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Operator
Operator
Hello, everyone. Thank you for joining us and welcome to the Innate Pharma first half 2026 business update and financial results. (Operator Instructions)
各位好。感謝各位參與,歡迎收聽 Innate Pharma 2026 年上半年業務更新與財務結果說明會。(接線員指示)
We will now hand the conference over to Stephanie Cornen, Vice President, Investor Relations, Communication and Commercial. Stephanie, please go ahead.
現在我們將把會議交給投資人關係、傳播與商務副總裁 Stephanie Cornen。Stephanie,請開始。
Stephanie Cornen - Vice President - Investor Relations, Communication & Commercial Strategy
Stephanie Cornen - Vice President - Investor Relations, Communication & Commercial Strategy
Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma's first half 2026 business update and financial results conference call. The press release and today's presentation are both available on the IR section of our website.
各位早安、午安。感謝各位參與 Innate Pharma 2026 年上半年業務更新與財務結果電話會議。新聞稿與今日簡報皆可於我們網站的投資人關係(IR)專區取得。
Before we begin, I would like to remind everyone that today's presentation includes forward-looking statements based on current expectations. These statements involve risks and uncertainties that could cause actual results to differ materially.
在開始之前,我想提醒各位,今日簡報包含基於目前預期的前瞻性陳述。這些陳述涉及風險與不確定性,可能導致實際結果出現重大差異。
To briefly cover today's agenda, our CEO, Jonathan Dickinson, will begin with a strategic overview and outlook.
簡要說明今日議程,我們的執行長 Jonathan Dickinson 將先進行策略概覽與展望。
Marcus Jensen, our Chief Medical Officer, and Yannis Morel, our Chief Operating Officer, will then take us through updates on Lacutamab, IPH4502, Monalizumab, and our preclinical ADC pipeline. Frederic Lombard, our Chief Financial Officer, will then review our financial results. Jonathan will return for our upcoming catalysts and closing remarks before we open the call for Q&A.
接著,我們的首席醫學官 Marcus Jensen 與首席營運官 Yannis Morel 將帶來 Lacutamab、IPH4502、Monalizumab 以及我們臨床前 ADC 產品線的最新進展。之後,我們的財務長 Frederic Lombard 將回顧財務結果。在開放問答之前,Jonathan 將回到台上說明即將到來的催化劑與結語。
With that, I will now hand it over to Jonathan.
接下來,我把時間交給 Jonathan。
Jonathan Dickinson - Chief Executive Officer, Director
Jonathan Dickinson - Chief Executive Officer, Director
Thank you, Stephanie. Good morning to those joining from the US and good afternoon to our European participants. Turning to slide 5.
謝謝你,Stephanie。向來自美國的與會者道早安,也向歐洲的與會者道午安。請看第 5 張投影片。
The first half of 2026, together with development since the end of the period, has been marked by important progress across our focus portfolio.
2026 年上半年,以及期末之後的研發進展,均顯示我們聚焦產品組合在多個面向取得重要進展。
Starting with Lacutamab, in August, we announced our strategic partnership with Sobi to advance the program in T-cell lymphoma.
先從 Lacutamab 談起:我們在 8 月宣布與 Sobi 建立策略合作夥伴關係,以推進該計畫在 T 細胞淋巴瘤的開發。
As announced yesterday, that partnership is now effective following the closing of the deal and the TELLOMAK-3, Phase 3, has been initiated. We are targeting the first patient in the study in Q1 '27 as we work toward a filing for accelerated approval in Sezary syndrome in the second half of 2027.
如同昨日所宣布,隨著交易完成交割,該合作現已生效,且 TELLOMAK-3 第 3 期試驗已啟動。我們目標在 2027 年第一季完成本研究首位受試者入組,並朝向於 2027 年下半年就 Sezary 症候群提出加速核准申請。
For IPH4502, as announced in July, we completed Phase 1 dose escalation and cohort enrichment enrollment and have seen preliminary anti-tumor activity, including objective responses in post-EV urothelial cancer, as well as in non-small cell lung cancer and head and neck cancer, with a favorable safety profile observed to date. We will share initial Phase 1 dose escalation data at the EORTC-NCI-AACR meeting on November 18, 2026, in Barcelona.
