Biodexa Pharmaceuticals PLC (BDRX) 2021 Q2 法說會逐字稿

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  • Tim Metcalfe

    Tim Metcalfe

  • Well, it seems like most people are with us now. So welcome. My name is Tim Metcalfe. And with me today, I've got Stephen Stamp, who's CEO and CFO of Midatech Pharm. Unfortunately, Stephen is traveling on business at the moment. And where he is, the Internet connection is not great. So unfortunately, we won't have video for Stephen today, but he will run you through the presentation following the release of the company's interim results on Friday. And then following the presentation, we'll have the opportunity for a question-and-answer session. Thank you very much to everybody who submitted questions in advance of the session. That's really appreciated, but we do welcome questions during it.

    嗯,看來現在大多數人都跟我們在一起了。非常歡迎。我叫蒂姆·梅特卡夫。今天和我在一起的還有 Midatech Pharm 的執行長兼財務長 Stephen Stamp。不幸的是,史蒂芬目前正在出差。而且他所在的地方,網路連線不是很好。不幸的是,我們今天沒有史蒂芬的視頻,但他將在周五發佈公司中期業績後向您介紹演示。演講結束後,我們將有機會進行問答環節。非常感謝在會議之前提出問題的所有人。非常感謝,但我們也歡迎在此期間提出問題。

  • Unfortunately, given the number of people who are attending, it's not possible to go to individuals directly and ask them to unmute and put their questions to Stephen. (Operator Instructions)

    不幸的是,考慮到參加人數眾多,不可能直接去找個人並要求他們取消靜音並向史蒂芬提出問題。(操作員說明)

  • So without further ado, I'll hand over to Stephen to run you through the presentation. Steve?

    言歸正傳,我將把演示交給 Stephen 來帶領您完成演示。史蒂夫?

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • Thank you, Tim, and good afternoon, everybody. Let's start, if we may, Tim, with Slide 2. And with your permission, I will take Slide 2 as read, other than to recommend that you read our public filings, which can be accessed through our website.

    謝謝蒂姆,大家下午好。提姆,如果可以的話,讓我們從幻燈片 2 開始。

  • So jumping to Slide 3. We have in front of us our summary profit and loss for the first half of 2021 compared with the first half of 2020. We had a nice bump in revenues. This was a result of our collaboration partnership, working on our Q-Sphera programs. More of that in a second. But the most striking thing was that despite working on 8 more projects in this half, actually our costs are pretty much halved. And the reason for that is that the first half of this year no longer reflects the cost of closing down Spain nor the operating costs of the Spanish operation.

    現在跳到投影片 3。我們的收入大幅成長。這是我們在 Q-Sphera 專案上合作的結果。稍後會講更多。但最引人注目的是,儘管這半年多做了 8 個項目,但實際上我們的成本幾乎減半了。原因是,今年上半年不再反映關閉西班牙的成本,也不再反映西班牙業務的營運成本。

  • So R&D was just about GBP 2 million. Admin costs of GBP 1.6 million for a total net loss of just over GBP 3 million or about GBP 0.5 million a month, and that kind of reflects our ongoing run rate.

    所以研發費用約 200 萬英鎊。管理成本為 160 萬英鎊,總淨損失略高於 300 萬英鎊,即每月約 50 萬英鎊,這反映了我們持續的運作率。

  • So moving on to balance sheet. The balance sheet was similarly cleaned up this half year. All of the Spanish loans have now been repaid. We took an impairment, if you may recall, last year of about $11.3 million, I think, it was for intangible assets. The only addition to the balance sheet is a new lease for our new headquarters and a large space in Cardiff, which is being capitalized in accordance with IFRS 16.

    因此,轉向資產負債表。今年半年,資產負債表也進行了類似的清理。西班牙的所有貸款現已償還。如果你還記得的話,去年我們進行了約 1,130 萬美元的減值,我想,這是無形資產。資產負債表中唯一的新增內容是我們新總部的新租約以及位於卡迪夫的一個大空間,該空間將根據 IFRS 16 進行資本化。

  • Cash on the balance sheet at the half year was GBP 4.5 million, but we raised another GBP 9 million in July. So actually, our current cash is more closer to GBP 12 million, and that gives us a runway into the first quarter of 2023.

