Entasis Therapeutics Holdings Inc.

Good day and welcome to the Entisys Therapeutics Third Quarter 2021 Earnings Conference Call. Today's conference is being recorded. At this time, I will turn the call over to Bruce, Managing Director with LiveSci Advisors. Please go ahead, sir.

Thank you, Operator. 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, It 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 this morning, 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, and Mike Gutsch, Chief Financial Officer. Manos will provide a brief summary of highlights of the quarter and recent weeks before turning it over to Mike for a review of the financial results. Following their prepared remarks, David Alterac, Chief Medical Officer, and Ana Diaz-Triola, Chief Commercial Officer, will join Manos and Mike for our question and answer session. I will now turn the call over to Manos.

Thank you, Bruce, and good morning, everyone. Thank you for joining us on today's call. We will cover what has been a really exciting quarter parenthesis with compelling data from our lead program, Soldor, and the prospect of a safe and effective life-saving treatment were seriously ill, as in intubated patients. This morning, we issued a press release of LNVs and other highlights for the period, as well as our third quarter financial results. I'll spend a few moments summarizing some of the most significant pipelines and corporate developments before turning the call over to Mike for a review of our financials. Then we will be happy to take your questions. The major news for the period was, of course, the positive top-line data from the ATT&CK Phase III trial that evaluated Solbactam, Dulobactam, or Soldor for the treatment of aceticobacter infections. In this landmark study, Soldor demonstrated efficacy in 28-day all-cause mortality, with all analysis assessed to date unequivocally favoring Soldor. In addition, there was a statistically significant difference in clinical cure rates at the end of treatment and at test of cure, also favoring Soldor. Soldor was also generally well-tolerated with fewer drug-related adverse events compared to standard of care and a statistically significant reduction in nephrotoxicity with a p-value of 0.0002. This endpoint is particularly meaningful for patients who are already vulnerable and may suffer from multiple comorbidities, which current standard of care options frequently exacerbate. Soldor is the first investigational agent to demonstrate efficacy in a well-controlled trial in patients with acinetobacter. Rarely seen combination of efficacy and safety in seriously ill patients suffering from drug-resistant gram-negative infections. Our data is unequivocal and compelling, as I know many of you have found in antibacterial field where in recent years we have seen mostly incremental improvements. This is not by chance. First of all, SOLDER was designed and developed to treat Acinetobacter from the drawing boards of our labs forward. Then with ATT&CK, we studied Soldor in critically ill patients with few treatment options. These are the patients who would most benefit from Soldor if approved. ATT&CK was designed to be the single pivotal study which will underlie filings to regulatory agencies in the US, Europe, and China. This may be a first new antibacterial field, but the idea of delivering a clinical study to provide clear efficacy and safety in the appropriate patient population is not new. The scientific and medical landscape, as well as our own work over the past six years, enabled an antibacterial personalized medicine approach that ensures the right drug in the right patient at the right time. This is an approach that has already made a difference in many other therapeutic areas, like oncology and rare diseases. In our R&D strategy, we adopt some of the same principles that underlie the success in those areas. Careful characterization of the medical need, selection of the right molecular target and modality, and the diagnostic to select the patients who will benefit most from our new treatments. It is this unique effort at Entesys over the past six years which led to the successful outcome of the ATT&CK trial, with a strong top-line result that we disclosed we have high confidence in the data package that we are assembling for regulatory submissions, as well as a highly innovative, focused, and streamlined commercialization approach. Speaking of which, the data that we disclosed this past week is not only compelling proof of the validity of our scientific approach, it also provides evidence which is becoming the foundation of our commercial strategy. Here's a few numbers from the ATT&CK trial that really bring this message home. of yasinitobacter patients enrolled in ATT&CK had a carbapenem-resistant infection. Over 30% of those patients had spent more than 14 days in an intensive care unit before they were even enrolled and were treated with today's standard of care. 32% sadly died within 28 days, and that despite being enrolled in a well-controlled clinical trial and randomized to the best care one