就 IPH4502 而言,如同 7 月所宣布,我們已完成第 1 期劑量遞增與隊列擴增入組,並觀察到初步抗腫瘤活性,包括在 EV 治療後的尿路上皮癌出現客觀反應,以及在非小細胞肺癌與頭頸癌亦有反應;截至目前安全性概況良好。我們將於 2026 年 11 月 18 日在巴塞隆納舉行的 EORTC-NCI-AACR 會議上分享第 1 期劑量遞增的初步數據。
Turning to Monalizumab, enrollment in the PACIFIC-9 Phase 3 study has been completed, and we continue to expect the Phase 3 readout in the second half of 2026. Financially, our position has been strengthened by the $75 million Sobi upfront payment associated with the closing of the deal and the EUR30 million equity financing.
接著談 Monalizumab:PACIFIC-9 第 3 期研究已完成入組,我們仍預期於 2026 年下半年取得第 3 期讀出結果。在財務方面,隨著交易交割所帶來的 Sobi 7,500 萬美元預付款,以及 3,000 萬歐元股權融資,我們的財務狀況已獲強化。
Together, these are expected to extend our projected cash runway through the end of the first quarter of 2028. Taken together, we believe these developments position Innate for several important catalysts in the second half of 2026. Let me start with Lacutamab.
綜合而言,預期可將我們的現金可支撐期間延長至 2028 年第一季末。整體來看,我們相信這些進展使 Innate 在 2026 年下半年具備數個重要的催化劑。我先從 Lacutamab 開始。
Lacutamab is our anti-KIR3DL2 antibody being developed in cutaneous T-cell lymphoma, or CTCL. Turning to slide 7, as I mentioned, in August, we announced a strategic partnership with Sobi to license Lacutamab in T-cell lymphoma.
Lacutamab 是我們針對 KIR3DL2 的抗體,正在皮膚 T 細胞淋巴瘤(CTCL)中開發。請看第 7 張投影片,如我所提到的,我們在 8 月宣布與 Sobi 建立策略合作夥伴關係,授權其在 T 細胞淋巴瘤領域的 Lacutamab。
The transaction has now closed. TELLOMAK-3, our confirmatory Phase 3 study in CTCL, has been initiated with the first patient expected in the first quarter of 2027. Innate will conduct the Phase 3 study, and we will file for accelerated approval in Sezary syndrome based on the existing Phase 2 TELLOMAK data.
該交易現已完成交割。TELLOMAK-3——我們在 CTCL 的確認性第 3 期研究——已啟動,預期首位受試者將於 2027 年第一季入組。Innate 將執行第 3 期研究,並將基於既有第 2 期 TELLOMAK 數據,就 Sezary 症候群提出加速核准申請。
Upon the potential accelerated approval, Sobi will receive exclusive global rights to commercialize Lacutamab.
在可能取得加速核准後,Sobi 將獲得 Lacutamab 的全球獨家商業化權利。
Considering positive Phase 3 results, Sobi will be eligible to obtain full global development rights. Under the terms of the agreement, the transaction includes a $75 million upfront payment, up to $40 million in near-term milestones connected to Sezary syndrome.
若第 3 期結果為正面,Sobi 將有資格取得完整的全球開發權利。依據協議條款,本交易包含 7,500 萬美元預付款,以及最高 4,000 萬美元與 Sezary 症候群相關的近期里程碑款。
And up to an additional $465 million related to Sobi's option to obtain full development rights and future regulatory and commercial milestones. The agreement also includes tiered double-digit royalties on future net sales.
此外,尚包含最高 4.65 億美元,與 Sobi 行使取得完整開發權利之選擇權,以及未來法規與商業里程碑相關。協議亦包含對未來淨銷售額按級距計算的兩位數權利金。
I'll now hand it over to Marcus to review the regulatory and development path forward. Marcus.
接下來我把時間交給 Marcus,請他說明後續的法規與開發路徑。Marcus。
Markus Jensen - Chief Medical Officer
Markus Jensen - Chief Medical Officer
Thank you, Jonathan. Lacutamab is now progressing towards Phase 3 clinical initiation and planned accelerated approval filing. So, from a regulatory and development perspective, the path forward is well-defined.
謝謝你,Jonathan。Lacutamab 目前正推進至第 3 期臨床啟動,以及規劃中的加速核准申請。因此,從法規與開發角度來看,後續路徑已相當明確。
We have FDA clearance to proceed with TELLOMAK-3, which now has been initiated with the first patient expected in the first quarter of 2027. The study includes a confirmatory cohort in Sezary syndrome and a registration cohort in mycosis fungoides.