    半年資產負債表上的現金為 450 萬英鎊,但我們在 7 月又籌集了 900 萬英鎊。事實上,我們目前的現金更接近 1200 萬英鎊,這為我們進入 2023 年第一季提供了一條通道。

  • Next slide, please. So we -- in the first half of this year, we have managed to move our portfolio along, both brexpiprazole and tacrolimus Q-Sphera internal programs have been moved from formulation into preclinical. We have preclinical data to show you for brexpiprazole. Tacrolimus, we're probably need one more iteration of that program. The data we have are promising, but we need to refine that formulation one more time, I think. And 213, 214 and 216 are in collaboration with our partner. We've delivered proof-of-concept formulations for 214 and 216. Our partners started in vivo animal testing with those formulations, and we should have data on those in the next few weeks. And 213, I'll update you on in a second.

    請下一張投影片。因此,今年上半年,我們成功地推進了我們的產品組合,brexpiprmaze 和他克莫司 Q-Sphera 內部專案已從製劑轉移到臨床前。我們有臨床前數據向您展示布瑞哌唑。他克莫司,我們可能需要該程式的再一次迭代。我們掌握的數據很有希望,但我認為我們需要再次完善這個表述。213、214 和 216 是與我們的合作夥伴合作的。我們已經提供了 214 和 216 的概念驗證配方。我們的合作夥伴開始使用這些配方進行體內動物測試,我們應該在接下來的幾週內獲得有關這些數據的數據。213,我稍後會向您通報最新情況。

  • The other thing that moved is MTX110. Two programs there. Our DIPG program is now moving into Phase II and our GBM program is moving into Phase I, and we'll have -- I'll talk about that in a second, too. So nice progress in the 6 months in our pipeline.

    另一件被移動的是MTX110。那裡有兩個程序。我們的 DIPG 專案現在正在進入第二階段,我們的 GBM 專案正在進入第一階段,我們稍後也會討論這一點。我們的管道在這 6 個月裡取得瞭如此好的進展。

  • So let's start with MTX110. You'll recall this is our MidaSolve technology applied to panobinostat to create a liquid form of panobinostat that can be injected via pump and catheter direct to tumor. And we've been able to achieve concentrations of -- close to 100,000x concentration you would -- compare with what you would get taking the product orally in tumor.

    那我們就從MTX110開始吧。您會記得這是我們應用於帕比司他的 MidaSolve 技術,以創建液體形式的帕比司他,可以透過幫浦和導管直接注射到腫瘤中。與口服該產品在腫瘤中的濃度相比,我們已經能夠達到接近 100,000 倍的濃度。

  • So we've slightly moved this program around. We've decided to prioritize glioblastoma multiforme, or GBM, mainly because its much larger market potential. There are between 2 to 3 per 100,000 population diagnosis per annum, and that equates to a sort of $3 billion to $5 billion market. Secondly, we were encouraged by the survival data we saw with our DIPG program, which we announced last October that you remember showed that we were getting something like median survival of 26 months versus about 10 months in the literature. But I should also say that was not a statistically significant result because there are only 7 patients enrolled in the study.

    所以我們稍微改變了這個程序。我們決定優先考慮多形性膠質母細胞瘤(GBM),主要是因為它的市場潛力更大。每年每 10 萬人中有 2 到 3 人被確診,這相當於一個 30 億到 50 億美元的市場。其次,我們對 DIPG 計劃看到的生存數據感到鼓舞,我們去年 10 月宣布,您還記得,我們​​的中位生存期為 26 個月,而文獻中的中位生存期約為 10 個月。但我還應該說,這並不是一個具有統計意義的結果,因為只有 7 名患者參與了這項研究。

  • However, we were encouraged by those data. And what we've done, as illustrated here on the 2 charts on the slide. The top chart reflects the much slower growth in tumor volume of our product compared with control in vivo. That was in a single GBM cell line. And then we repeated the experiment in vitro with 4 additional cell lines and showed 100% cell death and looks to be therapeutically feasible concentrations of drug. So we've got some nice preclinical evidence, and we are working with our partners in the U.S. to set up a Phase I trial, which we'll begin recruiting in the next few months.

    然而,這些數據令我們感到鼓舞。我們已經做了什麼,如幻燈片上的兩張圖表所示。上圖反映了我們的產品與體內對照組相比,腫瘤體積的增長要慢得多。那是在單一 GBM 細胞系中。然後我們用另外 4 個細胞系在體外重複了實驗,結果顯示細胞 100% 死亡,看起來是治療上可行的藥物濃度。因此,我們已經獲得了一些很好的臨床前證據,並且正在與美國的合作夥伴合作進行第一階段試驗,我們將在接下來的幾個月內開始招募該試驗。

  • I haven't got anything to report in terms of the panobinostat license. You may recall that our former partners, Secura Bio, terminated our license over a year ago now, last, I think, it was May for reasons claiming that we were liquidating the company. They then sought to terminate again a second time in June this year, this time for a material breach. The reason being they were now alleging material breaches that they are demanding a nonexclusive license to our IPs, so they can compete with us. As you might expect, we've rejected that twice now and so we wait to hear from them.

