Athenex Inc (ATNX) 2022 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Athenex Third Quarter 2020 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 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one your telephone keypad. To withdraw your question please press star then two. Please note, this event is being recorded.

女士們先生們，美好的一天，歡迎來到 Athenex 2020 年第三季度收益電話會議。所有參與者都將處於僅收聽模式。如果您需要幫助，請按星號鍵然後按 0 向會議專家發出信號。今天的演講結束後，您將有機會提問。要提出問題，您可以按星號鍵，然後按您的電話鍵盤。要撤回您的問題，請按星號，然後按二。請注意，正在記錄此事件。

(Operator Insructions]

（操作員說明]

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.

我現在想將會議交給 LifeSci Advisors 投資者關係董事總經理 Tim McCarthy。謝謝，交給你了。

Good morning, and thank you for joining our conference call. Today, an update on Phoenix' 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 earlier 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. Jeff Yordon, Chief Operating Officer; and Mr. Joe Annoni, Chief Financial Officer. I will now turn the call over to Johnson for introductory remarks.

早上好，感謝您加入我們的電話會議。今天，將提供 Phoenix 業務的最新情況以及對 2022 年第三季度財務業績的回顧。詳細介紹業績的新聞稿於今天上午早些時候發布，可在公司網站上查閱。該電話的重播也將在公司網站上存檔。在電話會議期間，公司將對未來事件做出預測或前瞻性陳述，包括關於 2022 財年及以後預期的財務、業務和臨床里程碑的陳述。我們鼓勵您查看公司過去和未來向美國證券交易委員會提交的文件，這些文件確定了可能導致實際結果或事件與前瞻性陳述中描述的結果或事件存在重大差異的具體因素。您可以在 www.sec.gov 的 EDGAR 數據庫或我們網站 www.athenex.com 的投資者關係部分找到我們向 SEC 提交的文件。首席執行官劉強生博士將在今天上午的電話會議上發言； Athenex Cell Therapy 總裁 Daniel Lang 博士； Cell Therapy 首席醫療官 Darrel Cohen 博士； Jeff Yordon 先生，首席運營官；首席財務官 Joe Annoni 先生。我現在將把電話轉給約翰遜作介紹性發言。

Thank you, Tim, and 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 we are 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 noncore 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 30, 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.

謝謝蒂姆，也謝謝大家今天早上參加我們的電話會議。對於 Athenex 來說，這是另一個富有成效的季度，因為我們致力於將公司轉變為 NKT 細胞療法的純粹領導者。首先，我們在 8 月份通過股權發行籌集了 3000 萬美元。我也很高興地宣布，與去年相比，我們正在順利實現運營支出減少 50% 的目標。我們的財務指導也保持在正軌上。內部支出目標和我們的財務優先事項保持不變。我們通過將非核心資產貨幣化並確定業務中的潛在價值來源，同時繼續專注於審慎的資本配置，繼續加強我們的資產負債表。迄今為止，我們已動用合併交易所得款項來償還大部分債務，從去年底的 1.5 億美元減至截至 2022 年 9 月 30 日的 4750 萬美元。我們此前宣布有意剝離我們在中國的 API 業務七月。由於與 COVID 相關的限制，某些行政程序已被延遲。不過，我很高興地說，我們已經滿足了所有的成交條件，並且正處於完成交易的最後階段。

We are confident that we can complete the closing and receive 70% of the proceeds from the sale as soon as the quoted 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 have a meeting with NASDAQ on October 20 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 14, 2023. We are now planning to hold a virtual Special Shareholders Meeting on November 22 at 9:30 a.m. Eastern time, and you issued a proxy filing on October 11 that provides additional details. This meeting is being held to authorize a potential reverse split of the stock, among other things.