我們已取得 FDA 核准可推進 TELLOMAK-3;該研究現已啟動,預期首位受試者於 2027 年第一季入組。本研究包含 Sezary 症候群的確認性隊列,以及蕈樣肉芽腫(mycosis fungoides)的註冊性隊列。
The existing Phase 2 TELLOMAK data are intended to support an accelerated approval filing in Sezary syndrome once TELLOMAK-3 is underway.
既有第 2 期 TELLOMAK 數據,預計在 TELLOMAK-3 啟動後,用以支持就 Sezary 症候群提出加速核准申請。
The filing currently planned for the second half of 2027. As a reminder, Lacutamab received breakthrough therapy designation from the FDA for relapsed or refractory Sezary syndrome, as well as fast track designation from the FDA, PRIME designation from the EMA, and an orphan drug status in both US and Europe.
目前規劃於 2027 年下半年提出申請。提醒各位,Lacutamab 已獲 FDA 授予復發或難治型 Sezary 症候群之突破性療法認定(breakthrough therapy designation),亦獲 FDA 快速通道(fast track)認定、EMA 的 PRIME 認定,並在美國與歐洲皆取得孤兒藥資格。
So, with the regulatory pathway established and the Sobi partnership now effective, our focus is on advancing TELLOMAK-3 towards first patient enrollment first quarter 2027.
因此,在法規路徑已建立且與 Sobi 的合作現已生效的情況下,我們的重點是推進 TELLOMAK-3,朝 2027 年第一季首位受試者入組邁進。
Turning slide, please. I now move to IPH4502, our differentiated Nectin-4 specific ADC, which is in Phase 1 clinical development for advanced solid tumors.
請翻頁。接著我將談到 IPH4502——我們具差異化、針對 Nectin-4 的 ADC——目前正於晚期實體腫瘤進行第 1 期臨床開發。
IPH4502 was designed to address some of the key limitations of the first generation of Nectin-4 ADCs. The molecule combines an exatecan-topoisomerase-1 payload with our proprietary stable linker, of affinity Nectin-4 antibody that binds non-overlapping epitope compared with enfortumab vedotin.
IPH4502 的設計旨在解決第一代 Nectin-4 ADC 的一些關鍵限制。該分子結合 exatecan-拓撲異構酶 1(topoisomerase-1)載荷與我們專有的穩定連接子,以及一種對 Nectin-4 具親和力的抗體;相較於 enfortumab vedotin,其結合的是不重疊的表位。
We believe these features provide an important point of differentiation as the Nectin-4 ADC landscape continues to evolve.
我們相信,隨著 Nectin-4 ADC 領域持續演進,這些特性提供了重要的差異化優勢。
Importantly, we are now beginning to see that profile translate clinically and have observed preliminary anti-tumor activity to objective responses in heavily pretreated patients, including patients with urothelial cancer following prior enfortumab vedotin treatment, as well as in non-small cell lung cancer and head and neck cancer.
重要的是,我們現在開始看到該特徵在臨床上得到轉化,並且在接受過大量既往治療的患者中觀察到初步的抗腫瘤活性,且已出現客觀緩解,包括先前接受過 enfortumab vedotin(EV)治療後的尿路上皮癌患者,以及非小細胞肺癌與頭頸癌患者。
The safety profile observed to date has been favorable with limited hematological toxicity. We completed dose escalation in July and are broadly tracking in line with our expectations across expansion cohorts with approximately 15 patients enrolled in both post-EV urothelial carcinoma and head and neck cancer.
迄今觀察到的安全性特徵良好,血液學毒性有限。我們已於 7 月完成劑量遞增,並且在各擴展隊列的進展大致符合我們的預期;在 EV 後尿路上皮癌與頭頸癌兩個隊列中,各約入組 15 名患者。
And somewhat lower enrollment in non-small cell lung cancer cohort. Data cleaning is ongoing, and we look forward to presenting the initial Phase 1 dose escalation data set at the EORTC-NCI-AACR Symposium on November 18, 2026.
而非小細胞肺癌隊列的入組略低。資料清理仍在進行中,我們期待於 2026 年 11 月 18 日在 EORTC-NCI-AACR 研討會上發表第一期劑量遞增的初始資料集。
Next slide, please.
