Jaguar Health Inc (JAGX) 2023 Q3 法說會逐字稿

Before I turn the call over to the 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, impact of competitive products and pricing, industry trends and product initiatives, including products in the development stage, which may not achieve scientific objectives or meet stringent regulatory requirements.

在我將電話轉交給管理層之前，我想提醒您，管理層可能會就以下事項做出前瞻性陳述：公司的持續成長前景、產品市場接受度的不確定性、競爭產品的影響和定價、產業趨勢和產品舉措，包括處於開發階段的產品，可能無法實現科學目標或滿足嚴格的監管要求。

Forward-looking statements are not subject to risks and uncertainties that would cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management's current assumptions, expectations and projections about future events.

前瞻性陳述不受可能導致實際結果與此類前瞻性陳述中預期結果有重大差異的風險和不確定性的影響。這些陳述是基於目前可獲得的資訊以及管理階層目前對未來事件的假設、預期和預測。

While management believes its assumptions, expectations and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements. 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 sections of the company's Form 10-K for the year 2022.

儘管管理層認為，鑑於目前可獲得的信息，其假設、預期和預測是合理的，但請注意不要過度依賴這些前瞻性陳述。由於多種原因，包括公司 2022 年 10-K 表格的前瞻性陳述和風險因素部分中所述的原因，本公司的實際結果可能與本次網路廣播中討論的結果有重大差異。

Which was filed March 24, 2023, 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.

該文件於 2023 年 3 月 24 日提交，以及向 SEC 提交的其他文件，可在捷豹網站的投資者關係部分查看。除法律要求外，捷豹承諾沒有義務更新或修改本簡報中包含的任何前瞻性聲明以反映新資訊、未來事件或其他情況。

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，公司透過提供非 GAAP、EBITDA 和非 GAAP 經常性 EBITDA 來補充其按 GAAP 基礎提交的簡明合併財務報表。捷豹認為，這些非 GAAP 措施的揭露項目為投資者提供了額外的信息，反映公司管理階層評估和經營業務的基礎。

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 substitute for or superior to measures of financial performance in conformity with GAAP. Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health, Founder, President and CEO officer. Lisa, the floor is yours.

這些非 GAAP 財務指標不應被孤立地看待，也不應被視為 GAAP 淨銷售額和 GAAP 淨虧損的替代品，並且不能替代或優於符合 GAAP 的財務業績指標。今天的會議正在錄製中。此時，我很高興將電話轉接給 Jaguar Health 創辦人、總裁兼執行長 Lisa Conte。麗莎，地板是你的。

Thank you very much. I'm glad we didn't miss that opportunity to hear the very important forward-looking statements. Thank you all for joining. My name is Lisa Conte. And following my comments this morning, Carol Lizak, our Chief Financial Officer, will provide a detailed recap of the key financial results for the third quarter of 2023.

非常感謝。我很高興我們沒有錯過這個聆聽非常重要的前瞻性陳述的機會。感謝大家的加入。我叫麗莎·孔特。在我今天早上發表評論之後，我們的財務長 Carol Lizak 將詳細回顧 2023 年第三季的主要財務業績。

Although I will preempt Carol to say that we're pleased to report that net revenue increased 5% in the third quarter of 2023 versus the second quarter of 2023. However, this is a momentous time for Jaguar and and hopefully a momentum time, the most important takeaway from today's webcast.

儘管我要先跟卡羅爾說，我們很高興地報告，2023 年第三季的淨收入比2023 年第二季度增長了5%。然而，這對捷豹來說是一個重要時刻，並且希望是一個勢頭強勁的時刻，今天網路廣播中最重要的內容。

As regarding the potential opportunity to expand the current indications of our FDA-approved product Crofelemer under the trade name Mytesi from the current specialty indication of noninfectious diarrhea in adults living with HIV/AIDS on antiretroviral therapy. Specialty is a very important indication. It was fast track priority review by the FDA. So, it's a relatively small indication in the United States.

關於擴大我們 FDA 批准的產品 Crofelemer（商品名 Mytesi）的當前適應症的潛在機會，該產品的當前適應症是接受抗逆轉錄病毒治療的愛滋病毒/愛滋病成人非感染性腹瀉的當前特殊適應症。專業是一個非常重要的指標。這是 FDA 的快速優先審查。因此，這在美國是一個相對較小的跡象。

And we're looking to potentially expand into the much more profound and frankly, much larger neglected needs for the preventative treatment of diarrhea in adult cancer patients with solid tumors receiving targeted therapy with or without standard chemotherapy. Top-line results from our pivotal Phase 3 trial referred to as the OnTarget trial, which is investigating safety and efficacy for this indication of Crofelemer are expected to be out before Thanksgiving 2023. So literally around the corner.

