Good day, ladies and gentlemen, and welcome to the Athenex Third Quarter 2022 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing 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 your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to hand the conference over to Tim McCarthy, Managing Director of Investor Relations at LifeSci Advisors. Thank you, and over to you. Good morning and thank you for joining our conference call. Today, an update on Athenex's business will be provided, as well as a review of financial results for the third quarter of 2022. The news release detailing the results crossed the wire early this morning and is available on the company's website. A replay of this call will also be archived on the company website. During the conference call, the company will make projections or forward-looking statements regarding future events, including statements about financial, business, and clinical milestones anticipated in fiscal year 2022 and beyond. We encourage you to review the company's past and future filings with the SEC, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements. You can find our SEC filings in the EDGAR database at www.sec.gov or in the investor relations section at our website at www.athenex.com. Speaking on the call this morning will be Dr. Johnson Lau, Chief Executive Officer, Dr. Daniel Lang, President of Athenex Cell Therapy, Dr. Darrel Cohen, Chief Medical Officer of Cell Therapy, Mr. Jeffrey Yordon, Chief Operating Officer, and Mr. Joe Annoni, Chief Financial Officer. I will now turn the call over to Johnson for introductory remarks. Thank you, Tim. Thank you everyone for joining our conference call this morning. It has been another productive quarter for Athenex as we work to transform the company into a pure-play leader in NKT cell therapy. First, we raised $30 million via an equity offering in August. I'm also very pleased to announce that we are tracking well to achieve the targeted 50% reduction in operating expenses compared to last year. We also remain on track with our financial guidance. Internal expense targets and our financial priorities remain unchanged. We continue to strengthen our balance sheet by monetizing non-core assets and identifying potential sources of value within the business while staying focused on prudent capital allocation. To date, we have deployed our combined deal proceeds to pay down a significant portion of our debt from $150 million at the end of last year to $47.5 million as of September 30th, 2022. We previously announced our intent to divest our China API business in July. Due to COVID-related restrictions, certain administrative procedures have been delayed. However, I'm pleased to say that we have met all closing conditions and are in the final stages of closing the transaction. We are confident that we can complete the closing and receive 70% of the proceeds from the sale as soon as the COVID restrictions are lifted by the government, with the remaining amounts to be received over the following few months. I would now like to provide an update about our Nasdaq listing. As you may know, we asked to receive a second 180-day calendar extension to regain compliance with the $1 trading rule in September. This request was rejected by Nasdaq, and we subsequently appealed the Nasdaq decision. We had a panel meeting with Nasdaq on October 20th and are delighted to announce that our appeal was successful. The Nasdaq hearings panel granted our request to continue listing and extended our period to regain compliance until March 14th, 2023. We are now planning to hold a virtual special shareholders meeting on November 22nd at 9:30 A.M. Eastern Time, and we issued a proxy filing on October 11th that provides additional details. This meeting is being held to authorize a potential reverse split of the stock, among other things. A favorable outcome provides the board with the authority to effect a reverse split in the case that the share price does not rebound over $1 by March 14th, 2023. We encourage you to review the proxy and vote in favor of the outlined proposals. Now, let me turn to a few pipeline updates. We continue executing our strategic pivot to transform into a leading NKT cell therapy company. We remain well positioned to evolve into a competitive player in the attractive and growing immune effective cell therapy sector. Our top priorities are to advance our innovative NKT cell therapy platform through dose escalation and continued patient enrollment, and present results to scientific and investor communities. With respect to our U.K. regulatory submission of oral paclitaxel in metastatic breast cancer, we remain on track with all regulatory interactions with the MHRA and have submitted comprehensive responses to their questions in September. We will provide another update on our progress at the appropriate time. Our oral paclitaxel is being studied in I-SPY2 trial, a phase II program evaluating oral paclitaxel in combination with dostarlimab ± carboplatin in the neoadjuvant treatment of breast cancer patients. The study is being conducted by the Quantum Leap Healthcare Collaborative and in conjunction with GlaxoSmithKline, which is the dostarlimab manufacturer. This study is expected to be completed before year-end. We hope to be able to share data from this