Biodexa Pharmaceuticals PLC (BDRX) 2018 Q4 法說會逐字稿

Good afternoon, everybody. I think -- this is Craig Cook from Midatech, CEO of Midatech, and I'm joined today by Nick Robbins-Jerry, the CFO of the company.

大家下午好。我想，我是來自 Midatech 的 Craig Cook，Midatech 的首席執行官，今天加入我的還有該公司的首席財務官 Nick Robbins-Jerry。

Thank you very much for attending the prelims analyst call. The format is, we'll have a presentation of approximately 20 to 25 minutes that will then be followed by a Q&A as necessary. Can I just confirm that everyone can hear Nick and I?

非常感謝您參加預賽分析師電話會議。格式是，我們將進行大約 20 到 25 分鐘的演示，然後根據需要進行問答。我可以確認每個人都能聽到我和尼克的聲音嗎？

I can hear you, Craig. It's [Heather] from IFC.

我能聽到你的聲音，克雷格。我是來自國際金融公司的[希瑟]。

Hi, Heather. Okay. Good. So to set the scene, I'm going to start with Slide 3 and jump straight to it.

嗨，希瑟。好的。好的。因此，為了設置場景，我將從幻燈片 3 開始並直接跳到它。

Does everyone have a copy of the presentation from the website? Okay. Well, Slide 3 sets the scene in terms of what Midatech does, i.e., we effectively make medicines better and secondly, how we do that. And this may be familiar to many of you, but we do that using our proprietary technologies that improve bio-delivery and bio-distribution of existing agents, which we do in 1 of 3 ways. Our Q-Sphera technology is a sustained release technology. We use a polymer microsphere basis and we purpose active pharmaceutical ingredients for controlled release over anything between 1 to 6 months.

每個人都有網站上的演示文稿副本嗎？好的。嗯，幻燈片 3 介紹了 Midatech 所做的事情，即我們有效地使藥物變得更好，其次是我們如何做到這一點。這對於你們許多人來說可能很熟悉，但我們使用我們的專有技術來改善現有製劑的生物遞送和生物分佈，我們通過三種方式之一來做到這一點。我們的 Q-Sphera 技術是一種緩釋技術。我們使用聚合物微球為基礎，我們的目的是在 1 至 6 個月內控制釋放活性藥物成分。

The second technology that we have is MidaSolve and this technology takes insoluble tablet forms of medications and converts them into a liquid form, such that they can be injected directly into the tumor. And our third technology is MidaCore. This improves bio-delivery and bio-distribution of existing agents by targeting signs of disease. These are very small nanoparticles. We decorate them with active pharmaceutical ingredients and other agents such that they can seek out the types of disease. So we select 1 of those 3 technologies and use them with existing agents in 1 of those 3 ways to improve bio-delivery and bio-distribution.

我們擁有的第二項技術是 MidaSolve，該技術將不溶性片劑形式的藥物轉化為液體形式，以便可以直接注射到腫瘤中。我們的第三項技術是 MidaCore。這通過針對疾病跡象改善了現有藥物的生物遞送和生物分佈。這些是非常小的納米顆粒。我們用活性藥物成分和其他藥劑裝飾它們，以便它們能夠找出疾病的類型。因此，我們選擇這 3 種技術中的一種，並以這 3 種方式中的一種將其與現有製劑一起使用，以改善生物遞送和生物分佈。

Importantly, each of these technologies have now successfully transitioned into the clinic and have an ongoing clinical program. And beyond the current opportunities, given that they are platform technologies, there is obviously additional indications and APIs that we can pursue.

重要的是，這些技術現在都已成功轉化為臨床，並有一個正在進行的臨床計劃。除了當前的機會之外，鑑於它們是平台技術，顯然我們還可以追求更多的指示和 API。

On Slide 4, this is an important slide because 2018 has been a year of enormous change for Midatech, which we believe has resulted in a strong foundation for a near and medium term potentially rich in value adding catalysts for the company. Most significantly, we refocused our strategy in 2018 to a pure-play R&D company rather than a hybrid commercial R&D operation. We streamlined the business with divestments of the U.S. that simplifies the operations substantially and allows us to focus totally on R&D without distraction. We've made solid clinical progress in 2 of our key clinical programs getting into the clinic, MTD201 and MTX110.

在幻燈片 4 上，這是一張重要的幻燈片，因為 2018 年對於 Midatech 來說是發生巨大變化的一年，我們相信這為公司近中期潛在的豐富增值催化劑奠定了堅實的基礎。最重要的是，我們在 2018 年將戰略重點重新調整為純粹的研發公司，而不是混合商業研發業務。我們通過撤資美國業務來簡化業務，這大大簡化了運營，使我們能夠完全專注於研發而不會分心。我們在進入臨床的兩個關鍵臨床項目 MTD201 和 MTX110 方面取得了紮實的臨床進展。

MTD201 has generated strong data that commenced in May of last year, completed in September and very encouraging data was an outcome of that study and MTX110 is progressing solidly since entering the clinic also in May of 2018. We established strong partnerships, most notably, with CMS and I'll touch on them a little bit later, but certainly a strong vote of confidence in Midatech and our programs and our technologies. And in addition to that, we have other collaborations that are ongoing, but the CMS one is certainly a key partnership for the company.

MTD201 產生了強勁的數據，從去年 5 月開始，到 9 月完成，該研究的結果是非常令人鼓舞的數據，MTX110 自 2018 年 5 月進入臨床以來正在穩步進展。我們建立了強有力的合作夥伴關係，尤其是與 CMS 建立的合作夥伴關係，我稍後會談到它們，但肯定是對 Midatech 以及我們的項目和技術投下了強烈的信任票。除此之外，我們還有其他合作正在進行中，但 CMS 無疑是公司的重要合作夥伴。

We have a solid and stable manufacturing setup. We had several challenges that we had to address in getting these programs into the clinic. Those challenges are now addressed and all our technologies into the clinic and that's a key part of the company was manufacturing underpins a lot of what we do and the way we control our programs. We've secured the runway with a successful fundraise, GBP 13.4 million fundraise, which covers our near term clinical goals through 2019 and '20, plus we secured Spanish loan finance for the scale up of our Bilbao facility in Spain to the tune of roughly EUR 8.6 million.

我們擁有堅實而穩定的製造體系。在將這些項目推向臨床時，我們遇到了一些必須解決的挑戰。這些挑戰現在已經得到解決，我們所有的技術都進入了臨床，這是公司的一個關鍵部分，製造支撐著我們所做的很多事情以及我們控制項目的方式。我們通過成功的籌款（1340 萬英鎊）確保了跑道的安全，這涵蓋了我們到 2019 年和 20 年的近期臨床目標，此外，我們還獲得了西班牙貸款融資，用於擴大我們在西班牙畢爾巴鄂的設施，規模約為860 萬歐元。

We've been very prudent with costs and have reduced costs significantly, most notably, by closure of the Milton Park, Abingdon base, which -- the activities of which we've incorporated into our Bilbao and Cardiff sites. And finally, the leadership of the company is very much R&D focused and I think the progress that we made is testament to the capability of the team and delivering on what we say we're going to deliver.