我們有信心，一旦政府取消報價限制，我們就能完成交割並獲得 70% 的出售收益。剩餘金額將在接下來的幾個月內收到。我現在想提供有關我們納斯達克上市的最新信息。如您所知，我們要求在 9 月獲得第二次 180 天的日曆延期，以重新遵守 1 美元交易規則。該請求被納斯達克拒絕，我們隨後對納斯達克的決定提出上訴。我們將於 10 月 20 日與納斯達克舉行會議，並很高興地宣布我們的上訴成功。納斯達克聽證會小組批准了我們繼續上市的請求，並將我們恢復合規的期限延長至 2023 年 3 月 14 日。我們現在計劃在東部時間 11 月 22 日上午 9 點 30 分召開虛擬特別股東大會，您發布了代理10 月 11 日提交的文件提供了更多詳細信息。召開這次會議是為了授權對股票進行潛在的反向拆分等。

A favorable outcome provides the board with the authority to effect a reverse split. In the case that the share price does not rebank over 1$ by March 14, 2023. We encourage you to review the proxy and vote in favor of the outline 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 and 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 MHA and have submitted comprehensive responses to their questions in September. We will provide another update on our progress at the appropriate time. Our old paclitaxel is being studied in I-SPY 2 trial, a Phase II program evaluating oral paclitaxel in combination with Dostarlimab plus or minus carboplatin in the new adjuant treatment of breast cancer patients.

有利的結果為董事會提供了進行反向拆分的權力。如果到 2023 年 3 月 14 日股價沒有回升超過 1 美元。我們鼓勵您審查委託書並投票贊成大綱提案。現在讓我談談一些管道更新。我們繼續執行我們的戰略支點，轉變為一家領先的 NKT 細胞治療公司，並保持有利地位，以發展成為有吸引力且不斷增長的免疫有效細胞治療領域的競爭者。我們的首要任務是通過劑量升級和持續患者招募來推進我們創新的 NKT 細胞治療平台，並將結果展示給科學界和投資者界。關於我們在英國提交的口服紫杉醇治療轉移性乳腺癌的監管報告，我們繼續與 MHA 進行所有監管互動，並在 9 月份提交了對他們問題的全面答复。我們將在適當的時候再次更新我們的進展情況。我們的舊紫杉醇正在 I-SPY 2 試驗中進行研究，這是一項 II 期項目，評估口服紫杉醇與 Dostarlimab 加或減卡鉑聯合用於乳腺癌患者的新輔助治療。

This study is being conducted by the Quantum Leap Healthcare Collaborative and in conjunction with GlaxoSmithKline, which is the dose direct 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% to 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 will turn the call over to Dr. Dan Lang to provide some updates on our NKT cell therapy program. Dan, please go ahead.

這項研究由 Quantum Leap Healthcare Collaborative 與劑量直接製造商葛蘭素史克 (GlaxoSmithKline) 聯合進行。這項研究預計將在年底前完成。我們希望能夠在可用時共享來自該程序的數據。如果結果是積極的，那麼我們的下一步可能是將口服紫杉醇推進到一項關鍵研究中，我們將尋求與開發夥伴合作這樣做。我們的 APD 業務符合我們第三季度的內部目標。我們將之前發布的產品銷售增長指引維持在 20% 至 25% 的範圍內。我們通過優先考慮 FDA 藥品短缺清單上列出的產品，繼續推進新產品的發布並最大限度地增加收入機會。與此同時，我們正在穩步提高利潤率。有了這個，我將把電話轉給 Dan Lang 博士，以提供有關我們的 NKT 細胞治療計劃的一些更新。丹，請繼續。

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 therapeutic approaches. The combined innate and adaptive immune properties or banking T cells together with the ability of CART-T 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 2 lead investigational programs, CR1, an autologous GD2 CAR NKT cell therapy for patients with relapsed refractory hydrous evoglastoma; 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 UNICA 2 study of KUR-501 at ASGCT in May and from the ANCHOR study of KUR-502at AFTCT 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 1 to 2 weeks post infusion.

