KALA BIO Inc (KALA) 2022 Q2 法說會逐字稿

Good day. My name is Shantel, and I will be your conference operator today. At this time, I would like to welcome everyone to the Kala Pharmaceuticals Second Quarter 2022 Financial Results Conference Call. As a reminder, today's conference call is being recorded. (Operator Instructions). Hannah Deresiewicz from Stern Investor Relations. You may begin your conference.

大家好。我是 Shantel，今天將擔任本次電話會議的接線生。現在，我謹代表 Kala Pharmaceuticals 歡迎各位參加 2022 年第二季財務業績電話會議。請注意，本次電話會議正在錄音。 （接線生提示）我是 Stern Investor Relations 的 Hannah Deresiewicz。您可以開始會議了。

Thank you, operator, and thank you all for participating in today's call. Joining me from the company are Mark Iwicki, Chairman and Chief Executive Officer; Kim Brazzell, Head of R&D and Chief Medical Officer; and Mary Reumuth, Chief Financial Officer. Darius Kharabi, our Chief Business Officer, will also be joining us for the Q&A portion of today's call.

謝謝接線員，也謝謝各位參加今天的電話會議。公司方面，與我一同參加會議的有：董事長兼執行長馬克‧伊維基 (Mark Iwicki)；研發主管兼首席醫療官金‧布拉澤爾 (Kim Brazzell)；以及財務長瑪麗‧雷穆斯 (Mary Reumuth)。首席商務官達裡烏斯·哈拉比 (Darius Kharabi) 也將參加今天的問答環節。

During this call, we will be referring to non-GAAP financial measures, which are not prepared in accordance with generally accepted accounting principles. A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measures is available in our press release issued today, which can also be found on our website.

在本次電話會議中，我們將提及非公認會計準則（非GAAP）財務指標，這些指標並非依照公認會計準則編製。非GAAP財務指標與最直接可比較的GAAP指標的調節表已在今天發布的新聞稿中提供，您也可以訪問我們的網站查看該新聞稿。

On this call, we will make certain comments about Kala's future expectations, plans and prospects that are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements will include statements regarding the development program and market potential of KPI-012, planned production and operating expenses and the sufficiency of our cash resources.

在本次電話會議上，我們將就 Kala 的未來預期、計畫和前景發表一些評論，這些評論屬於 1995 年《私人證券訴訟改革法案》所界定的前瞻性陳述。這些陳述將包括有關 KPI-012 的開發計劃和市場潛力、計劃的生產和運營費用以及我們現金資源的充足性的陳述。

These and other forward-looking statements are based on the beliefs and expectations of management as of this conference call. Our actual results may differ materially from our expectations. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances that occur after this conference call, except as required by law.

這些以及其他前瞻性陳述均基於管理階層截至本次電話會議時的信念和預期。我們的實際業績可能與預期有重大差異。除法律要求外，本公司不承擔任何義務對本次電話會議後發生的事件或情況進行修訂或更新任何前瞻性陳述。

Investors should carefully read the risks and uncertainties described in today's press release as well as the risk factors, which identify specific factors that may cause actual results or events to differ materially from those described in our forward-looking statements included in the company's quarterly report on Form 10-Q and other filings we make with the SEC.

投資者應仔細閱讀今天新聞稿中描述的風險和不確定性以及風險因素，這些風險因素列出了可能導致實際結果或事件與公司季度報告（10-Q 表格）以及我們向美國證券交易委員會提交的其他文件中所包含的前瞻性聲明中描述的結果或事件存在重大差異的具體因素。

I will now turn the call over to Kala's CEO, Mark Iwicki.

現在我將把電話轉交給 Kala 的執行長 Mark Iwicki。

Thanks, Hannah, and thank you, everyone, for joining us this morning. We are entering the second half of 2022 focused on transitioning from a commercial stage company back to our roots as an R&D organization with our efforts targeted on developing novel medicines that can improve the care and treatment of serious eye diseases.

