Nektar Therapeutics (NKTR) 2025 Q2 法說會逐字稿

Hello and thank you for standing by. Welcome to the Nectar Therapeutics second-quarter 2025 financial results conference call.

您好，感謝您的支持。歡迎參加 Nectar Therapeutics 2025 年第二季財務業績電話會議。

(Operator Instructions)

（操作員指示）

Please be advised that today's conference is being recorded.

請注意，今天的會議正在錄音。

I would now like to hand the conference over to Corinne Franklin from Nectar Therapeutics Investor Relations to kick things off. Please go ahead.

現在，我想將會議交給 Nectar Therapeutics 投資者關係部門的 Corinne Franklin 來開始。請繼續。

Thank you and good afternoon, everyone. Thank you for joining us today.

謝謝大家，下午好。感謝您今天加入我們。

On the call today are Howard Robin, our President and Chief Executive Officer; Dr. Jonathan Zalevsky, our Chief Research and Development Officer; and Sandra Gardiner, our Chief Financial Officer.

今天參加電話會議的有我們的總裁兼執行長 Howard Robin、我們的首席研發長 Jonathan Zalevsky 博士；以及我們的財務長 Sandra Gardiner。

Dr. Brian Kotson, our Chief Medical Officer, will also be available during the question-and-answer session. On today's call, we expect to make forward-looking statements regarding our business, including statements regarding the therapeutic potential of and future development and regulatory plans for red peggabalein and our other drug candidates, the timing and plans for future clinical data presentations, and other statements regarding the future of our business.

我們的首席醫療官 Brian Kotson 博士也將出席問答環節。在今天的電話會議上，我們預計將對我們的業務做出前瞻性陳述，包括有關紅色 peggabalein 和我們的其他候選藥物的治療潛力和未來開發和監管計劃、未來臨床數據展示的時間和計劃的陳述，以及有關我們業務未來的其他陳述。

Because forward-looking statements relate to the future, they are subject to uncertainties and risks that are difficult to predict, many of which are outside of our control.

由於前瞻性陳述與未來有關，因此它們受到難以預測的不確定性和風險的影響，其中許多是我們無法控制的。

Our actual results may differ materially from these statements.

我們的實際結果可能與這些陳述有重大差異。

Important risks and uncertainties are set forth in our Form 10 that was filed on May 9, 2025 and is available at SEC.gov.

我們於 2025 年 5 月 9 日提交的 10 號表格中列出了重要的風險和不確定性，該表格可在 SEC.gov 上查閱。

We undertake no obligations to update any of these forward-looking statements, whether as a result of new information, future developments, or otherwise.

我們不承擔更新任何前瞻性聲明的義務，無論其是否出現新資訊、未來發展或其他原因。

A webcast of this call will be available on the IR page of Nectar's website at nectar.com.

本次電話會議的網路直播將在 Nectar 網站 nectar.com 的 IR 頁面上提供。

With that said, I would like to hand the call over to our President and CEO, Howard Robin. Howard?

話雖如此，我想把電話交給我們的總裁兼執行長霍華德羅賓。霍華德？

Thank you, Corinne.

謝謝你，科琳。

Good afternoon, everyone.

大家下午好。

The second quarter of 2025 was transformative for nectar.

2025 年第二季對花蜜來說是具有改變意義的一年。

In June, we reported highly compelling initial data and ectopic dermatitis for our lead clinical program, ResPEG Alvisleukin, also known as ResPEG.

6 月份，我們報告了我們的主要臨床項目 ResPEG Alvisleukin（也稱為 ResPEG）的極具說服力的初步數據和異位皮膚炎。

These data establish ResPA as a potential first in class novelty regulatory mechanism for patients suffering from this chronic relapsing inflammatory skin disorder.

這些數據證明 ResPA 是治療這種慢性復發性發炎性皮膚病患者的潛在首創新調節機制。

In 2023, we took the bold step to pursue T regulatory cell science across our pipelines. This science is focused on stimulating T. Regs in different ways to restore the proper balance between T effector cells and T regulatory cells and achieve homeostasis in the immune system, and we had the goal at that time to demonstrate that this important pathway. Could represent a completely new way to treat autoimmune and inflammatory disorders by mimicking the way our own immune system works to resolve inflammation.

2023 年，我們邁出了大膽的一步，在我們的整個研發過程中探索 T 調節細胞科學。這門科學的重點是以不同的方式刺激T. Regs，以恢復T效應細胞和T調節細胞之間的適當平衡，並實現免疫系統的體內平衡，我們當時的目標是證明這一重要途徑。透過模仿我們自身的免疫系統解決發炎的方式，可以代表一種治療自體免疫和發炎疾病的全新方法。

So in October of 2023, we initiated a 400 patient phase 2B study for ResEG in patients with moderate to severe ectopic dermatitis, where early proof of concept data in patients had shown promise at the time.

因此，在 2023 年 10 月，我們啟動了一項 400 名患者的 2B 期 ResEG 研究，研究對象為中度至重度異位皮膚炎患者，當時患者早期概念驗證數據已顯示出良好的前景。

For our second indication, we chose to run a phase 2B study in alopecia areata. This is a disease setting where the underlying T regulatory cell deficiency creates a known imbalance between T effector cells and T regulatory cells, leading to hair loss for these patients.

對於我們的第二個適應症，我們選擇對斑禿進行 2B 期研究。這是一種疾病環境，其中潛在的 T 調節細胞缺陷造成 T 效應細胞和 T 調節細胞之間已知的不平衡，導致這些患者脫髮。

The resolve AD study results we recently reported also validate Nectar's novel approach to access T. Regs through the IL-2 pathway with a unique molecular design as compared to the competitive landscape.

我們最近報告的解決 AD 研究結果也驗證了 Nectar 透過 IL-2 途徑存取 T. Regs 的新方法，與競爭格局相比，該方法具有獨特的分子設計。

While other approaches to access IL-2 have focused on the design of mutines, which we believe hindered their development recently and over the years, we instead took a straightforward and elegant approach of accessing Treg biology through a native sequence IL 2 and then applying pegation, a proven chemistry that has led to the approval of over 30 biologics and small molecules over the last several decades, and many of these are ones in which nectar played a role.

雖然獲取 IL-2 的其他方法都側重於突變體的設計，我們認為這在最近和過去幾年阻礙了它們的發展，但我們採取了一種直接而優雅的方法，即通過天然序列 IL-2 獲取 Treg 生物學，然後應用聚對苯二甲酸乙二醇酯 (PEG)，這是一種經過驗證的化學方法，在過去的幾十年裡是許多分子的化學方法，在過去的幾十年中獲得了許多生物。

Now that we've been granted FDA fast track designation for both ectopic dermatitis and alopecia, we have the opportunity to move more quickly in align with the FDA to design the most expeditious regulatory pathways.

現在，我們已經獲得了 FDA 對異位皮膚炎和脫髮的快速通道資格，我們有機會與 FDA 更快地協調，設計出最快捷的監管途徑。

This underscores that there are undoubtedly still remains a large unmet need in the setting of ectopic dermatitis and alopecia areata for for novel mechanisms of action, and we believe we're well positioned with a first in class novel Treg mechanism that is poised to enter phase redevelopment in 2026.

這強調了異位性皮膚炎和斑禿領域對於新型作用機制的治療無疑仍然存在大量未滿足的需求，我們相信，我們已做好準備，擁有一流的新型 Treg 機制，有望在 2026 年進入再開發階段。

Now since Dupison was launched eight years ago, the ectopic dermatitis market has grown to around $15 billion in US sales, with expectations that it could reach nearly $30 billion by 2033.

自 Dupison 八年前上市以來，異位性皮膚炎市場在美國的銷售額已成長至約 150 億美元，預計到 2033 年將達到近 300 億美元。

Our own recent market research has suggested that physicians would prescribe ResMed in both biologic naive and biologic experienced patients with ectopic dermatitis, and so our goal is to design a phase 3 program that captures this unique opportunity in front of us.

我們自己最近的市場研究表明，醫生會為未使用過生物製劑和使用過生物製劑的異位皮膚炎患者開瑞思邁的處方，因此我們的目標是設計一個 3 期計劃來抓住我們面前的這一獨特機會。

Currently, IL-13 based therapies dominate the treatment landscape, and about 50% of the patients failed to respond to this mechanism. Moreover, IL-13-based therapies are known to have side effect risks such as conjunctivitis and infection, which can pose a challenge for patients. So in view of these challenges, there's a significant opportunity for Respect.

目前，基於 IL-13 的療法佔據治療領域的主導地位，約 50% 的患者對這種機制沒有反應。此外，已知基於 IL-13 的療法具有結膜炎和感染等副作用風險，這可能對患者構成挑戰。因此，鑑於這些挑戰，Respect 面臨重大機會。

With a fast onset of easy response and itch relief. ResPEC is poised to take a differentiated position in this landscape.

具有快速起效、輕鬆緩解搔癢的效果。ResPEC 準備在這一領域佔據差異化地位。

As JZ will explain in more detail, our phase 3 strategy is designed to achieve a broad label in both naive and experienced patients, which would allow Respe to capture a substantial share of the growing multi-billion dollar ectopic dermatitis market.

正如 JZ 將更詳細地解釋的那樣，我們的 3 期策略旨在為初治患者和有經驗的患者實現廣泛的標籤，這將使 Respe 能夠在不斷增長的數十億美元異位皮膚炎市場中佔據相當大的份額。

Given the very high correlation between historically positive phase 2B results and the subsequent approvals in ectopic dermatitis, we're highly focused on moving quickly into phase 3, and our readiness activities are underway.

