Spero Therapeutics, Inc.

Good afternoon and welcome to the Spiro Therapeutics first quarter of 2022 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. 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 announcement on the Spiro Therapeutics website at www.spirotherapeutics.com. At this time, I would like to turn the conference over to Mr. Ted Jenkins, Vice President, Industrial Relations 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 first 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 Tevipenem HBR and the timing thereof, potential value of Tevipenem HBR, if approved, and the prospects of partnership and or other opportunities for the Tevipenem HBR program, the plans for the company's ongoing development of SBR 720 and SBR 206, The design, initiation, timing, progress, and 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 Sparrow Theoretics' filings with the SEC, including in the risk factor section of our annual report on Form 10-K, filed on March 31, 2022. 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, Dr. David Melnick, Chief Medical Officer, and Sat Shukla, our Chief Financial Officer. And with that, I'd like to turn the call over to Dr. Ankit Mahadevia. Please go ahead, Ankit.

Thank you, Ted, and thanks to all who have joined us for our earnings call today. As many of you know, we recently hosted an update call to discuss our new strategic direction and decision to restructure the company. As difficult as that was, we are pleased to be sharing our path forward with you today. To recap our recent news, feedback from an FDA late cycle meeting, which took place at the end of April, suggested the data from tebupenem-HPR's new drug application may be insufficient to support approval during this review cycle. This led us to make the extremely difficult decision of having to suspend commercial notation activities for tebupenem-HPR and reduce our workforce by approximately 75%. While we wait for agency guidance on the path forward for tebupenem-HBR, we have shifted our focus and resources to development activities for each program in our pipeline. For those interested in hearing about the specifics behind FDA's view of the tebupenem-HBR NDA, I suggest you listen to the replay of our May 3rd conference call, which is available on our website. The primary purpose of today's call is to discuss how Sparrow is positioned for the future in our efforts to bring medicine to patients with unmet needs. We have three key objectives to create value, which drive our optimism. First is to achieve key clinical and regulatory milestones in our pipeline within our capital runway. Second is to clarify and execute on the path forward for Tevye Penham, including through potential collaborations. And finally is to execute on those milestones, employing good stewardship capital and the creative partnerships to build a company, which have been a hallmark of our history. Our first objective is to execute on our late stage pipeline, which includes two phase two ready assets beyond Tevipenem, namely SPR 720 and SPR 206. This ensures the company's outlook is not tied to any single event and positions us to achieve important clinical and regulatory milestones with a regular cadence. In this endeavor, we are supported by established partnerships with premier organizations, including Pfizer, Everest Medicine, the Department of Defense, and the National Institute of Allergies and Infectious Disease. These relationships have enabled us to work with some of the world's most established thought leaders in the antibiotic space, as well as providing avenues for additional funding. For example, our relationships are allowing us to entirely fund the SPR206 program through Phase 2 from external non-dilutive sources. This, in turn, has helped us provide us with a cash runway that is expected to take us through multiple potential inflection points including interim data from SPR 720's Phase 2 program in 2023. David will speak more about these deliverables during his portion of the call. Our second objective is to build a path forward for Tebby Penham. It's important to note that our view of Tebby Penham HBR's value proposition has not changed. Tebby Penham HBR has patent life extending into at least 2038. It's been granted Qualified Infectious Disease Product, or QIDP, status that confers 10 years of market exclusivity and has a robust clinical data set of support. This data set extends far beyond even the clinical studies carried out by Sparrow, as a granular formulation of tebupenem has been approved and marketed in Japan by our partner, Meiji Seika, for over 10 years. In total, over a dozen studies evaluating tebupenem's efficacy have been conducted, plus a dozen more specifically designed to evaluate tebupenem's pharmacokinetic profile. Many of these studies are summarized in a peer-reviewed paper published in Drug Profile, and another, our ADAPT-PO study, has recently been published in the New England Journal of Medicine. Additionally, extensive post-marketing surveillance of tebupenem with nearly 4 million patients has been conducted in Japan. Thanks to all these data collection efforts, we have an extraordinarily thorough understanding of tebupenem's safety and pharmacologic profile. This gives us confidence in Tebby's ability to potentially address the pressing NMET needs posed by the increasing prevalence of fluoroquinolone-resistant and ESBL-producing gram-negative bacteria. Other considerations would be potential positive impact of providing these patients with an effective oral treatment, which could deliver substantial value to payers, physicians, and patients. We thus remain confident that Tebby Pennant will provide us with an important and complementary source of value as we explore strategic partnerships and other ways to enable its advancement in a capital-efficient manner. Though we are no longer preparing for Tebby Penham's immediate commercialization, we do firmly believe there is a path forward for Tebby Penham to a potential FDA approval. In 2022, we are focused on gaining clarity on the requirements for Tebby Penham's ultimate approval through our interactions on this current review cycle and through interactions with the agency after the review cycle, Further, we are focused as we map that path out on working with our existing partners and potential new partners on the path to create value for Sparrow through Tebby Penham. Finally, we aim to be good stewards of capital as we deliver on these important value creation points. A major driver making the difficult decision to halt commercialization without delay was to preserve capital necessary to deliver value for shareholders. We aim to do this as we always have through prudent management of our operations and through the types of creative partnerships and collaborations that have been a part of our history. With that, I'll now hand the call over to David to talk about our development plans for SPR 720 and SPR 206. Thank you, Ankit.