謝謝漢娜，也謝謝各位今天早上的參與。我們即將進入2022年下半年，重點在於從商業化公司轉型，回歸研發機構的初心，致力於開發能改善嚴重眼疾照護和治療的新型藥物。

In July, we completed the sale of EYSUVIS and INVELTYS and transitioned all responsibilities for the global commercialization of both assets to Alcon Inc. This was an important transaction for Kala and more importantly, for the patients and health care providers we aim to help.

7 月，我們完成了 EYSUVIS 和 INVELTYS 的出售，並將這兩項資產的全球商業化所有責任移交給了愛爾康公司。這對 Kala 來說是一項重要的交易，更重要的是，對我們旨在幫助的患者和醫療保健提供者也是如此。

Kala made meaningful progress in launching these products in the United States, including building awareness among health care professionals and securing strong payer coverage. We believe Alcon is particularly well suited to expand the reach of both medicines. Alcon has decades of experience delivering market-leading vision care products around the world and benefits from robust franchises in dry eye disease and surgical care, including long-standing relationships with the eye care professionals and patients EYSUVIS and INVELTYS are targeted to. We are excited about the Alcon transaction and look forward to seeing many more patients benefit as a result of their efforts.

Kala 在美國成功推出了這些產品，包括提升了醫療保健專業人員的認知度，並獲得了強有力的醫療覆蓋範圍。我們相信，Alcon 尤其適合擴大這兩種藥物的覆蓋範圍。 Alcon 擁有數十年的經驗，在全球範圍內提供市場領先的視力保健產品，並在乾眼症和手術治療領域擁有強大的業務基礎，包括與 EYSUVIS 和 INVELTYS 的目標客戶——眼科專業人員和患者——建立的長期合作關係。我們對此次 Alcon 收購案感到非常興奮，並期待看到更多患者因他們的努力而受益。

With EYSUVIS and INVELTYS in Alcon's hands, we've turned our focus to our mesenchymal stem cell secretome platform, which we are evaluating for the treatment of multiple rare diseases of the front and back of the eye. As Kim will describe shortly, we are on track to initiate a Phase II/III clinical trial of KPI-012 for the treatment of persistent corneal epithelial defect in the fourth quarter of this year. And we anticipate expanding development of KPI-012 into 2 additional indications, partial limbal stem cell deficiency and Sjogren's disease. Together, these rare diseases affect nearly 300,000 people in the United States alone, resulting in significant morbidity, including potential loss of vision. These indications represent large markets, for which there are currently no approved prescription treatments and provide ample opportunity for us to positively impact the treatment of patients in need.

隨著 EYSUVIS 和 INVELTYS 的上市，我們已將重心轉向間質幹細胞分泌組平台，並正在評估其治療多種罕見眼部疾病（包括前眼部和後眼部疾病）的潛力。正如 Kim 稍後將要介紹的，我們正按計劃於今年第四季啟動 KPI-012 治療持續性角膜上皮缺損的 II/III 期臨床試驗。此外，我們計劃將 KPI-012 的研發拓展至另外兩種適應症：部分角膜緣幹細胞缺乏症和乾燥症候群。光是在美國，這兩種罕見疾病就影響著近 30 萬人，導致嚴重的併發症，甚至可能造成視力喪失。這些適應症代表著龐大的市場，目前尚無核准的處方藥，這為我們提供了充分的機會，能夠為亟需治療的患者帶來正面的影響。

R&D is at the core of who we are as a company, and our team is eager to leverage our development expertise to advance KPI-012 through the clinic and to further develop our secretome platform. Importantly, we also have the means to invest substantially in these efforts. At the close of the transaction, we received $65 million from Alcon, which included an upfront cash payment of $60 million plus an additional $5 million for the purchase of inventory. And going forward, we are eligible to receive up to $325 million in commercial-based milestone payments. We believe our existing cash resources and recent reductions in operating expenses will allow us to fund our operations beyond the data readout from the planned Phase II/III trial of KPI-012 in PCED.