鑑於歷史上積極的 2B 期結果與隨後在異位皮膚炎方面的批准之間存在高度相關性，我們高度專注於快速進入 3 期，並且我們的準備活動正在進行中。

Our oversubscribed $115 million equity financing in June now puts us in an even stronger financial position to complete important phase 3 enabling CMC and regulatory planning activities to ensure that Reseg will be Phase 3 ready in the first half of 2026.

我們在 6 月超額認購了 1.15 億美元的股權融資，這讓我們擁有了更強大的財務狀況，可以完成重要的第三階段，支持 CMC 和監管規劃活動，確保 Reseg 在 2026 年上半年為第三階段做好準備。

In addition, the financing also positions us to extend our cash runway into 2027.

此外，這筆融資還能讓我們將現金流延長至 2027 年。

Looking ahead, the ongoing resolve AD study will generate additional data in Q1 of 2026, which we expect will further characterize the durability and depth of response for reseg out to week 52.

展望未來，正在進行的解決 AD 研究將在 2026 年第一季產生更多數據，我們預計這些數據將進一步表徵第 52 週重新註冊的持久性和回應深度。

We plan to present patient reported outcome data including quality of life and symptom assessments from the 16 week induction period at a medical meeting this year. This data presentation will also include a planned data cut for patients who received placebo in the induction phase and who then crossed over to a treatment escape arm.

我們計劃在今年的醫學會議上展示患者報告的結果數據，包括 16 週誘導期內的生活品質和症狀評估。此數據展示還將包括在誘導階段接受安慰劑治療然後轉入治療逃避組的患者的計劃數據剪切。

With this new upcoming data cut, we're excited to see whether easy responses deepen with continued treatment with respe beyond the 16 week induction. I'll let Jay Z talk more about this key data set in a moment.

隨著這一新數據即將發布，我們很高興看到在 16 週的誘導期之後繼續進行治療是否會加深輕鬆反應。稍後我會讓 Jay Z 詳細談論這個關鍵資料集。

Now, in addition, we're on track to report data from the separate phase 2B study in alopecia areata in December of this year.

此外，我們也計劃在今年 12 月報告斑禿單獨 2B 期研究的數據。

This is an indication where we are directly addressing the underlying pathology of hair loss in alopecia patients.

這表明我們正在直接解決脫髮患者脫髮的潛在病理。

Another positive outcome here would position ResPegg as a novel mechanism in a dermatological setting where there is only one mechanism approved for patients, JAC inhibitors.

另一個積極的成果是將 ResPegg 定位為皮膚病學環境中的一種新機制，其中只有一種機制被批准用於患者，即 JAC 抑制劑。

These carry multiple well known black box warnings and are associated with high relapse rates upon discontinuation.

這些藥物帶有多個眾所周知的黑框警告，並且停藥後復發率很高。

The market for alopecia areata treatments is projected to grow to $2 billion by 2033, and we believe that a new mechanism, ResPEG, could take a very significant share of this market.

預計到 2033 年，斑禿治療市場將成長到 20 億美元，我們相信，新機制 ResPEG 可以佔據該市場的很大份額。

And now I'll hand it over to Jay-Z for some more details on Respeg and our earlier programs in our Python.

現在我將把話題交給 Jay-Z，讓他來提供有關 Respeg 和我們早期 Python 程式的更多詳細資訊。

Thanks, Howard, and thank you to everyone on the call for joining us today. To start, I'd like to remind you of the key takeaways from our June 24th webcast where we announced top line 16 week induction data from the ongoing phase 2B study known as resolve AD.

謝謝，霍華德，也感謝今天參加電話會議的所有人。首先，我想提醒大家我們 6 月 24 日網路廣播中的關鍵要點，我們在此次廣播中公佈了正在進行的 2B 期研究（稱為解決 AD）的 16 週誘導頂線數據。

Resolve AD enrolled 393 patients and is testing repealdi leukin in biologic naive patients with moderate to severe atopic dermatitis.

Resolve AD 招募了 393 名患者，正在對未接受過生物製劑治療的中度至重度異位性皮膚炎患者進行 repealdi leukin 測試。

The study met its primary endpoint of statistical significance for mean percent change and easy score from baseline for all respagalbis Lucan arms versus placebo at week 16.

該研究達到了其主要終點，即第 16 週時所有 respagalbis Lucan 組與安慰劑組相比，相對於基線的平均百分比變化和簡單評分均具有統計意義。

All three Raspagaldi Lucan arms met significance on the E 50, EZ 75, and BSA.

Raspagaldi Lucan 的所有三支槍械在 E 50、EZ 75 和 BSA 上都達到了顯著水平。

The every 2 weeks regimens met significance on VIGA, AD and H NRS, and the high dose of 24 mcg per kilogram every 2 weeks also achieved statistical significance on EZ 90.

每 2 週一次的治療方案在 VIGA、AD 和 H NRS 方面均達到了統計學意義，每 24 mcg/kg 的高劑量在 EZ 90 方面也達到了統計學意義。

Both easy reduction and magnitude of each improvement were seen after the first few doses of respe, which we think could truly differentiate it from other systemic therapies in terms of a faster onset of action.

在服用前幾次 respe 後，我們既看到了症狀的輕鬆減輕，也看到了每次改善的幅度，我們認為，這在起效速度更快方面可以真正將其與其他全身療法區分開來。

Also, the safety profile for RESPEG in the phase 2B study was consistent with previously reported results from other ResSPEC clinical studies, and there was no increased risk of incidence of conjunctivitis, oral herpes, or oral ulcers, as is seen with other agents which are approved or in development.

此外，2B 期研究中 RESPEG 的安全性與先前報告的其他 ResSPEC 臨床研究結果一致，且沒有增加結膜炎、口腔皰疹或口腔潰瘍的發病風險，而其他已獲批准或正在開發的藥物則存在此風險。

The maintenance period of the study is ongoing, and we expect to share the top line results for 52 weeks of dosing, for the 36 week Q4 week and Q12 week maintenance regimens, as well as the Q2 week escape arm regiment in Q1 2026.

研究的維持期仍在進行中，我們預計將於 2026 年第一季分享 52 週給藥方案、36 週 Q4 週和 Q12 週維持方案以及 Q2 週逃脫組方案的頂線結果。

As Howard mentioned earlier, we are looking forward to presenting additional differentiating end points from the induction phase of the resolve AD study at a medical meeting in the fall of this year.

正如霍華德之前提到的，我們期待在今年秋季的醫學會議上展示解決 AD 研究誘導階段的更多區分終點。

These include quality of life assessments such as sleep quality, skin pain reduction, overall patient experience, and other important metrics that are meaningful for patients battling atopic dermatitis.

這些包括生活品質評估，如睡眠品質、皮膚疼痛減輕、整體患者體驗以及其他對抗異位性皮膚炎患者有意義的重要指標。

In that presentation, we are also planning a data cut which looks at patients who have received 24 weeks of treatment with the highest dose induction regimen of ResPak, 24 mcg per kilogram Q2 week.

在該演示中，我們還計劃進行數據剪切，該剪切針對已接受 24 週治療且採用最高劑量誘導方案 ResPak（每公斤 24 微克，第二週）的患者。

You'll recall that our study design allowed patients from induction who had easy scores of less than 50 to advance to a treatment escape arm for up to 36 weeks.

您會記得，我們的研究設計允許誘導治療後得分低於 50 的患者進入治療逃脫組，最長可達 36 週。

As we reported in June, 42 patients who were in the placebo arm during the 16 week induction had a week 16 E score worse than EZ 50.

正如我們 6 月所報告的，在 16 週誘導治療期間接受安慰劑治療的 42 名患者的第 16 週 E 評分低於 EZ 50。

And entered into this escape treatment arm.

並進入了這個逃脫治療組。

These patients represent a true crossover population for studying the extended duration of respagalvi's leukin dosing.

這些患者代表了研究 respagalvi 的白細胞介素給藥延長時間的真正交叉人群。

By this fall, we expect that more than half of the patients in this crossover cohort will have completed 24 weeks of treatment.

到今年秋天，我們預計該交叉隊列中超過一半的患者將完成 24 週的治療。

So with this new upcoming data cut, we are excited to see whether easy responses can deepen with continued treatment with ResPA beyond week 16 and out to week 24.

因此，隨著這項新數據即將發布，我們很高興看到，在第 16 週之後和第 24 週繼續使用 ResPA 治療是否可以加深輕鬆的反應。

This is a phenomenon not observed with IL-13 agents whose treatment effect tends to be capped at the end of induction, and we are excited about this potential because our reported data of ResPA in 16 weeks is comparable to 24 weeks of treatment reported with the aux 40 agents, but with a faster onset of E 75 in each response than what is seen with those agents.

這種現像在 IL-13 藥物中是沒有觀察到的，因為 IL-13 藥物的治療效果往往在誘導結束時受到限制，我們對這種潛力感到興奮，因為我們報告的 16 週 ResPA 數據與報告的 24 週輔助 40 藥物治療數據相當，但每次反應中 E 75 的起效速度比這些藥物更快。

As we announced in February of this year, we received fast track designation for ResPA for the treatment of adult and pediatric patients 12 years of age and older with moderate to severe atopic dermatitis, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

正如我們在今年 2 月宣布的那樣，我們獲得了 ResPA 的快速通道資格，用於治療患有中度至重度異位性皮膚炎的成人和 12 歲及以上兒童患者，這些患者的病情無法通過局部處方療法得到充分控制，或者不建議使用局部處方療法。

As Howard stated, we have already begun phase 3 readiness activities and clinical trial design planning as we prepare for an end of phase 2 meeting with the FDA later this year.

