Mereo BioPharma Group PLC (MREO) 2020 Q2 法說會逐字稿

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Mereo BioPharma 2020 Interim Results Conference Call. (Operator Instructions) It is now my pleasure to turn the call over to Steve Klass, Vice President with Burns McClellan. Please go ahead, sir.

早安，女士們，先生們。感謝您的支持，歡迎參加 Mereo BioPharma 2020 年中期業績電話會議。 （操作員指示）現在我很高興將電話轉給 Burns McClellan 副總裁 Steve Klass。請繼續，先生。

Thank you, operator. Good morning, everyone. Good afternoon to those of you in the UK and thank you for joining Mereo's 2020 interim financial results and corporate update conference call. Earlier today, the company issued a press release providing an overview of recent business progress as well as financial results for the six months ended June 30, 2020. This press release may be accessed on the Investors portion of Mereo's website at www.mereobiopharma.com.

謝謝你，接線生。大家，早安。英國的各位下午好，感謝您參加 Mereo 的 2020 年中期財務業績和公司更新電話會議。今天早些時候，該公司發布了一份新聞稿，概述了近期業務進展以及截至2020 年6 月30 日的六個月的財務業績。部分訪問。

Leading the call today will be Dr. Denise Scots-Knight, Mereo's Chief Executive Officer, who will provide a summary of the Company's recent clinical and corporate developments. Afterward, Michael Wyzga, Interim CFO of Mereo, will provide a brief overview of the financial highlights for the six months ended June 30, 2020. We will then open the line for questions. Dr. John Lewicki, Mereo's Chief Scientific Officer, will also be available for Q&A.

Mereo 執行長 Denise Scots-Knight 博士將主持今天的電話會議，他將總結公司最近的臨床和企業發展。隨後，Mereo 臨時財務長 Michael Wyzga 將簡要概述截至 2020 年 6 月 30 日的六個月的財務亮點。 Mereo 首席科學官 John Lewicki 博士也將出席問答環節。

As a reminder, the discussion today will contain forward-looking statements. These statements are based on assumptions as of the current date and involve risks and uncertainties that could cause actual results to differ materially from these statements. We caution you to consider the important risk factors that could cause the actual results to differ materially from those in the forward-looking statements in the press release and this conference call. These risk factors are described in today's press release and are more fully detailed under the caption Risk Factors in filings with the SEC.

提醒一下，今天的討論將包含前瞻性陳述。這些陳述基於截至當前日期的假設，涉及可能導致實際結果與這些陳述有重大差異的風險和不確定性。我們提醒您考慮可能導致實際結果與新聞稿和本次電話會議中的前瞻性聲明中的結果存在重大差異的重要風險因素。這些風險因素在今天的新聞稿中進行了描述，並在向 SEC 提交的文件中的「風險因素」標題下進行了更全面的詳細說明。

In addition, please note the date of this conference call is September 29, 2020, and any forward-looking statements that are made today are based on assumptions that we believe to be reasonable as of this date. The Company undertakes no obligation to update these statements as a result of new information or future events. I will now turn the call over to Denise.

此外，請注意本次電話會議的日期是 2020 年 9 月 29 日，今天發表的任何前瞻性陳述均基於我們認為截至該日期合理的假設。本公司不承擔因新資訊或未來事件而更新這些聲明的義務。我現在將把電話轉給丹尼斯。

Thank you, Steve, and thank you to everyone for joining us today. It's a pleasure to welcome all of you to our 2020 interim financial results and the business update conference call.

謝謝你，史蒂夫，也謝謝大家今天加入我們。很高興歡迎大家參加我們的 2020 年中期財務業績和業務更新電話會議。

This is a very exciting time for Mereo. We've made substantial progress over the course of 2020, including our change in strategy to focus on advancing the development of etigilimab, our anti-TIGIT antibody with potential broad utilization in oncology alongside our rare disease product portfolio. In June of this year, we also closed a $70 million financing with leading US institutional investors to further advance etigilimab alongside our rare disease product portfolio.

