Galectin Therapeutics Inc (GALT) 2016 Q4 法說會逐字稿

Good morning, ladies and gentlemen. Welcome to the 2016 year end Galectin Therapeutics business update conference call. At this time, all participants are in a listen-only mode. Later we will conduct a Q&A session, and instructions will follow at that time.

女士們，先生們，早安！歡迎參加Galectin Therapeutics公司2016年年終業務更新電話會議。目前，所有與會者都處於聆聽模式。稍後我們將進行問答環節，屆時將提供相關說明。

(Operator Instructions)

（操作員指示）

As a reminder, this conference call is being recorded. I would now like to turn the call over to Mr. Jack Callicutt, of Galectin Therapeutics.

提醒一下，本次電話會議正在錄音。現在我想將電話轉給Galectin Therapeutics公司的Jack Callicutt先生。

Thank you and good morning. I'm Jack Callicutt, Chief Financial Officer for Galectin Therapeutics, and I'd like to welcome you to our business update conference call for the fourth quarter and year end of 2016.

謝謝大家，早安。我是Galectin Therapeutics財務長Jack Callicutt，歡迎大家參加我們2016年第四季及年終業績更新電話會議。

These calls are intended to provide a corporate update and to discuss company's financial results. Today we'll cover several items that were included in the press release that we issued earlier this morning.

這些電話會議旨在提供公司最新動態並討論公司財務表現。今天我們將討論今天早上發布的新聞稿中包含的幾個內容。

Joining me this morning is Dr. Peter Traber, our President and Chief Executive Officer and Chief Medical Officer. Before I turn the call over to Peter, I'd like to remind you that certain comments made during this conference call, particularly those anticipating our future financial condition and results of operations, results of our clinical trials and our strategic plans constitute forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

今天上午，我們的總裁兼執行長兼首席醫療官彼得·特拉伯博士也與我一同出席。在將電話會議轉交給彼得之前，我想提醒大家，本次電話會議中的某些評論，尤其是對我們未來財務狀況和經營業績、臨床試驗結果以及戰略計劃的預測，構成了《1995年私人證券訴訟改革法》安全港條款所定義的前瞻性陳述。

These forward-looking statements, by their very nature, are subject to certain risks and uncertainties that may cause actual results, events and performances to differ materially from those referred to in such statements. These risks and other risks are discussed in our Securities and Exchange Commission filings, including our Form 10-K, which was also filed earlier this morning.

這些前瞻性陳述本身受某些風險和不確定性因素的影響，可能導致實際結果、事件和績效與此類陳述中所述的內容有重大差異。這些風險和其他風險已在我們提交給美國證券交易委員會的文件中進行了討論，其中包括我們今天上午提交的10-K表格。

A transcript of this presentation will be available on our website.

本次演講的文字記錄將在我們的網站上提供。

I would now like to turn the call over to Dr. Traber. Peter?

現在我想把電話轉給 Traber 博士。彼得？

Thank you, Jack. Good morning and thank you to all for joining us. Today I will provide a comprehensive view of the state of the company and its drug development programs.

謝謝，傑克。早安，感謝大家的參與。今天我將全面介紹公司現況及其藥物開發專案。

We achieved a number of significant milestones in 2016, in the development of our lead compound, GR-MD-02, and we anticipate reporting critical clinical data in our NASH-CX trial in December, 2017.

2016 年，我們在先導化合物 GR-MD-02 的開發中取得了許多重要的里程碑，我們預計將於 2017 年 12 月在 NASH-CX 試驗中報告關鍵臨床數據。

Now before recapping the company's progress, our plans for the upcoming year and opening this call to questions, let me first turn the call back over to Jack to cover our financial position and results. Jack?

現在，在回顧公司的發展歷程、來年的計劃以及開始回答問題之前，我先把電話轉回給傑克，讓他介紹一下我們的財務狀況和業績。傑克？

Thanks, Peter. For the year ended December 31, 2016, the company reported a net loss applicable to common shareholders of $22.4 million, or $0.76 per share, compared with a net loss applicable to common shareholders of $21.1 million, or $0.88 per share, for 2015. The increased net loss is largely due to higher research and development expenses, primarily related to our Phase 2 clinical program.

謝謝，彼得。截至2016年12月31日的財年，公司報告普通股股東淨虧損為2,240萬美元，合每股虧損0.76美元，而2015年普通股股東淨虧損為2,110萬美元，合每股虧損0.88美元。淨虧損增加的主要原因是研發費用增加，主要與我們的第二階段臨床項目有關。

Research and development expense for 2016 were $15.3 million, compared with $13.1 million for 2015. Again, the increase primarily relates to costs for the NASH-CX Phase 2 clinical trial, partially offset by lower preclinical costs.

2016 年研發費用為 1,530 萬美元，而 2015 年為 1,310 萬美元。同樣，成長主要與 NASH-CX 第 2 階段臨床試驗的成本有關，但臨床前成本的降低部分抵消了這一增長。

General and administrative expense for 2016 was $6.2 million, compared with $7.0 million for 2015, primarily due to a decrease in stock-based compensation.

2016 年一般及行政開支為 620 萬美元，而 2015 年為 700 萬美元，主要原因是股票薪酬減少。

As of December 31, 2016, the company had $15.4 million of non-restricted cash and cash equivalents. In January and February 2017, the company raised a total of $1.5 million in net proceeds from issuance of common stock. The company believes that it has sufficient cash to fund currently planned operations and research and development activities through December 31, 2017.

截至2016年12月31日，本公司擁有1,540萬美元的非限制性現金及現金等價物。 2017年1月和2月，公司透過發行普通股籌集了總計150萬美元的淨收益。公司相信，截至2017年12月31日，公司擁有充足的現金來支持目前計畫的營運和研發活動。

Peter?

彼得？

Thank you, Jack, for that recap of the finances. In setting the stage for this update, I will start with some history.

傑克，謝謝你對財務狀況的回顧。為了準備這次更新，我先從一些歷史開始。

Since taking the helm at Galectin in 2011, my goal has been to build shareholder value by realizing the tremendous potential for targeting galectin proteins in many human diseases. That's because the galectin protein is associated with inflammation, scarring and many other processes that are involved in the development of multiple diseases.

自2011年執掌Galectin以來，我的目標一直是透過挖掘Galectin蛋白在多種人類疾病中的巨大潛力來創造股東價值。這是因為Galectin蛋白與發炎、疤痕形成以及多種疾病發展過程中的許多其他過程有關。

There is a growing body of research demonstrating the galectin-3 is increased and involved in the development of many types of chronic human diseases, including liver, lung, kidney and heart fibrosis, most cancers, serious skin diseases, diabetes, atherosclerosis and more.

越來越多的研究表明，半乳糖凝集素-3的增加與多種人類慢性疾病的發展有關，包括肝臟、肺、腎臟和心臟纖維化、大多數癌症、嚴重皮膚病、糖尿病、動脈粥狀硬化等。

In 2011, we began testing various animal disease models that represented large, unmet, medical needs using two different carbohydrate-based drugs that bind to galectin-3. One drug was GM-CT-01 or DAVANAT which was previously in development by the company for other purposes. And a new drug candidate we named GR-MD-02.