我們希望有可能擴展到更深刻、坦率地說、更大的被忽視的對患有實體瘤的成年癌症患者的腹瀉預防性治療的需求，這些患者接受有或沒有標準化療的標靶治療。我們的關鍵 3 期試驗（稱為 OnTarget 試驗）的主要結果預計將在 2023 年感恩節之前公佈，該試驗正在研究 Crofelemer 這一適應症的安全性和有效性。

This trial is studying an indication. We also refer to as preventative treatment of chemotherapy induced overactive balance. If you've ever heard the term chemotherapy induced nausea and vomiting, chemotherapy-induced pain and neuropathy chemotherapy-induced overactive bound, which includes symptoms such as unpredictable and or chronic debilitating diarrhea, loosened, watery stools and urgency.

該試驗正在研究一個適應症。我們也將化療引起的過度活躍平衡稱為預防性治療。如果您聽說過「化療引起的噁心和嘔吐」、「化療引起的疼痛」和「化療引起的神經病變」、「過度活躍」等術語，其中包括不可預測的和/或慢性使人衰弱的腹瀉、稀便、水樣便和尿急等症狀。

We believe Crofelemer represents a paradigm approach and mechanism of action a new way of treating and potentially preventing treatment limiting diarrhea, cancer treatment, limiting diarrhea associated with cancer therapy in these patients necessary in terms of the potential patient benefit for patient comfort, patient Dignity, potential and patient quality of life, and the opportunity to expand dramatically the number of people that can access and benefit from Crofelemer.

我們相信Crofelemer 代表了一種範例方法和作用機制，一種治療和潛在預防治療的新方法，限制腹瀉、癌症治療、限制這些患者與癌症治療相關的腹瀉，這對於患者舒適度、患者尊嚴、患者潛在利益而言是必要的。潛力和患者的生活質量，以及大幅增加能夠從 Crofelemer 獲得和受益的人數的機會。

I've recently been conducting a listening tour of patient advocacy groups, particularly the metastatic cancer patient population. The metastatic patient voice is becoming more and more prominent. They are living longer five, 10, 20 years with the amazing breakthroughs in targeted therapies. So, as I'm hearing and learning at what cost to quality of life, with side effects from cancer therapies, targeted therapie, that will be on for the rest of their life.

我最近對患者權益團體進行了一次傾聽之旅，特別是轉移性癌症患者群體。轉移患者的聲音越來越突出。隨著標靶治療的驚人突破，他們的壽命延長了 5 年、10 年、20 年。因此，正如我所聽到和了解到的那樣，癌症治療和標靶治療的副作用會影響他們的生活質量，而這些副作用將伴隨他們的餘生。

I had the founder of a cancer patient advocacy organization till yesterday that she has no doubt. Most of our patient members would prefer to have a shorter survival time with less severe side effects. In fact, a patient and caregiver survey that was published this past August in the journal JCO oncology practice indicated that quality of life, was the number one topic of importance to patients, quality of life ranked higher than survival rate higher than access to care rate higher than cost of care.

直到昨天我才得知癌症病患權益組織的創辦人對此毫無疑問。我們的大多數患者成員希望生存時間較短且副作用較輕。事實上，去年 8 月在《JCO 腫瘤學實踐》雜誌上發表的一項患者和護理人員調查表明，生活品質是患者最重要的話題，生活品質的排名高於生存率，高於獲得護理的比率高於護理費用。

What are some of these side effects, more than 80 targeted cancer therapies are FDA-approved, many of which cause diarrhea in 50% to 100% of patients. In addition, cancer patients suffer from pain, neuropathy, muscle cramping, nausea fatigue, alopecia rashes, itching and more patients want to live, not just exist. And at the same time, recognizing that their lives are likely to be different.

這些副作用有哪些，超過 80 種標靶癌症療法已獲得 FDA 批准，其中許多會導致 50% 至 100% 的患者腹瀉。此外，癌症患者還會遭受疼痛、神經病變、肌肉痙攣、噁心疲勞、脫髮皮疹、搔癢等困擾，更多的患者想要活下去，而不僅僅是存在。同時，認識到他們的生活可能會有所不同。

As an example, one patient I spoke with has unpredictable. Diarrhea incontinent, she almost didn't know if it should be called diarrhea because it doesn't happen to every day, not even every week, which is another issue trying to gain a common understanding of the definition of diarrhea. Anyway, the unpredictability causes her to wear diaper when she leaves home. She also mentioned when she has a long Zoom call anyway, when she leaves home, she feels particularly valuable when she is walking for exercise, which used to be a daily activity of hers, along with her friend, hiking tribe.

