Spero Therapeutics, Inc.

Good afternoon and welcome to the Spiro Therapeutics second quarter 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 a replay will be available. You can find information on the replay and further information related to today's announcements on the Spiro Therapeutics website. at www.spirotherapeutics.com. At this time, I would like to turn the call over to Ted Jenkins, Vice President, Investor Relations and Strijic Finance at Spiro Therapeutics. Mr. Jenkins, please go ahead.

Thank you, Operator, and thank you all for participating in today's conference call. This afternoon, Spiro Therapeutics released financial results and provided a pipeline update for the second quarter of 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 contained in the news release and on this conference call contains forward-looking statements based on our current expectations, including statements about the potential review, status, and prospects of approval for Tebupenem HBR and the timing era, potential value of Tebupenem HBR if approved, and the prospects of partnership or other opportunities for the Tebupenem HBR program, the plans for the company's ongoing development of SPR 720 and SPR 206, The design, initiation, timing, progress, and the results of the company's preclinical studies and the 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 Spiro Therapeutics' filings with the SEC, including in the risk factors section of our annual report on Form 10-Q filed 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 release and call. Participating in today's call are Dr. Ankit Mahadevia, Chief Executive Officer, Seth Shukla, Chief Financial Officer, and Dr. David Melnick, Consultant and Senior Clinical Advisor. With that, I'd like to turn the call over to Dr. Ankit Mahadevia. Please go ahead, Ankit.

Thank you, Ted, and good afternoon to everyone listening to our call today. Those who have followed Sparrow over the past few months know about the company's decision during the second quarter to restructure and pursue a new strategic direction with SBR 720 as our lead asset and TepiPenem HBR and SPR 206 as our designated partnership directed programs. We made this decision promptly following our FDA late cycle meeting during which the agency suggested the data from Sparrow's new drug application Seeking approval for tebupenem HBR for the treatment of complicated urinary tract infections would likely be insufficient to support approval during the first review cycle. A subsequent complete response letter confirmed that this was the FDA's view while also indicating additional clinical study would be required to support an approval. While ceasing tebupenem's commercial activities and restructuring was difficult, our swift decision to do so almost immediately after the late cycle meeting set us on a path that leaves us well positioned for future growth. We have strong data that clearly differentiates our three clinical stage assets, cash runway that takes us through key clinical milestones, and world-class partners to help us advance these assets. We have made progress this quarter against our core objectives to foster this growth. First, we continue to progress toward key clinical and regulatory milestones in our pipeline within our capital runway. And David will speak further about our progress on both the SPR 720 and 206. Second, we have requested and completed a Type A meeting with the FDA to gain further insights as to the pathway forward towards a potential regulatory approval for Debbie Penham HBR. We believe the meeting was constructive, and we expect to receive written minutes during the third quarter of 2022. Finally, we continue to employ good stewardship of capital and continue to seek kinds of creative partnerships that have been a hallmark of our history. With that in as an introduction, I'd like to give a brief overview of today's call. I'll begin with additional commentary on Tebby Penham HBR. Following that, Dr. David Melnick, our senior clinical advisor, will provide an update on our progress advancing SPR 720 and SPR 206. Finally, our chief financial officer, South Shikla, will then close with a discussion of our current financials and cash runway, and then we'll follow up with Q&A. So let's shift gears briefly to Tebby Penham. The core components of Tebby Penham's value proposition have not changed. There remain millions of patients with complicated urinary tract infections who would benefit from an oral therapy that could replace IV treatments and allow them to potentially return home from the hospital sooner or possibly avoid hospitalization altogether. There's substantial economic incentives for healthcare providers and payers to treat patients out of the hospital. And tebupenem continues to have intellectual property protection extending into at least 2038. Additionally, tebupenem's potential to solve the challenges posed by the increasing prevalence of fluoroquinolone-resistant and ESBL-producing gram-negative bacteria has been thoroughly demonstrated by data from dozens of clinical studies, as well as surveillance efforts in Japan, where it has been marketed for over a decade. These data have been thoroughly vetted by leading experts and the peer review process of prestigious journals, including the New England Journal of Medicine, which published the results of the Phase III ADAPT-PO trial in the second quarter. Accordingly, a key objective for us this quarter was clarifying the outstanding requirements for potential regulatory approval through continued engagement with the FDA. As I mentioned earlier, we've completed our Type A meeting, which we believe was constructive. Upon receipt of the Type A meeting minutes that will confirm our discussion, we plan to advance additional Phase III clinical development and eventual commercialization through external partnership. We believe gaining clarity on the requirements for type dependence approval will leave us well positioned as we seek to work with existing and potentially new partners to chart its best course forward. We believe that this will allow us to work towards unlocking type dependence value in a capital efficient manner that provides a runway through key anticipated milestones across our pipeline. Our strong track record of establishing partnerships with premier organizations adds to our optimism on WDM's outlook, and we look forward to this program's continued advancement. With that, let's shift gears to 720 and 206, and I'll hand the call to David. David?