2011年，我們開始使用兩種不同的碳水化合物類藥物（與半乳糖凝集素3結合）來測試各種動物疾病模型，這些模型代表著巨大的、尚未滿足的醫療需求。一種藥物是GM-CT-01，又稱DAVANAT，該公司之前曾將其用於其他用途。另一種候選新藥，我們命名為GR-MD-02。

Both of these drugs were tested in each animal model of disease. We started with models of fibrosis, because it had been shown that galectin-3 was crucial for the development of fibrosis. And, a therapy that can reduce or reverse fibrosis would address a very large group of disorders that are responsible for a major burden of disease.

這兩種藥物都在各自的動物模型上進行了測試。我們從纖維化模型開始，因為已經證明半乳糖凝集素-3對纖維化的發展至關重要。而且，一種能夠減少或逆轉纖維化的療法將解決大量造成沉重疾病負擔的疾病。

One of the two compounds, GR-MD-02, was discovered to have a more profound effect on fibrosis of the liver, kidney and lung in these animal experiments. As a result of this more profound effect on fibrosis, GR-MD-02 rather than GM-CT-01 has been the focus of our efforts.

在這些動物實驗中，我們發現GR-MD-02對肝臟、腎臟和肺部纖維化有更顯著的療效。由於其對纖維化更顯著的療效，GR-MD-02（而非GM-CT-01）一直是我們研究的重點。

It is important to note that we have strong intellectual property claims for our lead compound and its uses, with 15 granted patents in the United States, 24 granted patents outside the U.S., six patent applications in the U.S. and 49 patent applications outside the U.S.

值得注意的是，我們對我們的先導化合物及其用途擁有強大的智慧財產權，在美國擁有 15 項授權專利，在美國以外擁有 24 項授權專利，在美國有 6 項專利申請，在美國以外有 49 項專利申請。

We decided that liver fibrosis due to fatty liver disease would be the lead indication. This has turned out to be a good decision, since it is now widely believed that fatty liver disease, or NASH, is a very large opportunity in drug development.

我們決定將脂肪肝引起的肝纖維化作為主要適應症。事實證明，這是一個明智的決定，因為現在普遍認為脂肪肝（NASH）在藥物研發中蘊藏著巨大的潛力。

Cancer was chosen as a second area of focus, because galectin-3 had been shown to be important in the aggressiveness of tumors, and inhibition of galectin may be beneficial.

癌症被選為第二個關注領域，因為已證明半乳糖凝集素 3 對腫瘤的侵襲性具有重要意義，而抑制半乳糖凝集素可能有益。

Finally ? and much later ? a third area of focus arose serendipitously, when a patient with cirrhosis enrolled in our Phase 1 NASH trial had a remarkable remission of her disease.

最後——也是很久以後——第三個關注領域偶然出現了，當時參加我們第一階段 NASH 試驗的一名肝硬化患者的病情得到了顯著緩解。

Therefore, the company has three clinical development programs for GR-MD-02:

因此，公司針對GR-MD-02有三個臨床開發方案：

The lead program in fatty liver disease or non-alcoholic steatohepatitis called NASH, with the most advanced form of fibrosis called cirrhosis.

研究的主要對像是脂肪肝疾病或非酒精性脂肪性肝炎（NASH），其中最嚴重的纖維化形式是肝硬化。

Two, chronic inflammatory skin diseases, including moderate to severe plaque psoriasis and severe atopic dermatitis.

二、慢性發炎性皮膚病，包括中度至重度斑塊狀乾癬、重度異位性皮膚炎。

And three, combination immunotherapy for cancer.

第三，癌症聯合免疫療法。

Based upon the clinical trials conducted to this point, these programs have demonstrated a number of critical characteristics of GR-MD-02 that are very encouraging.

根據迄今為止進行的臨床試驗，這些項目已經證明了 GR-MD-02 的一些非常令人鼓舞的關鍵特性。

First, the compound seems to be safe and well-tolerated, with thousands of doses having been administered without any serious drug-related complications.

首先，該化合物似乎是安全且耐受性良好的，已經使用數千劑，沒有任何嚴重的藥物相關併發症。

The compound also appears to demonstrate biological activity in humans, as shown by results in ameliorating severe skin diseases.

該化合物似乎也表現出對人類的生物活性，如改善嚴重皮膚病的結果所示。

We believe these characteristics make GR-MD-02 an attractive candidate for further investigation along all the indications currently under development.

我們相信這些特性使得 GR-MD-02 成為目前正在開發的所有適應症的進一步研究的有吸引力的候選藥物。

First I will discuss our program in NASH cirrhosis. Our preclinical results show that GR-MD-02 has significant anti-fibrotic effects in multiple animal models, including liver, kidney, lung, pulmonary artery and heart fibrosis. The liver disease NASH was chosen as the first target for development of GR-MD-02 for a number of reasons.

首先，我將討論我們在NASH肝硬化方面的項目。我們的臨床前結果表明，GR-MD-02在多種動物模型中均具有顯著的抗纖維化作用，包括肝臟、腎臟、肺臟、肺動脈和心臟纖維化。基於多種原因，肝病NASH被選為GR-MD-02開發的首個標靶。

First, it is the most common liver disease, with one in four individuals in the world having fatty liver, and about 2 percent of those destined to die of complications of late-stage NASH cirrhosis.

首先，它是最常見的肝病，全球四分之一的人患有脂肪肝，約有2%的人死於晚期NASH肝硬化併發症。

Second, there are no currently approved drugs for NASH, and the market for NASH drugs globally in 2025 may be as high as $40 billion annually, according to some analysts. This makes NASH one of the largest potential markets for drug development today, as evidenced by a number of significant recent transactions in the industry.

其次，目前尚無核准的NASH藥物，而一些分析師預測，到2025年，全球NASH藥物市場規模可能高達每年400億美元。這使得NASH成為當今最大的藥物開發潛在市場之一，業內近期發生的一系列重大交易也印證了這一點。

NASH is a chronic disorder, with fat accumulation in the liver resulting in inflammation and progressive fibrosis, or scarring. Over years, this can ultimately lead to the end stage of scarring called cirrhosis. Because of the long duration, potentially decades, of underlying, asymptomatic disease before reaching cirrhosis, which is when complications and death may occur, the timing of intervention during the course of disease is an important issue.

NASH 是一種慢性疾病，脂肪在肝臟中堆積，導致發炎和進行性纖維化（或疤痕形成）。數年後，最終可能導致瘢痕形成的末期，即肝硬化。由於潛在的無症狀疾病在發展為肝硬化之前可能持續數十年，而肝硬化可能導致併發症甚至死亡，因此在疾病發展過程中，幹預的時機至關重要。

We have targeted GR-MD-02 therapy to patients with NASH cirrhosis who have not yet had serious complications. With a goal of reducing the progression of ? or, reversing ? fibrosis.