對於 Mereo 來說，這是一個非常令人興奮的時刻。我們在 2020 年取得了實質進展，包括我們改變策略，專注於推進 etigilimab 的開發，etigilimab 是我們的抗 TIGIT 抗體，與我們的罕見疾病產品組合一起，在腫瘤學領域具有廣泛的應用潛力。今年 6 月，我們還與美國領先的機構投資者完成了 7,000 萬美元的融資，以進一步推進 etigilimab 和我們的罕見疾病產品組合。

We believe this financing has left us well capitalized to execute on our strategy. I'm pleased to share with you today a review of our recent progress as well as to outline the opportunities we have in front of us as we enter the fourth quarter of 2020 and prepare for an eventful 2021, which we believe will help catalyze the next stage of Mereo's growth.

我們相信，此次融資使我們有充足的資本來執行我們的策略。今天，我很高興與您分享我們最近的進展，並概述了我們在進入 2020 年第四季度並為多事之秋做好準備時所面臨的機遇，我們相信這將有助於促進Mereo 成長的下一階段。

Let me first begin with etigilimab. As I mentioned, etigilimab is a novel antibody against TIGIT, a next-generation checkpoint receptor shown to block T cell activation and the body's natural anticancer immune response. Specifically, etigilimab is an IgG1 monoclonal antibody, which binds to the human TIGIT receptor on immune cells with the goal of improving the activation and effectiveness of T-cell and NK cell antitumor activity.

讓我先從etigilimab開始。正如我所提到的，etigilimab 是一種針對 TIGIT 的新型抗體，TIGIT 是一種下一代檢查點受體，可阻止 T 細胞活化和人體自然抗癌免疫反應。具體來說，etigilimab是一種IgG1單株抗體，它與免疫細胞上的人類TIGIT受體結合，目的是提高T細胞和NK細胞抗腫瘤活性的活化和有效性。

We believe etigilimab is competitive with other Anti-TIGIT approaches as it is a novel lgG1 with both inhibitory as well as ADCC characteristics having an intact effector function. As part of our clinical development strategy, we plan to focus the development of etigilimab on tumor types with high PD-L1 and TIGIT expression with poor responses to anti PD-L1 or PD-1 and on tumor types where we saw evidence of responses in our Phase 1a/1b studies.

我們相信 etigilimab 與其他抗 TIGIT 方法相比具有競爭力，因為它是一種新型 IgG1，具有抑制性和 ADCC 特性，且具有完整的效應器功能。作為我們臨床開發策略的一部分，我們計劃將 etigilimab 的開發重點放在 PD-L1 和 TIGIT 高表達、對抗 PD-L1 或 PD-1 反應較差的腫瘤類型以及我們在我們的 1a/1b 期研究中。

Etigilimab has completed a Phase 1a dose escalation trial in patients with advanced solid tumors, and patients were also enrolled in a Phase 1b study in combination with nivolumab in select tumor types.

Etigilimab 已完成針對晚期實體瘤患者的 1a 期劑量遞增試驗，患者也參與了與納武單抗聯合治療選定腫瘤類型的 1b 期研究。

In the Phase 1a dose escalation study, 23 patients with multiple tumor types were enrolled and no dose-limiting toxicities were observed. In the Phase 1b combination study, a total of 10 patients with multiple tumor types, nine of whom had progressed on prior anti-PD-1 or PD-L1 therapies were enrolled.

在 1a 期劑量遞增研究中，招募了 23 名患有多種腫瘤類型的患者，沒有觀察到劑量限制性毒性。在 1b 期聯合研究中，共有 10 名患有多種腫瘤類型的患者入組，其中 9 名患者在先前的抗 PD-1 或​​ PD-L1 治療中病情出現進展。

Eight patients were evaluable for tumor growth assessment. And all of these patients had progressed on prior PD-1 or PD-L1 therapies with best responses, including two patients with a partial response in stable disease. Patients remained on study for up to 224 days and, similar to the Phase 1a study, no dose-limiting toxicities were observed.

八名患者可進行腫瘤生長評估。所有這些患者均在先前的 PD-1 或​​ PD-L1 治療中取得了進展，並取得了最佳反應，其中包括兩名在病情穩定時獲得部分反應的患者。患者持續​​研究長達 224 天，與第 1a 期研究類似，未觀察到劑量限制性毒性。

As many of you are aware, interest in anti-TIGIT approaches has been very strong and this is a rapidly evolving landscape in oncology. TIGIT's role in tumor immunosurveillance is analogous to the PD-1/PD-L1 axis in tumor immunosuppression. Based on preclinical studies, both TIGIT and PD-L1 are upregulated in a variety of different cancers.

