TuHURA Biosciences Inc (HURA) 2015 Q4 法說會逐字稿

Good morning and welcome to the DelMar Pharma's business update. My name is Jordan and I will be facilitating the audio portion of today's interactive broadcast. (Operator Instructions)

早安，歡迎收聽 DelMar Pharma 的業務更新。我叫喬丹，將負責今天互動直播的音訊部分。 （操作員指示）

At this time I would like to turn the show over to Jenene Thomas, Investor Relations. You may begin.

現在，我想把節目交給投資者關係部的 Jenene Thomas。您可以開始啦。

Thank you, Jordan, and thank you all for joining us this morning for DelMar Pharma's quarterly business update conference call to discuss the Company's financial results for the fiscal year ending June 30, 2015, recent corporate highlights, and goals for the upcoming year.

謝謝喬丹，也謝謝大家今天早上參加 DelMar Pharma 的季度業務更新電話會議，討論公司截至 2015 年 6 月 30 日的財政年度的財務業績、近期的公司亮點以及來年的目標。

Today's call and webcast will be accompanied by a slide presentation that can be found on the Company's website. If you haven't done so already, you can access the presentation at www.DelMarPharma.com on the home page under Latest News.

今天的電話會議和網路直播將附帶幻燈片演示，可在公司網站上查看。如果您尚未訪問，請登入 www.DelMarPharma.com 主頁的「最新消息」欄位查看。

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 provisions of the federal securities laws. Information contained in the forward-looking statements is based on current expectations and is subject to change, and actual results may differ materially from the forward-looking statements. As a result, you should not place undue reliance on any forward-looking statements.

在此，我想提醒各位聽眾，本次電話會議的言論可能顯示管理階層的意圖、希望、信念、期望或對未來的預測。這些前瞻性陳述包含風險和不確定性。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。前瞻性陳述中包含的資訊是基於當前預期，可能會發生變化，實際結果可能與前瞻性陳述有重大差異。因此，您不應過度依賴任何前瞻性陳述。

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 DelMar Pharma files with the SEC from time to time. These documents are available on the Company's corporate website and the SEC website, and we encourage you to review these documents carefully.

一些可能導致實際結果與此類前瞻性陳述預期結果存在重大差異的因素已在 DelMar Pharma 不時向美國證券交易委員會 (SEC) 提交的定期報告中進行了討論。這些文件可在公司網站和 SEC 網站上查閱，我們建議您仔細閱讀。

Joining me on the call today are Jeffrey Bacha, DelMar Pharma's President and CEO; Scott Praill, the Company's CFO; and Dr. Dennis Brown, the Company's co-founder and Chief Scientific Officer. Following the prepared remarks we will then open the conference call up for a question-and-answer session. It is now my pleasure to turn the call over to Jeff Bacha.

今天與我一起參加電話會議的嘉賓有：DelMar Pharma 總裁兼執行長 Jeffrey Bacha、公司財務長 Scott Praill 以及公司聯合創始人兼首席科學官 Dennis Brown 博士。在準備好的發言之後，我們將進入電話會議問答環節。現在，我很高興將電話會議交給 Jeff Bacha。

Thank you, Jenene; and thank you, everybody, for taking the time to hear the update today and our plans for going into and through the next fiscal year. As we go through the slides, hopefully you have had a chance to download them from our website, and we'll prompt you to follow along.

謝謝Jenene！也感謝各位抽出時間聆聽今日的更新，以及我們下一財年的計畫。在我們播放投影片的過程中，希望您已經從我們的網站下載了投影片，我們會提醒您繼續觀看。

This is the business update call for September 4, 2015. The second slide obviously is reiterating the forward-looking statements call.

這是 2015 年 9 月 4 日的業務更新電話會議。第二張投影片顯然重申了前瞻性陳述電話會議。

Just going to slide 3 here, it's talking about some of the very big-picture recent corporate momentum, including our significant scientific and clinical research progress with our lead program. I thought as we got into the discussion I would let Dennis Brown, our Chief Scientific Officer, make a couple of remarks in terms of his vision and view of the progress that we've made during the year. Dennis?

就來看第三張投影片，它談到了近期公司發展的一些宏觀動態，包括我們主導計畫在科學和臨床研究方面取得的重大進展。我想，既然我們進入了討論階段，我想請我們的首席科學官丹尼斯·布朗談談他對我們今年取得的進展的願景和看法。丹尼斯？

Great, thanks, Jeff. Good morning, everyone; and again, thanks for joining on.

太好了，謝謝，傑夫。大家早安！再次感謝大家的參與。

We've had a really, I think, a terrific year in terms of moving the project forward both clinically and in the laboratory. I'd just give you a couple little highlights. I think you're probably aware of some of the progress, but just want to reiterate some of the key points.

我認為，就計畫在臨床和實驗室的進展而言，我們度過了非常棒的一年。我只想簡單介紹幾個要點。我想你們可能已經了解了一些進展，但我還是想重申關鍵點。

As you know, we've been focusing on VAL-083 for the treatment of patients with brain cancer, GBM, who have really failed all forms of other therapy. Over the last bit of time we've been working our way up in a Phase I dose-escalation study to determine the maximum tolerated dose for patients who have failed Temodar, they've been surgical failures, radiation failures, and have failed Avastin.

如您所知，我們一直專注於VAL-083，用於治療腦癌（膠質母細胞瘤）患者，這些患者已接受過所有其他療法但均告失敗。最近一段時間，我們一直在進行I期劑量遞增研究，以確定替莫唑胺（Temodar）、手術失敗、放療失敗以及阿瓦斯汀（Avastin）治療失敗的患者的最大耐受劑量。

At ASCO we had a chance to report the data that we had reached the maximum tolerated dose and that the side effect profile was as predicted: primarily just thrombocytopenia, platelet; and that those platelet reductions were relatively rapid return to relatively normal levels. So we got to achieve a very high dose -- higher than we expected, at least in my opinion -- and that the side-effect profile was predictable and as discussed or it has been identified over the years by NCI and the literature.

在ASCO年會上，我們有機會報告數據，顯示我們已達到最大耐受劑量，且副作用情況與預期一致：主要表現為血小板減少和血小板減少；這些血小板減少量相對較快地恢復到相對正常的水平。因此，我們達到了非常高的劑量——至少在我看來，這比我們預期的要高——而且副作用情況是可以預測的，正如NCI和文獻多年來討論或確認的那樣。

So while we were able to report that at ASCO, there were other findings that we had described, including the trending that patients were surviving longer as they reach the higher doses. This is obviously early days, but very exciting for us as we move into the expansion phase.

因此，雖然我們能夠在ASCO大會上報告這一點，但我們之前也描述了其他一些發現，包括患者接受更高劑量治療後生存時間更長的趨勢。這顯然還處於初期階段，但隨著我們進入擴展階段，這對我們來說非常令人興奮。

And there were some other features about the study in terms of -- as we dug back into the data -- finding that not only did patients fail conventional therapies, but in most cases they had already been treated with an experimental therapy and progressed through that. So we are moving forward towards the expansion phase, heading towards the registration-directed studies that we've been talking about with you for the last period of time. That has been moving forward at, I think, a very good pace, and we're excited about the progress we've made.

這項研究還發現了其他一些特點——深入研究數據後，我們發現，患者不僅對常規療法無效，而且大多數情況下，他們已經接受過實驗性療法並取得了進展。因此，我們正在推進擴展階段，朝著我們之前與您討論過的註冊導向研究邁進。我認為，這項工作進展非常順利，我們對所取得的進展感到非常興奮。

But additionally, we started to speak about the other opportunities for this product, not only in GBM, where we can be in the refractory setting, but in the upfront and potentially alter the way patients are treated relative to Temodar, based on MGMT status. That's moving forward, and Jeff will probably speak to that in a few minutes, but we've been expanding the utility of the compound into other indications.

此外，我們開始討論該產品的其他應用前景，不僅局限於膠質母細胞瘤（GBM），我們可以將其應用於難治性治療，而且可以作為前期治療，並可能根據MGMT的狀態，改變患者相對於替莫唑胺的治療方式。這正在推進，Jeff可能稍後會談到這一點，但我們一直在拓展該化合物在其他適應症中的應用。

At AACR and going forward -- actually at a meeting coming up next week in Denver -- at the lung cancer conference we started to speak about the opportunity for this compound to be useful for patients who are resistant to platinum-based therapy for non-small cell lung cancer, and that is the fundamental primary first-line therapy for about 75% of lung cancer patients. The data -- this was in collaboration with MD Anderson -- started to speak about the opportunity for platinum resistance, the opportunity to identify patients even de novo who may have problematic p53 status where platinums don't work very well, and we started to present data, again, in collaboration with MD Anderson.

在AACR以及之後——實際上是在下週丹佛舉行的一次會議上——在肺癌會議上，我們開始討論這種化合物對鉑類療法耐藥的非小細胞肺癌患者的潛在療效，而鉑類療法是約75%肺癌患者的基本一線治療方案。這些數據——這是與MD安德森癌症中心合作的——開始探討鉑類抗藥性的可能性，以及識別p53狀態可能存在問題、鉑類療法效果不佳的初治患者的可能性。我們再次與MD安德森癌症中心合作，開始展示相關數據。

The balance of the year we'll be at additional scientific meetings presenting additional data in these settings and some other scientific development that's ongoing, not only at MD Anderson but UCSF and up in Vancouver at UBC. I think there will be additional presentations, a number of them, even in the balance of this year.

今年剩下的時間裡，我們會在其他科學會議上展示這些背景下的更多數據，以及其他一些正在進行的科學進展，不僅在MD安德森癌症中心，還在加州大學舊金山分校和溫哥華的UBC癌症中心。我認為今年剩下的時間還會有更多報告，而且會有很多。

So I think with that I'll just turn it back to Jeff and will hope to have some questions at the end.

所以我想我會把它交還給傑夫，並希望最後能有一些問題。

Thanks, Dennis. I think for the audience, the idea is highlighting the breadth and the opportunity of this first compound, VAL-083. What we're seeing in the laboratory and clinically really is realizing the vision that Dennis had initially when he identified the compound and when we started the Company. So during the year we've made significant clinical and research progress with VAL-083, and the majority of the presentation will go through that in some detail.