謝謝你，約翰遜，大家早上好。我們仍然專注於推進我們一流的 NKT 細胞治療平台，該平台有可能克服當前免疫效應細胞治療方法的局限性。結合先天性和適應性免疫特性或儲存 T 細胞，以及 CART-T 細胞靶向腫瘤和腫瘤微環境的能力，使高效現成治療的潛力成為可能，這種治療毒性更低，更容易被患者接受。更廣泛的患者群體。我們正在進行的實體瘤和血液惡性腫瘤臨床試驗已經顯示出早期的希望，我們仍然對這種新型細胞治療方法的治療潛力感到高度鼓舞。上個季度，我們繼續推進我們的 2 個主要研究項目，CR1，一種自體 GD2 CAR NKT 細胞療法，用於治療復發性難治性含水成細胞瘤患者； KUR-502 是一種用於復發/難治性 B 細胞惡性腫瘤患者的同種異體 CD19 CAR NKT 細胞療法。我們提供了來自 5 月份在 ASGCT 的 KUR-501 UNICA 2 研究和 4 月份在 AFTCT 的 KUR-502 ANCHOR 研究的中期 I 期劑量遞增數據更新。這兩項研究的數據支持一致的發現，包括在低劑量水平下令人鼓舞的反應，有利的動力學特徵表明 CAR NKT 細胞能夠在所有患者中安全地擴增過繼轉移後的能力，並在輸注後約 1 至 2 周達到峰值。

Also promising was 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 and NKT cells. There are few cases of low-grade cytokine release syndrome that did occur for a manageable and reversible. Overall, those data support why 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 GITICATE-2 study of KUR-501 in heavily pretreated patients with relapsed/refractory high-risk neuroblastoma included 3 objective responses in 12 patients. With 2 of these 3 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 CV62L expression. Given the encouraging data with KUR-501 in hybrid neuroblastoma, we continue to explore GD2 CAR NKT cell therapy opportunities in more prevalent solid tumor indications with leading experts. As another reminder, results from the interim ANCHOR study of KUR-502 in heavily pretreated patients with relapsed/refractory B-cell malignancies also showed encouraging responses.

同樣有希望的是，CAR NKT 細胞位於腫瘤部位。這兩個項目都保持了良好的安全性，沒有任何輸液相關反應、劑量限制毒性、神經毒性、移植物抗宿主病或與 CAR 和 NKT 細胞相關的嚴重副作用。很少有低度細胞因子釋放綜合徵的病例確實發生了可控和可逆的。總的來說，這些數據支持為什麼 KUR-501 和 KUR-502 的治療窗口有可能進一步增加劑量，以幫助安全地推動更深入、更持久的反應。提醒一下，GITICATE-2 對 KUR-501 在經過大量預處理的複發/難治性高危神經母細胞瘤患者中進行研究的中期數據包括 12 名患者的 3 項客觀反應。這 3 名患者中有 2 名在劑量水平 4 下達到反應，包括持續超過 12 個月的持久完全反應。反應的預測因子包括 KUR-501 暴露和 CV62L 表達。鑑於 KUR-501 在混合神經母細胞瘤中令人鼓舞的數據，我們將繼續與領先的專家一起探索 GD2 CAR NKT 細胞治療更普遍的實體瘤適應症的機會。另一個提醒是，KUR-502 在經過大量預處理的複發/難治性 B 細胞惡性腫瘤患者中的中期 ANCHOR 研究結果也顯示出令人鼓舞的反應。

Out of the 5 evaluable patients with non-pattern lymphoma treated at low doses, a 60% overall response rate was observed, including 2 complete responses persisting over 6 months and complete or partial responses in 2 or 4 patients who were previously treated with CD19 directed CAR-T cell therapy. A 50% overall response rate was also observed in the 2 patients with ALL at the first dose level, including 1 complete response lasting until the patient died 6 weeks later due to unrelated causes. The clinical efficacy achieved this early in Phase I clinical trial follow a single infusion of KUR-502 at the low doses of 10 million and 30 million cells per meter square contains a high probability of technical success moving forward with dose escalation. Lastly, for our KUR-503 program in allogeneic GPC3 CAR NKT cell therapy for patients with advanced GPC3 expressing solid tumors represented early preclinical data at ASCO in June. These data highlighted enhanced persistence and antitumor activity with BATF3 compared to IL-15, providing foundational support for clinical development in patients with advanced GPC3 expressing hepatocellular carcinoma.

