Jaguar Health Inc (JAGX) 2025 Q2 法說會逐字稿

Good morning. Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends and product initiatives, including products in development stage, which may not achieve scientific objectives or meet stringent regulatory requirements.

早安.在我將電話轉給管理層之前，我想提醒您，管理層可能會對公司持續成長前景、產品市場接受度的不確定性、競爭產品和定價的影響、行業趨勢和產品計劃（包括處於開發階段的產品）等事項做出前瞻性陳述，這些產品可能無法實現科學目標或滿足嚴格的監管要求。

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are made based on current available information and management's current assumptions, expectations and projections about future events. While management believes its assumptions, expectations and projections are reasonable in view of the currently available information, you are cautioned not to place undue reliance on forward-looking statements.

前瞻性陳述受風險和不確定性的影響，可能導致實際結果與前瞻性陳述中預期的結果有重大差異。這些聲明是基於目前可用的信息以及管理層對未來事件的當前假設、預期和預測做出的。儘管管理層認為根據目前可用的信息，其假設、預期和預測是合理的，但請注意不要過度依賴前瞻性陳述。

The company's actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the forward-looking statements and Risk Factors section of the company's Form 10-K for the year 2024, which was filed March 31, 2025, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar's website. Except as required by law, Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise.

由於多種原因，本公司的實際結果可能與本次網路直播中討論的結果存在重大差異，包括公司 2024 年 10-K 表格（於 2025 年 3 月 31 日提交）的前瞻性陳述和風險因素部分以及向美國證券交易委員會提交的其他文件（可在捷豹網站的投資者關係部分查閱）。除法律要求外，捷豹不承擔更新或修改本簡報中包含的任何前瞻性陳述以反映新資訊、未來事件或其他情況的義務。

Additionally, please note that the company supplements, its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which company management assesses and operates the business.

此外，請注意，本公司透過提供非 GAAP EBITDA 和非 GAAP 經常性 EBITDA 來補充其以 GAAP 為基礎呈現的簡明合併財務報表。捷豹認為，這些非公認會計準則指標的揭露項目為投資者提供了額外的信息，反映了公司管理層評估和運營業務的基礎。

These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance in conformity with GAAP.

這些非 GAAP 財務指標不應被孤立地看待或作為 GAAP 淨銷售額和 GAAP 淨虧損的替代品，也不能替代或優於符合 GAAP 的財務績效指標。

Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President and Chief Executive Officer. Lisa, the floor is yours.

今天的會議正在錄製中。現在，我很高興將電話轉給 Jaguar Health 的創辦人、總裁兼執行長 Lisa Conte。麗莎，現在輪到你了。

Thank you very much. Thank you for those introductory statements. Hello. Thank you for joining our webcast today. As you heard, my name is Lisa Conte. I am the Founder, President and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals. And I'm the Chairman of our Italian subsidiary, Napo Therapeutics.

非常感謝。感謝您的開場發言。你好。感謝您今天參加我們的網路廣播。正如您所聽到的，我的名字是麗莎·康特 (Lisa Conte)。我是 Jaguar Health 及其全資子公司 Napo Pharmaceuticals 的創辦人、總裁兼執行長。我是我們義大利子公司 Napo Therapeutics 的董事長。

So as usual, if you've been on these webcasts before, I may use the words Jaguar and Napo interchangeably to refer to our company and our company activities. So as announced, this is an earnings webcast. And after I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the second quarter of 2025.

因此，像往常一樣，如果您以前看過這些網路廣播，我可能會交替使用 Jaguar 和 Napo 這兩個詞來指我們的公司和我們的公司活動。正如所宣布的，這是一場收益網絡直播。在我發言之後，我們的財務長 Carol Lizak 將回顧 2025 年第二季的財務亮點。

And as in the past, I am going to steal the thunder of Carol as we're pleased to report that our combined net second quarter 2025 revenue of approximately $3 million for prescription and non-prescription products, including license revenue, increased approximately 35% versus net Q1 2025, and it increased approximately 10% versus net Q2 2024. We're quite pleased with that.

和過去一樣，我要搶卡羅爾的風頭，因為我們很高興地報告，我們 2025 年第二季度的處方藥和非處方藥淨收入約為 300 萬美元，包括許可收入，與 2025 年第一季度的淨收入相比增長了約 35%，與 2024 年第二季度的淨收入相比增長了約 10%。我們對此非常滿意。

And to move along to the bigger picture for the company, 2025 continues to be the year of convergence of key clinical and regulatory catalysts for Jaguar. Catalysts that we feel will be transformative in terms of the value they bring to all the stakeholders in the company from patients, first and foremost, to our shareholders.