謝謝，丹尼斯。我想對觀眾來說，這個想法凸顯了首個化合物VAL-083的廣度和潛力。我們在實驗室和臨床上看到的成果，真正實現了丹尼斯最初發現化合物以及我們創立公司時的願景。因此，在這一年中，我們在VAL-083的臨床和研究方面取得了重大進展，本次演講的大部分內容將詳細介紹這一點。

We did top up our balance sheet recently through a registered direct financing of $2.6 million, as well as we've continued to access non-dilutive financing through grant funding. That's really the funding that supports the basic research that has enabled us to continue to peel back the layers of the onion of value and promise for VAL-083 in multiple indications. And, of course, we always keep our eye on a major goal for us of moving to a national stock exchange, which we believe will unlock liquidity and release value for our shareholders as we go forward.

我們最近確實透過260萬美元的註冊直接融資補充了資產負債表，同時我們也繼續透過撥款獲得非稀釋性融資。這些資金真正支持了基礎研究，使我們能夠繼續層層剝開VAL-083在多種適應症中的價值和前景。當然，我們始終關注著一個重要目標：在全國證券交易所上市，我們相信這將在未來釋放流動性，並為股東創造價值。

The next slide, slide 4, really is the evolution of that unlocking of value in VAL-083. If you were to go back in time and look at this same slide two years ago, it would have just said refractory glioblastoma. Last year we started discussing frontline opportunities and a little bit about lung cancer. And now really that mechanism work that has been supported by grant funding and our investment beyond the clinical program in refractory glioblastoma has begun to unlock other areas of significant value.

下一張投影片，也就是第四張投影片，真正展現了VAL-083價值釋放的演變過程。如果你回到兩年前看這張投影片，它只會提到難治性膠質母細胞瘤。去年，我們開始討論第一線治療機會，並略微談到肺癌。現在，這項由撥款和我們在難治性膠質母細胞瘤臨床計畫之外的投資支持的機制研究，已經開始釋放其他具有重大價值的領域。

Next slide. Our first program and target market is refractory glioblastoma. This is a slide that we've had for some time and that's kind of representative of this particular cancer.

下一張投影片。我們的第一個計畫和目標市場是難治性膠質母細胞瘤。這張幻燈片我們已經有一段時間了，它在某種程度上代表了這種特殊的癌症。

Unfortunately, glioblastoma is one of the cancers that's been left behind in all of the progress that's been made in the treatment of cancer in the last 25 years. Glioblastoma is the most common aggressive form of brain cancer. 20 years ago, the median survival was about 15 months from diagnosis, and today it's about 15 months from diagnosis.

不幸的是，膠質母細胞瘤是過去25年來癌症治療領域的所有進展中被遺忘的癌症之一。膠質母細胞瘤是最常見的惡性腦癌。 20年前，確診後的中位存活期約為15個月，而如今也約為15個月。

The reason for that is multifold. Number one, following surgery, it is nearly impossible or impossible for a surgeon to get all of the tumor out of the brain, because of the nature of the tumor and the fact that a resection involving a wide margin of healthy tissue surrounding the malignancy is not possible in the brain. So recurrence following surgery is nearly 100%.

造成這種情況的原因是多方面的。首先，由於腫瘤的性質，以及在腦內切除惡性腫瘤周圍大面積健康組織是不可能的，因此手術後外科醫師幾乎不可能或根本不可能將腫瘤全部切除。因此，手術後復發率幾乎達到100%。

Challenge number two is that the cancer is in the brain, and most drugs do not cross the blood-brain barrier and are unavailable to clinicians to treat this type of cancer. Thirdly -- and most importantly in the context of DelMar Pharmaceuticals -- is that most patients fail the standard of care.

第二個挑戰是癌症發生在腦部，大多數藥物無法穿過血腦屏障，臨床醫生無法獲得治療此類癌症的藥物。第三點——對德爾瑪製藥公司而言，也是最重要的一點——是大多數患者未能達到標準治療標準。

Following surgery, patients will receive a combination of temozolomide or Temodar and radiation, and two-thirds of them have a repair enzyme that causes resistance to that therapy. They fail that therapy. The tumor continues to grow and, unfortunately, the patients succumb.

手術後，患者將接受替莫唑胺或替莫達合併放射治療。其中三分之二的患者體內有一種修復酶，導致對該療法產生抗藥性。這些患者最終無法接受該療法。腫瘤繼續生長，不幸的是，最終患者死亡。

Avastin was approved in 2009 as second-line therapy, but unfortunately on the label it says directly there is no impact on improvement of survival. So most patients who are diagnosed fail the available therapies, and there is nothing available for them.

阿瓦斯汀於2009年獲準作為二線治療藥物，但不幸的是，其標籤上直接註明對改善存活率沒有作用。因此，大多數確診患者在現有療法下均告失敗，因此沒有其他治療方案可供選擇。

Based on the mechanisms of VAL-083 and the historical clinical data in this indication, we believe that we have an opportunity to address this problem. That's the basis on which we started the Company and moved the program of VAL-083 back into clinical trials.

基於VAL-083的機制以及該適應症的歷史臨床數據，我們相信有機會解決這個問題。這正是我們創立公司並將VAL-083計畫重新推進至臨床試驗階段的初衷。

Slide 6 is a little bit of data supporting that where -- the statement at the beginning, which is what you can see in the literature is two-thirds of the patients have a high expression of this MGMT enzyme that causes resistance to standard of care. That enzyme, MGMT, is highly correlated with patient outcomes. If you're a high expresser the chance of the patient surviving for two years beyond diagnosis is less than 10%.

幻燈片6提供了一些數據來支持這一點——正如開頭的陳述，也就是文獻中提到的，三分之二的患者MGMT酶表達水平較高，這會導致對標準治療產生抗藥性。 MGMT酶與患者的預後高度相關。如果患者MGMT酶表現量較高，那麼確診後存活兩年的幾率不到10%。

Now the first place we started in our excitement around VAL-083 was published literature demonstrating activity of VAL-083 against glioblastoma. The second place that got our excitement was the fact that the mechanism of VAL-083 is distinct from temozolomide and other chemotherapies that have shown activity in the disease; and because of that distinct mechanism it is independent of the repair mechanism that causes resistance to standard of care and is the reason that most patients fail and succumb rapidly to the disease.

我們對 VAL-083 感到興奮的首要原因是，已發表的文獻證明了 VAL-083 對抗膠質母細胞瘤的活性。其次，讓我們興奮的是，VAL-083 的作用機制與替莫唑胺和其他已證明對該疾病有效的化療藥物截然不同；正因為這種獨特的機制，它獨立於導致標準治療抗藥性的修復機制，而這種修復機制正是大多數患者治療失敗並迅速死於該疾病的原因。

The data here, what we're showing -- this is some work that was done at the University of California-San Francisco and presented originally at the Society for Neuro-Oncology meeting last year. What you're seeing here is that untreated tumors that were taken from a patient and grown in the laboratory that have a high expression of this MGMT enzyme, if you hit them with 50 milligrams of temozolomide, TMZ, compared to null, untreated control -- and just as an aside, that's 5 times the therapeutic dose -- you see no activity, including in combination with radiation, radiotherapy XRT.

這裡的數據，也就是我們所展示的數據——是加州大學舊金山分校所進行的一些研究成果，最初發表於去年的神經腫瘤學會會議。你們看到的是，從患者體內取出並在實驗室中培養的未經治療的腫瘤，其MGMT酶表達水平較高，如果給它們注射50毫克替莫唑胺（TMZ），與未接受治療的對照組相比——順便說一句，這是治療劑量的5倍——你看不到任何活性，即使與放射療法（XRT）聯合使用也是如此。

What we are -- what that means is that two-thirds of the patients that have been diagnosed with this disease in the last 15 years have had no benefit from standard of care. The tumor has continued to grow. The patient has died.

這意味著，在過去15年裡，三分之二被診斷出患有這種疾病的患者，並沒有從標準治療中受益。腫瘤持續生長，最終導致患者死亡。

What you can see with VAL-083 is that, independent of radiation and in combination with radiation, there is a marked benefit in terms of impact on the tumor and a potentiation and synergy with the radiation at a dose of only 2.5 micromolar, which is well within the range that we achieve in treating this tumor with our dosing regimen. These data and other that we have presented along the way indicate to us that VAL-083 represents a potential paradigm shift in the chemotherapeutic treatment of glioblastoma.

VAL-083 的療效顯而易見，無論獨立於放射治療或與放射治療合併使用，其對腫瘤的影響均顯著改善，且在劑量僅為 2.5 微摩爾時即可增強放射治療的療效並產生協同效應，這完全符合我們目前治療該腫瘤的劑量方案。這些數據以及我們在過程中提供的其他數據表明，VAL-083 代表了膠質母細胞瘤化療治療領域的潛在範式轉移。

Based on these data and the historical clinical data, we've moved to the program into clinical trials in patients that have failed temozolomide and Avastin. Slide 7 outlines the structure of that clinical trial, which you could review in detail at clinicaltrials.gov; and the identifier number is there on the slide for you. We initiated this study as a dose-escalation study to modernize the dosing regimen in the refractory disease population and identify a dosing regimen for advancement into registration-directed Phase II/III clinical trials.

基於這些數據和歷史臨床數據，我們已將該計畫轉入替莫唑胺和阿瓦斯汀治療失敗患者的臨床試驗。幻燈片7概述了此臨床試驗的結構，您可以在clinicaltrials.gov網站上詳細查看；幻燈片上也提供了編號。我們最初將這項研究作為劑量遞增研究，旨在改善難治性疾病族群的給藥方案，並確定一種可推進註冊導向型II/III期臨床試驗的給藥方案。

Slide 8 outline some of the things that we've seen along the way. Number one, we announced at ASCO this year that we had completed the dose escalation of the clinical trial. One of the important things is that we noted a promising dose-response trend, in that patients that were receiving higher doses of VAL-083 were surviving longer than those who were at a lower dose. It was a clinically meaningful survival benefit, and we'll walk through that little bit.

