MediciNova Inc (MNOV) 2011 Q4 法說會逐字稿

Welcome, everyone. I would now like to hand the conference over to Mr. Mark Johnson, Director of Investor Relations and Corporate Development.

歡迎各位。現在我想把本次電話會議交給投資人關係與企業發展總監 Mark Johnson 先生。

Thank you, everyone, for calling in today. On the call we have five members from MediciNova executive management -- Dr. Yuichi Iwaki, the President and Chief Executive Officer; Michael Coffee, the Chief Business Officer; Dr. Kirk Johnson, the Chief Scientific Officer; Dr. Kazuko Matsuda, the Chief Medical Officer; and Michael Gennaro, the Chief Financial Officer. The executive team will provide an update business presentation followed by a Q&A.

感謝各位今天來電參與。本次電話會議有 MediciNova 執行管理團隊五位成員出席——總裁兼執行長 Yuichi Iwaki 醫師；首席商務長 Michael Coffee；首席科學長 Kirk Johnson 醫師；首席醫療長 Kazuko Matsuda 醫師；以及首席財務長 Michael Gennaro。管理團隊將先進行業務更新簡報，隨後進入問答環節。

Please note the following Safe Harbor statement. Statements in this call that are not historical in nature constitute forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding our progress and expectations on future progress in the development of our drug candidates, expected timing of clinical trials' results, and any implication as to the results of our development, partnering, and funding efforts of the Company that will have the ability to execute on its priorities. These forward-looking statements may be preceded by, followed by, or otherwise include the words believes, expects, anticipates, intends, estimates, projects, can, could, may, will, would, or similar expressions.

請注意以下「安全港」聲明。本次電話會議中非屬歷史事實之陳述，依 1995 年《私人證券訴訟改革法》之安全港條款，構成前瞻性陳述。此等前瞻性陳述包括但不限於：我們在藥物候選產品開發上的進展與對未來進展的預期、臨床試驗結果的預期時程，以及任何關於本公司開發、合作夥伴關係與募資努力之結果的暗示，這些結果將影響公司執行其優先事項的能力。此等前瞻性陳述之前、之後或以其他方式可能包含 believes、expects、anticipates、intends、estimates、projects、can、could、may、will、would 或類似用語。

These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks and uncertainties inherent in clinical trials, including the unknown outcome of the Phase 2 trial of MN-221 for the treatment of acute exacerbations of asthma; product development and commercialization risks; the uncertainty of whether the results of the clinical trials will be predictive of results in later stage of product development; the risks of delays or failure to obtain and maintain regulatory approval; risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights; the risks of failure of third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected; the risk of increased costs and delays due to delays in the commencement, enrollment, completion, or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, costs, and design of future clinical trials and research activities; the timing of expected filings with the regulatory authorities; risks relating to the completion of the joint venture in China; MediciNova's collaborations with third parties; the availability of funds to complete product development plans; and MediciNova's ability to raise sufficient capital when needed; and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission including its annual report, Form 10-K, for the year ended December 31, 2011, and its subsequent periodic reports on Forms 10-Q and 8-K.

此等前瞻性陳述涉及多項風險與不確定性，可能導致實際結果或事件與該等前瞻性陳述所明示或暗示者有重大差異。可能導致實際結果或事件與此等前瞻性陳述所明示或暗示者有重大差異之因素包括但不限於：臨床試驗固有之風險與不確定性（包括用於治療氣喘急性惡化之 MN-221 第 2 期試驗之未知結果）；產品開發與商業化風險；臨床試驗結果是否可預測產品開發後期結果之不確定性；取得並維持監管核准之延遲或失敗風險；產品候選之智慧財產權風險及防禦與執行該等智慧財產權之能力；MediciNova 所倚賴之第三方在執行臨床試驗及製造產品候選時未能如預期履行之風險；因臨床試驗啟動、收案、完成或分析延遲，或臨床試驗設計充分性或執行方面之重大問題，而導致成本增加與延宕之風險，以及未來臨床試驗與研究活動之時程、成本與設計；預期向監管機關申報之時點；與在中國完成合資企業相關之風險；MediciNova 與第三方之合作；完成產品開發計畫所需資金之可得性；以及 MediciNova 在需要時籌措足夠資本之能力；以及 MediciNova 向美國證券交易委員會（SEC）提交之文件中所述之其他風險與不確定性，包括截至 2011 年 12 月 31 日止年度之年報 Form 10-K，以及其後續定期報告 Form 10-Q 與 8-K。

Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

不應過度依賴此等前瞻性陳述，該等陳述僅截至本聲明日期為準。MediciNova 不承擔亦無意修訂或更新此等前瞻性陳述之任何意圖或義務。

And now, a brief commentary from Dr. Yuichi Iwaki, President and CEO of MediciNova.