正如霍華德所說，我們已經開始了第 3 階段的準備活動和臨床試驗設計規劃，為今年稍後與 FDA 舉行第 2 階段結束會議做準備。

Our goal is to position ResSPEG to enter its first phase 3 study in the first half of 2026.

我們的目標是讓 ResSPEG 在 2026 年上半年進入第一階段第 3 期研究。

We are actively evaluating several design pathways, including those that provide a clear line of sight to approval of Rasagalis leukin in patients who are both biologic naive and biologic experience.

我們正在積極評估幾種設計途徑，包括那些為在生物學初治患者和有生物學經驗的患者中批准使用 Rasagalis 白細胞介素提供清晰視線的途徑。

We will finalize the trial design following our end of phase two meeting with the FDA later this year.

我們將在今年稍後與 FDA 結束第二階段會議後最終確定試驗設計。

With the strong data from resolve AD confirming the optimal induction dose and target patient population, we're focused on maintaining our momentum to progress reSPA as quickly as possible in atopic dermatitis.

憑藉來自解決 AD 的強有力數據，確認了最佳誘導劑量和目標患者群體，我們專注於保持勢頭，盡快在異位性皮膚炎領域推進 reSPA。

Now moving on to Alopecia areata. The phase 2B resolve AA trial completed enrollment in February, and we're excited to share topline results in December.

現在討論斑禿。2B 期解決 AA 試驗於 2 月完成招募，我們很高興在 12 月分享主要結果。

In this trial, in patients with severe to very severe alopecia areata.

本次試驗的對象為患有重度至極重度斑禿的患者。

Respe is being evaluated at doses of 18 mcg per kilogram or 24 mcg per kilogram every 2 weeks versus placebo. A total of 94 patients were enrolled and the week 36 primary endpoint in the study is the mean percent improvement in salt score.

目前正在對 Respe 的劑量進行評估，劑量為每 2 週 18 微克/公斤或 24 微克/公斤，並與安慰劑進行比較。總共有 94 位患者入組，研究第 36 週的主要終點是鹽分的平均改善百分比。

Keep in mind that alopecia areata is another dermal disease, and so our results in atopic dermatitis and also reinforced by an earlier separate study in psoriasis point to this regulatory cell mechanism having strong signals of efficacy in dermatological settings.

請記住，斑禿是另一種皮膚病，因此我們在異位性皮膚炎方面的研究結果以及早期在牛皮癬方面的獨立研究的結果都表明，這種調節細胞機制在皮膚病學環境中具有強烈的療效信號。

Alopecia areata is a disease in which the patient's immune system mistakenly attacks the hair follicle and disrupts the body's normal ability to keep and grow hair, leading to severe hair loss and lack of hair regrowth.

斑禿是一種患者的免疫系統錯誤地攻擊毛囊並破壞身體正常的保持和生長毛髮的能力，導致嚴重脫髮和毛髮無法再生的疾病。

We know the underlying cause here is the imbalance in T effector cells, the Tregulatory cells around the hair follicle.

我們知道，根本原因是毛囊周圍的 T 效應細胞（T 調節細胞）失衡。

And this imbalance results in the T effector cells attacking and damaging the hair follicle and prohibits T. Regs from signaling to and promoting the function of hair stem cells. So by stimulating T regulatory cells, we are seeking to overcome the pathogenesis of the disease and restore immune homeostasis.

這種不平衡導致效應T細胞攻擊和破壞毛囊，並阻止調節性T細胞向毛髮幹細胞發出信號並促進其功能。因此，透過刺激 T 調節細胞，我們正在尋求克服疾病的發病機制並恢復免疫穩態。

In resolve AA, we will assess the number of secondary endpoints as well, including the proportion of patients with a greater than or equal to 50% reduction in salt at week 36 and other assessed time points and the regulatory approval endpoints for phase 3 studies, salt 20 and salt 10 responder analysis.

在解決 AA 問題時，我們還將評估次要終點的數量，包括第 36 週和其他評估時間點鹽減少量大於或等於 50% 的患者比例以及第 3 階段研究的監管批准終點、鹽 20 和鹽 10 反應者分析。

Following the week 36 assessment, patients who did not achieve a salt score of less than or equal to 20. But did demonstrate substantial hair regrowth over the 36 weeks, are eligible to enroll in a 16-week treatment extension which allows us to have a subset of patients and will be treated for 52 weeks.

經過第 36 週的評估，未達鹽評分的患者小於或等於 20。但在 36 週內確實表現出明顯的毛髮再生，有資格參加 16 週的延長治療，這使我們能夠擁有一部分患者，並將接受 52 週的治療。

Returning to type 1 diabetes, another autoimmune disease where ResPA has great potential as a Treg therapy, we believe ResPA can potentially slow the progressive loss of insulin producing beta cells, which are the target of the patient's overactive immune cells in this disease.

回到第 1 型糖尿病，另一種自體免疫疾病，ResPA 作為 Treg 療法具有巨大潛力，我們相信 ResPA 可以潛在地減緩產生胰島素的 β 細胞的逐漸喪失，而 β 細胞是這種疾病中患者過度活躍的免疫細胞的目標。

As previously announced, Trialnet is sponsoring and conducting an investigator-sponsored phase 2 clinical trial evaluating ResPEG in 66 patients with new onset type 1 diabetes with funding from the NIH.

如前所述，Trialnet 正在 NIH 的資助下贊助並進行一項由研究者贊助的 2 期臨床試驗，對 66 名新發 1 型糖尿病患者使用 ResPEG 進行評估。

We expect Trinet to begin the study before the end of the year.

我們預計 Trinet 將在年底前開始這項研究。

And finally, Nectar 0165, our TNFR2 agonist antibody program, is progressing through IND enabling studies with a goal to advance this program into the clinic in 2026.

最後，我們的 TNFR2 激動劑抗體計畫 Nectar 0165 正在透過 IND 支持研究取得進展，目標是在 2026 年將該計畫推進到臨床階段。

TNFR2 agonism potentiates t rag function as well as maintenance oft-rag lineage stability.

TNFR2 激動劑可增強 t-rag 功能並維持 t-rag 譜系穩定性。

Especially in the non-lymphoid tissue compartments.

特別是在非淋巴組織區室。

The first preclinical data from this program was presented last year at UULar and demonstrated that nectar 0165 has a very high specificity for signaling through TNFR2 on Tregs and enhancing their immuno regulatory phenotype. It also showed that the agonist we discovered is able to signal to the TNFR2 multimeric receptor as a single arm monovalent antibody.

該計畫的首批臨床前數據於去年在 UULar 上公佈，證明 Nectar 0165 對透過 TNFR2 在 Treg 上發出訊號並增強其免疫調節表型具有非常高的特異性。它還表明我們發現的激動劑能夠作為單臂單價抗體向 TNFR2 多聚體受體發出訊號。

And we believe this is the only antibody in this class being developed that has this attribute.

我們相信這是正在開發的此類抗體中唯一具有這種屬性的抗體。

Since the TNFR2 epitope we discovered can function as a single arm agonist, we have leveraged this innovation into a platform of bi-specific and multi-specific assemblies.

由於我們發現的 TNFR2 抗原決定基可以作為單臂激動劑發揮作用，我們利用這項創新建立了雙特異性和多特異性組裝平台。

The first agent from that pipeline, nectar 0166 pairs TNFR2 agonism with a well validated target to create a molecule with a novel mechanism of action and highly innovative properties. We look forward to providing more updates on nectar row 166 and other agents in the coming quarters. I'll now turn it over to Sandra for the financials.

作為此管線中的第一種藥物，nectar 0166 將 TNFR2 激動劑與經過充分驗證的標靶配對，從而創造出具有新穎作用機制和高度創新特性的分子。我們期待在未來幾季提供有關 Nectar Row 166 和其他代理商的更多更新資訊。現在我將財務事宜交給桑德拉。

Thank you, Jay-Z, and good afternoon everyone. On today's call, I'll briefly review our quarterly financials and share updates to our financial guidance for 2025.

謝謝你，Jay-Z，大家下午好。在今天的電話會議上，我將簡要回顧我們的季度財務狀況，並分享我們 2025 年財務指導的最新情況。

We ended the second quarter of 2025 with $15.9 million in cash and investments and with no debt on our balance sheet. As Howard stated earlier, on July 2, 2025, we completed a secondary public offering, resulting in approximately $107.5 million in net proceeds. This fundraising further strengthened our financial position, extending our cash runway into the first quarter of 2027, while also enabling us to invest in our respaid program to progress to phase 3 and further develop Nectar 0165 and Nectar 0166, our TNFR2 agonist antibody candidates.

截至 2025 年第二季度，我們擁有 1,590 萬美元的現金和投資，資產負債表上沒有債務。正如霍華德之前所說，2025 年 7 月 2 日，我們完成了二次公開募股，淨收益約為 1.075 億美元。此次融資進一步增強了我們的財務狀況，將我們的現金流延長至 2027 年第一季度，同時也使我們能夠投資於我們的償還計劃，以進入第 3 階段並進一步開發我們的 TNFR2 激動劑抗體候選藥物 Nectar 0165 和 Nectar 0166。

Our expanded 2025 plan includes Respegg Phase 3 clinical startup activities and securing additional manufacturing for ResPegg.

我們擴展的 2025 年計畫包括 Respegg 第 3 階段臨床啟動活動以及確保 ResPegg 的額外製造。

We now expect to end the year with approximately 180 to $185 million in cash and investments.

我們現在預計今年年底的現金和投資將達到約 1.8 億至 1.85 億美元。

Turning to the income statement, our non-cash royalty revenue was $11.2 million for the second quarter of 2025. We still expect our non-cash royalty revenue to total approximately $40 million for the full year.

