Spero Therapeutics, Inc.

Good afternoon and welcome to Spiral Therapeutics fourth quarter and year end 2022 financial results conference call. At this time all participants are in a listen-only mode. Following the company's formal remarks we will open up the call for questions. Please be advised that this call is being recorded and the replay will be available. You can find information on the replay and further information related to today's announcement on the Spiral Therapeutics website at www.SpiralTherapeutics.com. At this time, I would like to turn the call over to Ted Jenkins, Vice President, Investor Relations and Strategic Finance at Spiral 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 fourth quarter and full year 2022. 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 SPR 720, SPR 206, and Tebby Penham HBR, and the design, initiation, timing, progress, and results of the company's preclinical studies and clinical trials and its research and developmental 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 annual report on Form 10-K for the year ended December 31, 2022, 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 after the date of today's call. Participating in today's call are Dr. Ankit Mahadevia, Chief Executive Officer, Dr. Kamal Hamad, Chief Medical Officer, and Seth Shukla, Chief Financial Officer. And with that, I'd like to turn the call over to Dr. Ankit Mahadevia. Please go ahead, Ankit.

Thanks, Ted, and thanks to everyone listening. Spare us off to a strong 2023, thanks to recent achievements that have provided us with a strong balance sheet and world-class partners to support the advancement of our multi-program pipeline of differentiated medicines. We remain committed to developing a pipeline of medicines that marry unmet need with high commercial potential, and we continue to do so while placing a premium on capital efficiency and complementing our efforts with those of our partners in pharma and in public agencies. Kamal will be providing an update on SPR 720 and SPR 206. So I'll focus my part of the call on Tebby Penham HBR, which we are developing as potentially the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections, or CUTI. As a reminder, Tebepenem HBR is the subject of an exclusive license agreement with GSK, which closed last quarter. This agreement came with a $66 million upfront payment to us, as well as a $9 million equity investment in our common stock, both of which have now been received. In addition, we are eligible for up to $525 million in development, sales, and milestone payments, as well as single-digit to low double-digit royalties on net product sales. In exchange for all this, GSK was granted an exclusive license for Tebby Penham HBR's development and commercialization in all territories except Japan and certain other Asian countries, where rights are being retained by our partner, Meiji Seika. Per the agreement, we hold responsibility for an upcoming Phase III trial of tepipenem-HBR, while GSK will be responsible for additional development and commercialization activities outside of the Meiji-Seika territory. We're engaged with the FDA on the planned protocol for tepipenem-HBR's upcoming clinical trial. As you may recall, we had a Type A meeting with the agency in 2022, during which we aligned on high-level aspects of the trial design and received feedback indicating that positive results from the trial, together with confirmatory non-clinical evidence of efficacy, could be sufficient to support Tebby Penham's approval in CUTI, including pyelonephritis for a limited-use indication. We still anticipate providing an update on our engagement with the FDA in the first half of this year. This update will include details of the clinical trial design, as well as granularity on the specific regulatory and development activities over the coming months that will trigger milestone payments from our GSK partnership. We'll continue to anticipate initiating the Phase 3 trial in the second half of 2023, and if all goes well with the program, we believe Tebby Penham HBR could reach commercialization by 2026, as noted by GSK on their earnings call last month. I'd like to thank GSK for their role in what's been a very productive partnership to date. As we work to advance tebupenem-HBR through the regulatory process and complete the Phase 3 trial, it's the program's strong foundation that fuels our enthusiasm. This foundation consists of three key pillars. The first of these pillars is the extensive dataset supporting tebupenem's safety and efficacy. Between our work and that of Meiji Seika, tebupenem has been evaluated in 24 clinical trials that have been collectively enrolled over 2,500 subjects. These are highlighted by our double-blind, placebo-controlled Phase 3 trial, ADAPT-TO. Moreover, post-marketing surveillance efforts on tepipenem in Japan, where it's approved for pneumonia, otitis media, and sinusitis, have demonstrated its efficacy while noting no safety issues in a review of more than 3,300 patients. The second key pillar of Tepipenem's foundation is its potential to address a clear and pressing unmet need. There are currently no oral carbapenem antibiotics available for millions of CUTI patients in the U.S., many of whom have no other option other than to receive an IV therapy in a hospital setting. By successfully developing tebupenem, we believe we can provide these patients with an at-home oral treatment that could provide health and economic benefits for them, while also improving costs for the healthcare system. The last key pillar making up tebupenem's foundation for success comes from the support of our partners. We believe GSK is the ideal partner to lead tebupenem's commercialization, if approved, given its well-established commercial organization and commitment to serving patients with infection, including urinary tract infections. We're also grateful for the continued support of BARDA for the advancement of tebupenem. With that, I'll turn the call over to Kamal to discuss SPR 720 and SPR 206.