Xenetic Biosciences Inc (XBIO) 2016 Q4 法說會逐字稿

Greetings and welcome to the Xenetic Biosciences quarterly conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded.

大家好，歡迎參加 Xenetic Biosciences 季度電話會議和網路廣播。（操作員指示）提醒一下，本次會議正在錄音。

It is now my pleasure to introduce your host, Miss Jenene Thomas, investor relations. Thank you. Ms. Thomas, you may begin.

現在我很高興向大家介紹主持人、投資者關係部珍妮‧湯瑪斯女士。謝謝。托馬斯女士，你可以開始了。

Good morning, everyone, and thank you for joining Xenetic Biosciences' quarterly business update conference call and webcast. I would like to remind you that today's webcast will be accompanied by a slide presentation that can be found under the investors section of the Company's website, XeneticBio.com, under events and presentations.

大家早安，感謝您參加 Xenetic Biosciences 的季度業務更新電話會議和網路廣播。我想提醒您，今天的網路廣播將附帶幻燈片演示，可以在公司網站 XeneticBio.com 的投資者部分的活動和演示下找到。

At this time I would like to remind our listeners that remarks made during this call may state management's intentions, hopes, beliefs, expectations, or predictions of the future. These are forward-looking statements that involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provision of the federal securities laws.

此時，我想提醒我們的聽眾，本次電話會議的言論可能表明管理層的意圖、希望、信念、期望或對未來的預測。這些是涉及風險和不確定性的前瞻性陳述。本次電話會議中的前瞻性陳述是根據聯邦證券法的安全港條款做出的。

These forward-looking statements are based on Xenetic Biosciences current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Xenetic Biosciences files with the Securities and Exchange Commission.

這些前瞻性聲明是基於 Xenetic Biosciences 目前的預期，實際結果可能存在重大差異。因此，您不應過度依賴任何前瞻性陳述。Xenetic Biosciences 向美國證券交易委員會提交的定期報告中討論了一些可能導致實際結果與此類前瞻性陳述所預期的結果有重大差異的因素。

These documents are available in the investors section of the Company's website and on the Securities and Exchange Commission website. We encourage you to review these documents carefully.

這些文件可在公司網站的投資者部分和美國證券交易委員會網站上查閱。我們鼓勵您仔細閱讀這些文件。

Following the Company's prepared remarks, the call will be opened up for a question-and-answer session. Joining me on the call today are Scott Maguire, the Company's Chief Executive Officer; Jeff Eisenberg, Chief Operating Officer; and Dr. Curt Lockshin, Chief Scientific Officer. It is now my pleasure to turn this call over to Scott Maguire.

在公司準備好發言之後，電話會議將進入問答環節。今天與我一起參加電話會議的還有公司執行長 Scott Maguire；傑夫·艾森伯格（Jeff Eisenberg），首席營運長；以及首席科學官 Curt Lockshin 博士。現在我很高興將這個電話轉給史考特·馬奎爾。

Thank you, Jenene, and first of all, I would like to think everyone for taking time out of their day to listen to the Xenetic earnings call. I am pleased we are now in a routine to have these calls on a regular quarterly basis. It is this type of interaction and communication that gives the Company and the technologies the visibility they deserve.

謝謝你，Jenene，首先，我想感謝大家抽出時間來聆聽 Xenetic 的收益電話會議。我很高興我們現在已形成每季定期召開此類電話會議的慣例。正是這種互動和溝通讓公司和技術獲得了應有的知名度。

Speaking of visibility, Xenetic rang the bell on NASDAQ last week on Thursday morning. It was a great event enjoyed by all of Xenetic's staff and advisers that played a critical role in getting Xenetic listed on NASDAQ. With that I would now like to go through the achievements since our last call.

說到知名度，Xenetic 上週四早上在納斯達克上市。這是 Xenetic 所有員工和顧問都十分享受的一次盛事，他們在 Xenetic 在納斯達克上市過程中發揮了關鍵作用。現在我想回顧一下我們上次通話以來所取得的成就。

As we announced the beginning of January, we received a $3 million milestone payment from Shire for hitting an inflection point in our license agreement. This is related to Shire's advancing SHP656 through the Phase 1/2A clinical study and it is a long-acting form of Factor VIII, a treatment for hemophilia A.

正如我們在一月初宣布的那樣，我們收到了 Shire 支付的 300 萬美元里程碑付款，以表彰我們許可協議的進展。這與 Shire 推進 SHP656 的 1/2A 期臨床研究有關，它是凝血因子 VIII 的長效形式，可用於治療血友病 A。

We also announced recently that we will be announcing, hopefully the end of next month, that we have achieved a FDA approval on the protocol that we filed recently under an existing IND for a biomarker study of XBIO-101 for the treatment of triple negative breast cancer. And we also expanded our patent portfolio quite significantly since the last time we announced our patents in November 2014. We have expanded those into the key geographic markets; we have strengthened our portfolio across the board covering our therapeutic technologies.