接下來，請 MediciNova 總裁兼執行長Yuichi Iwaki 醫師做簡短評論。

Thank you, Mark, and everyone, for joining the call. 2011 and the beginning of 2012 has been an exciting time for MediciNova and we are pleased to discuss our most important accomplishments, including completion of the enrollment in MN-221-CL-007 clinical trial; commencement of enrollment in our MN-221-CL-012 clinical trial; continued progress with the ibudilast program and its patent portfolio.

謝謝你，Mark，也感謝各位參與本次電話會議。2011 年以及 2012 年初對 MediciNova 而言是令人振奮的時期，我們很高興與各位討論我們最重要的成果，包括：完成 MN-221-CL-007 臨床試驗的收案；啟動 MN-221-CL-012 臨床試驗的收案；以及 ibudilast 計畫及其專利組合的持續進展。

To provide more detail, Mike Coffee, Chief Business Officer of MediciNova, will now deliver a brief business presentation.

為提供更多細節，MediciNova 首席商務長 Mike Coffee 現在將進行簡短的業務簡報。

Thank you, Yui. Our goal today is to review our fourth-quarter and year-end 2011 financial results; to discuss our recent developments; to summarize our upcoming milestones; to review our current financial status and provide conference call participants with an opportunity to ask questions. Let's start with our fourth-quarter and year-end 2011 financial results. To present, I would like to introduce Michael Gennaro, MediciNova's Chief Financial Officer.

謝謝你，Yui。我們今天的目標是回顧 2011 年第四季與全年財務結果；討論近期進展；總結即將到來的里程碑；檢視目前的財務狀況，並提供電話會議與會者提問的機會。我們先從 2011 年第四季與全年財務結果開始。接下來我想介紹 MediciNova 首席財務長 Michael Gennaro 進行說明。

Thanks, Mike. For the quarter ended December 31, 2011, MediciNova reported a net loss of $3.5 million or $0.22 per share; and for the year ended December 31, 2011, MediciNova reported a net loss of $17.7 million or $1.20 per share.

謝謝你，Mike。截至 2011 年 12 月 31 日止季度，MediciNova 報告淨損 350 萬美元，或每股 0.22 美元；截至 2011 年 12 月 31 日止年度，MediciNova 報告淨損 1,770 萬美元，或每股 1.20 美元。

Research and development expenses were $1.4 million for the fourth quarter and $7.8 million for the year. General and administrative expenses were $2.1 million for the quarter and $8.3 million for the year.

研發費用第四季為 140 萬美元，全年為 780 萬美元。一般及行政費用該季度為 210 萬美元，全年為 830 萬美元。

At December 31, 2011, we had $15.1 million of cash and cash equivalents. We believe, given our current run rate, that MediciNova has sufficient capital to continue operations into the second quarter of 2013.

截至 2011 年 12 月 31 日，我們持有現金及約當現金 1,510 萬美元。我們相信，以目前的資金消耗速度（run rate）來看，MediciNova 擁有足夠資本可將營運延續至 2013 年第二季。

The capital on hand will be used for funding development for the study closing and the subsequent data analysis of MN-221-CL-007 trial, as well as for the ongoing MN-221-CL-012 clinical trial, and for ongoing general and administrative expenses. If you have any further questions on our financials, I will be available to answer any questions.

現有資金將用於資助 MN-221-CL-007 試驗的研究結案及後續資料分析，以及正在進行的 MN-221-CL-012 臨床試驗，並用於持續的一般及行政費用。若各位對我們的財務還有任何進一步問題，我也會在此回答。

And now I will turn it back to Mike Coffee to continue with the business presentation.

現在我把時間交還給 Mike Coffee，繼續業務簡報。

Thanks, Mike. Let's start with a trial update for the MN-221-CL-007 trial. MediciNova recently announced we have completed enrollment in our Phase 2 clinical trial, evaluating the efficacy and safety of MN-221 for treatment of acute exacerbations of asthma for patients who do not respond to standard pharmacotherapy. We are currently in the process of auditing and organizing the data and preparing to lock the database for a complete analysis. We anticipate releasing study results in the second quarter of 2012.

謝謝你，Mike。我們先從 MN-221-CL-007 試驗的最新進度開始。MediciNova 近期宣布，我們已完成第 2 期臨床試驗的收案，該試驗評估 MN-221 用於治療對標準藥物治療無反應之患者的氣喘急性惡化之療效與安全性。我們目前正在稽核並整理資料，並準備鎖定資料庫以進行完整分析。我們預期於 2012 年第二季公布研究結果。

Now as you may recall, MN-221-CL-007 trial is a randomized, double-blind, placebo-controlled Phase 2 clinical trial. The trial enrolled a total of 176 patients and was conducted at around 20 sites in the United States.