在以低劑量治療的 5 名可評估的非型淋巴瘤患者中，觀察到 60% 的總體反應率，包括 2 名持續超過 6 個月的完全反應，以及 2 名或 4 名先前接受過 CD19 定向治療的患者的完全或部分反應CAR-T細胞療法。在第一個劑量水平的 2 名 ALL 患者中也觀察到 50% 的總體反應率，包括 1 名完全反應持續到患者 6 週後因無關原因死亡。在以每平方米 1000 萬個和 3000 萬個細胞的低劑量單次輸注 KUR-502 後，在 I 期臨床試驗早期就達到了這一臨床療效，隨著劑量的增加，技術成功的可能性很高。最後，對於我們針對晚期 GPC3 表達實體瘤患者的同種異體 GPC3 CAR NKT 細胞療法的 KUR-503 計劃，代表了 6 月份 ASCO 的早期臨床前數據。這些數據強調了 BATF3 與 IL-15 相比增強了持久性和抗腫瘤活性，為晚期 GPC3 表達肝細胞癌患者的臨床開發提供了基礎支持。

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?

我們對這些令人鼓舞的早期數據保持高度樂觀，並期待隨著我們的數據進一步成熟提供更多更新。有了這個，我現在將把電話轉給我們的細胞治療首席醫療官 Darrel Cohen 博士，他將討論我們 NKT 細胞治療管道的下一步。達雷爾？

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 the 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 2 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 NKT cell therapies.

謝謝丹，大家早上好。我們的 NKT 細胞治療計劃繼續穩步推進，我對基於 NKT 細胞治療的門診潛力以及與其他免疫效應細胞治療方案相比提高安全性、有效性和可及性的潛力充滿熱情。我們的開發管道支持對實體瘤和血液惡性腫瘤的自體和同種異體 NKT 細胞療法選項進行臨床評估。 NKT 細胞向腫瘤部位歸巢、給藥後擴展並持續存在的自然趨向性表明這些細胞類型具有持久的治療潛力。值得注意的是，我們在我們的前 2 款研究性 CAR NKT 細胞治療產品的早期劑量遞增研究中看到的有效抗腫瘤活性發生的劑量水平大大低於使用 CAR-T 細胞和 CAR 實現臨床療效所需的劑量水平NKT 細胞療法。

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 relapsed/refractory high-risk neuroblastoma in the single institution GENAKIT-2 study of autologous GD2 CAR NKT cells at the 2 highest dose levels, starting with dose level 5 or 300 million cells per meter squared 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. We 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 1 or 2 cycles of allogeneic CD19 CAR NKT cells is presently expanding into a multicenter ANCHOR 2 study in order to expedite enrollment of patients with relapsed/refractory B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia or acute lymphocytic leukemia.

這種效力使劑量升級和重複劑量能夠安全地驅動更深入和更持久的反應。展望未來，對於 KUR-501，在單一機構 GENAKIT-2 研究中招募更多患有復發/難治性高危神經母細胞瘤的兒科患者，以 2 個最高劑量水平（從劑量水平 5 或 300 開始）對自體 GD2 CAR NKT 細胞進行研究每平方米百萬個細胞，同時仍然保持提供第二個鞏固治療週期的機會正在進行中。我們預計將在 2023 年上半年為這項研究提供數據更新，評估劑量遞增、安全性和初步療效。我們最終希望在操作完成後不久就啟動一項關鍵的註冊導向研究做出通過或不通過的決定可行性評估和衛生當局的反饋。對於 KUR-502，針對 1 或 2 個週期的同種異體 CD19 CAR NKT 細胞的單一機構 ANCHOR 研究目前正在擴展為多中心 ANCHOR 2 研究，以加快招募患有復發/難治性 B 細胞非霍奇金淋巴瘤、慢性淋巴細胞白血病或急性淋巴細胞白血病。

We are also in the process of amending the protocol to explore 2 higher dose levels as well as a multiple weekly times 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 cellulose therapies. I will now turn the call over to Jeff to discuss operations. Jeff?