請看下一張投影片。
Our area of particular interest for IPH4502 is urothelial cancer following prior EV treatment. While EV plus pembrolizumab has significantly changed the treatment landscape, most patients progress within two years and there remains no established second-line standard treatment after progression of FITS regime.
我們對 IPH4502 特別感興趣的領域,是先前接受 EV 治療後的尿路上皮癌。雖然 EV 合併 pembrolizumab 已顯著改變治療版圖,但多數患者會在兩年內疾病進展,而在 FITS 方案進展後仍缺乏已確立的二線標準治療。
Against that backdrop, the preliminary activity we have observed with IPH4502 in heavily pretreated post-EV patients, including objective responses, is encouraging.
在此背景下,我們在接受過大量既往治療、且為 EV 後的患者中觀察到 IPH4502 的初步活性(包括客觀緩解),令人鼓舞。
These remain early Phase 1 observations, and the upcoming data set will help us to determine how to best advance the program.
這些仍屬於第一期的早期觀察結果,而即將公布的資料集將協助我們判斷如何最佳推進該計畫。
Slide 11, please, slide 12, please.
請看第 11 張投影片,請看第 12 張投影片。
I move forward to Monalizumab, which is our NKG2A antibody being co-developed with AstraZeneca in non-small cell lung cancer. PACIFIC-9 is a randomized Phase 3 trial with unresectable stage 3 non-small cell lung cancer patients who have not progressed following a definitive platinum-based concurrent chemoradiotherapy.
我接著談 Monalizumab,這是我們的 NKG2A 抗體,正與 AstraZeneca 共同開發,用於非小細胞肺癌。PACIFIC-9 是一項隨機分派的第三期試驗,納入不可切除的第 3 期非小細胞肺癌患者;這些患者在接受以鉑類為基礎的同步放化療根治性治療後未出現疾病進展。
The study enrolled 1,051 patients in comparison to Durvalumab plus Olecumab, Durvalumab plus Monalizumab and Durvalumab plus Placebo as a control, with progression-free survival as the primary endpoint.
該研究共入組 1,051 名患者,比較 Durvalumab 合併 Olecumab、Durvalumab 合併 Monalizumab,以及 Durvalumab 合併安慰劑作為對照組,主要終點為無惡化存活期(PFS)。
The program is supported by three earlier Phase 2 studies non-small cell lung cancer, including COAST, NEOCOAST and NEOCOAST 2. With enrollment complete, Phase 3 data remain expected in the second half of 2026.
該計畫由三項較早期的第二期非小細胞肺癌研究支持,包括 COAST、NEOCOAST 與 NEOCOAST 2。目前入組已完成,第三期數據仍預計於 2026 年下半年公布。
I now hand over to Yannis to briefly review the economics of our partnership with AstraZeneca.
我現在把時間交給 Yannis,請他簡要回顧我們與 AstraZeneca 合作的經濟條款。
Yannis Morel - Chief Operating Officer, Executive Vice President
Yannis Morel - Chief Operating Officer, Executive Vice President
Thank you, Markus. As a reminder, under our Monalizumab partnership with AstraZeneca, we have received up to date EUR450 million.
謝謝你,Markus。提醒一下,在我們與 AstraZeneca 的 Monalizumab 合作中,截至目前我們已收到 4.5 億歐元。
And the additional potential milestone in the agreement are up to EUR825 million. Together with double-digit royalties outside Europe and 50% profit sharing in Europe.
此外,協議中的潛在里程碑款最高可達 8.25 億歐元。並且在歐洲以外享有兩位數比例的權利金,以及在歐洲享有 50% 的利潤分成。
Turning to slide 15, I'll move now to our next generation ADC pipeline.
接著看第 15 張投影片,我現在轉到我們的下一代 ADC 產品線。
Beyond IPH4502, we are using our internal capabilities and technology to build a broad portfolio of differentiated ADC candidates.
除了 IPH4502 之外,我們正運用內部能力與技術,建立一個廣泛且具差異化的 ADC 候選藥物組合。
Turning to slide 16.
請看第 16 張投影片。
Leveraging our antibody discovery and engineering expertise, we have built a comprehensive ADC platform to develop a portfolio of next-generation ADCs designed to overcome the limitation of the current ones.