正如你們許多人所知，人們對抗 TIGIT 方法的興趣非常濃厚，這是腫瘤學領域快速發展的領域。 TIGIT 在腫瘤免疫監視中的作用類似於腫瘤免疫抑制中的 PD-1/PD-L1 軸。根據臨床前研究，TIGIT 和 PD-L1 在多種不同癌症中均上調。

Data show that combination therapy using anti-TIGIT and PD-L1 or PD-1 antibodies conferred greater responses than anti-PD-L1 or PD-1 treatment alone, implying a synergistic mechanism following interruption of these two inhibitory checkpoints. Our Phase 1b/2 will be a combination of etigilimab with an anti-PD-1 in a range of tumor types in 75 to 100 patients, and this will include a cohort of rare tumor types.

數據顯示，使用抗TIGIT 和PD-L1 或PD-1 抗體的聯合治療比單獨使用抗PD-L1 或PD-1 治療具有更好的反應，這意味著這兩個抑制性檢查點中斷後存在協同機制。我們的 1b/2 期試驗將在 75 至 100 名患者的一系列腫瘤類型中聯合使用 etigilimab 和抗 PD-1，其中包括一組罕見的腫瘤類型。

Initiation of this study remains on track for the fourth quarter, and we plan to host a webinar teach-in in the fourth quarter to share more details about our program and the Phase 1/2 combination study design. Assuming this study initiates as planned in the fourth quarter, we expect to be in a position to report the first clinical data starting mid-2021. We're very enthusiastic about the potential for this program.

這項研究的啟動仍將在第四季度按計劃進行，我們計劃在第四季度舉辦一次網路研討會，以分享有關我們的專案和 1/2 期組合研究設計的更多細節。假設這項研究按計畫在第四季度啟動，我們預計能夠從 2021 年中期開始報告第一份臨床數據。我們對該計劃的潛力充滿熱情。

I'd like to now turn to our rare disease portfolio, which includes setrusumab for the treatment of Osteogenesis imperfecta, or OI, as well as alvelestat for the treatment of severe alpha-1 antitrypsin deficiency and other potential indications including COVID-19 respiratory disease.

我現在想談談我們的罕見疾病產品組合，其中包括用於治療成骨不全症(OI) 的setrusumab，以及用於治療嚴重α-1 抗胰蛋白酶缺乏症和其他潛在適應症（包括COVID-19呼吸道疾病）的avelestat 。

Before I spend a few minutes discussing these programs in greater detail, I also wanted to note that our product portfolio includes leflutrozole, for hypogonadotropic hypogonadism as well as acumapimod for acute exacerbations of COPD or AECOPD. As many of you know, we have previously generated positive Phase 2 data in both of these indications and partnering discussions for leflutrozole and acumapimod are well underway.

在我花幾分鐘更詳細地討論這些計劃之前，我還想指出，我們的產品組合包括用於治療低促性腺激素性性腺功能減退症的來氟曲唑，以及用於治療COPD 或AECOPD 急性加重的acumapimod。正如你們許多人所知，我們之前已經在這兩個適應症中產生了積極的 2 期數據，並且來氟曲唑和 acumapimod 的合作討論正在順利進行中。

Turning to our rare disease portfolio, in late 2019, we announced positive top line results from the Phase 2b ASTEROID study with setrusumab. This was the largest investigational clinical study that has ever been conducted in adult OI patients in the US and EU.

談到我們的罕見疾病產品組合，2019 年末，我們宣布了 setrusumab 的 2b 期 ASTEROID 研究取得了積極的頂線結果。這是迄今為止在美國和歐盟針對成人成骨不全患者進行的最大規模的研究性臨床研究。

As a reminder, setrusumab is a human monoclonal antibody targeting sclerostin. We believe this mechanism is particularly well-suited to treat OI because, unlike other agents which are either anabolic or antiresorptive, setrusumab has been demonstrated to be a strong bone building agent that also reduces the resorption of bone, creating a dual action anabolic effect to build overall bone density. The Phase 2b ASTEROID study demonstrated a very clear dose-dependent bone-building effect of setrusumab.