我們還在修改方案以探索 2 個更高的劑量水平以及每週 3 次的多次給藥方案，這可能會進一步增強已經在較低劑量水平下觀察到的臨床反應的深度和持續時間。我們預計將在 2023 年上半年進行另一次中期 I 期錨定劑量遞增安全性和初步療效數據更新。最後，我們計劃在 2023 年提交 KUR-503 的 IND 申請，用於晚期 GPC3 表達肝細胞癌患者的研究性治療癌。 NKT 細胞在避免移植物抗宿主病方面結合了兩種 NK 細胞的優點，而無需 T 細胞受體基因編輯和 T 細胞在製造方面的優點，包括增殖、激活後和冷凍保存因為記憶力和持久性繼續支持 NKT 細胞作為纖維素療法的金發姑娘的巨大治療潛力。我現在將電話轉給 Jeff 來討論操作。傑夫？

Good morning, everyone. I want to begin by talking about some of the growth drivers of our business. Let me start with an update on our upcoming myelo pharma 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 charge list, and we expect competition to be very limited. Turning to GlanPharma. We just completed a deal with land, 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 Mpure and its injectable company Advent. Athenex already launched the first product from this collaboration in the third quarter. This product was isoproterenol, otherwise known as Isoprol under the Abbott label. By the end of the year, we plan to launch the same product under the Athenex label.

大家，早安。我想首先談談我們業務的一些增長動力。讓我從我們即將推出的 myelo pharma 發布的最新消息開始。我們目前預計在 2022 年底或 2023 年第一季度初推出第一個產品。我們對此次發布感到非常興奮，因為該產品一直在 FDA 收費清單上，我們預計競爭非常有限。轉向 GlanPharma。我們剛剛完成了土地交易，這應該使我們能夠在 2023 年第一季度推出令人興奮的新產品。我還想更多地了解我們與 Mpure 及其註射劑公司 Advent 在美國的合作夥伴關係。 Athenex 已經在第三季度推出了此次合作的第一款產品。該產品是異丙腎上腺素，也稱為雅培標籤下的異丙醇。到今年年底，我們計劃在 Athenex 標籤下推出相同的產品。

We are also on target to launch 2 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 Mpure 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. Mpure 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 2 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 puzzle to solve. And 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.

我們還計劃在今年年底之前通過該合作夥伴關係推出另外 2 款產品。此外，我們有機會推出 Mpure 管道中最重要的產品之一，我們正在與他們合作，有可能在新年伊始推出該產品。我們合作的其他重要產品預計將在整個 2023 年推出。Mpure 還反向集成到許多這些產品的 API 中，這為 Athenex 提供了極具競爭力的轉讓價格。這些未來的發布可能會成為我們業務的重要增長動力。 5月，我們在市場形成時推出了培美曲塞和硼替佐米2個注射劑藥物。這兩種藥物都吸引了大量的競爭者。結果，價格迅速下跌。這兩種藥物的進入壁壘都非常低，我的意思是 API 隨時可用，沒有製造問題，也沒有需要解決的複雜配方難題。未來，我們將專注於確實具有重大進入壁壘的產品，我們預計在專利到期後會有更大的收入以及更高的利潤率。

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% to 25% revenue growth guidance. I will now turn it over to Joe to discuss our financial performance.

我們很高興地報告，我們的 APD 和 APS 業務實現了第三季度的目標。我們仍然希望達到我們之前規定的 20% 至 25% 的收入增長指導。我現在將把它交給喬來討論我們的財務業績。

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 noncore assets and reduce operating expenses. And 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 in 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.

謝謝你，傑夫，大家早上好。隨著我們繼續進入崩潰和重建的季節，我很高興地報告，我們正在實施我們今年早些時候在第四季度呼籲剝離非核心資產和減少運營費用時概述的計劃。在動蕩的市場中，我們最近也經歷了有利的勝利，幫助我們前進。 2022 年上半年，我們通過出售資產籌集了 1.25 億美元。下半年繼續執行該計劃，完成出售我們的中國 API 業務將在未來幾個月帶來約 1800 萬美元的總收益。同樣在接下來的幾個月裡，我們將繼續讓您了解我們執行其他戰略交易的情況。我們已使用這些資產出售收益將我們的債務餘額從 2021 年底的 1.5 億美元減少到 2022 年 9 月底的 4750 萬美元，隨後還會進一步減少。

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 a Dunker sale, the Closure 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 use 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%. And on a sequential basis, this change from the second quarter of 2022 represents a 14% decrease. For the first 9 months of 2022, cash used totaled $52.5 million, down 46% from the $97 million in the first 9 months of 2021.