舉個例子，我採訪過的一位患者的情況是不可預測的。腹瀉失禁，她幾乎不知道是否應該稱為腹瀉，因為它不是每天都會發生，甚至不是每週都會發生，這是另一個試圖對腹瀉定義達成共識的問題。不管怎樣，這種不可預測性導致她出門時必須穿尿布。她還提到，無論如何，當她進行長時間的 Zoom 通話時，當她離開家時，她覺得步行鍛煉身體特別有價值，這曾經是她和她的朋友徒步部落的日常活動。

However, a common story here is that friends about cancer can't face the reality of their now metastatic fending off and find excuses to not be there. So, this woman had a bit of a happy story for animal lovers. She got to go up so high with Hermine. We know dogs don't mind thinking things. So, she is comfortable with the unpredictability when she's with Hermine. This is patient reality, diapers and docks when clinical studies refer to manageable toxicities patients as manageable for whom you can hear more of my patient quality of life stories from the video podcast series I initiated and which you can view on Jaguar's social media channels.

然而，這裡的一個常見故事是，關於癌症的朋友無法面對他們現在抵抗轉移的現實，並找到藉口不去那裡。對於動物愛好者來說，這個女人有一個快樂的故事。她必須和赫爾米娜一起爬到那麼高的位置。我們知道狗不介意思考事情。所以，當她和 Hermine 在一起時，她對不可預測性感到滿意。當臨床研究將可控制的毒性患者稱為可控制的患者時，這就是患者的現實、尿布和碼頭，您可以從我發起的視訊播客系列中聽到更多關於患者生活品質的故事，您可以在捷豹的社交媒體頻道上觀看。

So, Crofelemer, back to Crofelemer, is the active ingredient in Mytesi, our prescription drug product is already commercially available FDA-approved and the OnTarget trial is evaluating the same formulation, same dose of Crofelemer that comprises Mytesi. All patients enrolled in the on targeted study or solid tumor patients on targeted therapies. We focused the enrollment criteria on targeted therapies that cause diarrhea in more than 50% of patients with or without cytotoxic chemotherapy.

因此，Crofelemer，回到 Crofelemer，是 Mytesi 中的活性成分，我們的處方藥產品已經獲得 FDA 批准上市，OnTarget 試驗正在評估包含 Mytesi 的相同配方、相同劑量的 Crofelemer。所有參與標靶研究的患者或接受標靶治療的實體瘤患者。我們將入組標準集中在超過 50% 接受或未接受細胞毒性化療的患者中引起腹瀉的標靶治療。

And that number of targeted agents is 24 of the more than 80 approved targeted therapies. This is what's referred to as a basket trial designed to bring benefit to as much of the patient population as possible. Mytesi is already in commerce. We plan to file a supplemental new drug application while Mytesi. Mytesi is approved under a new drug application for its HIV indication, we plan to file a supplemental new drug application for the prevention of cancer therapy-related diarrhea based on the on-target results from most new drug applications fail or get delayed because of a safety issue or manufacturing issue.

這個數字是 80 多種已批准的標靶治療藥物中的 24 種。這就是所謂的籃子試驗，旨在為盡可能多的患者群體帶來益處。 Mytesi 已經投入商業。我們計劃在 Mytesi 期間提交補充新藥申請。 Mytesi 的 HIV 適應症新藥申請獲得批准，我們計劃根據大多數新藥申請失敗或延遲的目標結果，提交一份補充新藥申請，用於預防癌症治療相關的腹瀉。安全問題或製造問題。

Mytesi is already approved for its HIV indication, which is a chronic indication and therefore, chronic safety testing has already been completed. And the drug, of course, is available from a network of specialty pharmacies throughout the United States. So what we're focused on with the top line results before the end of before Thanksgiving, so what we're focused on with these top line results of the on-target trial is statistical significance of the primary efficacy endpoint to support a potential expanded label and expenses, expanded educational and promotional activity.

Mytesi 的 HIV 適應症已獲得批准，這是一種慢性適應症，因此，長期安全性測試已經完成。當然，這種藥物可以從遍布美國的專業藥房網絡購買。因此，我們重點關注感恩節前結束前的頂線結果，所以我們關注的目標試驗的這些頂線結果是主要療效終點的統計顯著性，以支持潛在的擴展標籤和費用，擴大教育和促銷活動。

This brings me to the second key takeaway for today's webcast. Second, key clinical takeaway. Jaguar supporting investigator initiated an investigator IND proof of concept studies of a different formulation of pro forma. The powder formulation of Crofelemer for him in this illustration as liquid oral solution, which is a distinct product, it's distinct from Mytesi as for the rare disease indications of microbials inclusion disease, I'm going to refer to that as MVID, which is a congenital diarrheal disorders and short bowel syndrome.

這讓我想到了今天網路廣播的第二個要點。其次，關鍵的臨床要點。捷豹支持調查員發起了一項調查員對不同備考形式的 IND 概念驗證研究。在這張插圖中，Crofelemer 的粉末配方是液體口服溶液，這是一種獨特的產品，它與 Mytesi 不同，對於微生物包涵體疾病的罕見疾病適應症，我將其稱為 MVID，這是一種先天性腹瀉病和短腸症候群。

I'm going to refer to that as SBS, with intestinal failure and we're supporting these trials on three different continents, US. Europe and the Middle East, North Africa Regions development has been granted orphan drug designation by both the FDA and the European Medicines Agency, which is called the EMA. for MVID. and SBS, with intestinal failure.