從公司的整體發展來看，2025 年仍將是捷豹關鍵臨床和監管催化劑融合的一年。我們認為，這些催化劑將帶來變革，因為它們將為公司的所有利益相關者（首先是患者，然後是股東）帶來價值。

Simply put, with the recent achievement of these catalysts, our strategy is to seek, and we are seeking business development partnerships for licensed rights to the development and commercialization of Jaguar's Human and Animal Health products with the goal of generating nondilutive funding for Jaguar.

簡而言之，隨著這些催化劑最近的成就，我們的策略是尋求，並且我們正在尋求業務發展夥伴關係，以獲得捷豹人類和動物健康產品的開發和商業化的許可權，目標是為捷豹產生非稀釋性資金。

So important at this time of pullback and hopefully, temporary pullback of investor support for innovations in emerging pharma companies well beyond what we're seeing here at Jaguar. These catalysts are the key to those deals.

在投資者對新興製藥公司創新的支持出現回調（希望是暫時回調）的時期，這一點非常重要，而且這種回調的程度遠遠超出了我們在捷豹所看到的情況。這些催化劑是這些交易的關鍵。

To recap our recent catalysts, and may I comment that these remarkable, groundbreaking results are the culmination of years of regulatory and clinical planning activities and implementation, in some cases, up to eight years. And it just so happens that we have a convergence of critical catalysts at this time, again, in support of the opportunities for really important business development deals.

回顧我們最近的催化劑，我可以評論說，這些卓越的、突破性的成果是多年監管和臨床規劃活動和實施的結果，在某些情況下，長達八年。而恰好的是，此時我們再次匯聚了關鍵催化劑，以支持真正重要的業務發展交易的機會。

On April 30 of this year, we released initial results from an independent investigator-initiated proof-of-concept study in pediatric patients in Abu Dhabi of a novel liquid formulation of crofelemer, our first-in-class plant-based paradigm-shifting prescription drug for intestinal failure associated with what we call MVID, that's microvillus inclusion disease.

今年 4 月 30 日，我們發布了一項由獨立研究者發起的概念驗證研究的初步結果，該研究針對阿布達比的兒科患者，研究對像是一種新型液體製劑 Crofelemer，這是我們首創的植物性範式轉換處方藥，用於治療與我們所說的 MVID（即微絨毛包腸涵體病）相關的衰竭。

I'm going to refer to it as MVID, which is an ultra-rare disease. And also intestinal failure associated with short bowel syndrome, SBS, SBS-IF. For both these indications, crofelemer has orphan drug designation in the US and Europe, conferring opportunities for expedited development, regulatory approval, which leads to reimbursement. So what is intestinal failure?

我將其稱為 MVID，這是一種極為罕見的疾病。以及與短腸症候群、SBS、SBS-IF 相關的腸衰竭。對於這兩種適應症，Crofelemer 在美國和歐洲都被指定為孤兒藥，從而有機會加快開發、獲得監管部門批准並獲得報銷。那什麼是腸衰竭呢？

It's a condition where intestines cannot adequately absorb the nutrients of life, protein, carbs, vitamins, et cetera. And patients also suffer from devastating diarrhea, and therefore, dehydration. These are lifelong conditions, and they often require for the patient to survive total parenteral nutrition, TPN, total parenteral nutrition, IV nutrition up to seven days a week for more than 20 hours a day.

這是腸道無法充分吸收生命營養物質、蛋白質、碳水化合物、維生素等的狀態。患者還會遭受嚴重的腹瀉，並因此脫水。這些都是終身疾病，通常需要患者每週七天、每天超過 20 小時接受全腸外營養、TPN、全腸外營養、靜脈營養。

Obviously, a catastrophic health situation, impacting hugely any quality of life of both patients and caregivers, which is usually and often the family with many complications and huge expense to the health care system of hundreds of thousands of dollars a year per patient. For MVID patients, in particular, TPN, total parenteral nutrition, is necessary from the first day of birth. The patient needs to be diagnosed and put on TPN to survive. Otherwise, they die.