我們將 GR-MD-02 療法應用於尚未出現嚴重併發症的 NASH 肝硬化患者，旨在減緩肝纖維化的進展，甚至逆轉肝纖維化的進程。

Unlike the treatment of early stage NASH, where the medical benefits are uncertain, reducing the progression of fibrosis or reversing existing fibrosis in cirrhosis is likely to reduce complications, help avoid liver transplant, or may ultimately prevent death from complications of cirrhosis.

與早期 NASH 的治療不同，早期 NASH 的醫療益處尚不確定，而減緩纖維化的進展或逆轉肝硬化中現有的纖維化可能會減少併發症，有助於避免肝移植，或最終可能防止因肝硬化併發症而死亡。

Our robust data in animal models of liver fibrosis and cirrhosis have shown the ability of GR-MD-02 to reverse fibrosis and cirrhosis. While there are many companies and different drugs targeting pre-cirrhotic NASH, we are one of only three companies with clinical trials in NASH cirrhosis. And, we anticipate being the only company to report data this year in a NASH cirrhosis clinical trial.

我們在肝纖維化和肝硬化動物模型中累積的可靠數據表明，GR-MD-02 能夠逆轉肝纖維化和肝硬化。雖然目前有許多公司和不同的藥物針對肝硬化前期 NASH，但我們是僅有的三家進行 NASH 肝硬化臨床試驗的公司之一。並且，我們預計將成為今年唯一一家報告 NASH 肝硬化臨床試驗數據的公司。

The NASH-CX trial is the ongoing Phase 2b clinical trial that studies the effect of GR-MD-02 in NASH cirrhosis in patients. And, it has a number of important aspects.

NASH-CX試驗是一項正在進行的2b期臨床試驗，旨在研究GR-MD-02對NASH肝硬化患者的影響。該試驗具有許多重要方面。

The study has a rigorous, FDA-agreed design that measures many parameters in patients with NASH cirrhosis, who have not had serious complications and are not yet candidates for a liver transplant.

這項研究採用嚴格的、經 FDA 認可的設計，測量了 NASH 肝硬化患者的多項參數，這些患者沒有出現嚴重併發症，也還不適合接受肝臟移植。

The trial has enrolled 162 patients in three treatment arms: placebo and two doses of drugs, the treatment given every other week for 52 weeks, or essentially, one year of therapy.

該試驗招募了 162 名患者，分為三個治療組：安慰劑組和兩劑藥物組，每隔一周進行一次治療，持續 52 週，或基本上是一年的治療。

The primary endpoint of the trial is the baseline adjusted reduction in portal blood pressure, as assessed by hepatic venous pressure grading, or HVPG. Increased portal pressure occurs in advancing cirrhosis, and is directly related to patient outcomes. This is potentially an acceptable regulatory endpoint for provisional approval with follow-up outcomes data.

試驗的主要終點是基線校正門靜脈血壓的降低，該降低透過肝靜脈壓力分級（HVPG）進行評估。門靜脈壓力升高發生在進展性肝硬化中，與患者預後直接相關。這可能是可接受的監管終點，並結合後續結果數據以獲得臨時批准。

Secondary endpoints importantly include liver biopsy, serum biomarkers, complications and several non-invasive measures of liver structure and function, including FibroScan and the methacetin breath test.

次要終點包括肝臟活檢、血清生物標記、併發症以及幾種肝臟結構和功能的非侵入性測量，包括 FibroScan 和美沙西丁呼氣試驗。

This study is powered at greater than 80 percent, to demonstrate a difference in HVPG of at least 2 millimeters of mercury, a change that is potentially clinically significant in these patients. Seventy-one patients have completed therapy in the NASH-CX trial, but the data will remain blinded until all patients have completed the trial. Again, we are on track to report topline data in December of 2017.

這項研究的功效超過80%，足以證明HVPG至少有2毫米汞柱的差異，這項變化對這些患者而言可能具有臨床意義。 NASH-CX試驗中已有71名患者完成治療，但數據將維持盲態，直到所有患者完成試驗為止。我們預計於2017年12月公佈最終數據。

Data from the NASH-CX trial will represent a significant milestone in NASH therapy and for the company. Success of this trial could be a breakthrough finding for liver cirrhosis. The company cannot provide any guidance regarding the next steps in the program in NASH cirrhosis following positive NASH-CX trial data, until the data are analyzed at the end of the trial and the FDA is consulted regarding next steps.

NASH-CX 試驗的數據將成為 NASH 治療領域以及公司發展歷程中的重要里程碑。該試驗的成功或將成為肝硬化治療領域的突破性發現。在 NASH-CX 試驗數據呈陽性後，公司無法就 NASH 肝硬化治療計畫的後續步驟提供任何指導，除非在試驗結束時對數據進行分析，並就後續步驟諮詢 FDA。

The pharmaceutical industry is very interested in NASH. We have had discussions with multiple companies over the last couple of years. With positive data from the NASH-CX trial, it is likely that further partnership discussions will ensue.

製藥業對NASH非常感興趣。過去幾年，我們已經與多家公司進行了洽談。鑑於NASH-CX試驗的積極數據，我們很可能會進一步洽談合作。

Next I will discuss skin diseases. GR-MD-02 seems to have an important and clinically relevant effect in cirrhosis and atopic dermatitis, two serious skin diseases. An exploratory open-label Phase 2a trial was conducted in five adults with moderate to severe plaque psoriasis. One patient had over an 80 percent reduction in disease activity after 13 every-other-week infusions, while the other four patients reached 50 percent reduction in disease activity by their tenth infusion.

接下來我將討論皮膚病。 GR-MD-02 似乎對兩種嚴重的皮膚病—肝硬化和異位性皮膚炎—具有重要且具有臨床意義的療效。一項探索性開放標籤 IIa 期臨床試驗在五名患有中度至重度斑塊狀乾癬的成年人中進行。其中一名患者在每隔一週輸注 13 次後，疾病活動性降低了 80% 以上，而其他四名患者在第十次輸注時，疾病活動性降低了 50%。

We also studied GR-MD-02 in the treatment of severe and refractory atopic dermatitis, in three patients in an open-label investigator-initiated study. Atopic dermatitis is also commonly known as eczema. All three patients showed clinical response after receiving six every-other-week doses, with two patients achieving an average of approximately 70 percent reduction in disease activity after receiving only three doses of GR-MD-02.

我們也進行了一項由研究者發起的開放標籤研究，探討了GR-MD-02在治療三例重度難治性異位性皮膚炎方面的作用。異位性皮膚炎通常也稱為濕疹。三例患者在接受六次每隔一週的GR-MD-02治療後均出現臨床反應，其中兩名患者在僅接受三劑GR-MD-02治療後，病情活動性平均降低了約70%。

These preliminary but clinically relevant findings provide two important conclusions. First, they show that GR-MD-02 has a clinical effect in two galectin-dependent human diseases, validating activity of the drug in clinical situations.