研發是我們公司的核心所在，我們的團隊渴望利用自身的研發專長，推動KPI-012的臨床試驗，並進一步開發我們的分泌組平台。更重要的是，我們有足夠的資金投入這些研發工作。交易完成後，我們從愛爾康公司獲得了6500萬美元，其中包括6000萬美元的預付款以及用於購買庫存的500萬美元。此外，我們還有資格獲得高達3.25億美元的商業里程碑付款。我們相信，現有的現金儲備以及近期營運費用的削減，將使我們能夠在KPI-012治療PCED的II/III期臨床試驗數據公佈後，繼續為後續營運提供資金支持。

Now I'd like to turn the call over to Kim to discuss our pipeline programs.

現在我想把電話交給 Kim，讓她來討論我們的管道項目。

Thank you, Mark. I'm happy to share our progress with the KPI-012 program and additional work we're doing with our mesenchymal stem cell secretome platform. As Mark mentioned, we're on track to file an IND for KPI-012 and to initiate a Phase II/III clinical trial in persistent corneal epithelial defect patients in the fourth quarter of this year.

謝謝馬克。我很高興與大家分享KPI-012計畫的進展，以及我們在間質幹細胞分泌組平台方面進行的其他工作。如馬克所提到的，我們正按計畫推進KPI-012的IND申請，並計畫於今年第四季啟動持續性角膜上皮缺損患者的II/III期臨床試驗。

We've also made significant progress towards identifying additional front-of-the-eye indications that are currently evaluating potential KPI-012 for the treatment of partial limbal stem cell deficiency and the ocular manifestations of moderate-to-severe Sjogren's, both of which are areas of significant unmet medical need. In addition, we're also exploring some exciting retinal applications for the secretome program.

我們在識別其他眼部適應症方面也取得了顯著進展，目前正在評估KPI-012治療部分角膜緣幹細胞缺乏症和中重度乾燥綜合徵眼部表現的潛力，這兩個領域都存在著巨大的未滿足醫療需求。此外，我們也正在探索分泌組學計畫在視網膜方面的一些令人振奮的應用。

As we've discussed previously, KPI-012 is an application of our novel technology utilizing secretome harvested from human bone marrow-derived mesenchymal stem cell. The secretome approach allows us to produce a cell-free therapy comprised of the [essential] biomolecule secreted by the mesenchymal stem cell, including growth factors, protease inhibitors, matrix proteins and neurotrophic factors with the potential for multiple therapeutic applications.

正如我們之前討論過的，KPI-012 是我們利用從人類骨髓間質幹細胞中提取的分泌組技術的一種應用。這種分泌組方法使我們能夠生產一種無細胞療法，該療法包含間質幹細胞分泌的[必需]生物分子，包括生長因子、蛋白酶抑制劑、基質蛋白和神經營養因子，具有多種治療應用潛力。

Because our approach is cell-free, allows for many of the same benefits as more traditional cell therapy without the need for the administration of intact cells, which we believe will avoid many of the safety and logistics concerns associated with current cell therapy approaches. We are initially advancing KPI-012 for the treatment of persistent corneal epithelial defect, or PCED, which is defined as a nonhealing corneal wound or defect that is refractory to conventional treatments.

由於我們的方法無需使用細胞，因此無需輸注完整細胞即可獲得與傳統細胞療法相同的諸多益處，我們相信這將避免目前細胞療法中存在的許多安全性和後勤方面的問題。我們目前正在推進KPI-012的研發，用於治療持續性角膜上皮缺損（PCED）。 PCED是指對常規治療無效的難癒合角膜傷口或缺損。

PCED is a disease of impaired corneal healing that can be the result of numerous underlying etiologies, including, but not limited to, neurotrophic keratitis, infectious keratitis, surgical or nonsurgical trauma and severe ocular surface disease of various causes. Corneal healing is a highly regulated multifactorial process that involves numerous biological pathways and molecules. And we believe that effective treatment of PCED across its various etiologies require a multifactorial mechanism of action, such as that of KPI-012, to address the impaired healing that is the hallmark of the disease.