顯然，災難性的健康狀況會極大地影響患者和照護者的生活質量，而照護者通常是家庭，並帶來許多併發症，而每位患者每年的醫療費用高達數十萬美元，給醫療保健系統帶來巨大的負擔。特別是對於MVID患者，從出生第一天起就需要進行TPN（全腸外營養）。患者需要接受診斷並接受 TPN 治療才能存活。否則，他們就會死。

And that need not change and does not change during what is often their short life, a short life due to the complications from TPN of liver, renal failure, cognitive issues, never get on a full growth curve, IV line complications and others. There are no drugs approved for MVID, and we're not aware of any approach even in clinical development.

而這一點不需要改變，而且在他們通常短暫的一生中也不會改變，他們的短暫生命是由於肝臟 TPN 併發症、腎衰竭、認知問題、無法達到完整的生長曲線、靜脈輸液併發症等造成的。目前尚無批准用於治療 MVID 的藥物，我們甚至不知道有任何處於臨床開發階段的方法。

The biggest impact one can have on a patient with intestinal failure is reduction in the quantity and, or time of TPN. It's remarkably toxic treatment to go through. And as announced and presented on April 26, 2025, at the Annual Ped Elite GI Congress, initial proof-of-concept results from the ongoing trial in Abu Dhabi showed that crofelemer reduced the required TPN and supplementary intravenous fluids in the first participating MVID patient by up to 27%, huge, 27%. And the first participating SBS patient with intestinal failure by up to 12.5%. And that was at the end of 12 weeks of treatment with an escalation study.

對腸衰竭患者來說，最大的影響就是減少 TPN 的量和/或時間。這是一次毒性極大的治療。正如 2025 年 4 月 26 日在年度兒科精英胃腸道大會上宣布和展示的那樣，阿布扎比正在進行的試驗的初步概念驗證結果顯示，Crofelemer 將第一位參與的 MVID 患者所需的 TPN 和補充靜脈輸液量減少了高達 27%，這是一個巨大的數字，27%。而第一位參加SBS的患者腸衰竭發生率高達12.5%。這是在 12 週升級治療研究結束時的結論。

In addition, the data showed that crofelemer reduced stool volume, output and, or frequency of watery stools and increased the urine output, which is important, an indicator of improved oral absorption of nutrients. These results represent stunning, ground breaking disease progression modification benefits from the treatment from crofelemer.

此外，數據顯示，Crofelemer 減少了糞便量、排出量和/或水樣便的頻率，並增加了尿量，這是重要的，是改善口服營養物質吸收的一個指標。這些結果代表了 Crofelemer 治療在改善疾病進展方面具有令人震驚的、突破性的益處。

In addition, at the end of the 12 weeks, these patients, there was as part of the protocol, they were taken off crofelemer. And in each case, they relapsed within 10 days and needed to be put back on crofelemer, which we're now providing indefinitely to these patients.

此外，在 12 週結束時，作為治療方案的一部分，這些患者被停用 Crofelemer。在每個病例中，他們的病情都在 10 天內復發，需要重新服用 Crofelemer，我們現在無限期地為這些患者提供這種藥物。

A third intestinal failure patient completed this IIT protocol with similar results, and we expect patient data from this trial to continue to be generated throughout the year and are seeking -- the investigator is seeking further publications and presentations as well.

第三名腸衰竭患者完成了此 IIT 方案並獲得了類似的結果，我們預計該試驗的患者數據將在全年持續生成，並且正在尋求——研究人員也在尋求進一步的出版物和演示文稿。

Well, short bowel syndrome affects approximately 40,000 people around the world, MVID is an ultra-rare condition with an estimated prevalence of just a couple of hundred patients globally, given this situation and nothing approved for these patients, initial results in even a single-digit number of MVID patients showing benefit, crofelemer may support pathways for expedited regulatory approval for this indication, including something called the PRIME program at EMA, European Medicines Agency, the equivalent of the FDA in Europe, for expedited and assisted regulatory approval in the full 27 countries of the EU and then also FDA's breakthrough therapy program for expedited regulatory approval in the US.

