Coherus Oncology, Inc.

Good day, and thank you for standing by. Welcome to the fourth quarter and full year 2021 Kors Biosciences Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then 0. I would now like to hand the conference over to your host today, McDavid Stilwell, Chief Financial Officer. Please go ahead, sir.

Thank you, operator. Good afternoon, everyone, and thank you for joining us. We issued our press release earlier announcing our 2021 fourth quarter and full year results. This release can be found on the Coheris Biosciences website. Today's call includes forward-looking statements regarding Coheris' 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 candidate 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, and our ability to meet the same, our projections about margin, as well as our ability to draw down amounts under our new credit facility. all of which 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 complied by the forward-looking statements. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in our press release that we issued today, as well as in the documents that we file with the Securities and Exchange Commission, including those in our annual report on Form 10-K and quarterly reports on Form 10-Q. 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, and Teresa Navalny, Chief Development Officer. And I will now turn the call to Denny. Thank you, McDavid, and thank you all for joining us this afternoon. Today, I'll describe how, over the past year, we've delivered on our objective to transform Coheris into an innovative immuno-oncology company supported by income from a diversified portfolio of FDA-proof products. I'll begin today with a brief review of our achievements toward our strategic initiative in immuno-oncology, detailing the progress of our foundational assets for OpalMed and of our preclinical and clinical stage innovative combination agents. Then I'll review recent progress to grow and diversify our commercial portfolio. Now, with respect to our immuno-oncology programs, you may recall that in November we announced the FDA-granted priority review for the VLA for Toropalmab for the treatment of nasopharyngeal carcinoma, an indication with no FDA-approved cancer immunotherapy options and for which Toropalmab has breakthrough therapy and orphan drug designations. The BLA review is progressing well towards the target action date of April 30th, which is about 10 weeks from now. Torpalimab's clinical profile continues to strengthen across indications. In December, we announced that Torpalimab plus chemotherapy demonstrated a statistically significant overall survival benefit in a pre-specified interim analysis of the Choice I clinical trial for the first-line treatment of advanced non-small cell lung cancer. This builds on other first-line indications in esophageal squamous cell carcinoma and nasopharyngeal carcinoma, where we have seen a robust benefit of both the progression-free survival and overall survival. We've also made progress with our clinical stage mid-stage IO acid strategy. In January, we initiated the process to exercise our option license, JS006, a targeted antibody developed by June Chief BioScience as our partner. which they are evaluating in a study combination with Toro Palmet. Dr. Teresa Lavalle, our new chief development officer, will provide additional details about JS006 and our development plans for you in just a moment. Our immunology preclinical research and development team is proving to be highly productive. In January, we announced that we're advancing an eternally generated pipeline of PD-1 combination candidates, and we expect to file the first IND in mid-2023. With Torapalmab nearing its first potential approval, a TIGIT-targeted immune checkpoint blocker entering mid-stage development, and our in-house early-stage immuno-oncology candidates successfully advancing towards human clinical trials, Coheris is evolving into an innovative immuno-oncology company with a broad pipeline of product candidates and the potential to drive long-term growth over this decade. I'd now like to introduce Dr. Teresa Lavalle, a recently appointed Chief Development Officer who brings more than 25 years of drug discovery and development experience and is recognized for her immuno-oncology expertise. Most recently, Dr. Lavalle was Vice President of Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy, where she provided scientific leadership for the clinical strategy for development of novel immunocology therapies. and help establish the Institute's translation and regulatory organization. Prior to that, from 2008 to 2013, Dr. Lavallee was a member of the immuno-oncology team, developing checkpoint inhibitors and related diagnostics at MedImmune in AstraZeneca. Teresa.