我們對成本非常謹慎，並顯著降低了成本，最值得注意的是，通過關閉阿賓登基地的米爾頓公園，我們已將其活動納入我們的畢爾巴鄂和卡迪夫基地。最後，公司的領導層非常注重研發，我認為我們取得的進展證明了團隊的能力以及我們承諾的交付成果。

So all of the above have allowed us to focus hard on our R&D pipeline, which leads us onto the next slide, the pipeline slide. And this shows a well-balanced pipeline with clear focus on near-term priorities and deliverables for the programs and platforms. We see our 3 technologies: Q-Sphera, MidaSolve and MidaCore. We see our successful progress into the clinic with each of these technologies and transitioning between Phase I and Phase II for the 2 key programs. We see the underserved markets that we are in, such as NET and acromegaly for Q-Sphera and brain cancer for MidaSolve. We see the competitive advantages and thus, the opportunity to make a real difference in these diseases as we match our competitive advantage to the unmet needs of these diseases. And finally, we see the commercial opportunity of these indications given that they are all substantial markets with clear commercial opportunity.

因此，上述所有內容使我們能夠集中精力於我們的研發管道，這將我們引向下一張幻燈片，即管道幻燈片。這顯示了一個均衡的管道，明確關注項目和平台的近期優先事項和可交付成果。我們看到了 3 項技術：Q-Sphera、MidaSolve 和 MidaCore。我們看到我們的每一項技術都成功進入臨床，並在兩個關鍵項目的第一階段和第二階段之間進行過渡。我們看到了我們所處的服務不足的市場，例如 Q-Sphera 的 NET 和肢端肥大症以及 MidaSolve 的腦癌市場。我們看到了競爭優勢，因此，當我們將我們的競爭優勢與這些疾病未得到滿足的需求相匹配時，我們就有機會在這些疾病方面發揮真正的作用。最後，我們看到了這些跡象的商業機會，因為它們都是具有明確商業機會的巨大市場。

So to set up progress and deliver the full potential of the pipeline, on Slide 6, our key priorities for 2019 are related to MTD201, which I'll go into a little bit more detail for all of these priorities after the presentation, but for MTD201, we want to establish and implement a route to approvable product and enable a successful NDA submission in 2021.

因此，為了取得進展並充分發揮管道的潛力，在幻燈片 6 上，我們 2019 年的主要優先事項與 MTD201 相關，我將在演示結束後對所有這些優先事項進行更詳細的介紹，但對於MTD201，我們希望建立並實施一條獲得批准產品的途徑，並在 2021 年成功提交 NDA。

For MTX110, we want to complete and confirm the safety of MTX110, the dose for MTX110 and then take that into an efficacy phase through to completion of a proof-of-concept study in 2020. And then from a manufacturing perspective, we want to establish and implement the solution in Bilbao and potentially together with partners so that we are certain we can provide all manufacturing needs for medium- to long term, especially for MTD201 where we require the commercial stage data -- manufacturing data for an NDA submission.

對於 MTX110，我們希望完成並確認 MTX110 的安全性、MTX110 的劑量，然後將其納入療效階段，直至 2020 年完成概念驗證研究。然後從製造角度來看，我們希望在畢爾巴鄂並可能與合作夥伴一起建立和實施該解決方案，以便我們確信我們能夠滿足中長期的所有製造需求，特別是對於我們需要商業階段數據的 MTD201 -- 提交 NDA 的製造數據。

So let's focus on the first of those priorities, MTD201. This is using our Q-Sphera technology. And on Slide 8, our first indication, as I mentioned, is in NET, neuroendocrine tumors, carcinoid syndrome and acromegaly. These are tumor based debilitating diseases of neurohormonal origin or nature. Octreotide is the mainstay of medical treatment for carcinoid and acromegaly and Midatech MTD201 has been developed as an alternative to Novartis' Sandostatin LAR.

因此，讓我們關注第一個優先事項：MTD201。這是使用我們的 Q-Sphera 技術。在幻燈片 8 上，正如我提到的，我們的第一個適應症是 NET、神經內分泌腫瘤、類癌綜合徵和肢端肥大症。這些是神經激素起源或性質的基於腫瘤的衰弱疾病。奧曲肽是治療類癌和肢端肥大症的主要藥物，Midatech MTD201 已被開發作為諾華 Sandostatin LAR 的替代品。

And we believe that based on the Q-Sphera technology that we developed in-house and the validation that we've seen coming out of the Phase I study, that there are several advantages to the MTD201 product. First of all, the technology precision and how we deliver it and how we formulate it convert into demonstrable and proven clinical benefits. We've seen that in both preclinical as well as in the Phase I study. The quicker, safer and more productive production process converts into an altogether more efficient manufacturing platform. The competitive advantage that accrues as a result of the clinical benefit and I'm going to touch on those in a little bit more detail on the next couple of slides. Those clinical benefits plus the options that we have to potentially extend the injection interval that is required currently for the treatment of acromegaly plus the potential for higher doses with our formulation, plus the potential for subcutaneous administration could really set this product apart in the treatment of these diseases. And to round it all off, we have patent protection of our intellectual property and know-how well into the 2030s.

我們相信，基於我們內部開發的 Q-Sphera 技術以及我們從第一階段研究中看到的驗證，MTD201 產品有幾個優勢。首先，技術的精度以及我們如何提供它以及我們如何制定它轉化為可證明和經過驗證的臨床效益。我們在臨床前和第一階段研究中都看到了這一點。更快、更安全、更高效的生產流程將轉變為更高效的製造平台。由於臨床效益而產生的競爭優勢，我將在接下來的幾張幻燈片中更詳細地討論這些優勢。這些臨床益處加上我們必須潛在地延長目前治療肢端肥大症所需的注射間隔的選擇，再加上我們的配方更高劑量的潛力，再加上皮下注射的潛力，確實可以使該產品在治療肢端肥大症方面脫穎而出。這些疾病。最後，到 2030 年代，我們的知識產權和專有技術都受到專利保護。

The next slide just shows an overview and a reminder of the Phase I study. It was a Phase I study in healthy volunteers where we had set PK and PD endpoints, commenced in May 2018, completed in September 2018. Strong data was generated on the release profile, therapeutic effects as well as the usability of 201 and it was a very solid validation of the Q-Sphera technology as a sustained release drug delivery platform.

下一張幻燈片僅顯示第一階段研究的概述和提醒。這是一項針對健康志願者的 I 期研究，我們設定了 PK 和 PD 終點，於 2018 年 5 月開始，於 2018 年 9 月完成。關於 201 的釋放曲線、治療效果以及可用性產生了強有力的數據，這是對 Q-Sphera 技術作為緩釋藥物遞送平台的非常可靠的驗證。

The next slide, 10, all of this is likely familiar data to you. So the intention is not to go into detail, but it's worth repeating and summarizing on a single slide to capture how significant and advanced the Q-Sphera MTD201 could be. There is 5 boxes of information, I'll go through each of them individually.