如各位所記得，MN-221-CL-007 試驗為隨機、雙盲、安慰劑對照的第 2 期臨床試驗。該試驗共收納 176 名患者，並在美國約 20 個試驗中心進行。

Once a patient received the initial standardized care treatment regimen -- and this is consistent with the National Asthma Education and Prevention Program and Global Initiative of Asthma guidelines -- the patient was assessed for response to that treatment. If the patient's forced expiratory volume in 1 second, or FEV1, was less than or equal to 50% of the predicted FEV1 and the patient met all other study entry criteria, the patient was randomized to receive either MN-221 or placebo while continuing to receive standardized care as needed. The primary efficacy endpoint is improvement in FEV1. A number of secondary endpoints, including reduction in hospital admissions and various clinical significances, will be examined.

當患者接受初始的標準化照護治療方案——且此方案符合「國家氣喘教育與預防計畫」以及「全球氣喘倡議」（GINA）指引——之後，會評估患者對該治療的反應。若患者第一秒用力呼氣量（FEV1）小於或等於預測 FEV1 的 50%，且符合所有其他入組標準，則患者會被隨機分派接受 MN-221 或安慰劑，同時視需要持續接受標準化照護。主要療效終點為 FEV1 的改善。將檢視多項次要終點，包括住院率降低及各種臨床意義指標。

Now, next let me update on the MN-221-CL-012 trial. MediciNova has commenced enrollment of a Phase 1b/2a clinical trial with MN-221 in patients with stable, moderate to severe chronic obstructive pulmonary disease, COPD, involving multiple administrations of intravenous MN-221 over several days in typical patients with concomitant illnesses.

現在，接下來讓我更新 MN-221-CL-012 試驗的進展。MediciNova 已開始招募一項在病情穩定、屬中度至重度慢性阻塞性肺病（COPD）患者中進行的 MN-221 第 1b/2a 期臨床試驗；該試驗在具有合併疾病的典型患者中，於數天內多次靜脈注射給予 MN-221。

This trial has implications not only for testing the safety and efficacy of MN-221 in COPD patients, but the results from this trial will have significant utility in the ongoing MN-221 acute asthma program, including two important areas. One, it will provide safety data for repeat doses of MN-221; and second, it will allow expanded safety profile for use of MN-221 in patients with comorbidities and concomitant medications.

此試驗的意義不僅在於檢驗 MN-221 在 COPD 患者中的安全性與有效性，其結果也將對正在進行的 MN-221 急性氣喘計畫具有重大用途，包含兩個重要面向。第一，它將提供 MN-221 重複給藥的安全性資料；第二，它將使 MN-221 在具有共病與併用藥物患者中的使用安全性概況得以擴充。

We believe this data can help us in our discussions with the FDA and allow us to expand our inclusion/exclusion criterion for a Phase 3 development program for MN-221 in acute asthma. If you have further questions on the COPD trial, Dr. Kazuko Matsuda, our Chief Medical Officer, is on the line to answer those questions.

我們相信這些資料可協助我們與 FDA 討論，並使我們得以擴大 MN-221 用於急性氣喘之第 3 期開發計畫的納入／排除標準。若您對 COPD 試驗有進一步問題，我們的首席醫學官 Kazuko Matsuda 醫師在線上可回答相關問題。

Now let me provide an ibudilast update. MediciNova is very encouraged with the progress made on ibudilast these past 12 months. Collaborative trial planning with drug addiction investigators at organizations like Columbia and New York State's Psychiatric Institute and UCLA has led to the National Institute of Drug Abuse supported clinical investigations with ibudilast for both opioid and methamphetamine addiction. In addition, an investigator-sponsored trial in chronic medication overuse headache pain is also ongoing in Australia.

現在讓我提供 ibudilast 的最新進展。MediciNova 對過去 12 個月 ibudilast 所取得的進展感到非常振奮。與哥倫比亞大學、紐約州精神醫學研究所及 UCLA 等機構的藥物成癮研究人員共同規劃試驗，促成了由美國國家藥物濫用研究所（NIDA）支持、以 ibudilast 針對鴉片類與甲基安非他命成癮的臨床研究。此外，在澳洲亦有一項研究者發起的試驗正在進行，針對慢性藥物過度使用性頭痛疼痛。

MediciNova continues exploring collaborations to advance ibudilast into Phase 2 proof-of-concept clinical development for progressive multiple sclerosis and/or neuropathic pain. The progressive MS development opportunity has recently been advanced and is validated by MediciNova's receipt of a method-of-use patent in progressive MS, which extends our expected patent exclusivity out to 2029. If you have further questions on the ibudilast program, we have Dr. Kirk Johnson, our Science Chief Scientific Officer, on the line to answer those questions.

MediciNova 持續探索合作，以推進 ibudilast 進入針對進行性多發性硬化症（progressive MS）及／或神經病理性疼痛的第 2 期概念驗證（proof-of-concept）臨床開發。進行性 MS 的開發機會近期已向前推進，並因 MediciNova 取得一項進行性 MS 的用途方法（method-of-use）專利而獲得驗證，該專利將我們預期的專利排他期延長至 2029 年。若您對 ibudilast 計畫有進一步問題，我們的科學長（Chief Scientific Officer）Kirk Johnson 醫師在線上可回答相關問題。

So with that, let me turn this back to Mark to open it up for questions and answers. Mark?