我們最近也宣布，預計將在下個月底宣布，我們最近根據現有 IND 提交的用於治療三陰性乳癌的 XBIO-101 生物標記研究的方案已獲得 FDA 批准。自 2014 年 11 月上次公佈專利以來，我們的專利組合也大幅擴展。我們已將其擴展到主要地理市場；我們全面加強了涵蓋治療技術的產品組合。

We also announced the appointment of Dr. Ed Benz, the former CEO of the Dana-Farber Cancer Institute, one of the world's leading cancer institutes; he has become a member of our Board. Ed, along with Roger Kornberg, bring global credibility and global recognition to Xenetic.

我們也宣布了任命世界領先的癌症研究所之一丹娜—法伯癌症研究所前執行長Ed Benz博士；他已成為我們董事會的成員。Ed 與 Roger Kornberg 一起為 Xenetic 帶來了全球信譽和全球認可。

We also appointed Dr. Curt Lockshin as the Chief Scientific Officer. He is a very experienced R&D professional who has been a part of the Xenetic team for the past two years, but he has now become a full-time member at the position of Chief Scientific Officer.

我們也任命 Curt Lockshin 博士為首席科學官。他是一位經驗豐富的研發專業人士，過去兩年一直是 Xenetic 團隊的一員，但現在他已成為首席科學官一職的全職成員。

Now just this morning we announced the expansion of our executive management team with the appointment of James F. Parslow, Jim as we call him, as the Chief Financial Officer. Jim has 25 years of financial and business leadership experience, both of which are important components to execute on shareholder value enhancement.

就在今天早上，我們宣布擴大我們的執行管理團隊，並任命 James F. Parslow（我們稱他為 Jim）為財務長。吉姆擁有 25 年的財務和商業領導經驗，這兩者都是實現股東價值提升的重要組成部分。

I would now like Jim to introduce himself to you all and give a reason or two for joining the Xenetic team.

現在我想讓 Jim 向大家介紹自己，並提出加入 Xenetic 團隊的一兩個理由。

Thank you, Scott. It is great to be joining such a great team here at Xenetic at such an exciting time in the Company's evolution.

謝謝你，斯科特。在公司發展如此令人興奮的時刻，能夠加入 Xenetic 如此優秀的團隊真是太棒了。

The business model is very compelling and I believe there is tremendous opportunity to unlock significant value. I also believe that my extensive background and approach to financial management will be complementary to the management team's expertise as we have opportunities in front of us to accelerate our business strategy.

這種商業模式非常引人注目，我相信它蘊藏著巨大的機會來釋放巨大的價值。我也相信，我豐富的財務管理背景和方法將與管理團隊的專業知識相輔相成，因為我們面前有機會加速我們的業務策略。

Importantly, I am humbled to be part of a Company that could have a significant impact on people's lives as we advance XBIO-101 to provide solutions where there remain significant unmet need in treating cancers. I look forward to working with this impressive team and Board of Directors from both a strategic and financial perspective to execute our strategy and drive shareholder value.

重要的是，我很榮幸能夠成為一家可能對人們的生活產生重大影響的公司的一員，因為我們推進 XBIO-101 以提供治療癌症方面仍未滿足的重大需求的解決方案。我期待從策略和財務角度與這個出色的團隊和董事會合作，執行我們的策略並推動股東價值。

With that I will turn it back to Scott.

說完這些，我就把話題轉回給史考特。

Thank you, Jim, and welcome aboard again. I would also like to thank Joe Frattaroli, who has been our contract CFO, for his hard work and dedication the last two years.

謝謝你，吉姆，歡迎再次加入。我還要感謝我們的合約財務長喬·弗拉塔羅利 (Joe Frattaroli) 在過去兩年中的辛勤工作和奉獻精神。

As of December 31, 2016, Xenetic had $4 million in cash and cash equivalents. This is excluding the Shire milestone payment, so we have capital to hit on our Q2 clinical and license inflection points, including the Phase 2A data readout from Shire.

截至 2016 年 12 月 31 日，Xenetic 擁有 400 萬美元的現金和現金等價物。這還不包括 Shire 的里程碑付款，因此我們有資金來實現第二季度的臨床和許可拐點，包括 Shire 的 2A 階段數據讀數。

Now the NASDAQ listing enables us access to a whole pool of capital that we did not have previously and this is from groups of investors called fundamental investors that are the real drivers of shareholder value in the biotech world. This is important since, in all likelihood, we will be seeking to access the capital markets over the course of this year.