憑藉我們在抗體發現與工程化方面的專長,我們建立了一個完整的 ADC 平台,以開發一系列旨在克服現有 ADC 侷限性的下一代 ADC。
Building on IPH4502 linker, which stability in patients is demonstrated by our emerging clinical data, we are developing a drug candidate portfolio around three approaches.
以 IPH4502 的連接子為基礎,其在患者體內的穩定性已由我們逐步累積的臨床資料所證實;我們正圍繞三種策略開發候選藥物組合。
First, dual targeted bispecific ADCs to address tumor antigen heterogeneity and to expand addressable indication compared to single tumor antigen targeting.
第一,雙靶點的雙特異性 ADC,用以因應腫瘤抗原異質性,並相較於單一腫瘤抗原靶向,擴大可涵蓋的適應症範圍。
Second, bispecific ADCs with enhanced internalization to unlock the activity in antigen low expressing tumors. And finally, dual payload ADCs using complementary mechanism of action to overcome resistance.
第二,具增強內吞作用的雙特異性 ADC,以釋放其在低抗原表達腫瘤中的活性。最後,採用互補作用機制的雙載荷 ADC,以克服抗藥性。
I now hand over to Frederic for our financial results.
我現在把時間交給 Frederic,說明我們的財務結果。
Frederic Lombard - Chief Financial Officer
Frederic Lombard - Chief Financial Officer
Thank you, Yannis. I'll now provide a brief overview of our financial position for the first half of 2026. Turning to slide 18.
謝謝你,Yannis。我將簡要概述我們 2026 年上半年的財務狀況。請看第 18 張投影片。
So, as of June 30, 2026, our cash, cash equivalent, and financial assets were amounting for EUR21.4 million. That balance does not include the $75 million Sobi upfront payment, equivalent to EUR65 million, nor the proceeds from the EUR30 million equity offering.
截至 2026 年 6 月 30 日,我們的現金、約當現金及金融資產合計為 2,140 萬歐元。該餘額不包含 Sobi 的 7,500 萬美元預付款(約當 6,500 萬歐元),也不包含 3,000 萬歐元股權發行的募集款。
The offering represents EUR30 million on gross proceeds or approximately EUR28 million in expected net proceeds.
本次發行的總募集款為 3,000 萬歐元,預計淨募集款約為 2,800 萬歐元。
The primary use of proceeds is the continued clinical development of IPH4502, the advancements of our preclinical ADC portfolio, and as well as general corporate purposes.
募集資金的主要用途為持續推進 IPH4502 的臨床開發、推動我們臨床前 ADC 產品組合的進展,以及一般公司用途。
Together with the Sobi upfront payment, these proceeds are expected to extend our cash runway through the end of the first quarter of 2028.
連同 Sobi 的預付款,預期這些資金將把我們的現金可支撐期延長至 2028 年第一季末。
I now hand over to Jonathan.
我現在把時間交給 Jonathan。
Jonathan Dickinson - Chief Executive Officer, Director
Jonathan Dickinson - Chief Executive Officer, Director
Thank you, Frederick. Moving to slide 20 and turning to our key catalysts for the remainder of 2026. For Lacutamab, following closing of the strategic partnership with Sobi, TELLOMAK-3 has been initiated with the first patient planned for the first quarter of 2027, followed by a plan and filing for accelerated approval in the second half of 2027.
謝謝你,Frederick。請看第 20 張投影片,接著說明 2026 年剩餘期間的關鍵催化劑。就 Lacutamab 而言,在與 Sobi 的策略合作完成後,TELLOMAK-3 已啟動,首位患者預計於 2027 年第一季入組,之後計畫於 2027 年下半年提出加速核准的申請與送件。
For IPH4502, dose escalation enrollment is complete with preliminary anti-tumor activity and a favorable safety profile observed to date. We will report initial Phase 1 dose escalation data at the EORTC-NCI-AACR meeting on November 18, 2026.
就 IPH4502 而言,劑量遞增入組已完成,迄今已觀察到初步抗腫瘤活性與良好的安全性特徵。我們將於 2026 年 11 月 18 日在 EORTC-NCI-AACR 會議上報告第一期劑量遞增的初始數據。
And for Monalizumab, PACIFIC-9 enrollment is complete, with the Phase 3 readout expected in the second half of this year.