    關於帕比司他許可證,我沒有任何可報告的資訊。您可能還記得,我們​​的前合作夥伴 Secura Bio 一年多前終止了我們的許可證,我認為最後一次是在 5 月份,原因是我們正在清算該公司。隨後,他們於今年 6 月第二次尋求終止合同,這次是因為重大違約。原因是他們現在聲稱存在重大違規行為,要求獲得我們智慧財產權的非獨家許可,以便他們可以與我們競爭。正如您所料,我們已經拒絕了兩次,所以我們等待他們的消息。

  • So moving on then to DIPG. We are in the process of setting up a Phase II study. We had a very productive meeting with FDA, a pre-Phase II meeting. And we're refining the protocol based on the advice they gave us. And again, we expect to start recruiting for that trial in the not-too-distant future. The challenges with this program are that there are very few patients. Obviously, this is ultra-orphan, only 1,000 patients a year. And finding patients which meet the entry criteria to the study and recruiting them is not easy. And that's one of the reasons, to be honest with you, why we switched to GBM where there are many more patients available for entering the study.

    那麼接下來就到 DIPG 了。我們正在進行第二階段研究。我們與 FDA 進行了一次非常有成效的會議,這是一次第二階段前的會議。我們正在根據他們給我們的建議來完善協議。再次,我們預計將在不久的將來開始招募該試驗。該計劃面臨的挑戰是患者很少。顯然,這是超孤兒,一年只有1000名患者。要找到符合研究進入標準的患者並招募他們並不容易。老實說,這就是我們轉向 GBM 的原因之一,因為那裡有更多的患者可以參與研究。

  • So let's now talk about our Q-Sphera programs and start with our partner collaborations. 214 and 216 are small molecules and we delivered proof of concept formulations in June. And as I said, the partner is undertaking vivo studies, and we should have data on those studies for both programs, either at the end of this month or early next month. And as far as we know, they're progressing the plan. 213 is a large molecule and we presented data on that at the end of August. And our partner has asked us to submit a proposal for an expanded research collaboration, and we're working that up now. And hopefully, we'll have something to announce on that in the next couple of 3 weeks. So that's our partner collaborations.

    現在讓我們談談我們的 Q-Sphera 計劃並從我們的合作夥伴合作開始。214 和 216 是小分子,我們在 6 月提供了概念驗證配方。正如我所說,合作夥伴正在進行體內研究,我們應該在本月底或下個月初獲得這兩個計畫的研究數據。據我們所知,他們正在推進該計劃。213 是一個大分子,我們在 8 月底提供了相關數據。我們的合作夥伴要求我們提交一份擴大研究合作的提案,我們現在正在處理該提案。希望我們能在接下來的三週內就此宣布一些消息。這就是我們的合作夥伴合作。

  • The first of our internal pipeline is Q-brexpiprazole. You've seen this chart before. These are our in vivo pharmacokinetics study in rabbits. The blue line is our formulation of brexpiprazole, and you can see that we've got a nice therapeutic blood levels out through 91 days. And the orange line is the suspension of the immediate release product. And you can -- so you can see there that as you would expect, the (inaudible) that tail off quite quickly. So here, we've developed a 3-month product. And as illustrated by Janssen latest offering in the antipsychotic market, Hafyera, they're moving to a 6-month product. And in fact, the whole market is moving here to longer-acting products. So our formulation of brexpiprazole, in our opinion at least, fits nicely with market trends.

    我們的第一個內部管道是 Q-brexpiprmaze。您以前見過這個圖表。這些都是我們在兔子身上進行的體內藥物動力學研究。藍線是我們的 brexpiprmaze 配方,您可以看到我們在 91 天內獲得了良好的治療血液水平。橙色線是立即釋放產品的暫停。你可以——所以你可以看到,正如你所期望的那樣,(聽不清楚)很快就消失了。所以在這裡,我們開發了一個為期 3 個月的產品。正如楊森在抗精神病藥物市場上最新推出的 Hafyera 所示,他們正在轉向 6 個月的產品。事實上,整個市場正在轉向長效產品。因此,至少在我們看來,我們的 brexpiprmaze 配方非常符合市場趨勢。

  • Good. So let's move on now to talk about biologics. You might recall we talked about this in our R&D update. They are notoriously difficult to formulate because they are very large and very delicate molecules, easily denatured in the manufacturing process. We always had an inkling that our process being printing and rather benign solvents and no use of heat would have the potential to formulate a protein. And we focused on a monoclonal antibody, one of the larger proteins, more than 150-kilodaltons. And actually, we were successful.