下一張幻燈片 10，所有這些可能都是您熟悉的數據。因此，我們的目的不是要詳細介紹，但值得在一張幻燈片上重複和總結，以體現 Q-Sphera MTD201 的重要性和先進性。有 5 個信息框，我將逐一瀏覽。

Box number one, looks at the pharmacodynamics and I appreciate that there is a lot of information and the graphics are slightly small, but as I mentioned, the intention is not to go into detail, but just to capture these individual aspects. So box one is looking at the pharmacodynamics where we assess the suppression of the growth -- normalization of growth hormone in MTD201 subjects versus Sandostatin LAR subjects. These graphs are looking at the comparison of baseline reduction versus day 28 reduction. The top plot of each graph is baseline and the bottom plot of each graph is day 28. And we see both for MTD201 as well as Sandostatin LAR, very, very similar therapeutic effect in terms of suppression and normalization of growth hormone, roughly about 25% for each of the patient groups. So very solid performance on the therapeutic side of things effectively matching the Novartis product, which is what we intended to do and we set out to do.

第一個方框是藥效學，我很欣賞其中有很多信息，而且圖形有點小，但正如我提到的，目的不是要深入細節，而只是為了捕捉這些單獨的方面。因此，方框一是研究藥效學，我們評估了 MTD201 受試者與善寧 LAR 受試者的生長抑制——生長激素正常化。這些圖表著眼於基線減少量與第 28 天減少量的比較。每個圖的頂部圖是基線，每個圖的底部圖是第 28 天。我們發現 MTD201 和 Sandostatin LAR 在生長激素抑制和正常化方面的治療效果非常非常相似，每個患者組的治療效果大約為 25% 左右。因此，在治療方面的表現非常可靠，與諾華產品有效匹配，這正是我們打算做的，也是我們著手做的。

The second box there is looking at pharmacokinetics and the key message here is we generated very favorable release kinetics and far less variable release profile compared to Sandostatin LAR. The top plot over there is looking at the full 63 days of the patient period for the study. The orange profile is Sandostatin LAR. The blue profile is MTD201. Quite clearly, the Sandostatin LAR, the orange profile, administration from the beginning is not really under control. There is an immediate burst or dumping of active pharmaceutical ingredient Octreotide that then settles down in the first 24 hours and then there is a second, large, uncontrolled peak, even larger than the initial peak and then it settles down and declines over the 63 days, whereas the MTD201 profile, the blue plot, a nice gradual uptake, a plateau and then tapering off towards the end of the treatment period.

第二個方框是藥代動力學，這裡的關鍵信息是我們產生了非常有利的釋放動力學，並且與 Sandostatin LAR 相比，釋放曲線的變化要小得多。上面的圖顯示了該研究的患者整個 63 天的時間。橙色輪廓是善寧 LAR。藍色配置文件是 MTD201。很明顯，善寧 LAR（橙色輪廓）的給藥從一開始就沒有真正受到控制。活性藥物成分奧曲肽立即爆發或傾倒，然後在前 24 小時內穩定下來，然後出現第二個較大的、不受控制的峰值，甚至大於初始峰值，然後在 63 天內穩定下來並下降，而 MTD201 曲線，藍色圖，良好的逐漸吸收，平台期，然後在治療期結束時逐漸減少。

The 2 bottom graphs look at individual patient profiles. So the top graph is looking at average profiles for the 2 groups and the bottom 2 graphs are looking at individual profiles of the first 7 days. If you look at the left one of those, I am still in box 2 just to be clear. If you look at the left of those, that is MTD201 Octreotide profile and it's very consistent, very linear, very predictable and no surprises, really under control. If we look at the graph on the right, which is the Sandostatin LAR graph, it's very erratic, highly variable. Some subjects are getting super normal levels of Octreotide. Other subjects are not getting any Octreotide for a period of time. So overall, very encouraging performance of the technology and the product.

底部的 2 個圖表顯示了患者的個人資料。因此，頂部的圖表查看的是 2 個組的平均概況，底部的 2 個圖表查看的是前 7 天的個人概況。如果你看一下左邊的一個，為了清楚起見，我仍然在方框 2 中。如果你看一下左邊的數據，那就是 MTD201 奧曲肽曲線，它非常一致、非常線性、非常可預測，沒有意外，真正處於控制之中。如果我們看一下右邊的圖表，即善寧 LAR 圖，它非常不穩定，變化很大。有些受試者的奧曲肽水平超正常。其他受試者在一段時間內沒有服用任何奧曲肽。總的來說，技術和產品的表現非常令人鼓舞。

The third and fourth box look at usability of the product for healthcare practitioners and physicians, which is an important aspect of this treatment given that they are such chronic diseases and highly intensive in terms of healthcare needs. Reconstitution is done at the bedside for both 201 and Sandostatin LAR. Following the published process of Novartis' MTD201, that product takes up to 40 minutes to reconstitute. It requires 26 or 27 steps. That's very lab intensive, so the healthcare practitioner needs to be around to perform all of these steps as and when they are required. And once the product is reconstituted, it needs to be injected immediately. It cannot be left to stand because it will just congeal and that product will be wasted, which sales at several thousand pounds or dollars a pop becomes expensive.

第三個和第四個框著眼於產品對醫療保健從業者和醫生的可用性，這是這種治療的一個重要方面，因為它們是慢性疾病並且在醫療保健需求方面高度密集。201 和善寧 LAR 均在床邊進行重構。按照諾華 MTD201 公佈的流程，該產品最多需要 40 分鐘才能重新配製。它需要 26 或 27 個步驟。這是實驗室密集型工作，因此醫療保健從業者需要在需要時執行所有這些步驟。一旦產品被重構，就需要立即註射。它不能靜置，因為它只會凝結並且該產品將被浪費，每瓶售價數千英鎊或美元的價格變得昂貴。

MTD201 on the other hand, it takes 6 or 7 steps, maximum 10 minutes, on average 5 to 7 minutes. And once it's reconstituted, it's stable for up to 2 hours. So there is no urgency for the healthcare practitioner or the patient to administer it immediately. If something -- if they need to do something or go to the toilet or whatever, there is no issue with that. And the result is of the reconstitution process is that there's far less wastage in the MTD201 product compared to Sandostatin LAR. Far less errors, far simpler and overall, a much improved patient and healthcare provider experience.

而MTD201則需要6到7步，最多10分鐘，平均5到7分鐘。一旦重新配製，它可以穩定長達 2 小時。因此，醫療保健從業者或患者並不急於立即給藥。如果有什麼事情——如果他們需要做某事或者去廁所之類的，那沒有問題。重構過程的結果是，與 Sandostatin LAR 相比，MTD201 產品的浪費要少得多。錯誤少得多，簡單得多，總體而言，患者和醫療保健提供者的體驗大大改善。

Block #4 looks at needle size and the Sandostatin LAR needle size is a 19-gauge needle, which is a large needle that is required to inject this into the muscle of the buttocks typically and it's a deep injection, it's a painful injection with the 19-gauge needle.

第 4 部分查看針頭尺寸，善寧 LAR 針頭尺寸為 19 號針頭，通常需要將其註射到臀部肌肉中，這是一個大針頭，並且是深層注射，這是一次痛苦的注射19 號針。

Over and above that in 30% of cases, the 19-gauge needle will -- it will block because of the formulation, meaning that, that particular injection will be wasted and subsequently, an 18-gauge needle is often used by the healthcare practitioner. And an 18-gauge needle -- if a 19-gauge needle hurts, an 18-gauge needle stings. So not very pleasant for the patient at all.