幻燈片8概述了我們在過程中觀察到的一些情況。首先，我們在今年的ASCO大會上宣布，我們已經完成了臨床試驗的劑量增加。其中一件重要的事情是，我們注意到一個令人鼓舞的劑量反應趨勢，即接受高劑量VAL-083治療的患者比接受低劑量治療的患者存活時間更長。這是一個具有臨床意義的生存獲益，我們將對此進行簡要介紹。

Based on that, we have initiated a Phase II expansion cohort to gather more information around the dose that we plan to take forward into registration trials. That will enable us to properly power our registration-directed Phase II/III clinical trial, and we're hoping to move there as rapidly as possible. We have continued to present additional data differentiating VAL-083 from standard of care, and we've continued to expand our clinical sites to maximize the velocity of our enrollment so we can move forward as quickly as possible.

基於此，我們啟動了II期擴展隊列研究，以收集更多關於我們計劃用於註冊試驗的劑量的資訊。這將使我們能夠更好地推進註冊導向的II/III期臨床試驗，並希望盡快推進。我們持續提供更多數據，以區分VAL-083與標準治療，並持續擴展我們的臨床研究中心，以最大限度地提高患者入組速度，從而盡快推進。

The next few slides will walk through some of the data. Slide 9, this is what we're seeing in terms of the dose-response trend. Now, with the caveat that it is a small number of patients in both samples, what we've done is we've looked at what essentially is a subtherapeutic dose -- doses up to 5 milligrams per meter squared -- and compared that to a dose that should be achieving the level of tissue concentration of the drug that is at or above the IC50 for activity in multiple GBM cell lines in the lab.

接下來的幾張投影片將介紹一些數據。幻燈片9是我們所看到的劑量反應趨勢。現在，需要注意的是，這兩個樣本中的患者數量都很少，我們所做的是，我們觀察了本質上是亞治療劑量（劑量高達每平方米5毫克），並將其與應該達到藥物組織濃度水平的劑量進行了比較，該濃度水平在實驗室中對多種膠質母細胞瘤細胞系具有活性，達到或超過IC50。

We had previously reported that there was an interesting and promising difference in the median survival. But if you look at the survival over time in those two groups at six months, at nine months, at 12 months, you can see that there is clearly a separation in the curves that points toward a benefit of the activity of the drug.

我們之前曾報道過，中位存活期有一個有趣且令人鼓舞的差異。但如果你觀察這兩組患者6個月、9個月和12個月的存活率隨時間的變化，你會發現曲線明顯分離，這表示藥物的活性是有益的。

Importantly, patients that are coming into our trial have a life expectancy of 2 to 5 months. So that what we're seeing here as marked survival at 12 months is certainly something that we find very exciting.

重要的是，參與我們試驗的患者的預期壽命為2至5個月。因此，我們觀察到12個月的顯著存活率，這無疑讓我們感到非常興奮。

Again, the caveat that these are small patient numbers, and we have a lot of work to do. But the excitement that we feel about the opportunity for benefiting patients based on data like these is very profound.

再次強調，這些患者數量很少，我們還有很多工作要做。但我們對能夠利用這些數據造福患者的機會感到非常興奮。

The other thing that gives us comfort and excitement is that we can look at the pharmacokinetic observations as outlined on slide 10 and so that they are consistent with the dose-response. That low dose, 5 milligrams per meter squared times 3 days, is achieving a tissue concentration that is well below the threshold that you would expect for activity. But at a 40-milligram dose we are achieving certainly concentrations at the tumor that you would expect to drive activity, and that's certainly what we believe that we're seeing.

另一件讓我們感到欣慰和興奮的事情是，我們可以查看投影片10中概述的藥物動力學觀察結果，這些觀察結果與劑量反應一致。低劑量（5毫克/平方米，3天）達到的組織濃度遠低於預期的活性閾值。但在40毫克劑量下，我們確實達到了預期的腫瘤活性濃度，這絕對是我們相信我們所看到的。

The VAL-083 compound is well tolerated at the dose of 40 milligrams per meter squared, as outlined in detail in our ASCO presentation. But we did see dose-limiting toxicity at the 50-milligram dose, which is one of the reasons that we have chosen to take 40 milligrams per meter squared forward.

VAL-083化合物在40毫克/平方公尺的劑量下耐受性良好，正如我們在ASCO報告中詳細闡述的那樣。但我們在50毫克劑量下觀察到了劑量限制性毒性，這也是我們選擇繼續採用40毫克/平方公尺劑量的原因之一。

How clinically meaningful is this? Looking on slide 11 you can see the expected survival from Avastin failure. If someone is just sent to hospice the average survival -- excuse me, the median survival is about 2 months.

這在臨床上有多大意義？請看第11張投影片，你可以看到阿瓦斯汀治療失敗後的預期存活期。如果有人被送往安寧療護醫院，平均存活期——不好意思，中位存活期大約是2個月。

There are salvage therapies that are often tried with the patient, and things like carboplatin that don't cross the blood-brain barrier, or putting somebody back on temozolomide that they have already failed. These are essentially palliative efforts that -- a patient may live a little bit longer, but that may have as much to do with the patient's desire to keep fighting as it does with a drug that probably isn't doing anything.

患者通常會嘗試一些挽救性療法，例如無法穿過血腦屏障的卡鉑，或讓已經失效的患者重新服用替莫唑胺。這些本質上都是安寧療護——患者或許可以活得更久一些，但這或許與患者繼續戰鬥的意願有關，也可能與某種可能毫無效果的藥物有關。

You'll see that our low dose of VAL-083 looks exactly like that. The dose is too low to actually be doing anything. It looks like any other salvage therapy that probably isn't doing much.

你會發現，我們低劑量的VAL-083看起來就是這樣。劑量太低，實際上沒有任何效果。它看起來就像任何其他可能沒什麼效果的挽救療法一樣。

But you can see the therapeutic dose is nearly doubling the survival of those patients, and we find that certainly very exciting. This is with only one or two cycles of treatment, and we believe that keeping the patients on the drug longer will increase this benefit potentially.

但你可以看到，治療劑量幾乎使這些患者的存活期翻了一番，這確實令人興奮。這只是一兩個療程的療效，我們相信，讓病人繼續服藥更長時間，可能會增加這種益處。

As I mentioned, we have moved into a Phase II expansion to gather more information around this dose. Slide 12 gives you an update on where we are in terms of that enrollment.

正如我所提到的，我們已經進入II期擴展研究，以收集更多關於該劑量的資訊。幻燈片12展示了我們目前的最新招募。

We plan to enroll approximately 14 patients in the Phase II expansion. The purpose of this is to gather data to guide the design of our registration-directed trial as well as to continue to develop data supporting the activity and the safety of this dosing regimen.

我們計劃在II期擴展研究中招募約14名患者。此舉旨在收集數據，指導我們註冊導向試驗的設計，並持續累積支持此給藥方案有效性和安全性的數據。

Since moving into the registration-directed trial in late June we have screened 19 patients. A number of them, unfortunately, were not eligible for the study. So we have 11 patients at this time that we have moved forward with.

自6月底進入註冊導向試驗以來，我們已經篩選了19名患者。遺憾的是，其中一些患者不符合研究資格。因此，目前我們已推進了11名患者的研究。

Six are on drug at the 40-milligram dose. Two are pending treatment washout of prior therapy.

其中六人正在服用40毫克劑量的藥物。兩人正在等待先前治療的治療終止。

We have also initiated a parallel 45-milligram dose to explore whether or not we can increase the therapeutic window. This was something that was indicated as a desire to us by the clinicians and our Advisory Board at ASCO. The reason is that because between the 40 milligram dose that was safe and well tolerated and 50 where we saw dose-limiting toxicity is a 20% difference.

我們也啟動了45毫克劑量的平行試驗，以探索是否可以擴大治療窗口。這是ASCO的臨床醫生和顧問委員會向我們表達的願望。原因是，安全且耐受性良好的40毫​​克劑量與我們觀察到劑量限制性毒性的50毫克劑量之間有20%的差異。

This is a very difficult disease, and the clinicians suggested to us that if we could push the dose even a little bit higher, get just that little bit more drug to the tumor safely, that we may be able to do even better than we've seen so far.

這是一種非常難治的疾病，臨床醫生建議我們，如果我們能夠將劑量稍微提高一點，讓更多的藥物安全地到達腫瘤，我們可能會取得比目前更好的結果。

That cohort has been fully enrolled, that 45-milligram cohort. And if the safety data warrants, we would continue the dose escalation into 45 milligrams. That doesn't necessarily mean we're doubling the size of it, but we will have enough data to properly design a registration-directed trial based on what we've seen at 40 and potentially 45.

那個45毫克劑量的隊列已經全部入組。如果安全性數據允許，我們會繼續將劑量增加到45毫克。這並不一定意味著我們要將劑量翻倍，但我們將擁有足夠的數據，根據我們在40毫克劑量，甚至可能是45毫克劑量下觀察到的情況，來合理地設計一項註冊導向試驗。

The timeline going forward is outlined on slide 13. We have moved into the Phase II enrollment and initiated registration-directed activities. Those will involve completing the enrollment in the Phase II expansion, continuing to present data, of course, to communicate, including next week at the GBM 2015 meeting in Toledo, Spain.

未來的時間表已在第13張投影片中概述。我們已進入II期臨床試驗的入組工作，並啟動了註冊指導活動。這些活動將包括完成II期擴展試驗的入組工作，並繼續提交數據，當然，也包括下週在西班牙托萊多舉行的GBM 2015會議上進行溝通。

We will be requesting a guidance meeting with the FDA to discuss registration trial design and particularly around the powering of a study and any control arms that we will be required to enroll against. We expect to move into the Phase II/III registration-directed trial as rapidly as possible and remain on track to file an NDA, we believe, in 2017.

我們將申請與FDA舉行指導會議，討論註冊試驗的設計，特別是研究的動力以及我們需要納入的任何對照組。我們預計將盡快進入II/III期註冊指導試驗，並預計在2017年提交NDA。

There are opportunities to accelerate this program -- the Fast Track Designation through the Orphan Designation that we already have. And obviously the potential in benefiting patients who have no other available therapies in a deadly disease like this could make us eligible for Breakthrough Therapy status, and that would be something that would obviously accelerate the development potentially in a great manner.

我們有機會加速這個計畫——透過我們現有的孤兒藥認定獲得快速通道認定。顯然，它有可能使那些在這種致命疾病中沒有其他可用療法的患者受益，從而讓我們有資格獲得突破性療法認定，這顯然會大大加速研發進程。

So we are moving very rapidly toward a registration-directed trial in refractory glioblastoma with a drug that has historical activity in the space, where we've differentiated the mechanism to demonstrate that we should be able to address a significant unmet medical need. And our data to date supports that we're accomplishing exactly that. So this has been a big year for us in 2015, and we really look forward to fiscal 2016 and continuing to move that ball forward.