    好的。現在讓我們繼續討論生物製劑。您可能還記得我們在研發更新中討論過這一點。眾所周知,它們很難配製,因為它們是非常大且非常脆弱的分子,在製造過程中很容易變性。我們總是有一種暗示,我們的製程是印刷和相當良性的溶劑,並且不使用熱量有可能配製蛋白質。我們專注於單株抗體,這是一種較大的蛋白質,超過 150 千道爾頓。事實上,我們成功了。

  • And the 3 charts on Slide 13 illustrates that success. So the chart on the left is a immediate release product. And this was the starting material that we used. And as the concentration moves left to right on the chart, so the signal, which is a signal of inhibition, declines. And as the concentration gets higher and higher, so you get a lower -- and you get greater and greater inhibition, which shows antigen binding of the monoclonal antibody. So what that tells us is that we had a good assay and that it bound with increasing concentrations. So that was all good.

    第 13 張投影片上的 3 張圖表說明了這項成功。所以左圖是立即發布的產品。這就是我們使用的起始材料。隨著濃度在圖表上從左向右移動,抑制訊號的訊號也會減弱。隨著濃度越來越高,抑製作用也越來越低,這顯示單株抗體與抗原結合。這告訴我們,我們進行了良好的檢測,並且它與濃度的增加結合在一起。所以這一切都很好。

  • On the middle chart here. Now what we did was we took that same protein and heat treated it, so we basically killed it. And we got 0 inhibition, which is kind of the result we expect. We got positive control with the immediate release product of 100%. And in the Q-Sphera formulation with the protein, we also got 100%. So that also matched with what we would hope to see.

    在中間的圖表上。現在我們所做的就是採用相同的蛋白質並對它進行熱處理,所以我們基本上殺死了它。我們得到了 0 抑制,這正是我們所期望的結果。我們得到了陽性對照,速釋產品為100%。在含有蛋白質的 Q-Sphera 配方中,我們也獲得了 100% 的效果。所以這也符合我們希望看到的。

  • And on the far right-hand side, we've got a chart, which shows the Q-Sphera formulation, again that increasing concentrations showing increasing amounts of inhibition. So rather than 100%, we've got increasing amounts of it, and it's sort of correlate. So all very good. So you saw all that chart before, the big news since the R&D update is that the Midatech team in Cardiff have been able to increase the drug loading threefold since we started out with this process, which is fantastic news. So that really is a big deal in terms of opening up the opportunities for Midatech in the large molecule protein space for our Q-Sphera technology. So delighted to announce that today.

    在最右邊,我們有一張圖表,顯示了 Q-Sphera 配方,同樣,濃度的增加表明抑制量的增加。因此,我們得到的不是 100%,而是越來越多,而且它是相關的。所以一切都很好。所以你之前看到了所有的圖表,自研發更新以來的大新聞是,自從我們開始這個過程以來,卡迪夫的 Midatech 團隊已經能夠將藥物裝載量增加三倍,這是一個很棒的消息。因此,這對於為 Midatech 在大分子蛋白質領域為我們的 Q-Sphera 技術開闢機會來說確實是一件大事。今天很高興宣布這一消息。

  • So let's summarize then the first half. I hope you'd agree that we've got our costs under control. We're down at GBP 0.5 million a month burn rate, working on 10 programs across the company. And we've extended our cash runway to the first quarter of 2023. We're prioritizing the much larger GBM market for MTX110. To be honest, I have to say, we've been a little bit disappointed with the response we've seen with our DIPG data last October.

    那我們來總結一下前半部。我希望您同意我們已經控制了成本。我們在整個公司開展 10 個項目,每月的燒錢率下降了 50 萬英鎊。我們已將現金跑道延長至 2023 年第一季。我們優先考慮 MTX110 更大的 GBM 市場。說實話,我必須說,我們對去年 10 月 DIPG 數據的反應有點失望。

  • Increasing survival from 10 to 26 months, there's no mean feat in the cancer world. And yes, there didn't seem to be a lot of response to that. I suspect it's because it's not a big market. GBM is a very large market, and there has been something of a graveyard here for big pharma for various reasons, one of which is that many or most drugs don't cross the blood-brain barrier. And of course, you'll recall with our catheter and pump system, we've dodged that -- and we've delivered drug straight to the tumor. We also delivered, in the first half, 2 proof-of-concept formulations to our partner.