除此之外，在 30% 的情況下，19 號針頭會因配方而堵塞，這意味著該特定注射將被浪費，隨後醫療保健從業者通常會使用 18 號針頭。還有 18 號針——如果 19 號針刺痛，那麼 18 號針也會刺痛。所以對於病人來說根本不是很愉快。

For the MTD201 administration, it's a 21-gauge needle and we're working to even smaller gauge needles, that's far less painful. No blockage whatsoever even though it's a small needle. And we see that in the clinical study this translated into lower pain and tenderness at the injection site of only 8% for MTD201 versus more than 80% for Sandostatin LAR. So a clear difference between the patient experience on 201 and Sandostatin LAR.

對於 MTD201 管理，它是 21 號針頭，我們正在研究更小號的針頭，這樣痛苦要小得多。即使是小針，也沒有任何堵塞。我們在臨床研究中發現，MTD201 的注射部位疼痛和壓痛減輕程度僅為 8%，而善寧 LAR 的疼痛和壓痛程度則超過 80%。因此，患者對 201 和善寧 LAR 的體驗存在明顯差異。

The final, block #5 on that slide, captures the additional competitive advantages. So the first 4 blocks of the slide cover off several advantages based on the clinical data. And if that wasn't enough, we also have additional differentiators over and above that, specifically and by the way, Sandostatin LAR cannot do any of these. Specifically, any increased dosing interval of up to 6 to 8 weeks compared to the 4 weeks with Sandostatin LAR, a higher dose, currently, the dose of Sandostatin LAR is 30 milligrams and it is not possible to increase that dose unless an additional injection is used. In other words, they cannot load additional dosing to the vial. So if a higher dose is needed, then it means a second painful, complicated, expensive injection.

最後，該幻燈片上的第 5 塊，體現了額外的競爭優勢。因此，幻燈片的前 4 塊涵蓋了基於臨床數據的幾個優點。如果這還不夠，我們還有其他差異化優勢，特別是，順便說一句，善寧 LAR 無法做到這些。具體來說，與善寧 LAR 的 4 週相比，任何增加的給藥間隔長達 6 至 8 週，劑量更高，目前善寧 LAR 的劑量為 30 毫克，除非額外注射，否則不可能增加該劑量。用過的。換句話說，他們無法將額外的劑量裝載到小瓶中。因此，如果需要更高的劑量，則意味著需要進行第二次痛苦、複雜且昂貴的注射。

Whereas with Midatech MTD201, we can go up to 45, potentially 60 milligrams and more in the same vial with the same injection volume or potentially even reduced injection volume and that's the key factor -- key second differentiator. And the third key differentiator is subcutaneous dosing, rather than intramuscular. So with Sandostatin LAR, it has to be given intramuscular. With the Midatech formulation, we can give it subcutaneous as well, that's part of our ongoing assessment. And subcutaneous would be an important advance in this disease because it allows patients to self administer, whereas currently they need to go into the clinic every 4 weeks, travel from afar, incur costs, et cetera, et cetera. Whereas for subcutaneous injection, self administration and potentially also via autoinjector.

而使用 Midatech MTD201，我們可以在同一小瓶中以相同的注射量或什至可能減少注射量，達到 45 毫克、可能 60 毫克甚至更多，這是關鍵因素——關鍵的第二個差異化因素。第三個關鍵區別是皮下給藥，而不是肌肉注射。因此，對於善寧LAR，必須肌肉注射。通過 Midatech 配方，我們也可以皮下注射，這是我們正在進行的評估的一部分。皮下注射將是這種疾病的一個重要進步，因為它允許患者自行給藥，而目前他們需要每 4 週去一次診所，遠道而來，產生費用等等。而皮下注射則需要自行給藥，也可能通過自動注射器給藥。

Slide #11 covers the next steps. So we're going to finalize the optimal study design in the first half of this year, which will look at the differentiated product versus an equivalent product. We will commence the follow-on study program in H2, 2019, and then planning for NDA and subsequent commercialization in 2021.

幻燈片 #11 介紹了後續步驟。因此，我們將在今年上半年完成最佳研究設計，該設計將比較差異化產品與同等產品。我們將在2019年下半年開始後續研究計劃，然後計劃在2021年進行NDA和隨後的商業化。

The second priority that I wanted to talk to is our MTX110 program. I'm now on Slide 13. Using our MidaSolve technology where we solubilize insoluble drugs and our first indication is childhood brain cancer, DIPG an ultra-orphan disease, very debilitating, 1000 patients worldwide with a median survival of roughly 9 months. There are no effective treatments whatsoever. Drug cannot cross the blood-brain barrier. The treatments that are used are very toxic and the disease is debilitating, the treatment is debilitating, but patients and parents have no options because there is nothing else.

我想談的第二個重點是我們的 MTX110 項目。我現在在幻燈片 13 上。使用我們的 MidaSolve 技術，我們可以溶解不溶性藥物，我們的第一個適應症是兒童腦癌，DIPG 是一種超級孤兒疾病，非常使人衰弱，全世界有 1000 名患者，中位生存期約為 9 個月。沒有任何有效的治療方法。藥物不能穿過血腦屏障。使用的治療方法毒性很大，疾病使人衰弱，治療使人衰弱，但患者和家長別無選擇，因為別無選擇。

The active ingredient we use is Panobinostat, which has been found in 85%, which -- let me start that again. In 85% of these tumors, a genetic mutation called the K27M-H3.3 has been found in these DIPG tumors in 85% of them and that has resulted in a high level of interest in drugs called HDAC inhibitors, such as Panobinostat.

我們使用的活性成分是 Panobinostat，其含量為 85%，讓我再次開始。在 85% 的這些腫瘤中，在 85% 的 DIPG 腫瘤中發現了一種稱為 K27M-H3.3 的基因突變，這導致人們對稱為 HDAC 抑製劑（例如帕比司他）的藥物產生了高度興趣。

Panobinostat is the active ingredient for MTX110 and they act directly on those genetic mutations. It has been demonstrated preclinically as most potent, maybe the most potent agent against human DIPG cells. It is only available in oral form. So from that perspective, it cannot be used in this disease. We've converted it into a liquid form and we're looking to establish a new treatment paradigm using MTX110, where Panobinostat in the form of MTX110 is injected directly into the tumor.

帕比司他是 MTX110 的活性成分，它們直接作用於這些基因突變。它已在臨床前被證明是最有效的，也許是對抗人類 DIPG 細胞的最有效的藥物。它僅以口頭形式提供。所以從這個角度來說，它不能用於這種疾病。我們已將其轉化為液體形式，並希望使用 MTX110 建立一種新的治療範例，其中將 MTX110 形式的帕比司他直接注射到腫瘤中。

Slide 14. This is the study design commenced in May of this year -- sorry, of 2018. It's a Phase I -- combined Phase I and Phase II. Phase I is safety and dose escalation, Phase II is efficacy. The Phase I was originally planned and scheduled for 5 doses. The program has gone very well. The patients have tolerated the therapy very well. And in fact, that has allowed us to add an additional 2 doses to the study design. So we now have dose level 6 and dose level 7. Still on track to finish at the originally estimated time line of H1, 2019. And once we get to dose level 7, assuming that, that is safe and the patients do well out of that then that will become the recommended Phase II dose that we'll take into the efficacy phase of the -- efficacy component of the study and of the program.