談到損益表，我們 2025 年第二季的非現金特許權使用費收入為 1,120 萬美元。我們仍然預計全年非現金特許權使用費收入總計約為 4000 萬美元。

Our R&D expense was $29.9 million for the second quarter of 2025, and we now anticipate full year R&D expense to range between $125 and $130 million including approximately $5 to $10 million of non-cash depreciation and stock-based compensation expense.

我們 2025 年第二季的研發費用為 2,990 萬美元，現在我們預計全年研發費用將在 1.25 億美元至 1.3 億美元之間，其中包括約 500 萬至 1,000 萬美元的非現金折舊和股票薪資費用。

Our GNA expense was $17.1 million for the second quarter. We now expect GNA for the full year of 2025 to be between $70.75 million dollars, including approximately $5 to $10 million of non-cash depreciation and stock-based compensation expense.

我們第二季的 GNA 支出為 1710 萬美元。我們現在預計 2025 年全年的 GNA 將在 7,075 萬美元之間，其中包括約 500 萬至 1,000 萬美元的非現金折舊和股票薪酬費用。

This increase in guidance reflects updated estimates for professional services in the second half of the year, including legal and other accounting consulting services.

此次指引的上調反映了下半年專業服務（包括法律和其他會計諮詢服務）的最新估計。

Non-cash interest expense for the second quarter was $5.4 million and is expected to remain at a similar level for the remaining two quarters, totaling approximately $20 million for 2025.

第二季的非現金利息支出為 540 萬美元，預計剩餘兩季將維持在類似水平，2025 年總計約 2,000 萬美元。

As a reminder, in the first quarter of 2025, we began accounting for our investment in the new portfolio company Gannet Biochem.

提醒一下，從 2025 年第一季開始，我們開始計算對新投資組合公司 Gannet Biochem 的投資。

Under the equity method of accounting, we calculate our non-cash gain or loss based on the change in our share of Gannet Biochem's equity each quarter.

根據權益法，我們根據每季所持有的 Gannet Biochem 股權的變化來計算非現金收益或損失。

Our non-cash loss from equity method investment was $2.4 million in the second quarter of 2025, and we still expect a non-cash loss of approximately $10 million for the full year of 2025 on our income statement.

2025 年第二季度，我們的權益法投資非現金損失為 240 萬美元，我們仍預期 2025 年全年損益表中的非現金損失約為 1,000 萬美元。

We have no commitments to contribute cash to Gannet as an equity investor.

我們沒有承諾作為股權投資者向 Gannet 注入現金。

Our net loss for the second quarter was $41.6 million or $2.95 basic and diluted net loss per share.

我們第二季的淨虧損為 4,160 萬美元，即每股基本淨虧損和稀釋淨虧損 2.95 美元。

Excluding the non-cash loss from our equity method investment, our non-gap net loss totaled $39.2 million or $2.78 basic and diluted net loss per share.

不包括權益法投資的非現金損失，我們的非缺口淨虧損總計 3,920 萬美元，或每股基本和稀釋淨虧損 2.78 美元。

And as I stated earlier, we now expect to end the year with approximately 180 to $185 million in cash and investments with our cash runway now extending into the first quarter of 2027.

正如我之前所說，我們現在預計今年年底的現金和投資將達到約 1.8 億至 1.85 億美元，我們的現金流將延續到 2027 年第一季。

And with that, I will ask the operator to open the lines for Q&A.

說完這些，我將請接線生開通問答專線。

(Operator Instructions)

（操作員指示）

Jay Olsson, Oppenheimer & Co.

奧爾森（Jay Olsson），奧本海默公司

This is Chung on the line for Jay and just want to congratulations again on the very impressive results we shared recently.

我是 Chung，代表 Jay 再次祝賀我們最近取得的令人印象深刻的成果。

Just wondering first, have you maybe started to engage with regulators, with the 16 week data and since you started some activity to prepare for the phase 3 initiation, any color you can share how are you thinking about the trial design and also maybe the number of trials you are planning for the phase 3 program. And maybe separately just like wondering you saw some partnership opportunity for RPA and AT and specifically when would be the optimal time to bring a partner on board and any kind of a characteristic would you define the partner.

首先想問一下，您是否已經開始與監管機構接觸，利用 16 週的數據，並且自從您開始為第 3 階段的啟動做準備以來，您能否分享一下您對試驗設計的看法，以及您為第 3 階段計劃進行的試驗次數。也許您單獨想知道您是否看到了 RPA 和 AT 的一些合作機會，具體來說什麼時候是引入合作夥伴的最佳時機，您會用什麼特徵來定義合作夥伴。

Thank you so much.

太感謝了。

I'll let this Howard, I'll let Jay-Z answer the first part of the question. I'll take the second part. Jay.

我讓霍華德，讓 Jay-Z 來回答問題的第一部分。我將選擇第二部分。傑伊。

Z. Yeah, thanks, Howard, and thanks John. So in terms of your first question was how we began to engage with the regulators, so that's ongoing. So our plan, as I mentioned earlier, is an end of phase two meeting that we intend to hold, before the end of the year. And so at this time we're basically putting together, the meeting request and the briefing package that we go in and The substrate of what we'll be discussing there is indeed the trial design and so our our basic concept in the trial design is we expect to have two monotherapy studies that are basically identical in design as well as a long term extension study which enables you to collect long term safety data and then for this division, there are a number of additional studies that are required. That are typical, for every single BLA submission for a new molecule. In terms of the studies, as we mentioned earlier in the call.

Z. 是的，謝謝，霍華德，也謝謝約翰。所以就您的第一個問題而言，我們是如何開始與監管機構合作的，所以這是持續的。因此，正如我之前提到的，我們的計劃是在年底之前舉行第二階段的結束會議。因此，此時我們基本上正在整理會議請求和簡報包，我們將要討論的內容的基礎確實是試驗設計，因此我們在試驗設計中的基本概念是，我們期望進行兩項設計基本相同的單一療法研究以及一項長期擴展研究，這使您能夠收集長期安全數據，然後對於這個部門，還需要進行一些額外的研究。對於每個新分子的 BLA 提交來說，這都是典型的情況。就研究而言，正如我們之前在電話中提到的那樣。

We understand that there is a significant opportunity for resPAG in multiple lines in atopic dermatitis. We have very strong data and biologic naive patients, and we've shown that right in our phase to results that you commented on, and so that will be a substantial portion of our patient population, but our plan is to also include biologic experienced patients in the trial as well. So in that regard.

我們了解到 resPAG 在異位性皮膚炎的多個治療領域有著巨大的發展機會。我們擁有非常強大的數據和未接受過生物製劑治療的患者，並且我們已經在您所評論的結果階段中證明了這一點，因此這將成為我們患者群體的很大一部分，但我們的計劃是將有生物製劑治療經驗的患者也納入試驗中。因此就這一點而言。

Similar to the kind of studies that Amgen and KOA ran with Roca where they combined both naive and experienced patients in the same study. We think that was a very efficient approach, and our goal is to use that same approach and also have both patient populations in into our phase 3 program which would enable us to have the broadest label when we move to register resPA.

類似於安進和 KOA 與 Roca 共同進行的研究，他們在同一項研究中結合了初治患者和經驗豐富的患者。我們認為這是一種非常有效的方法，我們的目標是使用相同的方法，並將兩組患者納入我們的 3 期計劃，這將使我們在註冊 resPA 時擁有最廣泛的標籤。

So I think that addresses your questions about some of the health authority engagements and trial designs and how it'll I'll turn it over to you about partnership and timing.

所以我認為這回答了您關於一些衛生當局參與和試驗設計的問題，以及我將如何將其交給您關於合作關係和時間安排的問題。

Yeah, sure, thanks, Jay Z. Look, as we said on the call, we hope to end the year with, $180 to $185 million and we will be prepared to put res into the clinic in phase three in 2026. We have a runway that goes into 27. We don't have any plans for an additional financing at this point. We have a number of important data catalysts ahead of us, and we're actively talking to partners about the potential to collaborate on Reseg and including strategics as well as financing partners. There's ways to do this that are a collaboration with another company. There's also ways to do this with non-dilutive financial methods. So we also have some, we also have other sources of non-dilutive capital. For example, we own, 3 to 4% of Dainab, UCDs drug for in phase 3 for lupus.

是的，當然，謝謝 Jay Z。你看，正如我們在電話會議上所說的那樣，我們希望在今年年底獲得 1.8 億至 1.85 億美元的收入，並且我們準備在 2026 年將研究投入到第三階段的臨床中。我們有一條通往 27 號跑道。目前我們沒有任何額外融資計劃。我們面前有許多重要的數據催化劑，我們正在積極與合作夥伴討論在 Reseg 上合作的可能性，包括策略和融資合作夥伴。有多種方法可以實現這一目標，那就是與其他公司合作。也可以透過非稀釋性財務方法來實現這一點。因此，我們也有一些，我們也有其他非稀釋性資本來源。例如，我們擁有 Dainab 的 3% 至 4% 的股份，Dainab 是用於治療狼瘡的 UCD 藥物，處於第 3 階段。

So I think there's, and we're certainly looking at, monetizing that asset. So there's a lot of opportunities for us, but I would say that right now we're, engaged in partnership discussions.

所以我認為，我們確實在考慮將該資產貨幣化。因此，我們面臨很多機會，但我想說的是，目前我們正在進行合作討論。

Got it.

知道了。

Thank you so much and congrats again on the progress.