    將存活期從 10 個月延長至 26 個月,在癌症領域絕非易事。是的,對此似乎沒有太多回應。我懷疑這是因為它不是一個大市場。GBM 是一個非常大的市場,由於各種原因,這裡一直是大型製藥公司的墓地,其中之一是許多或大多數藥物不能穿過血腦屏障。當然,您會記得我們的導管和幫浦系統,我們已經避免了這一點 - 我們已經將藥物直接輸送到腫瘤。上半年,我們也向合作夥伴交付了 2 個概念驗證配方。

  • And we've initiated a licensee search for our brexpiprazole product. We're using a European company called Liberi to help with that, and they've already started work and I think they've reached out to more than 100 potential partners already. Of course, we don't want 100 people interested, but we're hoping to create something of an auction there.

    我們已經開始尋找我們的 brexpiprmaze 產品的被授權人。我們正在聘請一家名為 Liberi 的歐洲公司來幫助解決這個問題,他們已經開始工作,我認為他們已經聯繫了 100 多個潛在合作夥伴。當然,我們不希望 100 個人感興趣,但我們希望在那裡舉辦一些拍賣活動。

  • And then the really big news in the half year was the protein [ladder] with the monoclonal antibody, which offers very significant opportunities for our Q-Sphera platform.

    然後這半年真正的大新聞是帶有單株抗體的蛋白質[階梯],它為我們的 Q-Sphera 平台提供了非常重要的機會。

  • So thank you for your time today. That's all I had to present, but I'm happy to take questions, Tim, when you're ready.

    謝謝您今天抽出時間。這就是我要介紹的全部內容,但蒂姆,當你準備好時,我很樂意回答問題。

  • Tim Metcalfe

    Tim Metcalfe

  • Well, thank you very much, Stephen. I have had a number of questions coming in as you've been presenting. I'm just going through those. But a number of people have obviously focused on Q-Sphera and its use with large molecules, particularly proteins and monoclonal antibodies. Could you talk in a little bit of more detail about some of the technical challenges that have been overcome in recent times and some of those that you'll be looking to address in the next sort of 12 months?

    嗯,非常感謝你,史蒂芬。在你介紹的過程中,我收到了很多問題。我正在經歷這些。但許多人顯然關注 Q-Sphera 及其在大分子(尤其是蛋白質和單株抗體)中的應用。您能否更詳細地談談最近已克服的一些技術挑戰以及您希望在未來 12 個月內解決的一些技術挑戰?

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • So -- and that's a very pertinent question. So the major challenge, we think we have overcome, and that is to demonstrate that we can encapsulate the protein in Q-Sphera microsphere without denaturing it. The problem in most manufacturing processes is that the protein itself gets denatured, the molecule gets smashed up and then it doesn't do what it's supposed to do. So we've overcome that technical hurdle so we can put a checkmark there.

    所以——這是一個非常相關的問題。因此,我們認為我們已經克服了主要挑戰,那就是證明我們可以將蛋白質封裝在 Q-Sphera 微球中而不使其變性。大多數製造過程中的問題是蛋白質本身變性,分子被粉碎,然後它就無法發揮其應有的作用。所以我們已經克服了這個技術障礙,所以我們可以在那裡打勾。

  • The next technical hurdle is to get the drug loading up to an appropriate level. Obviously, if you can't deliver much drug in the Q-Sphera microsphere, then you're not going to have a 3-month product. You're going to have a 3-day product. And what I can tell you is that we're well on the way there. But the team in Cardiff, as I said, have increased that 3x. So I'm going to give that a sort of a small check mark. That piece is done.

    下一個技術障礙是使載藥量達到適當的水平。顯然,如果您無法在 Q-Sphera 微球中輸送大量藥物,那麼您就不會擁有 3 個月的產品。您將獲得為期 3 天的產品。我可以告訴你的是,我們正在朝著這個目標前進。但正如我所說,卡迪夫的團隊將這一數字提高了 3 倍。所以我要給它一個小複選標記。那一塊就完成了。

  • The next piece we've done is -- challenge is dissolution. And specifically coming up with an assay that we can measure the dissolution profile of the product over a period of time. And the challenge here is that as the microspheres release drug into the dissolution medium, so the medium actually does -- has the effect of denaturing the proteins, you can't measure it anymore. So we are working feverishly to come up with an assay that we can measure the dissolution of the product over a period of time in vitro. We want to do that in vitro because we can do much faster turnaround and it's much quicker and cheaper than doing it in vivo.