PCED是一種角膜癒合障礙性疾病，其病因多種多樣，包括但不限於神經營養性角膜炎、感染性角膜炎、手術或非手術創傷以及各種原因引起的嚴重眼表疾病。角膜癒合是一個高度調控的多因素過程，涉及許多生物路徑和分子。我們認為，針對各種病因引起的PCED，需要採用多因子作用機制，例如KPI-012的作用機制，以解決此疾病的標誌性特徵－角膜癒合障礙。

PCED affects an estimated 100,000 patients each year in the U.S., and we believe it represents a potential market opportunity in excess of $1 billion. There is 1 approved therapy in the PCED space, OXERVATE, which has only been shown to be effective for the treatment of neurotrophic keratitis, which is estimated to be the underlying etiology for only 1/3 of all PCED cases. This therapy is quite burdensome for the patients. It is dosed 6 times a day at 2-hour intervals for 8 weeks and requires a multistep reconstitution process prior to each dose.

在美國，每年約有10萬名患者受多發性角膜內皮營養不良症（PCED）的影響，我們認為這代表著超過10億美元的潛在市場機會。目前，PCED領域僅有一種核准療法－奧施康定（OXERVATE），但該藥僅被證實對治療神經營養性角膜炎有效，而據估計，神經營養性角膜炎僅佔所有PCED病例的三分之一。這種療法對患者來說負擔相當重。它需要每天服用6次，每次間隔2小時，療程為8週，並且每次服用前都需要進行多步驟的配製。

We believe there is a clear unmet need for a new therapy that can provide benefit for all the various etiologies of PCED and improve the vision and quality of life of all PCED patients. As we have shared previously, the initial clinical trial conducted with KPI-012 in PCED patients of various etiologies demonstrated benefit in all 8 evaluable PCED patients with complete healing of the PCED lesion in 6 of 8 of these patients. KPI-012 was well tolerated in the trial with no significant safety issues.

我們認為，目前迫切需要一種新的療法，能夠惠及所有病因引起的先天性角膜內皮營養不良（PCED）患者，並改善所有PCED患者的視力和生活品質。如我們先前所述，針對不同病因的PCED患者進行的KPI-012初步臨床試驗顯示，所有8例可評估的PCED患者均獲益，其中6例患者的PCED病灶完全癒合。試驗中KPI-012耐受性良好，未出現顯著的安全性問題。

Pending FDA clearance of our planned IND, we plan to initiate a Phase III trial in PCED patients in the fourth quarter of 2022, which, if positive, could serve as one of the 2 required pivotal trials necessary for FDA approval. We expect top line results from this Phase II/III trial in the first quarter of 2024.

待FDA批准我們的IND申請後，我們計畫於2022年第四季啟動針對PCED患者的III期臨床試驗。如果結果積極，該試驗可作為FDA批准所需的兩項關鍵性試驗之一。我們預計將於2024年第一季獲得此II/III期臨床試驗的主要結果。

Based on the compelling mechanism of action and numerous interactions with key opinion leaders, we're also evaluating the potential of KPI-012 for the treatment of partial limbal stem cell deficiency or partial LSCD, as we call it, and for the ocular manifestations of moderate-to-severe Sjogren's.

基於其令人信服的作用機制以及與關鍵意見領袖的多次互動，我們也在評估 KPI-012 治療部分角膜緣幹細胞缺乏症（我們稱之為部分 LSCD）以及中重度乾燥綜合徵眼部表現的潛力。

Limbal stem cell deficiency is an ocular surface disease, characterized by the loss or deficiency of stem cells in the junction of the cornea and limbus, where they play an essential role in the generation and repopulation of corneal epithelial cells. When the limbal stem cell population is reduced or depleted, the ability of the corneal epithelium to prepare and renew itself is compromised, which can result in recurrent epithelial breakdown, neovascularization, conjunctival overgrowth and other sequelae that can lead to loss of corneal clarity and vision impairment as well as significant pain and diminished quality of life.