非常感謝您，並再次祝賀您的進展。

Yasmin Raimi from Piper Sandler. Your line is open.

派珀桑德勒 (Piper Sandler) 飾演的 Yasmin Raimi。您的線路已開通。

Good afternoon team. Congrats on all the updates and all the great commentary. I guess my question is, as the next near term data catalyst is the upcoming AA readout, if JZ, you could walk us through how your thought process around what is a competitive product profile to advance to a later stage development and whether also we will see at the time of the top line data some of the patients who continued into the longer extension, or should we not expect that, and I'll jump back into the queue.

大家下午好。祝賀所有的更新和所有精彩的評論。我想我的問題是，由於下一個近期數據催化劑是即將到來的 AA 讀數，如果是 JZ，您可以向我們介紹一下您的思考過程，即什麼是具有競爭力的產品概況，以推進到後期開發，以及我們是否也會在頂線數據時看到一些繼續進入更長期擴展的患者，或者我們不應該期待這一點，我會跳回隊列。

Yeah, sure. Thanks, yes. So, it's a great question. One of the things that's really important to consider about alopecia is that there are currently no approved biologics for alopecia areata and there's really no therapy that's demonstrated the sustained treatment effect. So jacks are efficacious and even most recently Revok posted probably class leading Jack inhibitor data in the space and the the first of their phase 3 studies that read out a few weeks ago. And it still has, a profile that's well known. So it's a mechanism that requires continuous dosing. If you stop dosing with the jack inhibitor, the patients lose the hair that they may have grown. And then also you have to carry the additional safety liability and it's particularly challenging in this disease as many patients are younger, they have their disease for their entire life, and the concept of, chronically taking a Jack inhibitor for many years is difficult.

是的，當然。謝謝，是的。所以，這是一個很好的問題。關於脫髮，真正需要考慮的重要一點是，目前尚無批准用於治療斑禿的生物製劑，也沒有任何療法能夠證明其具有持續的治療效果。因此傑克是有效的，甚至最近 Revok 發布了可能是該領域領先的傑克抑制劑數據，以及幾週前讀出的第三階段研究中的第一份數據。而它依然擁有眾所周知的形象。所以這是一個需要持續給藥的機制。如果停止使用傑克抑制劑，患者就會失去可能長出的頭髮。然後，您還必須承擔額外的安全責任，這對於這種疾病來說尤其具有挑戰性，因為許多患者都比較年輕，他們一生都患有這種疾病，而且長期服用 Jack 抑製劑多年是困難的。

For us, the way we designed the study, for this phase two is a primary endpoint based on percent change from baseline and salt scores.

對我們來說，我們設計第二階段研究的方式是基於基線和鹽分數的百分比變化作為主要終點。

And while we don't need to necessarily sort of hit some of the jack metrics, we still use the jack metrics. They're very useful as frames of reference as we put together the TPP that we're considering for this indication. And so this is like some kind of benchmarks to keep an eye on for that end point salt percent change from baseline low dose jack achieves about a 30% reduction in salt score and high dose jack about a 40% reduction in salt score. So we're looking to be in that range and ideally, if it, respe shows the kind of scientific approach that we think is very meaningful for this particular biology, then obviously our goal is to even push that. And then of course we'll also be focusing on the key registrational endpoints as those are very informative as we sort of continue and look beyond, the faith to be studied in alopecia areata. So specifically the Salt 20 and salt 10 endpoints are are key. Salt 20 is the FDA accepted threshold and Salt 10 is the standard in Europe. And the DAC inhibitors have about a 20 and 10% for salt 20 and 10 at the low dose and 35 and 25 at the high dose. So again, we're using those as benchmarks along with the data that Revoke posted. But we're very excited about the data set that's coming for us later this year. I'm very excited about the opportunity of taking Respect forward for yet another terminological indication.

儘管我們不一定需要達到某些千斤頂指標，但我們仍然使用千斤頂指標。當我們為此指示整合我們正在考慮的 TPP 時，它們作為參考框架非常有用。因此，這就像某種基準，需要關注終點鹽分百分比相對於基線的變化，低劑量傑克酒可使鹽分分數降低約 30%，高劑量傑克酒可使鹽分分數降低約 40%。因此，我們希望處於這個範圍內，理想情況下，如果它顯示出我們認為對這種特定生物學非常有意義的科學方法，那麼顯然我們的目標就是推動它。當然，我們也將重點放在關鍵的註冊終點，因為這些終點非常有用，因為我們將繼續展望斑禿研究的前景。因此具體來說 Salt 20 和 Salt 10 端點是關鍵。Salt 20 是 FDA 接受的門檻，Salt 10 是歐洲的標準。DAC 抑制劑在低劑量時鹽含量約為 20% 和 10%，在高劑量時鹽含量約為 35% 和 25%。因此，我們再次將這些與 Revoke 發布的數據一起用作基準。但我們對今年稍後即將獲得的數據集感到非常興奮。我很高興有機會將“尊重”一詞進一步推廣到另一個術語指示。

One where we know T. Rex plays such an important role in even just the fundamental biology of hair growth and having the chance of being potentially the first biologic in this space.

我們知道霸王龍在毛髮生長的基本生物學中發揮著重要作用，並有可能成為該領域的第一種生物製劑。

Thank you so much, Daisy.

非常感謝，黛西。

Julian Harrison from BTIG. Her line is open.

BTIG 的 Julian Harrison。她的線路暢通。

Hi, thank you for taking the question, and congrats on all the recent progress. It's great to hear that you plan to include biologic experience, atopic term in your first registrational program for ResPEG. Can you remind us of what underpins your confidence that respe will be active in the segment?

您好，感謝您提出這個問題，並祝賀您最近的所有進展。很高興聽到您計劃在 ResPEG 的第一個註冊計劃中加入生物學經驗、特異性術語。您能否提醒我們一下，是什麼讓您有信心 respe 會在該領域發揮積極作用？

Yeah, certainly, thanks Julian for the question. It's interesting. I mean, we, we're tending to see that multiple agents are showing activity in bioexperience, right? We've seen that now for a few examples. Leverry had that example. Oka seems to be also, having that example, but for us we have this basic understanding that our mechanism. Is in no way overlapping or canceled out or contrary to any of the post IL 13, kind of biology. For example, if a patient has a disease that's more mixed in presentation, say TH2, but additional T helper endotypes that are driving the inflammation. I mean, obviously if you take a TH2 inhibitory mechanism like an IL 4 IL 13, you leave the other parts of the immune system, kind of untouched. Well, we know that we have a breadth, of ability to block multiple kinds of polarized T cell inflammation, and there's also really no additional kind of a priori knowledge or scientific reason why there wouldn't be an effect. Also, because we're an agonist and not an antagonist agent, and we're a cellular agonist, it gives us confidence that RESPE should have activity, whether the patient is biologic naive or experienced. And of course, there are multiple ways that patients fail, those ages, whether it's tolerability signal or a loss of efficacy signal. Again, and both of those cases, we think has potential.

是的，當然，感謝朱利安提出這個問題。這很有趣。我的意思是，我們傾向於看到多種藥劑在生物體驗中表現出活性，對嗎？我們現在已經看到了幾個例子。萊韋裡就曾舉過這樣的例子。Oka 似乎也有這個例子，但對我們來說，我們對我們的機制有基本的了解。與 IL 13 之後的任何生物類型均無任何重疊、抵消或矛盾。例如，如果患者患有表現形式更為複雜的疾病，例如 TH2，但有其他 T 輔助細胞內型會導致發炎。我的意思是，顯然如果你採用 TH2 抑制機制，如 IL 4 IL 13，那麼免疫系統的其他部分就不會受到影響。我們知道，我們有能力阻止多種極化 T 細胞炎症，而且實際上也沒有其他先驗知識或科學原因可以解釋為什麼不會產生效果。此外，由於我們是激動劑而不是拮抗劑，而且我們是細胞激動劑，因此我們相信 RESPE 應該具有活性，無論患者是生物學基礎還是經驗豐富。當然，患者失敗的原因有很多，無論是耐受性訊號還是療效喪失訊號。再次強調，我們認為這兩種情況都有潛力。

Very helpful.

非常有幫助。

Thank you.

謝謝。

Arthur Hee from HCW. Your line is now open.

來自 HCW 的 Arthur Hee。您的線路現已開通。

Hey, good afternoon. How.

嘿，下午好。如何。

Are team. Congrats on the progress report.

是團隊。祝賀進度報告。

So I just had a quick question, on.

所以我只想問一個簡單的問題。

The potential of the pivotal study for the respect for the.

關鍵研究對於尊重的潛力。

AD, regarding the biological experimentation for.

AD，關於生物實驗。

What's.

什麼。

Your thoughts around the.

您的想法圍繞著。

The biological.

生物。

Prior.

事先的。

Biological therapy? Would that be heavily focused on the.

生物療法？這是否會重點關注？

New texting.

有新簡訊。

Exam patient or you going to do kind of the basket patient cohort?

檢查病人還是您要對病人進行分類？

Yeah, thank, thanks. That's a, it's a great question. So you know our goal is to begin our first phase 3 study in the first half of next year. At that time, the major approved mechanisms would be the IL 4 and a 13 class, right, so that would be dopiin, Lebrismumab, right, Adritraumab as well, and then nimmaliumab is also approved as a 31 antagonist, that would also be bio experienced. In our case, while the aux 40 class will not yet be approved, likely, by the time we begin, likely the first entrant will probably reach approval during, obviously there aren't as many people that have taken those drugs yet, but again that would also represent a biologic experienced patient population. I hope that answers your question.