因此，我們正在快速推進一項針對難治性膠質母細胞瘤的註冊導向試驗，該試驗採用一種在該領域具有歷史意義的藥物，我們已經明確了其機制，以證明我們能夠滿足一項重大的未滿足的醫療需求。迄今為止，我們的數據也支持了這個目標。因此，2015年對我們來說是意義非凡的一年，我們非常期待2016財年，並繼續推進這項工作。

Slide 14 really also talks about unlocking the value in glioblastoma in a bigger way. VAL-083 will be active independent of MGMT resistance.

第14張幻燈片其實也探討如何更深入地挖掘膠質母細胞瘤的價值。 VAL-083的活性將不受MGMT抗藥性的影響。

A major problem -- and the reason that this disease is so severe by the time we get to it in the third-line -- is because patients have failed in the first-line. We can identify the patients that are not going to respond to standard of care. They are not going to respond to temozolomide.

一個主要問題——也是這種疾病在我們進入第三線治療時已經如此嚴重的原因——是因為患者在一線治療中已經失敗。我們可以辨識出那些對標準治療沒有反應的患者。他們對替莫唑胺沒有反應。

We can identify it by measuring the level of MGMT, that repair enzyme that causes resistance; and by doing that we can introduce VAL-083 as an alternative in the two-thirds of the patients who are going to fail temozolomide, before they ever do. This is where we can have a major survival impact and quality of life impact for many, many patients, before they are in the situation where they're in third-line and they are nearly guaranteed to eventually succumb to the disease.

我們可以透過測量MGMT（一種導致抗藥性的修復酶）的水平來識別它；透過這種方式，我們可以在三分之二的替莫唑胺治療失敗的患者中，在他們真正失敗之前，引入VAL-083作為替代方案。這可以顯著改善許多患者的生存率和生活質量，讓他們免於淪為三線治療，避免最終死於疾病。

This is a major market opportunity, and we believe that we are in a position with our modernized dosing regimen to move in that direction. We have plans to do so during the coming year and we are very excited about that opportunity.

這是一個重要的市場機遇，我們相信，憑藉我們現代化的給藥方案，我們有能力朝著這個方向邁進。我們計劃在明年實現這一目標，我們對這個機會感到非常興奮。

Beyond glioblastoma, we've been well aware that the literature around VAL-083 opens potentially other doors in solid tumors and hematologic malignancies. These are based on the 40-plus clinical publications from the original NCI work.

除了膠質母細胞瘤之外，我們深知VAL-083的文獻可能為實體腫瘤和血液系統惡性腫瘤開闢了其他治療途徑。這些文獻是基於NCI原始研究的40多篇臨床出版品。

So as we've gone forward we've also been looking backward and backfilling basic science to ask questions about the mechanism of VAL-083, like we did in glioblastoma, to say: In these other indications where the literature supports clinical activity, is there a niche where we can address an unmet medical need? That may be a small niche or, in the cases of what we've seen, it could potentially be a very big niche.

因此，在前進的過程中，我們也一直在回顧和補充基礎科學，以探討VAL-083的作用機制，就像我們在膠質母細胞瘤研究中所做的那樣。我們會問：在這些文獻支持臨床活動的其他適應症中，是否存在一個我們可以滿足未滿足醫療需求的利基市場？這可能是一個小的利基市場，或者，就我們所見的情況而言，它可能是一個非常大的利基市場。

What we've demonstrated -- and as Dennis mentioned, this work has been done in collaboration with MD Anderson -- is that the cytotoxic mechanism of VAL-083 is distinct from platinum-based chemotherapy. This is driven primarily by observations that the activity and the tumor-killing ability of VAL-083 is not dependent on wild-type p53 or p53 activation.

正如Dennis所提到的，這項工作是與MD Anderson合作完成的，我們已經證明VAL-083的細胞毒性機制與鉑類化療不同。這主要基於以下觀察：VAL-083的活性和腫瘤殺傷能力不依賴野生型p53或p53活化。

This means -- and what we've observed -- is that the drug is active in both platinum- and TKI-resistant non-small cell lung cancer strains in the laboratory and in animal models. In fact, head-to-head it's more potent.

這意味著——正如我們觀察到的——該藥物在實驗室和動物模型中對鉑類和TKI抗藥性的非小細胞肺癌菌株均有效。事實上，在頭對頭對比中，它的藥效更強。

In addition, we've observed synergy with platinum-based chemotherapy without evidence of overlapping toxicities. This is very exciting to us, as you can see on slide 16. Because if you look at where platinum-based chemotherapy remains standard of care in major cancer indications, where p53-mediated resistance is a major unmet medical need, and you marry that with where VAL-083 has historical clinical activity from published Phase II studies, you unlock some very interesting opportunities: lung cancer, ovarian cancer, and other solid tumors.

此外，我們觀察到與鉑類化療的協同作用，且無毒性重疊的證據。正如您在第16張投影片上看到的，這讓我們非常興奮。因為，如果考慮到鉑類化療在主要癌症適應症中仍然是標準治療，而p53介導的抗藥性是主要的未滿足醫療需求，再加上VAL-083在已發表的II期研究中具有歷史臨床活性，就能發現一些非常有趣的治療機會：肺癌、卵巢癌和其他實體瘤。

And that's exactly where we're going to go next. The first step is to move into non-small cell lung cancer. It's the leading cause of cancer death worldwide, as outlined on slide 17.

這正是我們下一步要討論的。第一步是研究非小細胞肺癌。正如第17張投影片所述，它是全球癌症死亡的主要原因。

Non-small cell lung cancer represents the majority of patients diagnosed with lung cancer and is a significant unmet medical need with an overall survival rate of only 15% over five years. Existing and new data support the potential of VAL-083 in lung cancer, including in the differentiation from platinum therapy and platinum-refractory and TKI-refractory patients.

非小細胞肺癌佔肺癌確診患者的大多數，這是一個巨大的未滿足醫療需求，其五年總存活率僅為15%。現有和新的數據支持VAL-083在肺癌治療中的潛力，包括將其與鉑類療法、鉑類抗藥性患者區分。

Interestingly, as many of you know, VAL-083 is approved in China for the treatment of lung cancer broadly. What we hope to do is provide direction to clinicians in that country where the drug is already approved, so they can use it to treat patients appropriately, but also to establish proof-of-concept in the modern treatment of lung cancer for global development.

值得一提的是，正如各位所知，VAL-083 已在中國獲準用於廣泛治療肺癌。我們希望為該藥物已獲批准國家的臨床醫生提供指導，以便他們能夠合理地使用該藥物治療患者，同時也為肺癌的現代治療建立概念驗證，推動全球發展。

We plan to initiate before the end of 2015 a lung cancer trial which will be initially open in Shanghai, China, and funded through our collaboration with Guangxi Wuzhou Pharmaceuticals. That program will also serve as a Phase IIa proof-of-concept for global development. Obviously, lung cancer is a Big Pharma opportunity, multibillion-dollar opportunity, that presents us with some new partnering opportunities as we go forward.

我們計劃在2015年底前啟動一項肺癌臨床試驗，該試驗將首先在中國上海開展，資金將由我們與廣西梧州藥業合作提供。該專案也將作為IIa期概念驗證，用於全球開發。顯然，肺癌是大型製藥公司的機會，價值數十億美元，這將為我們未來的發展帶來一些新的合作機會。

Beyond lung cancer, we've also recently announced that we will be presenting data in ovarian cancer. Ovarian cancer is a platinum-treated disease where resistance develops quickly, and opportunities for synergy with platinum treatment are readily available to us.

除了肺癌，我們最近也宣布將發布卵巢癌的數據。卵巢癌是一種鉑類治療疾病，抗藥性發展迅速，我們隨時有機會與鉑類療法產生協同作用。

If you look at the literature from the historical work around VAL-083, the promise in ovarian cancer is equal to or greater than the activity demonstrated in glioblastoma. This is certainly a place where we believe it is an important niche for us that can address unmet medical needs in a major cancer market.

如果你查閱VAL-083的歷史研究文獻，你會發現它在卵巢癌治療中的前景與在膠質母細胞瘤治療中表現出的療效相當，甚至更佳。我們堅信，這是一個重要的利基市場，能夠滿足主要癌症市場中尚未滿足的醫療需求。

We will present our nonclinical data at a meeting, an AACR meeting, coming up shortly. We are developing plans and a strategy to move toward clinical development over time. Of course, this is well -- it represents a major global partnering opportunity.

我們將在即將舉行的AACR會議上展示我們的非臨床數據。我們正在製定計劃和策略，逐步推進臨床開發。當然，這代表著一個重要的全球合作機會。

Switching gears away from the scientific update in terms of the finances on slide 19, as I mentioned we recently completed a registered direct financing of $2.6 million. The snapshot of the financials, the capital structure, is on the slide here.

就財務方面而言，我們先從幻燈片19上的科學更新說起，正如我之前提到的，我們最近完成了一筆260萬美元的註冊直接融資。財務狀況和資本結構的概況就在這張投影片上。

But I'd like to turn it over to Scott Praill briefly to walk through the financials from the year at a high level. And of course, you all can review those in the 10-K filing from last night. Scott?

但我想把時間交給斯科特·普雷爾（Scott Praill），讓他簡要地介紹一下今年的財務狀況。當然，你們都可以在昨晚提交的10-K文件中查看。史考特？

Thanks, Jeff, and thanks to everyone for joining us today. Just to quickly reiterate what Jeff was just mentioning, at June 30, 2015, we had cash of $1.7 million, which is also our working capital. Combined with the gross proceeds from the financing we completed subsequent to year-end we have operating funds into the third quarter of 2016.

謝謝傑夫，也謝謝各位今天加入我們。我來快速重申傑夫剛才提到的內容，截至2015年6月30日，我們擁有170萬美元的現金，這也是我們的營運資金。加上我們在年底後完成的融資所得，我們有足夠的營運資金來維持2016年第三季的營運。

With respect to our capitalization, at June 30 we have 35.2 million shares outstanding, and we have 4.2 million shares in an entity called ExchangeCo. Essentially what this is, when we went public anyone with a Canadian address, in order to not pay taxes, we put their shares in a separate entity. But for all intents and purposes they should be considered issued and outstanding.

