Seagen Inc.

and welcome to the CJEN third quarter 2022 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touchdown phone. To withdraw your question, please press star then two. Please note today's event is being recorded. I would now like to turn the conference over to Doug Maffei, Vice President, Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon, everyone. I'm pleased to welcome you to CGEN's third quarter 2022 financial results conference call. This afternoon, we issued a press release with our results. The press release and supporting slides are available on our website in the Investors section, Events and Presentations page. Speakers on today's call will be Roger Danzy, Interim Chief Executive Officer and Chief Medical Officer, Todd Simpson, Chief Financial Officer, and Chip Romp, Executive Vice President, Commercial US. Following our prepared remarks, we'll open the line for questions. We aim to keep this call to one hour and ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A during our call today. Today's conference call will include forward-looking statements regarding future or anticipated events and results, including the company's 2022 financial outlook, anticipated product sales, revenues, costs and expenses, potential clinical and regulatory milestones, including data readouts and regulatory submissions, potential marketing approvals and commercial performance. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference including the difficulty in forecasting sales, revenues, costs and expenses, impacts related to the COVID-19 pandemic and the uncertainty associated with the pharmaceutical development and regulatory approval process. More information about the risks and uncertainties faced by CGEN is contained under the caption Risk Factors, included in the company's quarterly report on Form 10-Q for the quarter ended June 30th, 2022, filed with the Securities and Exchange Commission, and the company's subsequent reports filed with the SEC. Now I'll turn the call over to Roger.

Thank you, Doug. Good afternoon, everyone, and welcome to our third quarter call. This was a quarter where we delivered strong financial results with total quarterly revenue of $510 million, representing growth of 20% compared to the same quarter last year and reflecting robust sales across our approved portfolio. We also made substantial progress on multiple fronts, including clinical, regulatory, research, and corporate development. We presented pivotal data for PADSEV and to Kaiser, and we submitted supplemental regulatory applications to the FDA for PADSEV, to Kaiser, and to Tetris. We opened a new IND in our early stage pipeline with a product candidate that targets immune cells in the tumor microenvironment, and we extended the geographic footprint for TifTac with a new commercialization partnership in China and other parts of Asia. Turning to our overall strategy, we are an ADC company at our core, as demonstrated by three of our four commercial products and five of our last six INDs. And moving forward, we will remain laser-focused in this area. Nevertheless, as with Teqiza, we continue to acquire complementary assets that target tumors through mechanisms different from ADCs. In that vein, we recently licensed an innovative biospecific technology from Lava which addresses a target not readily amenable to an ADC construct and fits in well with the overall focus on targeted drug development. Beginning today with PAD-SEV, our first-in-class ADC for metastatic urothelial cancer, together with Estelis and Merck, we presented data from cohort K of the EV103 trial at the ESMO meeting in September. As a reminder, this is a study primarily evaluating PAD-SEV in combination with Keytruda in frontline cisplatin ineligible patients with unresectable, locally advanced, or metastatic urethelial cancer. This combination demonstrated a confirmed overall response rate per independent radiographic review of 64.5% with a median duration of response not reached. The combination had a manageable and tolerable safety profile. The PADSEV monotherapy arm showed a confirmed overall response rate of 45.2% with a median duration of response of 13.2 months, demonstrating its contribution to the combination. Frontline patients who are not eligible to receive cisplatin have a high unmet medical need, and we are encouraged by these data. We have submitted a supplemental BLA to the FDA to support a potential accelerated approval in the United States in mid-2023. Further development for PADSIF continues, including our EV302 Global Phase III trial in combination with Keytruda in a broader population of patients, regardless of cisplatin eligibility. We expect enrollment to complete before year end, and our intention is to use EV302 as a confirmatory study in the United States and to support submissions around the world. Beyond the frontline metastatic setting, Additional studies evaluating PADSF in muscle-invasive and non-muscle-invasive bladder cancer are ongoing. Together with the stellists, we are also considering PADSF's potential in other Nectin-4-expressing solid tumors and look forward to sharing data next year. Moving to Takaiza, we recently filed a supplemental NDA for patients with previously treated HER2-positive metastatic colorectal cancer. The