那麼，接下來我把時間交回給 Mark，開放問答。Mark？

Thank you, Mike. Please take this opportunity to ask management any questions you might have. And if you have any further questions after the call, please feel free to reach out to us at any time. Keisha?

謝謝你，Mike。請把握這個機會向管理團隊提出任何問題。如果在電話會議後您還有任何進一步問題，也歡迎隨時與我們聯繫。Keisha？

(Operator Instructions) Matt Kaplan, Ladenburg Thalmann.

(接線員指示) Matt Kaplan，Ladenburg Thalmann。

Hi, this is Matt Kaplan. Can you hear me, guys?

嗨，我是 Matt Kaplan。各位聽得到我嗎？

Yes, we can, Matt.

是的，Matt，我們聽得到。

Great. Thanks for doing the call today and congrats on the progress you've made, and especially the recent completion of enrollment in the 007 study. Can you give us a little bit more clarity or detail in terms of the process you are going through right now? You alluded to that in your prepared remarks.

太好了。感謝今天召開電話會議，也恭喜你們取得的進展，尤其是近期完成 007 研究的受試者招募。你們能否就目前正在進行的流程提供更清楚或更詳細的說明？你們在事先準備的發言中有提到一些。

And a little bit more detail in terms of potential timing and when we should expect the data to be announced from the study.

另外也請更詳細說明可能的時程，以及我們應該何時預期該研究的數據會對外公布。

Matt -- go ahead; I would like -- Dr. Matsuda, would you like to talk about that?

Matt——你先請；我想——Matsuda 醫師，妳願意談談這部分嗎？

Hi, this is Kazuko. Right now, so what we are doing is we are in the process of data locking. Usually it takes four to six weeks, and we are working so hard to make the data clean and available as possible.

嗨，我是 Kazuko。目前我們正在進行資料鎖定（data lock）的流程。通常需要四到六週，我們正非常努力，讓資料盡可能乾淨且可用。

Right now, our CRO said the target time of data lock is early May, but they are working so hard, so it could be happen end of April. So that is our timing for the data locking, and we are going to start analysis of the data from there.

目前我們的 CRO 表示資料鎖定的目標時間是 5 月上旬，但他們也非常努力，因此也可能在 4 月底完成。這就是我們資料鎖定的時程，之後我們將從那時開始進行資料分析。

With that analysis process, do you think that would give you the opportunity to potentially announce data by May, or what is your thoughts right now?

依照這個分析流程，你認為是否有機會在 5 月就公布數據？或者你目前的想法是什麼？

Yes, so we are planning to announce the data end of May, that is our planning.

是的，我們計畫在 5 月底公布數據，這是我們的規劃。

Okay. As a follow-up to that question, primary endpoint is FEV1, change in FEV1 over I guess -- AEC over 3 hours.

好的。作為追問，主要終點是 FEV1，也就是我想——在 3 小時內 AEC 的 FEV1 變化。

That's right, yes. From baseline to 3 hours; yes, that's correct.

沒錯，是的。從基線到 3 小時；是的，正確。

What should we -- what do you expect to see in that in terms of, I guess, the absolute numerical change? What would be exciting to you to see?

就這個指標而言，我們應該——你預期會看到什麼樣的絕對數值變化？看到什麼會讓你覺得令人振奮？

So as you know, this trial is placebo-controlled. However, the patient continues to receive standard care, which is albuterol and anti-cholinergic inhaler as needed. So actually we are comparing MN-221 there to the standard of care.

如你所知，這項試驗是安慰劑對照。不過，患者仍會持續接受標準治療，也就是按需使用沙丁胺醇（albuterol）與抗膽鹼吸入劑。因此實際上我們是在將 MN-221 與標準治療進行比較。

So we expect the placebo group who are going to receive standard of care also have some improvement of FEV1 because they are receiving albuterol and anti-cholinergic. So we are expecting about 5% of improvement compared to placebo group, which we believe is clinically important improvement compared to placebo.

因此我們預期接受標準治療的安慰劑組，其 FEV1 也會有一些改善，因為他們正在使用沙丁胺醇與抗膽鹼藥物。所以我們預期相較於安慰劑組約有 5% 的改善，我們認為相較於安慰劑，這是具臨床重要性的改善幅度。

Okay, great. Thank you. Then in terms of the secondary endpoints, what should we be looking for as you announce those?

好的，很棒。謝謝。那麼就次要終點而言，你們公布時我們應該關注哪些指標？

Right. We'd like to see some clinical impact from the improvement of respiratory status, so we are looking for admission rates and also hospital stay period, how long patients stay in the hospital, that kind of stuff. Also we also are looking for the respiratory rate change, accessory muscle use, and also supplemental oxygen use, that kind of clinical sign of asthma.