嗯，短腸症候群影響著全世界約 40,000 人，MVID 是一種極其罕見的疾病，全球估計只有幾百名患者患病，鑑於這種情況，並且沒有針對這些患者的藥物獲得批准，初步結果顯示甚至只有個位數的 MVID 患者顯示出益處，Crofelemer 可能支持加快該適應症的監管途徑，包括歐洲藥品 (EMA) 的全部歐盟計劃個國家進行加速和協助監管批准，然後還有 FDA 的突破性治療計劃，用於在美國加快監管批准。

And we're talking about a single-digit number of patients' approval potentially as early as the end of 2026. And I believe at this time, we have three additional MVID patients who are in treatment. We are also supporting an investigator-initiated trial in adult patients with short bowel syndrome and intestinal failure at the Cleveland Clinic in the United States with the first patients enrolled in that trial.

我們談論的可能是最早在 2026 年底獲得個位數批准的患者數量。我相信目前我們還有另外三位 MVID 患者正在接受治療。我們也支持美國克利夫蘭診所針對患有短腸症候群和腸衰竭的成年患者開展一項由研究者發起的試驗，首批患者已參與該試驗。

Beyond these remarkable, really remarkable and important IIT results with crofelemer investigator-initiated trial results, Jaguar and through Napo Therapeutics, our subsidiary in Italy, which is important to have a footprint in Europe as we're dealing with the EMA, we're dealing with PRIME designation.

除了這些非凡的、真正非凡的和重要的 IIT 結果以及 crofelemer 研究者發起的試驗結果之外，Jaguar 和透過我們在義大利的子公司 Napo Therapeutics，在歐洲佔有一席之地非常重要，因為我們正在處理 EMA，我們正在處理 PRIME 稱號。

We're currently conducting two placebo-controlled Phase II trials for crofelemer, one in the US and in the EU for pediatric MVID patients and one for adults' short bowel syndrome, intestinal failure in the US, EU and the MENA regions. Patient treatment has begun in both of these Phase II trials and results are expected in the first half of 2026. And the MVID trial is also occurring in the MENA region. I think I said that backwards.

我們目前正在對 Crofelemer 進行兩項安慰劑對照的 II 期試驗，一項在美國和歐盟針對兒童 MVID 患者進行，另一項在美國、歐盟和中東和北非地區針對成人短腸症候群和腸衰竭進行。這兩項 II 期試驗均已開始對患者進行治療，預計結果將於 2026 年上半年公佈。MVID 試驗也在中東和北非地區進行。我覺得我說反了。

So US, EU and MENA for MVID, US and EU for our short bowel syndrome. And one of the reasons for that in areas where there's consanguineous marriages as part of the culture, there's often an increased incidence and prevalence of congenital disorders, and MVID is a congenital disorder as well as a certain population of short-bowel syndrome patients.

因此，美國、歐盟和中東和北非地區針對 MVID，美國和歐盟針對我們的短腸症候群。其中一個原因是，在近親結婚成為文化一部分的地區，先天性疾病的發生率和盛行率往往會增加，而 MVID 是一種先天性疾病，也是特定人群的短腸症候群患者。

Okay. Now I'm going to talk about our other core crofelemer development program, cancer therapy-related diarrhea, which I will refer to as CTD, which is an opportunity for label extension supplemental New Drug Application for the already approved Mytesi product.

好的。現在我要談談我們的另一個核心 Crofelemer 開發項目，即癌症治療相關性腹瀉，我將其稱為 CTD，這是為已經批准的 Mytesi 產品進行標籤擴展補充新藥申請的機會。

Mytesi is approved for HIV-related diarrhea. What we're looking to do is expand the indication, the opportunity to promote the opportunity for reimbursement for cancer therapy-related diarrhea. Same product, same formulation, same dosing expand the label.

Mytesi 被批准用於治療 HIV 相關腹瀉。我們希望擴大適應症，增加癌症治療相關腹瀉的報銷機會。相同的產品、相同的配方、相同的劑量擴大標籤。

For this goal -- towards this goal, last year, Jaguar completed a global Phase III study, a prophylactic clinical trial of crofelemer for the prophylaxis of diarrhea in cancer patients with all solid tumors. There are about 10 different tumor types on 24 different targeted agents with or without cytotoxic chemotherapy, and this was termed the on-target trial.

為了這個目標——朝著這個目標，去年，捷豹完成了一項全球性的 III 期研究，即 Crofelemer 用於預防所有實體瘤癌症患者腹瀉的預防性臨床試驗。大約有 10 種不同類型的腫瘤需要接受 24 種不同的標靶藥物治療，有時還需合併細胞毒性化療，稱為標靶試驗。

It was a basket trial. It was a big, big hug, big grab to the cancer community since there are close to -- or there are many, many dozens, close to 100 different targeted therapies out there now being used in the cancer community. The trial did not meet its primary endpoint for all the tumor types. However -- and often nothing is heard after that. However, the trial did need statistical significance for the prespecified subgroup of breast cancer patients, which accounted for 64% of the 287 participants in this study.

