Kevin DeGeeter

Kevin DeGeeter of Ladenburg Thalmann & Co. Inc. inquired about the strategic positioning of OptuneLua as 'post-platinum' and its potential influence on NCCN guidelines and payer feedback. He also asked about the expected timeline for securing broad commercial coverage in the U.S.

Answer

Frank Leonard, EVP & President - Novocure Oncology, stated they don't see a direct link between their marketing message and influencing NCCN's guideline structure, but they are publishing real-world evidence to shape physician perception. CEO Ashley Cordova noted that reimbursement is not a binary switch, with early successes building through 2025 and more material top-line growth from it expected in 2026.

Kevin DeGeeter, on behalf of Chris Shibutani at Goldman Sachs, inquired about the first-line lung cancer strategy, asking if the company would pursue a non-G12C indication and when data for the chemo-free triplet might be released.

Answer

President of R&D Dr. Stephen Kelsey explained their strategy divides RAS-mutant lung cancer into two groups. The elironrasib-daraxonrasib triplet combination is planned for G12C-mutant lung cancer, while daraxonrasib would be prioritized for all other non-G12C RAS mutations. He did not provide a specific timeline for the triplet data release, noting they are awaiting durability maturation, but highlighted they have already shown their inhibitors are combinable with pembrolizumab at full doses.

Kevin DeGeeter, on behalf of Brian Abrahams at RBC Capital Markets, asked about the regulatory bar for the upcoming LGMD Type 2E data and how that standard might apply to other LGMD subtypes.

Answer

CEO Douglas Ingram stated that after extensive work with the FDA, the bar for these ultra-rare diseases involves demonstrating strong protein expression and a good safety profile in small, single-arm studies. He expressed high confidence based on prior SRP-9003 cohort data and the extensive safety and expression data from ELEVIDYS. Dr. Louise Rodino-Klapac added that this approach, leveraging rh74 and full-length genes, will be similar for the other sarcoglycan programs.

Kevin DeGeeter from Oppenheimer & Co. Inc. inquired about any hypothesis-generating findings from the tumor-agnostic basket of the ORIC-101 trial and asked for details on the target product profile for the new PLK4 program.

Answer

CEO Jacob Chacko responded that in the tumor-agnostic basket, which included 20 patients across seven tumor types, they observed one partial response in an esophageal cancer patient and nothing else of note. Regarding the PLK4 program, he deferred detailed specifics to an upcoming AACR poster but described it as a potent and selective first-in-class synthetic lethality approach for breast cancer.

Kevin DeGeeter from Oppenheimer asked for an update on the pharma services business backlog, a breakdown of recovery trends between the PancraGEN and thyroid diagnostic tests, and any revised timeline for achieving cash flow breakeven.

Answer

President and CEO Jack Stover explained that while specific backlog figures are not disclosed, the pharma business is seeing a solid increase in bookings and a rising average contract value, now well above $100,000. He noted that, contrary to expectations, the hospital-based PancraGEN test is recovering at a slightly higher rate than the physician office-based thyroid test. CFO Fred Knechtel added that the timeline to EBITDA breakeven has likely been pushed back by one quarter due to the pandemic, with a focus on Q4 for significant recovery.

Kevin DeGeeter from Oppenheimer asked about the potential for delayed clinical test volumes to be permanently lost, the go-to-market strategy for the BarreGEN test, and whether the current economic environment has changed valuations or appetite for M&A.

Answer

Executive Jack Stover responded that the company does not anticipate losing significant test volume, as these are essential cancer-related diagnostics that are delayed, not canceled. For BarreGEN, the strategy is to focus on the ablative evaluation market, leveraging the existing PathFinder platform. Regarding M&A, Stover acknowledged that buying opportunities are emerging due to capital constraints elsewhere, and while Interpace's private equity partners are supportive, the immediate focus is on integrating the recent BioPharma acquisition.

Kevin DeGeeter from Ladenburg Thalmann inquired about the expected scope of the upcoming Shire SHP656 update, the specifics of using the Shire agreement as a model for future PolyXen partnerships, and the enrollment timeline and interim data expectations for the XBIO-101 Phase 2 trial.

Answer

CEO Scott Maguire stated the Shire update will be a joint release focused on contractual endpoints, with detailed data to follow at a future conference. COO Jeff Eisenberg clarified the Shire deal is a model for future partnerships primarily due to its economic structure, noting they would aim for even better terms going forward. CSO Curt Lockshin projected activating up to 20 sites for the XBIO-101 trial by year-end and aims to enroll approximately 40 patients by mid-2018 to support an interim data readout on about 20 patients by the end of 2018.