好的。我們希望從呼吸狀態改善中看到一些臨床影響，因此我們會觀察住院收治率，以及住院天數，也就是患者在醫院停留多久等。另外我們也會觀察呼吸頻率變化、輔助呼吸肌使用情況，以及補充氧氣使用等，這類氣喘的臨床徵象。

Great. Thank you. I guess, could you give us an update with respect to I guess the ongoing COPD study as well? Where you are with that?

很好。謝謝。另外，你能否也就正在進行的 COPD 研究提供最新進展？目前進度如何？

Yes, we started enrollment, enrolled patients in units. So we are expecting to have 20-patient enrollment, so it is not going to be a big trial. And we already started enrollment this month, so hopefully we have results by summer of this year.

是的，我們已開始招募，並在各單位收案。我們預計招募 20 名患者，因此不會是一個大型試驗。我們本月已開始收案，因此希望在今年夏天前取得結果。

Okay. Is this more of a safety study in terms of looking at multiple doses? Is that what you are looking for primarily? Or are you also looking at FEV as your primary endpoint here?

好的。這是否主要是一項安全性研究，用來觀察多次給藥的情況？這是你們主要想看的嗎？還是你們也會以 FEV 作為此處的主要終點？

Right, primary evaluation is safety and tolerability of MN-221 repeat dose for the patients who have COPD with other comorbidity and concomitant meds. But we're also checking FEV1 with spirometry and also checking peak flow with digital peak flow meter. So that is a secondary evaluation, but we're also looking for efficacy of MN-221 repeat dose for the patient with COPD.

沒錯，主要評估是 MN-221 重複給藥在合併其他共病並同時使用其他藥物之 COPD 患者中的安全性與耐受性。但我們也會用肺量計檢測 FEV1，並使用數位尖峰流量計檢測尖峰呼氣流量。因此那是次要評估，但我們也在觀察 MN-221 重複給藥對 COPD 患者的療效。

What is the primary safety parameter that you are looking for?

您主要關注的安全性參數是什麼？

Yes, we like to see MN-221 safe to use with patients who have COPD and other baseline disease, such as diabetes or hypertension or congestive heart failure, which is common disease for the patients older and have long smoking history. So that -- if we have expand the safety profile with this trial, then that is going to make us very -- that actually open up our future trial plan. So that is the reason we are doing this study.

是的，我們希望看到 MN-221 能安全用於同時患有 COPD 與其他基礎疾病的患者，例如糖尿病或高血壓或充血性心衰竭；這些在年長且有長期吸菸史的患者中很常見。所以——如果我們能透過這項試驗擴充安全性概況，那將讓我們非常——那其實會開啟我們未來的試驗規劃。這就是我們進行這項研究的原因。

Okay. Thank you for that detail. And another question I guess, shifting, changing gears a little bit with respect to ibudilast; I guess maybe for Kirk. Where are you in your decision-making process in terms of bringing that product forward in Phase 2 development? You listed a couple indications. And I guess obviously the issuance of the patent, the method-of-use patent for MS, progressive MS, makes it pretty attractive to pursue that. Or what are your thoughts now?

好的。謝謝你提供這些細節。另外一個問題，我想稍微轉換一下話題，關於 ibudilast；我想可能問 Kirk。就把這個產品推進到第二期（Phase 2）開發而言，你們目前的決策流程進展到哪一步？你提到幾個適應症。而且我想很明顯地，MS、進行性 MS 的用途方法專利（method-of-use patent）獲准/核發，讓追求這個方向相當有吸引力。你們現在的想法是什麼？

Yes, hey, Matt. Thanks. All of the clinical therapeutic indication areas that are being worked on or are under development are all now supported well with method-of-use allowed or issued US patents and then patents coming up in other parts of the world as well. So yes, the more recent one with the progressive MS was important to log that in as well. And it is important from an exclusivity standpoint because the composition-of-matter has expired years ago, and it is a new chemical entity in most of the world.

是的，嗨，Matt。謝謝。目前正在推進或處於開發中的所有臨床治療適應症領域，現在都有用途方法已獲准或已核發的美國專利支持，並且在世界其他地區也有專利正在進行中。所以是的，最近那個關於進行性 MS 的專利也很重要，我們也把它納入記錄。從專屬權（exclusivity）的角度來看這也很重要，因為物質組成專利（composition-of-matter）多年前就已到期，而且在世界大多數地區它屬於新的化學實體（NCE）。

So our intention is to focus from the corporate standpoint on particularly the progressive MS at this point in time, although we do have some discussions ongoing in planning around the chronic neuropathic pain as well. So we will continue to nurture in an oversight and drug supply and regulatory support manner for our investigator-initiated and outside-funded trials, and focus on what we believe are the two most optimal commercial paths -- progressive MS and chronic neuropathic pain.