我們通過 8 月份的股票發行進一步加強了我們的資產負債表，募集資金 3000 萬美元。與此同時，現金消耗仍然是首要考慮因素，所以我想再次強調一個你可以認為是該指標的代表的數字。這個數字是我們來自經營活動和持續經營活動的現金流量。該數字不包括 Dunker 銷售、Closure 特許權使用費銷售和中國 API 設施的未決銷售結果，這些在已終止運營項下報告。 2022 年第三季度，現金使用量為 1570 萬美元。相比之下，2021 年第三季度使用的現金為 3320 萬美元，同比下降 53%。與 2022 年第二季度相比，這一變化環比下降了 14%。 2022 年前 9 個月，現金使用總額為 5250 萬美元，比 2021 年前 9 個月的 9700 萬美元下降了 46%。

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 for $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 30, 2022, Athenex had cash, cash equivalents and restricted cash of $40.4 million. I will now turn the call back to Johnson for closing remarks.

現在讓我們回顧一下第三季度的財務狀況。請參閱我們今天早些時候發布的新聞稿，了解我們結果的完整摘要，但我將強調以下內容。 2022 年第三季度總收入為 3350 萬美元，而 2021 年同期為 3140 萬美元。產品銷售收入比 2021 年第三季度增加 500 萬美元或 19%。第三季度研發費用總計 920 萬美元，同比減少 850 萬美元或 48%，這主要歸因於口服紫杉醇開發成本以及其他運營成本的減少。第三季度 SG&A 費用總計 940 萬美元，與去年同期的 1810 萬美元相比減少 870 萬美元或 48%，這主要與口服紫杉醇商業化費用減少有關。 2022 年第三季度歸屬於 Athenex 的淨虧損為 1970 萬美元或攤薄後每股 0.14 美元，而 2021 年第三季度為 3610 萬美元或攤薄後每股 0.33 美元。截至 2022 年 9 月 30 日，Athenex 的現金、現金等價物和受限制現金為4040 萬美元。我現在將把電話轉回給約翰遜，請他作結束語。

Thank you, everyone, for joining our investor call today. We continue to execute on Athenex's 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 noncore 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.

感謝大家今天加入我們的投資者電話會議。我們繼續執行 Athenex 轉型為一家精簡的純 NKT 細胞治療公司。本季度，我們取得了重大進展，並繼續加強我們的資產負債表。在我們追求目標的過程中，我們計劃尋求更多機會將非核心資產貨幣化，減少運營費用並擴大我們的現金跑道，同時適當支持我們令人興奮的 NKT 細胞治療業務的增長。我們相信，我們的 NKT 細胞治療項目有潛力成為市場領導者，造福全球實體瘤和血液惡性腫瘤患者。感謝您的關注。

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 speaker phone, 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 a roster.

非常感謝。我們現在開始問答環節。要提出問題，您可以按電話鍵盤上的星號和一個。如果您使用免提電話，請在按鍵前拿起聽筒。要撤回您的問題，請按星號，然後按二。這時候，我們會暫時停下來整理名單。

(Operator Insructions]

（操作員說明]

Thank you. The first question comes from the line of Jonathan Miller with Evercore ISI. Please go ahead.

謝謝。第一個問題來自 Evercore ISI 的 Jonathan Miller。請繼續。

Hi guys. Thanks so much for having my question and congrats on your progress moving towards the 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 IPI 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 cases -- case scenarios for KUR-502? And then secondly, we had several pieces of commentary on the spec pharma business and growing that out, increasing margins. Are you still planning on divesting that business outright as well? And if so, what is the gating factor for selling that?