這些初步但具有臨床意義的研究結果提供了兩個重要結論。首先，它們顯示GR-MD-02對兩種半乳糖凝集素依賴性人類疾病具有臨床療效，驗證了該藥物在臨床情況下的活性。

Second, they provide a potential opportunity for additional drug registration pathways.

其次，它們為額外的藥品註冊途徑提供了潛在的機會。

While there are already multiple effective drugs on the market for the treatment of moderately severe to severe plaque psoriasis, and generics are also entering the market, atopic dermatitis may present an opportunity. Atopic dermatitis is an important, unmet medical need that can cause very serious, debilitating problems for adults as well as children, and there have been no new agents approved in 30 years.

雖然目前市面上已有多種有效藥物用於治療中度至重度斑塊狀乾癬，仿製藥也正在進入市場，但異位性皮膚炎或許是個機會。異位性皮膚炎是一個重要的、尚未滿足的醫療需求，它可給成人和兒童帶來非常嚴重的、令人衰弱的問題，而且30年來一直沒有新的藥物獲批。

While there are several new biological drugs in late clinical development, our preliminary results in a few patients compare favorably with the other drugs in development.

雖然有幾種新的生物藥物處於臨床開發後期，但我們在少數患者身上取得的初步結果與其他正在開發的藥物相比更為有利。

Galectin is exploring partnerships and other options to finance a potential program in atopic dermatitis, or possibly psoriasis, although no decisions have been made beyond the existing clinical studies. Until the results of the NASH-CX trial are known, potential skin disease partners would have to assure us that they would not impede subsequent partnerships with GR-MD-02 for NASH cirrhosis.

Galectin 正在探索合作夥伴關係及其他選擇，以資助一項針對異位性皮膚炎（或可能為銀屑病）的潛在項目，但除現有臨床研究外，尚未做出任何決定。在 NASH-CX 試驗結果公佈之前，潛在的皮膚病夥伴必須向我們保證，他們不會妨礙後續與 GR-MD-02 合作，用於治療 NASH 肝硬化。

I will next discuss cancer immunotherapy. Galectin-3 production has increased in most cancers with multiple effects, including reducing the ability of the immune system to kill tumor cells. This prompted studies in combination with known immunotherapies.

接下來我將討論癌症免疫療法。半乳糖凝集素-3的產生在大多數癌症中都有所增加，並產生了多種影響，包括降低免疫系統殺死腫瘤細胞的能力。這促使人們進行與已知免疫療法結合的研究。

Investigators at Providence Cancer Center have tested GR-MD-02 as well as our other carbohydrate-based compound, GM-CT-01, in multiple sophisticated cancer animal models, in combination with known cancer immunotherapeutic drugs. GR-MD-02 showed a synergistic effect on multiple cancers in combination with different immunotherapies. GM-CT-01, on the other hand, had no effect.

普羅維登斯癌症中心的研究人員已在多種複雜的癌症動物模型中測試了 GR-MD-02 以及我們另一種基於碳水化合物的化合物 GM-CT-01，並將其與已知的癌症免疫療法藥物聯合使用。 GR-MD-02 與不同的免疫療法合併使用，對多種癌症表現出協同作用。而 GM-CT-01 則沒有這種效果。

The Providence Cancer Center recently reported early results of GR-MD-02 in five patients with advanced melanoma, who were treated with a combination of 2 milligrams per kilogram GR-MD-02 and pembrolizumab, brand name Keytruda.

普羅維登斯癌症中心最近報告了 GR-MD-02 對五名晚期黑色素瘤患者的早期治療結果，這些患者接受了每公斤 2 毫克 GR-MD-02 和帕博利珠單抗（品牌名 Keytruda）的聯合治療。

Out of these five patients, there has been one partial response which is moving toward a complete response; and one mixed response. While we cannot conclude that the responses were related to the addition of GR-MD-02, these findings provide a clinically relevant signal to follow as GR-MD-02 are escalated. The clinical trial is ongoing, with increasing doses of GR-MD-02 and relevant data will be reported as determined by the principal investigator. There will likely be additional data reported in early 2018.

在這五名患者中，一名患者出現部分緩解，目前正逐漸轉為完全緩解；另有一名患者出現混合緩解。雖然我們無法斷定這些緩解是否與添加 GR-MD-02 有關，但這些結果提供了一個臨床相關的訊號，顯示隨著 GR-MD-02 劑量的增加，患者可以採取相應措施。臨床試驗仍在進行中，GR-MD-02 的劑量將逐步增加，相關數據將由主要研究者決定後再報告。更多數據預計將於 2018 年初報告。

A decision to move to a controlled Phase 2 trial of combination immunotherapy will be based on the response rate of the combination of pembrolizumab with GR-MD-02 as compared to historical response rates to pembrolizumab alone. The Providence Cancer Center is funding these trials. Potential partnerships will depend on the results of additional clinical data.

是否進入聯合免疫療法的對照II期臨床試驗，將基於帕博利珠單抗與GR-MD-02聯合治療的緩解率，並與帕博利珠單抗單藥治療的歷史緩解率進行比較。普羅維登斯癌症中心正在資助這些試驗。潛在的合作將取決於進一步臨床數據的結果。

So in summary, our clinical development program for GR-MD-02 progressed significantly during 2016 and we will have critical results in 2017. Paramount among those results and a value inflection point, will be reporting of topline data for the NASH-CX trial. Expected to be the next clinical trial in the treatment of NASH cirrhosis to read out, with topline data in December of 2017.

總而言之，我們GR-MD-02的臨床開發計畫在2016年取得了顯著進展，並將在2017年取得關鍵成果。這些成果中最重要的，也是價值的轉捩點，是NASH-CX試驗的頂線資料報告。預計下一項治療NASH肝硬化的臨床試驗將於2017年12月公佈頂線數據。

In atopic dermatitis, additional data will be reported by the end of Q3, as patients continue on their GR-MD-02 therapy. We cannot predict whether there will be additional data on cancer immunotherapy in 2017, as this trial is controlled by Providence Cancer Center.

在異位性皮膚炎方面，隨著患者繼續接受 GR-MD-02 治療，更多數據將於第三季末公佈。由於該試驗由普羅維登斯癌症中心管理，我們無法預測 2017 年是否會有更多癌症免疫療法數據。

We believe we have a very safe drug candidate, with thousands of doses given to humans with no serious adverse events related to GR-MD-02. This is an exciting year for the company, and the reporting of topline NASH-CX data will culminate the efforts of a program that was initiated in 2011.

我們相信我們擁有一款非常安全的候選藥物，數千劑已用於人體，未發生與 GR-MD-02 相關的嚴重不良事件。對於公司而言，這是激動人心的一年，NASH-CX 核心數據的報告將使自 2011 年啟動的該計畫取得圓滿成功。

Additionally, it is exciting for the entire field of galectin-3 inhibitors, which have multiple potential applications beyond those indications the company is currently investigating.

此外，這對於整個 galectin-3 抑制劑領域來說也是令人興奮的，除了公司目前正在研究的適應症之外，該抑制劑還有多種潛在應用。

I thank you for your attention, and I will now take questions from individuals on the call.