現在，在納斯達克上市使我們能夠獲得以前沒有的大量資金，這些資金來自被稱為基本面投資者的投資者群體，他們是生物技術領域股東價值的真正驅動力。這很重要，因為我們很可能會在今年尋求進入資本市場。

Now the three-headed execution strategy on creating shareholder value is being opportunistic in evaluating strategic financing options, potential licensing revenue from existing shareholder relationships, and leverage the positive data to execute more PolyXen-like partnerships for our drug delivery platform technology.

現在，創造股東價值的三頭執行策略正在機會主義地評估策略性融資選擇、現有股東關係的潛在許可收入，並利用積極數據為我們的藥物傳輸平台技術建立更多類似 PolyXen 的合作夥伴關係。

Now the business model is, quite simply, leverage off of the platform technology to seek or leverage non-dilutive capital to execute further Serum Institute of India-like deals. So Shire and Serum Institute of India-like deals is what we seek further from our platform technology. And this is to find our proprietary oncology pursuits, our therapeutic developments, with the end goal of leading to a market launch on the oncology programs. So that is the main business strategy for the Company.

現在的商業模式很簡單，利用平台技術來尋求或利用非稀釋性資本來執行類似印度血清研究所的進一步交易。因此，我們進一步尋求從平台技術中獲得類似 Shire 和印度血清研究所的交易。這是為了找到我們專有的腫瘤學研究和治療發展，最終目標是將腫瘤學課程推向市場。這就是公司的主要業務策略。

I would now like to hand over to our COO, Jeff Eisenberg, to provide an update on ErepoXen and Shire. Jeff?

現在，我想將時間交給我們的營運長 Jeff Eisenberg，來提供有關 ErepoXen 和 Shire 的最新情況。傑夫？

Thank you, Scott. To follow on Scott's point, we now have a business model and strategy that truly positions Xenetic for substantial growth. As part of our ongoing strategic review, our team engaged in a concerted effort late last year to refine our strategy, recognizing that applying our resources to only the highest value projects and focusing on execution would be beneficial internally and would be attractive to potential fundamental investors.

謝謝你，斯科特。根據史考特的觀點，我們現在有了真正讓 Xenetic 大幅成長的商業模式和策略。作為我們正在進行的策略審查的一部分，我們的團隊在去年年底齊心協力完善我們的策略，認識到將我們的資源僅應用於最高價值的項目並專注於執行將對內部有利，並對潛在的基本面投資者俱有吸引力。

So now, especially for our long-term shareholders, I would like to provide an update on our polysialylated EPO project, ErepoXen, being developed for the treatment of anemia and chronic kidney disease.

因此現在，特別是針對我們的長期股東，我想提供有關我們的聚唾液酸化 EPO 項目 ErepoXen 的最新信息，該項目正在開髮用於治療貧血和慢性腎病。

After completing three patient cohorts of our Phase 2 clinical trial and following our November fundraise, we decided to focus our efforts where we believe we can best add value and that is on our lead internal candidate, XBIO-101, which will be reviewed later in this call and about which we are really excited. The ErepoXen project was always intended to be an out-license opportunity. And we feel we have sufficient data with our three completed cohorts to attract a partner, if there is a partner to be found.

在完成 2 期臨床試驗的三組患者並在 11 月籌集資金後，我們決定將精力集中在我們認為能夠最大程度增加價值的領域，那就是我們的主要內部候選藥物 XBIO-101，我們將在本次電話會議的稍後部分對其進行審查，我們對此感到非常興奮。ErepoXen 專案始終旨在成為一個對外授權的機會。我們認為，如果有合作夥伴的話，我們已完成的三個隊列有足夠的數據來吸引合作夥伴。

We have shown that our technology works. We see a dose response that corrects hemoglobin levels with extended half-life in CKD patients, which is exactly what we set out to demonstrate. Meanwhile, our strategic partners and shareholders, Pharmsynthez and Serum Institute of India, continue to pursue development in their markets and if they are successful, we would earn royalties from their sales.

我們已經證明我們的技術是有效的。我們觀察到劑量反應可以糾正 CKD 患者的血紅素水平並延長半衰期，這正是我們想要證明的。同時，我們的策略合作夥伴和股東 Pharmsynthez 和印度血清研究所繼續在其市場中尋求發展，如果他們取得成功，我們將從他們的銷售中獲得版稅。

Now I will turn to PolyXen and our collaboration with Shire on SHP656, or polysialylated Factor VIII. Shire continues to advance this important project which is completing its Phase 1/2 study. We expect top-line data from Shire in Q2 of this year.

現在我將談談 PolyXen 以及我們與 Shire 在 SHP656（即聚唾液酸化因子 VIII）的合作。Shire 繼續推進這項重要項目，即將完成第一/第二階段的研究。我們預計 Shire 將在今年第二季公佈營收數據。

Scott and the Xenetic team have done an amazing job with this partnership which started with Baxter and then migrated to Baxalta and now Shire. One of the reasons we are all so excited about this opportunity is that we really believe we have the right product for the right market with the right partner at the right time.