至於 Monalizumab,PACIFIC-9 入組已完成,第三期讀出預計於今年下半年公布。
We have three important near-term catalysts across our focus portfolio, together with a strengthened financial position that supports our continued execution of these priorities.
在我們聚焦的產品組合中,近期有三項重要催化劑;同時,我們的財務狀況也已強化,足以支持我們持續執行這些優先事項。
With that, operator, we are ready to open the call for questions.
接下來,接線員,我們準備開放提問。
Operator
Operator
(Operator Instructions) Daina Graybosch, Leerink Partners.
(接線員指示) Daina Graybosch,Leerink Partners。
Unidentified Participant
Unidentified Participant
Good morning, everyone. I got some of the updates. So, this one for me, I got [Bill] on for Daina. So, we've seen the prior ADC show some pretty good activity in the post setting, but it did have some, pretty high heme toxicities. And so, can you talk about IPH-45 stable linker design and sort of what gives you confidence you won't see the same sort of issues? Thank you.
各位早安。我收到一些更新。這題由我來問,我是代替 Daina 的 [Bill]。我們看到先前的 ADC 在後線治療情境中顯示相當不錯的活性,但也出現一些相當高的血液學毒性。因此,你們能否談談 IPH-45 的穩定連接子設計,以及是什麼讓你們有信心不會看到同樣類型的問題?謝謝。
Jonathan Dickinson - Chief Executive Officer, Director
Jonathan Dickinson - Chief Executive Officer, Director
Thank you for the question. Maybe Yannis, you can take that one. Yes, maybe I can start and let Marcus comment. I mean, we have worked on the design of the linker and based on what we have seen at ASCO.
謝謝你的提問。也許 Yannis,你可以回答這題。好的,我可以先開始,然後再請 Marcus 補充。我的意思是,我們在連接子的設計上做了很多工作,並且根據我們在 ASCO 上所看到的結果。
Yannis Morel - Chief Operating Officer, Executive Vice President
Yannis Morel - Chief Operating Officer, Executive Vice President
By others with their own linker, it seems that the stability of our linker that we have seen in preclinical models, including in non-human primates, seems to be transferred, translated into the human situation, leading to a very limited release of a free payload, which is one of the reasons of the systemic pathological toxicity of some ADCs.
由其他人使用他們自己的連接子來看,我們在臨床前模型(包括非人靈長類)中所觀察到的連接子穩定性,似乎已被轉移並體現在人體情況中,導致游離載荷的釋放非常有限;而這正是某些 ADC 出現全身性病理毒性的原因之一。
Markus Jensen - Chief Medical Officer
Markus Jensen - Chief Medical Officer
Yeah, what we can add is the Lilly data that have been released recently actually state that based on their own data that have seen in the trial. So the unstable linker was used as an explanation for the hematologic toxicity in this data set.
是的,我們可以補充的是,Lilly 最近公布的數據其實指出,根據他們在試驗中看到的自身數據。因此,在這組數據中,不穩定的連接子被用來解釋血液學毒性。
Unidentified Participant
Unidentified Participant
Great. Thank you.
很好。謝謝。
Operator
Operator
Jeet Mukherjee, US Bancor BTIG.
Jeet Mukherjee,美國 Bancor BTIG。
Jeet Mukherjee - Equity Analyst
Jeet Mukherjee - Equity Analyst
Great. Good morning, and thanks for taking the question. So, pending, you know, an accelerated approval there, could you speak to the potential for frontline off-label use for Lacutamab and Sezary syndrome, given that seems to be the case with Mogamulizumab? And I have a follow up question.
很好。早安,謝謝讓我提問。那麼,在那邊等待加速核准的同時,鑑於 Mogamulizumab 似乎就是這樣的情況,您能否談談 Lacutamab 在 Sezary 症候群的一線超適應症使用(off-label)的潛力?我還有一個追問。
Jonathan Dickinson - Chief Executive Officer, Director
Jonathan Dickinson - Chief Executive Officer, Director
Yeah, maybe I will take that question, Jeet. Our expectation is that Lacutamab will be listed in the NCCN guidelines, following the accelerated approval for both Sezary syndrome and for mycosis fungoides. I think with that listing, it seems to leave it open for physicians to be able to use the product across the different lines of therapy.