    我們要做的下一件事情是──挑戰是解散。具體來說,我們提出了一種可以測量產品在一段時間內的溶離曲線的測定方法。這裡的挑戰是,當微球將藥物釋放到溶離介質中時,介質實際上具有使蛋白質變性的作用,您無法再測量它。因此,我們正在積極研究一種可以測量產品在體外一段時間內溶解情況的測定方法。我們希望在體外做到這一點,因為我們可以做到更快的周轉,而且比在體內進行更快、更便宜。

  • And then the last thing that we need to work on is injectability. We don't see any problems with that right now. So we need the product, which is as sufficiently liquid and not this -- too viscous, but it can go down a syringe needle and into a patient without causing undue pain. So out of the 4 things that we've done, I think we've got sort of 2.5, maybe 3 done. And the one big thing to work and now, as I say, the dissolution assay. Does that cover the question?

    我們需要解決的最後一件事是可注射性。我們現在沒有看到任何問題。因此,我們需要這種產品,它具有足夠的液體,而不是太黏稠,但它可以透過注射器針頭進入患者體內,而不會造成過度的疼痛。因此,在我們所做的 4 件事中,我認為我們已經完成了 2.5 件,也許 3 件。正如我所說,現在要做的一件大事就是溶離度測定。這涵蓋了問題嗎?

  • Tim Metcalfe

    Tim Metcalfe

  • I think it does. I've had some questions sort of adjacent to that. And one we should ask you is -- the question was asked, were you disappointed with the termination of the Dr. Reddy partnership. And was this due to the fact that their molecules weren't suitable for Q-Sphera? Or were there other reasons for the termination?

    我認為確實如此。我有一些與此類似的問題。我們應該問你的一個問題是——你對雷迪博士合作關係的終止感到失望嗎?這是因為它們的分子不適合 Q-Sphera 嗎?還是有其他原因導致終止?

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • You broke up there a bit, but I think I got the gist of the question. So the Dr. Reddy molecule they gave us to work on was challenging from the get-go, is the nature of the beast. Our suspicion is that they'd already tried to formulate it themselves actually. They have a subsidiary company called OctoPlus. And my belief anyway is that they tried -- OctoPlus tried to formulate, it couldn't. So they shipped it off to us and learned that we couldn't either. It's just the nature of the molecule itself. It wasn't well suited to PLGA microsphere formulation. So disappointing, yes, but it happens.

    你在那裡有點分裂,但我想我明白了問題的要點。因此,他們給我們的雷迪博士分子從一開始就具有挑戰性,這就是野獸的本性。我們懷疑他們實際上已經嘗試自己制定它。他們有一家名為 OctoPlus 的子公司。無論如何,我相信他們嘗試過——OctoPlus 試圖制定,但沒有成功。所以他們把它寄給我們,卻發現我們也不能。這只是分子本身的本質。它不太適合 PLGA 微球配方。是的,很令人失望,但它確實發生了。

  • Tim Metcalfe

    Tim Metcalfe

  • Absolutely. So the read across from that shouldn't be that it's putting a particular limitation on the use of Q-Sphera. This was just one particular use case that was challenging, and it's not suitable for all.

    絕對地。因此,這不應該是對 Q-Sphera 的使用施加特定限制。這只是一個具有挑戰性的特定用例,並不適合所有人。

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • Yes.

    是的。

  • Tim Metcalfe

    Tim Metcalfe

  • Yes. Obviously, there's potentially a huge market here with proteins, monoclonal antibodies and big pharma. You've got, obviously, a focus on certain in-house programs and certain partnerships at the moment. Is there a strategic desire to widen those number of partnerships to enter into sort of wider licensing deals to try and get this technology to market potentially in a far wider and quicker way?

    是的。顯然,蛋白質、單株抗體和大型製藥公司存在潛在的龐大市場。顯然,目前您重點關注某些內部計劃和某些合作夥伴關係。是否有擴大合作夥伴數量以達成更廣泛的許可協議的戰略願望,以嘗試以更廣泛和更快的方式將該技術推向市場?

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • Sorry, you broke up again there. Sorry, Tim. So our goal here is to maintain a balanced portfolio if we can. What we'd like to do is to have a small number of internal programs that we work on. The reason for that is that we can determine the time lines ourselves within our available resources. And ideally, we have the opportunity to create an auction or some competitive pricing tension at least when we've delivered proof of concept.