我將其稱為 SBS，即腸道衰竭，我們支持在美國三個不同大陸進行的這些試驗。歐洲和中東、北非地區的開發已獲得 FDA 和歐洲藥品管理局（簡稱 EMA）的孤兒藥稱號。對於MVID。和SBS，伴隨腸衰竭。

And we expect to have proof of concept data coming from six different third-party proof-of-concept studies on three different continents between the end of the year and the beginning of 2024. Again, just around the corner in accordance with the guidelines of specific European countries. Published data from such clinical investigations could support reimbursed early patient access to Crofelemer for SBS, and or MVID, for these catastrophic and often lifelong conditions, and we're looking to we're targeting by late 2024.

我們預計從今年年底到 2024 年初，將獲得來自三個不同大陸的六項不同的第三方概念驗證研究的概念驗證數據。同樣，根據特定的歐洲國家。來自此類臨床研究的已發布數據可以支持患者儘早使用 Crofelemer 治療 SBS 和/或 MVID，以治療這些災難性且通常是終生的疾病，我們的目標是在 2024 年底之前。

This is a program the early patient access program to reimburse early patient access program that does not exist in the United States. By forming Napo Therapeutics in 2021. In Italy, we put a commercial footprint in Europe to be able to take advantage of this opportunity.

這是一項早期患者訪問計劃，用於報銷美國不存在的早期患者訪問計劃。 2021 年成立 Napo Therapeutics。在義大利，我們在歐洲建立了商業足跡，以便能夠利用這一機會。

Well, the product is going through a full global development program. MVID is a severe it is actually ultra-rare infant disease characterized by intestinal failure, dairrhea, malabsorption acid base instability, bottom line requiring intensive parenteral support for nutritional and fluid management every single day. There are currently no approved drug treatments or any other therapeutic agents in development that we're aware of for MVID. Intestinal failure is a catastrophic health situation that often afflicts patients with short bowel syndrome as well in the short bowel syndrome patients.

嗯，該產品正在經歷一個完整的全球開發計劃。 MVID 是一種嚴重的、實際上是極其罕見的嬰兒疾病，其特徵是腸道衰竭、腹瀉、吸收不良、酸鹼不穩定，每天需要強化腸外支持以進行營養和液體管理。據我們所知，目前尚無批准的 MVID 藥物治療或任何其他正在開發的治療藥物。腸衰竭是一種災難性的健康狀況，經常困擾短腸症候群患者以及短腸症候群患者。

A typical gun is about 2025 feet for a normal person, a short bowel might be five feet or less. It could be due to congenital reasons it could be do surgery could be due to an accident in this situation. There's not enough intestinal surface area to absorb the nutrients of life proteins, cars, vitamins, minerals, et cetera. These patients typically end up on parenteral nutrition, seven days a week, 20 hours a day and absolutely catastrophic situation, as I mentioned, in a significant opportunity also for infections and complications.

對於正常人來說，典型的槍長約為 2025 英尺，短腸可能為 5 英尺或更短。這種情況可能是由於先天原因，可能是因為手術，也可能是因為意外。腸道表面積不足以吸收生命蛋白質、汽車、維生素、礦物質等營養素。這些患者通常每週 7 天、每天 20 小時接受腸外營養，這絕對是災難性的情況，正如我所提到的，這也是感染和併發症的重要機會。

This need for daily IV injury intervention has high morbidity, unfortunately, high mortality and high expense, it can cost from $0.5 million of $1 million a year to take care of these patients in the resulting complication. There is a product approved for short bowel syndrome, which is called to do new liquid tide. It's not the standard of care and it's utilized in a small percentage of patients.

這種每日靜脈損傷幹預的需要具有高發病率、高死亡率和高費用，每年可能花費 50 萬至 100 萬美元來照顧這些患者所產生的併發症。有一種產品被批准用於短腸綜合症，叫做做新液潮。這不是護理標準，僅用於一小部分患者。

It's basically a growth hormone and everything in the pipeline that we've been able to find in this category is in the category of a growth hormone when you're attempting to grow the debt a bit. So, the parenteral nutrition can be reduced by about 15% to 20%. And now you have an accepted regulatory endpoint. What we're looking to do with Crofelemer is to decrease the secretions were novel anti secretory agent to hit that regulatory endpoint of decreasing the need for parenteral nutrition by about 15% or 20%, as well as benefits to information, as you can imagine with the shortcut, it's like I said, what goes in comes right out.