史考特和 Xenetic 團隊在這次合作中做得非常出色，合作始於 Baxter，然後轉移到 Baxalta，現在又轉移到 Shire。我們對這個機會如此興奮的原因之一是，我們真的相信我們在正確的時間與正確的合作夥伴一起為正確的市場提供了正確的產品。

Our agreement with Shire covers a series of novel polysialylated blood coagulation factors, including SHP656, that utilize our proprietary PolyXen delivery system. Shire is the market leader in the category with well over $3 billion in sales and the market is substantial. By the time SHP656 is launched the global hemophilia A market should exceed $10 billion.

我們與 Shire 的協議涵蓋一系列新型聚唾液酸化凝血因子，包括 SHP656，這些因子利用我們專有的 PolyXen 輸送系統。Shire 是該類別的市場領導者，銷售額超過 30 億美元，市場規模龐大。到 SHP656 推出時，全球血友病 A 市場規模應超過 100 億美元。

In addition to being a great strategic partner, Shire is also a significant investor in Xenetic, having invested $13 million to date.

Shire 除了是 Xenetic 的優秀策略合作夥伴之外，也是 Xenetic 的重要投資者，迄今已投資 1,300 萬美元。

I already mentioned that Shire is completing a Phase 1/2 trial and that data readout is expected in Q2. If the trial is successful, we expect Shire to move into a Phase 3 trial this calendar year, at which point we believe there will be much more visibility into this project and its potential impact on Xenetic from our existing shareholders as well as prospective investors. And this is one of the main reasons that that this year could be transformational for Xenetic.

我已經提到 Shire 正在完成第 1/2 階段試驗，預計數據將在第二季公佈。如果試驗成功，我們預計 Shire 將在今年進入第三階段試驗，屆時我們相信現有股東和潛在投資者將對該項目及其對 Xenetic 的潛在影響有更深入的了解。這也是今年對 Xenetic 來說可能具有變革意義的主要原因之一。

Shire's objective for SHP656 is to develop a once-weekly or even less frequently dosed Factor VIII product, and I will discuss the significance of that in a moment.

Shire 對 SHP656 的目標是開發一種每週一次甚至更少劑量的第八因子產品，稍後我將討論其重要性。

The terms of our deal are quite meaningful for a Company of our size: up to $100 million in milestones and approximately high single-digit royalties on sales. We received our first clinical milestone payment of $3 million earlier this year.

對於我們這種規模的公司來說，交易條款意義重大：高達 1 億美元的里程碑付款和大約個位數的銷售特許權使用費。今年早些時候，我們收到了第一筆 300 萬美元的臨床里程碑付款。

The data shown here will help explain our optimism about the prospects for a successful trial outcome. Presented here are preclinical data for Advate, Baxter's original Factor VIII molecule; Adynovate, the next-generation pegylated version; and SHP656. As you can see clearly there is a consistent, positive trend in mean residence time from the rodent to the primate model in all three products, with SHP656 being the longest, and a similarly positive trend in humans for Advate and Adynovate. If that trend continues in the pending trial, we think there is a good chance that we will have helped Shire achieve its objective of once-weekly dosing.

這裡顯示的數據將有助於解釋我們對成功試驗結果前景的樂觀態度。這裡介紹的是 Baxter 原始因子 VIII 分子 Advate 的臨床前數據； Adynovate，下一代聚乙二醇化版本；和 SHP656。您可以清楚地看到，這三種產品從囓齒動物到靈長類動物模型的平均停留時間呈現出一致的正向趨勢，其中 SHP656 最長，而 Advate 和 Adynovate 在人類中也呈現出類似的正向趨勢。如果這一趨勢在即將進行的試驗中繼續保持，我們認為我們很有可能幫助 Shire 實現每週一次給藥的目標。

The next slide presents the competitive landscape in hemophilia A, the market targeted by SHP656. Shire believes that frequency of dosing is and will continue to be a key differentiator in this large global market. And a take away from this chart is that there is no product on the market for this indication that is labeled to be dosed once per week.

下一張投影片展示了 SHP656 所針對的血友病 A 市場的競爭格局。Shire 認為，給藥頻率是並將繼續成為這個龐大的全球市場中的關鍵差異化因素。從這張圖表可以看出，市面上沒有針對此種症狀的產品標示每週服用一次。

ACE-910 has the potential to dose weekly, but that product has faced some very well-publicized safety challenges in the clinic. So we feel that if our product works as intended, then Shire will be very well positioned to compete in this market and perhaps even grow its share over time.