    對不起,你們又在那裡分手了。對不起,提姆。因此,我們的目標是盡可能保持平衡的投資組合。我們想做的是擁有少量的內部專案。原因是我們可以在可用資源範圍內自行確定時間表。理想情況下,至少當我們提供概念驗證時,我們有機會進行拍賣或一些有競爭力的價格緊張。

  • Having said that, it's also nice to have some partnered programs because the partner pays for the development costs, but you're stuck with one customer. So you don't have the opportunity to create an auction, and you're basically marching to that customer's timelines and his resource capabilities. Now most of the companies we talk to have more resources than we do, so that part isn't a problem. But what big pharma like, they switch up their strategies. They're going to do different places. It happens. So hence, we'd like to keep a balance.

    話雖如此,擁有一些合作夥伴計劃也很好,因為合作夥伴支付開發成本,但你只能與一個客戶合作。因此,您沒有機會創建拍賣,並且您基本上是在按照該客戶的時間表及其資源能力進行操作。現在,與我們交談的大多數公司都擁有比我們更多的資源,因此這部分不是問題。但大型製藥公司喜歡改變策略。他們要去不同的地方。它發生了。因此,我們希望保持平衡。

  • Tim Metcalfe

    Tim Metcalfe

  • No, that's absolutely understood. And obviously, with the recent funding, there are the funds there to do the in-house programs as well as those that are financed by third parties.

    不,這絕對是明白的。顯然,透過最近的資金,有資金用於內部專案以及第三方資助的專案。

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • Absolutely. And so the first quarter '23 cash runway number assumes a number of in-house programs.

    絕對地。因此,23 年第一季的現金跑道數字假設有許多內部計劃。

  • Tim Metcalfe

    Tim Metcalfe

  • Yes. And doesn't assume presumably significant license fees from third parties.

    是的。且不承擔第三方的巨額許可費用。

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • It assumes 0. Our advisers advise us we should always tread on the conservative side there.

    它假設為 0。

  • Tim Metcalfe

    Tim Metcalfe

  • Okay. Thank you for clarifying that. I've had a couple of questions relating to history and MTD201. And whether that program is still something that you look at? Whether it has any value other than really is a proof of concept for Q-Sphera? Or have we genuinely moved on and the focus is now on this much wider and potentially significantly larger opportunity?

    好的。感謝您澄清這一點。我有幾個有關歷史和 MTD201 的問題。您是否仍然關注該計劃?除了確實是 Q-Sphera 的概念證明之外,它是否還有其他價值?或者我們是否真正繼續前進,現在的重點是這個更廣泛且可能更大的機會?

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • So the data that we accumulated for MTD201 is good. And we have 2 Phase I trials. One was a PK trial compared with the Novartis product and the other one compared intramuscular versus subcutaneous administration. And both gave us very nice data. And we tried long and hard to find a licensee for that product. The reason for that was we couldn't take it any further ourselves because the product clearly was not going to be bioequivalent to Novartis' Sandostatin. In my opinion, it was a much better product, much less inter-patient variability and inter-batch variability associated with the Novartis product. In fact, I'm not even sure that product would be approved by today's standards. But the fact of the matter is, Tim, we went far our way to find a licensee and we couldn't generate any interest. So we had to stop the program. If somebody wants to come forward, great, but we have to move on.

    所以我們為MTD201累積的數據是好的。我們有兩個第一階段試驗。一項是與諾華產品進行比較的 PK 試驗,另一項是將肌肉注射與皮下注射進行比較。兩者都為我們提供了非常好的數據。我們花了很長時間努力尋找該產品的被授權人。原因是我們自己無法再進一步,因為該產品顯然不會與諾華的善寧具有生物等效性。在我看來,這是一個更好的產品,與諾華產品相關的患者間變異性和批次間變異性要小得多。事實上,我甚至不確定該產品是否會符合當今的標準。但事實是,提姆,我們千辛萬苦地尋找被授權人,但我們無法產生任何興趣。所以我們只好停止這個計劃。如果有人願意挺身而出,那很好,但我們必須繼續前進。

  • Tim Metcalfe

    Tim Metcalfe

  • Yes, absolutely. As you might expect, on a session like this, there's obviously a number of existing shareholders here. I think I'm right in saying, and I'm personally a shareholder, but everybody is a little disappointed at the moment with where the share price is. Could you just share with us some of the things that you've been doing, and I'm obviously aware of, to generate further interest in the stock and the meetings that you've been having with institutions, for example, which while they're not yet reflected in the share price, hopefully, will be in the future. Just to reassure people that there is quite a lot going on behind the scenes that they don't see.