幻燈片 14。這是今年 5 月開始的研究設計——抱歉，是 2018 年開始的。這是第一階段——第一階段和第二階段的結合。I 期是安全性和劑量遞增，II 期是療效。第一階段最初計劃注射 5 劑。該計劃進展順利。患者對治療的耐受性很好。事實上，這使我們能夠在研究設計中添加額外的 2 劑劑量。因此，我們現在有劑量水平 6 和劑量水平 7。仍有望在 2019 年上半年的最初預計時間線完成。一旦我們達到劑量水平 7，假設這是安全的並且患者表現良好，那麼這將成為推薦的 II 期劑量，我們將進入該研究的功效部分的功效階段和該計劃。

So in fact, progressing ahead of schedule. Patients have tolerated the therapy very well and we're looking forward to establishing a higher recommended Phase II dose than we had originally planned for without compromising the time line.

事實上，進展提前了。患者對該療法的耐受性非常好，我們期待在不影響時間線的情況下確定比我們最初計劃更高的推薦 II 期劑量。

So Slide 15, next step there is to complete the U.S. clinical study and pending data, had some serious discussions with the regulators. And then, as a follow-on program, GBM is effectively the adult counterpart of this disease that we will be looking to potentially establish an IND/enabling

因此幻燈片 15，下一步是完成美國臨床研究和待定數據，與監管機構進行了一些認真的討論。然後，作為後續計劃，GBM 實際上是這種疾病的成人對應物，我們將尋求潛在地建立 IND/使能

program in 2019, that's currently preclinical, but depending on data, we could be looking to enter the clinic at some point in time.

2019 年的項目，目前處於臨床前階段，但根據數據，我們可能希望在某個時間點進入臨床。

From a manufacturing perspective, this is the next slide. This is the third priority that I spoke to -- that I mentioned. On Slide 17, we see 2 photos there. The top photo is the current facility, the second floor of the current facility where we do all our own in-house manufacturing. Midatech is unique in this regard and the fact that we manufacture in-house allows us to control our own intellectual property, control our know-how, control our cost, control our time lines and this is a key part of the organization. We're licensed by the Spanish Medicines Agency. The lower photo over there is looking at the commercial scale up, which will be on the same technology park in Bilbao in Spain.

從製造角度來看，這是下一張幻燈片。這是我談到的第三個優先事項——我提到過。在幻燈片 17 上，我們看到了 2 張照片。上面的照片是當前的工廠，當前工廠的二樓，我們在那裡進行所有內部製造。Midatech 在這方面是獨一無二的，我們內部製造的事實使我們能夠控制我們自己的知識產權、控制我們的專有技術、控制我們的成本、控制我們的時間線，這是組織的關鍵部分。我們獲得了西班牙藥品管理局的許可。那邊下面的照片是商業規模的擴大，它將位於西班牙畢爾巴鄂的同一個科技園區。

It will complete primary manufacture of our product and potentially fill and finish of the final product as well or we could do that in partnership with CMOs. The current target is 150,000 vials per year of MTD201, which is probably about 10 -- 10% to 15% of the global volume of vials. We require to complete this prior to filing of the NDA in 2021. And as I mentioned earlier, we're very pleased to secure loan finance from the Spanish government in the total amount of EUR 8.6 million.

它將完成我們產品的初級製造，並有可能完成最終產品的填充和完成，或者我們可以與 CMO 合作來完成。目前的目標是每年生產 150,000 瓶 MTD201，這可能約佔全球小瓶數量的 10 - 10% 至 15%。我們要求在 2021 年提交 NDA 之前完成此工作。正如我之前提到的，我們非常高興能夠從西班牙政府獲得總額為 860 萬歐元的貸款融資。

Next slide, 18, a bit about China Medical Systems. So these were the cornerstone investor on the last fundraise and now a majority shareholder in the company. They are well-established, innovation driven, highly regarded pharmaceutical company based out of Hong Kong, listed on the Hong Kong Stock Exchange, were previously on the AIM London Stock Exchange. Their market cap is roughly $4 billion. They cover 44,000 hospitals and have up to 4,000 strong sales representatives and that doesn't take into account the rest of the staff they had. We've entered into a license agreement with them where they have a license for all of our assets -- our pipeline assets in greater China and Southeast Asia for 3 years, preclinical and clinical, and for that we get regulatory and sales milestones plus royalties.

下一張幻燈片，18，介紹一下中國醫療系統。因此，他們是上次融資的基石投資者，現在是公司的大股東。他們是一家歷史悠久、創新驅動、備受推崇的製藥公司，總部位於香港，在香港證券交易所上市，此前曾在 AIM 倫敦證券交易所上市。他們的市值約為 40 億美元。他們覆蓋 44,000 家醫院，擁有多達 4,000 名強大的銷售代表，這還不包括他們的其他員工。我們與他們簽訂了一份許可協議，他們擁有我們所有資產的許可——我們在大中華區和東南亞的管道資產，為期三年，包括臨床前和臨床，為此我們獲得監管和銷售里程碑以及特許權使用費。

There is also the opportunity for CMS to identify opportunities that Midatech are not focused on or cannot -- because of capacity constraints, cannot focus on. And we would develop it to a point, tech transfer to CMS and they would complete the development thereof. For such product, if they do get marketing approval, CMS will retain or own the rights in China and Southeast -- Greater China and Southeast Asia and Midatech will retain those rights in the rest of the world.

CMS 還有機會發現 Midatech 不關注或無法關注的機會——由於能力限制，無法關注。我們會將其發展到一定程度，將技術轉讓給 CMS，他們將完成其開發。對於此類產品，如果獲得上市批准，CMS將保留或擁有在中國和東南亞——大中華區和東南亞的權利，而Midatech將保留在世界其他地區的這些權利。

So Slide 19 and the financial slides, I'm going to hand over to Nick, Midatech's CFO.

因此，我將把幻燈片 19 和財務幻燈片交給 Midatech 的首席財務官 Nick。

Thank you very much, Craig. Good afternoon and good morning, everybody depending on where you are. So looking at Slide 19, the financial highlights for the year ended 31 December 2018.

非常感謝你，克雷格。下午好，早上好，每個人都取決於你在哪裡。請看幻燈片 19，這是截至 2018 年 12 月 31 日止年度的財務摘要。

During the year, as Craig has said, we sold our U.S. commercial operation, Midatech Pharma US, and that has resulted in a number of accounting peculiarities that I think it's important to understand in terms of how we're required to present our financial information for 2018.

正如克雷格所說，這一年裡，我們出售了我們的美國商業業務 Midatech Pharma US，這導致了許多會計特點，我認為了解我們如何提供財務信息非常重要2018 年。

So the income statement and the financial highlights are shown on Slide 19. They are for continuing operations. This represents the ongoing European R&D business. On the income statement, the discontinued operations, i.e., U.S. commercial business is represented by a single line and that continuing operations basis is true of the 2018 numbers, but also for the comparative numbers, 2017 and 2016. The balance sheet, the 2018 numbers are for the continuing operations but somewhat confusingly, we have to present the prior year figures on an all operations basis. So you'll see a bit of a mismatch there. We'll have a look at those figures shortly. And the cash flow, that is presented on an all operations basis.