關於我們的資本總額，截至6月30日，我們擁有3520萬股流通股，並在一家名為ExchangeCo的實體中持有420萬股。本質上，當我們上市時，所有擁有加拿大地址的股東，為了避免納稅，都會將其股份放入一個單獨的實體中。但無論出於何種目的，這些股份都應被視為已發行且流通在外的股份。

So if you're looking at Yahoo Finance, for example, it will show you 35.2 million. But our real issued and outstanding is 39.4 million.

例如，如果你查看雅虎財經，它會顯示3520萬股。但我們實際發行流通的股票數量是3940萬股。

In addition to that, we have 13.5 million warrants outstanding at June 30. Those have a weighted average exercise price of roughly $0.92.

除此之外，截至 6 月 30 日，我們還有 1,350 萬張未償認股權證。這些認股權證的加權平均行使價約為 0.92 美元。

As noted in the asterisk there at the bottom, included in the 13.5 million warrants are 4.3 million that can be called at $0.786. That's a bit of an odd number, but that's the result of our issuing shares subsequent to year-end. There is a repricing feature in our previously priced $0.80 warrant, so we're able to call those and you can see the details below: share price $1.60 for 20 consecutive trading days.

正如底部的星號所示，1350萬份認股權證中，有430萬份可以以0.786澳元的價格贖回。這個數字有點奇怪，但這是我們在年底後發行股票的結果。我們之前定價0.80澳元的認股權證有重新定價功能，所以我們可以贖回這些認股權證，您可以看到以下詳情：連續20個交易日，股價為1.60澳元。

With respect to our statement of operations, we had a loss for the year of $4.8 million, which works out to $0.13 a share. In the prior year we had an income of $3.1 million, and that was exclusively due to the revaluation of our derivative liability.

就我們的營運報表而言，我們本年度虧損480萬美元，相當於每股虧損0.13美元。上一年我們的利潤為310萬美元，這完全是由於我們對衍生負債的重估。

If you were to look at our cash flow real quickly for the two years we -- in terms of and including working capital adjustments -- burned roughly $4 million each year, which is -- I mean in a quarter, which is pretty much what we've been burning -- well, it has been our burn for the last two years. That will go up of course now. As we move into the next phase of our clinical trials, our R&D spend increases.

如果你快速看一下我們這兩年的現金流——包括營運資本調整——我們每年大約消耗400萬美元，也就是說——我的意思是一個季度，這幾乎就是我們過去兩年的消耗——嗯，這是我們過去兩年的消耗。當然，現在還會上升。隨著我們進入臨床試驗的下一階段，我們的研發支出也會增加。

Jeff, anything else? Back to you.

Jeff，還有什麼事嗎？回到你這裡。

No, I think, Scott, thanks for the update. Just from a capital point of view, following the latest round of financing, issued and outstanding shares in total would be 43.7 million and fully diluted would be 65.1 million. I know everybody can do the math themselves from the press releases and the K; but those should be what the numbers work out to.

不，斯科特，我想，謝謝你的更新。僅從資本角度來看，最新一輪融資後，已發行及流通股本總額將達到4,370萬股，完全稀釋後將達到6,510萬股。我知道每個人都可以從新聞稿和K字頭數據自己算出來；但這些數字應該就是最終結果。

Just the last couple of slides. As we go into fiscal 2016, we believe that there are significant value-driving milestones ahead of us that hopefully will unlock value for our shareholders and continue to allow us to grow the opportunity for VAL-083.

就最後幾張幻燈片。隨著我們進入2016財年，我們相信，未來將有重要的價值驅動里程碑等著我們，希望這些里程碑能為股東釋放價值，並繼續讓我們擴大VAL-083的機會。

First and foremost is completing the enrollment of the Phase II expansion study in refractory glioblastoma and advancing the program into registration-directed Phase II/III clinical trials. We will continue to maximize the value of VAL-083 by initiating additional clinical trials in new indications.

首要任務是完成難治性膠質母細胞瘤II期擴展研究的入組工作，並將該計畫推進至註冊導向的II/III期臨床試驗。我們將繼續啟動更多針對新適應症的臨床試驗，以最大限度地發揮VAL-083的價值。

These trials in non-small cell lung cancer and front-line glioblastoma will be supported by our collaboration with Guangxi Wuzhou Pharmaceutical Company. Therefore, they are not going to come through our P&L or impact our balance sheet. It's a very nice partnership for us, to be able to leverage that opportunity to unlock value with VAL-083 and leverage the work that we've done in grant-supported research along the way.

這些針對非小細胞肺癌和第一線膠質母細胞瘤的試驗將由我們與廣西梧州製藥公司的合作計畫支持。因此，這些試驗不會計入我們的損益表，也不會影響我們的資產負債表。這對我們來說是一次非常好的合作，我們能夠利用這個機會釋放VAL-083的價值，並充分利用我們在過程中獲得資助的研究成果。

We will continue to actively communicate our progress to the investment and medical communities through peer-reviewed presentations and publications. In a couple of slides I'll walk through the upcoming presentations so you all can put those on your calendar.

我們將繼續透過同儕審查的簡報和出版物，積極地向投資界和醫學界通報我們的進展。我將用幾張幻燈片介紹即將舉行的演示文稿，以便大家將其添加到日曆中。

We'll continue to build our intellectual property portfolio. VAL-083 does have an Orphan Drug designation in both the United States and Europe for the treatment of gliomas. We will continue to expand the Orphan designation in other jurisdictions where it is available to us.

我們將繼續建立我們的智慧財產權組合。 VAL-083 在美國和歐洲均已獲得治療膠質瘤的孤兒藥資格認定。我們將繼續在其他適用的司法管轄區擴大孤兒藥資格認定。

And we will continue to file new patents as well. VAL-083 benefits from five newly issued United States patents and three international patents, and there are many filings that are moving through the process around the world based on our research since we initiated the Company. To date our patent protection takes us out through 2032, and we'll continue to build that portfolio as we go forward.

我們也會繼續申請新的專利。 VAL-083 已獲得五項新頒發的美國專利和三項國際專利，並且自公司成立以來，基於我們的研究成果，全球各地正在申請多項專利。迄今為止，我們的專利保護期將持續到 2032 年，未來我們將繼續建構這項專利組合。

Of course, another important aspect of unlocking value is moving the Company onto a national exchange, and we will continue to implement strategy to do so.

當然，釋放價值的另一個重要方面是將公司轉移到全國交易所，我們將繼續實施這項策略。

On the next slide, the overview of the program development and commercial movement. Refractory glioblastoma, moving into the Phase II/III clinical trial, first and foremost a goal for the year.

下一張投影片概述了專案開發和商業化進度。難治性膠質母細胞瘤進入II/III期臨床試驗，這是今年的首要目標。

Secondly, initiating clinical studies in lung cancer that will be supported by our partner, Guangxi Wuzhou Pharmaceuticals, as well as beginning to unlock the value in newly diagnosed patients; and again the initial work there will be funded by Guangxi Wuzhou Pharmaceuticals. And finally, leveraging what we have now observed and begin to report about other indications including ovarian cancer and thinking about opportunities for partnering in these major cancer indications as well.

其次，我們將啟動肺癌臨床研究，該研究將由我們的合作夥伴廣西梧州藥業提供支持，並開始在新診斷患者中釋放其價值；廣西梧州藥業也將資助該研究的初期工作。最後，我們將利用目前觀察到的成果，開始報告包括卵巢癌在內的其他適應症，並考慮在這些主要癌症適應症上合作的機會。

Slide 22, where you can see us and where you can expect updates. Next week we will be outlining the strategy for the clinical trial in lung cancer at the World Conference for Lung Cancer 2015 in Denver, Colorado. We will also be presenting a business update at the Rodman & Renshaw Investment Banking Conference next week.

幻燈片22，您可以在這裡看到我們以及了解最新進展。下週，我們將在科羅拉多州丹佛市舉行的2015年世界肺癌大會上概述肺癌臨床試驗的策略。我們也將在下週的羅德曼投資銀行會議上發布業務更新。

And finally at the end of next week a more formal update on the clinical trial progress, where we will be going further into the detail that we've shared on the call today from our GBM trial in refractory glioblastoma to date, at the end of next week at the GBM 2015 meeting. You can also expect data to be presented from us in ovarian cancer at the AACR Advances in Ovarian Cancer meeting in October, an investor presentation at the BIO Investor Forum in San Francisco, as well as a presentation -- more mechanistic and scientific, in terms of mechanism of action and differentiation from standard of care across a number of tumor types -- at the AACR-NCI-EORTC meeting in Boston in November.

最後，下週末我們將發布更正式的臨床試驗進展更新，屆時我們將在下週末舉行的GBM 2015會議上進一步詳細討論今天電話會議上分享的關於難治性膠質母細胞瘤GBM試驗迄今為止的進展。您還可以期待我們在10月份的AACR卵巢癌進展會議上展示卵巢癌相關數據，在舊金山舉行的BIO投資者論壇上進行投資者報告，以及在11月份於波士頓舉行的AACR-NCI-EORTC會議上進行一場更具機制性和科學性的報告，內容涵蓋作用機制及其與多種腫瘤類型標準治療的區別。

Finally, we'll wrap up the year with a presentation at the Society for Neuro-Oncology annual meeting in November in San Antonio, Texas. This will be the first data that we will be presenting in terms of outcomes from the 14-patient expansion study. We are currently enrolling that study, have been for some time, so we should be able to at least give top-line signals in terms of the activity that we're seeing in that expansion cohort at that time.

最後，我們將在11月於德州聖安東尼奧舉行的神經腫瘤學會年會上進行報告，以結束今年的工作。這將是我們首次展示14例患者擴展研究的結果數據。我們目前正在招募研究的患者，並且已經招募了一段時間，因此我們至少應該能夠根據當時在該擴展隊列中觀察到的活動情況，提供一些重要的信號。

And the LD Micro investor meeting in Los Angeles in December. So you'll see it will be a very effective fall and into the end of the year for us in terms of progress and communications of that progress to the market.

LD Micro 投資者會議將於 12 月在洛杉磯舉行。因此，從秋季到年底，我們將在進展和向市場溝通方面取得顯著成效。

Finally, VAL-083 and DelMar Pharmaceuticals, the investment opportunity. Why are we excited about investing our own money into this Company and continuing to do so? And hopefully other people will see us doing that and follow along and be as excited as we are.