感謝大家的關注，現在將回答電話會議中各位嘉賓的提問。

(Operator Instruction) Ed Arce, H.C. Wainwright.

（操作員指示）Ed Arce，H.C. Wainwright。

Thank you. Hi, Peter, it's good to talk to you again.

謝謝。嗨，彼得，很高興再次和你聊天。

Yes, hi Ed.

是的，你好，艾德。

So just a few questions. First, a couple on NASH-CX. I just wanted to confirm, we talked about this before, but as you report the data and get the full results, you will then, I assume, evaluate whether to pursue either a cohort that decreases HVPG to 10 millimeters of mercury or the other -- that stops the progression to that level?

所以就幾個問題。首先，關於NASH-CX的幾個問題。我只是想確認一下，我們之前討論過這個問題，但當你報告數據並獲得完整的結果時，我想你會評估是否要開展一個將HVPG降低到10毫米汞柱的隊列，還是另一個阻止其進展到該水平的隊列？

And then the other question is, the last update we had on the number of dropouts was five patients. I know that that's still below the level that you assumed for your design. I was just wondering if you had an update on that?

另一個問題是，我們上次更新的退出人數是5名患者。我知道這仍然低於您在設計中假設的水平。我想知道您是否有這方面的更新資訊？

And then I have a couple follow ups.

然後我還有一些後續問題。

Yes. Let me answer that second question first, because it's straightforward. We have had a total of 10 dropouts out of 162, which is about a 6 percent rate. We had anticipated at the beginning of the trial that there would be a 25 percent dropout rate. So we're still well below the rate that we had anticipated for the trial.

是的。我先回答第二個問題，因為它很簡單。我們162位受試者中，總共有10人退出，退出率約6%。我們在試驗開始時預期的退出率是25%。所以，我們目前的退出率仍然遠低於試驗時的預期。

And let me go back to your first question, which is a complicated one in a number of aspects. Let me sort this out a little bit for you and the other callers.

讓我回到你的第一個問題，這個問題在很多方面都很複雜。讓我為你和其他來電者稍微梳理一下。

First of all, portal hypertension, or high blood pressure in the portal vein, is defined as a pressure above 5 millimeters of mercury. Clinically significant portal hypertension is defined as 10 millimeters of mercury, because above 10 millimeters of mercury is when complications begin to occur, such as the development of esophageal varices.

首先，門靜脈高壓（即門靜脈高壓）定義為壓力超過5毫米汞柱。臨床上顯著的門靜脈高壓定義為10毫米汞柱，因為超過10毫米汞柱時，併發症就開始出現，例如食道靜脈曲張。

We designed the clinical trial to enroll patients that had a mean portal pressure, or would have been expected to have a mean portal pressure, between 12 and 15 millimeters of mercury. And without telling you the exact number, which we haven't revealed, we were successful in enrolling a group of patients with a mean HVPG or portal pressure between 12 and 15 millimeters of mercury.

我們設計的臨床試驗招募的是平均門靜脈壓力（或預期平均門靜脈壓力）在12至15毫米汞柱之間的患者。雖然沒有透露具體數字，但我們成功招募了一組平均HVPG（門靜脈壓力）在12至15毫米汞柱之間的患者。

So the mean patients have clinically significant portal hypertension, but not so severe that they're in the end stage. Once we see the results of this trial on the mean change in portal pressure, we will also look at different groups of patients. Those that started below 10 and those that start above, which were about two-thirds of the patients, and we will be able to determine then what the next design of a clinical trial might look like based on the analysis of those results.

因此，平均而言，患者有臨床上顯著的門脈高壓，但病情並不嚴重到末期。一旦我們看到這項試驗關於門脈壓力平均變化的結果，我們還將研究不同的患者群體。起始壓力低於10的患者和起始壓力高於10的患者（約佔患者的三分之二）將基於這些結果的分析，以確定下一步臨床試驗的設計方案。

But we are pleased that we were able to enroll a patient population with clinically significant portal hypertension. And we know that a 10 to 20 percent reduction in portal hypertension has clinically important outcome results in patients. So that's why we're targeting, or our statistical analysis targets, 2 millimeter of mercury drop in patients that have above 12 millimeters of mercury of portal hypertension.

但我們很高興能夠招募到一群臨床上有顯著門脈高壓的患者。我們知道，門脈高壓降低10%到20%，對患者而言有重要的臨床療效。因此，我們設定的目標，或者說我們的統計分析目標是，對於門脈高壓超過12毫米汞柱的患者，門脈高壓下降2毫米汞柱。

Ed, I'm not sure if that fully answered your question?

艾德，我不確定這是否完全回答了你的問題？

Yes, it does. I just wanted to confirm that you would be looking at both sets of patients, was below and above that threshold of 10 millimeters of mercury.

是的，確實如此。我只是想確認一下，你會觀察兩組患者，看看血壓是否低於和高於10毫米汞柱的閾值。

Yes.

是的。

And it sounds like you've got one-third to two-third split, so that's helpful.

聽起來你已經得到了三分之一到三分之二的分割，所以這很有幫助。

You had also mentioned the other two programs that are focused on NASH cirrhosis. I was just wondering if you had any thoughts you'd care to share about how you view those programs and the approaches that they have.

您還提到了另外兩個專注於NASH肝硬化的項目。我想知道您是否願意分享您對這些項目及其方法的看法。

Yes, the other two programs, one is a pan-caspase inhibitor from Conatus who have just started a clinical trial enrolling even more severe patients with portal hypertension. And the second program is a Gilead clinical trial that is using an ASK-1 inhibitor and they are enrolling a large clinical trial. Both of these clinical trials will not read out until long after ours, because they've just been initiated.

是的，另外兩個項目，一個是Conatus公司研發的泛胱天蛋白酶抑制劑，該公司剛啟動了一項臨床試驗，招募更嚴重的門靜脈高壓患者。第二個計畫是吉利德公司進行的臨床試驗，該試驗使用一種ASK-1抑制劑，他們正在招募一項大型臨床試驗。這兩個臨床試驗的結果都要比我們的試驗晚很久才會公佈，因為它們才剛啟動。

OK. And then a couple last follow ups. Do you expect to have any presence at ISAL next month?

好的。最後還有幾個後續問題。您預計下個月會出席 ISAL 會議嗎？

And also, I guess the last question for Jack is, how should we think about operating expenses for 2017? Just perhaps even just qualitatively. Thanks.

另外，我想問傑克的最後一個問題是，我們該如何考慮2017年的營運費用？甚至可以從定性的角度來考慮。謝謝。

I'll answer the ISIL question. We will be attending ISIL. We do have a late-breaking abstract at ISIL, which is focused on an analysis of the methacetin breath test that we're doing in conjunction with Exalenz.

我來回答關於ISIL的問題。我們會參加ISIL。我們在ISIL上確實有一份最新的摘要，重點是我們與Exalenz合作進行的美沙西丁呼氣測試的分析。

The presentation will be regarding the baseline values of the C-13 methacetin breath test as it correlates with HVPG, so we will be reporting data at ISIL from that.