因此，損益表和財務亮點如幻燈片 19 所示。它們用於持續運營。這代表了正在進行的歐洲研發業務。在損益表中，已終止經營業務（即美國商業業務）由一條線表示，持續經營基礎適用於 2018 年的數據，也適用於 2017 年和 2016 年的比較數據。資產負債表中，2018 年的數據針對的是持續經營業務，但有些令人困惑的是，我們必須在所有業務的基礎上呈現上一年的數據。所以你會發現那裡有一點不匹配。我們很快就會看到這些數字。以及以所有運營為基礎呈現的現金流量。

So back on Slide 19, revenues from continuing operations for the year ended December 2018, this includes collaboration income where we're working with partners utilizing our platform technologies and also from large grant programs [Master and Jim] grant programs, 2 in particular, both funded by the European Union. So revenues were up 96% for the year. There is a relatively small amount of collaboration income in there, GBP 149,000, which is consistent with 2017 and the balance from these 2 large grant programs.

回到幻燈片 19，截至 2018 年 12 月的持續運營收入，其中包括我們與利用我們的平台技術的合作夥伴合作的合作收入，以及來自大型贈款計劃 [Master 和 Jim] 贈款計劃的收入，特別是 2，兩者均由歐盟資助。因此，全年收入增長了 96%。其中合作收入相對較少，為 149,000 英鎊，與 2017 年以及這兩個大型資助計劃的餘額一致。

The expectation base principally around one of the ongoing grant program and another that is kicking off as we speak is that collaboration income will be significantly high for 2019.

主要圍繞正在進行的贈款計劃和我們講話時正在啟動的另一個贈款計劃的預期基礎是，2019 年的合作收入將非常高。

R&D expenditure was up 12% on the prior year and this really reflects the activities in putting both the MTD201 and MTX110 programs into the clinic and then running those clinical trials throughout 2018.

研發支出比上一年增長了 12%，這確實反映了將 MTD201 和 MTX110 項目投入臨床並在 2018 年進行這些臨床試驗的活動。

Admin costs, up 3%. However, once you strip out depreciation and amortization and this is set out in note 3 to the consolidated financial statements, which is included within the prelims announcement that we published today. So once you strip out depreciation and amortization, the admin cost is GBP 4.09 million and that's down 4% on 2017 and this is despite there being GBP 0.5 million of one-off costs associated with the early settlement of the mid-cap loan facility that we secured at the end of 2017 and repaid in November 2018 as part of that MPUS, Midatech Pharma US sale process.

管理成本上漲 3%。然而，一旦剔除折舊和攤銷，這將在合併財務報表附註 3 中列出，該附註包含在我們今天發布的初步公告中。因此，一旦剔除折舊和攤銷，管理成本為 409 萬英鎊，比 2017 年下降 4%，儘管與提前結算中盤貸款便利相關的一次性成本為 50 萬英鎊，作為 MPUS（Midatech Pharma US 銷售流程的一部分），我們於 2017 年底獲得貸款並於 2018 年 11 月償還。

2018 also reflects a full year of reduced Board costs. So we undertook to shareholders in October of 2017 to reduce Board costs and all members of the Board took a significant salary and pay reduction. So those costs are fully reflected -- those cost savings were fully reflected throughout 2018. And also Craig has mentioned earlier, the closure of the Abingdon, Milton Park R&D facility. That unfortunately resulted in 12 redundancies. The redundancy costs for those 12 people are included in the 2018 numbers. So if you factor all that in, the expectation is that admin costs for 2019 will be materially lower than they were for '18.

2018 年還反映出全年董事會成本的減少。因此我們在2017年10月向股東承諾降低董事會成本，所有董事會成員都大幅減薪。因此，這些成本得到了充分體現——這些成本節約在 2018 年得到了充分體現。克雷格之前也提到過，關閉米爾頓公園阿賓登研發設施。不幸的是，這導致了 12 名裁員。這 12 人的裁員成本包含在 2018 年的數字中。因此，如果將所有這些因素考慮在內，預計 2019 年的管理成本將大大低於 18 年。

And the final of those highlights from Slide 19, cash and deposits at the end of 2018, GBP 2.34 million. However, as Craig has said, we concluded the fundraise in February of this year where we raised GBP 13.4 million gross, GBP 12.5 million net, after costs and that extends the runway well into 2020, allowing us to deliver a number of the milestones that Craig has outlined earlier.

第 19 張幻燈片中的最後一個要點是，2018 年底的現金和存款為 234 萬英鎊。然而，正如克雷格所說，我們於今年 2 月完成了融資，扣除成本後，我們籌集了總額 1,340 萬英鎊的資金，淨額為 1,250 萬英鎊，並將融資期限延長到 2020 年，使我們能夠實現以下幾個里程碑：克雷格早些時候已經概述過。

And just briefly, some of the other figures on that page. Net loss from continuing operations GBP 10.37 million that is down 11% on the prior year. The loss from discontinued operations, this is the U.S. business, GBP 4.66 million, that includes one-off GBP 1.41 million loss realized on disposal of that business.

簡單地介紹一下該頁上的其他一些數字。持續經營業務淨虧損 1037 萬英鎊，比上年下降 11%。終止經營造成的損失，這是美國業務，466萬英鎊，其中包括因處置該業務而實現的一次性損失141萬英鎊。

Net cash outflow in the period, GBP 10.88 million. However -- and that compares to GBP 4.51 million in the prior year. However, the 2018 figure includes the proceeds from the sale of the U.S. business, but also the repayment of the mid-cap loan facility. And similarly the '17 numbers, that includes proceeds from a fundraise and also, the mid-cap loan advance. If you adjust both of those figures for those exceptional items, then the 2018 figure is GBP 14.7 million and that compares to GBP 15.12 million, so down 3% cash outflow for '18 compared to '17.

期內現金淨流出1088萬英鎊。然而，相比之下，去年的收入為 451 萬英鎊。然而，2018 年的數字包括出售美國業務的收益，也包括中型貸款融資的償還。與 17 年的數據類似，其中包括籌款收益以及中型股貸款預付款。如果您調整這些特殊項目的這兩個數字，那麼 2018 年的數字為 1,470 萬英鎊，而相比之下為 1,512 萬英鎊，因此 18 年的現金流出比 17 年下降了 3%。

So turning to the income statement. I have talked already about I think some of the more interesting features. I'll draw out a couple of other points. So the impairment charge in 2017, for those of you who are not familiar with Midatech, we have an asset called OpsiSporin, and it's another sustained-release formulation. And to the point Craig was making, it is not our current focus. That asset is still valid, but we took the decision in 2017 to park it and focus our resources on the main programs. So that impairment charge relates to that asset. And in 2018, if you look at the tax line, GBP 2.032 million compared to GBP 1.2 million in the previous year, these represent R&D tax credits receivable from the U.K. tax authorities. And because the level of qualifying R&D activity has increased during the year, then we are entitled to receive more in the way of these R&D tax credits, very useful.