Thank you, Denny. It is exciting to join Coheris as the company gains momentum in its transition to an innovative immuno-oncology leader. I believe our broadening product portfolio with early, mid, and late-stage complementary IO products is well-positioned to clinically succeed in immuno-oncology. Commercially, our oncology-focused organization has proven that Coherence can be very successful in highly competitive fields. Coherence has both the in-house expertise and assets needed to support a successful transformation. Antibody development for BD1 combinations and co-formulations required world-class analytics, protein science, and bioinformatics capabilities. We have that at our Camarillo, California site, a 25,000 square foot facility we moved into two years ago. On the development side, our clinical and regulatory teams have repeatedly demonstrated the ability to develop drugs that gain FDA approval. Our Scientific Advisory Board of recognized IO experts from academia and industry is actively involved in our target and moiety selection, playing a key role, for example, in selecting toropalimab from a due diligence review of more than 10 PD-1 product candidates, as well as vetting the TIGIT asset from Junichi. For Coheris, these investments are paying off. Taurapalimab, our foundational immuno-oncology asset, is establishing an excellent safety and efficacy profile in the ongoing clinical trials. The Taurapalimab BLA for nasopharyngeal carcinoma and unmet medical need with no approved immunotherapies, is under priority review by the FDA with an action date of April 30th. Denny mentioned earlier that toropalimab's clinical profile continues to strengthen across indications. Case in point, the positive progression-free survival and overall survival data from the Jupiter-6 study in esophageal squamous cell carcinoma which showed a significant overall survival benefit even in low PD-L1 patients. We have and will continue to engage the FDA on the potential for submission later this year of a supplemental BLA for toropalimab in combination with chemotherapy for first-line treatment of ESCC. Another important immune-responsive tumor type is hepatocellular carcinoma. which also is highly prevalent in patients of Asian descent, and which the FDA has said could warrant regulatory flexibility for new PD-1. We are conducting two pivotal clinical trials evaluating toropalimab in HCC, including a frontline trial randomizing approximately 520 advanced HCC patients to linvatinib and placebo versus linvatinib plus toropalimab In adjuvant therapy, we have a trial with approximately 400 HCC patients randomized to toropalimab or placebo following resection. Initial clinical data from these studies are expected later this year. The February 10th ODAC meeting discussing the InnoVent Glili VLA for non-small cell lung cancer provided helpful insights into the FDA's expectations for sponsors seeking approval for PD-1s for indications with available immunotherapy options. We believe it is wise to fully engage with the FDA early and prior to submission decisions to fully understand their views. We are continuing to meet with the FDA frequently for toropalimab for multiple potential indications And we'll discuss with them this year the pathway for toropalimab in combination with chemotherapy for first-line treatment of non-small cell lung cancer. Although there are FDA-approved checkpoint inhibitors for non-small cell lung cancer, new and more effective treatment options are needed as the majority of patients still die rapidly from this deadly disease. We are focused on addressing unmet patient needs. So non-small cell lung cancer will be the first tumor type we pursue for the combination of toropalimab with JS006. We are excited about the development of this TIGID antibody. TIGID is emerging as an important checkpoint to enhance PD-1 antitumor immunity. After a decade of translational research with IO, the field understands better how PD-1 inhibitors work and why they have been foundational for IO treatments. Cancers trick attacking T cells into shutting off prematurely. A subset of T cells that exhibit stemness have the potential to be reactivated by the unique crosstalk between PD-1 and TIGIT pathways. All of this is consistent with the observed improved clinical activity with PD-1 and TIGIT inhibitors in the clinic, and specifically in non-small cell lung cancer. In preclinical studies, JS006 has demonstrated excellent binding affinity and strong inhibition of the TIGIT pathway, as well as enhanced antitumor activity in combination with toropalimab in preclinical mouse models. A clinical study evaluating JS006 as monotherapy and in combination with toropalimab in patients with advanced solid tumors is ongoing. The IND for JS006 is open in the United States, and we are planning to advance JS006 in combination with toropalimab in a clinical trial in the U.S. later this year. Clinical data news flow will continue this year as results come in from trials evaluating toropalimab for first-line treatment of small cell lung cancer and two additional non-small cell lung cancer studies one in the neoadjuvant setting, as well as a trial in patients with EGFR mutations who have failed prior TKI therapy, and also pivotal studies in triple negative breast cancer, hepatocellular carcinoma, and interhepatic cholangiocarcinoma. Depending on clinical outcomes and conversations with the FDA, these studies could lead to additional indications for toropalimab in the United States. I will now turn the call back to Denny.