因此，從公司層面來看，我們目前的意圖是特別聚焦在進行性 MS，雖然我們也正在就慢性神經病理性疼痛進行一些討論與規劃。所以我們會持續以監督、藥品供應與法規支援的方式，培育我們由研究者發起（investigator-initiated）且由外部資金支持的試驗，並聚焦在我們認為兩條最理想的商業化路徑——進行性 MS 與慢性神經病理性疼痛。

And with the progressive MS, we may stand in a most differentiated and unique position relative to anything out there competition-wise. So combined with the Phase 2 brain atrophy and neuroprotective benefits observed in our prior large-patient trial in Central and Eastern Europe, we feel that that is most advantageous right now.

而在進行性 MS 方面，相較於市面上任何競爭產品，我們可能處於最具差異化且獨特的位置。再加上我們先前在中東歐進行的大型受試者試驗中，在第二期觀察到的腦萎縮改善與神經保護效益，我們認為目前這是最有利的。

So we are at both, as I think Mike referred to, in discussions and planning for either potential pharma-supported continued development, or independent, and our own sources of funding and consortium-type approaches. So they are both in formulation, and we don't expect to have anything substantial to report for a few months; but perhaps this summer we will be able to provide a little more solid information on that.

因此，我們目前同時在進行——如我想 Mike 提到的——針對可能由藥廠支持的後續開發，或是獨立開發、以我們自有資金來源與聯盟（consortium）式方法推進的討論與規劃。兩者都在形成中，我們預期在接下來幾個月不會有任何重大事項可報告；但也許今年夏天我們能提供更具體一些的資訊。

Okay, fair enough. Very good. Maybe just one more question, going back to 221. I guess, can you give us an update in terms of what is going on with your joint venture in China for 221?

好的，可以理解。很好。也許再問一個問題，回到 221。你能否就你們在中國針對 221 的合資企業目前進展提供更新？

Yes, this is Yuichi Iwaki. The Chinese joint venture is officially initiated, and we are in the process to prepare all the documents to file the IND in China. Hopefully this Chinese joint venture will catch up to the level that we are in the United States, so that when we commence the Phase 3, plus or minus in the timing, that they will [process it by] to some extent.

是的，我是 Yuichi Iwaki。中國的合資企業已正式啟動，我們正在準備所有文件，以便在中國提交 IND。希望這個中國合資企業能追上我們在美國的進度，這樣當我們啟動第三期（Phase 3）時，在時間上可能有些正負差異，他們也能在某種程度上[把流程跑完]。

Will the developments there initially focus on acute asthma as well, or COPD?

那邊的開發一開始也會聚焦在急性氣喘，還是 COPD？

Right now, they are targeting the acute asthma. But we are targeting the COPD, obviously, because the smoking rate there is especially high. And the potential market could have more leaning toward the COPD.

目前他們鎖定的是急性氣喘。但我們顯然鎖定的是 COPD，因為那邊的吸菸率特別高。而潛在市場可能會更偏向 COPD。

Very good. I guess final question, cash and cash burn. I guess, what are your assumptions now? I guess you ended the year with about a little bit more than $15 million in cash.

很好。我想最後一個問題，關於現金與現金消耗。你們現在的假設是什麼？我想你們年底的現金大約是 1,500 萬美元多一點。

Where can that get you? And what is your expected burn for -- give us some guidance in terms of 2012?

這筆錢可以支撐到什麼時候？以及你們預期的消耗——能否就 2012 年提供一些指引？

Hi, Matt. This is Mike Gennaro. We posted an 8-K on the SEC's website this morning related to the Japanese Tanshin that we filed yesterday. There is a statement in there that says anticipated cash burn for the year ended December 31, 2012, is less than $12 million. So think of it as about $1 million a month.

嗨，Matt。我是 Mike Gennaro。我們今天早上在 SEC 網站上發布了一份 8-K，與我們昨天提交的日本 Tanshin 相關。裡面有一段聲明指出，截至 2012 年 12 月 31 日止年度的預期現金消耗低於 1,200 萬美元。所以可以把它想成大約每月 100 萬美元。

Okay. In your numbers for -- can you give us a sense? I haven't really looked closely; I don't know if you broke out your non-cash charges, stock options, 123-R in terms of your -- for the year 2011 and also fourth-quarter, what those were.

好的。在你們的數字裡——你能否讓我們了解一下？我還沒有仔細看；我不確定你們是否把非現金費用、股票選擇權、123-R 等在你們——2011 年全年以及第四季的部分分別列出，那些金額是多少。

Yes, I will tell you what they are. They are in the cash flow statement.

是的，我可以告訴你。它們在現金流量表裡。

But for the quarter we had $3.1 million -- I'm sorry, $440,000 of stock-based compensation; so without that, about $3.1 million of spending, so actual cash spending. Then similarly for the year, we had a little under $1.4 million of stock-based comp. So if you back that out, our operating expense net or excluding stock-based comp was $14.7 million for the year.

