Clovis Oncology, Inc.

Good morning. My name is Samantha, and I will be your conference operator today. At this time, I would like to welcome everyone to the Closest Oncology Second Quarter 2022 Operating Results Conference Call. Today's conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star 1 once again. Thank you. I would now like to turn the call over to your Vice President of Investors Relations and Corporate Communications and Assessment. You may begin your conference.

Thanks, Samantha. Good morning, everyone. Welcome to the Clovis Oncology Second Quarter 2022 Conference Call. We appreciate you joining us. You've likely seen this morning's news release, and if not, it's available on our website at clovisoncology.com. As a reminder, this conference call is being recorded in webcast. Remarks may be accessed live on our website during the call and will be available in our archive for the next several weeks. Today's agenda includes the following. Patrick Mahaffey, our president and CEO, will discuss the second quarter and recent highlights. And then Dr. Lindsay Rolfe, our chief medical officer, will provide a summary of the recently presented FAP-2286 data at SNMMI and Athena Monodata at ASCO and the plans for RECA regulatory filings. Lindsay will also provide additional regulatory updates, as well as the anticipated upcoming clinical milestones for FAP 2286 and Rubraka. Then Dan Muehl, our Chief Financial Officer, will cover the financial results for the quarter. Patrick will then make a few closing remarks, and then we'll open the call for Q&A, during which time Pat, Lindsay, and Dan will be available to answer questions. Before we begin, please note that during today's conference call, we may make forward-looking statements, within the means of the federal securities laws, including statements concerning our financial outlook and expected business plans. All these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Our actual results could differ materially due to a number of factors, including the extent and duration of the effects of the COVID-19 pandemic and the timing and extent of recovery from it. Please refer to our recent filings at the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made, and Clovis undertakes no obligation to update or revise any forward-looking statement. Additionally, please note that we'll be discussing cash burn, a non-GAAP financial measure, during today's call. Required disclosures related to this are in today's news release, which can be found on our website. Now, I'll turn the call over to Pat Mahaffey.

Thanks, Anna. Excuse me. Good morning. Welcome, everybody. We appreciate your time today. Good start. Sorry about that. We achieved a key milestone in the second quarter with the presentation of the first clinical data from the Lumiere trial of FAP2286. The data, which were presented at the Society of Nuclear Medicine and Molecular Imaging Annual Conference, showed the first evidence of safety and clinical activity for our first peptide-targeted radionuclide therapy candidate, and importantly, further demonstrate that fibroblast activation protein, or FAP, is a promising theranostic target with expression across many types of solid tumors. Lindsay, our chief medical officer, will discuss the data in greater detail shortly, but we are obviously encouraged by the initial results and look forward to presenting additional clinical data and initiating Phase II expansion cohorts in multiple tumor types later this year. Turning to Rubracca, sales in Q2 2022 were $32.1 million, 6% lower than the prior quarter and 13% lower year-over-year compared to Q2 2021. The reduction in ovarian cancer diagnoses in fewer patient starts in the U.S. in previous quarters as a result of COVID has continued to impact second-line maintenance treatment. While ovarian cancer diagnoses appear to be reverting to pre-pandemic levels, the effect of this increase is almost wholly observed on frontline treatments and will not likely impact the second-line indications for several quarters. In addition, we believe that the adoption of PARP inhibitors in the frontline setting is impacting the use of PARP inhibitors in later line settings. Despite the decline in sales, we remain confident in Rubracca's potential to address larger patient population in earlier lines of therapy for both ovarian and prostate cancer based on our ongoing and recently reported Phase III studies. The positive results from Athena Mono Phase III were presented at the recent ASCO Annual Meeting and at the prestigious Best of ASCO Meeting Series. ASCO also provided us the opportunity to interact with the clinical community, where we received overwhelmingly positive feedback on the Athena Mono results. We intend to submit regulatory applications for approval in this indication to both the FDA and EMA during this quarter this year. Following Athena Mono, two additional top-line Phase III data readouts for Rubraka are expected in the next three quarters. Data from the Triton III trial in the second-line prostate cancer treatment setting is expected early in the fourth quarter this year. Data from the Athena Combo trial of Rubraca in combination with Obivo in the frontline ovarian cancer maintenance treatment setting is expected in the first quarter of 2023. Before I turn the call over to Lindsay, I also want to reiterate our efforts to improve our balance sheet. While we were disappointed that resolutions related to a potential reverse stock split and authorized shares did not achieve the threshold to pass, we were grateful that a solid majority of the shares voted were in favor of our proposals. We are currently exploring alternatives and strategies to allow the flexibility for future equity raises. Our efforts to raise additional capital also include entering into strategic partnerships or licensing arrangements. And we are currently in preliminary discussions related to partnering certain development and commercialization rights to FAP 2286 for an upfront payment with the potential for milestones, research, and development support and warranties. And with that, I'll turn the call over to Lindsay.