ACE-910 有可能每週服用一次，但該產品在臨床上面臨一些廣為人知的安全挑戰。因此我們認為，如果我們的產品能夠達到預期的效果，那麼 Shire 將在這個市場上佔據非常有利的競爭地位，甚至可能隨著時間的推移擴大其份額。

Now I'd like to step back and talk more broadly about our PolyXen technology and our strategy to exploit it. In the four months since I joined the Xenetic management team I have grown increasingly enthusiastic about this platform. The PolyXen platform has significant potential across a wide range of biologics and the potential to create products that can make a real impact in their markets. In that sense, we expect PolyXen to be a significant growth driver for us for years to come and our plans include aggressive business development efforts to expand our collaboration pipeline.

現在我想退一步，更廣泛地談談我們的 PolyXen 技術以及我們利用它的策略。加入 Xenetic 管理團隊四個月以來，我對這個平台的熱情與日俱增。PolyXen 平台在廣泛的生物製劑領域具有巨大潛力，並有可能創造出能夠對其市場產生真正影響的產品。從這個意義上講，我們預計 PolyXen 將在未來幾年成為我們重要的成長動力，我們的計劃包括積極的業務發展努力以擴大我們的合作管道。

In that regard, we believe that success of SHP656 would further validate our technology and help to accelerate our partnering efforts. Our goal is to enter into more early-stage collaborations, leading to demonstration of feasibility and, ultimately, to additional Shire-like license deals. We do have feasibility work ongoing and, even though these are not announceable events, they could lead to more announceable events and potential value drivers as we move forward.

在這方面，我們相信 SHP656 的成功將進一步驗證我們的技術並有助於加速我們的合作努力。我們的目標是進行更多早期合作，以證明可行性，並最終達成更多類似 Shire 的授權協議。我們確實正在進行可行性工作，儘管這些不是可宣布的事件，但隨著我們前進，它們可能會帶來更多可宣布的事件和潛在的價值驅動因素。

For the reasons Scott covered earlier, we do feel that this technology has tremendous value with or without SHP656. We have compelling human data in a number of different compounds, including the ErepoXen data I described earlier. So we feel that we have the right pieces in place to effectively advance this technology and use it to drive growth and provide non-dilutive capital.

由於 Scott 先前提到的原因，我們確實認為無論有沒有 SHP656，這項技術都具有巨大的價值。我們擁有多種不同化合物的令人信服的人類數據，包括我之前描述的 ErepoXen 數據。因此，我們認為我們已經具備了適當的條件來有效地推進這項技術，並利用它來推動成長和提供非稀釋性資本。

And with that I'm going to turn the call over to Dr. Curt Lockshin, our Chief Scientific Officer, to discuss XBIO-101.

接下來，我將把電話轉給我們的首席科學官 Curt Lockshin 博士，討論 XBIO-101。

Thank you, Jeff. I am pleased today to provide an update on XBIO-101, Xenetic's lead internal product candidate.

謝謝你，傑夫。今天我很高興提供有關 Xenetic 的主要內部候選產品 XBIO-101 的最新消息。

Since we obtained the asset in 2015, our internal team has been working with outside advisers and key opinion leaders to execute on development plans which will give us the best chance for successful clinical outcomes in various oncology settings. Drugs that target hormone receptors can be an effective tool against certain cancers. Prime examples would be progestins that target the progesterone receptor or tamoxifen, which targets the estrogen receptor.

自 2015 年獲得該資產以來，我們的內部團隊一直與外部顧問和關鍵意見領袖合作執行開發計劃，這將使我們在各種腫瘤學環境中獲得成功臨床結果的最佳機會。針對荷爾蒙受體的藥物可以成為對抗某些癌症的有效工具。主要的例子是針對黃體素受體的黃體素或針對雌激素受體的他莫昔芬。

However, patients whose tumor tissues lack those relevant receptors are not candidates for hormone receptor-targeted therapy. Well-known examples would include progesterone receptor-negative endometrial tumors, which lack the progesterone receptor, and triple negative breast cancer tumors, which lack all three of the progesterone, estrogen, and HER2 receptors.

然而，腫瘤組織缺乏相關受體的患者不適合接受荷爾蒙受體標靶治療。眾所周知的例子包括黃體素受體陰性子宮內膜腫瘤（缺乏黃體素受體）和三陰性乳癌腫瘤（缺乏黃體素、雌激素和 HER2 受體）。

Our objective with XBIO-101 is to increase levels of hormone receptors and tumor tissues in order to render them sensitive to hormone therapies. XBIO-101 is currently the subject of a Phase 2 study in progesterone-resistant endometrial cancer and in addition, consistent with our guidance at the end of 2016, we recently filed a protocol for a biomarker study of XBIO-101 in triple negative breast cancer.