好的,Jeet,這題也許我來回答。我們預期在 Sezary 症候群以及蕈樣肉芽腫(mycosis fungoides)獲得加速核准後,Lacutamab 會被列入 NCCN 指南。我認為有了這項收錄,似乎就讓醫師能夠在不同治療線別中使用該產品。
So our expectation based on the safety profile of Lacutamab which is pretty benign, we expect that you will see some off-label usage in the first line setting. And so, yes, I mean, I think there's an expectation you will see that.
因此,基於 Lacutamab 相當溫和的安全性概況,我們預期您會在一線治療情境中看到一些超適應症使用。所以,是的,我的意思是,我認為確實會有這樣的預期。
And also. Despite the fact that the accelerated approval will be in Sezary syndrome, there will also be an expectation based on the potential listing in the NCCN guidelines for mycosis fungoides that you will also see usage in mycosis fungoides. Hopefully that answers your question.
另外。儘管加速核准會是在 Sezary 症候群,但基於其可能被列入 NCCN 指南、涵蓋蕈樣肉芽腫的預期,您也會在蕈樣肉芽腫看到使用。希望這回答了您的問題。
Jeet Mukherjee - Equity Analyst
Jeet Mukherjee - Equity Analyst
Great. I appreciate that. Maybe just two other quick follow-ups. Just any initial thoughts on pricing? Do you think you could price at a premium to Mogamulizumab?
很好。我很感謝。再兩個很快的追問。對於定價有沒有任何初步想法?您認為能否以高於 Mogamulizumab 的溢價來定價?
And then separately on PACIFIC-9, in terms of just the update format, uh, you know, anticipate perhaps a press release at minimum from AstraZeneca. will Innate have their own press release and analyst call as well? Thank you.
另外,關於 PACIFIC-9,就更新形式而言,呃,您知道,是否至少會由 AstraZeneca 發布新聞稿?Innate 也會發布自己的新聞稿並舉行分析師電話會議嗎?謝謝。
Jonathan Dickinson - Chief Executive Officer, Director
Jonathan Dickinson - Chief Executive Officer, Director
Yes. So in terms of pricing, we have completed pricing research in the US, which was conducted by ZS Associates. And what we were able to establish with US payers was that we can price, between $500,000 and $625,000 per patient per annum. And that will be supported by our clinical data and the NCCN listing.
是的。就定價而言,我們已完成由 ZS Associates 在美國進行的定價研究。我們與美國付款方所能確立的是,我們可以將每位病患每年的價格訂在 50 萬至 62.5 萬美元之間。而這將由我們的臨床數據與 NCCN 收錄所支持。
Um, so there is an expectation here that you will be able to achieve premium pricing, particularly in an indication like Sezary syndrome with a relatively low incidence, and then be able to carry that forward into the mycosis fungoides indication, which is a larger indication, but still an orphan disease.
嗯,因此我們預期能夠實現溢價定價,特別是在像 Sezary 症候群這種發生率相對較低的適應症;接著也能將此延伸到蕈樣肉芽腫適應症,該適應症規模較大,但仍屬於罕見疾病。
So that's pricing. And then with respect to PACIFIC-9, you're correct. The expectation is that there will be a press release from AstraZeneca when the results are available. And we would also look to press release that as well and potentially do some analyst calls following the availability of that primary endpoint data.
以上是定價。至於 PACIFIC-9,您說得沒錯。預期在結果可用時,AstraZeneca 會發布新聞稿。我們也會發布新聞稿,並可能在主要終點數據公布後舉行一些分析師電話會議。
Jeet Mukherjee - Equity Analyst
Jeet Mukherjee - Equity Analyst
Great, thank you.
很好,謝謝。
Jonathan Dickinson - Chief Executive Officer, Director
Jonathan Dickinson - Chief Executive Officer, Director
Hopefully that answers the question.
希望這回答了問題。
Operator
Operator
The next question will be read by Stephanie Cornyn. Stephanie, please go ahead.
下一個問題將由 Stephanie Cornyn 代為宣讀。Stephanie,請開始。
Stephanie Cornen - Vice President - Investor Relations, Communication & Commercial Strategy
Stephanie Cornen - Vice President - Investor Relations, Communication & Commercial Strategy
Yes, so we have a question from Clement Stiers from Stifel. The first question is, as dose escalation and cohort expansion enrollment are now complete, should we expect the initial ENA dataset to be primarily a safety pharmacology update or mature enough to inform subsequent development decisions?