演示將涉及 C-13 美沙西丁呼氣測試的基線值，因為它與 HVPG 相關，因此我們將報告 ISIL 的數據。

And Jack, do you want to?

傑克，你想這麼做嗎？

Yes, as far as our research and development expenses, as well as our G&A expenses, we think those will be similar to 2016. And as we've mentioned, we've got cash currently to fund operations through the end of the year. But we think those expenses will be about the same as they were last year.

是的，就我們的研發費用以及一般行政費用而言，我們認為這些費用將與2016年持平。正如我們之前提到的，我們目前擁有足夠的現金來維持到年底的營運。但我們認為這些費用將與去年大致相同。

OK, great. Thank you, guys.

好的，太好了。謝謝大家。

Thanks.

謝謝。

Thomas Yip, FBR & Company.

Thomas Yip，FBR & Company。

Hi, good morning, everyone. Thank you for taking our questions. Just asking a couple of quick questions for Vernon.

大家早安。感謝您回答我們的提問。我只想問Vernon幾個簡單的問題。

We see that you have a large number of other galectin inhibitor candidates. Can you outline some R&D activities that you have ongoing? And when should we expect to see some early quarter presentation or medical conferences data for those comp panels?

我們看到你們有大量其他的半乳糖凝集素抑制劑候選藥物。您能否概述一下你們正在進行的一些研發活動？我們什麼時候能看到這些藥物的早期季度報告或醫學會議數據？

Yes, thank you, Thomas and good to talk to you, and Vern. We have a program in discovery for identifying additional galectin-3 and other galectin inhibitors. We have not announced any information regarding those additional galectin inhibitors, but that program is ongoing, and when we have some animal data or additional data regarding those, we will communicate them. But we don't have the timing of that at this point.

是的，謝謝托馬斯，很高興和你和弗恩聊天。我們有一個正在研發的項目，旨在識別更多半乳糖凝集素-3和其他半乳糖凝集素抑制劑。我們還沒有公佈關於這些額外半乳糖凝集素抑制劑的任何信息，但該項目正在進行中，當我們獲得一些動物數據或其他相關數據時，我們會告知大家。但目前我們還沒有確定具體時間。

Thanks, Thomas.

謝謝，托馬斯。

OK, so I guess from, you know, from a bigger picture standpoint, if you see a similar level of activity compared to GR-MD-02, I mean obviously they are still in pre-clinic stage. What are your plans to monetize them? Have you given any thought about that so far?

好的，所以從更宏觀的角度來看，如果您看到與 GR-MD-02 類似的活躍度，那麼顯然它們仍處於臨床前階段。您計劃如何將它們商業化？到目前為止，您有考慮過這方面的問題嗎？

Yes. Well, the GR-MD-02, as you know, is a parenteral IV-administered drug. The drugs that we are working on, in discovery, would have the potential for other routes of administration, including oral administration.

是的。您知道，GR-MD-02 是一種靜脈注射給藥的藥物。我們正在研發的藥物，也有可能採取其他給藥途徑，包括口服給藥。

Additionally, we are working on higher potency and more specificity with regard to galectin-3 inhibition.

此外，我們正在研究提高半乳糖凝集素 3 抑制的效力和特異性。

OK, that sounds good. We'll just have to keep our eyes out for that.

好的，聽起來不錯。我們得繼續留意了。

I guess I will switch gears a little bit, then. I have questions about your pipeline in (NASH). Given the IST that you have right now with Providence, what exactly do you need to file the IND and to go into Phase 2 clinical trials? Do you need to in-license it back from Providence? Or, do you have the rights to that panel?

那麼，我想稍微換個話題。我有一些關於您在NASH方面的研發線的問題。考慮到您目前與普羅維登斯公司合作的IST（免疫療法），您究竟需要什麼才能提交IND（新藥申請）並進入II期臨床試驗？您是否需要從普羅維登斯公司獲得許可？或者，您是否擁有該小組的使用權？

We have exclusive rights to GR-MD-02, and while we have pending intellectual property jointly with Providence with regard to the method of use, we have exclusive license to that as well. So there are no licensing or intellectual property issues there.

我們擁有 GR-MD-02 的獨家權利，雖然我們與 Providence 共同擁有使用方法的智慧財產權，但我們也擁有該藥物的獨家許可。因此，不存在許可或知識產權問題。

The decision to go to a Phase 2 is going to be related, as I mentioned, to the results of ascending doses of GR-MD-02 in combination with pembrolizumab as compared to historical controls. And with a significant difference in either the response or immunologic markers which we are measuring as well. That would then lead us to a decision point about going to a Phase 2 controlled trial.

正如我之前提到的，是否進入 II 期臨床試驗的決定取決於 GR-MD-02 與派姆單抗合併用藥劑量遞增後的結果，並與歷史對照組進行比較。此外，我們還將測量療效或免疫標記物，以確定是否有顯著差異。這將決定我們是否進入 II 期對照試驗。

OK, that sounds good. Thanks for the clarity. Just one final question regarding the data that you've seen so far in atopic dermatitis. So you've outlined that earlier that you plan to out-license that indication or to enter partnerships.

好的，聽起來不錯。感謝您的澄清。關於您目前在異位性皮膚炎方面獲得的數據，我只想問最後一個問題。您之前提到過，您計劃將該適應症授權給第三方，或建立合作關係。

So can you describe, just on a very top level, what would an ideal partnership look like? What specific characteristics will you be looking for?

那麼，您能否從最高層面描述一下，理想的合作關係是什麼樣的呢？您會尋求哪些具體特質？

Yes. It's a good question. As I mentioned in the review, because it's the same compound as we're using in NASH cirrhosis, whatever deal we did with a partner around atopic dermatitis or skin disease would have to not impair the very large potential of the deal in NASH. So we are focusing on international companies rather than multi-national or U.S. companies, skin-specific companies, and companies where we might do a deal that would not impede a subsequent deal in NASH.

是的，這是個好問題。正如我在評論中提到的，由於它與我們用於治療NASH肝硬化的化合物相同，因此我們與合作夥伴就特應性皮膚炎或皮膚病達成的任何交易都必須不損害NASH領域的巨大潛力。因此，我們專注於國際公司，而不是跨國公司或美國公司、皮膚專科公司，以及我們可能進行交易且不會妨礙後續NASH交易的公司。

So that's kind of the focus of where we're looking at this point.

這就是我們現在關注的重點。

OK, that sounds good. Thank you again for taking my questions, and we will look forward to the progress this year, and look forward to the (inaudible) data later this year.

好的，聽起來不錯。再次感謝您回答我的問題，我們期待今年的進展，也期待今年稍後的（聽不清楚）數據。

Thank you, Thomas.

謝謝你，托馬斯。

Len Lavi, (Dotdot) Partners.

Len Lavi，（Dotdot）合夥人。

Thank you very much. Peter, as I speak with clinicians about how they think the NASH market will evolve with therapeutics over time, they're drawing the parallel, albeit the sizes are different, to the Hep-C market where they're of the opinion that insurers will likely approve treatment for those patients with F-3/F-4 fibrosis, cirrhosis initially because they are most at risk for having complications.

