Entasis Therapeutics Holdings Inc.

Good morning, ladies and gentlemen, and welcome to the Entisys Therapeutic Second Quarter Results Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Bruce Mackle, Managing Director with LifeSci Advisors. Please go ahead, sir.

Thank you, Alex. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release we issued yesterday and in our Form 10-Q, which may be accessed from the investor's page of the Entesys website. Joining me on today's call from Entesys are Manos Peros, President and Chief Executive Officer, Mike Gutsch, Chief Financial Officer and Chief Business Officer and David Alterac, Chief Medical Officer. Manos will provide a summary of the company's progress during the quarter and recent weeks before turning it over to Mike for a review of the company's financial results. Following their prepared remarks, the management team will be available for your questions. I will now turn the call over to Manos.

Thank you, Bruce, and good morning, everyone. Thank you for joining us. On behalf of the management team and all of us Entesys employees, welcome to the inaugural Entesys quarterly results call. As the company progresses toward commercial stage, it is our intention to formalize our investor outreach and provide regular opportunities for interactive dialogue. We appreciate your attendance today and look forward to our discussion on this and future quarterly calls. Yesterday, after market close, we issued a press release outlining our second quarter financial results, as well as the progress made advancing our pipeline. I'll spend just a few brief moments summarizing these developments before turning the call over to Mike for a review of our financials. Then we will be happy to take your questions. I'll begin with our ATT&CK Phase 3 Registrational Trial that is evaluating our novel combination, Solbactam-Durlobactam, or SOLDOR, for the treatment of Acinetobacter infections, including multidrug-resistant or MDR strains. As we announced recently, together with our partner, Zylab, we completed patient enrollment in July and expect to release top-line data early in the fourth quarter. As a reminder, ATT&CK is a Phase III registrational trial evaluating the safety and efficacy of Sodor in patients with confirmed carbapenem-resistant Acinetobacter infections. In total, we have enrolled over 200 patients in the trial. In part A, which evaluates the efficacy of Soldor compared to Colistin in patients with pneumonia and or bloodstream infections, we have enrolled over 120 valuable patients, of which approximately one quarter were enrolled in China. Part B of the trial, which enrolled over 25 patients, is a non-randomized cohort of patients with confirmed Acinetobacter infections that are treated with Soldor but are not eligible for Part A due to factors that could include colistin resistance, colistin intolerance, or a sematobacter infection in another body site unresponsive to colistin therapy. Completion of ATT&CK enrollment is a significant milestone for both Entesys and XyLab, and we thank the patients, their families, and healthcare professionals for the collective effort that enabled us to complete enrollment during such challenging times. To our knowledge, ATT&CK is the largest antibiotic-resistant pathogen-specific registrational trial to be conducted globally, and the first to focus specifically on carbapenem-resistant acinetobacter infections. We look forward to announcing top-line data in the coming months. Concurrent with the ATT&CK trial, we made SOLDOR available via an expanded access protocol from compassionate use cases in the U.S. One case originating from our AAP program was the subject of a study published recently in Antimicrobial Agents in Chemotherapy, a publication of the American Society of Microbiology. The case study by Dr. Zaidan, Hornak, and Reynoso of the University of Texas Medical Branch in Galveston, Texas, highlighted the problem of a critically ill patient due to COVID-19 respiratory failure who developed extremely drug-resistant Acinetobacter baumannii pneumonia and septic shock. the patient received a combination cocktail of antibiotics, culminating in 14 days of Soldor plus cefiderocol. Despite a very poor prognosis, the patient significantly improved on therapy, recovering well enough to eventually be discharged and return home. We believe this case highlights both the growing threat of antimicrobial drug resistance, as well as the potential of Soldor to address a critical unmet medical need. As we look beyond top-line data release and begin our commercialization planning for solar and our other programs, we are pleased to welcome Anna D'Astriola as our new Chief Commercial Officer. Anna comes to us from Summit Therapeutics, where she was instrumental in developing the commercial strategy for the company's first product against C. difficile infections. Prior to Summit, Anna held commercial leadership roles at Flexion Therapeutics, Chiasma, Cubist, and Biogen. With her track record of commercializing products across multiple therapeutic areas, including antibacterials, we are delighted to welcome her to our leadership team and look forward to working with her to build the commercialization capabilities which will complement our R&D platform. Completing our update on Soldor, Later this month, we will be hosting an expert perspectives webinar on Acimetobacter infections. This program will feature presentations by infectious diseases experts, Dr. David Van Duyn of UNC Chapel Hill and Dr. Michael Rybak of Wayne State University, who will discuss the burden and current treatment landscape of Acimetobacter infections. We believe this will be an informative and timely discussion ahead of a top-line data readout from the ATT&CK trial and are delighted to have such distinguished experts speaking about the medical need associated with this multidrug-resistant infection. The program is open to all interested parties, and registration details are available on our website. Turning now to the next candidate in our portfolio, we continue to support the Global Antibiotic Research and Development Partnership, or GARDP, and the Phase III Registrational Trial of Soliflodacin, for the treatment of uncomplicated gonorrhea. The trial, designed to assess the safety and efficacy of a single oral dose of zoliflodacin versus a global standard of care, which is a combination of intramuscular subtraction plus oral azithromycin, is actively enrolling patients with uncomplicated gonorrhea, including infections potentially caused by multidrug-resistant strains of Neisseria gonorrhea. Our partner of the program, GARDP, has now activated clinical trial sites in the U.S., the Netherlands, Thailand, and South Africa. Unfortunately, due to ongoing challenges with the pace of patient enrollment related to the ongoing COVID-19 pandemic, we remain unable to provide guidance for completion of the trial at this time. We will provide enrollment updates and guidance for completion of the trial when appropriate. Finally, we also continue to make progress with our early portfolio programs. Last month, we participated in the World Micro Forum, where we presented 11 posters across the portfolio, and we're very pleased to be selected for an oral presentation highlighting ETX0462, a novel, first-in-class diazobisaclo-octanone molecule. ETX0462 is our initial product candidate from a non-beta-lactam inhibitor of penicillin-binding proteins, or NBP platform, which we're developing with support from CARB-X. We believe NBPs constitute a potential new class of gram-negative antibacterial agents that are designed to target a broad spectrum of multidrug resistant bacterial pathogens that overcome the main source of beta-lactam resistance, which is driven by beta-lactamases. We selected ETX0462 as our initial candidate, given its antimicrobial activity against multiple gram-negative pathogens, including Pseudomonas aeruginosa, as well as a number of high priority biothreat pathogens. We are currently working to complete the required preclinical activities to advance ETX0462 into the clinic and look forward to updating you all on the progress of this exciting program. With that, I will now turn it over to Mike for a review of our financial results and other business developments.