這是一次籃球測驗。這對癌症界來說是一個很大的擁抱，因為目前癌症界正在使用近 100 種不同的標靶療法。該試驗並未達到所有腫瘤類型的主要終點。然而──此後往往就再也沒有聽到任何消息了。然而，該試驗確實需要對預先指定的乳癌患者亞組具有統計意義，該亞組佔本研究 287 名參與者的 64%。

And these results, these breast cancer results were the subject of presentation on December 11, 2024, at the acclaimed San Antonio Breast Cancer Symposium. An additional significant results in adult breast cancer patients from this study were the subject of an abstract presented that MASCC, which is the Multinational Association of Supportive Care in Cancer, and that meeting was in Seattle just this past June.

這些結果，這些乳癌結果是 2024 年 12 月 11 日在著名的聖安東尼奧乳癌研討會上發表的主題。該研究對成年乳癌患者的另一個重要結果是國際癌症支持治療協會 MASCC 提交的摘要的主題，該會議於今年 6 月在西雅圖舉行。

So let's talk about the diarrhea in targeted therapy. Diarrhea is a very common side effect of targeted cancer therapies, specifically a type of diarrhea that is mediated by chloride ion secretion, which is the target of the mechanism, the groundbreaking paradigm-shifting mechanism that crofelemer is able to normalize. And the effect of this diarrhea is that it can lead to dose changes, treatment delays or even cessation -- termination of the cancer treatment altogether.

那我們來談談標靶治療中的腹瀉。腹瀉是標靶癌症治療的一種非常常見的副作用，具體來說是一種由氯離子分泌介導的腹瀉，而氯離子分泌正是該機制的目標，即Crofelemer能夠使這種突破性的範式轉換機制正常化。這種腹瀉的後果是，它會導致劑量改變、治療延遲甚至停止——完全終止癌症治療。

And now you're talking about an impact on the outcome of the cancer treatment of these patients. So in this analysis, which was called a responder analysis of the on-target patients with breast cancer and on targeted therapies, crofelemer resulted in a greater proportion of the monthly responders of diarrhea improvement compared to the placebo. It was a placebo-controlled trial. Overall, crofelemer was significantly more effective than placebo in providing sustained response in breast cancer patients.

現在您正在談論對這些患者癌症治療結果的影響。因此，在這項針對乳癌患者和接受標靶治療的患者的反應者分析中，與安慰劑相比，Crofelemer 導致每月腹瀉改善的患者比例更高。這是一項安慰劑對照試驗。總體而言，Crofelemer 在為乳癌患者提供持續治療方面比安慰劑更有效。

The important regulatory catalyst for this program occurred on May 28, 2025, when Jaguar participated in an in-person Type C meeting with the FDA to discuss these results. The meeting kicked off with patient advocates who are formal members of our Scientific Advisory Board.

該計劃的重要監管催化劑發生在 2025 年 5 月 28 日，當時捷豹參加了與 FDA 的面對面 C 類會議，討論這些結果。會議由我們科學顧問委員會正式成員的病患倡議者拉開序幕。

In discussing the impact of diarrhea on their ability in the entire community, the cancer community, the ability to stay on life-saving therapy as well as the devastating impact on quality of life and comfort. One advocate had received an off-label prescription for crofelemer and targeted agents, and these are categories that you may have heard of. We all seem to have been touched somewhere in our relationships in our networks by cancer.

在討論腹瀉對整個社區、癌症社區的能力、堅持救命治療的能力以及對生活品質和舒適度造成的毀滅性影響時。一位倡導者收到了 Crofelemer 和標靶藥物的標籤外處方，這些是您可能聽說過的類別。我們所有人似乎都曾在人際關係網絡的某個地方受到癌症的影響。

So agents that are TKIs, CDK4/6s, epidermal growth factor receptor antibodies, they can have rates of diarrhea and they all have diarrhea, secretary chloride ion-mediated diarrhea, but some of them has rates as high as 80% to 90%.