非常感謝。彼得，我和一些臨床醫生討論NASH市場將如何隨著療法的發展而發展，他們將其與丙肝市場進行了類比，儘管規模不同。他們認為，保險公司很可能會先批准F-3/F-4纖維化、肝硬化患者的治療，因為他們出現併發症的風險最高。

A lot of the NASH targets that other companies are developing seem to be aimed at earlier stages, when the progression hasn't yet gone as far, and therefore the likelihood possibly of complications isn't as great.

其他公司開發的許多 NASH 目標似乎都是針對早期階段，此時病情進展還不算太遠，因此出現併發症的可能性並不大。

And I was just wondering if you could give us your thoughts on, what's the progression in years from NAFLD to NASH to cirrhosis and beyond is, and what indications, if any, you have will along that timeline you think that the initial treatments will be authorized by insurers or doctors who will want patients treated?

我只是想知道您是否可以告訴我們，從 NAFLD 到 NASH 再到肝硬化以及更嚴重的疾病，在幾年內會經歷怎樣的進展？您認為在這段時間內，有哪些跡象（如果有的話）會導致初始治療獲得保險公司或希望患者接受治療的醫生的授權？

Yes, I think that's an insightful question and also mirrors the discussions that we've had with thought leaders in NASH and liver disease.

是的，我認為這是一個有見地的問題，也反映了我們與 NASH 和肝病思想領袖的討論。

The progression from early fatty liver disease to cirrhosis is on the order of 20 years. So it progresses relatively slowly. There are some patients that may progress faster, and so forth, but you can think of about a 20-year period.

從早期脂肪肝發展到肝硬化大約需要20年的時間。所以進展相對較慢。有些病人的進展速度可能更快，等等，但你可以想像大約20年的時間。

Once you develop cirrhosis, it's still about five years to developing complications of cirrhosis, and then a year or two before death or liver transplant. So we are focused on those with well-compensated cirrhosis in that timeframe where you have about five years or so to reverse or stave off the progression of fibrosis, so that it doesn't get to cirrhosis complications.

一旦患有肝硬化，大約五年後才會出現肝硬化併發症，之後一兩年內才會死亡或需要肝臟移植。因此，我們重點關注的是那些在這段時間內肝硬化得到良好代償的患者，他們有大約五年左右的時間來逆轉或延緩纖維化的進展，從而避免肝硬化併發症。

It's very clear that that target is going to be more accepted by both physicians, insurers and governments, because you're much closer to an outcome; a serious outcome. Whereas in early stages of NASH, in long-term follow-up studies that have been done ? one study that was done in Sweden where they followed patients for 33 years ? those with F-1 or F-2, Stage 1 or Stage 2 fibrosis, when followed for 33 years, had no difference in mortality or morbidity with relationship to a reference group.

很明顯，這個目標將會被醫生、保險公司和政府更廣泛地接受，因為你離最終結果更近了一步，一個嚴重的結果。然而，在NASH的早期階段，在已經進行的長期追蹤研究中——一項在瑞典進行的研究，他們對患者進行了33年的隨訪——那些患有F-1或F-2（即1期或2期纖維化）的患者，在33年的隨訪中，與對照組相比，其死亡率和發病率沒有差異。

So an argument could be made that those patients with early disease, we can't predict who's going to progress, and they may not have any outcome problems, so that governments, insurers and physicians are going to be more reluctant to treat somebody for decades with the early form of the disease, particularly when lifestyle changes such as weight loss, exercise and so forth can make a big impact at that time.

因此，可以說，對於早期疾病患者，我們無法預測誰的病情會惡化，而且他們可能不會出現任何預後問題，因此政府、保險公司和醫生將更不願意在幾十年的時間裡治療早期疾病患者，特別是當減肥、運動等生活方式的改變可以在那時產生巨大影響時。

So I do think that it's the late stage fibrosis that is the most important approach to targeting this disease. Thanks, Len.

所以我確實認為，晚期纖維化是治療這種疾病最重要的方法。謝謝，Len。

Thank you.

謝謝。

Sa'ar Yaniv, Roth Capital Partners, LLC.

Sa'ar Yaniv，羅斯資本合夥人有限責任公司。

Hi, good morning, guys. Thank you so much for taking my call, I appreciate it.

大家早安！非常感謝你們接聽我的電話，我非常感激。

Hi, Sa'ar.

你好，薩爾。

Hi. I had a couple of questions about the cirrhosis study, and then some other ones.

你好。我有幾個關於肝硬化研究的問題，還有一些其他的問題。

First of all, it seems like the completed enrolment of the study was in last August. So, should we expect completion of the last patient in the study around August or September of this year?

首先，這項研究的招募似乎是在去年8月完成的。那麼，我們預期這項研究的最後一名患者應該在今年8月或9月左右完成嗎？

Yes, that's correct.

是的，正確。

OK, so we're looking at about two to two-and-a-half months for you to compile the data for the study?

好的，那麼我們需要大約兩到兩個半月的時間來收集研究數據？

Yes, just to follow up on that a bit, Sa'ar, so after the last infusion, two weeks later the patient gets their final HVPG and other testing, and their last visit is about a month after that. So there's about six weeks of additional data gathering before the database can be locked. So you can think of mid-October as being database lock with that analysis and data report in December.

是的，Sa'ar，我稍微跟進一下，最後一次輸液後兩週，患者會進行最後一次HVPG和其他檢測，最後一次復診大約在一個月後。所以在資料庫鎖定之前，大約還有六週的時間進行額外的資料收集。所以你可以認為10月中旬是資料庫鎖定時間，12月份會進行分析並提交資料報告。

OK, sounds good. You're not planning on having any interim analysis for safety or futility in the study?

好的，聽起來不錯。您不打算對研究中的安全性或無效性進行任何中期分析嗎？

We have three scheduled safety interim analysis that's done by an independent drug safety monitoring board. Two of those have already been completed and there's been no safety signals. The third and final DSMB before the end of the study will be in June timeframe. So there are safety monitoring analysis, but no interim efficacy analysis until the final patient and the database lock.

我們計劃進行三次由獨立藥物安全監測委員會（DSMB）進行的安全性中期分析。其中兩次已經完成，但尚未發現任何安全信號。研究結束前的第三次也是最後一次DSMB將在6月進行。因此，我們進行了安全性監測分析，但在最終患者入組和資料庫鎖定之前，不會進行中期療效分析。

OK, great. You mentioned earlier that you had expected in the design to have a 25 percent dropout rate.

好的，太好了。你之前提到過，設計上預期的dropout率是25%。

Yes.

是的。

It seems a little high, and I wanted to know what was the reason for such high expectations for dropout?

這似乎有點高，我想知道對輟學率如此高的期望是什麼原因？

It's a historical rate. Previous companies that have done clinical trials with patients with cirrhosis doing multiple procedures such as the HVPG and liver biopsy have had rates as high as 25 percent drop out. So when we were designing this study, it was the recommendation of KOL's and our CRO, and the FDA in fact recommended that a dropout rate of 25 percent would not be unreasonable.