角膜緣幹細胞缺乏症是一種眼表疾病，其特徵是角膜與角膜緣交界處的幹細胞流失或不足。這些幹細胞在角膜上皮細胞的生成和再生中起著至關重要的作用。當角膜緣幹細胞數量減少或耗竭時，角膜上皮的自我修復和更新能力受損，這可能導致上皮反覆破損、新生血管形成、結膜增生以及其他後遺症，最終導致角膜透明度下降、視力障礙，並伴有明顯的疼痛和生活品質下降。

There are currently no approved pharmaceutical products for the treatment of LSCD. Approximately 70% of LSCD patients or about 70,000 patients in the U.S. have partial LSCD, meaning they have some level of remaining stem cells, but still suffer significant pathology and symptomatology. We believe these patients would be appropriate candidates for KPI-012 to maintain the integrity of the ocular surface and avoid the vision impairment and pain associated with the disease.

目前尚無核准的藥物用於治療LSCD。在美國，約有70%的LSCD患者（約7萬名患者）患有部分性LSCD，這意味著他們體內仍殘留一定量的幹細胞，但仍飽受嚴重的病理改變和症狀困擾。我們認為，這些患者適合接受KPI-012治療，以維持眼表完整性，避免疾病相關的視力障礙和疼痛。

In addition to the effects of KPI-012 on corneal healing observed in both animal models and in PCED patients in the previous trial, the stat on the literature that suggests that MSC secretomes could also restore the limbal stem cell niche, which would be a significant benefit in both partial and complete LSCD.

除了在動物模型和先前試驗中觀察到的 KPI-012 對角膜癒合的影響外，文獻統計數據表明 MSC 分泌組還可以恢復角膜緣幹細胞微環境，這對部分和完全性 LSCD 都將有顯著益處。

The other ocular surface indication of interest is Sjogren's, a chronic multisystem autoimmune disease, characterized by insufficient fluid production in certain glands of the body, leading to substantial dryness, primarily of the eyes and of the mouth. Approximately 90% of Sjogren's patients suffer from ocular manifestations and experience significant ocular symptoms, which [often impacts] patients' daily life and productivity. And as a result, the quality of life in Sjogren's patients can be significantly diminished.

另一個值得關注的眼表疾病是乾燥綜合徵，這是一種慢性多系統自體免疫疾病，其特徵是體內某些腺體分泌液體不足，導致嚴重的干燥，主要表現為眼睛和口腔乾燥。約90%的乾燥症患者會出現眼部表現，並經歷明顯的眼部症狀，這往往會影響患者的日常生活和工作效率。因此，乾燥症患者的生活品質會顯著下降。

Despite current treatments, many Sjogren's patients do not achieve significant improvement in their ocular symptoms. There's a significant unmet need for new therapies that can provide meaningful improvement in the ocular symptoms, visual impair and quality of life to the approximately 50% of Sjogren's patients or roughly 95,000 people in the U.S. who suffer with moderate-to-severe disease.

儘管目前已有多種治療方法，但許多乾燥症患者的眼部症狀並未顯著改善。大約50%的乾燥症患者（在美國約有95,000人）患有中重度乾燥綜合徵，因此迫切需要新的療法來切實改善他們的眼部症狀、視力障礙和生活品質。

We estimate that partial limbal stem cell deficiency and the ocular manifestations of moderate-to-severe Sjogren's together represent a total potential market opportunity of between $1.5 billion and $2 billion in the United States alone.

我們估計，光是在美國，部分角膜緣幹細胞缺乏症和中重度乾燥症的眼部表現加起來，就代表著15億至20億美元的潛在市場機會。

Finally, as we mentioned earlier, we also believe our secretome platform has potential utility for retinal degenerative diseases, such as retinitis pigmentosa and Stargardt disease. We plan to initiate preclinical trials evaluating the utility of our secretome platform for retinal degenerative diseases in the coming months with the goal of selecting a retinal indication for further development in the second half of 2023.