最後，VAL-083 和 DelMar Pharmaceuticals 是一個投資機會。為什麼我們如此興奮地將自己的資金投入這家公司並持續投資下去？希望其他人能看到我們這樣做，並像我們一樣興奮。

VAL-083 is a first-in-class compound with a unique mechanism that we believe will unlock value and address unmet medical needs in major cancers. That activity has been demonstrated already across a range of cancers from prior work that was published at the National Cancer Institute.

VAL-083 是一種具有獨特機制的首創化合物，我們相信它將釋放價值並解決主要癌症領域尚未滿足的醫療需求。美國國家癌症研究所先前發表的研究已證實該藥物對多種癌症有效。

So this isn't a compound that we picked up from the university and we hope it works in man. We have clinical evidence of activity in the cancers which we are interested in; and our job is to differentiate and move quickly into those to address unmet medical needs.

所以，這不是我們從大學抄來的化合物，我們希望它對人體有效。我們有臨床證據表明，它對我們感興趣的癌症有效；我們的工作是區分這些癌症，並迅速採取行動，以滿足尚未滿足的醫療需求。

In the first indication, glioblastoma in the refractory disease, we have reported promising outcomes data and are moving into a Phase II/III registration trial. We have an Orphan Drug designation there, we have new patents, and our data and the work that we're doing is driving us into other indications where the clinical data from history demonstrates activity, and the modern science that we have developed demonstrates the ability through mechanism to address an unmet medical need.

在第一個適應症——難治性疾病中的膠質母細胞瘤——中，我們報告了有希望的療效數據，並正在進入II/III期註冊試驗。我們在該領域擁有孤兒藥資格認定，並擁有新的專利，我們的數據和正在進行的工作正在推動我們進入其他適應症，這些適應症的歷史臨床數據證明了其有效性，而我們開發的現代科學技術也證明了其能夠透過機制解決尚未滿足的醫療需求。

We have an experienced team that has done this before with a history of success, and a business model of taking an asset that's been proven, understanding the mechanism, plugging it in where it makes sense, solving problems, and building value that has been proven in the past.

我們擁有一支經驗豐富的團隊，他們之前曾成功做到這一點，並且擁有一種商業模式，即利用已被證實的資產，理解其機制，將其插入合理的位置，解決問題，並創造已被過去證實的價值。

So thank you very much for your attention and we would be happy to take any questions at this time.

非常感謝您的關注，我們很樂意回答您的任何問題。

(Operator Instructions) Joe Pantginis, ROTH Capital Partners.

（操作員指示）喬·潘特吉尼斯 (Joe Pantginis)，羅仕資本合夥公司 (ROTH Capital Partners)。

Hey, guys. Thanks for taking the question. Jeff and Dennis, maybe, can you just discuss your background activities in being able to move into the Phase II/III? I guess specifically, what are the gating factors right now? How much does the 45 dose preclude you from moving forward into the Phase II/III?

嘿，大家好。感謝你們回答這個問題。 Jeff 和 Dennis，能否請你們談談你們在進入 II/III 期臨床試驗方面所做的背景工作？具體來說，目前的門檻因素是什麼？ 45 劑量的劑量對你們進入 II/III 期臨床試驗有多大阻礙？

How much does the planned FDA meeting act as a gating factor, where you might not see maybe too many different changes to the design? But what kind of background activities are you working on right now?

FDA 計劃召開的會議在多大程度上起到了門檻作用？在會議期間，你可能不會看到太多設計上的改變。那麼，你目前正在進行哪些幕後工作呢？

Right, I'll start; and, Dennis, you can add some color. In terms of where the 45-milligram dose may be a gating factor, it's really not a gating factor. The 45-milligram dose certainly appears to have promising activity in terms of the dose-response, in terms of a meaningful clinical impact. But as we said in the presentation, being able to cut the difference between 40 and 50, which is a -- between 40 and 50, that's a 20% difference in Cmax and exposure, and that's a big window.

好的，我先開始；丹尼斯，你可以補充說明一下。至於45毫克劑量是否為門控因素，其實它並非一個門控因素。 45毫克劑量在劑量反應和有意義的臨床影響方面確實表現出良好的活性。但正如我們在演講中所說，能夠縮小40毫克和50毫克之間的差異，也就是40毫克和50毫克之間，Cmax和暴露量有20%的差異，這是一個很大的窗口。

So the clinicians said: If we had the opportunity to be a little bit higher -- because the way the protocol was originally written, we were handcuffed at stopping at 40. So being able to file a protocol amendment, and explore it at 45, and say we have that extra therapeutic window to work with as we go into the registration trial, that would be a great thing.

因此臨床醫生說：如果我們有機會將治療時間提高一點——因為根據方案最初的製定方式，我們被限制在 40 歲。因此，如果能夠提交方案修正案，並在 45 歲時進行探索，並且在進入註冊試驗時擁有額外的治療窗口，那將是一件很棒的事情。

So if we see toxicity at 45, that's fine. That means that 40 is still the maximum tolerated dose.

所以如果我們在45毫克劑量時發現毒性，那就沒問題。這意味著40毫克劑量仍然是最大耐受劑量。

If we don't, then we'll be able to enroll patients at 45 as we continue the expansion phase of the study and then obviously into the registration trial. So that's -- it's really trying to see if we can expand that therapeutic window or the safety ceiling of the drug in order to get a little bit more into the patients.

如果沒有，那麼我們將在45歲時招募患者，繼續進行研究的擴展階段，然後當然會進入註冊試驗。所以，這實際上是在嘗試看看我們能否擴大藥物的治療窗口或安全上限，以便讓更多患者受益。

In terms of the FDA meeting, again, it's an important step for us for clarification, but it's not necessarily a major gating factor for us. We have been involved in a number of brain tumor workshops that have been sponsored by the National Brain Tumor Society over the last year. The FDA and the senior people at the FDA are actively involved in those meetings.

就FDA會議而言，這對我們來說是澄清事實的重要一步，但這不一定是我們的主要門檻。過去一年，我們參加了一系列由美國腦腫瘤協會主辦的腦腫瘤研討會。 FDA及其高層人員積極參與這些會議。

The purpose of those meetings is really -- this is a tough situation, refractory glioblastoma. There's nothing for these patients. What are we going to do? So the FDA is very supportive and encouraging for strategies and programs in this area, and certainly we're one of them.

這些會議的目的其實是──難治性膠質母細胞瘤的情況很棘手。這些病人沒有任何治療手段。我們該怎麼辦？因此，FDA 非常支持和鼓勵該領域的策略和項目，我們當然也是其中之一。

The main point of that meeting is going to be to, obviously, discuss the registration trial design. We certainly expect that the primary endpoint is going to be overall survival.

顯然，這次會議的重點是討論註冊試驗的設計。我們當然希望主要終點是總存活期。

FDA's question to us is: Overall survival compared to what? So would we be able to point to historical literature and try to build a case that we should be able to demonstrate a survival benefit versus historical? Certainly that's a conversation we can have.

FDA 向我們提出的問題是：總生存期與什麼相比？那麼，我們能否引用歷史文獻，並嘗試證明與歷史數據相比，我們能夠獲得生存期優勢？當然，我們可以進行討論。

But the expectation is that it will be randomized versus a control arm in an open-label fashion. So we need to define and have agreement on what are the therapies that are in that dealer's choice control arm. The nice thing is that there's a lot of data already about things that fail in refractory glioblastoma, so we have a pretty good handle on what the survival in the control arm will look like.

但預期是，該試驗將以開放標籤的方式隨機分組，並設對照組。因此，我們需要明確並就經銷商選擇的對照組的治療方法達成一致。好消息是，目前已經累積了大量關於難治性膠質母細胞瘤治療失敗的數據，因此我們對對照組的生存情況有了相當清晰的了解。

Then the final discussion with the FDA is: Okay, well, then how are we going to power the study? What is your comfort level? Is it 80% power, 90% power?

然後與FDA的最終討論是：好吧，那我們該如何推動這項研究？你的舒適度是多少？是80%的力度，還是90%的力度？

And that in combination with what we know about historical data and what we are observing in terms of overall survival as we expand the Phase II in the refractory glioblastoma program, that will enable us to determine the number of patients that we need in the study. Based on what we're seeing to date, it will be a reasonably small study of between 80 to 100 patients including both arms.

結合我們所掌握的歷史資料以及我們在難治性膠質母細胞瘤計畫II期擴展過程中觀察到的總存活率，我們就能確定研究中所需的病患數量。根據我們目前的情況，這將是一項規模相當小的研究，包括兩組，患者數量將在80到100名之間。

So that's what we know today. All of those things will be clarified based on, A, data from the 14-patient expansion; B, whether or not we can push the therapeutic ceiling and enroll patients at a little bit of a higher dose along the way; and C, the discussion with the FDA about the trial design and powering. Dennis, do you want to add anything to that?

這就是我們今天所知道的。所有這些事情都將基於以下幾點來澄清：A、14名患者擴展試驗的數據；B、我們是否可以突破治療上限，並在試驗過程中以略高的劑量招募患者；C、與FDA就試驗設計和動力進行的討論。丹尼斯，你還有什麼要補充的嗎？

Yes, thanks, Joe. I think the key thing is 40 is an active dose, and 40 has been safely administered in multiple cycles. That's very, very valuable. Just the fact that we can know what potentially a clinician, if he needed or wanted to drive that goes up a little bit, in case he had a patient who could tolerate a little higher dose, is very meaningful for us to understand.

是的，謝謝，喬。我認為關鍵在於40毫克/公升的劑量是有效劑量，而40毫克/公升的劑量已經在多個療程中安全使用。這非常非常有價值。光是這一點就能讓我們知道，如果臨床醫生遇到的患者能夠耐受稍高的劑量，他可能需要或希望稍微增加劑量，這對我們理解這一點非常有意義。

But the 40 has been successfully administered with great safety. I think it's important that we be able to have the knowledge about potential for that 45 dose, but I think it really doesn't impact the strategy about regulatory discussions as well as trial design and development.

但40劑疫苗已成功給藥，安全性極高。我認為了解45劑疫苗的潛力很重要，但這實際上不會影響監管討論以及試驗設計和開發的策略。

Okay. Thanks, guys.