這是歷史性的退出率。之前一些公司對肝硬化患者進行臨床試驗，並進行多項檢查，例如肝門靜脈造影（HVPG）和肝臟活檢，退出率高達25%。所以，當我們設計這項研究時，這是KOL和我們的CRO的建議，事實上，FDA也建議25%的退出率並非不合理。

We had originally estimated lower than that, but it was really the FDA questioning us about the size of the dropout rate. So we planned for 25 percent, but we're pleased to see that it's running around 6 percent.

我們原本的估計比這還要低，但其實是FDA質疑我們退出率有多高。所以我們計劃是25%，但我們很高興地看到，這個數字在6%左右。

OK. That's very helpful, thank you.

好的。這很有幫助，謝謝。

And then my last question about the study, are you looking at any pre-specified subgroup analysis in the study? So you mentioned, for example, the HVPG rate, you know, above 5 and above 10 and then the 12 to 15 millimeter HG. Are you looking at different groups there?

關於這項研究的最後一個問題，你們在研究中是否進行了任何預先指定的亞組分析？例如，您提到了HVPG發生率，例如5毫米以上、10毫米以上，以及12至15毫米HG。你們研究的是不同的組別嗎？

Yes. We have prespecified analysis for looking at 5 to 10, 10 to 15, 15 and above. So we do have, as well as above and below 10, so we have prespecified subgroup analysis as well.

是的。我們預先設定了 5 到 10、10 到 15、15 及以上的分析。所以，我們確實有 10 以上和 10 以下的分析，所以我們也有預先設定的亞組分析。

OK. One quick question with the NASH fibrosis study, you announced the results in September 2016.

好的。關於NASH纖維化研究，我有一個簡短的問題，你們在2016年9月公佈了研究結果。

Yes.

是的。

What's the status of GR-MD-02 in NASH?

GR-MD-02 在 NASH 的地位如何？

Well, that study, as you know, is in NASH with Stage 3 fibrosis and we, in that short evaluation, we did not see a difference in non-invasive testing. The result of that study was twofold. One, to evaluate non-invasive tests and two, to see if there was any effect in the short-term therapy.

嗯，如你所知，那項研究針對的是患有3期纖維化的NASH患者，在那個短暫的評估中，我們並沒有發現非侵入性檢測有任何差異。那項研究的結果有兩個面向。一是評估非侵入性檢測；二是觀察短期治療是否有效。

We don't have any plans on doing additional trials in non-cirrhotic NASH at this point.

目前我們還沒有針對非肝硬化 NASH 進行額外試驗的計畫。

OK. So right now, the program is focused only on NASH cirrhosis?

好的。那麼目前，該計畫只關注NASH肝硬化嗎？

Yes, that's correc.t

是的，沒錯。

OK. And what about the cirrhosis program? What's the plan in that program? Are you only looking to go forward with a partner, as you suggested earlier, or will consider taking that forward by yourself?

好的。那麼肝硬化項目呢？這個項目的具體計劃是什麼？您是像之前說的那樣，只考慮和合作夥伴一起推進，還是會考慮自己繼續前進？

Well, we will consider taking forward by ourselves the atopic dermatitis findings, because as I mentioned, the market is much less mature, there hasn't been a drug approved in 30 years in atopic dermatitis, so we see the opportunity there as greater than cirrhosis. But we would be willing to move both forward with a partner, depending on those discussions.

嗯，我們會考慮自行推進異位性皮膚炎的研究成果，因為正如我所提到的，市場還不夠成熟，30年來還沒有一款治療異位性皮膚炎的藥物獲批，所以我們認為這方面的機會比肝硬化更大。但我們願意與合作夥伴共同推動這兩項研究，這取決於雙方的討論。

And just to be clear, there are three patients in the atopic dermatitis study?

需要明確的是，異位性皮膚炎研究中有三名患者？

Yes, just three patients, investigator-initiated.

是的，只有三名患者，由研究者發起。

So is there a plan to do a slightly larger study?

那麼是否有計劃進行更大規模的研究？

Yes. Almost any study would be slightly larger than three. We are exploring those options. At the present time, we haven't made a decision on initiating a new trial, and it would have to come with funding for supporting that.

是的。幾乎所有研究的規模都會略大於三人。我們正在探索這些選項。目前，我們還沒有決定是否啟動新的試驗，但必須有資金支持。

OK. And then the final question, if you don't mind, do you have any plans on publishing any of the data that you've announced recently from NASH, from the cirrhosis data in August ? I think you, for the NASH data in September ? the atopic dermatitis. Any plans on conferences or scientific publications?

好的。最後一個問題，如果您不介意的話，您有沒有計劃發布最近公佈的NASH數據，例如8月的肝硬化數據？我想您還有9月的NASH數據？還有異位性皮膚炎的數據。您有計劃參加會議或發表科學論文嗎？

The cirrhosis data was presented by the principal investigator at an academic conference, Maui Dermatology, just this past week and we're preparing a publication of that information. And we will be publishing. We're preparing a publication for the NASH-FX trial. The atopic dermatitis, we may present that at a meeting, but we don't have plans right now for publishing that.

就在上週，首席研究員在學術會議 Maui Dermatology 上公佈了肝硬化的數據，我們正在準備將這些資訊發表出來。我們也會發表的。 NASH-FX 試驗的數據我們也在準備發表。至於異位性皮膚炎的數據，我們可能會在會議上公佈，但目前還沒有發表的計畫。

OK, but sorry, you said for the NASH you're looking to publish that in a scientific journal?

好的，但抱歉，您說您希望在科學期刊上發表有關 NASH 的文章嗎？

Yes.

是的。

Any plans on presenting that at any of the upcoming scientific conferences or meetings?

有沒有計劃在即將召開的科學會議或會議上展示這一點？

No, we're not presenting the data at the upcoming ISIL meeting, but we are preparing a manuscript.

不，我們不會在即將舉行的 ISIL 會議上展示數據，但我們正在準備一份手稿。

OK, great. Thank you so much for taking my questions.

好的，太好了。非常感謝您回答我的問題。

Thanks, Sa'ar.

謝謝，薩爾。

Thank you, Sa'ar.

謝謝你，薩爾。

Thank you. And at this time, the question-and-answer session is completed and I will now turn the call back over to Dr. Traber for final remarks.

謝謝。至此，問答環節結束，我將把電話轉回給特拉伯博士進行最後的演講。

We thank you very much for your attention and for the excellent questions, and we look forward to delivering on the promise of the therapy of GR-MD-02 during the course of this year. So thank you very much for your attention.

非常感謝大家的關注與提出的精彩問題，我們期待今年兌現GR-MD-02療法的承諾。非常感謝大家的關注。

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's conference. You may all disconnect. Everyone have a great day.

女士們，先生們，感謝各位參加今天的會議。今天的會議到此結束。各位可以斷開連接了。祝大家有愉快的一天。