program when it's available. If results are positive, then our next step will likely be to advance oral paclitaxel into a pivotal study, and we will seek to do so in collaboration with a development partner. Our APD business is tracking in line with our internal targets for the third quarter. We are maintaining the previously issued product sales growth guidance in the range of 20%-25%. We continue to advance new product launches and maximize revenue opportunities by prioritizing products listed on the FDA's drug shortage list. At the same time, we are steadily working to improve our profit margins. With that, I'll turn the call over to Dr. Daniel Lang to provide some updates on our NKT cell therapy program. Dan, please go ahead. Thank you, Johnson, and good morning, everyone. We remain focused on advancing our first-in-class NKT cell therapy platform with potential to overcome limitations of current immune effector cell therapy approaches. The combined innate and adaptive immune properties of NKT cells, together with the ability of CAR-NKT cells to target both tumor and tumor microenvironment, enable the potential for a highly effective off-the-shelf treatment that is lower in toxicity and more accessible to a broader patient population. Our ongoing clinical trials in both solid tumors and hematological malignancies have demonstrated early promise, and we remain highly encouraged by the therapeutic potential of this novel cell therapy approach. This past quarter, we continued to advance our two lead investigational programs, KUR-501, an autologous GD2 CAR-NKT cell therapy for patients with relapsed/refractory high-risk neuroblastoma, and KUR-502, an allogeneic CD19 CAR-NKT cell therapy for patients with relapsed/refractory B-cell malignancies. We provided interim phase I dose escalation data updates from the GINAKIT-2 study of KUR-501 at ASGCT in May, and from the ANCHOR study of KUR-502 at ASTCT in April. Data from both studies supported consistent findings, including encouraging responses at low dose levels, favorable kinetic profiles demonstrating the ability of CAR-NKT cells to safely expand post-adoptive transfer in all patients and peaking about one-two weeks post-infusion. Also promising is the fact that CAR-NKT cells home to tumor sites. Both programs have maintained a favorable safety profile without any infusion-related reactions, dose-limiting toxicities, neurotoxicity, graft versus host disease, or severe side effects related to CAR-NKT cells. The few cases of low-grade cytokine release syndrome that did occur were manageable and reversible. Overall, those data support wide therapeutic windows for both KUR-501 and KUR-502, with potential to dose escalate further to help safely drive deeper, more durable responses. As a reminder, the interim data for GINAKIT-2 study of KUR-501 in heavily pretreated patients with relapsed refractory high-risk neuroblastoma included three objective responses in 12 patients, with two of these three patients achieving responses at dose level 4 that included a durable complete response persisting for over 12 months. Predictors of response included KUR-501 exposure and CD62L expression. Given the encouraging data with KUR-501 in high-risk neuroblastoma. We continue to explore GD2 CAR-NKT cell therapy opportunities in more prevalent solid tumor indications with leading experts. Results from the interim ANCHOR study of KUR-502 in heavily pretreated patients with relapsed refractory B-cell malignancies also showed encouraging responses. Out of the five evaluable patients with non-Hodgkin lymphoma treated at low doses, a 60% overall response rate was observed, including two complete responses persisting over six months and complete or partial responses in two of four patients who were previously treated with CD19-directed CAR-NKT cell therapy. A 50% overall response rate was also observed in the two patients with ALL at the first dose level, including one complete response lasting until the patient died six weeks later due to unrelated causes. The clinical efficacy achieved this early in phase I clinical trial following a single infusion of KUR-502 at the low doses of 10 million and 30 million cells/m² portends a high probability of technical success moving forward with dose escalation. Lastly, for our KUR-503 program, an allogeneic GPC3 CAR-NKT cell therapy for patients with advanced GPC3-expressing solid tumors, we presented early preclinical data at ASCO in June. This data highlighted enhanced persistence and antitumor activity with VAT F3 compared to IL-15, providing foundational support for clinical development in patients with advanced GPC3-expressing hepatocellular carcinoma. We remain highly optimistic with these encouraging early data and look forward to providing additional updates as our data matures further. With that, I will now turn the call over to our Chief Medical Officer for cell therapy, Dr. Darrel Cohen, who will discuss next steps for our NKT cell therapy pipeline. Darrel? Thank you, Dan, and good morning, everyone. Our NKT cell therapy programs continue to steadily advance, and I'm highly enthusiastic by the outpatient potential of NKT cell-based treatments and their potential for improved safety, efficacy, and accessibility over other immune effector cell therapy options. Our development pipeline