好的。謝謝大家。

Grant Zeng.

格蘭特曾。

Hi, Jeff. Congratulations on the progress made on VAL-083. Just a quick question about the planned Phase [IV] lung cancer and the Phase II of front-line GBM. Is this -- will it be funded by your partner, Guangxi Wuzhou, [marketing] that? Will this be conducted in China or in the US?

你好，Jeff。祝賀VAL-083取得進展。關於計畫中的肺癌IV期和第一線膠質母細胞瘤II期臨床試驗，我只想問一個簡單的問題。這個臨床試驗會由你的合作夥伴廣西梧（負責市場推廣）資助嗎？它會在中國還是美國進行？

The initial work in both of those studies will be conducted in China. Those are -- that's part of the agreement with Guangxi Wuzhou, is that if we conduct studies -- or any clinical studies that are conducted in China or expenditures in China that will drive value in that market where the drug is approved they will pay for.

這兩項研究的初步工作都將在中國進行。這是與廣西梧州達成的協議的一部分，即如果我們在中國進行研究——或者任何臨床研究，或者在中國的支出，能夠推動該藥物獲批市場的價值，他們就必須支付費用。

In both cases, we have identified leading clinicians who are world-class and experienced in global clinical trials, who will be leading those efforts. In lung cancer, Shun Lu at the Shanghai Chest Center, the lung cancer clinic there, he was the former head of CSCO, which is Chinese ASCO. He was a major enroller in Boehringer Ingelheim's last Phase III lung cancer clinical trial; in fact, I believe he was the top enroller in the world.

在這兩個項目中，我們都選定了世界一流、在全球臨床試驗方面經驗豐富的頂尖臨床醫生來領導這些工作。在肺癌方面，上海市胸腔科中心肺癌門診的陸順醫師曾任CSCO（即中國臨床腫瘤學會）的負責人。他是勃林格殷格翰上一項III期肺癌臨床試驗的主要招募者；事實上，我相信他是全球頂尖的招募者。

And he collaborates with folks that you would recognize the names from MD Anderson or from Mayo, etc. So if you look at the publications he is obviously -- if you want to do some lung cancer work in China, he's the guy.

他與 MD Anderson 或 Mayo 等機構的醫生合作。所以，如果你看一下他的出版物，顯然——如果你想在中國做一些肺癌研究，他就是那個人。

Likewise, in glioblastoma, that initial work will be conducted in Guangzhou with Professor ZongPing Chen. Professor Chen trained with Susan Chang at UCSF, who is obviously one of our clinical sites. And the majority of his clinical team actually came out of Al Yung's group at MD Anderson.

同樣，膠質母細胞瘤的初步研究也將在廣州由陳宗平教授進行。陳教授曾在加州大學舊金山分校（UCSF）接受Susan Chang的培訓，加州大學舊金山分校顯然是我們的臨床中心之一。他的臨床團隊的大部分成員實際上都來自MD安德森癌症中心Al Yung的團隊。

So again, world-class. He's the chair of the Chinese Society for Neuro-Oncology and a world-class clinic, a world-class clinician.

再說一遍，世界級。他是中華醫學會神經腫瘤分會主任委員，也是一家世界級的診所，一位世界級的臨床醫生。

One of the things that we've done in terms of the collaboration is ensure that, while Guangxi Wuzhou Pharmaceuticals is responsible for funding, DelMar Pharmaceuticals is responsible for the overall conduct of the trial to make sure that the data is captured and the trial is conducted under ICH guidelines. The CROs that we've hired for monitoring the studies are globally recognized CROs.

我們在合作方面採取的措施之一是確保廣西梧州藥業負責資金，而德瑪製藥負責試驗的整體實施，以確保數據收集和試驗按照ICH指南進行。我們聘請的負責監測研究的CRO均為全球知名的CRO。

So we will make sure that all of the data that we are capturing through this work funded by Guangxi Wuzhou will be leverageable around the world, including here in the United States with the FDA. Does that answer your question?

因此，我們將確保透過廣西梧州資助的這項研究收集的所有數據都能在世界各地使用，包括在美國FDA。這回答了您的問題嗎？

Yes, that's great. Thank you.

是的，太好了。謝謝。

(Operator Instructions) Vesselin Mihaylov, New-Coast Health.

（操作員指示）Vesselin Mihaylov，新海岸健康。

All right, so my first question is on the selection criteria for these 14 patients. Are you selecting people that are basically at the end of their Avastin treatment and then immediately putting them on VAL-083? Or do you have an exception where you can take some patients that are one or two months past failure, therefore in worse shape?

好的，我的第一個問題是關於這14名患者的選擇標準。你們會選擇那些已經基本結束阿瓦斯汀治療的患者，然後立即讓他們接受VAL-083治療嗎？或者你們會不會有例外，允許一些已經失敗一兩個月、病情更嚴重的患者接受治療？

Okay, sounds like you have a two-part question so I'll answer the first part first. In the enrollment criteria for the dose escalation as well as the expansion phase, patients must have demonstrated progression following Avastin if they are eligible for Avastin therapy.

好的，聽起來你的問題分成兩個部分，所以我先回答第一部分。在劑量遞增和擴展階段的入組標準中，患者必須在接受阿瓦斯汀治療後出現病情進展，才有資格接受阿瓦斯汀治療。

So if you look at all the patients that we enrolled in the dose expansion there was only one patient who hadn't had Avastin. That was because they were ineligible for it.

所以，如果你看看我們參與劑量擴展試驗的所有患者，你會發現只有一個患者沒有使用過阿瓦斯汀。那是因為他們不符合使用條件。

So these are -- so when somebody fails Avastin they become eligible for our study. But there is a washout period between Avastin and our -- and VAL-083.

所以，如果有人對阿瓦斯汀治療失敗，他們就有資格參加我們的研究。但阿瓦斯汀和我們的──以及VAL-083之間有一個洗脫期。

That's important for twofold. Number one, you want to have all of the Avastin out of the system so that we're able to look at the activity of our drug and not potentially have some hanging-on activity from Avastin.

這有雙重重要性。首先，要將阿瓦斯汀完全排出體外，這樣我們才能觀察藥物的活性，並避免阿瓦斯汀留下的殘留活性。

Number two, from a safety perspective, Avastin carries with it a potential bleeding risk and our dose-limiting toxicity is thrombocytopenia. So you want to make sure that's out of the way.

第二，從安全角度來看，阿瓦斯汀有潛在的出血風險，而我們的劑量限制性毒性是血小板減少症。所以要確保這個問題不會被忽略。

And thirdly -- this is an anecdotal but very important observation -- is that when a patient fails Avastin in many cases there is a strong rebound of the tumor and that patient will deteriorate and die very rapidly. The washout period would capture, unfortunately, those patients who are going to have that phenomena of a rapid rebound and robust growth of the tumor following Avastin.

第三，這是一個軼事，但非常重要的觀察結果：當患者對阿瓦斯汀治療失敗時，許多情況下會出現腫瘤強烈反彈，病情會惡化並迅速死亡。不幸的是，洗脫期會捕捉那些在服用阿瓦斯汀後會出現腫瘤快速反彈和強勁生長現象的患者。

So through the washout period, we're hopefully selecting patients that are going to have the life expectancy that gives us a chance to slow that tumor down, or stop it, or shrink it, and impact their survival with a good quality of life. So that's the way the protocol is written.

因此，在洗脫期，我們希望篩選出預期壽命尚可的患者，以便我們有機會減緩、阻止或縮小腫瘤，從而提高他們的生存率和生活品質。方案就是這樣制定的。

In reality, what we tend to see, at least in the dose escalation, is patients had failed Avastin and they had failed one or more salvage therapies before they got into our trial. So they are well down that post-Avastin progress toward death, and we're still able to see a meaningful benefit in terms of survival.

事實上，至少在劑量遞增過程中，我們觀察到的情況是，患者在參加我們的試驗之前，已經對阿瓦斯汀治療失敗，並且已經接受過一種或多種挽救性治療，但仍然無法治愈。因此，在阿瓦斯汀治療後，他們的死亡進展已經很緩慢，但我們仍然能夠看到生存率的顯著提高。

One of the other things -- and you'll see this in more detail in the discussion at the conference next week -- is there is no correlation between what that salvage therapy might have been, if there was carboplatin or putting somebody back on temozolomide or putting somebody on CCNU. I mean, there is no correlation with any of those other random salvage therapies that may have been thrown at the patient before they got to us and the impact that we're seeing with our drug.

另一件事——你們會在下週的會議上更詳細地討論——是，如果使用卡鉑、替莫唑胺或CCNU進行挽救治療，兩者之間沒有任何關聯。我的意思是，在病人接受我們治療之前，其他隨機的挽救治療與我們藥物的效果沒有任何關聯。

So these are very sick patients and it looks like, fortunately, we're able to do something for a number of them at the higher doses.

這些都是病情非常嚴重的患者，幸運的是，我們能夠透過較高劑量為其中一些患者提供一些治療。

The other thing that we've done in the registration trial that is different from the dose escalation is we are requiring the ability to know the MGMT and IDH1 status of the patients in the expansion phase. It's not an enrollment criteria; they don't have to be positive or negative, high, low MGMT. But we just have to be able to know what that status is through tissue samples or if they've already had the typing done, because we want to be able to look at that in a more robust way than we have in the past.

在註冊試驗中，我們所做的另一件事與劑量遞增不同，那就是我們要求在擴展階段了解患者的MGMT和IDH1狀態。這不是入組標準；患者的MGMT不必是陽性或陰性，高或低。但我們必須能夠透過組織樣本或患者是否已經完成基因分型來了解他們的狀態，因為我們希望能夠以比過去更穩健的方式審視這一點。

Does that answer your first question?

這回答了你的第一個問題嗎？

Yes, it does. Next question. The three patients that are on the 45-milligram regimen, are you basically treating them as if they were already -- they were actually on the 40 milligrams? That is, every 21 days continuously?

是的，確實如此。下一個問題：那三位接受45毫克治療方案的患者，你們的治療方式基本上是把他們當成已經服用過40毫克的劑量了嗎？也就是說，每21天連續服用一次？

Yes, sorry -- I didn't mean to cut you off. Yes, the dosing regimen of the cycle is exactly the same.