它基本上是一種生長激素，當你試圖增加一點債務時，我們在這一類別中找到的所有產品都屬於生長激素類別。因此，腸外營養可減少約15%～20%。現在您有了一個公認的監管終點。我們希望用 Crofelemer 來減少分泌物，這是一種新型抗分泌劑，以達到將腸外營養需求減少約 15% 或 20% 的監管終點，以及資訊的好處，正如你可以想像的那樣有了捷徑，就像我說的，進來的就出來了。

When we go back to the growth hormone approach, they also have no benefit in a situation where the gut is fully intact, but not functioning, which is the case in several different congenital diarrheal disorders like MVID. The gut is fully intact. But there is intestinal failure. So, there's nothing to grow. There's no benefit of a growth hormone approach.

當我們回到生長激素方法時，它們在腸道完整但無法發揮功能的情況下也沒有任何好處，這種情況在幾種不同的先天性腹瀉疾病（如 MVID）中就是這種情況。腸道完好無損。但有腸道衰竭。所以，沒有什麼可以成長的。生長激素方法沒有任何好處。

And there's other limitations with the growth hormone approach. For example, some patient has cancer or risk of cancer or some abnormal hyper proliferative disease. You don't want to be giving a growth hormone patients recovering from surgery, which is the case for many of these patients typically need 15 to 18 months for bowel adaptation where they can't be administered a growth hormone.

生長激素方法還有其他限制。例如，有些患者患有癌症或有罹患癌症或某些異常過度增殖性疾病的風險。您不想給剛從手術中恢復的患者註射生長激素，因為許多患者通常需要 15 至 18 個月的時間來適應腸道，而此時他們無法注射生長激素。

Customers should not have any of these limitations. We are looking to have fulfillment become the standard of care in the treatment of intestinal failure broadly, whether it's due to short bowel syndrome or involves a fully intact gut, which from seems to be about 50% of the market.

客戶不應受到任何這些限制。我們希望讓滿足成為廣泛治療腸道衰竭的護理標準，無論是由於短腸症候群還是涉及完整的腸道，後者似乎佔市場的 50% 左右。

Now if I go back to cancer in our Ontarget trial, when we talk about prophylaxis for cancer therapy-related diarrhea, it's important to note that cancer is the number one side effect associated with cancer therapy. We think about an analogous situation, as I had mentioned, chemotherapy-induced nausea and vomiting, where there are agents approved, agents are typically used prophylactically for just the first three days in cytotoxic chemotherapy, as opposed to a chronic diarrhea, that we're talking about with these targeted therapies that patients are on often for the rest of their life.

現在，如果我回到 Ontarget 試驗中的癌症，當我們談論癌症治療相關腹瀉的預防時，需要注意的是，癌症是與癌症治療相關的第一大副作用。我們考慮類似的情況，正如我所提到的，化療引起的噁心和嘔吐，其中有批准的藥物，藥物通常僅在細胞毒性化療的前三天預防性使用，而不是慢性腹瀉，我們'我們談論的是患者餘生經常使用的這些標靶治療。

But to go back to chemotherapy-induced nausea and vomiting, the market, it is expected to be that at about $4 billion in 2029. And this is according to third party market research. I health care analyst and easily half of that market is priced. And valued as it as a generic. There are generic products available when we're talking about prophylaxis for cancer therapy related diarrhea, the targeted therapies that are taking long term and clinically often for the rest of the patient's life in a metastatic situation.

但回到化療引起的噁心和嘔吐市場，預計到 2029 年該市場規模將達到約 40 億美元。這是根據第三方市場研究得出的結果。我是醫療保健分析師，很容易就知道該市場的一半是定價的。並將其視為通用的。當我們談論癌症治療相關腹瀉的預防時，有一些通用產品可供使用，這些標靶治療在臨床上經常在轉移情況下的患者的餘生中長期服用。

We're talking about a much more profound situation for a number of patients and how long they can benefit standard of care for cancer therapy-related diarrhea, believe it or not to take the patient off their cancer therapy or to go to a subtherapeutic dose or to start some therapeutic dose when we think about promoting loperamide agents that you can get at the pharmacy, these are opioids an opioid based and you can't use an opioid based such as Imodium and loperamide on a chronic basis.

我們正在談論對許多患者來說更深刻的情況，以及他們可以在多長時間內受益於癌症治療相關腹瀉的標準護理，信不信由你，讓患者停止癌症治療或接受亞治療劑量或當我們考慮推廣您可以在藥房購買的洛哌丁胺藥物時，開始服用一些治療劑量，這些藥物是基於阿片類藥物的阿片類藥物，您不能長期使用基於阿片類藥物的藥物，例如易蒙停和洛哌丁胺。

They haven't specifically been tested or approved for cancer therapy-related diarrhea and when we think about a patient being taken off their cancer therapy, now we're talking about an impact on the outcome of the cancer care. And in some cases, once you go off of therapy. You then have to move on to another one.