supports clinical evaluation of both autologous and allogeneic NKT cell therapy options for solid tumors and hematological malignancies. The natural tropism of NKT cells to home towards tumor sites, expand following administration, and persist indicates a durable therapeutic potential for these cell types. It is notable that the potent antitumor activity that we are seeing in early dose escalation studies of our first two investigational CAR-NKT cell therapy products is occurring at dose levels that are substantially lower than those needed to achieve clinical efficacy with CAR- T cell and CAR- NK cell therapies. This potency enables the ability to dose escalate and repeat doses to safely drive deeper and more durable responses. Looking ahead, for KUR-501, enrollment of additional primarily pediatric patients with relapse-refractory high-risk neuroblastoma in the single-institution GINAKIT-2 study of autologous GD2 CAR-NKT cells at the two highest dose levels, starting with dose level 5 or 300 million cells/m², while still maintaining the opportunity to offer a second cycle of treatment for consolidation, is ongoing. We anticipate providing a data update for this study evaluating the dose escalation, safety, and preliminary efficacy in the first half of 2023. Ultimately hope to make a go or no-go decision about initiating a pivotal registration-directed study soon thereafter following operational feasibility assessments and health authority feedback. For KUR-502, the single-institution ANCHOR study of one or two cycles of allogeneic CD19 CAR-NKT cells is presently expanding into a multicenter ANCHOR2 study in order to expedite enrollment of patients with relapse refractory B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, or acute lymphocytic leukemia. We are also in the process of amending the protocol to explore two higher dose levels as well as a multiple weekly x 3 dosing regimen that may further enhance the depth and duration of the clinical responses already observed at the lower dose levels. We expect to have another interim phase I ANCHOR dose escalation safety and preliminary efficacy data update in the first half of 2023. Lastly, we plan to file an IND application for KUR-503 in 2023 for the investigational treatment of patients with advanced GPC3 expressing hepatocellular carcinoma. The ability of NKT cells to combine the best of both NK cells in terms of avoiding graft versus host disease without the need for T-cell receptor gene editing and T cells in terms of manufacturing, including proliferation, post-activation, and cryopreservation, as well as memory and persistence, continues to support the vast therapeutic potential of NKT cells as the Goldilocks of cellular therapies. I will now turn the call over to Jeff to discuss operations. Jeff? Good morning, everyone. I wanna begin by talking about some of the growth drivers of our business. Let me start with an update on our upcoming Milla Pharmaceuticals launch. We currently anticipate launching the first product at the end of 2022 or early in the first quarter of 2023. We are very excited about this launch as this product is consistently on the FDA shortage list, and we expect competition to be very limited. Turning to Gland Pharma, we just completed a deal with Gland, which should enable us to launch a new exciting product in the first quarter of 2023. I also wanted to provide more visibility on our U.S. partnership with AMPURE and its injectable company, Abbott. Athenex already launched the first product from this collaboration in the third quarter. This product was isoproterenol, otherwise known as ISUPREL, under the Abbott label. By the end of the year, we plan to launch the same product under the Athenex label. We are also on target to launch two additional products from this partnership before the end of the year. Additionally, we have been offered the opportunity to launch one of the most important products in the AMPURE pipeline, and we are working with them to potentially launch this product at the beginning of the new year. The other significant products from our collaboration are anticipated to launch throughout 2023. AMPURE is also back integrated in the API on many of these products, which provides a very competitive transfer price to Athenex. These future launches can be a significant growth driver for our business. In May, we launched two injectable drugs, Pemetrexed and Bortezomib, at market formation. Both drugs attracted a large number of competitors, and as a result of that, the price eroded very quickly. Both of these drugs have very few barriers to entry, which I mean readily available API, no manufacturing issues, and no complex formulation puzzles to solve. In the future, we focus on products that do have significant barriers to entry, and we expect larger revenues after patent expiration, as well as better margins. We are pleased to report that our APD and APS businesses achieved our objectives for the third quarter. We still expect to meet our previously stated 20%-25% revenue growth guidance. I will now turn it over to Joe to discuss our financial performance. Thank you, Jeff, and good morning, everyone. As we continue in our season of breaking down and building back up, I am pleased to report that we are delivering on the plan we outlined earlier this year on our