嗨，大家好。非常感謝你提出我的問題，並祝賀你在轉向純公司方面取得的進展。如果可以的話，我想把我的問題集中在那個話題上。從口服紫杉醇開始。顯然，我們還沒有看到 IPI，但你建議你可能會與合作夥伴一起開始一個關鍵。這與資產的徹底剝離相反嗎？你能不能給我一些關於你在各種情況下口服紫杉醇的計劃的最新想法——KUR-502 的情況？其次，我們對規格製藥業務發表了幾篇評論，並將其發展壯大，提高了利潤率。您是否還打算徹底剝離該業務？如果是這樣，出售它的門控因素是什麼？

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. So therefore, we will consider all options to unlock value for the shareholders with regard to all the noncore assets. And obviously, I mean, assets that are not related to NKT cell therapy, it will be considered as noncore assets that we would like to explore different approach with regard to unlocking shareholder value. So with regard to your first question, we are expecting the completion of the ICI data study very soon before the end of the year. And once we have more information and then we can get the such partnerships interest that will explore what's the best way to unlock value. And all options are on table for consideration. Now with regard to your second question with regard to the specialty pharma asset, again, certainly, we will consider all strategic options. But then 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 on any comments to the question?

謝謝你的問題。正如我們過去所指出的那樣，我們已決定將公司轉變為 NKT 細胞治療公司。因此，我們將考慮所有選項，為所有非核心資產的股東釋放價值。顯然，我的意思是，與 NKT 細胞療法無關的資產，將被視為非核心資產，我們希望探索不同的方法來釋放股東價值。所以關於你的第一個問題，我們預計 ICI 數據研究很快就會在年底前完成。一旦我們掌握了更多信息，我們就能獲得此類合作夥伴的興趣，從而探索什麼是釋放價值的最佳方式。所有選項都擺在桌面上供考慮。現在關於你關於專業製藥資產的第二個問題，當然，我們將再次考慮所有戰略選擇。但這是一個非常健康的部門，顯示出非常好的增長。因此，我們認為它具有很大的價值。傑夫，你想對這個問題添加任何評論嗎？

No, you've said it perfectly. We certainly will evaluate what's in the best interest of our shareholders as we move forward.

不，你說得很完美。在我們前進的過程中，我們當然會評估什麼最符合我們股東的利益。

Thank you. Mr. Miller, do you have any other questions?

謝謝。米勒先生，您還有其他問題嗎？

That's open now. Thank you.

那現在開放了。謝謝。

Thank you. The next question is from the line of I-Eh Jen with Laidlaw and Co. Please go ahead.

謝謝。下一個問題來自 I-Eh Jen 與 Laidlaw and Co 的合作。請繼續。

Good morning and thanks for taking the questions. Just focused on the NKT sale at this point. For the 501, you have 2 doses to escalate. I'm just curious at this point whether you already completed the first dose and moving to the second one? Or how should we think about the status of this progress. Then I have a follow-up.

早上好，感謝您提出問題。此時只關注 NKT 的銷售。對於 501，您有 2 劑需要升級。我現在很好奇你是否已經完成了第一劑並開始服用第二劑？或者我們應該如何看待這個進展的狀態。然後我有一個後續行動。

Thanks for the question. Just as a reminder, we presented data on dose level 4, where we show 2 responses out of 3 patients. And one of the patients was a complete response lasting for about 12 months. So 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 per meter square 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. So please stay tuned.

謝謝你的問題。提醒一下，我們提供了劑量水平 4 的數據，其中我們顯示了 3 名患者中的 2 名反應。其中一名患者的完全反應持續了大約 12 個月。所以我們對這些數據感到非常興奮。我們過去說的是，現在我們正在尋求劑量升級到劑量水平 5 和劑量水平 6，即每平方米 3 億個和 10 億個細胞。我們不會在患者登記方面提供增量更新，但我們期待在下一次適當的醫學會議或地點展示數據。所以請繼續關注。

Okay. Great. That's helpful. And maybe one on 502, which is the ANCHOR study you anticipate to provide interim data sometime next year or first half of next year. how should we think in terms of a possible to a number of patients by the time you have that internal 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