是的，謝謝，謝謝。這是一個很好的問題。所以你知道我們的目標是在明年上半年開始第一階段的第三階段研究。那時，主要批准的機制將是 IL 4 和 13 類，對，所以那將是多西環素、Lebrismumab、對，還有 Adritraumab，然後尼馬利單抗也被批准為 31 拮抗劑，這也是生物經驗。在我們的案例中，雖然 aux 40 類藥物尚未獲得批准，但很可能在我們開始的時候，第一個進入者可能會獲得批准，顯然目前服用這些藥物的人並不多，但這也代表了有生物學經驗的患者群體。我希望這能回答你的問題。

Yeah, that's a big thanks to.

是的，非常感謝。

Mayank Momtani from B. Riley Securities. Your line is open.

B. Riley Securities 的 Mayank Momtani。您的線路已開通。

Hi Dean, thanks for taking our questions and congrats on a very productive 2nd quarter. As part of the phase 3, I was wondering what your expectations for the induction efficacy primary endpoint, duration of therapy would be knowing that you. Not getting to the peak and its efficacy at 16 weeks and also the thought you might be putting in to get the remit of efficacy signal and obviously, is there anything to learn from the Ox trials that are sort of trying to get to a comparable goal and then I have a couple of follow up.

你好，Dean，感謝您回答我們的問題，並祝賀您在第二季度取得了豐碩的成果。作為第 3 階段的一部分，我想知道您對誘導療效的主要終點、治療持續時間的期望是什麼。在 16 週時沒有達到峰值和功效，而且您可能正在考慮獲取功效訊號的範圍，顯然，從 Ox 試驗中可以學到什麼嗎？這些試驗試圖達到一個可比較的目標，然後我有幾個後續行動。

Yeah, sure. Thanks, Mark. So one of the things that our phase 2B study we think really gave us clear, understanding of is the dose level and the regimen that we want to take forward into our phase 3 studies. And we've already used, since our top line, the results of the study to con to create a population PK model as well as an exposure response model. As both of those are key components of the end of phase two meeting package that are used to defend the dose level for the phase 3. So we feel very confident with that. We did mention earlier, right, that the way our study is designed. We have multiple portions of the study where patients are ongoing longer duration of treatment beyond week 16.

是的，當然。謝謝，馬克。因此，我們認為 2B 期研究真正讓我們清楚了解的一件事是我們希望在 3 期研究中採用的劑量水平和方案。並且，從我們的頂線開始，我們就已經利用該研究的結果來創建群體 PK 模型以及暴露反應模型。因為這兩者都是第二階段結束會議方案的關鍵組成部分，用於捍衛第三階段的劑量水平。因此我們對此非常有信心。我們之前確實提到過，我們的研究設計方式。我們的研究有多個部分，其中患者將接受超過 16 週的更長的治療。

We're very excited about the data cut that we talked about earlier in the, in our call, because that really starts to really sort of drill down, right into what are those effects and the potential of deepening responses when patients are treated beyond 16 weeks. For example, we know for some contemporary phase 3 studies, there's been a trend to move to longer induction end points. We also feel like we haven't quite even yet reached or seen the maximum efficacy of Razak, right? We think that's ongoing as people take more treatment. There's a strong potential that we can see deepening. So as we move forward into our end of phase two meeting, we'll also, clarify and propose the duration of our induction, and also, of course, the maintenance arms that we're testing in phase two now. Those are both Q4 and Q12, so we'll also get more information about how we want to take forward maintenance regimens, so both the duration of induction and then the maintenance portion of those studies, and we're planning 52 week studies in our phase 2, phase 3 program.

我們對先前在電話會議中談到的數據削減感到非常興奮，因為這確實開始深入研究這些影響以及患者接受 16 週以上治療後加深反應的可能性。例如，我們知道，對於一些當代的 3 期研究來說，有一種趨勢是轉向更長的誘導終點。我們也覺得我們還沒有達到或看到拉扎克的最大功效，對嗎？我們認為，隨著人們接受更多治療，這種情況將會持續下去。我們可以看到其巨大的潛力正在不斷深化。因此，隨著我們進入第二階段會議的結束，我們也將澄清並提出我們的入職培訓持續時間，當然還有我們現在正在第二階段測試的維修部門。這些都是 Q4 和 Q12，因此我們還將獲得更多關於如何推進維持方案的信息，包括誘導時間和這些研究的維持部分，我們計劃在第 2 階段、第 3 階段計劃中進行 52 週的研究。

Your other question was about the remittive potential. And so I want to first, just remind everyone that the way the phase 2b is designed is we had a 16 week induction that was followed by a 36 week maintenance or escape depending on how patients ended their 16 weeks and then there is a 52 week off drug follow up. So our intention is to treat people for a year. And then follow them for a year off drug to assess, remission or assess durability and stability or at the very least this prolongation of efficacy after you stop treatment. So our phase two study is really poised to give us an even richer data set than we obtained after our 12 week induction in the phase 1B study.

您的另一個問題是關於緩解潛力。因此，首先我想提醒大家，第 2b 階段的設計方式是，我們有一個 16 週的誘導期，然後是 36 週的維持期或結束期，取決於患者如何結束 16 週，然後是 52 週的停藥追蹤。所以我們的目的是治療人一年。然後追蹤他們一年的停藥情況，評估緩解情況或評估持久性和穩定性，或至少評估停止治療後療效的延長情況。因此，我們的第二階段研究確實有望為我們提供比我們在 1B 階段研究中 12 週誘導後獲得的更豐富的數據集。

So the way that we would be looking to leverage that in our phase 3 program is actually going to be similar to what you mentioned, both the light laab and the programs are doing. You do treatment withdrawal, at different points in those studies, and our goal would be to do that kind of an approach. So for example, one way we might approach this is that we would do a 52 week treatment. And then in our long term extension, we would have a randomized withdrawal component so that we would be assessing both the remittive potential as well as long-term treatment in a blinded, randomized withdrawal fashion.

因此，我們在第三階段計劃中尋求利用這一點的方式實際上與您提到的類似，包括輕型拉布和計劃正在做的事情。在這些研究的不同階段，你會停止治療，而我們的目標是採取這種方法。例如，我們可能採取的一種方法是進行 52 週的治療。然後，在我們的長期擴展中，我們將有一個隨機撤藥部分，以便我們能夠以盲法、隨機撤藥的方式評估緩解潛力以及長期治療。

Very helpful, JZ and maybe just staying in the same topic of learning from A40, the alopecia data we've seen so far maybe doesn't get up to the benchmarks you shared for jack inhibitors, but was just curious given that you know you're somewhere in the middle in AD does that read through to the alopecia trial and maybe just lastly for Harvard, any updates on the lili litigation. And if your belief, with the results now with you, any changes to your belief in the outcome and the related liabilities that you might be claiming, thanks for taking your questions.

非常有幫助，JZ，也許只是停留在從 A40 學習的同一主題上，到目前為止我們看到的脫髮數據可能沒有達到您為傑克抑製劑分享的基準，但只是好奇，因為你知道你在 AD 中處於中間位置，是否讀過脫髮試驗，也許最後對於哈佛來說，關於莉莉訴訟的任何更新。如果您對現在的結果有任何看法，您對結果的信念以及您可能聲稱的相關責任有任何改變，感謝您回答您的問題。

I mean, you want Jay Z, want you start and then I'll take the lili question. Yeah.

我的意思是，你想要 Jay Z，想要你開始，然後我會回答 lili 的問題。是的。

Sure, yeah, I'll start with the alopecia. So so firstly remember we have a 36 week end point. And alopecia, and remember we just discussed about longer duration of dosing beyond week 16, so I urge you to to keep those two things in mind. We think there's an opportunity for a very exciting outcome for us in alopecia areata, and we use the DAC inhibitor as benchmarks, but again, there's really not been a biologic that's that has established itself in this space and we're very excited with our mechanism.

當然，是的，我將從脫髮開始。所以首先請記住我們有一個 36 週的結束點。還有掉髮，記住我們剛剛討論過超過 16 週的延長用藥時間，所以我敦促你記住這兩件事。我們認為，在斑禿治療方面我們有機會取得非常令人興奮的成果，我們使用 DAC 抑制劑作為基準，但同樣，目前還沒有一種生物製劑能夠真正在這個領域站穩腳跟，我們對我們的機制感到非常興奮。

To do that. And so we think that if anything, the read-through that we have from atopic Durum is a positive read-through onto alopecia.

去實現那件事。因此，我們認為，如果有的話，我們對異位性硬皮症的解讀是對脫髮的積極解讀。

And how it'll turn over to you.

以及它將如何轉向你。

Okay, yeah, let me, obviously, we're not going to, we certainly can't comment on how, on the Lilly lawsuit. I think we are very committed to pursuing it. Based upon the resBEC data that we reported and the data that's developing, I think we believe the potential for this program is significant and will drive a lot of valuation from others. So I think the lawsuit is something that really will let me put it this way, the results that we have seen so far from ResPAG, I think will help us with the lawsuit, and I certainly don't think.

好的，是的，顯然，我們不會，我們當然不能對禮來訴訟案發表評論。我認為我們非常致力於實現這一目標。根據我們報告的 resBEC 數據和正在開發的數據，我認為我們相信該計劃的潛力巨大，並將帶來其他人的大量估值。所以我認為這場訴訟確實會讓我這樣說，到目前為止我們從 ResPAG 看到的結果，我認為會幫助我們打贏這場訴訟，但我當然不這麼認為。

That we are in a position to comment on the specifics other than to say that we're highly committed to pursuing this and we do believe we were significantly injured by Lilly.