它們尚未經過專門測試或批准用於與癌症治療相關的腹瀉，當我們考慮到患者停止癌症治療時，現在我們談論的是對癌症護理結果的影響。在某些情況下，一旦您停止治療。然後你必須轉向另一件事。

So you start to run out of options. One of the reasons why we designed the OnTarget trials, a prophylactic trial is to address the problem before it happens. So, the patient does not have to adjust their cancer therapy regimens, life-saving cancer regimen because of diarrhea. With the OnTarget trial there are different aspects of the study that I think resonate with different audiences, different benefits.

所以你開始沒有選擇了。我們設計 OnTarget 試驗（預防性試驗）的原因之一是在問題發生之前解決問題。因此，患者不必因為腹瀉而調整其癌症治療方案、挽救生命的癌症治療方案。透過 OnTarget 試驗，我認為研究的不同面向會引起不同受眾的共鳴，帶來不同的好處。

First, there's the goal of supporting the conferred in dignity of patients, the supportive care aspect of preventing diarrhea in these patients that are OnTarget therapies and what can be more important than patient quality of life. That's what it's all about in the pharmaceutical industry.

首先，目標是支持患者的尊嚴，預防這些患者腹瀉的支持性護理，這是 OnTarget 治療，以及比患者生活品質更重要的事情。這就是製藥業的全部內容。

Next though there is a third-party study, in fact, authored by Dr. Pablo C. Okhuysen, who is also the national principal investigator for our OnTarget study. And the study indicates that patients with cancer therapy-related diarrhea are 40% more likely to discontinue their chemotherapy or targeted therapy than patients without cancer therapy-related diarrhea.

接下來還有一項第三方研究，實際上是由 Pablo C. Okhuysen 博士撰寫的，他也是我們 OnTarget 研究的國家首席研究員。研究表明，患有癌症治療相關性腹瀉的患者比沒有癌症治療相關性腹瀉的患者停止化療或標靶治療的可能性高 40%。

And that may be something that resonates loudly with the oncologists as we mentioned, the opportunity for patients to stay on their cancer therapy and have an impact on the outcome of their cancer treatment.

正如我們所提到的，這可能會引起腫瘤學家的強烈共鳴，即患者有機會繼續接受癌症治療並對癌症治療的結果產生影響。

And then thirdly, there's also an independent third party studies authored by Dr. Eric Roeland, a member of Napo scientific advisory board. It shows that it costs about three times as much to take care of a cancer patient with diarrhea compared to patient without diabetes. It is the need for diary related visits to the hospital for rehydration office visits, prescriptions, certainly of interest to reimbursement organizations.

第三，還有一項由 Napo 科學顧問委員會成員 Eric Roeland 博士撰寫的獨立第三方研究。研究表明，治療患有腹瀉的癌症患者的費用大約是非糖尿病患者的三倍。需要進行與日記相關的去醫院補液辦公室就診、處方，這當然是報銷組織感興趣的。

So these different aspects these different potential benefits, patient quality of life, keeping the patient on their cancer therapy cost are all important to me. They may have different levels of priority in recognition of importance with different audiences. The cancer treatment landscape has radically changed where in the age of targeted therapies and essentially most targeted cancer therapies work by mechanism that induces the type of chloride ion channel diarrhea that is specifically addressed by crossfellimer, fulfillomer is novel.

因此，這些不同的面向、不同的潛在益處、病患的生活品質、病患的癌症治療費用對我來說都很重要。為了認識到不同受眾的重要性，他們可能有不同的優先順序。癌症治療格局已經發生了根本性的變化，在標靶治療時代，大多數標靶癌症治療都是透過誘導氯離子通道腹瀉類型的機制起作用，而這種機制是由Crossfellimer 專門解決的，fullomer 是新穎的。

It's a first-in-class anti secretory gastrointestinal chloride channel modulator normalized or fulfillment normalizes that function. There's no agent that's been specifically tested for this type of diarrhea. Immunizing normalizes gut function. If a patient is in a normal situation and takes Crofelemer, nothing happens. So, it's active and normalizing and providing its benefit is it normally active and secretory situation, which occurs often in cancer patients OnTarget therapy. When we get to the rare disease and orphan indications of intestinal failure that are associated with short bowel syndrome with congenital diarrheal diseases such as MVID that I described.

它是一流的抗分泌性胃腸道氯離子通道調節劑，使該功能正常化或正常化。目前還沒有專門針對此類腹瀉進行過測試的藥物。免疫使腸道功能正常化。如果患者在正常情況下服用 Crofelemer，則不會發生任何事情。因此，它是活躍的、正常化的，並在正常活躍和分泌的情況下提供其益處，這在癌症患者 OnTarget 治療中經常發生。當我們談到與短腸症候群和先天性腹瀉病（如我所描述的 MVID）相關的罕見疾病和孤兒腸道衰竭適應症。

You also have an agent here, Crofelemer that has demonstrated safety in order to be used on a chronic basis, global short bowel syndrome market is projected to reach a value of $4.6 billion, by 2027 and that's according to a third party report division research reports. And it's because of the significant morbidity mortality, expensive interventions, complications necessary to maintain these patients typically on parenteral nutrition, seven days a week 20 hours a day.

