Spero Therapeutics, Inc.

Good afternoon and welcome to the Spiro Therapeutics Full Year 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 Spiro Therapeutics website at www.spirotherapeutics.com. At this time, I would like to turn the call over to Michael Wood, Managing Director at Lifestyle Advisors. Mr. Wood, 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 business update for the fourth quarter and full year of 2023. The press release is available on the investors' page of Spira Therapeutics' website. Before I begin, I'd like to remind you that some of the information presented in this conference call contains forward-looking statements based on our current expectations, including statements about the future development and commercialization of Tebepenem HBR, SBR 720, SBR 206, and the design, initiation, timing, progress, and results of the company's pre-trial studies and clinical trials and its research development programs. management's assessment of the results of such preclinical studies and clinical trials, the company's cash forward and anticipated expenses, the sufficiency of the 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' filing for the SEC. including in the risk factor section of its annual report on Form 10-K for the year ended December 31, 2023, filed with the SEC today. These four looking statements speak only as of the date of this conference call, March 13, 2024, and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the company after the date of this call. Participating in today's conference call are South Shukla, Chief Executive Officer, Dr. Kamal Ahmed, Chief Medical Officer, and Esther Rejavalo, Chief Financial and Chief Business Officer. With that, I'd like to turn the call over to Spiro's CEO, Dr. Shukla. Please go ahead now.

Thanks, Michael. And I thank you all for joining us this afternoon. Spiro had a very productive 2023 with progress across its portfolio of development stage assets. SPR 720 is now in the later stages of a proof-of-concept study in NTMPD, and we are looking forward to reporting top-line data, which we expect to do in the second half of this year. The Phase III clinical trial for teripenem HBR is up and running. We recently received ING clearance for SPR 206 for the treatment of patients diagnosed with hospital-acquired or ventilator-associated pneumonia. The company has a strong balance sheet with the financial flexibility to execute on its plans. For me personally, 2023 was a particularly exciting year as I was honored to take on the CEO role and to be provided with the opportunity to lead a world-class team who share a vision to develop innovative therapies to help patients suffering from serious infections and rare orphan diseases. Let me begin with SPR720, which we are developing for non-tuberculous mycobacterial pulmonary disease, or NTMPD. We are developing SPR720 to be a first-line oral agent and believe it has exactly the right profile to address the unmet needs in NTMPD. NTMPG is a rare disease, but with a very well-identified patient population of approximately 245,000 diagnosed patients in developed markets. SPR-720 is an oral drug with a novel mechanism of action that is not exploited by other SOC agents or those in development for NTMPG. In the data we have seen so far, From completed in vitro and in vivo studies, there has been no evidence of cross-resistance against marketed antibiotics, and SVR720 has demonstrated a low propensity for selection of resistance. We have shown that it has potency against multiple NTM pathogens, and data support its potential for efficacy, safety and tolerability, and macrophage penetrations. SPR 720 has also been granted orphan drugs, QIGP, and fast-track designations. The goal of our phase 2A proof-of-concept clinical trial is to understand SPR 720's activity in NTMPD patients and to inform the design of a later stage and longer-term trial evaluating SPR 720 in combination with current standard-of-care agents. As a potential first-line oral agent, we believe the commercial opportunity for SPR720 is compelling. Kamal will provide further details on this program in a few minutes. Turning now to our partner programs, let me begin with Chebepenem HBR, which is partnered with GSK. We are developing Chebi as potentially the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections or CUTI. We were pleased to announce in January of this year that the Phase III PIVH-PO clinical trial is now underway, with the first patient first visit having occurred in the fourth quarter of 2023. During 2023, Sparrow received written agreement from the US FDA with a Special Protocol Assessment, or SPA, on the design and size of PIVH-PO. 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 aspects with respect to the design of the program have been de-risked substantially. Moving on to SPR-206, which is partnered with Pfizer for European markets. We submitted an ING for a phase 2 clinical trial in HapVap patients. and recently announced that the INT has been cleared with the FDA. With that, I would now like to hand the call over to Dr. Kamal Hamed, who will provide more details on the clinical program.