是的，抱歉——我不是故意打斷你的。是的，整個週期的給藥方案完全一樣。

Okay, so that's why you consider them part of the overall 14 count?

好的，所以這就是為什麼您認為它們是 14 個總數的一部分？

Yes. It's essentially as -- they're officially not part of the expansion phase by definition. But in terms of the counting toward getting enough data to power a registration trial, assuming that their safety data says that the 45-milligram dose is safe and well tolerated, then that certainly will be part of the mix.

是的。本質上來說——從定義上來說，他們正式不屬於擴展階段。但就取得足夠數據來支持註冊試驗而言，假設他們的安全數據顯示45毫克劑量是安全且耐受性良好，那麼這肯定會被納入考慮的範圍。

Okay. If and when that moment comes, the crossover where you see that, hopefully, that 45 milligram is well tolerated, would you make an announcement that everybody else going forward will be on 45 milligram? Is that a material event in your eyes?

好的。如果那一刻真的到來，你希望看到45毫克的劑量能夠被很好地耐受，你會宣布以後所有患者都會服用45毫克嗎？在你看來，這是一個重大事件嗎？

I think we could certainly make that announcement. I think the most material thing for us as determining the dose, whether or not that we can push the ceiling or not. I think that's important.

我認為我們當然可以宣布這一點。我認為對我們來說最重要的事情是確定劑量，以及我們能否突破上限。我認為這很重要。

So from that perspective, I think we could say that we would be continuing the dose expansion and enrolling further patients at 45. But the main thing is getting the data in hand that lets us power the registration trial so we can move forward as quickly as possible into the Phase II/III registration trial, so that we can get this drug moving toward an approval, hopefully.

因此從這個角度來看，我認為我們可以說我們將繼續擴大劑量並在 45 歲時招募更多患者。但最重要的是獲取數據，以便我們能夠推動註冊試驗，從而盡快進入 II/III 期註冊試驗，希望如此，這種藥物能夠獲得批准。

Because there is, obviously, a huge unmet medical need here, and we think we can address it.

因為顯然這裡存在著巨大的未滿足的醫療需求，我們認為我們可以解決這個問題。

Okay, great. My next question is, when was the first of these combined [eight] patients enrolled? Ballpark figure, in what month of the year?

好的，太好了。我的下一個問題是，這八名患者中，第一批入組是什麼時候？大概是幾月份？

Well, we announced that ASCO that we were proceeding forward into the expanded Phase II phase. That was in June, so the first patients would have been screened in June and enrolled a few weeks later in July.

嗯，我們之前在ASCO年會上宣布，我們將進入擴展II期臨床試驗。當時是6月份，所以第一批患者應該在6月份接受篩選，並在幾週後的7月份開始入組。

The fact that we are -- between midsummer and today that we've screened 19 patients I think is pretty remarkable. Glioblastoma trials don't historically enroll that rapidly. You tend to see 1.5 to 2 patients a month screened.

從仲夏到今天，我們已經篩選了19名患者，這非常了不起。膠質母細胞瘤試驗的入組速度以往並不快。通常每個月篩檢的患者只有1.5到2名。

The fact that we are seeing such a robust screening result here -- and obviously we have some screen failures -- but the fact that we are identifying so many patients I think is twofold. Number one, there is nothing else for these patients. So the study centers that are open for us are very aggressively looking to put patients on the trial because they don't have anything else for these patients, number one.

我們之所以能看到如此強勁的篩檢結果（當然，我們也有一些篩檢失敗案例），但我認為，我們識別出如此多的患者，這背後有兩個原因。首先，這些患者沒有其他治療方案。因此，我們開放的研究中心正在積極爭取讓患者參與試驗，因為他們沒有其他治療方案可以治療這些患者，這是第一點。

And number two, just the sheer excitement about an opportunity to treat these patients with the data that we're seeing out of ASCO, albeit small patient numbers and interim data, I think that's really driven the robustness of the recruitment effort that we've seen to date. So we're very pleased with that and I would expect that we will be able to fill out the rest of the enrollment here pretty quickly.

第二，我們非常興奮有機會利用ASCO提供的數據來治療這些患者，儘管患者數量不多，而且只是中期數據，但我認為這才是我們迄今為止招募工作如此順利的關鍵。我們對此非常滿意，我預計我們很快就能完成剩餘的招募。

Okay. Next question -- I'm getting close to the end here. But I assume -- this is my assumption only; but reading through the lines, you are saying that you are currently enrolling six patients; then there is obviously three in that that are cohort of 45 milligram. All of them are alive and continuously receiving treatment as prescribed; am I correct in that assumption?

好的。下一個問題——我快要結束了。但我假設—這只是我的假設；但仔細閱讀原文，您說您目前正在招募六名患者；那麼其中顯然有三名患者屬於45毫克劑量組。他們現在都還活著，並且持續接受處方治療；我的假設正確嗎？

People are on study and they will continue to receive drug as long as it's well tolerated and they are showing good clinical signs. We'll disclose what we're seeing in terms of median survival and the overall picture here as we go forward at the Society for Neuro-Oncology meeting.

患者正在接受研究，只要耐受性良好且臨床症狀良好，就會繼續接受藥物治療。我們將在神經腫瘤學會會議上揭露目前觀察到的中位存活期和整體情況。

Okay, and final question. This involves a few assumptions as well. If you enroll eight patients and all of them are still alive past 5.2 months, all of them are alive and the eighth, the last patient enrolled, is still alive after 5.2 months, it's safe to assume that the median survival time cannot be less than 5.2 times in this expansion program. Am I right?

好的，最後一個問題。這也涉及一些假設。如果您招募了8名患者，並且他們全部存活超過5.2個月，並且第8名（也就是最後一位患者）在5.2個月後仍然存活，那麼可以安全地假設，在這個擴展項目中，中位生存期不會低於5.2倍。我說得對嗎？

Does that constitute a material event? Would you announce it, that you are seeing essentially the same thing (multiple speakers)?

這是否構成重大事件？您能宣布一下嗎？您看到的本質上是同一件事嗎？ （多位發言者）

Your math is correct in terms of the median survival would be guaranteed to be 5.2 months or better. If we end up with a median survival of 5.2 months, that would not be good. So I wouldn't say that that would be a material event, that we look as good as salvage therapy.

你的計算是正確的，中位生存期保證在5.2個月或更長。如果最終中位存活期只有5.2個月，那就不太理想了。所以我不會說這會是一個重大事件，也不會說我們看起來和挽救性治療一樣好。

I think being able to confirm what we have seen so far in large patient numbers that allows us to properly power a registration trial is what we're after here. So it's really looking at a much longer survival benefit compared to what we've seen to date in the dose-escalation phase is what we're after here.

我認為，我們的目標是能夠證實目前在大量患者中觀察到的結果，以便能夠有效地進行註冊試驗。因此，我們真正追求的是比劑量遞增階段迄今為止觀察到的結果更長的生存益處。

Showing that we just have another salvage therapy out there is really not what we're shooting for. It's really -- we want to benefit patients in a material way with a drug that has a good quality of life and safety profile where, unfortunately, patients at this stage, the third-line therapy, who have failed temozolomide, have failed Avastin, are more than likely going to succumb to this disease.

我們的目的並非僅僅為了證明我們還有另一種挽救療法。我們真正想要的是——透過一種具有良好生活品質和安全性的藥物，為病人帶來實質的益處。不幸的是，在目前階段，接受第三線治療、替莫唑胺和阿瓦斯汀治療失敗的患者，很可能會死於這種疾病。

And our goal is, in this salvage patient population, the third-line, is to extend life in a meaningful way with a good quality of life. That is worth a lot to these patients and that's worth a lot in terms of value.

我們的目標是，在這類挽救性治療的患者群體中，也就是三線治療，以有意義的方式延長生命，並維持良好的生活品質。這對這些患者來說意義重大，而且從價值角度來看也非常有價值。

Ultimately, moving the drug into the front-line as an alternative to temozolomide, where if you look at patients who do respond to temozolomide, the minority, the third of the patients who do respond or so, some of them do very well and they live for years with a good quality of life, managing their disease. That's what we want to be able to do with VAL-083 in the two-thirds of the patients that are not going to respond to temozolomide on the front-line.

最終，該藥物將作為替莫唑胺的替代品進入一線治療。如果你觀察那些對替莫唑胺有反應的患者，你會發現，只有少數（大約三分之一）的患者病情良好，能夠持續多年，保持良好的生活質量，控制病情。我們希望VAL-083能夠幫助三分之二對第一線治療替莫唑胺無反應的患者實現這一目標。

So that's where we go eventually. But what we're starting is in that refractory population where it is a massive unmet need. There is nothing for these patients, and it looks like we're doing something. So getting more proof and meat around the survival number on the good end of a meaningful impact is what we're after here, and that's what we're anticipating and hoping that the 14-patient expansion will continue to show.

所以這就是我們最終的目標。但我們首先要從難治性患者群體開始，因為那裡存在著巨大的未滿足需求。目前還沒有針對這些患者的有效療法，而我們似乎正在有所作為。因此，我們的目標是在有意義的影響方面，獲得更多關於生存率的證據和實質內容，這也是我們期待並希望14例患者的擴展研究能夠繼續發揮作用的結果。

Okay. Thank you very much.

好的。非常感謝。

There are no further questions at this time. I'll turn the call back to Mr. Bacha.

目前沒有其他問題了。我會把電話轉回巴查先生。

Thank you very much, everybody, and thank you again for your attention and good questions today. You can follow our progress on our website at www.DelMarPharma.com and, as I mentioned, we will be at a number of scientific and investment conferences as we go through the year.

非常感謝各位，也再次感謝大家今天的關注與精彩的提問。您可以在我們的網站 www.DelMarPharma.com 上關注我們的進展。正如我之前提到的，我們今年將參加一系列科學和投資會議。

We look forward to continuing to update you on our progress as we move forward in developing VAL-083 based on the historical clinical activity and our new data that suggests and supports the ability to address major unmet medical needs in major cancer markets. Thank you very much and enjoy your afternoon.

我們期待繼續向您報告VAL-083的開發進展，這些進展基於以往的臨床研究和最新數據，這些數據表明並支持該藥物能夠滿足主要癌症市場中尚未滿足的醫療需求。非常感謝，祝您下午愉快。

This concludes today's conference. You may now disconnect.

今天的會議到此結束。您可以斷開連線了。