所以轉向損益表。我已經談到了我認為一些更有趣的功能。我將提出其他幾點。所以2017年的減值費用，對於那些不熟悉Midatech的人來說，我們有一種資產叫做OpsiSporin，它是另一種緩釋製劑。就克雷格所說的觀點而言，這不是我們當前的重點。該資產仍然有效，但我們在 2017 年決定將其擱置，並將資源集中用於主要項目。因此，減值費用與該資產相關。2018 年，如果你看一下稅收額度，你會發現，去年的稅收額度為 203.2 萬英鎊，而上一年為 120 萬英鎊，這些代表了應從英國稅務機關收到的研發稅收抵免。由於合格的研發活動水平在這一年中有所提高，因此我們有權以這些研發稅收抵免的方式獲得更多，這非常有用。

Turning to the balance sheet on Slide 21. Just to reiterate, the 2018 figures are on a continuing basis because as at the end of the year, that U.S. commercial operation was gone. So we don't reflect that on the balance sheet whereas the '17 numbers, that includes all operations. Current assets include that GBP 2.34 million of cash. The balance represents receivable, including the R&D tax credit of approximately GBP 2 million. Noncurrent liabilities is largely Spanish government's soft loans of roundabout or just under a GBP 1 million. These were originally advanced from about 2007 to help us build that manufacturing facility in Spain. And as Craig says, we are currently expecting to receive further Spanish government finance. And current liabilities, they are outlined in the notes of the account, but principally accruals and deferred income make up more than half of that figure.

轉向幻燈片 21 上的資產負債表。重申一下，2018 年的數據是連續的，因為截至年底，美國的商業運營已經結束。因此，我們不會在資產負債表上反映這一點，而 17 年的數字則包括所有業務。流動資產包括234萬英鎊現金。餘額為應收賬款，包括約 200 萬英鎊的研發稅收抵免。非流動負債主要是西班牙政府的軟貸款，金額略低於 100 萬英鎊。這些最初是從 2007 年左右開始推進的，目的是幫助我們在西班牙建設製造工廠。正如克雷格所說，我們目前預計將獲得西班牙政府的進一步資助。流動負債在賬戶附註中列出，但主要是應計費用和遞延收入，佔該數字的一半以上。

And finally, turning to the cash flow, I've already talked to the main points here, but just to reiterate, the cash generated from or used in investing activities. In 2018, that positive number includes proceeds of sales from the U.S. commercial operation and the cash generated from or used in financing activities. In 2018, that includes the repayment of the mid-cap loan facility and in 2017, includes the advance of that mid-cap loan facility, and also, the fundraise we did in that year. And now, I'll hand back to Craig.

最後，談到現金流，我已經討論了這裡的要點，但只是重申一下，投資活動產生或使用的現金。2018 年，該正數包括美國商業運營的銷售收益以及融資活動產生或使用的現金。2018 年，這包括償還中盤貸款便利，2017 年，包括預付中盤貸款便利，以及我們當年進行的籌款。現在，我將交還給克雷格。

Thank you, Nick. So Slide 23 illustrates and outlines the newsflow that we are expecting and planning for over the next 18 to 24 months. Starting with Q-Sphera. Clearly, the pivotal program is foremost in our focus starting with the phase start -- with the program starts during 2019, H2 2019 and completing towards the end of 2020, depending on which route we decide to take, whether it's a differentiated route or an equivalent route. That decision will be made during H1 2019, likely during the course of May, but certainly, during the first half of 2019.

謝謝你，尼克。因此，幻燈片 23 說明並概述了我們在未來 18 到 24 個月內預期和計劃的新聞流。從 Q-Sphera 開始。顯然，關鍵計劃是我們從階段啟動開始的首要關注點——該計劃於 2019 年、2019 年下半年開始，並於 2020 年底完成，具體取決於我們決定採取哪條路線，無論是差異化路線還是差異化路線。等效路線。該決定將在 2019 年上半年做出，可能是在 5 月份，但肯定是在 2019 年上半年。

In addition, as I mentioned, the manufacturing scale up, which has already commenced for 201, that is likely to take 18 to 24 months and that will complete or need to complete prior to NDA submission, which is planned for early 2021.

此外，正如我所提到的，生產規模擴大已於 201 年開始，可能需要 18 至 24 個月的時間，並將在計劃於 2021 年初提交 NDA 之前完成或需要完成。

For MidaSolve, the clear focus and newsflow will revolve around the Phase I study at UCSF and Memorial Sloan Kettering. As I mentioned earlier on, the safety Phase I component of that has progressed really well and we're looking to enter the Phase II component of that in H2 of this year and that is on track. And then, depending on data, we would like to have that all completed and recruitment, we would like to have all of that completed during the second half of 2020, probably towards the end.

對於 MidaSolve 來說，明確的焦點和新聞流將圍繞加州大學舊金山分校和紀念斯隆凱特林大學的第一階段研究。正如我之前提到的，第一階段的安全部分進展非常順利，我們希望在今年下半年進入第二階段的部分，並且正在按計劃進行。然後，根據數據，我們希望所有這些都完成，並且招聘，我們希望在 2020 年下半年（可能是年底）完成所有這些工作。

In addition, GBM is a potential option for us to pursue and if we did pursue that based on the data that we generate preclinically, then we would look for IND submission during the first half of 2020. There is a second study for MTX110 planned in Europe, but that is subject to grant funding as well as approval by Swissmedic.

此外，GBM 是我們追求的一個潛在選擇，如果我們確實根據臨床前生成的數據進行追求，那麼我們將在 2020 年上半年尋求 IND 提交。歐洲計劃對 MTX110 進行第二項研究，但這需要撥款以及 Swissmedic 的批准。

Business development is a big focus of the company given that all our technologies are now validated and into the clinic. So for this year, it's going to be a key focus of the company and we're pursuing multiple programs as well as for new platform technology. MidaCore, the gold nanoparticle technology, given resource constraints and the focus on Q-Sphera and MidaSolve, the programs in MidaCore will be supported, but not -- we won't be able to advance them until we get further funding. But for now, the programs that are ongoing will be supported and will continue to evaluate the data that is generated. And as Nick mentioned, the runway that we've secured as a result of the recent fundraise, we estimate to cover the near and medium term clinical goals for both MTD201, MTX110 as well as manufacturing.

鑑於我們所有的技術現已經過驗證並進入臨床，業務發展是公司的一大重點。因此，今年，這將成為公司的重點，我們正在尋求多個項目以及新的平台技術。MidaCore，金納米粒子技術，考慮到資源限制以及對 Q-Sphera 和 MidaSolve 的關注，MidaCore 中的項目將得到支持，但不是——在獲得進一步的資金之前，我們將無法推進它們。但目前，正在進行的計劃將得到支持，並將繼續評估生成的數據。正如 Nick 提到的，我們通過最近的融資獲得了跑道，我們預計將覆蓋 MTD201、MTX110 以及製造的近期和中期臨床目標。

So Slide 24, excuse me, just summarizes the contents that I have been through. 2018 really marked a new chapter for the company, characterized, we believe by strong fundamentals and exciting prospects in terms of several components, including first of all, the new strategy, which is delivering. We have an R&D-focused management team who know what is needed and how to do it and I think that is reflected in the achievements during 2018.

所以幻燈片 24，對不起，只是總結了我所經歷的內容。2018 年確實標誌著該公司的新篇章，我們相信，其特點是在多個方面具有強勁的基本面和令人興奮的前景，首先包括正在實施的新戰略。我們擁有一支專注於研發的管理團隊，他們知道需要什麼以及如何去做，我認為這反映在 2018 年的成就中。

The very promising clinical data that validates what we are doing and how we are doing it. And most programs are on schedule, on track, that will hopefully set up rich newsflow over the next 18 to 24 months. The second key pillar is the assets that we are developing, all in underserved markets where the significant unmet needs of these markets are met or matched by the competitive advantages of our programs and platforms. All of these programs are wholly owned and the data speaks for itself as I went through earlier.

