Spero Therapeutics, Inc.

good afternoon and welcome to the sparrow therapeutics first quarter 2023 financial results conference call at this time all participants are in listen-only mode following the company's formal remarks we will open up the call for questions to join the question queue please press star then one please be advised that this call is being recorded and 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 Ted Jenkins, Vice President, Investor Relations and Strategic Finance at Sparrow Therapeutics. Mr. Jenkins, 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 pipeline update for the first quarter of 2023. Our press release is available on the investor page of the Sparrow Therapeutics website. Before we begin, I'd like to remind you that some of the information presented on this conference call contains four different statements based on our current expectations, including statements about the future development and commercialization of SPR-720, SPR-206, and 7010-HBR, the design, initiation, timing, progress, and results of the company's preclinical studies and clinical trials and its research and development programs, management's assessment of the results of such preclinical studies and clinical trials, the company's cash forecast and anticipated expenses, and the sufficiency of its cash resources. Such forward-looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in such statements. Several factors that could cause or contribute to such differences are described in detail in Sparrow Therapeutics' filings with the SEC, including in the risk factor section of our quarterly report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC today. These forward-looking statements speak only as of the date of this conference call, and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the company at the date of today's call. With that, I'd like to turn the call over to Sparrow Chief Executive Officer, Dr. Ankit Mahadevia. Please go ahead, Ankit.

Thanks, Ted, and thanks to all who are listening. We continue to make strong progress across each of our three late-stage clinical programs last quarter and believe we have the key components in place to sustainably create value through the advancement of our pipeline. These components include an experienced and talented management team, premier partners across our industry and government, a strong balance sheet, and differentiated investigational medicines designed to address clear medical needs, and indications with strong commercial prospects. We outlined our clinical programs in detail only six weeks ago on our last earnings call. Given this, we will keep our prepared remarks today brief. After the prepared remarks, we'll move on to a Q&A session with myself, our Chief Financial Officer, South Shukla, and our Chief Medical Officer, Dr. Kamal Hamid. Let me start by discussing our LEAD-SPR 720 program, which aims to deliver the first novel oral treatment for nontuberculous mycobacterial disease, or NTMPD for short, serving first-line patients. I'm pleased to report that the program continues to advance according to plan. Our Phase II proof-of-concept trial is enrolling with more than 15 active sites currently and top-line data anticipated in the first half of 2024. A key goal of the trial is to show SPR720 driving an early microbiological response as a standalone agent versus placebo. with the primary endpoint evaluating changes in bacterial load and sputum samples from baseline. We believe pairing a positive result on this primary endpoint with supportive evidence and learning from the trial's secondary endpoints will enable us to substantially de-risk the program and move confidently into late-stage development. In late-stage development, we plan to evaluate SPR720 as part of a combination regimen. Given the limitations of the off-label combinations that are currently standard of care and first-line NTMPD, we believe our program has the potential to address a clear unmet need. Alongside the progress of our Phase II trial, we remain on track with the entire SPR 720 program as we perform additional development activities needed to support 720's advancement towards pivotal late-stage studies. As noted on our last earnings call, these activities include ongoing toxicology work, CMC and quality initiatives, engagement with FDA, and efforts to expand the 720 development program into Japan, where NTMPD has a sharply increased prevalence relative to other territories. In addition, we continue to execute on the steps needed to develop and validate relevant patient-reported outcomes for NTMPD. This is to ensure that our primary efficacy endpoints within our future clinical studies are conducted in line with the FDA's published guidance on developing drugs for the syndication. Next, I'll speak briefly about tebipenem-HPR, which is partnered with GSK and being developed as potentially the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections, or CUTI. We remain engaged with the FDA regarding a special, potential special protocol assessment agreement for a planned Phase III trial. Per a Type A meeting with the FDA conducted last year, positive results from this planned trial, together with confirmatory non-clinical evidence of efficacy, could be sufficient to support Debbie Penham HBR's approval. We would like to thank the FDA for its constructive engagement and expect to provide an update on the status of the Special Protocol Assessment Agreement by mid-year 2023. At that time, we also intend to outline the details of the planned Phase III trials design and the specific regulatory and development activities that may trigger milestones from our GSK agreement. To conclude my section of today's call, I'll very briefly touch on SPR206, which is an investigational next-generation polymixin antibiotic being developed to treat multidrug-resistant gram-negative infections. Efforts to advance SPR206 into a phase three trial in participants with hospital-acquired or ventilator-associated bacterial pneumonia are proceeding in line with prior guidance with submission of an IND application expected in the fourth quarter of the year. I'll remind those listening that the planned Phase II trial will be funded entirely by external non-dilutive sources, highlighting the capital-efficient approach being employed to advance our pipeline. With that, I'll turn over the call to Saf to review our quarterly financial results. Saf?