我們對 XBIO-101 的目標是提高荷爾蒙受體和腫瘤組織的水平，以使它們對荷爾蒙療法敏感。XBIO-101 目前是孕酮抗性子宮內膜癌 2 期研究的主題，此外，根據我們 2016 年底的指導，我們最近提交了 XBIO-101 在三陰性乳癌中的生物標記研究方案。

XBIO-101 is essentially a derisked repurposing opportunity. Its use outside the US has provided over 20 years of market history and surveillance from over 10 million doses sold in these territories, as well as safety and tolerability data from the supporting clinical trials. Given its known mechanism of action as an interferon inducer, its primary use has been for certain infectious diseases and other conditions where immunomodulation is indicated.

XBIO-101 本質上是一個無風險的再利用機會。該藥物在美國以外的使用已提供了超過 20 年的市場歷史和在這些地區銷售的超過 1000 萬劑的監測，以及來自支持性臨床試驗的安全性和耐受性數據。鑑於其作為幹擾素誘導劑的已知作用機制，其主要用於治療某些傳染病和其他需要免疫調節的疾病。

Importantly, however, in animal models XBIO-101 has been shown to increase levels of the progesterone receptor in receptor-negative endometrial tumors. This and other history is supported our US orphan designation in the treatment of PR-negative endometrial cancers, as well as of course our ongoing Phase 2 IND. Furthermore, we have preclinical evidence suggesting the utility of XBIO-101 in estrogen receptor-negative tumors, such as found in the case of triple negative breast cancer.

然而，重要的是，在動物模型中，XBIO-101 已被證明可以增加受體陰性子宮內膜腫瘤中的孕酮受體水平。這段歷史和其他歷史支持了我們在治療 PR 陰性子宮內膜癌方面獲得美國孤兒藥稱號，當然還有我們正在進行的 2 期 IND。此外，我們有臨床前證據表明 XBIO-101 在雌激素受體陰性腫瘤中具有效用，例如在三陰性乳癌中發現的。

Endometrial cancer is the most invasive gynecological cancer in the United States with around 60,000 cases diagnosed annually. Early-stage tumors can often be treated successfully with surgery or radiotherapy, but late stage and recurrent disease, about 20% of the diagnosis, carries more negative prognosis, fewer treatment alternatives, and it represents a dire unmet medical need with no FDA approved therapies for these patients. We are, therefore, enthusiastic about the potential role for XBIO-101 in these settings where there remains significant shortcomings in treatment options.

子宮內膜癌是美國最具侵襲性的婦科癌症，每年約有 6 萬例被診斷出來。早期腫瘤通常可以透過手術或放射療法成功治療，但晚期和復發性疾病（約佔診斷的 20%）預後更差，治療選擇更少，並且代表著迫切的未滿足的醫療需求，目前尚無 FDA 批准針對這些患者的治療方法。因此，我們對 XBIO-101 在這些治療方案仍存在重大缺陷的環境中發揮的潛在作用充滿熱情。

The Venn diagram on the next slide shows the US prevalence of these various patient groups. Around 20%, or 130,000 patients, are late stage, recurrent, or metastatic. Our orphaned-designated population, around 65,000 receptor-negative patients, are predominantly found in this category.

下一張投影片中的維恩圖顯示了美國不同患者群體的盛行率。約有 20%（即 13 萬名患者）處於晚期、復發性或轉移性狀態。在我們的孤兒指定族群中，約有 65,000 名受體陰性患者，主要屬於這一類。

Also within the late-stage population are nonresponders to progestin therapy, irrespective of receptor status, per se. In some cases, for example, this might be the result of desensitization by prior hormone therapy. If XBIO-101 is able to sensitize, or re-sensitize these patients as the case may be, to progestin therapy, they might potentially also be part of XBIO-101's addressable population, which we view as an exciting opportunity in and of itself.

此外，晚期患者中也有人對黃體素治療無反應，無論其受體狀態為何。例如，在某些情況下，這可能是先前荷爾蒙治療脫敏的結果。如果 XBIO-101 能夠使這些患者對黃體素療法敏感，或者根據具體情況重新敏感，他們也可能成為 XBIO-101 的目標群體的一部分，我們認為這本身就是一個令人興奮的機會。

Our Phase 2 endometrial cancer trial in the United States calls for enrollment of approximately 72 patients at up to 50 clinical sites with a one-year treatment period of XBIO-101 with progestin therapy, followed by a one-year surveillance period. It is designed to treat receptor-negative patients directly with an XBIO-101 progestin combination, as well as to identify other nonresponders who may then be entered into the combination regimen.

我們在美國進行的 2 期子宮內膜癌試驗需要在多達 50 個臨床地點招募約 72 名患者，進行為期一年的 XBIO-101 聯合孕激素治療，然後進行為期一年的監測期。其設計目的是利用 XBIO-101 黃體素組合直接治療受體陰性患者，並識別出其他可能進入合併治療方案的無反應患者。

To summarize, we are in the process of activating our Phase 2 trial of XBIO-101 with progestin therapy in endometrial cancer and we're on track to commence patient dosing this quarter. We expect to report interim data before the end of 2018.