這裡還有一種藥物 Crofelemer，它已證明可以長期使用的安全性，根據第三方報告部門的研究報告，到 2027 年，全球短腸症候群市場的價值預計將達到 46 億美元。這是因為這些患者通常每週 7 天、每天 20 小時接受腸外營養，死亡率很高、幹預措施昂貴、併發症也很嚴重。

And as I mentioned, with that administration comes those complications. So our goal is to introduce a completely new approach in standard of care to the management of intestinal failure and reducing the chronic need for parenteral nutrition in this patient population.

正如我所提到的，隨著政府的到來，出現了一些複雜的情況。因此，我們的目標是引入一種全新的護理標準方法來管理腸道衰竭，並減少該患者群體對腸外營養的長期需求。

Other upcoming catalysts at this moment is time for Jaguar include the very prestigious San Antonio, breast cancer conference, which is early in December, where the results of our pivotal OnTarget trial have been accepted for poster presentation, because this is a basket trial where enrollment includes all solid tumors.

此時此刻，捷豹即將到來的其他催化劑包括非常著名的聖安東尼奧乳腺癌會議，該會議將於12 月初舉行，我們關鍵的OnTarget 試驗的結果已被接受用於海報展示，因為這是一項籃子試驗，其中招募包括所有實體腫瘤。

We'll be able to put out that top line data this month and have the scientific presentation December focused on the breast cancer participants. And then also, we will present results at upcoming cancer conferences in 2024, focusing on, for example, the lung cancer patients, the liver patients, ultimately -- which is typically in May, which is the grand annual Cancer Conference.

我們將能夠在本月發布最重要的數據，並在 12 月進行乳癌參與者的科學演示。然後，我們還將在 2024 年即將舉行的癌症會議上展示結果，例如，最終重點關注肺癌患者、肝癌患者——通常是在 5 月，這是盛大的年度癌症會議。

We expect to simultaneously be pursuing the regulatory track, with positive data. We would plan to file a supplemental NDA for the current approved Mytesi to expand the indication to prophylaxis of cancer therapy-related diarrhea with the goal of achieving approval and having the product available to cancer patients in 2024. We are certainly manufacturing to that goal right now.

我們預計將同時追求監管軌道並提供積極的數據。我們計劃為目前批准的Mytesi 提交補充NDA，以擴大其用於預防癌症治療相關腹瀉的適應症，目標是在2024 年獲得批准並讓該產品可供癌症患者使用。我們當然正在朝著這個目標進行生產。現在。

So again, I can't say it enough in November, we'll have top line data from the on-target trial released and there'll be a continual flow of data and news, from this very rich trial thereafter.

所以，我再說一遍，在 11 月份，我們將發布來自目標試驗的頂線數據，此後將從這個非常豐富的試驗中獲得持續的數據和新聞流。

As indicated, the most important clinical events that we feel are momentum drivers and be, can be transformative for the value recognition of Jaguar's. Some very, very tough time in the biotech industry. We don't know any other company, our size, our evaluation that has this type of late-stage clinical data, certainly on a product that is already approved.

如前所述，我們認為最重要的臨床事件是動力驅動因素，並且可以對捷豹的價值認知產生變革性影響。生物技術產業經歷了一段非常非常艱難的時期。我們不知道任何其他公司、我們的規模、我們的評估擁有這種類型的後期臨床數據，當然是針對已經獲得批准的產品。

That will really bring some recognition to the pipeline and the strengths and then the collective need and the opportunity for all our stakeholders, including the shareholders in the company we have a lot of news coming up. We're a very high volume traded stock. We don't have any structured deals in our capitalization currently.

這確實會為我們的管道和優勢帶來一些認可，然後為我們所有利害關係人（包括公司股東）帶來集體需求和機會，我們有很多消息即將發布。我們是一支交易量非常大的股票。目前我們的資本中沒有任何結構性交易。

We don't have any warrants that anybody is trading around. So we feel like we're in a good position to not only have value for the patients, which is what it's all about their quality of life and also the coincident benefits that comes to, as I mentioned, all the stakeholders in the company as well.

我們沒有任何人可以交易的認股權證。因此，我們覺得我們處於有利地位，不僅可以為患者帶來價值，這關係到他們的生活質量，而且正如我所提到的，公司的所有利益相關者也能獲得一致的利益。

Before I hand the discussion over to our CFO, Carol Lizak, I'd like to tell all of you participating today and I know with important pivotal data around the corner, we will not be hosting the Q&A segment at the end of this webcast. We do expect to have another webcast with the OnTarget pivotal data release. As I mentioned around the corner, we'll now move to the financial results for the third quarter. Carol, you there.