除了說我們高度致力於追求這一目標並且我們確實認為我們受到了禮來公司的嚴重傷害之外，我們無法對具體細節發表評論。

In any case, for example, the program was delayed by a few years in the marketplace, so you can calculate out what that means in the long term. So overall I think we have a strong position. We're going to we're going to pursue this lawsuit to its completion. And I think we're pleased with the way it's going.

無論如何，例如，該計劃在市場上被推遲了幾年，因此您可以計算出從長遠來看這意味著什麼。所以總的來說我認為我們擁有強勢地位。我們將把這起訴訟進行到底。我認為我們對目前的進展感到滿意。

Appreciate the credit.

感謝您的信任。

Chacha Yang from Jeffrey's. Your line is open.

Jeffrey's 的 Chacha Yang。您的線路已開通。

Hi, can you hear me?

嗨，你聽得到我說話嗎？

Yes.

是的。

Okay, wonderful. Hi, this is Chacha on for Roger Song. I was hoping that you could give us any updates on your studies being done to better understand the ISRs, whether that's from a mechanistic perspective, or if you could give us any updates in regards to developing strategies for mitigating them upon commercialization.

好的，太棒了。大家好，我是 Chacha，為 Roger Song 節目節目。我希望您能向我們提供有關您正在進行的研究的任何最新信息，以便更好地了解 ISR，無論是從機械角度來看，還是您能向我們提供有關製定商業化後緩解 ISR 的策略的任何最新信息。

Sure, yeah, thanks for the question, Chacha.

當然，是的，謝謝你的提問，Chacha。

So, in our studies, we have been assessing, the biology of the ISR using various methods. One that's been quite useful for us is using a primary skin organoid cultures using skin that's obtained from tummy tuck surgery. It's very useful because that's abdominal skin and we, inject the abdomen, right? So one of the things that we've learned, so far is that this is really as we've known for a long time and IL2 effect.

因此，在我們的研究中，我們一直在使用各種方法來評估 ISR 的生物學特性。對我們來說非常有用的一種方法是使用從腹部整形手術中獲得的皮膚進行原代皮膚類器官培養。它非常有用，因為那是腹部皮膚，我們將藥物注射到腹部，對嗎？因此，到目前為止，我們了解到的一件事是，這確實正如我們很久以前所知道的那樣，是 IL2 效應。

So ILT is known to cause injection site reactions, and that was, discovered in the late 80s and early 90s when subcutaneous studies, started being done with the molecule. And so the pathways that we see induced are related to IL2. And that's actually a great observation for us to be able to model those in the organoid culture. We can study them at the mRNA level and the pathway level, and then that gives us, opportunities to be very specific with the kind of mitigation approaches that we can use because we know which pathways are firing. And we can even identify the cells that are signaling the most. Another important element for us is that we've been operating the program, basically using drug in a vial, and then, the drug is drawn up at the study sites and administered to the patient subcutaneously by the healthcare practitioner, but we'll be launching with product presentation in a pre-filled syringe packaged into an auto ejector. And we know that will have a positive effect because that will really standardize, the drug administration, the needle depth, the rate, the needle itself will be dry, plus all the things that we're learning from these biological approaches. We'll be doing all of those things while the phase 3 program is ongoing and we look to incorporate those into the auto injector that we'll have at the time of launch.

因此，ILT 已知會引起注射部位反應，這是在 1980 年代末和 1990 年代初開始對該分子進行皮下研究時發現的。因此，我們看到的誘導途徑與 IL2 有關。這實際上是一個很好的觀察結果，讓我們能夠在類器官培養中對其進行建模。我們可以在 mRNA 水平和通路水平上研究它們，這樣我們就有機會非常具體地確定可以使用的緩解方法，因為我們知道哪些通路正在被激活。我們甚至可以辨識出發出最多訊號的細胞。對我們來說，另一個重要因素是，我們一直在運行該計劃，基本上使用小瓶中的藥物，然後，在研究地點抽取藥物並由醫療保健從業者皮下注射給患者，但我們將以預填充注射器的形式推出產品，該注射器包裝在自動彈出器中。我們知道這將產生積極的影響，因為這將真正實現標準化，藥物管理、針頭深度、速度，針頭本身將是乾燥的，加上我們從這些生物學方法中學到的所有東西。我們將在第三階段計劃進行期間完成所有這些工作，並希望將它們納入我們在發佈時擁有的自動注射器中。

Yeah, let me also add to that.

是的，我也補充一點。

I think, look, I think from a marketing point of view it's not a barrier at all.

我認為，從行銷的角度來看，這根本不是一個障礙。

The patients, we had, I think, 2 patients drop out of the trial for injection site reactions. Most patients, they were mild to moderate. They self-resolved. They did not stop taking the drug because of them.

我認為，我們有 2 名患者因注射部位反應而退出試驗。大多數患者病情輕度至中度。他們自己解決了。他們並沒有因此而停止服藥。

And while we did have a lot of patients that had an injection site reaction, they may have only had 1 or 2, and they didn't have any further injection site reactions. Sometimes patients went months before they had one, and then they had one, and then they didn't have any more. So you have to really understand what happened here with injection site reactions. It's not that a large percentage of patients get them on every injection. That is not the case at all. And in any case, they were most of them were mild, and the patients didn't seem to care. So I think when you look at the problems associated with IL-13 drugs such as conjunctivitis, infections, I think that's actually much more concerning than mild to moderate self-resolving.

雖然我們確實有很多患者出現注射部位反應，但他們可能只有 1 或 2 個反應，並且沒有出現任何進一步的注射部位反應。有時病人幾個月前才得過一次病，後來又得過一次病，之後就再也沒有了。所以你必須真正了解注射部位的反應。並不是很大比例的患者每次注射都會出現這種情況。事實根本不是這樣。無論如何，大多數患者的病情都很輕微，患者似乎並不在意。因此，我認為，當你看到與 IL-13 藥物相關的問題（例如結膜炎、感染）時，我認為這實際上比輕度至中度的自我解決更令人擔憂。

Injection site reactions and I think Jay Z made a very excellent point. I think a lot of that will be cleared up by an auto injector. I think there's a lot of, I don't want to say sloppiness, but a lot of inconsistency in the way patients administer the drug themselves. They put it in a vial. It's a wet needle, etc. Etc. There's there's an auto injector should solve a number of those issues, and in any case, the level of ISRs that we saw, I don't think are meaningful from a marketing point of view.

注射部位反應，我認為 Jay Z 提出了一個非常好的觀點。我認為自動注射器可以解決很多問題。我認為有很多問題，我不想說是草率，而是患者自己用藥的方式存在著許多不一致。他們把它放進一個小瓶子裡。它是一根濕針，等等。自動注射器應該可以解決許多這些問題，無論如何，我們看到的 ISR 水平，我認為從行銷的角度來看沒有意義。

Okay, thank you.

好的，謝謝。

Alex Ramsey from William Blair. Your line is now open.

威廉布萊爾 (William Blair) 的亞歷克斯拉姆齊 (Alex Ramsey)。您的線路現已開通。

Hi, thanks so much for taking our question. This is Alex Rams on for Andy Shea at William Blair.

您好，非常感謝您回答我們的問題。這是威廉布萊爾 (William Blair) 的 Andy Shea 的 Alex Rams。

So just going back to the potential remittive effect of res peg and atopic germ, and that's something that we've been curious about. And so we have upcoming maintenance data in early next year. And we're just curious about curious about what data points or advocacy bar at this readout could be suggestive of a remittive effect or if you will need to wait until 2027 to get a gauge on this potential advantage of the regimen. So that's part one, and then part two is do you have a sense of how much you have to blunt disease recurrence to achieve a true remittive effect.

因此，回到 res peg 和過敏性細菌的潛在緩解作用，這是我們一直很好奇的事情。因此我們將在明年年初獲得即將到來的維護數據。我們只是好奇，好奇這個讀數中的哪些數據點或倡導欄可以暗示緩解效應，或者是否需要等到 2027 年才能衡量該方案的潛在優勢。這是第一部分，第二部分是您是否了解必須在多大程度上減緩疾病復發才能實現真正的緩解效果。

Yeah, thanks, Alex, those are great questions. So starting with the first one, so with primitive effect, the data in this part of the phase 2B resolve AD study is still on treatment data. So the people that exited week 16 induction that had an easy 50 or better, right, they moved into the maintenance arms. And in the maintenance arms, they stayed on the same dose level that they were on an induction, but they switched to either a once a month or once every 3 month regimen, and then they were on that regimen for 36 weeks. So, the data that we'll be presenting in the first quarter of next year, that will still be on treatment data. So I, I'll get to your remit of question for part two in a second. But just to specify, yeah, that first quarter 2026 data set will be treatment data, but we will have a very low frequency treatment, component. There will be a number of people.

是的，謝謝，亞歷克斯，這些都是很好的問題。因此，從第一個開始，因此具有原始效果，2B 期解決 AD 研究的這一部分的數據仍然是治療數據。因此，在第 16 週的訓練結束後，如果患者體重輕鬆達到 50 磅或以上，那麼他們就進入了維持組。在維持治療組中，他們保持與誘導治療相同的劑量水平，但改為每月一次或每 3 個月一次的治療方案，然後按照該方案治療 36 週。因此，我們將在明年第一季展示的數據仍將是治療數據。因此，我馬上就會回答您關於第二部分的問題。但需要說明的是，2026 年第一季的數據集將是治療數據，但我們將有一個非常低頻率的治療成分。將會有許多人。

About half of the people that entered into maintenance will be on a 12 week regimen. So we will be looking at a very low frequency dosing and comparing that to a Q4 week. And earlier in the call we talked a few times about the potential, deepening responses and the things that we're really interested to look for in the maintenance with ongoing dosing is for example, the proportion of people that entered that had an easy 50.