但就該季度而言，我們有 310 萬美元——抱歉，是 44 萬美元的以股票為基礎的薪酬；所以扣除那個之後，大約是 310 萬美元的支出，也就是實際的現金支出。同樣地，就全年而言，我們有略低於 140 萬美元的以股票為基礎的薪酬。所以如果把那個扣除，我們全年營業費用淨額，或說不含以股票為基礎的薪酬的營業費用，是 1,470 萬美元。

All right. Thank you very much, guys.

好的。非常感謝，各位。

Ed Arce, MLV & Company.

Ed Arce，MLV & Company。

Hi, guys. Thanks for taking my call. I think Matt covered a lot of the questions that I was interested in asking. But I just wanted to go over the lead compound and program, now that you have got -- you are working on data lock for the CL-007 trial, and you are going to be looking at also reporting results on the Phase 1b trial in COPD likely in the second quarter as well.

嗨，各位。謝謝接聽我的電話。我想 Matt 已經涵蓋了我有興趣問的很多問題。但我想就你們的主導化合物與計畫再確認一下，因為你們目前正在對 CL-007 試驗進行資料鎖定（data lock），而且你們也可能會在第二季公布 COPD 的第一期 b（Phase 1b）試驗結果。

Could you talk about how -- I guess, one, you mentioned how the results of that with regards to repeated administration and medications might feed into your thinking about the results of the asthma trial?

你能談談——我想，第一，你提到關於重複給藥與用藥的結果，可能會如何影響你們對氣喘試驗結果的思考？

Kazuko, do you want to take that?

Kazuko，你想回答這個問題嗎？

Yes, I'm sorry? Can you --?

是的，不好意思？你可以——？

I'm sorry, that was a bit convoluted in the way I asked that. What I guess I am trying to get at is -- assuming that you have got positive data coming out of the asthma trial, the 007 trial, could you give us a little more detail on how the results from the COPD trial would benefit those results in regards to planning for a Phase 3 later on in the year?

抱歉，我剛才提問的方式有點繞。我想問的是——假設你們在氣喘試驗、007 試驗中取得正向數據，你能否再多說明一下，COPD 試驗的結果將如何在規劃今年稍晚的第三期試驗方面，對那些結果帶來助益？

Yes, thank you. Of course it depends on what's the conversation between FDA. However, the reason we are doing actually this [12] study is actually -- you are right, we want to open up more opportunity for Phase 3 trial.

好的，謝謝。當然，這取決於與 FDA 的溝通內容。不過，我們之所以實際上進行這項 [12] 研究——你說得沒錯——是因為我們希望為第三期試驗開啟更多機會。

For example, if we can prove that MN-221 is safe with some -- the patient has other comorbidity and also then concomitant medication, then inclusion criteria/exclusion criteria for Phase 3 will be much more easier. We don't have to exclude patients because the patient has some other underlying disease or taking other medications.

例如，如果我們能證明 MN-221 在患者合併其他共病、且同時使用其他藥物的情況下仍然安全，那麼第三期的納入/排除標準就會容易得多。我們就不必因為患者有其他潛在疾病或正在服用其他藥物而排除他們。

Also, we are going to use -- we are going to compare digital peak flow and spirometry test. If we can see the correlation of digital peak flow result is as good as spirometry test, FEV1, we are planning to talk with FDA that we want to use peak flow instead of spirometry test in emergency room setting in the future trial.

另外，我們將使用——我們將比較數位峰值流量（digital peak flow）與肺量計（spirometry）檢測。如果我們看到數位峰值流量的結果與肺量計檢測（FEV1）一樣好、且具有相關性，我們計畫與 FDA 討論，希望在未來試驗的急診室情境中，以峰值流量取代肺量計檢測。

Because we learned from many PIs, many emergency room doctors, that spirometry is actually not their regular practice. So they don't use spirometry tests to evaluate patients' condition in emergency room for asthma exacerbation or COPD exacerbation, so it is not really practical evaluations for patients.

因為我們從許多主要研究者（PI）與許多急診醫師那裡得知，肺量計其實不是他們的日常作業。因此，他們在急診室評估氣喘惡化或 COPD 惡化患者的狀況時，不會使用肺量計檢測，所以對患者而言並不是很實用的評估方式。

But they use peak flow, and there is advanced technology. We have now digital peak flow which give us more concrete number of the peak flow test. So if we can show that there is a correlation between peak flow test and FEV1 from the 12 study, that will also give us opportunity to talk with FDA that we'd like to use peak flow test instead of FEV1.