在將討論交給我們的財務長 Carol Lizak 之前，我想告訴今天參與的所有人，我知道重要的關鍵數據即將到來，我們不會在本次網路廣播結束時主持問答環節。我們確實希望透過 OnTarget 關鍵數據發布再次進行網路廣播。正如我即將提到的，我們現在將討論第三季的財務表現。卡羅爾，你在那裡。

Very well, I'll begin my review of our financials for the third quarter of 2023 is the combined prescription net revenues for Mytesi And Canalevia-CA1 was $2.8 million in the third quarter of 2023, representing an increase of 5% compared the combined net revenue in the second quarter of 2023, which totaled approximately $2.7 million in a decrease of approximately 11% over the combined net revenue in the third quarter of 2022, which totaled approximately $3.1 million.

很好，我將開始審查我們 2023 年第三季的財務狀況，Mytesi 和 Canalevia-CA1 的合併處方淨收入在 2023 年第三季為 280 萬美元，與合併淨收入相比增長了 5% 2023 年第二季的總收入約為270 萬美元，比2022 年第三季的總淨收入約為310 萬美元減少約11%。

Mytesi prescription volume remained unchanged in the third quarter of 2023 compared to the second quarter of 2023 and decrease approximately 7.5% in the third quarter of 2023 compared to the third quarter of 2022. Prescription volume differed from invoice sales volume, which reflects, among other factors varying buying patterns among specialty pharmacies in a closed network as they manage their inventory levels.

與2023 年第二季相比，Mytesi 2023 年第三季的處方量保持不變，與2022 年第三季相比，2023 年第三季減少了約7.5%。處方量與發票銷售不同，這反映出，除其他外在管理庫存水準時，封閉網路中的專業藥局之間不同的購買模式受到影響。

Loss from operations decreased by $1.1 million from $9.9 million in the quarter ended September 30, 2022, to $8.8 million during the same period in 2023. Non-GAAP recurring EBITDA for the third quarter of 2023 and the third quarter of 2022 were a net loss of $6.2 million and $8.5 million respectively.

營運虧損從截至 2022 年 9 月 30 日的季度的 990 萬美元減少 110 萬美元，至 2023 年同期的 880 萬美元。2023 年第三季和 2022 年第三季的非 GAAP 經常性 EBITDA 為淨虧損虧損分別為620 萬美元和850 萬美元。

Net loss attributable to common shareholders decreased by approximately $4.7 million from $12.6 million in the third quarter ended September 30, 2022. The $7.8 million in the same period in 2023.

普通股股東應佔淨虧損較截至 2022 年 9 月 30 日止第三季的 1,260 萬美元減少約 470 萬美元，較 2023 年同期的 780 萬美元減少約 470 萬美元。

That concludes my recap of high-level financials for the third quarter of 2023. I will now hand it back to Lisa. Thank you,

我對 2023 年第三季高級財務狀況的回顧到此結束。現在我將其交還給麗莎。謝謝你，

And thank you, Carol. And as you can see in our Q-filing, our current cash position of over $6 million. To recap well, the market for small cap biotechs is in a horrible state at present. We at Jaguar are fortunate that we have two major and what we feel are transformative clinical events coming up shortly, literally around the corner with the potential to take pipeline opportunities, two major blockbuster opportunities.

謝謝你，卡羅爾。正如您在我們的 Q 文件中看到的，我們目前的現金部位超過 600 萬美元。回顧一下，小型生技公司的市場目前處於可怕的狀態。捷豹很幸運，我們有兩個重大的、我們認為是變革性的臨床事件即將到來，幾乎即將到來，有可能抓住管道機會，兩個重大的重磅機會。

And these are clinical efforts that started many years ago. So, as I mentioned, fortunate that they are concluding this year. These are two major opportunities to help address important significant neglected medical needs for patients. What follows from a focus on patients and the benefits to all the stakeholders in the company. We at Jaguar and our family of companies, including Napo Pharmaceuticals.

這些都是多年前開始的臨床工作。因此，正如我所提到的，幸運的是他們今年就結束了。這是幫助解決患者被忽視的重要醫療需求的兩個主要機會。關注患者以及公司所有利害關係人的利益會帶來什麼。我們捷豹和我們的公司家族，包括 Napo Pharmaceuticals。

So you often hear Napo and Jaguar used interchangeably are highly energized about these important near-term initiatives. Thank you for your attention and interest, and we expect to have another webinar shortly this year. Thank you.

因此，您經常會聽到 Napo 和 Jaguar 交替使用，它們對這些重要的近期舉措充滿了活力。感謝您的關注和興趣，我們預計今年很快將再舉辦一次網路研討會。謝謝。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。