Spero Therapeutics, Inc.

Good afternoon and welcome to the Sparrow Therapeutics third quarter 2023 financial results conference call. At this time, all participants are in a listen-only mode. Following the company's formal remarks, we will open the call 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 sparrowtherapeutics.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 third 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 forward-looking statements based on our current expectations, including statements about the future development and commercialization of Teddy Penham HBR, SPR 720, SPR 206, and 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 factors section of our quarterly report on Form 10Q for the quarter ended September 30, 2023, filed with the SEC today. These forward-looking statements speak only as of the date of this conference call, November 13, 2023. The company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the company after the date of today's call. Participating in today's call are Seth Shukla, President and Chief Executive Officer, Dr. Kamal Hamed, our Chief Medical Officer, Steve DePalma, our Interim CFO and Treasurer, and although not having a speaking part today, I would also like to welcome a special guest in attendance, Ms. Esther Rajuvalu, Sparrow's new Chief Financial Officer and Chief Business Officer. With that, I'd like to turn the call over to Sparrow's Chief Executive Officer, Seth Shukla. Please go ahead, Seth.

Thanks, Ted, and I thank you all for joining us this afternoon. 2023 has been a year of progress and execution for Sparrow. There are a number of achievements across clinical, regulatory, and financial-related fronts. Each of our late-stage assets is moving forward. We have an experienced management team in place and a strong balance sheet positioning us well to deliver on our mission to develop differentiated medicines for patients with rare orphan diseases, and serious multidrug-resistant bacterial infections. Let me begin with teripenem HVR, which we have partnered with GSK and which we are developing as potentially the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections, or CUTI. We were very pleased to announce on July 31st that we had received written agreement from the US FDA under a special protocol assessment, or SPA, on the design and size of our planned phase three trial, PIVH-PO. And SPA typically represents a very high level of concordance on the overall protocol design between the FDA and a sponsor. So we believe the regulatory aspect with respect to the design of the program had been de-risked substantially. Enrollment in PIVH-PO that first patient first visit is expected to begin in the current quarter. Kamal will touch on additional details in a few minutes. We also received a $30 million cash payment from GSK during the quarter in consideration for qualification of an additional development milestone as per our GSK agreement. In addition to this payment, we are also eligible to receive the following additional milestone or royalty payments under our agreement. These comprise of up to 120 million in remaining development milestones, up to 150 million in potential commercial milestones based on first commercial sales, up to 225 million in potential sales-based milestones, and low single-digit to low double-digit tiered royalties if sales exceed $1 billion on net product sales of Tewi Penem HBR in all territories except Japan and certain other Asian countries. Overall, we are very excited by our partnership with GSK. In addition to progress on Tewi Penem HBR, we continue to move our other assets forward. The Phase 2A proof-of-concept clinical trial for SPR720 continues patient enrollment and dosing, with 26 sites having been initiated. SPR206, our investigational next-generation polymixer, continues to be on track for a Phase 2 IND in this current quarter, funded by grant and other non-dilutive funding. As a recap for the management changes that came into effect on August 1, which were described on our last quarterly call, I was proud to take on the role of the company's president and CEO on that date, and my predecessor and co-founder of Sparrow, Dr. Ankit Mahadevia, transitioned to become chairman of the board of directors. The prior chairman, Dr. Milan Deshpande, has remained on the board as an independent director, and another board member, Dr. Patrick Wink, was appointed lead director. I would also like to highlight the recent appointment of Esther Rajuelu as chief financial officer and chief business officer, effective last week, November 6th. Esther has a strong track record in corporate finance from both industry and Wall Street and brings expertise in growth strategy, investor relations, financing, and M&A. We are very excited to have her join the team, and I would like to formally welcome her to Sparrow. I also want to take this opportunity to thank Steve DePalma, who has served as our interim CFO and treasurer during our recent management transition. I would now like to hand the call over to Dr. Kamal Hamed, who will provide more details on the clinical programs.