Atara Biotherapeutics, Inc.

Good afternoon, everyone. Thank you for standing by, and welcome to the ATARA Biotherapeutics Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Heilengren, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Please go ahead, sir.

Thank you, Operator. Good afternoon, everyone, and welcome to Atara's third quarter 2022 results conference call. Earlier today, we issued a press release announcing our third quarter financial results and corporate update. This press release and an updated slide deck are available in the Investors and Media section at atarabio.com. On today's call, members from the ATARA executive team will provide an update on our financial results, operational progress and strategy, and also review our upcoming key milestones and objectives. Joining me on today's call are Dr. Pascal Tuchon, President and Chief Executive Officer, Dr. Jacob Dupont, Executive Vice President and Global Head of Research and Development, Dupal Kopikar, Chief Financial Officer, and Dr. A.J. Joshi, Chief Medical Officer. We will begin with prepared comments from Pascal and Jacob, then open the call up for your questions. We would like to remind listeners that during the call, the company's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release, and the company's SEC filings. These statements are made as of today's date, and the company undertakes no obligation to update these statements. Now, I'd like to turn the call over to Pascal. Pascal?

Thank you, Eric, and thank you all for joining us this afternoon. We are extremely excited that TAPCEL, under the trade name of Edvalo, received a CHMP positive opinion for its first indication and is on track to obtain European Commission approval by the end of this year. This will be the first ever approval for an allogenic of the shell T cell therapy. That cell first indication addresses a very significant unmet medical need as these EBV positive PTLD patients have no approved therapy. and just a few weeks to a few months median survival. The EMA was accordingly very pleased to highlight EBVALO positive opinion in their public release as one of the landmark of the October CHMP meeting. Meanwhile, our commercial partner, Pierre Fabre, is actively preparing for the EBVALO launch in Europe in Q1 2023. We eagerly anticipate this launch, as we believe EBVALO can deliver a compelling value proposition for patients, payers, and European healthcare systems. With significant pricing potential in such an ultra-rare disease and high double-digit royalties, we believe EBVALO commercialization will progressively contribute to ATARA's revenues and cash runaway. I would like now to give an update on our progress with TAPCEL in the U.S. Following constructive discussions with the FDA, including senior leadership, we recently held a Type A CMC meeting with the review team that culminated in clear guidance and agreement on specific CMC Module 3 requirements for a BLA submission. A Type B clinical meeting request has been granted and is being scheduled to discuss and potentially align on the clinical data package requirements to prepare for a pre-BLA meeting. Following this meeting and possible further interactions with the FDA, we expect to give further guidance in Q1 2023 on progress to a BLA submission. At the ASH conference in December, we will present updated interim analysis efficacy and safety results of the phase three allele study in relapse-remitting EBV-positive PTLD, relapse refractory, EBV-positive PTLD, with additional patients and longer follow-up, confirming the transformative potential of TAP cells. We will also present exciting new data in patients with EBV-positive leiomyosarcoma, a type of EBV-associated solid tumor. Jacob will provide more details on this data in a moment. Finally, for TabCell, we have started to seek a commercial partner in the US. Entering into such a partnership will avoid further investment and could provide additional cash inflows further extend our cash runway. We are confident in a significant business opportunity that TAP cells represent in the U.S., with potential for peak sales over $500 million per year across multiple indications. Now on to ATA-188, or Potentially Transformative Therapy for Those Suffering from Progressive Forms of Multiple Sclerosis. At the ECTRIMS 2022 conference, we presented new MRI biomarker imaging and open-label extension clinical data from the Phase I study of ATA-188 in progressive MS. New biomarker imaging data suggests patients who achieved confirmed disability improvement, or CDI, demonstrated significantly less brain atrophy over time and increased NMTR in unenhancing chronic T2 lesions. support that brain structural changes, including potential remyelination, may underlie durable CDI or confirmed disability improvement associated with ATA-188. Also, updated results from the ongoing Open Label Extension with up to 46 months total follow-up in patients achieving CDI demonstrate durability of improvement once achieved. Remarkably, patients with stable disease, meaning no decline in EDSS, have maintained such stability for up to four years, which would also represent a transformational profile relative to the expected natural course of the disease. As a reminder, based on enrollment at the end of July for Phase II EMBAL study evaluating AT188 versus placebo in non-active PMS patients. Approximately 90 patients are planned to be included in the readout of the study Primary Endpoint of Confirmed Disability Improvement by EDSS at 12 months. We expect to communicate this final data readout in October of 2023. All in all, these new extremes data from our Phase I study and OLE, Open Label Extension, together with the two landmark studies published this year in Science and Nature, and our two fast-track designations with the FDA, further support our confidence in the possibility for 80188 to deliver transformational clinical improvement to progressive MS patients. We are truly excited. by 8188 potential as a unique game changer in MS, and we are eager to reach the unbold primary endpoint readout in October 2023. Meanwhile, we'll continue to be opportunistic in exploring potential partnering opportunities with biopharma companies that could maximize the value creation potential of 8188. Now, I would like to hand over to Jacob to provide more details on our pipeline portfolio and strategy before I give you an update on our financials. Jacob?