提醒一下，setrusumab 是一種針對硬化蛋白的人類單株抗體。我們相信這種機制特別適合治療成骨不全，因為與其他合成代謝或抗骨吸收藥物不同，setrusumab 已被證明是一種強效的骨構建劑，還能減少骨吸收，產生雙重作用的合成代謝效應建立整體骨密度。 2b 期 ASTEROID 研究證明了 setrusumab 具有非常明顯的劑量依賴性造骨作用。

There are currently no FDA or EMA approved therapies for OI. Osteogenesis imperfecta is particularly devastating for children and their families and has a significant impact on the quality of life for adult patients who can also fracture frequently and then very often suffer chronic pain. In recognition of this unmet need, setrusumab has received prime designation by the European Medicines Agency and has also been granted orphan drug status by both the EMA and the FDA.

目前尚無 FDA 或 EMA 核准的成骨不全療法。成骨不全症對於兒童及其家庭來說尤其具有破壞性，並且對成年患者的生活品質有重大影響，他們也可能經常骨折，然後經常遭受慢性疼痛。認識到這一未滿足的需求，setrusumab 已獲得歐洲藥品管理局的首要指定，並被 EMA 和 FDA 授予孤兒藥物地位。

Just last week, we announced that setrusumab received Rare Pediatric Disease Designation from the FDA. We believe this further highlights the significant unmet medical need facing children with OI and underscores the potential of setrusumab to become the first approved treatment option specifically for these patients.

就在上週，我們宣布 setrusumab 獲得 FDA 的罕見兒科疾病認定。我們相信，這進一步凸顯了成骨不全兒童面臨的重大未滿足的醫療需求，並強調了 setrusumab 成為第一個專門針對這些患者的批准治療選擇的潛力。

With the receipt of rare disease pediatric designation, we may also be eligible to receive a priority review voucher from the FDA. Following our regulatory discussions earlier this year. We're also pleased that both the FDA and EMA have agreed on the principles of the design of a single Phase 3 pivotal pediatric study in OI.

在獲得罕見疾病兒科指定後，我們也可能有資格獲得 FDA 的優先審查券。繼我們今年早些時候的監管討論之後。我們也很高興 FDA 和 EMA 就 OI 單一 3 期關鍵兒科研究的設計原則達成協議。

We believe there's a clear path forward for setrusumab in OI under continuing discussions with potential partners prior to the initiation of the Phase 3 study consistent with our strategy. These potential partnerships include a range of different structures with Mereo retaining commercial rights in certain regions. We very much look forward to updating you on these discussions in due course.

我們相信，在啟動符合我們策略的 3 期研究之前，透過與潛在合作夥伴的持續討論，setrusumab 治療成骨不全症有一條明確的前進道路。這些潛在的合作夥伴關係包括一系列不同的結構，Mereo 保留在某些地區的商業權利。我們非常期待在適當的時候向您通報這些討論的最新情況。

Turning to alvelestat, we're pleased to have resumed enrollment in our ongoing Phase 2 proof-of-concept study in patients with severe alpha-1 antitrypsin deficiency lung disease, following a pause due to COVID-19 earlier in the year. Top-line data from the study now remains on track for the second half of next year 2021.

談到 avelestat，我們很高興在今年稍早因 COVID-19 暫停後，我們正在進行的針對嚴重 α-1 抗胰蛋白酶缺乏性肺病患者的 2 期概念驗證研究已恢復入組。該研究的主要數據目前仍在 2021 年下半年發布。

Alvelestat is a small molecule that inhibits neutrophil elastase. Neutrophil elastase is an enzyme that attacks and progressively damages lung tissue. AATD patients either lack the protective alpha-1 antitrypsin protein or produce a small amount of abnormal ineffective protein that cannot reach the lung and fails to block neutrophil elastase from tissue destruction. Such patients suffer progressive lung deterioration, leading to cough, wheeze, COPD-like symptoms and ultimately reliance on respiratory support. Some patients actually go on to receive lung transplants.

