Spero Therapeutics, Inc.

for questions. Please be advised that this call is being recorded and a replay will be available. You can find information on the replay and further information related to today's announcements on the Sparrow Therapeutics website at www.sparrotherapeutics.com. At this time, I would like to turn the call over to Shai Biran, Senior Director, Investor Relations. Mr. Biran, 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 2024. The 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 under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our actual clinical program, future results, progress, timing, performances, or achievements to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties associated with our business and factors that could cause or contribute to such differences are described in detail in sterile therapeutic filings with the SEC, including in the risk factor section of its earnings report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC today. We also ask that you reference the cautionary statement or forward-looking statement included with the slide presentation accompanying this conference call. Participating in today's call are Saab Shukla, Chief Executive Officer, and Esther Rajavelu, Chief Financial Officer and Chief Business Officer. Seth Shukla will begin the discussion. Please go ahead, Seth.

Thank you, Shai. Good afternoon, everyone, and thank you for joining our conference call today. I am pleased to provide an update on the ongoing progress across our portfolio of clinical stage assets. Before that, I would like to note a change in our executive leadership team with the departure of our chief medical officer, Dr. Kamal Hamed. On behalf of the board, management, and all of our employees, we thank Dr. Hamed for his many contributions to Sparrow and wish him every success for the future. We are pleased to announce that Dr. John Portage, a distinguished industry veteran in our field and a member of Sparrow's board for the last six years, will help oversee and provide strategic guidance for our clinical programs during this transitionary period while we continue the search for our next chief medical officer. Moving to our clinical pipeline, let me begin with SPR 720, which we are developing as a first-line oral agent for non-tubicolous mycobacterial pulmonary disease, or NTMPD. NTMPG has an estimated patient population of 245,000 patients in the U.S., EU, and Japan, with approximately 95,000 of those patients in the U.S. There is currently no approved first-line therapy for these patients. The current guidelines recommend off-label TB drugs, which have a history of lack of efficacy as well as serious tolerability issues. SPR-720 has a novel mechanism of action that is different from other standard of care agents, as well as those in development for NTMPD. Sparrow has conducted extensive in vitro and in vivo studies, which have shown no evidence of cross-resistance against marketed antibiotics, as well as a low propensity for selection of resistance. Further, we have demonstrated SPR720 to be potent against multiple NTM pathogens. Overall, we believe the preclinical data supports SPR720's potential for therapeutic benefit. In Q4, we expect to share a comprehensive data set from our ongoing and recently completed clinical studies, which is anticipated to include data from the phase to a proof-of-concept study in treatment-naive and treatment-experienced non-refractory patients. We will also report data from two supportive Phase I studies in healthy volunteers, one of which assesses SPR720 exposure in lung as monotherapy, and the second of which assesses exposure in plasma when co-administered with standard of care agents, azithromycin and ethambutol. In Phase 2, a clinical trial comprised two doses of SPR-720, 500 megs and 1,000 megs, administered as monotherapy versus placebo in patients with NTMPD due to M-abium complex, or MAC. We have enrolled a total of 25 patients, including both treatment-naive and treatment-experienced patients who do not have treatment refractory disease. It is our hope that the data from this study will indicate that SPR720 as a monotherapy can decrease the NTM bacterial load over the treatment course of 56 days. To analyze this early bactericidal activity, we are measuring changes in bacterial loads in patient's escutcheon, including the rate of change in locked and colony-forming units per milliliter, which is our primary endpoint in these studies. We are also looking at the rate of change in time to positivity, which is a key secondary endpoint in the study. A clear numerical difference in these measures between the treated arms and placebo could indicate that SPR720 has a potential therapeutic effect in patients with NGMPD. We anticipate that success on these endpoints would also make SPR720 the only oral agent in development that we are aware of to demonstrate early bactericidal activity in patients with NTMPD due to MAC, and which enable us to move confidently into late-stage development. Ultimately, we believe that SPR-720 could be used as part of combination treatment regimens, and if the ongoing surgery confirms our expectations that the drug has monotherapy activity, we anticipate the future registration-enabling studies to be designed to include standard-of-care agents. Complementing the Phase IIa data, as previously mentioned, we will also share data from two Phase I studies and healthy volunteers. The first study used a bronchoalveolar lavage, or BAL, to examine intrapulmonary pharmacokinetics of SPR719, the active moiety of the prodrug SPR720. We expect to share PK measures showing the extent of exposures in the lungs, that is, the site of infection. The second study evaluates changes in plasma PK. The SPR720 is co-administered with azithromycin and ethambutol. We anticipate this data to be informative when selecting doses in future combination studies. Lastly, we recently completed an in vitro resistance study of SPR719 in combination with standard of care agents and anticipate sharing these data at ID Week in October. The team is excited about this upcoming data readout in Q4. These studies are expected to provide us with a robust data set that we will use to determine the registrational path for SPR720 as first-line oral treatment for NTM-PT. Turning now to tebupenem-HVR, which we are developing as the first potential oral carbapenem antibiotic for the treatment of complicated urinary tract infections, or CUTI. Enrollment in our ongoing Phase III Global PIVX-PO clinical trial is on track, and we are pleased with the progress made since the beginning of the year. Our goal remains to complete enrollment in the second half of 2025. Patients are randomized one-to-one in this pivotal Phase III clinical trial to receive teripenem HBR 600 megs orally every six hours, or inipenem filastatin 500 megs intravenously every six hours, for a total of seven to 10 days. Target enrollment is approximately 2,648 patients. The primary efficacy endpoint is overall response, which is a composite of clinical and microbiological response and the test of cure visit. The primary analysis for the trial will be an assessment of non-inferiority in the microbiological intent to treat population based on a 10% non-inferiority margin. As a reminder, Terrapenem HVR is partnered with GSK. We are responsible for the execution of the ongoing Phase III trial, and GSK is responsible for ex-U.S. development and worldwide commercialization, excluding certain rights in Asian territories held by another partner, Meiji Seika. COTR infections are a leading cause of hospitalization in the U.S. The incidence is estimated to be over 3 million cases per year, which translates into a significant burden on the healthcare system. Geripenem-HVR is, to our knowledge, the only oral carbapenem in development. If approved, it could address the need for an oral carbapenem in patients with complicated urinary tract infections caused by multidrug-resistant uropathogens, potentially eliminating the need for hospitalization or reducing length of stay with transitions from intravenous to oral carbapenem therapy. Finally, wrapping up with SPR206. SPR206 is an innovative, investigational, intravenously administered direct-acting polymyxin partnered with Pfizer for European markets. We announced that in the first quarter of this year, the FDA cleared the ING to advance SPR206 into a Phase II clinical trial in patients the hospital acquired or ventilator-associated bacterial pneumonia, and that the FDA also awarded SPR-206 fast-track designation. As a reminder, we plan to initiate a phase 2 study contingent on availability of non-dilutive funding. With that, I'll turn the call over to Esther to review our quarterly financial results.