因此，TKI、CDK4/6、表皮生長因子受體抗體等藥物都有可能引起腹瀉，而且它們都會引起腹瀉、分泌性氯離子介導的腹瀉，但其中一些藥物的發生率高達 80% 至 90%。

There's four grades of diarrhea. Even grade 2 is four to six loose watery stools a day with the uncertainty, the size surprise factor, the incontinence. As one of our patient advocates mentioned in the FDA meeting and looked at all the FDA regulators, where do you have time in your day to deal with that? Every single day.

腹瀉分為四個等級。即使是 2 級，每天也會出現四到六次稀水樣便，且具有不確定性、大小意外因素和失禁。正如我們的一位患者權益倡導者在 FDA 會議上提到的那樣，並查看了所有 FDA 監管機構，您一天中哪有時間來處理這些問題？每一天。

Targeted agents are taken in a metastatic situation for the rest of the patient's lives and wonderfully metastatic patients now are living 5, 10, 15 years and even in a curative situation for nine months with some recommendations for years for targeted therapy.

對於轉移性患者，標靶藥物可用於其終生治療，而轉移性患者現在可以存活 5 年、10 年、15 年，甚至可以存活 9 個月，而有些患者則建議進行多年的標靶治療。

With those powerful messages kicking off the meeting, Jaguar, the company, we then proposed two simultaneous pathways for making crofelemer available, in particular, to the metastatic breast cancer patients, with the significant unmet medical need of cancer therapy-related diarrhea. So the two pathways, number one, conducting a pivotal treatment trial, on-target trial was prophylaxis, so to expand to a treatment trial to facilitate the approval of crofelemer for CTD in this focused metastatic breast cancer patient population and initiating with promptly pursuit of authorization for an expanded access program immediately for breast cancer patients with CTD who may not be eligible for this study, and that could include breast cancer patients in both the adjuvant and neoadjuvant settings.

在會議開始時，捷豹公司就這些強有力的信息提出了兩種同時使用 Crofelemer 的途徑，特別是針對轉移性乳癌患者，因為癌症治療相關性腹瀉的醫療需求尚未得到滿足。因此，有兩種途徑，第一，進行關鍵治療試驗，靶向試驗是預防性的，因此擴展到治療試驗，以促進 Crofelemer 在這一重點轉移性乳腺癌患者群體中用於 CTD 的批准，並立即啟動擴大獲取計劃的授權，針對可能不符合本研究條件的 CTD 乳腺癌患者，這可能包括輔助和新輔助環境中的乳腺癌患者。

The FDA formally acknowledged both of these key discussion points in correspondence -- written correspondence to Napo and acknowledging the supportive data for prophylaxis from the on-target trial. So what we're doing now is we are preparing to submit a protocol to the FDA for a pivotal treatment trial for a smaller trial, smaller number, and this would be metastatic breast cancer patients using crofelemer, complete the trial in 2026 in support of our goal of expanding the label for a product that's already on the market, expanding the label and the approval of Mytesi to include metastatic breast cancer patients, give us the opportunity to promote and sell to that community and for them to gain reimbursement based on the label expansion.

FDA 在信函中正式承認了這兩個關鍵討論點——向 Napo 發出書面信函並承認目標試驗中預防的支持數據。因此，我們現在正在做的是，我們正準備向 FDA 提交一項關鍵治療試驗的方案，該試驗規模較小，受試者較少，針對的是使用 crofelemer 的轉移性乳腺癌患者，試驗將於 2026 年完成，以支持我們擴大已上市產品標籤的目標，擴大 Mytesi 的標籤和批准，將轉移性乳腺癌患者納入標籤，讓我們有機會向該群體推廣該群體，並根據標籤

We believe the current estimated US metastatic breast cancer population, which is growing, which is wonderful because of these treatments is approximately 150,000, 160,000 people, and this potentially qualifies as an orphan population in alignment with the company's core focus on orphan diseases and different, expedited pathways that, that provides and regulatory flexibility.

我們認為，目前估計美國轉移性乳癌患者人數約為 15 萬至 16 萬人，而且這一數字還在不斷增長，這得益於這些治療方法，這是一個好消息，這可能符合孤兒病患者群體的資格，這與公司對孤兒病和不同的快速治療途徑的核心關注相一致，這些途徑可提供監管靈活性。

We, therefore, intend to request orphan drug designation from the FDA for crofelemer, for CTD indication in this population, and you can look forward to us announcing that when we complete that application.