大約一半進入維持治療階段的人將接受為期 12 週的治療。因此，我們將研究非常低頻率的劑量並將其與第四季度的劑量進行比較。在電話會議早些時候，我們多次討論了潛在的、深化的反應，以及我們在持續用藥維持中真正感興趣的事情，例如，進入該治療的人數中，有 50% 的人的比例。

But not an easy 75. So how many of them deepened to 75? How many of the E 75 people deepened to 90 and so forth, and also looking at the people that had a response at the week 16 induction, how durable was that in the sense that with ongoing dosing, did they lose, or keep that response. So those are the two main buckets of data analysis, that we'll be looking at. And in the escape barn, we'll be looking at elements like the crossover population and so on when you move everyone to the high dose. So that next part really addresses duration and and 52 weeks of treatment.

但 75 分並不容易。那麼其中有多少加深到了 75 呢？有多少 E 75 患者加深到 90 等等，同時觀察在第 16 週誘導時有反應的患者，這種反應的持久性如何，即隨著持續服藥，他們是失去了反應，還是保持了反應。這些就是我們要研究的兩個主要數據分析領域。在逃生倉中，當你將每個人都轉移到高劑量時，我們會觀察交叉人群等因素。因此下一部分實際上討論了持續時間和 52 週的治療。

That's a very good marker for us, for the overall treatment length. Then the second question you had about the remittive effect was, is there a certain depth of disease that you need to reach before you would have, the best durability? I think that's a really great question. I mean, certainly a person that reaches EZ 75 and a person that reaches E 90.

對我們來說，對於整體治療時間來說，這是一個非常好的指標。那麼，關於緩解效應，您提出的第二個問題是，在獲得最佳持久性之前，是否需要達到一定的疾病深度？我認為這是一個非常好的問題。我的意思是，肯定有一個人達到了 EZ 75，還有一個人達到了 E 90。

Those are two different levels of efficacy. It's a really important question, to ask is there more remission in an easy 90 person or is it the same as in an easy 90 and an easy 75 individual. The only data that we really have to address that is from our phase one.

這是兩種不同層次的功效。這是一個非常重要的問題，即 90 歲患者的緩解程度是否更嚴重，還是與 90 歲和 75 歲患者的緩解程度相同。我們真正需要解決的唯一數據來自第一階段。

And in the phase one, we saw that people that had an IGA response at week 12 and that had an IGA response at week 48, even though they stopped treatment at week 12, had about 80% IGA maintenance and about 70%, 75 maintenance across that kind of 6 months, time horizon in the 6 month off drug period. So that data might hint that there may be a little bit better, remittive effect in people that have a deeper disease, but I think you really need a lot more data, to really be sure of that, and I'm excited to see some of the other mechanisms that we'll be trying to address that as well, such as the aux 40 mechanisms that are both including, treatment-free intervals in their phase 3 programs.

在第一階段，我們發現，在第 12 週出現 IGA 反應的患者和在第 48 週出現 IGA 反應的患者，即使在第 12 週停止治療，在 6 個月的停藥期內，IGA 維持率約為 80%，而 75% 左右的維持率則為 6 個月。因此，這些數據可能暗示，對於病情較重的人來說，緩解效果可能會更好一些，但我認為你真的需要更多的數據才能真正確定這一點，我很高興看到我們將嘗試解決的一些其他機制，例如輔助 40 機制，它們都包括其第 3 階段計劃中的無治療間隔。

Thanks for your question.

謝謝你的提問。

Thank you, that is super helpful. I really appreciate the added color.

謝謝，這非常有幫助。我真的很欣賞添加的顏色。

Thank you. And our next question comes from Jessica Py from JP Morgan. Your line is open.

謝謝。下一個問題來自摩根大通的傑西卡皮 (Jessica Py)。您的線路已開通。

Hey guys, good evening. Thanks for taking my questions. For Respe for AD, can you just speak to your comfort level with the powering of the maintenance phase of that trial after the dropouts and the induction portion? I think you had sort of planned for some attrition here. Just want to make sure that you still feel good about the powering for the the maintenance phase, and I think when you kind of presented the top line induction data in AD, we're sort of benchmarking off of aux 40. You spend a minute talking about why you think that's the right comp for this product.

大家好，晚上好。感謝您回答我的問題。對於 Respe for AD，您能否談談在退出和誘導部分之後對該試驗的維持階段的供電感到滿意的程度？我認為你已經計劃好了這裡的一些消耗戰。只是想確保您仍然對維護階段的供電感到滿意，我認為當您在 AD 中展示頂線感應資料時，我們正在對輔助 40 進行基準測試。您花了一分鐘時間談論為什麼您認為這是該產品的正確比較。

Thank you.

謝謝。

Sure, yeah, thanks, Jeff. So firstly, as we reported in June, we had 190 people that moved into the maintenance arm.

當然，是的，謝謝，傑夫。首先，正如我們 6 月報告的那樣，我們有 190 人進入維修部門。

So we think that's a good population. It's actually right in line with what we've modeled. That will cross over and that modeling was based on other phase 2 studies and, similar phase two patient populations, similar statistical methods used during induction, and then of course, heavily driven by our phase one data and our phase 1 results. So we're pretty happy with the number of people that moved into the maintenance portion and very much to your point, because we wanted to assess two regimens.

所以我們認為這是一個很好的群體。它實際上與我們所建模的完全一致。這將交叉，並且該建模基於其他第 2 階段研究和類似的第 2 階段患者群體、誘導期間使用的類似統計方法，當然，很大程度上受到我們的第 1 階段數據和第 1 階段結果的驅動。因此，我們對進入維持治療部分的人數感到非常高興，這非常符合您的觀點，因為我們想要評估兩種方案。

Right? You're basically randomizing them 1 to 1. The people that were on placebo, and there was a handful, right, it was less than 30%. Those stay on placebo, but everyone else is on Wespe, right, and then they're randomized 1 to 1 on either once a month or once every 3 month regiment. So we're right in line with how we designed the study, but we feel pretty good about that.

正確的？您基本上是將它們以 1 比 1 進行隨機化。服用安慰劑的人只有極少數，不到 30%。這些人繼續服用安慰劑，但其他人都服用 Wespe，對的，然後他們以 1:1 的比例隨機分配接受每月一次或每 3 個月一次的治療方案。因此，我們的研究設計完全符合預期，我們對此感到非常滿意。

And then to your next question about benchmarking to aux 40. Yeah, that, for us, it was really informative when we started to very closely compare the phase two studies, the study designs, the patient populations, and other elements, and when we looked at that, we saw that and kind of the health authority keep sort of driving you to more and more rigorous statistical designs, right? As you have more and more entrances, approaching through later stage clinical development, and it's common, all regulators like to do that, it really pushes the bar. And so we noticed that our study design, our statistical handling, even our sizes and patient populations and even geographic footprint is really much more similar to the aux 40 phase 2B studies.

然後回答您關於對 aux 40 進行基準測試的下一個問題。是的，當我們開始非常仔細地比較第二階段的研究、研究設計、患者群體和其他要素時，這對我們來說確實很有幫助，而且當我們觀察這些因素時，我們發現衛生當局一直在推動你們進行越來越嚴格的統計設計，對嗎？隨著您擁有越來越多的入口，透過後期臨床開發，這很常見，所有監管機構都喜歡這樣做，這確實推動了標準。因此，我們注意到，我們的研究設計、統計處理、甚至我們的規模和患者群體以及地理覆蓋範圍實際上與 aux 40 2B 期研究非常相似。

The other studies like DuP, I mean that was done many years ago, well over 10 years ago, very different, patient population and Trello, which came next, same, a very different patient population. Also, as you looked at new mechanisms.

其他研究，例如 DuP，那是很多年前做的，超過 10 年前，患者群體非常不同，而接下來的 Trello 也是一樣，患者群體也非常不同。另外，當您看到新的機制時。

For us, looking at res is a completely novel and first in class mechanism in atopicderm, and looking at the aux 40 class which was novel relative to the other 13. So we focused that as one of our areas of comparison for those reasons, but of course you have to consider all of it as well and that's why we showed all of the agents that are approved, including the ones in phase 3.

對我們來說，研究 res 是 atopicderm 中一種全新的、首創的機制，而研究 aux 40 類相對於其他 13 類而言是新穎的。因此，基於這些原因，我們將其作為比較的重點之一，但當然你也必須考慮所有因素，這就是為什麼我們展示了所有獲得批准的代理商，包括第 3 階段的代理商。

Thank you.

謝謝。

Thank you.

謝謝。

And I am showing no further questions from our phone lines, and I'd like to pass it back to Howard Robin for any closing remarks.

並且我的電話線中沒有其他問題，我想將其交還給霍華德·羅賓 (Howard Robin) 以作結束語。

Well, thank you, Crystal.

好吧，謝謝你，Crystal。

Before we close, I want to thank the new and existing investors that supported our recent capital raise, and we are truly grateful for your support as shareholders. I also want to thank our employees for their dedication and extremely hard work, and we look forward to delivering additional data updates later this year and engaging with regulators on our phase 3 program. So thank you for joining us today and please stay tuned.

在結束之前，我想感謝支持我們最近融資的新舊投資者，我們非常感謝你們作為股東的支持。我還要感謝我們員工的奉獻精神和辛勤工作，我們期待在今年稍後提供更多數據更新，並與監管機構就我們的第三階段計劃進行合作。感謝您今天加入我們，請繼續關注。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.

感謝您的參與。您現在可以斷開連線。祝大家有美好的一天。