Spero Therapeutics, Inc.

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 second 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 WPEN-MHBR, SBR 720, SBR 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 factor section of our quarterly report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC today. These forward-looking statements speak only as 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. 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. This is my first earnings call since becoming the company's President and CEO on August 1st. I want to say how excited and honored I am to take on this role at a very exciting time for Sparrow. Each of our three late-stage clinical programs is making excellent progress. I am pleased to be working with such an experienced and talented management team who share a vision to advance a pipeline of differentiated investigational medicines that are designed to address important unmet needs in infectious disease. I believe that together we have a great opportunity create value for patients and stakeholders in the company. Joining me on the call today are Dr. Kamal Hamed, our Chief Medical Officer, and Steve Dipama, our Interim CFO and Treasurer. Let me begin with Tevipenem HBR, which is partnered with GSK and which we are developing as potentially the first oral carbapenem antibiotic for treatment of complicated urinary tract infections, or CUTI. As we have discussed previously, we have been engaged with the FDA to agree on a path forward for this investigational drug, and we were very pleased to announce on July 31st that we received written agreement from the agency under a special protocol assessment, or SBA, on the design and size of our planned phase three trial. We see the SBA agreement as a major milestone in the terbipenem HVR program. As a SPA typically represents a very high level of concordance on the overall protocol design between the FDA and a sponsor, we believe the regulatory aspects with respect to the design of the program have been de-risked substantially. We expect to begin enrollment and pivot PO in the fourth quarter of this year, and Kamal will provide further details in a few minutes. Under the terms of our exclusive license agreement with GSK, we are now entitled to receive the first $30 million of up to $150 million of development milestones. This first payment has been invoiced and is expected to be received in the current quarter. In addition to this payment, we are also eligible to receive the following additional milestone royalty payments under the GSK agreement. These comprise of Up to $120 million in development milestones as the phase three trial progresses. Up to $150 million in potential commercial milestones based on first commercial sales. Up to $225 million in potential sales sales milestones and low single digit to low double digit tiered royalties if sales exceed $1 billion. On net product sales of teripenem HVR in all territories, except Japan and certain other Asian countries. In addition to progress on teripenem HVR, we continue to move our other assets forward. The Phase 2A proof-of-concept clinical trial for SPR720 continues enrollment, with sites open and patients enrolling and being dosed. Our investigation on Next Generation Polymexin continues to be on track for a Phase II ING in the fourth quarter of this year, funded by grant and other non-dilutive funding. On an organizational note, I want to spend a minute talking about the management changes we announced in June and that came into effect on August 1st. On that date, following a three-year tenure as Sparrow CFO, I took on the role of the company's president and CEO. My predecessor, Dr. Ankit Mahadevia, who is a co-founder of Sparrow, transitioned to become chairman of the board of directors. The prior chairman, Dr. Milind Deshpande, is remaining on the board as an independent director, and another board member, Dr. Patrick Wing, was appointed lead director. The net result here is that while some members of the executive team and the board have changed roles, the company has retained all of its officers or directors in these transitions. On behalf of my fellow directors and the management team, I want to thank Ankit for his contributions and leadership in getting Sparrow to this advanced stage, and we all look forward to continuing to work with him in his new role. Separately, we have launched a search for a permanent CFO. Until this process is completed, the board has appointed Steve DePalma as interim CFO and treasurer, who worked with Sparrow in the same capacity before I joined the company and who also is an experienced public company CFO. I would now like to hand the call over to Dr. Kamal Ahmed, who will provide more details on the clinical programs.