因此，我們打算向 FDA 申請將 Crofelemer 指定為孤兒藥，用於該人群的 CTD 適應症，您可以期待我們在完成該申請後宣布這一消息。

Now I'm going to talk about the Animal Health side of our business, which is a small piece of our business, but a remarkably important piece of our business. And our primary objective for our commercial product called Canalevia, this is crofelemer for chemotherapy-induced diarrhea in doggies. This is a prescription drug by the center of veterinary medicine of the FDA, and it's called something called condition approval -- conditional approval under the name Canalevia-CA1.

現在我要談談我們業務中的動物保健方面，這是我們業務的一小部分，但卻是我們業務中非常重要的一部分。我們商業產品 Canalevia 的主要目標，是用於治療狗狗化療引起的腹瀉的 crofelemer。這是 FDA 獸醫中心批准的一種處方藥，它被稱為有條件批准——名稱為 Canalevia-CA1 的有條件批准。

And our goal here is to identify a partner, a corporate partner from one of the large animal health companies or medium-sized animal health companies with which to collaborate to achieve three parallel goals for this drug.

我們的目標是找到一個合作夥伴，一個來自大型動物保健公司或中型動物保健公司的企業合作夥伴，與其合作實現該藥物的三個平行目標。

Obtain approval in the European Union for Canalevia for the treatment of general diarrhea, not just chemotherapy-induced diarrhea, general diarrhea, which includes chemotherapy-induced diarrhea in dogs. And this is based on the existing studies that we have in hand. Goal number two, maintain, of course, the continuity of the availability in the United States of Canalevia for chemotherapy-induced diarrhea in dogs, of course. We get a remarkable response there.

獲得歐盟批准Canalevia用於治療一般腹瀉，而不僅僅是化療引起的腹瀉，一般腹瀉，包括狗的化療引起的腹瀉。這是基於我們現有的研究。第二個目標當然是保持美國境內 Canalevia 藥物的供應連續性，用於治療狗狗化療引起的腹瀉。我們在那裡得到了顯著的回應。

And then also to expand the indication in the United States from just chemotherapy-induced diarrhea to the treatment of general diarrhea in doggies and other companion animals. The mechanism by which crofelemer works, the channels on which it works are highly conserved in mammals.

然後在美國將適應症從僅用於治療化療引起的腹瀉擴大到治療狗和其他伴侶動物的一般腹瀉。Crofelemer 的作用機制以及其作用的通道在哺乳動物中高度保守。

And so the opportunity to expand to companion animals is there for a company that is focused in the veterinary marketplace. We are currently in discussions with multiple potential animal health potential partners as, by the way, we are on the human side as well. I want to point that out, a major goal of the company and to collaborate on the Animal Health side to bring Canalevia to regulatory approval and commercialization for the general diarrhea population globally.

因此，對於專注於獸醫市場的公司來說，有機會將業務擴展到伴侶動物領域。我們目前正在與多個潛在的動物健康合作夥伴進行討論，順便說一句，我們也站在人類這邊。我想指出的是，該公司的一個主要目標是在動物保健方面進行合作，使 Canalevia 獲得監管部門的批准，並在全球範圍內為一般腹瀉人群進行商業化。

For dogs, in particular, diarrhea is one of the most common reasons owners bring their dogs to the vet. And it's the second most common reason for visits to the veterinary emergency hospital. And there's no FDA-approved drugs to treat general diarrhea in doggies.

特別是對狗狗來說，腹瀉是主人帶狗去看獸醫的最常見原因之一。這是前往獸醫急診醫院的第二大常見原因。目前還沒有經 FDA 批准的藥物可以治療狗的一般腹瀉。

So I find this remarkable a cancer patient in the United States experiencing diarrhea can have crofelemer promoted and prescribed, promoted by the company, prescribed by their health care provider, if that patient is a dog, but not a human, but not yet. I'm now going to hand the discussion over to Carol, who will go back to the financial reporting for today.

因此，我發現這很了不起，如果美國一位患有腹瀉的癌症患者是一條狗，而不是人，那麼他可以服用該公司推廣和開具的 Crofelemer，由他的醫療保健提供者開具處方，但目前還不行。我現在將討論交給卡羅爾，她將重新討論今天的財務報告。

And Carol, you can recap the financial highlights for the second quarter of 2025, please.