can receive today for an yasinitobacter infection. It is not surprising that real-world mortality numbers for these patients often exceed 40%, leading the World Health Organization to recognize Acimetobacter as a research and development priority, and the Centers for Disease Control as an urgent antibiotic-resistant threat. Acimetobacter is truly a global medical need which today's treatment options simply are not able to address. Beyond the undeniable impact on patients and their families, Acinetobacter puts a significant burden on the healthcare system. Treating this insidious pathogen also costs time and costs money. Acinetobacter costs time. The patient's length of stay in the hospital is measured in weeks instead of days. Acinetobacter also costs money. The cost for patients can exceed $75,000 in the US. While Acinetobacter is a rare pathogen, It is found in a variety of sites of care, including large urban hospital ICUs and outpatient specialty centers such as transplant, cancer, and burn centers. In addition to diverse settings of care, Acinetobacteria is also found on a variety of body sites, including the lung, the bloodstream, the urinary tract, and wounds. Today, many patients survive cancer or live long and active lives after organ transplantation. These patients are amongst the ones most vulnerable to drug-resistant bacterial infections acquired in the hospital. These tremendous medical advances and the significant resources dedicated to treating these patients should not be undermined by opportunistic infections, such as Acinetobacter, which used to be and could still be treatable with the right antibiotics. In this tough-to-treat patient population, the robust data in both safety and efficacy make a compelling case for the adoption of Soldor, if approved, as a life-saving medicine. As we complete the analysis of the ATT&CK trial data and prepare for submission of a new drug application in mid-2022, we continue to develop and refine our commercialization approach for Soldor. This will be a targeted commercial approach best suited to maximize the value of Soldor by focusing on sites of care where simetobacter patients can benefit the most from a potential life-saving option. Given the unmet medical needs and the strength of our Phase III clinical data, we believe that if approved, we can create a different commercial go-to-market strategy that will be pathogen-focused and result in a more streamlined effort. The next steps are focused on building physician awareness, site of care identification and virtualization, patient identification, and payer engagement. These initiatives will enable us to focus our commercialization efforts on the select areas where the burden of Acinetobacter is higher with a goal of supporting early uptake of solder. Equally important, these efforts will highlight this public health concern that is associated with increased morbidity and mortality due to the limited therapeutic options. Finally, we will continue to solicit physician and payer feedback on the top-line results that will further inform our commercialization strategy and support the value proposition of SOLDR. These elements are foundational to creating a differentiated commercial approach that is based on the successes and lessons learned in this space and from other product launches focused on rare, life-threatening diseases. To lead this rapidly developing effort and now transition to a commercial stage company, in the past quarter we welcomed Ana 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. With a track record of commercializing products across multiple therapeutic areas, including chronic, rare, and non-infective products, we are delighted to have her spearheading our effort to build the commercialization capabilities needed to bring solder to market and to complement our R&D platform. Before turning the call over to Mike, I'd like to say a few more words about the progress we made in the rest of the pipeline. With regard to Zoliflodasyn, we are pleased with the improvement in enrollment in the past quarter. In partnership with GARP, we are continuing enrollment in the global phase three trial in patients with gonorrhea, with clinical trial sites in the US, Europe, Asia, and Africa enrolling actively. In addition, we are continuing development of our earlier pipeline products, with support from our partners, CARB-X and the NIH. For these efforts, I would like to highlight the introduction of a new first-in-class candidate, ETX0462. This is a novel, there's a baclocyl-co-octane with antibacterial activity against multiple gram-negative pathogens, including Pseudomonas aeruginosa, as well as several high-priority biopsy pathogens. The discovery story of ETX0462 and the many scientific advances that underlie our rational design of novel antibiotics were recently published in the prestigious journal Nature. This is a significant recognition of the work of our scientists and external validation of the quality of our R&D platform. With that, I'll turn it over to Mike for a review of all of our financial results. Mike?