fourth quarter call to divest non-core assets and reduce operating expenses. In the midst of turbulent markets, we have recently also experienced favorable wins that have helped us move forward. In the first half of 2022, we raised $125 million from the sale of assets. Continuing on that plan, the second half of the year, the closing of the sale of our China API operations will bring in gross proceeds of approximately $18 million over the coming months. Also, over the coming months, we will continue to keep you informed as we execute on additional strategic transactions. We have used these asset sale proceeds to reduce our debt balance from $150 million at the end of 2021 down to $47.5 million at the end of September 2022, with more reductions to follow. We further strengthened our balance sheet with our equity offering in August, which generated proceeds of $30 million. In parallel, cash burn remains top of mind, so I want to again highlight a figure that you can think of as a proxy for this metric. This figure is our cash flows from operating activities and continuing operations. This number excludes results from the Dunkirk sale, the Klisyri royalty sale, and the pending sale of the China API facility, which are reported under discontinued operations. For the third quarter of 2022, the cash used was $15.7 million. This compares to the cash used in the third quarter of 2021, of $33.2 million, which represents a year-over-year decrease of 53%. On a sequential basis, this change from the second quarter of 2022 represents a 14% decrease. For the first nine months of 2022, cash used totals $52.5 million, down 46% from the $97 million in the first nine months of 2021. Now let's review the third quarter financials. I ask that you please refer to our press release that was issued earlier today for a full summary of our results, but I will highlight the following. Total revenues for the third quarter of 2022 were $33.5 million, compared to $31.4 million for the same period in 2021. Product sales revenue increased by $5 million or 19% over the third quarter of 2021. R&D expenses totaled $9.2 million for the third quarter, a decrease of $8.5 million or 48% year-over-year, attributed primarily to a reduction in oral paclitaxel development costs as well as other operational costs. SG&A expenses totaled $9.4 million for the third quarter, a decrease of $8.7 million or 48% as compared to $18.1 million in the prior year quarter, which was primarily related to decreased oral paclitaxel commercialization expenses. Net losses attributable to Athenex for the third quarter 2022 were $19.7 million or $0.14 per diluted share versus $36.1 million or $0.33 per diluted share in the third quarter of 2021. As of September 30th, 2022, Athenex had cash equivalents and restricted cash of $40.4 million. I will now turn the call back to Johnson for closing remarks. Thank you everyone for joining our investor call today. We continue to execute on Athenex transformation into a streamlined pure-play NKT cell therapy company. This quarter, we have made significant progress and continued to strengthen our balance sheet. As we pursue our goal, we plan to seek additional opportunities to monetize non-core assets, reduce operating expenses, and extend our cash runway, while at the same time appropriately supporting the growth of our exciting NKT cell therapy business. We are confident that our NKT cell therapy programs have the potential to become market leaders that can benefit patients with solid tumors and hematological malignancies worldwide. Thank you for your attention. Thank you very much. We will now begin the question and answer session. To ask a question, you may press star and one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Thank you. The first question comes from the line of Jonathan Miller with Evercore ISI. Please go ahead. Hi guys. Thanks so much for taking my question and congrats on your progress moving towards a pure-play company. I'd like to focus my questions on that topic, if I may. Starting with maybe oral paclitaxel. Obviously we haven't seen I-SPY2 yet, but you suggested that you'd start a pivotal, possibly with a partner. Is that as opposed to outright divestiture of the asset? Can you maybe give me some updated thoughts on what your plans are for oral paclitaxel in the various case scenarios for I-SPY2? Secondly, we had several pieces of commentary on the Specialty Pharma business and growing that out, increasing margins. Are you still planning on divesting that business outright as well? If so, what is the gating factor for selling that, yeah? Thank you for your question. As we have indicated in the past that we have made a decision to pivot the company into NKT cell therapy company, therefore we will consider all options to unlock value for the shareholders with regard to all the non-core assets. Obviously, I mean, assets that are not related to NKT cell therapy will be considered as non-core assets that we would like to explore different approach with regard to unlocking shareholder value. With regard to your first question, we are expecting sort of the completion of the I-SPY data study very soon, before the end of the year. Once we have more information and then we can get the sort of partnerships interest, then we'll explore what's the best way to unlock