非常有希望的臨床數據驗證了我們正在做的事情以及我們如何做。大多數計劃都按計劃進行，步入正軌，有望在未來 18 到 24 個月內建立豐富的新聞流。第二個關鍵支柱是我們正在開發的資產，所有這些資產都位於服務不足的市場，這些市場的未滿足的重大需求通過我們的計劃和平台的競爭優勢得到滿足或匹配。所有這些程序都是全資擁有的，正如我之前所經歷的那樣，數據不言而喻。

We have a de-risk or a risk managed portfolio based on the fact that we take existing agents for which safety and efficacy has really already been established and approved by regulators. All our technologies are into the clinic. That doesn't mean there is not going to be challenges. But it does mean that what we have addressed to this point and the fact that we're able to -- have been able to address those challenges as well as the fact that should future challenges appear, we're in a good space to address those. We're a multiple drug company with multiple programs. We aren't just a single drug company.

我們擁有去風險或風險管理的投資組合，基於這樣一個事實：我們採用的現有藥物的安全性和有效性確實已經得到監管機構的確定和批准。我們所有的技術都進入了臨床。這並不意味著不會遇到挑戰。但這確實意味著我們到目前為止所解決的問題以及我們能夠解決這些挑戰的事實以及如果未來出現挑戰的事實，我們有一個很好的空間來解決那些。我們是一家擁有多個項目的多元化製藥公司。我們不僅僅是一家製藥公司。

And then the final pillar, the platform opportunities. The nature of our technologies are platform and the fact that we have valuable programs that have now validated these technologies, means that there is clearly additional opportunities and additional programs that we can look at over and above MTD201 and MTX110 as well as the potential opportunities from a manufacturing perspective.

最後一個支柱是平台機會。我們技術的本質是平台，事實上我們擁有已經驗證了這些技術的有價值的計劃，這意味著除了 MTD201 和 MTX110 之外，我們顯然還可以考慮更多的機會和計劃，以及來自 MTX110 的潛在機會。製造角度。

So I hope that provides or provided a useful update and overview of 2018 and 2019 moving forward. We'll now take questions and we're not particularly pushed for time. So we're happy to take questions and just if you don't mind announcing your name and then stating the question.

因此，我希望本文能夠對 2018 年和 2019 年的未來提供有用的更新和概述。我們現在將接受提問，我們的時間並不特別緊迫。因此，我們很樂意回答問題，只要您不介意先報出您的名字，然後再提出問題。

And apologies in advance. This isn't the usual moderated conference call facility that we've used in the past. So it might sound a bit of a free for all if many of you have got questions, but we'll attempt to navigate our way through it. On the other hand, if nobody has any questions, it could be very short.

並提前道歉。這不是我們過去使用的通常的主持電話會議設施。因此，如果你們中的許多人有疑問，這聽起來可能有點免費，但我們會嘗試解決它。另一方面，如果沒有人提出任何問題，那麼它可能會很短。

Craig, Nick, it's Mike Mitchell here at Panmure Gordon. I'll keep it sort of focused on CMS, if that's okay. I'm just referring to the statement released this morning with regards to further product opportunities. Obviously, the key focus for you guys at the moment is on Q-Octreotide and MTX110, but in terms of other feasibility and other sort of screening options and technologies, I was wondering if you could give a little bit more color about the way in which that relationship is working? How much funding that you might put into the space, whether you'd be looking at complementary or differentiated indication areas? That'll be great.

克雷格、尼克，我是 Panmure Gordon 的邁克·米切爾。如果可以的話，我將把重點放在 CMS 上。我只是指今天早上發布的有關進一步產品機會的聲明。顯然，你們目前的重點是 Q-Octreotide 和 MTX110，但就其他可行性和其他類型的篩選選項和技術而言，我想知道您是否可以對其中的方式提供更多信息哪種關係有效？您可能會在該領域投入多少資金，無論您是在尋找互補還是差異化的適應症領域？那太好了。

So for these opportunities that are identified by CMS, they're going to be fully funded by CMS. It's not going to require any Midatech funds. That's the first important point. And the process to be followed will be such that Midatech, with the funded program, will develop the selected assets to a certain feasibility point, be that proof-of-concept -- preclinical proof-of-concept or clinical proof-of-concept, at which point, it would be tech transferred to CMS. And then CMS would take over the development through to potential approval. At approval, CMS will own the Greater China and Southeast Asian rights to the product and Midatech will retain the global rights for those products. Does that answer your question, Mike?

因此，對於 CMS 發現的這些機會，CMS 將全額資助它們。它不需要任何 Midatech 資金。這是第一點。遵循的流程是，Midatech 將通過資助項目將選定的資產開發到一定的可行性點，即概念驗證——臨床前概念驗證或臨床概念驗證，此時，技術將轉移到 CMS。然後 CMS 將接管開發直至獲得潛在批准。獲得批准後，CMS 將擁有該產品在大中華區和東南亞的權利，Midatech 將保留這些產品的全球權利。這能回答你的問題嗎，邁克？

Yes. And in terms of the sort of decisions on the areas that you would be or that would be considered in terms of new opportunities. Is the focus going to be on infilling around what you currently have for the platforms with Q-Octreotide in DIPG or might it be much more wide than that?

是的。就您將在哪些領域或將在新機會方面考慮的領域做出何種決策而言。重點是否是圍繞您目前在 DIPG 中使用 Q-奧曲肽的平台進行填充，或者可能比這更廣泛？

I think it'll probably be a bit of both, but CMS certainly see the value of the platform nature of the technologies and our current focus is certainly on oncology and rare diseases. But we've done several previous projects and formulations in a whole host of disease areas, including autoimmune, endocrine, vaccines, liver disease, renal disease, oncology, osteoporosis, the whole host ophthalmology, psychiatry and infectious. So the nature of CMS is they have a pipeline or an R&D pipeline that they are continuously supplementing from companies like Midatech and they will go through the process of what we have and the data and identify potential opportunities. And already, there is 2 potential opportunities based on what we've done in the past, but there may be other opportunities that we haven't attempted previously or looked at previously. But where CMS believes that there are technologies that are well matched through a potential API and then we would look at that afresh.

我認為可能兩者兼而有之，但 CMS 肯定看到了技術平台性質的價值，而且我們目前的重點肯定是腫瘤學和罕見疾病。但我們之前已經在許多疾病領域完成了幾個項目和配方，包括自身免疫、內分泌、疫苗、肝病、腎病、腫瘤學、骨質疏鬆症、全宿主眼科、精神病學和傳染病。因此，CMS 的本質是他們擁有一條管道或研發管道，他們不斷從 Midatech 等公司補充這些管道，他們將仔細研究我們所擁有的和數據的過程，並識別潛在的機會。根據我們過去所做的事情，已經有 2 個潛在機會，但可能還有其他我們之前沒有嘗試過或考慮過的機會。但 CMS 認為有些技術可以通過潛在的 API 很好地匹配，然後我們會重新審視這一點。

Any other questions from anybody? Okay, great. Well, thank you, everybody for your time. And I think on that note, we'll sign off.

還有其他問題嗎？好的，太好了。好的，謝謝大家抽出時間。我想在這一點上，我們會簽字。

Yes, thank you very much, everyone.

是的，非常感謝大家。