Coherus Oncology, Inc.

Good day and thank you for standing by. Welcome to the GoHarris Biosciences Incorporated first quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 in your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, McDavid Stilwell, Chief Financial Officer. Please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our financial results for the first quarter of 2022, and the results can be found, or the release can be found on the Coherence Biosciences website. Today's call includes forward-looking statements regarding Coherence's current expectations about future events. These statements include, but are not limited to, our ability to advance our product candidates through development and registration, the status of our product candidates clinical profile, our timing and ability to commercialize our products and product candidates in the future, our R&D and SG&A expense guidance for 2022, our revenue targets for 2026 and our ability to meet the same, our projections about margin, as well as our ability to draw down amounts under our recent credit facility, and the timing of the resubmission and review of the Toro Palamab BLA. All these future events involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from the results, performance, or achievements implied by the forward-looking statements. And these statements are not guarantees of future performance and are subject to substantial risks and uncertainties that are discussed in our press release that we issued today, as well as the documents that we file with the Securities and Exchange Commission, including those in our quarterly report on Form 10Q with today's date. The forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statements. With me on today's call are Denny Lanphier, CEO of Coheris, Paul Reeder, Chief Commercial Officer, Teresa Lavallee, Chief Development Officer, and Dr. Raj Dias, Chief Medical Officer. And I'll now turn the call to Denny. Thank you, McDavid. Good afternoon, everyone, and thank you for joining us today on our conference call. to review recent business highlights and financial results for the first quarter of 2022. Today, we'll provide updates on our current business, as well as our progress transforming Coheris into an innovative immunology company, supported by revenues from a diversified portfolio of FDA-approved products. Now, first, with respect to the complete response letter we received from the FDA pursuant to the 12th of May for advanced nasal and parent-child cancer, we are currently assembling the FDA meeting package. which will support an agency interaction to occur prior to the BLA submission. We expect mid-summer filing in the six-month review timeline. As we previously communicated, we believe the requested quality process change is straightforward and readily addressable. Further to the development side of the business, Dr. Teresa Lavalle, our Chief Development Officer, will provide additional detail regarding Toro Palva BLA as well as our work with our partner, Junichi Biosciences, on the development of Torpalimab for other indications, and in combination with CHS-006, our TIGIT-targeted antibody. On the commercial side of the business, Paul Reeder, our Chief Commercial Officer, will review recent Udenica performance in our preparation for the anticipated near-term commercial launches of, first, Torpalimab. we plan to launch for MPC once approved. Similarly, our Lucentis Biosimilar candidate, where the review of the BLA is proceeding well and progressing towards an August 2, 2022 action date. Yosemite, our Humira Biosimilar, where we are investing heavily in inventory built and robust supply availability is a key part of our market strategy. As well as the Udenica on-body injector presentation, significant market share growth opportunity for our Eugenica franchise. Today, we're also announcing the termination of our license relationship with InnoVent for the development of the biosimilar basket candidate, IBI 305. COVID commenced shortly after execution of this agreement and has caused significant delays to the development timeline. We have recently assessed the market dynamics and given ongoing and projected COVID-related delays we determined that this program no longer warrants our continued investment. Lastly, McDavid Stilwell, the company's chief financial officer, will review our first quarter financial results and provide an update on our operating expense guidance for the remainder of 2022. We'll then, of course, be happy to take your questions. Today, I want to introduce you to our new chief medical officer, Dr. Raj Dias, who is with us and will be happy to take your questions during the Q&A. Raj has over 18 years' experience in oncology across medical affairs, development, and commercialization, and we welcome Raj to our team. Now, at our Analyst Day event March 29th, we introduced 2026 Revenue Guidance Targets of $1.2 to $2.2 billion and further described how we will leverage our existing operational infrastructure to achieve our commercial and development objectives. With continued strong execution of regulatory approvals and commercial launches and the advancement of our novel immuno-oncology pipeline. We expect to transform Coheris into a rapidly growing, profitable, and innovative immuno-oncology company. Now I'll turn the call over to Dr. Lavalle for an update on the TORI BLA review and our other development programs. Teresa.

Thank you, Denny. As Denny referenced, the FDA issued a complete response letter for the biologics license application for Torapalamab for NPCs. The CRL requests a quality process change that we believe is straightforward and readily addressable. We plan to meet with the FDA to ensure our resubmission is complete and will submit the meeting request package in the next few days. We plan to resubmit the BLA by mid-summer 2022. The agency also communicated in the CRL that the review timeline for the BLA resubmission would be six months. As required, onsite inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China. The FDA has indicated that the existing toropalimab clinical data are supportive of the BLA submission. Toropalimab has demonstrated clinical efficacy in multiple tumor types including in tumors with low PD-L1 expression. This differentiated clinical activity may result from toropalimab's high binding affinity to a unique epitope that potentiates PD-1 internalization. The next clinical milestone for toropalimab would be the readout of the PFS and OS co-primary endpoints from the small cell lung cancer study, Jupiter-8, which is expected this year. We recently obtained orphan drug designation for this indication in the United States. Jupiter-8 is a randomized, double-blind, placebo-controlled, multi-center phase three clinical trial evaluating platinum chemotherapy plus etoposide alone, or in combination with toropalimab, as the first-line treatment of extensive stage small cell 1 cancer. This is an aggressive tumor characterized by rapid disease progression, low expression of PD-L1, and low levels of tumor infiltrating immune cells, as well as a high degree of immunosuppression. Efficacy of cancer immunotherapy has been limited in small cell lung cancer, and no PD-1 inhibitors are currently approved in the United States for this indication. Regarding additional potential indications in the United States, we announced at a recent Analyst Day event that we are working with Junshi to review possibilities to amend protocols of several studies to enroll patients in the United States to satisfy the FDA's needs for multi-regional clinical trials. We look forward to providing additional information on this topic in the future. At this time, we are not planning additional studies for toropalimab in combination with chemotherapy for first-line non-small cell lung cancer. However, we are planning to develop the dual IO treatment of toropalimab in combination with Artigid CHF006 for non-small cell lung cancer, leveraging the robust efficacy results reported in the CHOICE-1 study. An ongoing Phase I clinical trial evaluating CHF006 and toropalamab is being conducted in China and is expected to read out next year. An IND is open in the U.S. and we expect to begin enrolling cohorts of U.S. patients later this year or early next year. Blockage of the TIGIT pathway may be a crucial underlying mechanism for overcoming PD-1 resistance. We believe the dual immunotherapy approach of TIGIT with PD-1 could enhance PD-1 efficacy with the potential to extend survival and create a new standard of care for multiple tumor types. We expect to see important clinical data from several competing TGIP programs in coming months, and these data may inform the future direction of our CHS006 development program. At our recent Analyst Day, we introduced several fully-owned programs targeting ILT4 and CCR8 that are being developed by Coherent Sciences at our Research Center in Camarillo. We expect to submit an IND for a first of these CHS1000 targeting ILT4 next year and to file at least one new IND per year going forward. On the biosimilar development and regulatory front, we recently held the late cycle review meeting with the FDA for the similarly BLA, and that review is advancing towards the August action date. Upcoming in June, results of the PK-PD study evaluating our eugenica on-body injector device will be published in connection with the ASCO annual meeting. Recall that we previously announced that the study met all PK bioequivalence primary endpoints, as well as the key secondary pharmacodynamic endpoint of AMC. I'll now turn the call to Paul Reeder.