value, and all options are on table for consideration. Now, with regard to your second question, the specialty pharma asset, again, certainly we will consider all strategic options. It is a very healthy division, showing very good growth and, therefore, we consider that it has a lot of value. Jeff, do you want to add any comments to the question? No, you said it perfectly. We certainly will evaluate what's in the best interest of our shareholders, as we move forward. Thank you. Mr. Miller, do you have any other questions? That's all for now. Thank you. Thank you. Thank you. The next question is from the line of Yale Jen with Laidlaw & Co. Please go ahead. Good morning, and thanks for taking the questions. Just focused on the NKT cell at this point. For the KUR-501, you have two doses to escalate. I'm just curious at this point in whether you already completed the first dose and moving to the second one, or how should we think about the status of this progress? I have a follow-up. Dan? Hi, Yale. Thanks for the question. Just as a reminder, we presented data on dose level 4, where we show two responses out of three patients, and one of the patients was a complete response, lasting for about 12 months. We're very excited about that data. What we said in the past is that now we're looking to dose escalate into dose level 5 and dose level 6, which is 300 million cells/m² and 1 billion cells. We don't give incremental update in terms of patient enrollment, but we look forward to presenting data at the next appropriate medical conference or venue. Please stay tuned. Okay, great. That's helpful. Maybe on KUR-502, which is the ANCHOR study you anticipate to provide interim analysis data sometime next year or first half of next year. How should we think about in terms of a possible sort of number of patients by the time you know will have that interim data report as well as maybe the duration of some patients? In other words, what sort of expectations we should think about for that interim analysis? Yeah, thanks for the question. I can provide some framework for you to think about to answer your question. Again, we don't, you know, provide incremental update on, you know, patient enrollment and duration of response and the follow-up. We got our, you know, company sponsor IND back in March of this year, which allows us to expand the current single center study at Baylor to a multicenter study, you know, for ANCHOR, what we call ANCHOR 2 or KUR-502 product. We're, you know, working hard to stand up, you know, at different sites. We're looking to stand up, you know, up to eight-10 sites over time. We have... You know, this is really a function of, you know, how many patients, you know, are being enrolled as well as the, maturity of the data. You know, it's gonna be, you know, both factors will be input into when we present the data in an appropriate medical conference or a venue, sometime in the first half of 2023. Okay, great. That's again very helpful. Maybe just squeezing one more. In terms of the API specialty pharma business, the COGS, cost of goods this year over the last three quarters seems lower than prior years. Should we anticipate going forward this will improve and what may be the basis for improvement? Just a little bit color on that as well. Thanks. Jeff? Yeah. Thanks for the question, Yale. The process that we go through on the more mature products is we're constantly looking for alternative suppliers that can either reduce the profit shares that we have or most importantly, reduce the transfer price. We've been very successful on that. Many of the products as we move into the future do not include profit sharing, and many of our partners are back integrated in the raw material, which gives us a much lower transfer cost and a much higher margin because of no profit share. Lastly, when we have now moved forward on the AMPURE deal, we've launched the first product. All of these products will have no profit sharing, and AMPURE is back integrated in almost all the raw material, so the transfer price is very good. I think that the trend of higher margins or lower transfer price will continue as we move forward. Okay, great. Thanks a lot. That's very helpful. Thanks. The best of luck as things move forward. Thank you, Yale. Thank you. Again, if you have questions, please press star and one on your touchtone telephone. This is a reminder to the participants to ask a question, you may press star and one on your telephone keypad. As there are no further questions, this concludes our question and answer session. I would like to turn the conference back to Dr. Johnson Lau for closing comments. Over to you. Thank you everyone for joining us today. We'll continue to pivot the company towards a biotech focusing on NKT cell therapy. We continue to advance our programs in NKT cell therapy. We're expecting I-SPY2 study completion before the end of the year, and we'll continue to sort of work to strengthen our specialty pharma, but at the same time looking for strategic options to unlock value as well. We'll continue our mission to develop anticancer therapy for patients and the process to unlock value for the shareholders. Thank you very much for your attention. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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