好的。偉大的。這很有幫助。也許是 502 上的一個，這是你預計明年某個時候或明年上半年提供中期數據的 ANCHOR 研究。在您獲得內部數據報告以及某些患者的持續時間時，我們應該如何考慮對許多患者的可能性。換句話說，我們應該為中期分析考慮什麼樣的期望

Yes. Thanks for the question. So I can provide some framework for you to think about the answer to your question. Again, we don't provide incremental update on patient enrollment and duration of response and a follow-up. But we got our company-sponsored IND back in March of this year. which allows us to expand the current single send study at Baylor to a multicenter study for -- what we call ANCHOR 502 product. So we're working hard to stand up different sites. We're looking to stand up up to 8 to 10 sites over time. We have -- this is really a function of how many patients are being enrolled as well as the maturity of the data. So it's going to be -- both factors will be input into when we present the data in the appropriate medical conference or a venue sometime in the first half of '23.

是的。謝謝你的問題。所以我可以提供一些框架讓你思考你的問題的答案。同樣，我們不提供有關患者登記、反應持續時間和後續行動的增量更新。但我們在今年 3 月獲得了公司贊助的 IND。這使我們能夠將貝勒當前的單發送研究擴展到多中心研究——我們稱之為 ANCHOR 502 產品。所以我們正在努力建立不同的站點。隨著時間的推移，我們希望建立多達 8 到 10 個站點。我們有——這實際上取決於有多少患者被招募以及數據的成熟度。所以這將是——當我們在 23 年上半年的某個時間在適當的醫學會議或地點展示數據時，這兩個因素都會被輸入。

Okay. Great. That's, again, very helpful. Maybe just squeezing one more. In terms of the API Specialty Pharma business, the cost of goods this year over the last 3 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 of color on that as well.

好的。偉大的。這再次非常有幫助。也許只是再擠一個。就 API 專業製藥業務而言，今年過去 3 個季度的商品成本似乎低於往年。我們是否應該預測未來，這會有所改善？改進的基礎是什麼？也只有一點點顏色。

Yes. Thanks for the question, Neil. 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 Mpure deal, we've launched the first product. All of these products will have no profit sharing and Emcure is back integrated in almost all the raw material, so the transfer price is very good. So I think that the trend of higher margins, lower transfer price will continue as we move forward

是的。謝謝你的問題，尼爾。我們在更成熟的產品上經歷的過程是我們不斷尋找可以減少我們擁有的利潤份額或最重要的是降低轉讓價格的替代供應商。我們在這方面非常成功。我們走向未來的許多產品不包括利潤分享，我們的許多合作夥伴都在原材料中重新整合，由於沒有利潤分享，這使我們的轉移成本低得多，利潤率高得多。最後，當我們推進 Mpure 交易時，我們推出了第一個產品。所有這些產品都不會有利潤分享，而且 Emcure 幾乎所有的原材料都被整合回去，所以轉讓價格非常好。所以我認為隨著我們前進，更高利潤率、更低轉讓價格的趨勢將繼續下去

Okay. Great. That's very helpful. And the best luck for things move forward.

好的。偉大的。這很有幫助。事情向前發展的好運。

Thank you. Again if you have questions please press star then one on telephone. This is a reminder to the participants to ask a question you may press star and one on our telepone keypad.

謝謝。如果您有任何問題，請再次在電話中按星號，然後按一個。這是提醒參與者提出問題，您可以在我們的電話鍵盤上按星號和一個。

(Operator Insructions]

（操作員說明]

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.

由於沒有其他問題，我們的問答環節到此結束。我想將會議轉回給劉強生博士作閉幕評論。交給你了。

Thank you, everyone, for joining us today. We'll continue to visit the company towards a biotech focusing on an NKT cell therapy. We continue 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 be sort of working 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

謝謝大家今天加入我們。我們將繼續訪問這家專注於 NKT 細胞療法的生物技術公司。我們繼續推進我們在 NKT 細胞療法方面的項目。我們預計 I-SPY2 研究將在年底前完成，我們將繼續努力加強我們的專業製藥公司，但同時也在尋找戰略選擇來釋放價值。我們將繼續我們的使命，為患者開發抗癌療法，並為股東釋放價值。非常感謝您的關注

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

謝謝。會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。