    是的,一點沒錯。正如您所預料的那樣,在這樣的會議上,顯然有許多現有股東在這裡。我認為我的說法是對的,我個人是股東,但目前每個人都對股價感到有點失望。您能否與我們分享您一直在做的一些事情,我顯然知道這些事情,以引起人們對股票的進一步興趣以及您與機構舉行的會議,例如,雖然他們尚未反映在股價中,希望將來會反映在股價中。只是為了讓人們放心,幕後有很多他們看不到的事情。

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • Yes. So I have done many road shows in the U.K. and the U.S. I've got more coming up as -- was a hiatus in advance of announcing results, but I've got more coming up in the next couple of weeks. I'm planning on doing some investor conferences this autumn and I've been working with Edison to publish research on the company, which was also published actually on the day of the results, on the last Friday. So those are the things that have been happening. Obviously, it doesn't appear to have been a whole lot of positive reaction to share price.

    是的。因此,我在英國和美國進行了很多路演。我計劃今年秋天召開一些投資者會議,我一直在與愛迪生合作發布有關該公司的研究報告,該研究報告實際上也在結果公佈當天(即上週五)發布。這些就是已經發生的事情。顯然,這似乎並沒有對股價產生太多正面的反應。

  • Tim Metcalfe

    Tim Metcalfe

  • No, not yet. But I want to reassure everybody that there are a lot of efforts ongoing. You mentioned the Edison notes. If attendees haven't...

    還沒有。但我想向大家保證,我們正在做很多努力。你提到了愛迪生筆記。如果與會者還沒有...

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • Yes. And you're aware of some of those, Tim.

    是的。提姆,你知道其中一些。

  • Tim Metcalfe

    Tim Metcalfe

  • Personally absolutely I am, but I just want to get the message out to because we're getting a number of questions on it. But if you haven't -- any of the attendees haven't read the Edison research, it is readily available on their website. So we'll encourage you to go to the Edison research website and read that piece because it's quite comprehensive and can hopefully fill in a little bit more information.

    就我個人而言,我絕對是這樣,但我只是想傳達這個訊息,因為我們收到了很多關於它的問題。但如果您還沒有——任何與會者都沒有閱讀過愛迪生的研究報告,您可以在他們的網站上輕鬆找到該研究報告。因此,我們鼓勵您訪問愛迪生研究網站並閱讀該文章,因為它非常全面,並且有望補充更多資訊。

  • I'm getting to the end of the questions that people have been typing in. We do have a few more minutes. We wanted to keep this session to a half an hour quick update after the interims. But if anybody has got anything else, please try and type quickly. But if you do think of anything post the session, please do not hesitate to get in touch at any time. I can be contacted on midatech@investor-focus.co.uk, and we'll put any questions that you ask to Stephen and his colleagues and we'll endeavor to answer them. But rest assured, we are very keen to engage as much as we can with our current shareholders and attract as many new ones as we possibly can.

    我即將結束人們輸入的問題。我們還有幾分鐘。我們希望在間歇期後將本次會議的快速更新時間保持在半小時內。但如果有人還有其他內容,請嘗試快速輸入。但如果您在會議後確實有任何想法,請隨時與我們聯繫。您可以透過 midatech@investor-focus.co.uk 聯絡我,我們會將您向 Stephen 和他的同事提出的任何問題提出,我們將盡力予以解答。但請放心,我們非常熱衷於盡可能與現有股東接觸,並吸引盡可能多的新股東。

  • Well, I can't see anybody typing rapidly on my screen at the moment. So Stephen, I think your Internet has managed to stay stable long enough. So thank you very much.

    好吧,目前我看不到有人在我的螢幕上快速打字。所以史蒂芬,我認為你的互聯網已經成功地保持了足夠長的穩定。非常感謝。

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • Thank you.

    謝謝。

  • Tim Metcalfe

    Tim Metcalfe

  • Thank you very much to everybody who's joined us today. Much appreciated, and really appreciate your support. So thank you.

    非常感謝今天加入我們的所有人。非常感謝,也非常感謝您的支持。所以謝謝。

  • Stephen A. Stamp - CEO, CFO, Company Secretary & Director

    Stephen A. Stamp - CEO, CFO, Company Secretary & Director

  • Absolutely. Thanks all. And thanks, Tim.

    絕對地。謝謝大家。謝謝,蒂姆。

  • Tim Metcalfe

    Tim Metcalfe

  • Thank you.

    謝謝。