最後，正如我們之前提到的，我們也相信我們的分泌組平台在視網膜色素變性和斯塔加特病等視網膜退化性疾病方面具有潛在應用價值。我們計劃在未來幾個月內啟動臨床前試驗，評估我們的分泌組平台在視網膜退化性疾病的應用價值，目標是在2023年下半年選定一種視網膜適應症進行進一步開發。

Taken together, we believe our efforts with KPI-012 and our secretome platform provide ample opportunity to improve the treatment of a number of severe ocular surface diseases that impact thousands of patients around the world. We look forward to providing additional updates as we initiate our Phase II/III clinical trial in PCED planned for later this year and to potentially expand our efforts into additional indications in 2023.

我們相信，KPI-012及其分泌組平台為我們提供了充足的機會，可以改善多種嚴重眼表疾病的治療，這些疾病影響著全球成千上萬的患者。我們期待在今年稍後啟動針對PCED的II/III期臨床試驗，並於2023年將研究拓展至其他適應症，屆時我們將提供更多最新進展。

Now I'd like to pass the call to Mary to go over our financial results.

現在我想把電話轉給瑪麗，讓她來介紹一下我們的財務表現。

Thanks, Kim. During this discussion of our financial results, I will reference certain non-GAAP financial measures. These non-GAAP financial measures exclude stock-based compensation, noncash interest, depreciation and amortization, loss on extinguishment of debt, transaction costs related to the Alcon transaction and gain or loss on fair value measurements of deferred purchase consideration and contingent consideration. For a full reconciliation of our GAAP to non-GAAP financial measures, please refer to today's press release, which is available on our website.

謝謝，Kim。在討論我們的財務表現時，我將提及一些非公認會計準則（非GAAP）財務指標。這些非GAAP財務指標不包括股權激勵費用、非現金利息、折舊和攤銷、債務清償損失、與Alcon交易相關的交易成本以及遞延購買對價和或有對價的公允價值計量損益。如需查看我們GAAP與非GAAP財務指標的完整調節表，請參閱我們網站上發布的今日新聞稿。

Turning to a recap of the second quarter. Our cash position as of June 30, 2022 was $44.6 million compared to $92.1 million as of December 31, 2021. This decrease primarily reflects cash used in operations. Our cash position as of June 30 does not include the net proceeds received in early July in connection with the closing of the Alcon transaction. We anticipate that our cash resources, together with the net payments received from Alcon and planned reductions in operating expenses, will enable us to fund operations into the second quarter of 2024.

接下來回顧一下第二季的情況。截至2022年6月30日，我們的現金餘額為4,460萬美元，而截至2021年12月31日為9,210萬美元。這一減少主要反映了營運活動中使用的現金。截至6月30日的現金餘額不包括7月初因完成對愛爾康（Alcon）的交易而收到的淨收益。我們預計，我們的現金資源，加上從愛爾康收到的淨款項以及計劃中的營運費用削減，將使我們能夠維持營運至2024年第二季。

Over the course of the year, we have been working to reduce our operating expenses and extend our cash runway. Following the closing of the Alcon transaction, we have streamlined our corporate infrastructure and planned to reduce our non-GAAP operating expenses by more than 50% as compared to our non-GAAP total operating expenses for the first half of the year and by 60% to 70% for the full year 2023 compared to our non-GAAP total operating expenses for the full year 2021.

今年以來，我們一直致力於降低營運成本，延長現金流。在完成愛爾康的交易後，我們精簡了公司架構，並計劃將2023年上半年的非GAAP營運成本較上半年降低50%以上，將2023年全年的非GAAP營運成本較2021年全年降低60%至70%。

SG&A expenses were $22.7 million for the second quarter of 2022 compared to $27 million for the first quarter of 2022, primarily reflecting reductions in employee-related spending. Non-GAAP SG&A expenses were $20.4 million for the second quarter of 2022 compared to $24.7 million for the first quarter of 2022. R&D expenses were $4.5 million for the second quarter of 2022, which was consistent with the first quarter of 2022 and includes expenses related to the development of KPI-012.