Alvelestat 是一種抑制嗜中性球彈性蛋白酶的小分子。嗜中性球彈性蛋白酶是一種攻擊並逐漸損害肺組織的酵素。 AATD 患者要麼缺乏保護性 α-1 抗胰蛋白酶蛋白，要麼產生少量異常無效蛋白，這些蛋白無法到達肺部並且無法阻止嗜中性球彈性蛋白酶免遭組織破壞。此類患者的肺部逐漸惡化，導致咳嗽、喘息、慢性阻塞性肺病樣症狀，最終依賴呼吸支持。有些患者實際上繼續接受肺移植。

The primary endpoint for our 12-week proof-of-concept study is based on the biomarker, desmosine, which is a breakdown product of elastin, the target of neutrophil elastase. If the results demonstrate a positive impact on the blockade of neutrophil elastase, we intend to seek regulatory guidance in both the EU and the US on the design of a pivotal trial in both territories and to commence this as soon as possible thereafter. The only approved therapy for AATD. is plasma derived protein. However, this is not reimbursed and not available for use in all territories.

我們為期 12 週的概念驗證研究的主要終點是基於生物標記鎖鏈素，它是中性粒細胞彈性蛋白酶的標靶彈性蛋白的分解產物。如果結果顯示對嗜中性球彈性蛋白酶的封鎖有正面影響，我們打算就在這兩個地區設計一項關鍵試驗尋求歐盟和美國的監管指導，並在此後儘快開始這項試驗。唯一核准的 AATD 療法。是血漿來源的蛋白質。但是，此費用不予報銷，且並非在所有地區均可使用。

In August, we also announced the initiation of a Phase 1b/2 placebo-controlled study to evaluate the safety and efficacy of alvelestat in hospitalized adult patients with moderate to severe COVID respiratory disease. This is due to the underlying mechanism of alvelestat and we believe there's a rationale for blocking neutrophil elastase in these patients.

8 月，我們也宣布啟動一項 1b/2 期安慰劑對照研究，以評估 avelestat 對患有中度至重度新冠呼吸道疾病的住院成人患者的安全性和有效性。這是由於 avelestat 的潛在機制所致，我們相信在這些患者中阻斷嗜中性球彈性蛋白酶是有道理的。

This trial is led by Dr. Michael Wells and will be conducted at the University of Alabama. Approximately 15 patients will be randomized to receive either alvelestat plus standard of care or placebo plus standard of care for 10 days. The primary endpoint is safety and tolerability of alvelestat at day 10 with a safety follow up to day 90. Additional endpoints include blood biomarkers and oxygen deficit at day 10.

該試驗由邁克爾威爾斯博士領導，將在阿拉巴馬大學進行。大約 15 名患者將被隨機分配接受 avelestat 加標準護理或安慰劑加標準護理 10 天。主要終點是第 10 天時 avelestat 的安全性和耐受性，並進行安全性追蹤至第 90 天。

The trial will also assess clinical outcomes, including effect of disease progression measured by the need for respiratory support and disease severity, using the WHO nine-point ordinal score at day 29. We look forward to working closely with our colleagues at University of Alabama to investigate alvelestat in this patient population and to complete this study as rapidly as possible to help with the ongoing effort to solve the global COVID-19 crisis.

該試驗還將評估臨床結果，包括使用第29 天的世界衛生組織九分制評分來衡量疾病進展的影響，透過呼吸支持的需要和疾病嚴重程度來衡量。合作，調查該患者群體中的 alvelestat 並儘快完成這項研究，以幫助持續努力解決全球 COVID-19 危機。

In addition, as part of our broader development plans for alvelestat, we're continuing to support certain investigator-led studies, including the ATALANTa study into AATD, led by Mark Dransfield and his team, which is financially supported by an NCATS grant, and also a study into bronchiolitis obliterans or BOS, associated with graft versus host disease in patients receiving hematopoietic stem cell transplantation, which is led by Steve Pavletic at the NIH.

此外，作為我們更廣泛的avelestat 開發計劃的一部分，我們將繼續支持某些由研究者主導的研究，包括由Mark Dransfield 及其團隊領導的ATALANTa 對AATD 的研究，該研究得到了NCATS 撥款的資助，並且還有一項針對閉塞性細支氣管炎（BOS）的研究，該研究與接受造血幹細胞移植的患者的移植物抗宿主疾病相關，該研究由 NIH 的 Steve Pavletic 領導。

BOS is an orphan disease characterized by inflammatory obstruction of the lung's tiniest airways and is the primary cause of death in patients who receive lung transplant. We're excited about the potential broad utilization of alvelestat and look forward to reporting data from these studies.