好的,我們有一個來自 Stifel 的 Clement Stiers 的問題。第一個問題是:既然劑量遞增與隊列擴增的入組現在都已完成,我們是否應預期初步的 ENA 數據集主要是安全性藥理學的更新,還是已成熟到足以為後續開發決策提供資訊?
Jonathan Dickinson - Chief Executive Officer, Director
Jonathan Dickinson - Chief Executive Officer, Director
So Markus, maybe you can take that question.
那麼 Markus,也許你可以回答這個問題。
Markus Jensen - Chief Medical Officer
Markus Jensen - Chief Medical Officer
Yeah, the question is almost the answer. So, um, this is out of 11 different indications and 76 patients. So we are expecting to see relevant and, um, informative safety data. And we are also expecting response data from patients. And this will inform our next steps.
是的,這個問題幾乎就是答案。所以,嗯,這涵蓋 11 個不同適應症與 76 位病患。因此我們預期會看到具相關性且、嗯、具有資訊價值的安全性數據。我們也預期會看到病患的反應數據。而這將為我們的下一步提供依據。
We need to fully run the tables and we will review and disclose that as proposed on the ENA meeting.
我們需要把表格完整跑完,並會如同在 ENA 會議上所提議的那樣進行審閱與揭露。
Stephanie Cornen - Vice President - Investor Relations, Communication & Commercial Strategy
Stephanie Cornen - Vice President - Investor Relations, Communication & Commercial Strategy
Thank you. And there is another question from Clemence. With the strengthened balance sheet following the recent financing, how far along the development path could you advance IPH4502 on your own?
謝謝。另外還有一個來自 Clemence 的問題。在近期融資後資產負債表更為強健的情況下,您能在多大程度上自行推進 IPH4502 的開發進程?
Jonathan Dickinson - Chief Executive Officer, Director
Jonathan Dickinson - Chief Executive Officer, Director
So I think you're all aware that we did a small equity raise of EUR30 million. Um, a couple of weeks ago. The rationale behind that equity raise uh was to be able to progress seamlessly into the next steps for IPH4502.
我想大家都知道,我們在幾週前進行了一次規模不大的股權募資,金額為 3,000 萬歐元。嗯,就在幾週前。這次股權募資的理由是為了能夠無縫推進 IPH4502 的下一步。
So we're well positioned now to be able to move into the next steps, whatever that will be, as the data will dictate what that is, whether it's dose optimization, and we're equipped to be able to do that.
因此我們現在具備良好條件,可以進入下一步,不論那會是什麼;數據將決定那是什麼,例如是否需要劑量最佳化,而我們也具備執行該工作的能力。
If we would need to broaden the program, if the data supports going to potentially additional tumor types, uh then that would require uh additional funding to be able to uh conduct multiple dose optimizations across uh across different tumor types.
如果我們需要擴大該計畫,且數據支持可能拓展到額外的腫瘤類型,呃,那麼就需要額外資金,才能在不同腫瘤類型之間進行多項劑量最佳化研究。
For the initial steps, we're funded to be able to take those steps and take the product forward seamlessly into dose optimization. Hopefully that answers the question again.
就初步步驟而言,我們的資金足以採取這些步驟,並將產品無縫推進到劑量最佳化。希望再次回答了這個問題。
Operator
Operator
We have now reached the end of the Q&A session. I will turn the call back to Jonathan Dickinson, CEO, for closing remarks.
我們現在已到達問答環節的結尾。我將把電話會議交回給執行長 Jonathan Dickinson 作結語。
Jonathan Dickinson - Chief Executive Officer, Director
Jonathan Dickinson - Chief Executive Officer, Director
So thank you very much everybody for joining us today for our update and following our first-half results. We look forward to updating you as we progress through the important catalysts that we outlined today, which come across the remainder of the year. So thank you for your time and see you soon.
非常感謝各位今天加入我們的更新會議,並關注我們上半年業績。我們期待在今年剩餘時間內,隨著我們推進今天所概述的重要催化劑時,持續向各位更新。謝謝各位的時間,期待很快再見。
Operator
Operator
This concludes today's conference. Thank you for attending. You may now disconnect.
今天的會議到此結束。感謝各位出席。您現在可以掛線。