總而言之，我們正在啟動 XBIO-101 與黃體素治療子宮內膜癌的 2 期試驗，並且預計本季開始對患者進行給藥。我們預計將在 2018 年底前報告中期數據。

And as I have stated, we've also submitted a protocol to the US FDA for a biomarker study of XBIO-101 in triple negative breast cancer patients. This is designed to determine the effect of XBIO-101 on the levels of hormone receptors, in this case including the estrogen receptor.

正如我所說，我們也向美國 FDA 提交了一份針對三陰性乳癌患者進行 XBIO-101 生物標記研究的方案。這是為了確定 XBIO-101 對荷爾蒙受體水平的影響，在本例中包括雌激素受體。

We are excited to be advancing our internal XBIO-101 programs forward and believe 2017 will be filled with meaningful progress on the clinical development front. Thank you, I will now hand the conversation back over to Scott.

我們很高興能夠推進我們內部的 XBIO-101 項目，並相信 2017 年將在臨床開發方面取得有意義的進展。謝謝，現在我將話題交還給史考特。

Thank you, Curt, and also thank you, Jeff, both of you, for detailing these exciting programs.

謝謝 Curt，也謝謝 Jeff，你們兩位詳細介紹了這些令人興奮的節目。

Now the expected near-term milestones, which you may well agree could be transformational for any one of these as a standalone. However, we have three such near-term milestones coming up in Q2 only and that is the commencement of recruitment for our Phase 2 clinical study for XBIO-101 and the subsequent dosing relating to that study; the announcement of top-line data from Shire for their Phase 1/2A study in Q2 as well; and hopefully, receiving a milestone payment from Shire if the endpoints are achieved in the Phase 1/2A study. This would then move into a Phase 3 study the second half of this year. If the results are positive, we seek to leverage this relationship to execute more PolyXen partnerships that reflecting of the economics of the Shire license deal.

現在預期的近期里程碑，您可能會同意，對於其中任何一個獨立的事情來說，都可能具有變革性。然而，我們在第二季度就有三個這樣的近期里程碑，那就是開始招募 XBIO-101 的第二階段臨床研究以及與該研究相關的後續劑量； Shire 也公佈了其第二季度 1/2A 期研究的頂線數據；如果 1/2A 階段研究達到終點，預計將收到 Shire 的里程碑付款。這將在今年下半年進入第三階段研究。如果結果是正面的，我們將尋求利用這種關係來執行更多的 PolyXen 合作夥伴關係，以反映 Shire 授權協議的經濟效益。

We believe we have a very compelling investment opportunity: PolyXen, which is the drug delivery technology, one of the most versatile drug delivery technologies known to man without the subsequent adverse events. We would expect to drive significant growth going forward. We currently have four molecules in clinical development, under license, utilizing this technology.

我們相信我們有一個非常引人注目的投資機會：PolyXen，這是一種藥物輸送技術，是人類已知的最通用的藥物輸送技術之一，並且不會產生後續不良事件。我們期望未來能夠實現顯著成長。目前，我們有四種分子正在獲得許可，利用該技術進行臨床開發。

Of course, we have the Shire relationship, which could yield significant milestones and royalties in the near term in the biotech world. And our lead program, XBIO-101, in Phase 2 clinical studies for the treatment of endometrial cancer, as well as the pending FDA clearance of the clinical protocol for triple negative breast cancer.

當然，我們與 Shire 建立了合作關係，這可能在短期內為生物技術領域帶來重大的里程碑和專利費。我們的主導計畫 XBIO-101 正在進行子宮內膜癌治療的 2 期臨床研究，其針對三陰性乳癌的臨床方案也正在等待 FDA 的批准。

Now we have additional technologies and programs that have already been clinically vetted through our shareholder partnerships. Seven molecules covering nine different therapeutic areas have reported some form of clinical results, whether that is Phase 1 or Phase 2, whereby Xenetic owns all rights in the large markets, Europe and the United States. And these are ready for advancements in Europe and the United States as clinically-vetted molecules as resources allow.

現在，我們擁有更多已經透過股東合作夥伴關係進行臨床審查的技術和項目。涵蓋九個不同治療領域的七種分子均已報告了某種形式的臨床結果，無論是第 1 階段還是第 2 階段，Xenetic 擁有歐洲和美國等大型市場的所有權利。在資源允許的情況下，這些藥物已準備好作為經過臨床審查的分子在歐洲和美國推進。

2017 has started to be a transformational year and we expect to continue this trend with significant positive pipeline advancements.

2017 年已成為轉型之年，我們預計這一趨勢將持續延續，並在管道方面取得重大積極進展。

Now I would like to turn over to the operator, Michelle, for any questions that you may have.

現在我想把話務員米歇爾 (Michelle) 交給她，回答你們的任何問題。

(Operator Instructions) Kevin DeGeeter, Ladenburg Thalmann.