BOS 是一種罕見疾病，其特徵是肺部最微小氣道的發炎性阻塞，是接受肺移植的患者死亡的主要原因。我們對 avelestat 的潛在廣泛應用感到興奮，並期待報告這些研究的數據。

Before I turn the call over to Mike to review the financials, I also want to acknowledge the appointments of Dr. Brian Schwartz, former Chief Medical Officer of ArQule; and Dr. Jeremy Bender, former Vice President of Corporate Development at Gilead Sciences and recently appointed CEO of Day One Biopharmaceuticals, to our Board of Directors.

在我打電話給 Mike 審查財務狀況之前，我還要感謝 ArQule 前首席醫療官 Brian Schwartz 博士的任命；吉利德科學公司 (Gilead Sciences) 前企業發展副總裁、最近被任命為 Day One Biopharmaceuticals 執行長的傑里米·本德 (Jeremy Bender) 博士加入了我們的董事會。

Brian and Jeremy are industry veterans with deep experience in clinical and corporate development, specifically within oncology and rare diseases. Their collective skill sets will be a real asset to Mereo, as we continue to advance our programs and our business strategy. I'll now turn the call over to Mike.

Brian 和 Jeremy 是業界資深人士，在臨床和企業發展方面擁有豐富的經驗，特別是在腫瘤學和罕見疾病領域。隨著我們繼續推進我們的計劃和業務策略，他們的集體技能將成為 Mereo 的真正資產。我現在將電話轉給麥克。

Thank you, Denise, and good morning, everyone. I'd like to spend a few minutes giving an overview of the finances for the period. During the past six months, ending on June 30, 2020, our R&D expenditures fell by GBP3.4 million from the prior year to GBP8.5 million in total. During this year, we continued our development in our two rare disease assets, setrusumab and alvelestat, with expenditures for the adult Phase 2b study in setrusumab and the proof-of-concept study Phase 2 in alvelestat.

謝謝你，丹尼斯，大家早安。我想花幾分鐘概述一下這段時期的財務狀況。截至 2020 年 6 月 30 日的過去六個月中，我們的研發支出總計 850 萬英鎊，較前一年減少 340 萬英鎊。今年，我們繼續開發兩種罕見疾病資產 setrusumab 和 avelestat，並支出了 setrusumab 的成人 2b 期研究和 avelestat 的概念驗證研究 2 期。

In the same period of last year, our R&D expenses focused on setrusumab, again in the adult Phase 2B study, as well as the completion of the Phase 2 studies in our specialty products, acumapimod and leflutrozole. Again, in the period, our administrative expenses increased by GBP1.3 million to GBP8.2 million from the GBP6.9 million in 2019.

去年同期，我們的研發費用主要集中在setrusumab，再次進行成人2B期研究，以及完成我們的特色產品acumapimod和leflutrozole的2期研究。同樣，在此期間，我們的管理費用從 2019 年的 690 萬英鎊增加到 820 萬英鎊，增加了 130 萬英鎊。

This increase was predominantly caused by the one-off legal and professional fees, which increased by about GBP900,000. Our underlying administrative expenses without these one-offs were GBP4.9 million compared to the GBP5.3 million in 2019. So basically, there were no changes in our administrative expenses.

這一增長主要是由一次性法律和專業費用造成的，增加了約 90 萬英鎊。剔除這些一次性費用後，我們的基本管理費用為 490 萬英鎊，而 2019 年為 530 萬英鎊。

With regard to our cash, we started the year with GBP16.3 million in cash and short-term deposits. And as Denise mentioned, on June 4, 2020, the company announced the completion of a GBP56 million or $70 million fundraising. Net of transaction costs, this amount was GBP51.4 million or $64.2 million. After the expenditures in the first half of the year, we ended the period with cash and short-term deposits of GBP56.8 million.

關於我們的現金，年初我們擁有 1,630 萬英鎊現金和短期存款。正如丹尼斯所提到的，2020 年 6 月 4 日，該公司宣布完成 5,600 萬英鎊或 7,000 萬美元的融資。扣除交易成本後，這筆金額為 5,140 萬英鎊或 6,420 萬美元。扣除上半年支出後，期末我們的現金和短期存款為 5,680 萬英鎊。

Now, given our cash position at the end of the year and our current forecast, we are now well funded into 2022. This provides the company with sufficient runway to deliver both on our clinical programs as well as deliver on our business development milestones.