但他們會使用峰值流量，而且現在有更先進的技術。我們現在有數位峰值流量，可以提供更具體的峰值流量測試數值。因此，如果我們能從 12 研究顯示峰值流量測試與 FEV1 之間存在相關性，這也會讓我們有機會與 FDA 討論：我們希望用峰值流量測試取代 FEV1。

Also, for the future, if we can make the indication for not necessarily asthma exacerbation or COPD, but we can combine the indication for bronchospasm due to asthma or COPD, then that will also make our Phase 3 trial easier. So that is a plan we -- that is our concept that we started 12 study.

此外，未來如果我們能把適應症不限定於氣喘惡化或 COPD，而是將適應症合併為「因氣喘或 COPD 所致的支氣管痙攣」，那也會讓我們的第三期試驗更容易進行。所以這就是我們——這就是我們啟動 12 研究的計畫與概念。

Okay, great. I know we have touched upon this before, but you're fully intending to proceed when that time comes, assuming it is later in the year sometime, to proceed with the agreed-upon Phase 3 by yourself?

好的，很好。我知道我們之前提過這點，但你們完全打算在時機到來時——假設是今年稍晚——自行推進已同意的第三期試驗嗎？

That's our plan, absolutely. We are poised; we are ready to do that.

這絕對是我們的計畫。我們已就緒；我們準備好這麼做。

Okay. Then, beyond speculating on the date of that, assuming it would be later this year, do you have any sense -- early as it may be yet, before you have even talked to the FDA -- about what kind of a structure that would take? Aside from trying to look at peak flow as the primary endpoint.

好的。那麼，先不推測日期，假設會在今年稍晚，你是否有任何概念——即使現在還很早、甚至你們還沒和 FDA 談過——關於那會採取什麼樣的試驗架構？除了嘗試把峰值流量作為主要終點之外。

Well, we anticipate that -- current trial is focusing the FEV1 improvement as a primary endpoint. But we anticipate that the clinical significance could be the subject of the primary endpoint in the Phase 3 trial, if it happens.

嗯，我們預期——目前的試驗以 FEV1 改善作為主要終點。但我們預期，若第三期試驗成行，臨床意義可能會成為第三期試驗主要終點的主題。

Because historically, we have applied with the 221 trial to the Agency through the respiratory division. However, patients targeting this trial is taken care at the emergency room, not in the clinic, the pulmonary or pulmonologist or that kind of a setting.

因為從歷史上看，我們是透過呼吸科部門向主管機關申請 221 試驗。然而，本試驗鎖定的患者是在急診室接受照護，而不是在門診、肺科或由胸腔科醫師等那類場域照護。

So there is still a lot of [room] for us and for this in the Agency to be fully discussed what could be the primary endpoint. So we don't know exact answer yet. However, it is likely that it's shifting toward the different parameter as a primary endpoint.

因此，對我們以及主管機關而言，仍有很大的[空間]需要充分討論什麼可以作為主要終點。所以我們目前還不知道確切答案。不過，很可能會轉向以不同的參數作為主要終點。

Right. One last question. I think this is the first time I hear of perhaps the idea that you could get a regulatory okay to design the Phase 3 in which it combines both asthma patients and COPD. I am thinking about, if that comes through and you are able to move forward in looking at both patients in a combined Phase 3 patient trial, what kind of patient size do you think that would require?

了解。最後一個問題。我想這是我第一次聽到，也許你們可以獲得監管核准，設計一個把氣喘患者與 COPD 患者合併在一起的第三期試驗。我在想，如果這真的成了、而你們也能推進一個同時納入兩類患者的合併第三期試驗，你認為需要多大的受試者規模？

Together very good questions, but we anticipate that at least -- well, as many as the 1,500 patients need to be exposed to this MN-221. But again, it is an absolute discussion with the Agency. Hopefully less, which would allow us to minimize the Phase 3 trial; but it is very hard to answer that question right now.

這些都是很好的問題，但我們預期至少——嗯，可能需要讓多達 1,500 名患者暴露於 MN-221。但同樣地，這完全需要與主管機關討論。希望能更少，這樣我們就能把第三期試驗規模降到最低；但現在要回答這個問題非常困難。

Sure. Okay. Thank you very much.

當然。好的。非常感謝。

(Operator Instructions) There are no further questions in queue at this time. I would now like to hand the conference back over to Mr. Mark Johnson for any closing remarks.

(接線員指示) 目前佇列中沒有其他問題。現在我想把會議交回給Mark Johnson 先生作結語。

Thank you, Keisha. We hope this call has been helpful to all of you. We truly appreciate all your questions and hope you have answered them appropriately. If you do have further questions, please follow up with us at any time. Thank you, everyone, for your participation today and have a great night.

謝謝你，Keisha。我們希望這通電話對各位都有幫助。我們非常感謝大家的提問，也希望我們已適當地回答了各位的問題。如果你們還有進一步問題，歡迎隨時與我們聯繫。謝謝各位今天的參與，祝各位今晚愉快。

Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect your lines. Good day.

感謝各位參與今天的會議。簡報到此結束。各位現在可以掛線。祝各位日安。