combination of Dikaizer and Trastuzumab resulted in a confirmed overall response rate of 38% with a median duration of response of 12.4 months. Based upon the strength of these data, we have been granted breakthrough therapy designation as well as priority review by the FDA with a PDUFA action date of January 19th, 2023. As a reminder, our phase three trial has been initiated in frontline HER2-positive metastatic colorectal cancer with the goal of serving as a confirmatory trial in the United States and supporting global submissions. We continue to explore Tuchyser further in breast cancer with our partner Merck. This includes HER2CLIM-02, our Phase III study of Tuchyser in combination with Quetzila, which completed enrollment in June. We anticipate reporting top-line data in the first or second quarter of next year. Despite the evolving treatment landscape, Quetzila remains an important treatment option for patients with HER2-positive metastatic breast cancer. If successful, the combination of Tukeiza plus Catsyla has the potential to strengthen Tukeiza's position in the second-line setting, particularly in patients with brain metastases, and could provide an alternative important option in the third-line setting for those patients who would otherwise have received Catsyla monotherapy. Next to highlight are three key updates for Etcetris. which is a foundation of care in CD30-expressing lymphomas, and is being commercialized outside of the United States and Canada by our partner, Decatur. First, data from the pediatric trial has been filed with FDA with a target action date of November 16th, 2022. Etcetera's PLUS chemotherapy demonstrated superior event-free survival in the treatment of pediatric patients with previously untreated high-risk classical Hodgkin lymphoma when compared to a chemotherapy regimen that included gliomycin. Second, the statistically significant and clinically meaningful improvement in overall survival demonstrated in Echelon 1 for tetras in combination with AVD in patients with advanced Hodgkin lymphoma was recently published in the New England Journal of Medicine. We have submitted these data to the FDA for possible inclusion in the label. Last and important to note, the NCCN guidelines have now been updated based on the overall survival data to designate A plus AVD as a preferred treatment option for adult stage 3-4 Hodgkin lymphoma patients. Now transitioning to TIVDAC, our fourth approved product and first in class tissue factor directed ADC, which we co-develop and co-commercialize with our partner GenMAP. We recently announced a regional strategic collaboration and license agreement with Xilab that gives them exclusive rights to develop and commercialize TIVDAC in mainland China Hong Kong, Macau, and Taiwan. We partnered with Xilab given their expertise and track record of developing and commercializing innovative medicines in the region. The collaboration will support regional patient enrollment for Innovative 301, our phase three study of TIVDAC in patients with recurrent or metastatic cervical cancer. This global study is enrolling well and is intended to serve as the confirmatory trial in the United States and to enable global regulatory applications, including in Asia. Additional clinical development for TIVDAC continues in frontline cervical cancer and other solid tumors, including head and neck cancer. We look forward to data readouts in the coming year, which will inform our next steps in these two cancers. Dacitimab vedotin, or DV, is a late-stage novel HER2-directed ADC that utilizes our vedotin-based technology. Our clinical development program is evaluating monotherapy and combination approaches in a variety of cancers. We recently began enrolling patients into the pivotal phase two monotherapy trial in second line HER2-expressing metastatic urethelial cancer. We plan to initiate an additional pivotal study in bladder cancer over the next several months while continuing to explore development in other HER2-expressing solid tumors. Turning to our earlier stage pipeline, We are advancing multiple drug candidates in phase one clinical trials in a range of solid tumors and hematologic malignancies. Next month at the Annual Society for Immunotherapy of Cancer Conference, we look forward to disclosing initial phase one data for SGNB6A of a dotin ADC targeting integrin beta-6. This is an antigen which is highly expressed in a variety of solid tumors, including non-small cell lung, head and neck, and esophageal cancer. In addition, we will be presenting preclinical data on SGN-BB228, a novel bispecific molecule which provides a potent co-stimulatory bridge between tumor-specific T cells and CD228-expressing tumor cells. We look forward to initiating a phase one trial for SGN-BB228 in the coming months. In September, we announced an exclusive worldwide license to develop and commercialize LAVA1223 a bispecific T-cell engager targeting gamma-delta T-cells in the presence of EGFR-expressing solid tumors. We find the science compelling and look forward to advancing NAVA1223 into the clinic in the near term. Next, I'll turn the call over to Todd, who will discuss our financial results and provide updated guidance. Then Chip will provide an update on our commercial performance before we turn to Q&A. Todd.