現在，考慮到我們年底的現金狀況和目前的預測，我們現在有充足的資金進入 2022 年。

Now I'd like to turn it back over to the operator so we can take any questions.

現在我想將其轉回給接線員，以便我們可以回答任何問題。

(Operator Instructions) Joseph Schwartz, SVB Leerink.

（操作員說明）Joseph Schwartz，SVB Leerink。

Hi, thanks so much, and congrats on all the progress. Couple questions on alvelestat. I was wondering in terms of the COVID work, how should -- what's the timeframe that we should think about when that data might become available? That's the first question.

您好，非常感謝，並祝賀所有的進展。關於 avelestat 的幾個問題。我想知道就新冠病毒工作而言，我們應該如何考慮這些數據何時可用？這是第一個問題。

And then in alpha-1 antitrypsin, I was wondering what change in desmosine or isodesmosine are you hoping to see in that Phase 3 trial? And then where would alvelestat fit into the treatment landscape as it currently exists, as well as how it's evolving with some potential new treatment modality?

然後在 α-1 抗胰蛋白酶中，我想知道您希望在 3 期試驗中看到鎖鏈素或異鎖鏈素有何變化？那麼，alvelestat 將在目前的治療領域中發揮怎樣的作用，以及它如何隨著一些潛在的新療法而發展？

Okay. So, in terms of -- thanks, Joe, and thanks for your comments and your questions, great to hear you. So, in terms of the alvelestat data in our COVID study, we expect to be reporting that midyear, probably sometime in the second quarter is our current expectation.

好的。所以，謝謝喬，感謝您的評論和問題，很高興聽到您的聲音。因此，就我們的新冠肺炎研究中的 avelestat 數據而言，我們預計將在年中（可能是第二季的某個時間）報告我們目前的預期。

Great, thank you.

太好了謝謝。

And then --.

進而 - 。

And then in terms of the core work for alvelestat, just yeah, I think you got the question, but if you need, I can reprise it.

然後就 avelestat 的核心工作而言，是的，我認為您已經提出了這個問題，但如果您需要，我可以重複。

Oh no, it's fine, I got it. Thank you. So, in terms of the desmosine, so the study is powered to show a 6% or greater change in the levels of desmosine. And why did we choose that? Well, we chose that because that's correlated back to changes in lung density via CT scan data, so that's why we chose that level.

哦，不，沒關係，我明白了。謝謝。因此，就鎖鏈素而言，該研究有力地證明了鎖鏈素水平發生了 6% 或更大的變化。我們為什麼選擇這個？嗯，我們選擇這個水平是因為它通過 CT 掃描數據與肺密度的變化有關，所以這就是我們選擇這個水平的原因。

In terms of the treatment landscape, so a couple of points there, obviously our study is alvelestat as a monotherapy. I mentioned the NCAT study, and with that study we are now going on top, in fact, of Alpha-1 antitrypsin therapy. It's believed that the Alpha-1 Antitrypsin therapy is being given at lower therapeutic levels than the patients could actually benefit from. So, we are actually doing study looking at alvelestat on top of Alpha-1.

就治療前景而言，有幾點，顯然我們的研究是將阿維司他作為單一療法。我提到了 NCAT 研究，事實上，透過該研究，我們現在正在繼續進行 Alpha-1 抗胰蛋白酶治療。據信，Alpha-1 抗胰蛋白酶治療的治療水平低於患者實際受益的水平。所以，我們實際上正在研究 Alpha-1 之上的 avelestat。

In terms of the recent developments across the landscape, clearly the likes of Arrowhead, those are looking at the -- clearly at the liver disease, and we're very focused on the lung disease. So, we think those sit alongside each other.

就整個領域的最新發展而言，顯然像 Arrowhead 這樣的公司正在關注——顯然是肝臟疾病，而我們非常關注肺部疾病。所以，我們認為它們是並排的。

Okay, that makes sense. Thanks for taking my question.

好吧，這是有道理的。感謝您提出我的問題。

Okay.

好的。

Thank you. Ladies and gentlemen, I'm showing no further questions. This concludes today's call. You may now disconnect.

謝謝。女士們先生們，我不會再問任何問題了。今天的電話會議到此結束。您現在可以斷開連線。