（操作員指示）Kevin DeGeeter，Ladenburg Thalmann。

Hi, this is Jay Colby on the line for Kevin. Thanks for the questions. I guess first, how should we think about the pace of enrollment for the endometrial studies of XBIO-101? And then when could we see potential data from the triple negative breast cancer biomarker trial?

大家好，我是傑伊‧柯比 (Jay Colby)，找凱文 (Kevin)。感謝您的提問。我想首先，我們該如何考慮XBIO-101子宮內膜研究的招募速度？那我們什麼時候可以看到三陰性乳癌生物標記試驗的潛在數據？

That is a good question, Jay, and I am going to hand that over to Dr. Curt Lockshin, who detailed the XBIO-101 program.

傑伊，這是個好問題，我將把這個問題交給詳細介紹 XBIO-101 計劃的 Curt Lockshin 博士。

Thanks for the question. The pace of enrollment will be determined in the early going, I believe. There are a lot of variables that play into that. The pace can obviously increase -- be increased by opening up more sites as needed, so we have the ability to dynamically do that as time goes on.

謝謝你的提問。我相信，招生速度將在早期確定。有很多變數會影響這個結果。顯然，速度可以加快——透過根據需要開放更多網站來加快速度，因此我們有能力隨著時間的推移動態地做到這一點。

As I indicated, we expect to be able to report interim data towards the end of 2018, which means essentially that we would anticipate enrollment, full enrollment, taking on the order of one year.

正如我所指出的，我們預計能夠在 2018 年底報告中期數據，這基本上意味著我們預計入學人數、全部入學人數將需要一年的時間。

As far as the triple negative work, the start of that is really dependent on current available resources. But (multiple speakers) the biomarker study, of course, would be a much shorter proposition since it requires a shorter period of dosing and a much more rapid read out and better recruitment of TNBC patients as compared to late-stage endometrial.

就三重負面工作而言，其啟動實際上取決於目前可用的資源。但（多位發言者）生物標記研究當然會是一個更短的提議，因為與晚期子宮內膜癌相比，它需要更短的給藥時間、更快速的讀取和更好地招募 TNBC 患者。

Okay, great. So I guess for the interim analysis on endometrial that is from the full 72 patients, or is that from (multiple speakers)?

好的，太好了。所以我猜測子宮內膜的中期分析是來自全部 72 位患者，還是來自（多位發言者）？

Sorry to interrupt; no, that would be from approximately half of the patients.

抱歉打擾了；不，大約一半的患者都是如此。

Okay, great. And then I guess lastly for me, with the appointment of -- with the announcement of Jim as the CFO today, is your senior management team fleshed out at this point or do you see more hires down the road?

好的，太好了。最後，我想對我來說，隨著吉姆今天被任命為財務官，您的高階管理團隊是否已經充實，或者您認為未來會聘用更多員工？

Well, we have now added three C-level positions in the last four months, so I think the Company is perfectly placed now with a corporate structure ready to execute on all the value initiatives, as outlined in our presentation today.

嗯，我們在過去四個月中增加了三個 C 級職位，所以我認為公司現在已做好完美的企業結構準備，可以執行所有價值計劃，正如我們今天的演示中概述的那樣。

All right, thank you. That is it for me.

好的，謝謝。對我來說就是這樣。

(Operator Instructions) There are no further questions at this time. I would like to turn the call back over to Mr. Scott Maguire for closing remarks.

（操作員指示）目前沒有其他問題。我想將電話轉回給史考特·馬奎爾先生，請他做最後發言。

Thank you, Michelle, and thank you to the Xenetic team as well. This is -- as I said previously, this has started out to be a transformational year and we expect to continue this trend over the course of 2017. We look forward to communicating with you on a quarterly basis with these earnings calls. Now that we have this established as a firm routine with Jenene Thomas and her crew, we are looking forward to get more news coming up over Q2 which we have -- just to remind you, is the Shire data readout, the commencement of the endometrial cancer trial, and the triple negative breast cancer biomarker study moving to approval.

謝謝你，米歇爾，也感謝 Xenetic 團隊。正如我之前所說，這是轉型的一年，我們預計 2017 年將繼續保持這一趨勢。我們期待透過這些季度收益電話會議與您溝通。現在，我們已經與 Jenene Thomas 和她的團隊建立了固定的例行程序，我們期待在第二季度獲得更多新聞——只是提醒您，Shire 數據讀數、子宮內膜癌試驗的開始以及三陰性乳腺癌生物標誌物研究即將獲得批准。

So thank you very much again for your time today and we look forward to updating you in another quarter.

再次非常感謝您今天的抽出時間，我們期待在下一個季度向您更新最新情況。

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.

謝謝。今天的電話會議到此結束。現在您可以斷開線路。感謝您的參與並祝您有美好的一天。