2022年第二季銷售、管理及行政費用為2,270萬美元，而2022年第一季為2,700萬美元，主要反映了員工相關支出的減少。 2022年第二季非GAAP銷售、管理及行政費用為2,040萬美元，而2022年第一季為2,470萬美元。 2022年第二季研發費用為450萬美元，與2022年第一季持平，其中包括與KPI-012開發相關的費用。

That concludes our prepared remarks for today. I will now pass the call over to the operator for questions.

今天的發言到此結束。現在我將把電話交給接線員，回答大家的問題。

(Operator Instructions) Our first question comes from Yi Chen with H.C. Wainwright.

（操作說明）我們的第一個問題來自 H.C. Wainwright 的 Yi Chen。

Congratulations on all the progress. I'm [Tate], on behalf of Yi Chen. First on your pipeline progress, where are you with those 2 programs, LSCD and Sjogren's preclinically? Do you -- are you still waiting on some preclinical data before pushing in through to the clinic?

祝賀你們取得的所有進展。我是[Tate]，代表Yi Chen。首先，關於你們的研發管線進展，你們的LSCD和乾燥症這兩個計畫目前處於臨床前階段嗎？你們是否還在等待一些臨床前數據，然後再推進到臨床試驗階段？

And the second question I have is on KPI-012. I'm pretty sure you must have commented on this previously, but do you need to see some data from your Phase II/III study before you start thinking about the other pivotal study that is required for the eventual approval?

我的第二個問題是關於KPI-012的。我確信您之前肯定已經評論過這個問題，但是您是否需要看到一些來自二/三期研究的數據，才能開始考慮最終獲批所需的其他關鍵性研究？

And lastly, if you could comment on your cash runway and when you would potentially need to raise further funds, that would be helpful.

最後，如果您能談談您的現金儲備以及何時可能需要籌集更多資金，那就太好了。

This is Kim Brazzell. I'll comment on your first couple of questions. With regard to your second question, we certainly will be doing preparations prior to the top line data readout. But we will need the results from that readout to finalize the second pivotal Phase III trial around dose and duration of dosing and so forth.

我是金·布拉澤爾。我先回答您提出的前兩個問題。關於您的第二個問題，我們當然會在公佈主要數據之前做好準備。但我們需要這些結果來最終確定第二個關鍵性III期臨床試驗的劑量、給藥持續時間等參數。

With the other 2 indications, we're still doing analysis of the development pathways going forward and are looking into clinical designs for the protocol. So we're still a bit of a way off from being able to go in the clinic. One of the advantages of these 2 indications is that we can utilize the CMC and the clinical supplies that we are developing for the PCED program. So we won't have to do additional CMC work, and we'll be able to move into the clinic without having to do additional work on the product itself.

另外兩項適應症，我們仍在分析未來的研發路徑，並研究對應的臨床方案設計。因此，距離進入臨床試驗階段還有一段路要走。這兩項適應症的優點之一在於，我們可以利用正在為PCED計畫開發的CMC（化學、製造和控制）以及臨床用藥。如此一來，我們就無需進行額外的CMC工作，也無需對產品本身進行額外的研發，即可直接進入臨床試驗階段。

And I think there was a question on runway for Mark or for Mary.

我認為當時有人問馬克還是瑪麗會走上T台。

Sure. I can take the cash runway question. So we said that our cash resources, together with the net proceeds that we received from Alcon, would last us until the second quarter of 2024. That gets us beyond the data readout from our KPI-012 Phase II/III trial.

當然可以。我可以回答關於現金流的問題。我們之前說過，我們的現金儲備，加上從愛爾康公司獲得的淨收益，足夠我們維持到2024年第二季。這足以讓我們撐到KPI-012二/三期臨床試驗數據公佈之後。

(Operator Instructions) We have reached the end of the question-and-answer session. I'll now turn the call back over to Mark for closing remarks.

（操作員指示）問答環節到此結束。現在我將把電話轉回給馬克，請他作總結發言。

Well, thank you, everyone, for joining us today, and we look forward to continuing to update you as we make progress during the year. Have a great day.

感謝各位今天蒞臨，我們期待在今年持續向大家報告最新進展。祝大家今天愉快。

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

今天的電話會議到此結束。您可以掛斷電話了。