis with fewer enrolled patients than originally planned. These trial cost offsets are the primary driver of our extended runway. Total revenue for the 2025 was $14,200,000 compared with total revenue of $10,200,000 for the 2024.

Speaker 2

The revenue increase compared with the prior year period was primarily due to collaboration revenue from GSK. R and D expenses for the 2025 were $10,700,000 compared to twenty three point seven million dollars for the same period in 2024. The decrease in R and D expenses year over year was primarily due to reduced clinical expense related to the PIVOT PO study. G and A expenses for the 2025 were 5,900,000 compared to $5,500,000 for the same period in 2024. This increase compared with the prior year period was primarily due to increased personnel and professional services expenses.

Speaker 2

The company reported a net loss of $1,700,000 for the 2025 compared with a net loss of $17,900,000 for the 2024. Diluted net loss per share of common stock was $0.03 and $0.33 for these periods respectively. For further details on our financials, please refer to our 10 Q filed with the SEC this evening. Before opening the call for questions, I want to reiterate how excited we are about the positive PIVOT PO result. We believe that tebipenem HBr is now one step closer to being the first commercial product to emerge from Sparrow's pipeline with the potential to meaningfully improve the standard of care for patients with CUTI.

Speaker 2

I want to take this opportunity to thank the patients and investigators who participated in our clinical program, our partner GSK for their ongoing commitment to fulfill unmet medical needs within the anti infective therapeutic area, and my colleagues here at Spero for their hard work and dedication to improve patient outcomes. With that, we will now open the call for questions. Operator?

Operator

Thank you. We will now begin the question and answer session. Star then one on your touch tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2.

Operator

First question comes from Gavin Clark with Evercore. Please go ahead.

Speaker 4

Yeah. Hi. This is Gautam on for Gavin. Thanks for taking our question. So we have one question on the capital allocation.

Speaker 4

How are you thinking in terms of, you know, capital would be would you be focusing on BD or would go to more pipeline? Any guidance there would be helpful.

Speaker 2

Sure. Thanks for the question. So, you know, our primary objective is to make sure that PEDI gets to the regulatory process and gets to approval because that would be the real value driver going forward. So our runway currently considers funding, making sure that we're well funded to get that to the finish line. Following that, we would make decisions on what happens with the capital once we have line of sight into approval.

Speaker 4

Got it. Thank you.

Operator

Thank you. To ask a question, you may press star and 1. Again, if you have a question, please press star then 1. Thank you. This concludes our question and answer session.

Operator

I would like to turn back the conference over to the management for closing remarks.

Speaker 2

Thank you everyone for joining the call. We will talk to you soon.

Operator

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Thank

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