卡羅爾，請您回顧 2025 年第二季的財務亮點。

Good morning, Lisa, and thank you to all of you who have joined our webcast today. I'll begin my review of our financials for the second quarter of 2025. The combined net second quarter 2025 revenue of approximately $3 million for prescription and non-prescription products, including license revenue, increased approximately 35% versus the net first quarter 2025 revenue of approximately $2.2 million and increased approximately 10% versus net second quarter of 2024 revenue of approximately $2.7 million.

早安，麗莎，感謝今天參加我們網路直播的所有人。我將開始審查我們 2025 年第二季的財務狀況。2025 年第二季處方藥和非處方藥的合併淨收入（包括許可收入）約為 300 萬美元，比 2025 年第一季的淨收入約 220 萬美元增長約 35%，比 2024 年第二季的淨收入約 270 萬美元增長約 10%。

Mytesi prescription volume increased by approximately 6.5% in the second quarter of 2025 over the first quarter of 2025, and Mytesi prescription volume in the second quarter of 2025 was equal to the volume in the second quarter of last year.

2025 年第二季 Mytesi 處方量較 2025 年第一季增加約 6.5%，2025 年第二季 Mytesi 處方量與去年第二季持平。

Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns amongst specialty pharmacies in the closed network as they manage their inventory levels.

處方量與發票銷售量不同，這反映了封閉網路中的專業藥局在管理庫存水準時不同的購買模式等因素。

Loss from operations increased by $800,000 from $7.2 million in the quarter ended June 30, 2024, to $8 million during the same period this year. Non-GAAP recurring EBITDA for the second quarters of 2025 and 2024 were a net loss of $7.9 million and $8.8 million, respectively.

營業虧損從截至 2024 年 6 月 30 日的季度的 720 萬美元增加 80 萬美元至今年同期的 800 萬美元。2025 年和 2024 年第二季的非 GAAP 經常性 EBITDA 分別為淨虧損 790 萬美元和 880 萬美元。

Net loss attributable to common shareholders increased by approximately $900,000 from $9.5 million in the quarter ended June 30, 2024, to $10.4 million in the same period in 2025. And that concludes my recap of high-level financials for the second quarter of 2025.

歸屬於普通股股東的淨虧損從截至 2024 年 6 月 30 日的季度的 950 萬美元增加約 90 萬美元至 2025 年同期的 1,040 萬美元。這是我對 2025 年第二季高層財務狀況的回顧。

I will now hand the discussion back to you, Lisa.

現在我將討論的重心交還給你，麗莎。

Thank you very much, Carol. It's very exciting financial results. And let me conclude with all the members of Jaguar and Napo, Napo Therapeutics. We're energized and we are excited about the multiple, near term as well as an upcoming expected catalyst for crofelemer in the company, all of which we view as a value-enhancing and potentially transformative for patients, all our stakeholders, including our shareholders.

非常感謝，卡羅爾。這是非常令人興奮的財務結果。最後，請容許我與 Jaguar 和 Napo、Napo Therapeutics 的所有成員一起致詞。我們充滿活力，對 Crofelemer 在公司短期和未來預期中的多種催化劑感到興奮，我們認為所有這些都能為患者、所有利益相關者（包括我們的股東）帶來價值提升和潛在的變革。

These catalysts, as I mentioned, it's the year of catalysts represent the convergence of key potential inflection points in our major programs, and we are working and expect that these catalysts will bring in significant nondilutive dollars from business collaborations, licensing deals. This is a major focus of our activities right now based on these late-stage products and programs from the clinical and the regulatory side.

正如我所提到的，這些催化劑，這是催化劑之年，代表著我們主要項目中關鍵潛在拐點的匯聚，我們正在努力並期望這些催化劑將從業務合作、許可交易中帶來大量非稀釋性資金。基於臨床和監管方面的後期產品和項目，這是我們目前活動的重點。

So this concludes our webcast for today. Thank you very much for joining. Enjoy the rest of the summer. We will be furthering our business development and other company objectives based on these clinical and regulatory catalysts that we review today and continuing to work for all our stakeholders.

今天的線上直播就到這裡了。非常感謝您的加入。享受剩下的夏天吧。我們將根據今天審查的臨床和監管催化劑進一步發展我們的業務和其他公司目標，並繼續為所有利害關係人服務。

Thank you.

謝謝。

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的電話會議到此結束。現在您可以斷開線路。感謝您的參與。