Spero Therapeutics, Inc.

Good afternoon and welcome to the Spiro Therapeutics second quarter 2026 earnings conference call. Please be advised that this call is being recorded and a replay will be available. You can find the information on the replay and further information related to today's announcement on the Spiro Therapeutics website at spirotx.com. At this time, I would like to turn the call over to Shai Biren, Head of Investor Relations. Mr. Biren, please go ahead.

Thank you, operator, and thank you all for participating in today's conference call. This afternoon, Sparrow Therapeutics released financial results and provided a business update for the second quarter of 2026. A press release is available on the investor page of the Sparrow 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 within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. These forward-looking statements are based on Sparrow's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties associated with our business and factors that could cause or contribute to such differences are described in Sparrow's filings with the Securities and Exchange Commission, including in the Risk Factors section of the earnings report on Form 10Q for the quarter ended June 30, 2026, filed today. Leading the call today are Esther Rajavelu, our President and Chief Executive Officer, and Dr. Deborah Zak, our Chief Medical Officer. There will be a Q&A session following the prepared remarks. I will now turn the call over to Esther to begin.

Thank you, Shai. Good afternoon, everyone, and thank you for joining us on our second quarter earnings and business update call. I will begin with key highlights from the quarter, outline our strategy and priorities going forward, and then review our financial results. In the last 90 days, we had four major milestones. The FDA approved UTEP-Z, the first and only oral carbapenem for the treatment of complicated urinary tract infections, including pyelonephritis, which we developed with our licensing partner, GSK. We in-licensed SP-001 and repositioned the company's pipeline to focus on immune-mediated diseases. We closed $105 million non-dilutive, non-recourse financing. and we hired a chief medical officer. Let me start with the last one by welcoming Dr. Deborah Zak to the Sparrow team as our CMO. Deb is a board certified rheumatologist with a PhD in immunology and extensive drug development experience spanning research, clinical development and medical affairs. She brings more than 25 years of leadership in developing therapeutics for immune mediated diseases most recently as CMO at Exogen and before that in clinical leadership roles at Amgen, Zencore, and Novartis. She officially joined Sparrow as CMO on August 3rd to lead our clinical development strategy as we advance SP001 into the clinic. Deb, welcome. We are so glad you're here and look forward to your comments on SP001 later during this call. Let me now turn to the quarter. On June 17th, the FDA-approved eutepsi are tebic infections, including pyelonephritis, caused by certain susceptible pathogens in patients who have limited or no alternative oral treatments. It is the first and only oral carbapenem antibiotic approved in the United States. The approval was based on PIVOT-PL, the Phase 3 study we ran under our license agreement with GSK. The study was stopped early for efficacy in May 2025. GSK holds exclusive commercialization rights worldwide, excluding certain Asian territories where Meiji retains rights. CSK expects Utebsi to be available to U.S. patients in the second half of this year. Following more than a decade of commitment and work by the Sparrow team to progress this asset through the clinic, Utebsi's approval provided the company an opportunity to pursue other growth prospects in immunological diseases with high unmet medical need. which brings me to our announcements in July. On July 8th, we announced an exclusive license agreement with Innovent Biologics for SP-001, also known as IBI-355, for an estimated $1.1 billion in total contingent deal value. Separately, on July 8th, We also announced $105 million non-dilutive, non-recourse royalty financing with affiliates of healthcare royalty, a business of KKR. Let me begin with our newly in-licensed asset, FP001. Our agreement with InnoVid provides us with exclusive worldwide rights, excluding Greater China, to develop and commercialize FP001 for all indications. Innovant Retains Rights in Greater China. SP-001 is a third-generation, fully humanized, fe-silent IgG1 monoclonal antibody targeting CD40 ligand. In the clinic, SP-001 completed two Phase I studies in healthy volunteers, including a single ascending dose and a multiple ascending dose study. as well as a phase 1b multiple ascending dose study in primary Sjogren's disease. Data from the Sjogren's disease trial were presented in a poster at the ULAR Congress in June this year. We intend to advance SP001 in immunoglobulin G4 related disease or IgG4RD with a phase 2 trial expected to begin in the second quarter of 2027. In parallel, we will also evaluate additional development opportunities to potentially expand the FP001 value proposition. Dr. Zak will cover details on the drug, the CD40 ligand mechanism, and our development plan in IgG4RD. Moving on to our financing. We closed $105 million non-dilutive, non-recourse royalty financing with healthcare royalty. The structure of the financing, which is also discussed in our 10-Q filed today and our 8-K filed on July 8th, is as follows. A special purpose subsidiary issued $105 million in senior secured notes. The notes carry a 10% annual interest rate and a nine-year maturity. Principal and interest are payable quarterly and are derived solely from the milestone and royalty payments GSK owes us on UTEPSE. After the notes are repaid, Sparrow retains 35% of additional GSK milestone and royalty proceeds. Let me take a moment to emphasize that the notes are non-recourse to Sparrow and our other assets are not exposed to UTEPsy launch or sales risk. This transaction further strengthened our balance sheet and provided non-dilutive capital as we embark on an immunology focused strategy. By unlocking immediate value from a portion of future UTEPsy milestone and royalty streams, we are well positioned to execute on the clinical development for FP001. Following the transaction, We updated our cash runway guidance into the second half of 2029. Sparrow was founded with the strategy of in-licensing promising clinical stage assets and with an experienced and focused team advancing those programs through clinical development to commercialization. Following these transactions, we believe we continue to be well-positioned to execute on our business strategy. I will now turn the call over to Deb to provide an overview of SP001 CD40 ligand as a target and our development plan for IgG4RD.